Patent Application 18534109 - METHOD OF PROVIDING BIRTH CONTROL - Rejection

Patent Application 18534109 - METHOD OF PROVIDING BIRTH CONTROL

Title: METHOD OF PROVIDING BIRTH CONTROL

Application Information

• Invention Title: METHOD OF PROVIDING BIRTH CONTROL
• Application Number: 18534109
• Submission Date: 2025-05-13T00:00:00.000Z
• Effective Filing Date: 2023-12-08T00:00:00.000Z
• Filing Date: 2023-12-08T00:00:00.000Z
• Examiner Employee Number: 86478
• Art Unit: 1628
• Tech Center: 1600

Rejection Summary

• 102 Rejections: 0
• 103 Rejections: 2

Cited Patents

No patents were cited in this rejection.

Office Action Text

    DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .

Priority
This application claims the benefit of U.S. Application No. 17/726,305, filed on April 21 2022, abandoned, which claims the benefit of U.S. Application No. 16/830,608, filed on March 3, 2020, abandoned, which claims the benefit of U.S. Application No. 16/265,222, filed on February 01, 2019, now U.S. Patent No. 10,632,066. 

				Claim Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on February 18, 2025. Claims 1-11 are pending and under examination. 

				Action Summary
Claims 1-11 rejected under 35 U.S.C. 103 as being un-patentable over Saleh (US5,972,372) in view of Simmons, Contraception 97 (2018) 270–276, published in October 30, 2017, are withdrawn. 
Claims 1-11 rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,632,066, are withdrawn. 
Claims 1-11 rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,940,157 in view of Saleh (US5,972,372), are withdrawn.
Claims 1-11 rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,825,882 in view of Saleh (US5,972,372), are withdrawn. It is noted 10,825,882 is a typo. The correct patent number is 10/925,882. 
Claims 1-11 rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,850,251, are withdrawn. 
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-36 of copending Application No. 17520323 (reference application), are maintained. 

Affidavit
The Declaration by under 37 CFR 1.132 filed Bruce Variano is insufficient to overcome the rejection of claims 1-11. Acknowledgement is made of the receipt of the Declaration/Affidavit filed on February 18, 2025.  
The Declarant argues that the Differences Between the Claimed Contraceptive Ring and the Rings Disclosed in Saleh Impact the Performance and Functionality of the Claimed Contraceptive Ring. These differences impact the claimed ring system’s drug-release profiles and, importantly, improve the reproducibility of that drug release. These features, which are currently claimed and not disclosed or contemplated by Saleh, include:   
 
  a. a ring body that comprises a silicone elastomer having a platinum concentration of approximately 3 ppm to approximately 10 ppm and a hydride to vinyl ratio from approximately 1:1 to approximately 1.3:1 before curing;   
  b. a first cylindrical core that comprises a first and second condensation-cure silicone elastomers, dibutyltin dilaurate, and a viscosity agent;   
  c. a second cylindrical core that comprises a third condensation-cure silicone    elastomer (wherein the second and third condensation-cure silicone elastomers    are optionally the same) and dibutyltin dilaurate;   
  d. a ring system wherein no more than approximately 10% to approximately 20% of the ethinyl estradiol undergoes hydrosilylation with unreacted hydrosilane in the ring body after approximately 18 months of storage at 25 °C and 60% relative humidity; and   
  e. defined Cmax ranges for ethinyl estradiol and segesterone acetate, after 21 days, in each of a first, third, and thirteenth “product-use cycles.” A product-use cycle    is a 28-day period that includes a 21-day “first period,” during which the ring    system is present in a female’s vagina, and a 7-day “second period,” during    which the ring system is safely stored while the female menstruates.   
 In response, the Examiner finds the Declarant’s argument not persuasive. It is noted that the features upon which applicant relies (i.e., a platinum concentration of approximately 3 ppm to approximately 10 ppm and a hydride to vinyl ratio from approximately 1:1 to approximately 1.3:1 before curing; a first cylindrical core that comprises a first and second condensation-cure silicone elastomers, dibutyltin dilaurate, and a viscosity agent; a second cylindrical core that comprises a third condensation-cure silicone    elastomer (wherein the second and third condensation-cure silicone elastomers    are optionally the same) and dibutyltin dilaurate; and no more than approximately 10% to approximately 20% of the ethinyl estradiol undergoes hydrosilylation with unreacted hydrosilane in the ring body after approximately 18 months of storage at 25 °C and 60% relative humidity are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).

The Declarant argues that as described in the present application, the reusable vaginal ring system comprises a “ring body” and two “cores.” Each core is loaded with certain amounts of one or both of ethinyl estradiol and segesterone acetate. As soon as the cores are inserted into the ring body, the drugs begin to diffuse out of the cores. And because the ring system is not immediately inserted into a woman’s vagina, drug builds up in the ring body, as both active agents transition from high concentration environments (the cores), to a low concentration environment (the ring body). The longer the delay between production and first use, the more drug will be present in the ring body when the reusable vaginal ring system 1s inserted into a woman’s vagina. Upon first use, excess drug present in the ring body migrates out of the ring body and into the woman’s circulation, creating a “burst effect.” While a controlled initial burst effect is necessary, if the system is designed improperly, the initial burst effect can result in too much drug being absorbed by the body in a short period of time. This can lead to undesirable side effects such as such as nausea and vomiting. For a product designed to be reused over thirteen product-use cycles, the burst-effect phenomenon presents additional challenges because it must be accounted for at each initial insertion of the reusable system during each of the thirteen 21-day first periods. It must be accounted for because neither ethinyl estradiol nor segesterone acetate stops migrating out of the cores into the ring body during each of the thirteen 7-day “out” periods. During these 7-day “out” periods, drug once again builds up in the ring body, such that there is another burst of drug delivered when the woman reinserts the system. Failing to control how much drug is provided in each burst can cause serious side effects and/or lead to too little drug being available during later product-use cycles, such that the overall efficacy of the system is impacted. Saleh recognized this “burst effect” phenomenon and sought to control it by inserting the cores into the ring body just before patient use, stating in Col. 6, Il. 22-29, that “[i]n preferred embodiments, the core is positioned in the channel no later than about 4 days prior to use, more preferably within about 24 hours prior to use, and most preferably substantially immediately prior to use. In some unusual situations, however, core insertion may be conducted even more than one week prior to administration of the vaginal system.”  We further determined that it was necessary to use a platinum catalyst for the ring-body polymer, and that using the platinum catalyst required carefully controlling the hydride to vinyl ratio before curing. While we ultimately discovered that the changes described above resulted in a reusable ring system that could reliably release an efficacious amount of active over each of thirteen product-use cycles without an undesirable burst effect.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., bust effect, two polymer systems cured using dibutylin dilaurate, viscosity agent, and platinum catalyst required carefully controlling the hydride to vinyl ratio before curing) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is noted that the same situation applies to the other argument presented by the Declarant. In other words, all of the arguments are not commensurate with the instant rejection. Specifically, Saxena, Heil and Mgdolna references are not cited in the new rejections set forth below. 

Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.  
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 are rejected under 35 U.S.C. 103 as being un-patentable over Saleh (US5,972,372) in view of Simmons, Contraception 97 (2018) 270–276, published in October 30, 2017 and Pramod et al (IJPCBS 2015, 5(4), 1004-1017 ISSN: 2249-9504). Saleh and Simmons can be found in parent case # 16/830,608. 
Saleh teaches a method of intravaginally administering a drug to a female over a predetermined time period, which involves the steps of:
(a) providing a vaginal ring body containing a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said body and which channel is adapted to receive a intravaginally administrable drug-containing core through the opening;
(b) providing a core containing a pharmaceutically effective amount of the intravaginally administrable drug dispersed in a second polymeric material, wherein the first and second polymeric materials may be the same or different;
(c) positioning the core in the channel to thereby assemble the vaginal ring; and
(d) inserting the vaginal ring into the vagina so that the drug will be intravaginally delivered to the female for the predetermined period of time. In preferred embodiments, the vaginal ring is assembled (e.g., the core is positioned in the channel) within about four days prior to use, more preferably within about 24 hours prior to use, and most preferably substantially immediately prior to use, such that upon administration, there is no (i.e., negligible) initial burst of drug that otherwise tends to cause undesirable side effects such as nausea or vomiting. In addition, the vaginal ring body may be provided by molding the first polymeric material having the at least one hollow internal channel in a single step. (See column 3, lines 13-41.) Saleh teaches the ring body and the drug-containing core are Suitably packaged together So that the device can be assembled by a physician, pharmacist, or even the Subject, suitably prior to use. (See column 8, lines 41-44.) The packaging can reasonably be construed to encompass a storage case. 
Saleh also teaches a vaginal ring, comprising: a vaginal ring body comprising a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said vaginal ring body and which said hollow internal channel is adapted to receive an intravaginally administrable drug containing core through said opening, in combination with a drug-containing core positioned in said hollow internal channel, said drug-containing core containing a pharmaceutically effective amount of at least one intravaginally administrable drug dispersed in a second polymeric material, wherein said first and second polymeric materials may be the Same or different, wherein no portion of said drug-containing core is exposed to said exterior of said vaginal ring body. (See claim 1.) Moreover, Saleh teaches the core contains a first drug and a second drug. (See claim 8.) The first drug is norethindrone acetate and the second drug is ethynyl estradiol. (See claims 8-12.) Saleh teaches the vaginal ring comprising first and second hollow channels and first and second cores positioned in said first and second channels, respectively. (See claim 13.) The pharmaceutically effective amount of the drug is from about 1% to about 65% of the weight of said core. (See claim 15.) Additionally, Saleh teaches the Vaginal ring has an overall diameter of from about 48 mm to about 60 mm and a cross-sectional diameter of from about 4 mm to about 10 mm. (See claim 16 and claim 17.) The core has a cross-sectional diameter of from about 1.5 mm to about 5 mm. (See claim 18.) The core has a length of from about 5 mm to about 40 mm. Saleh further teaches a preferred vaginal ring was prepared using a platinum catalyzed dimethylsiloxane/methylvinylsiloxane copolymer (medical adhesive e.g., based methyl siloxane-based polymer) with the ring bodies having a 56 mm overall diameter and 8.4 mm cross-sectional diameter. The cores contained 12% ethynylestradiol and 40% NesteroneTM (aka segesterone acetate) with the cores having a 3 mm diameter and 15 mm or 20 mm in length. (See Example 3 and column, 3, lines 55-59.) Saleh teaches by the term “ring” it is meant any continuous curved or torous shape that does not comprise ease of administration, comfort, esthetic appeal, or efficacy, see col. 6, lines 3-7. The 40% NesteroneTM (aka segesterone acetate) fall within the scope of the claimed approximately 50% segesterone acetate. Saleh teaches the vaginal ring contains a plurality (e.g., two or three) of drug-containing cores, wherein each core may contain the same or a different drug, or more than one drug. (See column 2, lines 61-64.) Lastly, Saleh teaches the each of the two channels have a diameter of 2.8 mm in Example 6 and a diameter of about 3.8 mm in Example 7. While Saleh does not specifically teach each channel has a diameter of 3.0 mm, a person skilled in the art would reasonably expect a channel diameter 3.0 mm to be effectively release the contraceptive drugs with success. The length of the channels allows for the insertion of the core and amount of adhesive added, which a person of ordinary skill in the art routinely optimize specifically examples of Saleh teaches the length of each channel can be 15 mm or 20 mm. Optimization of parameters the for length of each channel claimed is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal length of each channel to use to allow insertion of the core and inclusion of adhesive. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Saleh does not teach 103 mg of segesterone acetate and 17.4 mg of ethinyl estradiol. Additionally, Saleh does not teach titanium dioxide. 
Simmons teaches a NES (nesterone)/EE (ethynyl estradiol) CVR (contraceptive vaginal ring) is made from a silicone elastomer with an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm and contains two cores comprised of silicone polymers mixed with 103 mg NES and 17.4 mg EE. It is designed to release approximately 150 μg of NES and 15 μg of EE daily. (See page 270, right column, last paragraph bridging page 271, left column first paragraph.) The 15 µg is equivalent to 0.015 mg and 15 µg is equivalent to 0.015 mg. The 0.015 mg falls within the scope of approximately 0.013 mg. 
Pramod teaches there are many types of pharmaceutical preparations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments and salves etc. The purpose of coloring varies with different formulations. Colorings may be required to increase the aesthetic appearance or to prolong the stability or to produce standard preparations or for identification of a particular formulation. (See Abstract.) Moreover, Pramod teaches TiO2 (Titanium dioxide) is also an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to products such as paints, coatings, plastics, papers, inks, foods, medicines (i.e. pills, tablets and also in topical pharmaceutical formulations) as well as most toothpastes. Owing to its high refractive index, titanium dioxide has light‐ scattering properties that may be exploited in its use as a white pigment and opacifier. (See second paragraph of page 1010.) 
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the contraceptive ring and method taught by Saleh by including the 103 mg NES and 17.4 mg EE for the purpose of Saleh and the titanium dioxide taught by Pramod to give Applicant’s claimed invention. One would have been motivated to include the combination of 103 mg NES and 17.4 mg EE due to their known therapeutic effects and also titanium dioxide to give the ring a uniform opaque appearance. One would reasonably expect the inclusion of said combination to achieve effective intravaginal delivery of the combination to a female. 
With regards to “the contraceptive ring system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol for up to 13 cycles of 21 days each” limitation and “the contraceptive efficacy of the active pharmaceutical ingredients diminished when the ring has been outside of the vagina for more than two cumulative hours during a twenty-one-day use cycle ring first period in a product” limitation; these limitations simply express the intended outcome or results of the method steps positively recited. Since the collective teachings of cited references render obvious the claimed method steps positively recited, the intended outcome or results are necessarily present absent evidence to the contrary. 
With respect to the Cmax values and the AUC values limitations; said limitations are the characteristics of the contraceptive ring. Since the prior art references in combination renders the claimed contraceptive vaginal ring obvious, said characteristics are necessarily present absent evidence to the contrary.
Acknowledgement is made of the receipt and entry of Applicant’s remark/argument filed on February 18, 2025. 
Applicant’s argument is noted to be the same arguments presented in the Declaration/Affidavit section. As such, the same response applies. 
		
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). 
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The U.S. patent claims teach a method Claims 1-11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,632,066 in view of Pramod et al (IJPCBS 2015, 5(4), 1004-1017 ISSN: 2249-9504).
The U.S. patent teaches a method of providing birth control over the course of thirteen 28-day product-use-cycle, the method comprising:
(a) initially inserting into the vagina of a female of reproductive potential on either day 2, 3, 4, or 5 of the female's menstrual cycle, a vaginal system comprising:
a silicone elastomer ring body, a first channel within the ring body, a second channel within the ring body, a first core disposed within the first channel, a second core disposed within the second channel, 103 mg of segesterone acetate, and 17.4 mg ethinyl estradiol, wherein the 103 mg of segesterone acetate is distributed throughout the first core and the second core; and wherein one of the first or second cores contains the 17.4 mg of ethinyl estradiol;
wherein the system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol in a 21-day first period as measured across thirteen 28-day product-use cycles; and
wherein the initial insertion on day 2, 3, 4, or 5 is the first day of the 21-day first period;
(b) removing the vaginal system from the female's vagina for more than two cumulative hours during the 21-day first period;
(c) storing the removed vaginal system for a second period of between five and seven days including the removal date of step (d), wherein the 21-day first period and second period together comprise a product-use cycle; and
(d) repeating steps (a), (b), and (c) for a total of up to thirteen product-use cycles including a first product-use cycle, wherein each initial insertion of step (a) is performed at approximately the same time of day as in a previous product-use cycle;
the method further comprising:
(e) removing the vaginal system from the female's vagina for more than two cumulative hours during at least one of the 21-day first periods in any of the thirteen product-use cycles;
(f) reinserting the vaginal system into the female's vagina following the removal of the vaginal system from the female's vagina in step (e); and
(g) employing a secondary contraception product that does not comprise estrogen for seven days after reinserting the vaginal system into the female's vagina. (See claim 6.) Moreover, the U.S. patent claims teach the method of further comprising removing the vaginal system from the female's vagina for more than two cumulative hours comprises intentionally, removing the vaginal system for more than two cumulative hours or unintentionally removing the vaginal system for more than two cumulative hours, or wherein removing the vaginal system for more than two cumulative hours comprises a combination of intentional and unintentional removals. (See claim 7.) The U.S. patent claims also teach unintentionally removing the vaginal system comprises expelling the vaginal system, the two cumulative hours out of the vagina are achieved via at least two instances wherein the vaginal system is removed from the vagina during the 21-day first period, the at least two instances take place on the same days or different days, and the different days are consecutive different days or nonconsecutive different days. (See claims 8-11.) 
The claims of the patent do not teach titanium dioxide. 
Pramod teaches there are many types of pharmaceutical preparations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments and salves etc. The purpose of coloring varies with different formulations. Colorings may be required to increase the aesthetic appearance or to prolong the stability or to produce standard preparations or for identification of a particular formulation. (See Abstract.) Moreover, Pramod teaches TiO2 (Titanium dioxide) is also an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to products such as paints, coatings, plastics, papers, inks, foods, medicines (i.e. pills, tablets and also in topical pharmaceutical formulations) as well as most toothpastes. Owing to its high refractive index, titanium dioxide has light‐ scattering properties that may be exploited in its use as a white pigment and opacifier. (See second paragraph of page 1010.) 
 It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the contraceptive ring and method taught by the U.S. patent claims by including the 103 mg NES and 17.4 mg EE for the purpose of Saleh and the titanium dioxide taught by Pramod to give Applicant’s claimed invention. One would have been motivated to include the combination of 103 mg NES and 17.4 mg EE due to their known therapeutic effects and also titanium dioxide to give the ring a uniform opaque appearance. One would reasonably expect the inclusion of said combination to achieve effective intravaginal delivery of the combination to a female. 
With regards to “the contraceptive ring system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol for up to 13 cycles of 21 days each” limitation and “the contraceptive efficacy of the active pharmaceutical ingredients diminished when the ring has been outside of the vagina for more than two cumulative hours during a twenty-one-day use cycle ring first period in a product” limitation, and the “Cmax and Auc values” limitation; these limitations simply express the intended outcome or results of the method steps positively recited. Since the collective teachings of cited references render obvious the claimed method steps positively recited, the intended outcome or results are necessarily present absent evidence to the contrary. 
With respect to the Cmax values and the AUC values limitations; said limitations are the characteristics of the contraceptive ring. Since the prior art references in combination renders the claimed contraceptive vaginal ring obvious, said characteristics are necessarily present absent evidence to the contrary.


Claims 1-11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,940,157 in view of Saleh (US5,972,372) and Pramod et al (IJPCBS 2015, 5(4), 1004-1017 ISSN: 2249-9504).
The patent claims teach a reusable vaginal ring system for preventing pregnancy comprising:
a) a silicone elastomer ring body, the ring body comprising a silicone elastomer having a platinum concentration of approximately 3 ppm to approximately 10 ppm and a hydride/vinyl ratio from approximately 1:1 to approximately 1.3:1 before curing; and
i. a first cylindrical channel adapted to receive a first cylindrical core; and
ii. a second cylindrical channel adapted to receive a second cylindrical core;
b) a first cylindrical core disposed within the first cylindrical channel, wherein the first cylindrical core comprises first and second condensation-cure silicone elastomers, dibutyltin dilaurate, and a viscosity agent selected from the group consisting of diatomaceous earth, cellulose, talc, and silica;
c) a second cylindrical core disposed within the second cylindrical channel, the second cylindrical core comprising a third condensation-cure silicone elastomer, wherein the second and third condensation-cure silicone elastomers are optionally the same, and dibutyltin dilaurate; and
d) approximately 103 mg of segesterone acetate and approximately 17.4 mg of ethinyl estradiol, wherein both the segesterone acetate and ethinyl estradiol are contained within the cores of the vaginal ring system;
wherein
the first cylindrical core comprises approximately 50% segesterone acetate by mass;
the second cylindrical core comprises approximately 40% segesterone acetate by mass and approximately 12% ethinyl estradiol by mass;
the first and second cylindrical cores have a volume ratio of about 11:18; further wherein
the system releases an approximate average of 0.15 mg/day of segesterone acetate and an approximate average of 0.013 mg/day of ethinyl estradiol, or bioequivalent amounts thereof, for up to 13 cycles of 21 days per cycle; and
wherein approximately 80% to approximately 90% of the ethinyl estradiol is recoverable from the system after approximately 18 months of storage at 25° C. and 60% relative humidity and wherein no more than approximately 10% to approximately 20% of the ethinyl estradiol undergoes hydrosilylation with unreacted hydrosilane in the ring body after approximately 18 months of storage at 25° C. and 60% relative humidity;
further wherein the contraceptive ring system achieves in a plasma sample of a female patient:
i. a segesterone acetate Cmax of approximately 1,147 pg/mL+/−315 pg/mL of segesterone acetate over a twenty-one-day first period during a first product-use cycle;
ii. a segesterone acetate Cmax of approximately 363 pg/mL+/−133 pg/mL of segesterone acetate over a twenty-one-day first period during a third product-use cycle;
iii. a segesterone acetate Cmax of approximately 294 pg/mL+/−116 pg/mL of segesterone acetate over a twenty-one days first period during a thirteenth product-use cycle;
iv. an ethinyl estradiol Cmax of approximately 129 pg/mL+/−39 pg/mL of ethinyl estradiol over a twenty-one-day first period during the first product-use cycle;
v. an ethinyl estradiol Cmax of approximately 60 pg/mL+/−32 pg/mL of ethinyl estradiol over a twenty-one-day first period during the third product-use cycle; and
vi. an ethinyl estradiol Cmax of approximately 39 pg/mL+/−16 pg/mL of ethinyl estradiol over a twenty-one-day first period during the thirteenth product-use cycle. (See claim 1.) Moreover, the patent claims teach the first cylindrical core has a length of approximately 11 mm and the second cylindrical core has a length of approximately 18 mm, the first cylindrical core has a diameter of approximately 3 mm, and the first and second cylindrical channels each have a diameter of approximately 3 mm. (See claims 2-6.) The first cylinder and the second cylinder are equivalent to the instant claimed each channel.  Additionally, the patent claims teach the outer diameter is approximately 56 mm and the cross-sectional diameter is approximately 8.4 mm. (See claims 12-14.) The cross-sectional diameter is approximately 8.4 mm. (See claim 14.)
The patent claims do not teach the claimed administration step and titanium dioxide. 
Saleh teaches a method of intravaginally administering a drug to a female over a predetermined time period, which involves the steps of:
(a) providing a vaginal ring body containing a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said body and which channel is adapted to receive a intravaginally administrable drug-containing core through the opening;
(b) providing a core containing a pharmaceutically effective amount of the intravaginally administrable drug dispersed in a second polymeric material, wherein the first and second polymeric materials may be the same or different;
(c) positioning the core in the channel to thereby assemble the vaginal ring; and
(d) inserting the vaginal ring into the vagina so that the drug will be intravaginally delivered to the female for the predetermined period of time. In preferred embodiments, the vaginal ring is assembled (e.g., the core is positioned in the channel) within about four days prior to use, more preferably within about 24 hours prior to use, and most preferably substantially immediately prior to use, such that upon administration, there is no (i.e., negligible) initial burst of drug that otherwise tends to cause undesirable side effects such as nausea or vomiting. In addition, the vaginal ring body may be provided by molding the first polymeric material having the at least one hollow internal channel in a single step. (See column 3, lines 13-41.) Saleh teaches the ring body and the drug-containing core are Suitably packaged together So that the device can be assembled by a physician, pharmacist, or even the Subject, suitably prior to use. (See column 8, lines 41-44.) The packaging can reasonably be construed to encompass a storage case. 
Saleh also teaches a vaginal ring, comprising: a vaginal ring body comprising a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said vaginal ring body and which said hollow internal channel is adapted to receive an intravaginally administrable drug containing core through said opening, in combination with a drug-containing core positioned in said hollow internal channel, said drug-containing core containing a pharmaceutically effective amount of at least one intravaginally administrable drug dispersed in a second polymeric material, wherein said first and second polymeric materials may be the Same or different, wherein no portion of said drug-containing core is exposed to said exterior of said vaginal ring body. (See claim 1.) Moreover, Saleh teaches the core contains a first drug and a second drug. (See claim 8.) The first drug is norethindrone acetate and the second drug is ethynyl estradiol. (See claims 8-12.) Saleh teaches the vaginal ring comprising first and second hollow channels and first and second cores positioned in said first and second channels, respectively. (See claim 13.) The pharmaceutically effective amount of the drug is from about 1% to about 65% of the weight of said core. (See claim 15.) Additionally, Saleh teaches the Vaginal ring has an overall diameter of from about 48 mm to about 60 mm and a cross-sectional diameter of from about 4 mm to about 10 mm. (See claim 16 and claim 17.) The core has a cross-sectional diameter of from about 1.5 mm to about 5 mm. (See claim 18.) The core has a length of from about 5 mm to about 40 mm. Saleh further teaches a preferred vaginal ring was prepared using a platinum catalyzed dimethylsiloxane/methylvinylsiloxane copolymer (medical adhesive e.g., based methyl siloxane-based polymer) with the ring bodies having a 56 mm overall diameter and 8.4 mm cross-sectional diameter. The cores contained 12% ethynylestradiol and 40% NesteroneTM (aka segesterone acetate) with the cores having a 3 mm diameter and 15 mm or 20 mm in length. (See Example 3 and column, 3, lines 55-59.) Saleh teaches by the term “ring” it is meant any continuous curved or torous shape that does not comprise ease of administration, comfort, esthetic appeal, or efficacy, see col. 6, lines 3-7. The 40% NesteroneTM (aka segesterone acetate) fall within the scope of the claimed approximately 50% segesterone acetate. Saleh teaches the vaginal ring contains a plurality (e.g., two or three) of drug-containing cores, wherein each core may contain the same or a different drug, or more than one drug. (See column 2, lines 61-64.) Lastly, Saleh teaches the each of the two channels have a diameter of 2.8 mm in Example 6 and a diameter of about 3.8 mm in Example 7. 
Pramod teaches there are many types of pharmaceutical preparations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments and salves etc. The purpose of coloring varies with different formulations. Colorings may be required to increase the aesthetic appearance or to prolong the stability or to produce standard preparations or for identification of a particular formulation. (See Abstract.) Moreover, Pramod teaches TiO2 (Titanium dioxide) is also an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to products such as paints, coatings, plastics, papers, inks, foods, medicines (i.e. pills, tablets and also in topical pharmaceutical formulations) as well as most toothpastes. Owing to its high refractive index, titanium dioxide has light‐ scattering properties that may be exploited in its use as a white pigment and opacifier. (See second paragraph of page 1010.) 
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to administer the contraceptive ring taught by patent claims and further include the method step and the patient population of Saleh and the titanium dioxide taught by Pramod to give Applicant’s claimed invention. One would have been motivated by the teaching of Saleh and also because Pramod teaches titanium dioxide can be used the pharmaceutical industry to give pharmaceutical product a uniform opaque appearance. One would reasonably expect success by inserting the vaginal ring taught by the patent claims to provide birth control and prevent pregnancy. 



Claims 1-11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,925,882 in view of Saleh (US5,972,372) in view of Pramod et al (IJPCBS 2015, 5(4), 1004-1017 ISSN: 2249-9504).
The patent claims teach a reusable vaginal ring system for preventing pregnancy comprising:
a) a silicone elastomer ring body having a platinum concentration of approximately 3 ppm to approximately 10 ppm and a hydride/vinyl ratio from approximately 1:1 to approximately 1.3:1 before curing, the ring body comprising
i. a first cylindrical channel adapted to receive a first cylindrical core;
ii. a second cylindrical channel adapted to receive a second cylindrical core;
b) a first cylindrical core disposed within the first cylindrical channel, wherein the first cylindrical core comprises first and second condensation-cure silicone elastomers, dibutyltin dilaurate, and a viscosity agent;
c) a second cylindrical core disposed within the second cylindrical channel, wherein the second cylindrical core comprises a third condensation-cure silicone elastomer and dibutyltin dilaurate; and
d) approximately 103 mg of segesterone acetate and approximately 17.4 mg of ethinyl estradiol, wherein both the segesterone acetate and ethinyl estradiol are contained within the cores of the vaginal ring system;
wherein at least one cylindrical core contains solubilized segesterone acetate and segesterone acetate Polymorphic form I and substantially no detectable amount of segesterone acetate Polymorphic form II; further wherein
the system releases an approximate average of 0.15 mg/day of segesterone acetate and an approximate average of 0.013 mg/day of ethinyl estradiol, or bioequivalent amounts thereof, for up to 13 cycles of 21 days per cycle;
further wherein the contraceptive ring system achieves in a plasma sample of a female patient:
i. a segesterone acetate Cmax of approximately 1,147 pg/mL+/−315 pg/mL of segesterone acetate over a twenty-one-day first period during a first product-use cycle;
ii. a segesterone acetate Cmax of approximately 363 pg/mL+/−133 pg/mL of segesterone acetate over a twenty-one-day first period during a third product-use cycle;
iii. a segesterone acetate Cmax of approximately 294 pg/mL+/−116 pg/mL of segesterone acetate over a twenty-one days first period during a thirteenth product-use cycle;
iv. an ethinyl estradiol Cmax of approximately 129 pg/mL+/−39 pg/mL of ethinyl estradiol over a twenty-one-day first period during the first product-use cycle;
v. an ethinyl estradiol Cmax of approximately 60 pg/mL+/−32 pg/mL of ethinyl estradiol over a twenty-one-day first period during the third product-use cycle; and
vi. an ethinyl estradiol Cmax of approximately 39 pg/mL+/−16 pg/mL of ethinyl estradiol over a twenty-one-day first period during the thirteenth product-use cycle. (See claim 1.) Moreover, the patent claims teach the first and second cylindrical cores each have a diameter of approximately 3 mm. (See claim 4.) Furthermore, the patent claims teach 12. The vaginal system of claim 11, wherein the outer diameter is approximately 56 mm and the cross-sectional diameter is approximately 8.4 mm. (See claims 12-14.)
The U.S. patent claims do not teach the administration step, a female of reproductive potential, and titanium dioxide. 
Saleh also teaches a vaginal ring, comprising: a vaginal ring body comprising a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said vaginal ring body and which said hollow internal channel is adapted to receive an intravaginally administrable drug containing core through said opening, in combination with a drug-containing core positioned in said hollow internal channel, said drug-containing core containing a pharmaceutically effective amount of at least one intravaginally administrable drug dispersed in a second polymeric material, wherein said first and second polymeric materials may be the Same or different, wherein no portion of said drug-containing core is exposed to said exterior of said vaginal ring body. (See claim 1.) Moreover, Saleh teaches the core contains a first drug and a second drug. (See claim 8.) The first drug is norethindrone acetate and the second drug is ethynyl estradiol. (See claims 8-12.) Saleh teaches the vaginal ring comprising first and second hollow channels and first and second cores positioned in said first and second channels, respectively. (See claim 13.) The pharmaceutically effective amount of the drug is from about 1% to about 65% of the weight of said core. (See claim 15.) Additionally, Saleh teaches the Vaginal ring has an overall diameter of from about 48 mm to about 60 mm and a cross-sectional diameter of from about 4 mm to about 10 mm. (See claim 16 and claim 17.) The core has a cross-sectional diameter of from about 1.5 mm to about 5 mm. (See claim 18.) The core has a length of from about 5 mm to about 40 mm. Saleh further teaches a preferred vaginal ring was prepared using a platinum catalyzed dimethylsiloxane/methylvinylsiloxane copolymer (medical adhesive e.g., based methyl siloxane-based polymer) with the ring bodies having a 56 mm overall diameter and 8.4 mm cross-sectional diameter. The cores contained 12% ethynylestradiol and 40% NesteroneTM (aka segesterone acetate) with the cores having a 3 mm diameter and 15 mm or 20 mm in length. (See Example 3 and column, 3, lines 55-59.) Saleh teaches by the term “ring” it is meant any continuous curved or torous shape that does not comprise ease of administration, comfort, esthetic appeal, or efficacy, see col. 6, lines 3-7. The 40% NesteroneTM (aka segesterone acetate) fall within the scope of the claimed approximately 50% segesterone acetate. Saleh teaches the vaginal ring contains a plurality (e.g., two or three) of drug-containing cores, wherein each core may contain the same or a different drug, or more than one drug. (See column 2, lines 61-64.) Lastly, Saleh teaches the each of the two channels have a diameter of 2.8 mm in Example 6 and a diameter of about 3.8 mm in Example 7. While Saleh does not specifically teach each channel has a diameter of 3.0 mm, a person skilled in the art would reasonably expect a channel diameter 3.0 mm to be effectively release the contraceptive drugs with success. The length of the channels allows for the insertion of the core and amount of adhesive added, which a person of ordinary skill in the art routinely optimize specifically examples of Saleh teaches the length of each channel can be 15 mm or 20 mm. Optimization of parameters the for length of each channel claimed is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal length of each channel to use to allow insertion of the core and inclusion of adhesive. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Pramod teaches there are many types of pharmaceutical preparations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments and salves etc. The purpose of coloring varies with different formulations. Colorings may be required to increase the aesthetic appearance or to prolong the stability or to produce standard preparations or for identification of a particular formulation. (See Abstract.) Moreover, Pramod teaches TiO2 (Titanium dioxide) is also an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to products such as paints, coatings, plastics, papers, inks, foods, medicines (i.e. pills, tablets and also in topical pharmaceutical formulations) as well as most toothpastes. Owing to its high refractive index, titanium dioxide has light‐ scattering properties that may be exploited in its use as a white pigment and opacifier. (See second paragraph of page 1010.) 
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to administer the contraceptive ring taught by patent claims and further include the method step and the patient population of Saleh and the titanium dioxide taught by Pramod to give Applicant’s claimed invention. One would have been motivated by the teaching of Saleh and also because Pramod teaches titanium dioxide can be used the pharmaceutical industry to give pharmaceutical product a uniform opaque appearance. One would reasonably expect success by inserting the vaginal ring taught by the patent claims to provide birth control and prevent pregnancy. 


Claims 1-11 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,850,251 in view of Pramod et al (IJPCBS 2015, 5(4), 1004-1017 ISSN: 2249-9504).
The patent claims teach a method of providing birth control over thirteen 28-day product-use cycles, the method comprising:
(a) initially inserting into the vagina of a female of reproductive potential on either day 2, 3, 4, or 5 of the female's menstrual cycle, a reusable vaginal ring system comprising:
i. a silicone elastomer ring body comprising a first silicone elastomer, the ring body having a platinum concentration of at least 2 ppm, wherein the silicone elastomer ring body further comprises:
(1) a first channel comprising a first core, the first core comprising second and third silicone elastomers, dibutyltin dilaurate, and a viscosity agent; and
(2) a second channel comprising a second core, the second core comprising a fourth silicone elastomer and dibutyltin dilaurate; and
ii. approximately 103 mg of segesterone acetate and approximately 17.4 mg of ethinyl estradiol, wherein the segesterone acetate is contained within at least the first core, and the ethinyl estradiol is contained within at least the second core;
further wherein the reusable vaginal ring system releases an approximate average of 0.15 mg/day of segesterone acetate and an approximate average of 0.013 mg/day of ethinyl estradiol, or bioequivalent amounts thereof, each day in a 21-day first period as measured across thirteen 28-day product-use cycles; and
wherein the initial insertion on day 2, 3, 4, or 5 is the first day of the 21-day first period, and wherein the initial insertion results in a segesterone acetate Cmax of approximately 1,147 pg/mL+/−315 pg/mL of segesterone acetate over the 21-day first period during a first product-use cycle and an ethinyl estradiol Cmax of approximately 129 pg/mL+/−39 pg/mL of ethinyl estradiol over the 21-day first period during the first product-use cycle;
(b) removing the reusable vaginal ring system on the day following the end of the 21-day first period;
(c) storing the reusable vaginal ring system removed in step (b) for a second period of between five and seven days including the day the reusable vaginal ring system in step (b) is removed, wherein the 21-day first period and second period together comprise a product-use cycle;
(d) reinserting the reusable vaginal ring system into the female's vagina after a preceding product-use cycle on either day 2, 3, 4, or 5 of the female's next menstrual cycle for a subsequent 21-day first period; and
(e) repeating steps (b), (c), and (d) for a total of up to thirteen product-use cycles including the first product-use cycle, wherein each reinsertion of step (d) is performed at approximately the same time of day as in a previous product-use cycle in order to achieve at least one of the following segesterone acetate or ethinyl estradiol pharmacokinetic parameters:
i. a segesterone acetate Cmax of approximately 363 pg/mL+/−133 pg/mL of segesterone acetate over a twenty-one-day first period during a third product-use cycle;
ii. a segesterone acetate Cmax of approximately 294 pg/mL+/−116 pg/mL of segesterone acetate over a twenty-one-day first period during a thirteenth product-use cycle;
iii. an ethinyl estradiol Cmax of approximately 60 pg/mL+/−32 pg/mL of ethinyl estradiol over a twenty-one-day first period during the third product-use cycle; or
iv. an ethinyl estradiol Cmax of approximately 39 pg/mL+/−16 pg/mL of ethinyl estradiol over a twenty-one-day first period during the thirteenth product-use cycle. (See claim 1.) Moreover, the patent claims teach the outer diameter of the ring is approximately 56 mm and the cross-sectional diameter is approximately 8.4 mm, and the first and second cores each have a diameter of approximately 3 mm. (See claims 4 and 7-9.) 
The patent claims do not teach titanium dioxide. 
Pramod teaches there are many types of pharmaceutical preparations which need to be colored such as tablets, tablets coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments and salves etc. The purpose of coloring varies with different formulations. Colorings may be required to increase the aesthetic appearance or to prolong the stability or to produce standard preparations or for identification of a particular formulation. (See Abstract.) Moreover, Pramod teaches TiO2 (Titanium dioxide) is also an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to products such as paints, coatings, plastics, papers, inks, foods, medicines (i.e. pills, tablets and also in topical pharmaceutical formulations) as well as most toothpastes. Owing to its high refractive index, titanium dioxide has light‐ scattering properties that may be exploited in its use as a white pigment and opacifier. (See second paragraph of page 1010.) 
 It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the contraceptive ring and method taught by the U.S. patent claims by including the 103 mg NES and 17.4 mg EE for the purpose of Saleh and the titanium dioxide taught by Pramod to give Applicant’s claimed invention. One would have been motivated to include the combination of 103 mg NES and 17.4 mg EE due to their known therapeutic effects and also titanium dioxide to give the ring a uniform opaque appearance. One would reasonably expect the inclusion of said combination to achieve effective intravaginal delivery of the combination to a female. 


Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-36 of copending Application No. 17520323 (reference application) in view of Pramod et al (IJPCBS 2015, 5(4), 1004-1017 ISSN: 2249-9504). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims teach a vaginal system for preventing pregnancy, the system comprising:a) a methyl siloxane-based polymer ring body, the ring body having an overall diameter of 56 mm and a cross-sectional diameter of approximately 8 mm, and comprising: i. a first cylindrical channel having a length of approximately 27 mm and a diameter of approximately 3 mm wherein the channel is adapted to receive a first cylindrical core; ii. a second cylindrical channel having a length of approximately 27 mm and a diameter of approximately 3 mm wherein the channel is adapted to receive a second cylindrical core; and iii. TiO2; b) a first cylindrical core disposed within the first cylindrical channel, wherein the first cylindrical core has a diameter of approximately 3 mm and comprises at least one silicone elastomer, dibutyltin dilaurate, and a viscosity agent; c) a second cylindrical core disposed within the second cylindrical channel, wherein the second cylindrical core has a diameter of approximately 3 mm and comprises at least one silicone elastomer and dibutyltin dilaurate; and d) approximately 103 mg of segesterone acetate and approximately 17.4 mg of ethinyl estradiol, wherein both the segesterone acetate and ethinyl estradiol are contained within the cores and wherein the segesterone acetate has a particle size D90 of not more than 10 microns; wherein the methyl siloxane-based polymer ring body, wherein approximately 80% to approximately 90% of the ethinyl estradiol is recoverable from the system after approximately 18 months of storage at 25 °C and 60% relative humidity; and wherein the methyl siloxane-based polymer ring body has a shore A hardness of approximately 25 to approximately 30, a mean fatigue parallel to the cores of approximately 95%, and a mean fatigue perpendicular to the cores of approximately 98%; further wherein the vaginal system achieves in a plasma sample of a female patient:i. a segesterone acetate Cmax of approximately 1,147 pg/mL+/- 315 pg/mL over a twenty-one day first period during a first product-use cycle; ii. a segesterone acetate Cavg of approximately 191 pg/mL +/- 34 pg/mL over a twenty-one-day first period during a first product-use cycle; iii. a segesterone acetate AUCo-21 day of approximately 96.2 ng*hr/mL +/- 16.9 ng*hr/mL over a twenty-one days first period during a first product-use cycle; iv. an ethinyl estradiol Cmax of approximately 129 pg/mL +/- 39 pg/mL of ethinyl estradiol over a twenty-one-day first period during the first product- use cycle; v. an ethinyl estradiol Cavg of approximately 44 pg/mL +/-19 pg/mL over a twenty-one-day first period during the first product-use cycle; and vi. an ethinyl estradiol AUCo-21 day of approximately 22.2 ng*hr/mL +/- 9.8 ng*hr/mL over a twenty-one-day first period during the first product-use cycle. (See claim 1.) The copending claims anticipate the instant claims. 
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.


Conclusion
	Claims 1-11 are not allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JEAN P CORNET/             Primary Examiner, Art Unit 1628