Patent Application 18292037 - PHOTOSTABILIZED COMPOSITIONS AND A METHOD FOR - Rejection
Patent Application 18292037 - PHOTOSTABILIZED COMPOSITIONS AND A METHOD FOR
Title: PHOTOSTABILIZED COMPOSITIONS AND A METHOD FOR STABILIZING PHOTOSENSITIVE COMPONENTS
Application Information
- Invention Title: PHOTOSTABILIZED COMPOSITIONS AND A METHOD FOR STABILIZING PHOTOSENSITIVE COMPONENTS
- Application Number: 18292037
- Submission Date: 2025-05-21T00:00:00.000Z
- Effective Filing Date: 2024-01-25T00:00:00.000Z
- Filing Date: 2024-01-25T00:00:00.000Z
- Examiner Employee Number: 82939
- Art Unit: 1654
- Tech Center: 1600
Rejection Summary
- 102 Rejections: 1
- 103 Rejections: 1
Cited Patents
The following patents were cited in the rejection:
- US 0390161đ
Office Action Text
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 .
Amendment after Non-final office action filed on May 6, 2025 is acknowledged.
Claims 1-6, 9-10, 15-19, 21 and 23 have been cancelled.
New claims 24-34 have been added.
Claims 7-8, 11-14, 20, 22 and 24-34 are pending in this application. Claims 11, 25-26 and 28 are withdrawn from consideration as being drawn to species not found in the prior art (please see below). Claims 7-8, 12-14, 20, 22, 24, 27, 29-34 are examined on the merits in this office action.
Please note: Claim 7 has been amended to define photosensitive composition comprising riboflavin and/or tryptophan. New claims 24-34 have been added to include other species. If these claims were originally presented, the Examiner would have issued at least an election of species for photosensitive composition (from riboflavin and tryptophan and cell culture, cosmetic, food application, parenteral nutritional formulation and drug product formulation). Since cell culture was prosecuted on the merits in the previous office action, claims 25-26 and 28 are withdrawn from consideration as being drawn to species not found in the prior art. Additionally, since riboflavin is found in the prior art, any claim drawn to tryptophan is being withdrawn (claim 11).
Withdrawn Objections and Rejections
Objection to claim 7 is hereby withdrawn in view of Applicantâs amendment to the claim.
Objection to claim 20 under 37 CFR 1.75 as being a substantial duplicate of claim 21 is hereby withdrawn in view of Applicant cancelling claim 21.
Objection to claim 22 under 37 CFR 1.75 as being a substantial duplicate of claim 23 is hereby withdrawn in view of Applicant cancelling claim 23.
Rejections of claims 16, 20 and 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are hereby withdrawn in view of Applicantâs amendment to the claims.
Rejection of claims 15-17 under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, is hereby withdrawn in view of Applicant cancelling claims 15-17.
Rejection of claims 15-17 under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, is hereby withdrawn in view of Applicant cancelling claims 15-17.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained and Revised Rejection
35 U.S.C. 102/103
13. 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 (i.e., changing from AIA to pre-AIA ) 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.
14. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless â
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
15. 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 (i.e., changing from AIA to pre-AIA ) 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.
16. 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.
17. 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 nonobviousness.
18. 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.
19. Claim(s) 7-8, 12-14, 22, 24, 27, 30 and 34 remain/are rejected under 35 U.S.C. 102(a)(1) or, in the alternative, under 35 U.S.C. 103(a) as obvious over Knaup et al (US 2019/0390161, filed with IDS). The rejection is maintained but revised in view of Applicantâs amendment to the claims.
20. Knaup et al teach a culture medium containing at least one oligopeptide of 2-10 amino acids in lengths, the amino acids are natural amino acids, at least one of the amino acids is lysine and one further is cysteine, cystine, leucine, tyrosine, valine or isoleucine, and the oligopeptide is present in an amount of at least 0.1 mM (see abstract). Knaup r et al further teach a method of manufacturing a cell culture product (see abstract, for example). Knaup et al teach animal cell cultures, wherein during the production phase the serum-free medium is supplemented with Tyr- and His-containing dipeptides (see paragraph [0009], and teach that an effect is only described for the dipeptides L-alanyl-L-tyrosine and L-alanyl-L-cystine (see paragraph [0010] and Table 4). Knaup et al teach that the oligopeptide of 2-10 amino acids in lengths, comprising at least one of amino acids being Lys, and one further amino acid is selected from the Cys, Cyss (cystine), Leu, Tyr, Val and Ile and the oligopeptide is present in an amount of at least 0.1 mM (see paragraph [0014])âŚthe comparison of a reference medium with other media containing the same molar amount of cysteine and cystine in the form of dipeptides showed that bis-lysyl-L-cysteine led to a performance comparable to bis-alanyl-L-cystineâŚthe cells were able to utilize the peptides for growth (see paragraph [0118]), meeting the limitation of instant claims 7 and 13, for example. Knaup et al further teach a method of manufacturing a cell culture product comprising the steps of (i) providing a cell capable of producing said cell culture product, (ii) contacting said cell with a culture medium, and (iii) obtaining said cell culture product (see paragraph [0016]). Knaup et al teach that âA culture medium shall be understood as being a liquid or solid mediumâ (see paragraph [0022]). Knaup et al teach that Lys-Leu, Lys-Tyr and Lys-Lys peptides have been analyzed (see paragraph [0064] and Tables 1 and 4), and teach that the oligopeptide is Lys-Xxx or XXX-Lys, wherein Xxx is a natural amino acid selected from Cys, Cyss, Leu, Tyr, Val and Ile (see paragraph [0070]). Knaup et al teach that 1.22 mM of Ala-Tyr is in the culture media
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(see Table 4), meeting the limitation of instant claims 7-8, 12, 14, 22, 24. Knaup et al teach that the culture media of the invention preferably comprise vitaminsâŚpyridoxal, riboflavin, thiamineâŚ(see paragraph [0083]), meeting the limitation of riboflavin of instant claims 7, 12-14, 22, 24, 32 and 34. Knaup et al teach that the Lys-containing oligopeptide is present in said culture medium in a concentration from 0.01 to 20 g/lâŚthe oligopeptide is present in a concentration of above 0.1, 0.2, 0.4 or 1 mMâŚthe oligopeptide is present in the medium at a concentration of from 0.1 mM to 20 mMâŚor 0.5 mM to 10 mMâŚ(see paragraph [0095]), meeting the limitation of instant claims 12, 30 and 32. The MPEP states the following: When the compound is not specifically named, but instead it is necessary to select potions of teachings within a reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated (See MPEP 2105). Knaup et al further teach that the cells to be cultured are CHO cells, COS cells, VERO cellsâŚHELA cellsâŚ(see paragraph [0101]), meeting the limitation of instant claim 34. Additionally, Knaup et al teach:
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(see paragraph [0102]). Knaup et al further teach that the dipeptides and their use in heat sterilized enteral or parenteral nutrition products as well as cell culture media (see paragraph [0005]), meeting the limitation of instant claim 27.
With respect to the limitation in the preamble of claims 7-8, 12-14, 22, 24, 27, 30 and 34, âA method for stabilizing a photosensitive composition, the method comprising..â, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Therefore, since the Knaup et al reference teaches the same active method steps (i.e., combining a tyrosine-comprising dipeptide (e.g., Ala-Tyr and Lys-Tyr) with a photosensitive component (e.g., riboflavin in the cell culture), the reference anticipates instant claims 7-8, 12-14, 22, 24, 27, 30 and 34.
As discussed above, the cited references disclose a method of culturing cells comprising a dipeptide and a photosensitive, aromatic compound (e.g., hormone). Consequently, the claimed method appears to be anticipated by the reference.
In the alternative, even if the claimed method is not identical to the referenced method with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced method is likely to inherently possess the same characteristics of the claimed method particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed method and concentration would have been obvious to those of ordinary skill in the art with the meaning of U.S.C. 103.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the art rejection above, please note that Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicantsâ product differs and, if so, to what extent, from that of discussed references. Therefore, with the showing of the references, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Response to Applicantâs Arguments
21. Applicant argues that âKnaup fails to disclose the reduction of brown coloration in photosensitive compositions, especially cell cultures or aqueous solutions, nor the superior results from the particular selection of the claimed dipeptides...â Applicant further argues that
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22. Applicantâs arguments have been fully considered but are not found persuasive. Knaup et al explicitly teach the dipeptide Ala-Tyr in a cell culture media (see Table 4) in a concentration of 1.22 mM. Therefore, since the Ala-Tyr in the concentration of 1.22 mM is in the cell culture media, the dipeptide would inherently have the same function and activity and the end results would be the same as instant claims (i.e., the dipeptide of Ala-Tyr in the cell culture media would stabilize the cell culture media, and stabilize the photosensitive composition against brown coloration). The MPEP § 2112 states: âOnce a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference â[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherencyâ under 35 U.S.C. 102, on prima facie obviousnessâ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].â The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).â Furthermore, Knaup et al teach that the oligopeptide is present in a concentration of above 0.1, 0.2, 0.4 or 1 mMâŚthe oligopeptide is present in the medium at a concentration of from 0.1 mM to 20 mMâŚor 0.5 mM to 10 mM. The MPEP states the following: When the compound is not specifically named, but instead it is necessary to select potions of teachings within a reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated (See MPEP 2105).
In regards to Applicantâs Table 3, it is unclear as to the unexpected results, since the solvent background is also â3â at day 7 for âwith 0.013 mM riboflavinâ. The data for âwithout 0.013 mM riboflavinâ, the solvent background is also â1â. Therefore, there is no unexpected results since the solvent background is giving a reading of â3â and â1â when the different concentrations of dipeptides are measured. Therefore, Knaup et al teach all of the active method steps of instant claims 7-8, 12-14, 22, 24, 27, 30 and 34. The rejection is deemed to be proper and is maintained but revised herein.
DOUBLE PATENTING
23. The nonstatutory 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 âright to excludeâ granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
24. Claims 7-8, 12-14, 20, 22, 24, 27 and 29-34 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/602421 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa. Please note: copending application is a CON of instant application. Therefore, the double patenting rejection is proper. The rejection is maintained and revised in view of Applicantâs amendment to the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
25. Instant claims are drawn to:
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26. Copending claims are drawn to:
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27. The dipeptides and the photosensitive component involved in the instant claims is same as the dipeptides and the photosensitive component involved in the copending claims. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa. Additionally, the copending application is a CON of instant application, therefore, the double patenting rejection is proper.
Response to Applicantâs Arguments
28. Applicant did not respond to the double patenting rejection.
29. Therefore, the double patenting rejection is deemed to be proper and is maintained and revised herein, in view of Applicantâs amendment to the claims.
New Rejections
U.S.C. 112(b)
30. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.âThe specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
31. Claims 11 and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
32. Claim 11 depends from a cancelled claim 10. Therefore, the metes and bounds of the claim is unclear. A claim cannot depend from a cancelled claim. Applicant is required to correct this error.
33. Claim 33 recites, âThe method of claim 7, which is carried out for at least seven days.â The metes and bounds of the claim is unclear. It is unclear what the phrase âwhich is carried out for at least seven daysâ is referring to.
U.S.C. 112(d)
34. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.âSubject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
35. Claims 31 and 32 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
36. Claim 31 recites, âThe method of claim 7, wherein the combining employs the Gly-Try, whereinâŚa molar ratio of the Ala-Tyr or Gly-Tyr to the riboflavin and/or tryptophan isâŚâ Claim 31 is referring to âGly-Tryâ in the preamble, but in the body of the claim is indicating âmolar ratio of Ala-Tyr or Gly-Tyrâ. Therefore, claim 31 body of the claim is broader than the preamble of claim 31.
37. Claim 32 recites, âThe method of claim 7, wherein the combining employs the Ala-Try, whereinâŚa molar ratio of the Ala-Tyr or Gly-Tyr to the riboflavin and/or tryptophan isâŚâ Claim 32 is referring to âAla-Tryâ in the preamble, but in the body of the claim is indicating âmolar ratio of Ala-Tyr or Gly-Tyrâ. Therefore, claim 32 body of the claim is broader than the preamble of claim 32.
CONCLUSION
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examinerâs supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
