Patent Application 15011990 - OXYGEN-CHARGED IMPLANTABLE MEDICAL DEVICES FOR

Title: OXYGEN-CHARGED IMPLANTABLE MEDICAL DEVICES FOR AND METHODS OF LOCAL DELIVERY OF OXYGEN VIA OUTGASSING

Application Information

Invention Title: OXYGEN-CHARGED IMPLANTABLE MEDICAL DEVICES FOR AND METHODS OF LOCAL DELIVERY OF OXYGEN VIA OUTGASSING
Application Number: 15011990
Submission Date: 2025-04-09T00:00:00.000Z
Effective Filing Date: 2016-02-01T00:00:00.000Z
Filing Date: 2016-02-01T00:00:00.000Z
National Class: 424
National Sub-Class: 600000
Examiner Employee Number: 89220
Art Unit: 1619
Tech Center: 1600

Rejection Summary

102 Rejections: 0
103 Rejections: 3

Cited Patents

The following patents were cited in the rejection:

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 .

DETAILED ACTION
Applicant’s Request for Reconsideration dated December 31, 2024 is acknowledged.
Claims 1, 7-13, 15-19 and 21-29 are pending.
Claims 2-6, 14, 20, 30 and 31 are cancelled.
Claims 1, 17 and 18 are currently amended.
Claims 17-19 and 21-29 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 7-13, 15 and 16 as filed on December 31, 2024 are under consideration.
This action is made FINAL.

Withdrawn Objections / Rejections
In view of the substitute specification and Applicant’s statements in the Remarks that the amendment thereof at page 10 to introduce material from page 23 of parent Application No. 14/893,115 introduces no new matter, all previous objections to the specification are withdrawn and all previous claim rejections under 35 USC 112(a) are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.

Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 14/893,115, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. The prior-filed application does not disclose an implantable medical device comprising all of the gases of claim 1, e.g., does not disclose carbon dioxide; does not disclose the devices of claim 11, e.g., does not disclose a stent; does not disclose the fasteners of claim 12; does not disclose the adaptions of claim 13; and does not disclose the coatings of claims 15 and 16.
The disclosure of the prior-filed application, Application No. 61/828,126, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. The prior-filed application does not disclose a 3D printed implantable medical device comprising the PLGA/PVA microtanks or all of the gases of claim 1, e.g., does not disclose carbon dioxide.
The earliest date available to the pending claims is February 1, 2016.

Maintained Grounds of Rejection / New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.

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 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kheir et al. (WO 2014/144364, published September 18, 2014, filed March 14, 2014 and claiming priority to March 15, 2013, of record) as evidenced by Wikipedia “Biological functions of nitric oxide,” last edited April 30, 2018, of record in view of Harrison et al. (US 2010/0112087, published May 6, 2010, of record) and Cima et al. (US 5,490,962, published February 13, 1996, of record).
Kheir teaches gas-filled stabilized particles having a hollow core-shell morphology (title; abstract; claims; Figure 1):

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The gas is oxygen, carbon dioxide, carbon monoxide, nitrogen, nitric oxide (signaling molecule and vasodilator as evidenced by Wikipedia), nitrous oxide, an inhalational anesthetic (additional component), hydrogen sulfide, argon, helium or/and xenon (claims 18, 31; pages 51-52, “Gas Core”), as required by instant claims 7-10. The gas is pressurized at greater than 1 atmosphere (hyperbaric); the particles may also be loaded with gas under pressurized conditions (hyperbarically loaded) (claim 45; page 2, lines 15-19; page 52, “Pressurized Gas”). The gas is able to diffuse through the envelop following administration (in use the gas is present / dissolved in the membranes) (page 51, lines 22-23).
The stabilized (outer) membrane comprises a polymer such as PLGA (claims 5, 6, 14; Figures 12, 14; Examples 5, 7; page 32, lines 16-28; pages 45-50, “Polymers”).
The sheath (inner) membrane comprises a polymer such as PVA (polyvinyl alcohol) (claims 7, 13, 14; Figure 14; Examples 7, 8; page 32, lines 16-28; pages 45-50, “Polymers”). Some of the hollow PLGA particles illustrated in Figure 14 contain PVA webbing in the core, leading to increased fluid filling (page 29, lines 9-15; Example 8).
The particle may further include a therapeutic agent (drug delivery device) (claim 22; paragraph bridging pages 57-58), as required by instant claim 11.
Kheir further teaches the particles may be suspended in a medium (one or more materials in which the gas is present / dissolved in use) (claims 15, 25, 26). Kheir further teaches bandages or wound healing devices (one or more materials in which the gas is present / dissolved in use) comprising the particles (page 62, lines 2-9).
Kheir further teaches the gas core of the gas-filled particles reaches an equilibrium across the membrane after administration, strongly favoring the tendency of oxygen to leave the core rather than remain within (page 60, lines 15-21).
Kheir does not teach 3D printed material as required by claim 1.
Kheir does not teach particles form a device that is a surgical fastener inclusive of a suture as required by claims 11, 12.
Kheir does not teach the device is adapted for fixation as required by claim 13.
These deficiencies are made up for in the teachings of Harrison and Cima.
Harrison teaches oxygen-generating compositions comprising a biodegradable polymer such as PLGA and an inorganic peroxide; the oxygen-generating active / peroxide can be included in the polymer in solid form, such as in the form of a plurality of solid particles (title; abstract; claims; paragraphs [0028]-[0029]). The compositions are suitable for wound treatment (paragraphs [0045]-[0050]). The compositions may be in the form of a suture (claim 29; paragraph [0051]), as required by instant claims 11, 12. A suture is used to close the skin flap surgical wound in an animal model (paragraph [0068]), as required by instant claim 13. The implantable oxygen releasing biomaterials can provide a sustained release of oxygen (paragraph [0058]).
Cima teaches medical devices for controlled release of bioactive agent(s) fabricated by 3D printing; 3D printing is used to precisely position the bioactive agent(s) within a release matrix to control the rate of release (title; abstract; claims; column 2, lines 32-41). Suitable matrix polymers include polymers of lactic acid and glycolic acid (column 7 and 8, “Selection of Polymers”, column 7, lines 45-65, column 8, lines 34-55). Bioactive agent(s) are incorporated as particles and include agents such as air (column 9, “Bioactive agents which can be incorporated”). For example, the devices can be composed of particles of bioactive agent dispersed or embedded in a matrix of degradable polymer such as PLGA (column 10, lines 16-30). Cima further teaches sutures (column 8, lines 34-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the suspension medium of the gas / oxygen filled stabilized particles of Kheir comprising at least one outer polymer membrane inclusive of PLGA and comprising PVA as the sheath or inner membrane as illustrated in Figures 1 and 14 to comprise a biodegradable polymer such as PLGA as taught by Harrison in order to form oxygenated sutures. It would have been obvious to one of ordinary skill in the art to modify the oxygenated sutures of Kheir in view of Harrison to further comprise gas / oxygen in the suspension medium / biodegradable PLGA at the same pressure as within the stabilized particles in order to prevent the gas / oxygen from the stabilized particles of Kheir from leaving the core prior to administration. It would have been obvious to one of ordinary skill in the art to fabricate the oxygenated sutures by 3D printing as taught by Cima in order to precisely position the stabilized particles of Kheir within the biodegradable polymer in order to control the rate of oxygen release.

Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kheir et al. (WO 2014/144364, published September 18, 2014, filed March 14, 2014 and claiming priority to March 15, 2013, of record) as evidenced by Wikipedia “Biological functions of nitric oxide,” last edited April 30, 2018, of record in view of Harrison et al. (US 2010/0112087, published May 6, 2010, of record) and Cima et al. (US 5,490,962, published February 13, 1996, of record) as applied to claims 1 and 7-13 above, and further in view of Malinski (WO 2011/082375, published July 7, 2011, of record).
The teachings of Kheir, Harrison and Cima have been described supra.
They do not teach the device is coated with a gas barrier layer as required by claim 15.
This deficiency is made up for in the teachings of Malinski.
Malinski teach topical gas delivery systems comprising at least one gas inclusive of oxygen and at least one gas permeable membrane for controlling diffusion (title; abstract; claims). The system may further comprise one or more gas impermeable members arranged and/or configured to limit a loss of the one or more gases during release (paragraph [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the oxygenated, 3D printed sutures of Kheir in view of Harrison and Cima comprising a suspension of gas / oxygen filled stabilized particles in a biodegradable polymer such as PLGA to further comprise one or more gas impermeable members as taught by Malinski in order to limit the loss of the gas / oxygen.

Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kheir et al. (WO 2014/144364, published September 18, 2014, filed March 14, 2014 and claiming priority to March 15, 2013, of record) as evidenced by Wikipedia “Biological functions of nitric oxide,” last edited April 30, 2018, of record in view of Harrison et al. (US 2010/0112087, published May 6, 2010, of record) and Cima et al. (US 5,490,962, published February 13, 1996, of record) as applied to claims 1 and 7-13 above, and further in view of Petisce et al. (US 2005/0054909, published March 10, 2005, of record).
The teachings of Kheir, Harrison and Cima have been described supra.
They do not teach the device is coated with a layer having high solubility for the gas as required by claim 16.
This deficiency is made up for in the teachings of Petisce.
Petisce teach oxygen enhancing membrane systems for implantable devices, wherein the membrane system includes a polymer such as a silicone that is a high oxygen soluble material (title; abstract; paragraphs [0010], [0080]-[0082] and [0087]). The membrane is disposed adjacent to an oxygen-utilizing source so as to dynamically retain high oxygen availability (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the oxygenated, 3D printed sutures of Kheir in view of Harrison and Cima comprising a suspension of gas / oxygen filled stabilized particles in a biodegradable polymer such as PLGA to further comprise an oxygen enhancing membrane as taught by Petisce so as to dynamically retain high oxygen availability at the site of the wound.

Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s argument at page 10 that claim 1 further defines the one or more gases as being hyperbarically loaded is acknowledged but not found persuasive because this limitation is reasonably construed as a product by process limitation (see MPEP 2113) and because this limitation is duplicative of the limitation of that the microtanks are “loaded with one or more gases at a hyperbaric pressure”. Should Applicant choose to again claim the “invention” disclosed within the instant specification as originally filed, Balding (US 2003/0190367, of record) as applied in the Non-Final Rejection mailed May 18, 2018 teaches oxygenation of materials with dissolved oxygen under pressure, Spears (US 6,197,279, of record) as applied in the Final Rejection mailed February 25, 2019 teaches polymers absorb gases such as oxygen under high pressure conditions and release the gases upon exposure to ambient pressure, Kolta (US 6,139,876, of record) as applied in the Non-Final Rejection mailed June 24, 2021 teaches a gelatin with increased oxygen content embedded within small bubbles at an overpressure, and Cantwell (US 6,000,403, of record) as applied in the Final Rejection mailed April 26, 2022 teaches a hyperbaric bandage which releases hyperbaric oxygen on release.
Applicant’s argument at page 10 that the use of an inorganic peroxide as taught by Harrison is fundamentally different hyperbaric loading citing to page 1 of Application No. 14/893,115 is acknowledged but not found persuasive because pages 7-8 of Application No. 14/893,115 disclose:

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That is, this passage of Application No. 14/893,115 states hyperbaric loading of microtanks encompasses loading of solid materials inclusive of peroxide which is capable of decomposing. See also page 6, lines 4-9 of Application No. 61/828,126. See also Klaveness et al. (US 5,676,925) disclosing gas-containing polymer microparticles and/or microballoons as an obvious alternative to gas-generating polymer microparticles and/or microballoons (e.g., title; abstract). Furthermore, the rejection is predicated on the obviousness of modifying the medium of Kheir which already comprises gas-filled stabilized particles, wherein the gas has a pressure greater than 1 atmosphere.
Applicant’s argument at page 11 that Cima does not disclose hyperbarically loading particles is unpersuasive as Kheir already discloses hyperbarically loading particles and Cima is relied upon to render obvious 3D printing of medical devices.
Applicant’s argument at page 11 that Malinski does not cure the defect of Kheir is acknowledged but not found persuasive as the base rejection over Kheir is not defective.
Applicant’s argument at page 12 that Petisce does not cure the defect of Kheir is acknowledged but not found persuasive as the base rejection over Kheir is not defective.
Therefore, the rejections over Kheir are properly maintained in modified form as necessitated by Applicant’s amendment.

Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Klaveness et al. (US 5,676,925) discloses gas-containing polymer microparticles and/or microballoons as an obvious alternative to gas-generating polymer microparticles and/or microballoons (e.g., title; abstract).

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 ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
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/ALISSA PROSSER/
Examiner, Art Unit 1619

/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600