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 .
Status of Claims
Claims 22-28 are currently pending and under consideration.
Priority
The present application, filed on 10/25/2022, is a divisional of US application no. 18049464, granted a notice of allowance on 05/11/2026, which was a continuation of PCT/EP2021/061222, filed on 04/29/2021 and claims priority to the international application (Kingdom of Denmark) DKPA202000521, filed on 05/01/2020. Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e) of Provisional application No. 62/775,994, filed on December 06, 2018. Acknowledgment is made of applicant' s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application and all claims are being examined with an effective filing date of May 01, 2020. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/02/2024, 12/02/2024, 05/08/2025, and 05/01/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 (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.
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 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 23 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Muhonen et al. (WO2016042211, cited in the IDS) and Drapeau et al. (US20130280303, cited in PTO-892).
Regarding claims 23, 25, and 27-28, Muhonen et al. teaches a three dimensional material comprising synthetic needle punched carded mesh and recombinant human collagen (Abstract). Specifically, Muhonen et al. disclose an exemplary carded mesh comprising PLA96/4, which was “needle punched followed by admixing with highly porous recombinant human collagen type II”. It is noted that “the needle punching method uses needles with specific barbs that are chosen on the basis of the used fibre. By moving the card or the bed of needles in perpendicular direction or at a chosen angle against or along the card, the barbs take on the fibres (i.e., fibers) and pull and push the fibres through the net- work of fibres. This results in the entanglement of the fibres in the network and a needle punched carded mesh structure is formed with mechanical interlocking of the fibres thus forming a structure for the medical device” and ““was subsequently gamma sterilized at 25 kGy” (Specification, Example 1, pg. 18). Muhonen et al. further teaches a recombinant human collagen solution, wherein the PLA mesh “was immersed throughout with the collagen solution and the structure was subsequently freeze-dried to form homogenous hybrid structure. The scaffolds were further cross-linked with 95% ethanol solution…” (Example 1, pg. bottom of pg. 18-19). Therefore, Muhonen et al. expressly teaches a collagen loaded scaffold, wherein the scaffold comprises fiber mesh containing PLA fibers. Muhonen et al. also teaches sterilization using gamma irradiation, thus establishing the suitability of gamma irradiation as a sterilization technique for the scaffold materials. However, Muhonen et al. does not explicitly teach gamma sterilization after collagen loading and packaging.
Drapeau et al. teaches a medical implant device that includes a “covering” that may be a 3D scaffold (para 0004 and 0097). Specifically, the covering comprises natural and synthetic polymers, which may comprise a structural material that may comprise a mesh material (para 0040, 0045). Drapeau et al. further teaches PLA and collagen as suitable mesh materials (para 0058), and expressly teaches mesh fibers (para 0060). Drapeau et al. also teaches packaging the device prior to gamma irradiation and using gamma irradiation as “a terminal sterilization step in final packaging”, which can be employed “when the device in in the package…” – i.e., sterilized after being packaged. Also noted is that and “gamma sterilization does not require high pressures or vacuum conditions, thus, package seals and other components are not stressed” and “gamma radiation eliminated the need for permeable packaging materials”. Moreover, “terminal sterilization of a product provides greater assurance of sterility than from processes such as an aseptic process, which require individual product components to be sterilized separately and the final package assembled in a sterile environment” (para 0015, and 0150-0151).
Regarding claim 26, PLA96/4, as taught by Muhonen et al., is poly (L/D) lactide (see comparative example 1, Muhonen Specification pg. 16). The instant specification states “PLA is intended to include polylactides in all stereoisomer forms…” including wherein the PLA contains both L and D forms of lactide. Therefore, PLA96/4 satisfies the limitation wherein the PLA is a lactide, as recited in claim 26.
An invention would have been obvious to a person of ordinary skill in the art if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Muhonen et al., which discloses a collagen-loaded scaffold comprising a PLA fiber mesh that was sterilized using gamma irradiation and recombinant human collagen, combined with the teachings of Drapeau et al., that medical implant devices comprising collagen and PLA mesh materials may be packaged prior to gamma irradiation and undergo terminal sterilization while contained within the package, would have led a person of ordinary skill in the art to modify the collagen-loaded scaffold of Muhonen et al. by performing gamma irradiation as a terminal sterilization step after packaging, to ensure sterilization of the entire structure. There is a reasonable expectation of success because Muhonen et al. already demonstrates successful use of gamma irradiation as a sterilization technique for the PLA fiber mesh, while Drapeau et al. demonstrates successful terminal gamma sterilization of packaged medical implant devices. A person of ordinary skill in the art would have been motivated to incorporate such a modification because Drapeau et al. teaches that terminal sterilization provides greater assurance of sterility than processes requiring individual product components to be sterilized separately and subsequently assembled under sterile conditions. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Muhonen et al. and Drapeau et al., as applied to claim 23 above, and further in view of Warnke, P. (US20130095167, cited in PTO-892).
The teachings of Muhonen et al. and Drapeau et al. as they apply to claim 23 have been discussed above. Briefly, Muhonen et al. teaches a carded mesh comprising PLA96/4, which was needle punched followed by admixing with highly porous recombinant human collagen type II. Drapeau et al. teaches that medical implant devices comprising collagen and PLA mesh materials may be packaged prior to gamma irradiation and undergo terminal sterilization while contained within the package. Neither reference teaches wherein the scaffold/device contained 5-25% w/w collagen, based on the total amount of PLA and collagen.
As discussed above, Muhonen et al. does not explicitly disclose the amount of collagen present in the scaffold. However, as set forth in MPEP 2144.05, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The collagen concentration of the scaffold taught by Muhonen et al. constitutes a result-effective variable because collagen content would have been recognized by a person of ordinary skill in the art as affecting scaffold properties, including structural characteristics and biological performance.
Furthermore, Warnke discloses compositions to regenerate or repair tissue, wherein the composition comprises three-dimensional (3D) nanofiber webbing and at least one agent, further teaching suitable natural and synthetic polymers that may be used to form the 3D nanofiber webbing include, inter alia, PLA or poly(L-lactic acid), PLGA or poly(lactide-co-glycolic acid), collagen, and mixtures thereof (para 209). Warnke expressly teaches wherein the composition of the membrane (i.e., webbing) is 75% PLGA and 25% collagen (para 0212, see also Fig. 6 “Collagen:PLGA 1:3”). It is noted that the instant specification states that “the term PLA also includes polylactide or co-polymers, such as those formed between lactide and glycolide, poly(lactide-co-glycolide) (PLGA)”. Therefore, the PLGA/collagen 3D membrane of Warnke, is a scaffold composition comprising 25% collagen based on the total amount of collagen and PLA (as defined by the instant specification).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to arrive at a collagen concentration within the claimed range, including 25% collagen, through routine optimization of the collagen-loaded scaffold of Muhonen et al. There would have been a reasonable expectation of success because Warnke discloses a collagen/PLA-type scaffold, comprising 25% collagen, and demonstrates that such scaffold compositions are suitable for tissue repair and regeneration applications. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
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 “right to exclude” 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.
Claim 23-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18705154 (reference application), further in view of Drapeau et al. (US20130280303, cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘154 claims make obvious the instant claims.
For example, claim 7 of ‘154 recites a sterilized scaffold comprising animal collagen in a concentration from 5% to 25% w/w collagen and PLA in a concentration from 75% to 95% w/w, the concentrations being based on the total weight of PLA and collagen, wherein the PLA is in the form of a fiber mesh containing fibers of polylactide polymer or copolymer (commonly denoted PLA).
As discussed above, Drapeau et al. teaches a medical implant device that includes a “covering” that may be a 3D scaffold (para 0004 and 0097). Specifically, the covering comprises natural and synthetic polymers, which may comprise a structural material that may comprise a mesh material (para 0040, 0045). Drapeau et al. further teaches PLA and collagen as suitable mesh materials (para 0058), and expressly teaches mesh fibers (para 0060). Drapeau et al. also teaches packaging the device prior to gamma irradiation and using gamma irradiation as “a terminal sterilization step in final packaging”, which can be employed “when the device in in the package…” – i.e., sterilized after being packaged. Also noted is that and “gamma sterilization does not require high pressures or vacuum conditions, thus, package seals and other components are not stressed” and “gamma radiation eliminated the need for permeable packaging materials”. Moreover, “terminal sterilization of a product provides greater assurance of sterility than from processes such as an aseptic process, which require individual product components to be sterilized separately and the final package assembled in a sterile environment” (para 0015, and 0150-0151).
A person of ordinary skill in the art would have been motivated to incorporate terminal gamma irradiation to sterilize the scaffold of ‘154, because Drapeau et al. teaches that terminal sterilization provides greater assurance of sterility than processes requiring individual product components to be sterilized separately and subsequently assembled under sterile conditions, and gamma sterilization does not require high pressures or vacuum conditions. There is a reasonable expectation of success because Drapeau et al. demonstrates successful terminal gamma sterilization of packaged medical implant devices. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art.
Additionally, it is noted that claim 25 of ‘154 recites a method for preparing a sterilized scaffold having 5% to 25% w/w collagen and PLA in a concentration from 75% to 95% w/w, the concentrations being based on the total weight of PLA and collagen, comprising steps that include loading collagen to a fiber mesh and sterilization with gamma irradiation. Thus, the method according to claim 25 of ‘154 would necessarily result in a sterile collagen loaded scaffold, according to instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 23-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-10, 17, 23-25, and 27-41 of copending Application No. 18705215 (reference application), further in view of Drapeau et al. (US20130280303, cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘215 claims make obvious the instant claims.
For example, claim 23 of ‘215 recites a sterilized PLA-collagen scaffold comprising collagen in a concentration from 5% to 25% w/w and PLA in a concentration from 75% to 95% w/w, the concentrations being based on the total weight of PLA and collagen. Claim 25 of ‘215 recites a sterilized PLA-collagen scaffold comprising collagen in a concentration from 5% to 25% w/w and PLA in a concentration from 75% to 95% w/w, wherein the collagen is a recombinant collagen, tissue derived collagen, or combinations thereof. Other claims, likewise recite the scaffold above, or the process in preparing the scaffold above, further reciting additional limitations identical or substantially similar to the instant claims.
Additionally, claim 27 recited a method for preparing a sterilized PLA-collagen scaffold comprising collagen in a concentration from 5% to 25% w/w and PLA in a concentration from 75% to 95% w/w, comprising steps of loading collagen to a PLA fiber mesh and sterilizing the PLA-collagen scaffold, resulting in the sterile collagen loaded scaffold of instant claim 1, when combined with the teachings of Drapeau et al. discussed above.
A person of ordinary skill in the art would have been motivated to incorporate terminal gamma irradiation taught by Drapeau et al. to sterilize the scaffold of ‘215, because Drapeau et al. teaches that terminal sterilization provides greater assurance of sterility than processes requiring individual product components to be sterilized separately and subsequently assembled under sterile conditions, and gamma sterilization does not require high pressures or vacuum conditions. There is a reasonable expectation of success because Drapeau et al. demonstrates successful terminal gamma sterilization of packaged medical implant devices. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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