DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Receipt and consideration of Applicant’s amended claim set and Applicant’s arguments/remarks submitted on October 23, 2025 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments. Applicant’s claim amendments have necessitated new grounds of rejections set forth below.
Status of the Claims
Claims 21-40 are newly added and under consideration in this action. Claims 1-20 are cancelled.
Terminal Disclaimer
The terminal disclaimer filed on October 23, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 10,463,768; 11,684,700; and 11,707,553 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Priority
Applicant’s claim 21 recites the limitation “providing a three-dimensional scaffold complex ccomprising polymeric fibers oriented to comprise a plurality of pores.” It appears that this limitation first appears in the parent application, Application No. 16/533,375. It is noted that the earlier parent applications recite that the three-dimensional scaffold comprises polymeric fibers oriented to produce a pluraity of pores. However, there does not appear to be support in the parent applications for the limitation as currently written, in particular wehrein the polymeric fibers are oriented to comprise a plurality of pores. Thus, the effective filing date of the instant claims 21-40 is August 6, 2019.
Response to Arguments
Applicant's arguments filed October 23, 2025 have been fully considered. In light of Applicant’s claim amendments, new rejections are set forth herein below. Comments and observations regarding Applicant’s arguments to prior art references cited in the previous office action are set forth herein below.
(1) Applicant argues that Zussman is particularly distinct and reports certain materials that are not crosslinked, citing paragraph 0022 of Zussman. Applicant aruges that Beachley and the other citations do not remedy this deficiency, noting that Beachley does not exemplify any covalently linked materials or indicate how Zussman might be modified as has been proposed. Applicant argues that Beachley reports fibers prepared as arrays of continuous fibers across the fiber mat, with no process of functional need to reduce the lengths of the individual fibers. Applicant argues that nowhere do the cited documents suggest a polymeric fiber crosslinked with a hydrogel material as Applicant discloses and claims, or the advantagese that can be provided by Applicant’s composition as discussed at pages 19-20 of the application.
With regards to Applicant’s argument (1), first, it is noted that the rejection was made over the combination of the cited references. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the present case, with regards to the limitation wherein the polymeric fibers or fragments thereof are covalently linked to a hydrogel material, as discussed above, Beachley discloses that fibers, such as those disclosed by Zussman, which include or can be functionalized to include a reactivity moiety, may be bonded to the encapsulating network covalently, non-covalently, charge/charge interaction, etc., and such materials were shown to exhibit excellent strength characteristics and good cellular ingrowth capabilities. In light of this disclosure, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Zussman and Beachley and covalently link and/or otherwise link (e.g., hydrogen bonding or charge/charge interaction) Zussman’s fibers to the Zussman’s hydrogel material as discussed in Beachley. One of ordinary skill in the art would have been motivated to do so in order to improve the strength characteristics and cellular ingrowth capabilities of Zussman’s hydrogel composites. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Beachley discloses that such bonding may be done between fiber materials, including electrospun fibers, and hydrogel materials that are disclosed by Zussman; and Shalaby and Lowman disclose that fibers covalently linked, or otherwise bonded, to the hydrogel material is a known feature of injectable fiber-reinforced hydrogels used in tissue regeneration.
It is further noted that Zussman discloses that the term “composite” is defined to refer to a construct including a fibrous component and a hydrogel component. While Zussman discloses that the components in the composite may be physically mixed together to form the composite (“physically mixed” being defined to mean that the hydrogel component and the fibrous component are merely dispersed in one another and do not chemically reach to form a new material), it is not a requirement to be physically mixed, but rather an alternative embodiment as evidenced by the term “may”. Thus, Zussman does not preclude the fibrous component and hydrogel component from being covalently bonded, and the additional cited prior art references, e.g., Beachley, are relied upon for the disclosure and motivation for covalently linking the fibrous and hydrogel components.
Furthermore, it is noted that the prior art disclosure is not limited to exemplified embodiments. Beachley discloses that fibers can be formed of materials that include or can be functionalized to include a reactivity moiety such as amine, carboxylate, or thio groups, that can allow covalent, non-covalent, charge/charge interaction (electrostatic interactions), or any other type of bonding of a protein or other component of an encapsulating network to a fiber surface (para.0067). As discussed in the above and in the previous office action, Beachley and Zussman disclose overlapping polymers that may make up the fibers.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites the limitation “polymeric fibers oriented to comprise a plurality of pores” in lines 2-3. Applicant does not appear to describe in the specification how polymeric fibers may be oriented to produce such a structure (i.e., plurality of pores on or within the polymeric fibers). Applicant fails to describe a representative number of polymeric fiber orientations that would produce a plurality of pores on the polymeric fibers and Applicant fails to describe structural features common to members of the claimed genus of orientations to produce polymeric fibers comprising a plurality of pores. Thus, the instant specification fails to provide an adequate description to support the breadth of the claims.
Claims 22-40 are subsequently rejected as they incorporate the limitation of claim 21 discussed above and do not remedy the issue discussed above.
Examiner suggests amending the limitation to read “polymeric fibers oriented to produce a plurality of pores” to be consistent with the instant specification and to clarify that the plurality of pores is on the scaffold, not the polymeric fibers.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The 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.
Claims 21-40 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.
With regards to claim 21, line 2 recites “providing a three-dimensional scaffold complex.” The instant specification defines “scaffold complex” to mean any covalent association of two components: a polymeric fiber and a hydrogel material (P.G. Pub., para.0126). However, lines 2-3 of the claim only recite the “three-dimensional scaffold complex” as comprising polymeric fibers and does not recite the inclusion of a hydrogel material. The hydrogel material is introduced in a later step to mix with the polymeric fibers to form a scaffold complex. The inconsistency in the use of the term “scaffold complex” renders the claim indefinite as it is unclear what is to be provided and what is ultimately to be formed in the next mixing step. For the purposes of improving clarity of the claim, Examiner suggests amending the limitation to read “providing a three-dimensional scaffold comprising” to be consistent with the specification.
Claims 22-40 are subsequently rejected as they incorporate the limitation of claim 21 and do not remedy the issue discussed above.
Claim 29 recites the limitation "the hyaluronic acid" in line 1. There is insufficient antecedent basis for this limitation in the claim because there is no previous introduction of a hyaluronic acid in claim 29 or the claims upon which it depends and incorporates (claim 21).
Claim 34 recites the limitation "the hyaluronic acid" in line 1. There is insufficient antecedent basis for this limitation in the claim because there is no previous introduction of a hyaluronic acid in claim 29 or the claims upon which it depends and incorporates (claims 21 and 23).
Claim 39 recites the limitation "the hyaluronic acid" in line 1. There is insufficient antecedent basis for this limitation in the claim because there is no previous introduction of a hyaluronic acid in claim 29 or the claims upon which it depends and incorporates (claims 21 and 24).
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.
Claims 21-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-30, 32, 33, and 41-48 of copending Application No. 18/210,003 (Copending 003).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim substantially similar and overlapping injectable scaffold complexes comprising polymeric fibers of fragments covalently linked to a hydrogel material. Both sets of claims also claim substantially similar and overlapping methods of using and making such injectable scaffold complexes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed October 23, 2025 have been fully considered. Applicant request the provisional rejection be held in abeyance until claims are otherwise determined to be allowable. Thus, the provisional rejection is maintained at this time.
Conclusion
Claims 21-40 are rejected. No claims are 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 MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616