DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
1. Applicant’s amendment and accompanying remarks filed 1/28/26 have been fully considered and entered. Claim 1 has been canceled and new claims 2-20 have been as requested. Applicant’s cancellation of claim 1 moots the objection of claim 1 as set forth in the Action dated 1/2/26. As such, this objection is hereby withdrawn. With regard to the information disclosure statement, Applicant’s remarks are found sufficient.
Election/Restrictions
2. Newly submitted claims 2-13 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 2-13 are directed to a method of producing a structure.
Since Applicant has received an action on the merits for the originally presented invention (a structure article), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 2-13 are withdrawn from consideration as being directed to a non-elected invention (e.g., method of producing a structure). See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
3. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
4. Claims 14-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al., US 2011/0287082 A1.
The published patent application issued to Smith et al., teach a non-woven multi-layer scaffold that is bioabsorbable/biodegradable (title and abstract). Smith et al., teach forming electrospinning biodegradable polymers to form fibers (paragraphs 0039-0045). Smith et al., teach forming first and second layers that can comprise fibers of differing materials (paragraph 0042-0045 and 0051-0052). Smith et al., teach that suitable biodegradable polymers include PLA (polylactic acid), PGA (polyglycolic acid) and poly-caprolactone (PCL) (paragraph 0041). With regard to the coupling limitations, Smith et al., teach that the layers can be joined via heat treatment, adhesive and/or solvent bonding (paragraph 0052-0054). With specific regard to claim 20, Smith et al., teach that the fibers of the scaffold may further be impregnated with active agents that can promote wound healing (paragraph 0050). Smith et al., further teach that additional layer of the scaffold can be added having optimized cell architecture for fibroblasts or keratinocytes or another cell type involved in wound healing (paragraph 0048). With specific regard to claim 14, the limitations pertaining to “the plurality of second polymeric fibers being configured to separate from the plurality of first polymeric fibers after at least one of a predetermined time and an environmental condition.”, Smith et al., teach that additional layers of the scaffold can be added into the wound bed following the absorption of the first and optionally the second layer. This is particularly advantageous as it enables the repair of deeper wounds (paragraph 0048). The Examiner is of the position that the absorption of the first layer meets the limitation of the wherein the plurality of the second polymeric fibers being “configured” to separate from the plurality of the first fibers after at least one of a “predetermined time” and “environmental conditions”. In other words, the if the first layer is absorbed it would inherently separate from the second layer.
Double Patenting
5. 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 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents US 10441685 B2; US 10682444 B2; US 11173234 B2; US 11253635 B2; US 11596717 B2; US 12109334 B2; US 12246114 B2; US 10124089 B2. Each of the cited U.S. patents comprise overlapping subject matter with that of instant claims 14-20. Examples of overlapping subject matter include electrospun nanofibers, first and second layers of electrospun nanofibers, electrospun nanofibers of varying densities, a three-dimensional scaffolding structure and articles used for tissue repair made to degrade over time as claimed. Although the claims of each of the cited U.S. patents at issue are not identical, they are not patentably distinct from each.
Conclusion
6. 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 LYNDA SALVATORE whose telephone number is (571)272-1482. The examiner can normally be reached M-F
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 examiner’s supervisor, Marla McConnell can be reached at 571-270-9672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDA SALVATORE/Primary Examiner, Art Unit 1789
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