DETAILED ACTION
This is a Non-Final Rejection for Application 19/350,571 filed October 06, 2025. This application is a continuation of U.S. Patent Application No: 17/283,740 filed April 8, 2021, which is a U.S. National Stage under 35 U.S.C. § 371 of international application number PCT/US2019/057810 filed October 24, 2019, and which depends from and claims priority to U.S. Provisional Application No: 62/749,974, filed October 24, 2018. Claims 1-17 are currently pending.
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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the recitation “wherein the one or more active agents an antimicrobial peptide, an antibody, a growth factor, insulin, or combinations thereof” should be corrected to “wherein the one or more active agents comprise an antimicrobial peptide, an antibody, a growth factor, insulin, or combinations thereof” for proper grammar.
Additionally, the recitation “the scaffold layer bound to the immediate release layer so as to be releasable from wound dressing upon contact with a body fluid” should be corrected to “the scaffold layer bound to the immediate release layer so as to be releasable from the wound dressing upon contact with a body fluid” since a wound dressing device is already recited. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the recitation “wherein the active agent comprises an antimicrobial a growth factor” should be corrected to “wherein the active agent comprises an antimicrobial peptide or a growth factor” for proper grammar. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the recitation “wherein scaffold layer comprises collagen” should corrected to “wherein the scaffold layer comprises collagen” since a scaffold layer is already recited. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 13 is 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.
Claim 13 recites the limitation “wherein the second wound dressing excludes a scaffold layer.” This limitation is indefinite as the second wound dressing is claimed as the dressing of claim 1, and the dressing of claim 1 requires a scaffold layer. Therefore, it is unclear if the scaffold layer in claim 1 is optional or the second wound dressing is not the dressing of claim 1. This rejection may be overcome by amending the second wound dressing to not be the wound dressing of claim 1.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims only require one or more active agents vitrified to the water stable polymer, while U.S. Patent No. 12,458,538 requires one or more active agents in the form of a stable glassy vitrified material in contact with the water stable polymer. It would be obvious to vitrify the one or more active agents to the water stable polymer of U.S. Patent No. 12,458,538 as the one or more active agents are already vitrified in contact with the water stable polymer.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 2 are claimed in claim 4 of U.S. Patent No. 12,458,538.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 3 are claimed in claim 5 of U.S. Patent No. 12,458,538.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 4 are claimed in claim 7 of U.S. Patent No. 12,458,538.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 5 are claimed in claim 8 of U.S. Patent No. 12,458,538.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 6 are claimed in claim 10 of U.S. Patent No. 12,458,538.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 2 are claimed in claim 4 of U.S. Patent No. 12,458,538.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15 and 19 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 8 are claimed in claim 1 of U.S. Patent No. 12,458,538.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15 and 19 of U.S. Patent No. 12,458,538 in view of US 2008/0103462 (Wenzel et al.). While U.S. Patent No. 12,458,538 does not claim wherein said scaffold layer comprises one or more omega-3-fatty acids, Wenzel teaches a wound healing patch comprising bioresorbable scaffold matrixes with incorporated bioactive agents, such as anti-inflammatory agents (i.e. omega-3 fatty acids, eicosanoids, prostaglandin E1), collagen, keratinocytes, and fibroblasts, which aid the wound-healing process; [0027]. It would be obvious to add omega-3-fatty acids to the scaffold layer of U.S. Patent No. 12,458,538 as taught by Wenzel to aid the wound-healing process.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15 and 19-20 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 10 are claimed in claim 20 of U.S. Patent No. 12,458,538.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 11 are claimed in claim 25 of U.S. Patent No. 12,458,538.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25-26 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 12 are claimed in claim 26 of U.S. Patent No. 12,458,538.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25-27 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 13 are claimed in claim 27 of U.S. Patent No. 12,458,538.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25-26 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 14 are claimed in claim 26 of U.S. Patent No. 12,458,538.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25-26 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of present claim 15 are claimed in claim 12 of U.S. Patent No. 12,458,538.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because it would be obvious to apply the wound dressing of U.S. Patent No. 12,458,538 to a surgical wound to promote healing of the surgical wound.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 19 and 25 of U.S. Patent No. 12,458,538. Although the claims at issue are not identical, they are not patentably distinct from each other because it would be obvious to apply the wound dressing of U.S. Patent No. 12,458,538 to a diabetic ulcer and for the active agent to comprise insulin to promote healing of the diabetic ulcer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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, Rachael Bredefeld can be reached at (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SETH R. BROWN/Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
