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
The amendment filed on September 9, 2025 has been entered.
Status of Claims
Claims 1-4, 6-10, 12-16, 20, 23-24, and 28-31 are pending.
Claims 1-4, 6-10, 12-16, 20, 23-24, and 28-31 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 9, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements is being considered by the examiner.
Response to Amendments/Arguments
Claim Objections - New
Claim 3 is objected to in the recitation of two terminal periods. Appropriate correction is required.
Specification - Withdrawn
Applicant’s arguments, see Section B at page 6 of the Remarks, filed September 9, 2025, with respect to the Specification have been fully considered and are persuasive. The abstract has been amended. Therefore, the objection of the Specification has been withdrawn.
Claim Rejections - 35 USC § 112(b) – Withdrawn, Maintained, & New
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.
Withdrawn Rejections
Applicant’s arguments, see Section C at page 6 of the Remarks, filed September 9, 2025, with respect to claims 1, 23-24, and 28 and claims 2-4, 6-10, 12-16, and 20 depending therefrom have been fully considered and are persuasive. Claims 1, 23-24, and 28 have been amended to delete the limitation “fibroblast-derived products”. Therefore, the rejection of claims 1, 23-24, and 28 and claims 2-4, 6-10, 12-16, and 20 depending therefrom under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Section C at page 6 of the Remarks, filed September 9, 2025, with respect to claims 2 and 29 have been fully considered and are persuasive. Claims 2 and 29 have been amended to delete the limitation “fragments or biologic components of fibroblast cells”. Therefore, the rejection of claims 2 and 29 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Section C at page 7 of the Remarks, filed September 9, 2025, with respect to claim 4 and claims 7-8 depending therefrom have been fully considered and are persuasive. Claim 4 has been amended to correct its antecedent basis. Therefore, the rejection of claim 4 and claims 7-8 depending therefrom under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Section C at page 7 of the Remarks, filed September 9, 2025, with respect to claim 6 have been fully considered and are persuasive. Claim 6 has been amended to correct its antecedent basis. Therefore, the rejection of claim 6 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Section C at page 7 of the Remarks, filed September 9, 2025, with respect to claims 6-7 and claim 8 depending therefrom have been fully considered and are persuasive. Claims 6-7 have been amended to delete “catalyzed”. Therefore, the rejection of claims 6-7 and claim 8 depending therefrom under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Section C at page 7 of the Remarks, filed September 9, 2025, with respect to claim 9 have been fully considered and are persuasive. Therefore, the rejection of claim 9 under 35 U.S.C. 112(b) has been withdrawn.
Maintained Rejections
Claim 3 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 3 recites the limitation “materials derived from immune cells, keratinocytes, and /or vasal epithelial cell”. The metes and bounds of the limitation in the context of the above claim are not clear. The specification does not define “materials derived” from immune cells, keratinocytes, vasal epithelial cells. Therefore, it is unclear what compounds are encompassed by the claim. Clarification is requested.
Applicant's arguments filed September 9, 2025 have been fully considered but they are not persuasive.
Applicant argues that amended claim 3 defines materials. This is not found persuasive. The specification does not define “materials derived” from immune cells, keratinocytes, vasal epithelial cells. Therefore, it is unclear what compounds are encompassed by the claim. Hence the rejection is maintained.
Claim 7 and claim 8 depending therefrom 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.
Claim 7 recites the limitation “biologic agent”. The metes and bounds of the limitation in the context of the above claim are not clear. The specification at paragraph [0067] describes an “agent”. However, it is unclear as to which of these disclosures, if any, are meant as being a “biologic”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2111.01 Section II. Therefore, it is unclear what compounds are encompassed by the claim. Clarification is requested.
Applicant's arguments filed September 9, 2025 have been fully considered but they are not persuasive.
Applicant argues that amended claim 7 is definite because one having ordinary skill in the art would understand the term “biological agent”, in the context of the claim, any agent that can activate or manipulate a cell. This is not found persuasive. The specification at paragraph [0067] describes an “agent”. However, it is unclear as to which of these disclosures, if any, are meant as being a “biologic”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2111.01 Section II. Hence the rejection is maintained.
New Rejection
Claims 2 and 29 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.
Claims 2 and 29 recites the limitation “fibroblast-derived material”. The metes and bounds of the limitation in the context of the above claims are not clear. The specification at paragraph [0077] describes “fibroblast-derived material”. However, it is unclear as to which of these materials, if any, are meant as being a ““fibroblast-derived product”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2111.01 Section II. Therefore, it is unclear what compounds are encompassed by the claim. Clarification is requested.
Applicant's arguments filed September 9, 2025 have been fully considered but they are not persuasive. Applicants should note that the rejection has been amended in light of the amendment of the claims.
Applicant argues that amended claim 29 is definite because the term “fibroblast-derived material” is sufficiently described in the application as filed. This is not found persuasive. The specification at paragraph [0077] describes “fibroblast-derived material”. However, it is unclear as to which of these materials, if any, are meant as being a “fibroblast-derived material”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2111.01 Section II. Therefore, it is unclear what compounds are encompassed by the claim. Hence the rejection has been maintained.
Claim 7 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 7 recites the limitation "wherein the cells.." in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends from claim 4. However, claim 4 does not recite cells. Therefore, it is unclear what cells are encompassed by the claim. Clarification is requested.
Claim 31 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 31 recites the limitation "wherein said fibroblast-derived material" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 31 depends from claim 1. However, claim 1 does not recite a fibroblast-derived material. Therefore, it is unclear if fibroblast is administered or if a fibroblast-derived material is administered. Clarification is requested.
Claim Rejections - 35 USC § 112(a) – Withdrawn
Applicant’s arguments, see Section D at page 7 of the Remarks, filed September 9, 2025, with respect to claims 1-4, 6-10, 12-16, 20, 23-24 and 28-29 have been fully considered and are persuasive. Claims 1 and 28 have been amended to narrow the genus to a topical administration of a 3D spheroid fibroblast. Applicant' s argument that the specification provides numerous examples to support the claimed genus has been found persuasive. Therefore, the rejection of claims 1-4, 6-10, 12-16, 20, 23-24 and 28-29 under 35 U.S.C. 112(a) for lack of written description has been withdrawn.
Claim Rejections - 35 USC § 102 – Withdrawn and New
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Withdrawn Rejections
Applicant’s arguments, see Section E at page 8 of the Remarks, filed September 9, 2025, with respect to claims 1-2, 6-9, 14, 16, and 28-29 have been fully considered and are persuasive. Claim 1 has been amended to require topical administration of a 3D spheroid, which is not taught by O’Heeron. Therefore, the rejection of claims 1-2, 6-9, 14, 16, and 28-29 under 35 U.S.C. 102(a)(1) or 102(a)(1) and/or as being anticipated by O’Heeron (102(a)(1): US 2020/0338133 – form PTO-892 or 102(a)(2): US 12,310,991 – form PTO-892) has been withdrawn.
Applicant’s arguments, see Section E at page 8 of the Remarks, filed September 9, 2025, with respect to claims 1-3, 10, 14-16, 20, and 23-24 have been fully considered and are persuasive. Claim 1 has been amended to require administration of a 3D spheroid, which is not taught by Moseley. Therefore, the rejection of claims 1-3, 10, 14-16, 20, and 23-24 under 35 U.S.C. 102(a)(1) and/or as being anticipated by Moseley (WO 2019/231562 – form PTO-1449) has been withdrawn.
Applicant’s arguments, see Section E at page 8 of the Remarks, filed September 9, 2025, with respect to claims 1, 4, and 28-29 have been fully considered and are persuasive. Claim 1 has been amended to require topical administration of a 3D spheroid, which is not taught by Weiss. Therefore, the rejection of claims 1, 4, and 28-29 under 35 U.S.C. 102(a)(1) and/or as being anticipated by Weiss (EP 3 566 713 – form PTO-892) has been withdrawn.
Applicant’s arguments, see Section E at page 8 of the Remarks, filed September 9, 2025, with respect to claims 1, 4, 10, 12-16, 20, 23-24, and 28-29 have been fully considered and are persuasive. Claim 1 has been amended to require administration of a 3D spheroid, which is not taught by Banerjee. Therefore, the rejection of claims 1-3, 10, 14-16, 20, and 23-24 under 35 U.S.C. 102(a)(1) and/or as being anticipated by Banerjee (US 2011/0020291 – form PTO-892 has been withdrawn.
New Rejection
Claim(s) 1, 6, 9-10, 16, 23-24, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bizik (WO 2008/020119 – form PTO-1449).
Regarding claims 1 and 28, Bizik discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising 3D spheroid fibroblast (claims 1 and 5-6, 2nd full paragraph at page 2, bottom of page 2 through middle of page 3, last paragraph at page 4, page 5, and page 8).
Regarding claim 6, Bizik discloses that the 3D spheroid fibroblast is activated (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claim 9, Bizik discloses that the fibroblast is activated in cultures, which reads on chemical agents (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claim 10, Bizik discloses topical administration on the surface of the wound (middle of page 6).
Regarding claim 16, Bizik discloses a method of treating an individual having skin burn (last paragraph at page 7).
Regarding claims 23-24, Bizik discloses covering the wound following administration of the 3D spheroid fibroblast with an adhesive bandage, which acts as a barrier over the wound to prevent the 3D spheroid fibroblast to leave the wound (last paragraph at page 7).
Therefore, the reference of Bizik anticipates claims 1, 6, 9-10, 16, 23-24, and 28.
Claim Rejections - 35 USC § 103 - New
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.
Claim(s) 1-3, 6, 9, 10, 14-16, 20, 23-24, and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bizik (WO 2008/020119 – form PTO-1449) and Moseley (WO 2019/231562 – form PTO-1449).
Regarding claims 1 and 28, Bizik discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising 3D spheroid fibroblast (claims 1 and 5-6, 2nd full paragraph at page 2, bottom of page 2 through middle of page 3, last paragraph at page 4, page 5, and page 8).
Regarding claim 6, Bizik discloses that the 3D spheroid fibroblast is activated (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claim 9, Bizik discloses that the fibroblast is activated in cultures, which reads on chemical agents (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claim 10, Bizik discloses topical administration on the surface of the wound (middle of page 6).
Regarding claim 16, Bizik discloses a method of treating an individual having skin burn (last paragraph at page 7).
Regarding claims 23-24, Bizik discloses covering the wound following administration of the 3D spheroid fibroblast with an adhesive bandage, which acts as a barrier over the wound to prevent the 3D spheroid fibroblast to leave the wound (last paragraph at page 7).
Bizik does not disclose a composition further comprising a fibroblast-derived material or administering antibiotics.
However, Bizik discloses any kind of fibroblasts capable of forming multicellular fibroblast spheroids can be used in the invention. Such fibroblasts are, e.g., stromal fibroblasts, bone marrow stromal cells and mesenchymal stem cells (6th paragraph at page 6).
Regarding claims 1-2 and 28-31, Moseley discloses a method of treating a wound and accelerating the wound in an individual by administering a therapeutically effective amount of a composition comprising exosomes derived from fibroblasts (abstract, paragraph 3 at page 1 through paragraph 5 at page 2, paragraph 16 pag page 5, paragraph 104 at page 37, and claims 1 and 9).
Regarding claim 3, Moseley discloses administering mesenchymal stem cell secretome derived from keratinocytes (paragraph 36 at page 10 and claims 1 and 9).
Regarding claim 10, Moseley discloses administering the composition into the wound, adjacent to the wound and/or on the surface of the wound (paragraphs 60-63 at pages 19-20).
Regarding claim 14, Moseley discloses a method of treating an individual having diabetes (paragraph 30 at page 9).
Regarding claim 15, Moseley discloses treating a wound that is chronic (paragraph 103 at page 37).
Regarding claim 16, Moseley discloses a method of treating an individual having burns, abrasions or ulcer, which reads on a cut (paragraph 61 at pages 19-20).
Regarding claim 20, Moseley discloses administering an antibiotic (paragraph 58 at page 18).
Regarding claims 23-24, Moseley discloses applying a cover over at least part of the would to prevent the fibroblast and/or fibroblast-derived products to leave the wound (paragraph 8 at page 2 and claim 8).
Therefore, in combining the teachings of the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to modify the composition of Bizik by add the exosome of Moseley and an antibiotic. One having ordinary skill in the art would have been motivated to do so in order to improve the method of Bizik and accelerate wound healing since Moseley discloses a method of treating a wound and accelerating the wound by administering an exosome and an antibiotic. One of ordinary skill in the art would have had a reasonable expectation of success since Bizik discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising 3D spheroid fibroblast and Moseley discloses a method of treating a wound and accelerating the wound by administering an exosome and an antibiotic. The rationale to support that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Therefore, the above references render claims 1-3, 6, 9, 10, 14-16, 20, 23-24, and 28-31 prima facie obvious.
Claim(s) 1, 4, 6-10, 12-16, 20, 23-24, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bizik (WO 2008/020119 – form PTO-1449) and Banerjee (US 2011/0020291 – cited previously on form PTO-892).
Regarding claims 1 and 28, Bizik discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising 3D spheroid fibroblast (claims 1 and 5-6, 2nd full paragraph at page 2, bottom of page 2 through middle of page 3, last paragraph at page 4, page 5, and page 8).
Regarding claim 6, Bizik discloses that the 3D spheroid fibroblast is activated (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claims 7-8, Bizik discloses activation of fibroblast by in a culture medium, which reads on fibroblasts that are manipulated by a biologic agent and light (abstract, 1st full paragraph at page 1).
Regarding claim 9, Bizik discloses that the fibroblast is activated in cultures, which reads on chemical agents (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claim 10, Bizik discloses topical administration on the surface of the wound (middle of page 6).
Regarding claim 16, Bizik discloses a method of treating an individual having skin burn (last paragraph at page 7).
Regarding claims 23-24, Bizik discloses covering the wound following administration of the 3D spheroid fibroblast with an adhesive bandage, which acts as a barrier over the wound to prevent the 3D spheroid fibroblast to leave the wound (last paragraph at page 7).
Bizik does not disclose a composition comprising 3D spheroid myofibroblast, activating the myofibroblast, and a composition further comprising an adjuvant.
Regarding claims 1 and 4, Banerjee discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising myofibroblast (abstract, [0008], [0013], and [0017]). Banerjee discloses that myofibroblasts are responsible for generation of mechanical forces that allow proper granulation tissue contraction and would healing ([0005]-[0006]).
Regarding claim 10, Banerjee discloses administering the composition into the wound, adjacent to the wound and/or on the surface of the wound ([0050]-[0051]).
Regarding claims 12-13, Banerjee discloses administering a biologically active agent, such as an adjuvant, which is a chemical ([0017]).
Regarding claim 14, Banerjee discloses a method of treating an individual having diabetes ([0069]).
Regarding claim 15, Banerjee discloses treating a wound that is chronic (abstract).
Regarding claim 16, Banerjee discloses that a wound comprises cuts, abrasions, and burns ([0032]).
Regarding claim 20, Banerjee discloses administering an antibiotic ([0053]).
Regarding claims 23-24, Banerjee discloses applying a cover over at least part of the would to prevent the fibroblast and/or fibroblast-derived products to leave the wound ([0051]).
Therefore, in combining the teachings of the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to modify the composition of Bizik by administering a 3D spheroid myofibroblast, an adjuvant and an antibiotic. One having ordinary skill in the art would have been motivated to do so in order to improve the method of Bizik and accelerate wound healing since Banerjee discloses that myofibroblasts are responsible for generation of mechanical forces that allow proper granulation tissue contraction and would healing and Banerjee discloses administering an adjuvant and an antibiotic. One of ordinary skill in the art would have had a reasonable expectation of success since Bizik discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising 3D spheroid fibroblast and Banerjee discloses a method of treating a wound and accelerating the wound by administering a myofibroblast, adjuvant, and an antibiotic. The rationale to support that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Therefore, the above references render claims 1, 4, 6-10, 12-16, 20, 23-24, and 28 prima facie obvious.
Double Patenting – Withdrawn & New
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.
Withdrawn Rejections
Claims 1 and 28 have been amended to recite a 3D spheroid fibroblast, which is not recited in claims 1-32 of U.S. Patent No. 12,310,991. Therefore, the nonstatutory double patenting rejection of claims 1-2, 6-9, 14, 16, and 28-29 as being unpatentable over claims 1-32 of U.S. Patent No. 12,310,991 has been withdrawn.
Claims 1 and 28 have been amended to recite a 3D spheroid fibroblast, which is not recited in claims1-32 of U.S. Patent No. 12,310,991 nor disclosed in Mosely and Banerjee. Therefore, the nonstatutory double patenting rejection of claims 1-4, 6-10, 12-16, 20, 23-24, and 28-29as being unpatentable over claims 1-32 of U.S. Patent No. 12,310,991 in view of Moseley (WO 2019/231562 – form PTO-1449) and Banerjee (US 2011/0020291 – form PTO-892) has been withdrawn.
New Rejection
Claims 1-4, 6-10, 12-16, 20, 23-24, and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12,310,991 (reference patent) in view of Bizik (WO 2008/020119 – form PTO-1449), Moseley (WO 2019/231562 – form PTO-1449) and Banerjee (US 2011/0020291 – cited previously on form PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because they are claiming common subject matter, as follows:
Regarding claims 1-2 and 28-31 of the instant application, claims 1 and 31 of the reference patent recites a method of treating a wound by stimulating angiogenesis in an individual thus accelerating wound healing by administering a therapeutically effective of a fibroblast-derived exosome.
Regarding claims 6-8 of the instant application, claims 6-8 and 10 of the reference patent recites that the exosomes are collected from fibroblast while said fibroblast are in a proliferating state under culture media, which reads on fibroblasts that are manipulated by a biologic agent and light.
Regarding claim 9 of the instant application, Claims 6-8 of the reference recites that the fibroblast or exosome are cultured in a media for fibroblast proliferation, wherein the media comprises a growth factor, which reads on activating the fibroblast with a growth factor ([0009]-[0010] and claims 6-8).
Regarding claim 14 of the instant application, claim 33 of the reference patent recites a method of treating an individual having diabetes.
Regarding claim 16, claim 32 of the reference patent recites a method of treating an individual having gastrointestinal ulcer, which reads on a cut.
The claims of the reference patent do not recite topical administration of a 3D spheroid fibroblast or myofibroblast nor a composition further comprising of an antibiotic and adjuvant.
Regarding claims 1 and 28, Bizik discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising 3D spheroid fibroblast (claims 1 and 5-6, 2nd full paragraph at page 2, bottom of page 2 through middle of page 3, last paragraph at page 4, page 5, and page 8).
Regarding claim 6, Bizik discloses that the 3D spheroid fibroblast is activated (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claims 7-8, Bizik discloses activation of fibroblast by in a culture medium, which reads on fibroblasts that are manipulated by a biologic agent and light (abstract, 1st full paragraph at page 1).
Regarding claim 9, Bizik discloses that the fibroblast is activated in cultures, which reads on chemical agents (abstract, 1st paragraph at page 1, last two paragraphs at page 4, and pages 5-6).
Regarding claim 10, Bizik discloses topical administration on the surface of the wound (middle of page 6).
Regarding claim 16, Bizik discloses a method of treating an individual having skin burn (last paragraph at page 7).
Regarding claims 23-24, Bizik discloses covering the wound following administration of the 3D spheroid fibroblast with an adhesive bandage, which acts as a barrier over the wound to prevent the 3D spheroid fibroblast to leave the wound (last paragraph at page 7).
Regarding claims 1-2 and 28-29 of the instant application, Moseley discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising exosomes derived from fibroblasts (abstract, paragraph 3 at page 1 through paragraph 5 at page 2, paragraph 104 at page 37, and claims 1 and 9).
Regarding claim 3 of the instant application, Moseley discloses administering mesenchymal stem cell secretome derived from keratinocytes (paragraph 36 at page 10 and claims 1 and 9).
Regarding claim 10 of the instant application, Moseley discloses administering the composition into the wound, adjacent to the wound and/or on the surface of the wound (paragraphs 60-63 at pages 19-20).
Regarding claim 14 of the instant application, Moseley discloses a method of treating an individual having diabetes (paragraph 30 at page 9).
Regarding claim 15 of the instant application, Moseley discloses treating a wound that is chronic (paragraph 103 at page 37).
Regarding claim 16 of the instant application, Moseley discloses a method of treating an individual having burns, abrasions or ulcer, which reads on a cut (paragraph 61 at pages 19-20).
Regarding claim 20 of the instant application, Moseley discloses administering an antibiotic (paragraph 58 at page 18).
Regarding claims 23-24 of the instant application, Moseley discloses applying a cover over at least part of the would to prevent the fibroblast and/or fibroblast-derived products to leave the wound (paragraph 8 at page 2 and claim 8).
Regarding claims 1, 4, and 28-29 of the instant application, Banerjee discloses a method of treating a wound and thus accelerating the wound in an individual by topically administering a therapeutically effective amount of a composition comprising myofibrolast (abstract, [0008], [0013], and [0017]).
Regarding claim 10 of the instant application, Banerjee discloses administering the composition into the wound, adjacent to the wound and/or on the surface of the wound ([0050]-[0051]).
Regarding claims 12-13 of the instant application, Banerjee discloses administering a biologically active agent, such as an adjuvant, which is a chemical ([0017]).
Regarding claim 14 of the instant application, Banerjee discloses a method of treating an individual having diabetes ([0069]).
Regarding claim 15 of the instant application, Banerjee discloses treating a wound that is chronic (abstract).
Regarding claim 16 of the instant application, Banerjee discloses that a wound comprises cuts, abrasions, and burns ([0032]).
Regarding claim 20 of the instant application, Banerjee discloses administering an antibiotic ([0053]).
Regarding claims 23-24 of the instant application, Banerjee discloses applying a cover over at least part of the would to prevent the fibroblast and/or fibroblast-derived products to leave the wound ([0051]).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the claims of the reference patent by topically administering a 3D spheroid myofibroblast, keratinocytes, adjuvant, and/or antibiotic, administer into the wound, adjacent to the wound, or on the surface of the wound with a bandage/cover in an individual with chronic wound. One having ordinary skill in the art would have been motivated to do so in order to further improve and/or accelerate treating the wound. A normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine the optimum method by varying the components of the composition that is administered to an individual and delivery of the composition. “[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.”, see MPEP 2144. One of ordinary skill in the art would have had a reasonable expectation of success since the claims of the reference patent recites a method of treatment of a wound by administering a fibroblast-derived exosomes, Bizik discloses wound healing by topical administration of a 3D spheroid fibroblast, and Moseley and Banerjee teach administering keratinocytes, myofibroblast, adjuvant, and/or antibiotic, administer into the wound, adjacent to the wound, or on the surface of the wound with a bandage/cover in an individual with chronic wound.
Therefore, the conflicting claims are not patentably distinct from each other.
Conclusion
Claims 1-4, 6-10, 12-16, 20, 23-24, and 28-31 are pending.
Claims 1-4, 6-10, 12-16, 20, 23-24, and 28-31 are rejected.
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.
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/YONG D PAK/Primary Examiner, Art Unit 1652