DETAILED ACTION
This action is in reply to papers filed 10/13/2025. Claims 6-9 and 16 are pending and
examined herein.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220152119A1, Published 5/19/2022.
Withdrawn Claim Rejections
The 112 (a) scope of enablement rejection of claims 6-9 and 16 are withdrawn in view of Applicant’s amendment to independent claim 6.
Claim Rejections - 35 USC § 112
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 16 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 16 recites, inter alia, “…, the one or more proliferation biomolecules, the one or more angiogenic biomolecules, the one or more migration biomolecules, the plurality of anti- inflammatory biomolecules..” At issue here is that claim 6 has been amended such that it now recites “a plurality of proliferation biomolecules… a plurality of angiogenic biomolecules… a plurality of migration biomolecules…” Thus, the recitation “the one or more proliferation biomolecules”, “…the one or more angiogenic biomolecules, and “…the one or more migration biomolecules” lacks antecedent basis. Applicant can overcome this rejection by amending claim 16 to recite “the plurality” rather than “the one or more” in the recitations cited above.
Appropriate correction is requested.
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 6-9 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 17842156 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claims are drawn to a method for treating a subject suffering from degenerative joint disease, the method comprising: administering a therapeutically effective amount of an acellular human amnion-derived composition to soft tissue of the subject, said acellular human amnion-derived composition comprising: a plurality of tissue-remodeling biomolecules comprising cystatin B (CSTB), cystatin C (CST3), plasminogen activator inhibitor-1 (PAI-1), matrix metallopeptidase 1 (MMP1), matrix metallopeptidase 13 (MMP13), nidogen-1 (NID1), cathepsin L (CTSL), extracellular matrix metalloproteinase inducer (EMMPRIN), TIMP metallopeptidase inhibitor 1 (TIMP1), TIMP metallopeptidase inhibitor 2 (TIMP2), decorin (DCN); and growth differentiation factor 15 (GDF15), a plurality of proliferation biomolecules comprising erb-b2 receptor tyrosine kinase 2 (ERBB2), dipeptidyl peptidase 4 (DPP4), epidermal growth factor receptor (EGFR), macrophage-colony stimulating factor (MCSF), and activated leukocyte cell adhesion molecule (ALCAM), a plurality of angiogenic biomolecule comprising pentraxin 3 (PTX3), angiogenin (ANG), fms related tyrosine kinase 1 (FLT1), thrombospondin 1 (THBS1), urokinase-type plasminogen activator (uPA), and transforming growth factor beta induced (TGFBI), a plurality of migration biomolecules comprising syndecan 4 (SDC4), neuronal cell adhesion molecule (NRCAM), dickkopf WNT signaling pathway inhibitor 3 (DKK3), and angiotensinogen (AGT), a plurality of anti-inflammatory biomolecules comprising follistatin like 1 (FSTL1) and galectin 1 (LGALS1), and one or more anti-microbial biomolecules comprising beta-2-microglobulin (B2M), and Cl a plurality of biomolecules comprising follistatin like 3 (FSTL3) , Fas cell surface death receptor (FAS), tumor necrosis factor receptor 1 (TNFR1), IGFBP2, IGFBP6, and Ferritin; whereby the subject is treated.
Claim 1 of App ‘156 is drawn to An acellular human amnion-derived composition, comprising: one or more tissue-remodeling biomolecules selected from the group consisting of: cystatin B (CSTB); cystatin C (CST3); plasminogen activator inhibitor-1 (PAI-1); matrix metallopeptidase 1 (MMP1); nidogen-1 (NID1); cathepsin L (CTSL); clusterin (CLU); extracellular matrix metalloproteinase inducer (EMMPRIN); TIMP metallopeptidase inhibitor 1 (TIMP1); TIMP metallopeptidase inhibitor 2 (TIMP2); decorin (DCN); tumor necrosis factor superfamily member 11A (TNFRS11A); transforming growth factor beta-induced protein ig-h3 (BIGH3); or a combination thereof, one or more proliferation biomolecules selected from the group consisting of: dipeptidyl peptidase 4 (DPP4); macrophage-colony stimulating factor (MCSF); or a combination thereof, one or more angiogenic biomolecules selected from the group consisting of: pentraxin 3 (PTX3); angiogenin (ANG); fms related tyrosine kinase 1 (FLT1); thrombospondin 1 (THBS1); transforming growth factor beta induced (TGFBI); angiopoietin 1 (ANG1); or a combination thereof, one or more migration biomolecules selected from the group consisting of: syndecan 4 (SDC4); dickkopf WNT signaling pathway inhibitor 3 (DKK3); tyrosine protein kinase receptor UFO (AXL); urokinase-type plasminogen activator receptor (UPAR); or a combination thereof, one or more anti-inflammatory biomolecules selected from the group consisting of: follistatin like 1 (FSTL1); galectin 1 (LGALS1); c-x-c motif chemokine 14 (CXCL14); or a combination thereof, and one or more anti-microbial biomolecules including beta-2-microglobulin (B2M), for use in treating a subject suffering from a connective tissue disease, hair follicle arrest, or a chronic skin wound.
The intended use recitation of the composition claims renders the method of using the composition to treat degenerative joint disease (a type of connective tissue disease) prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632