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 following Action is in response to the papers filed on February 4, 2025. Claims 7-14 are currently pending as per claims filed on February 4, 2025. Claims 1-6 have been cancelled, claims 7 and 8 have been amended, and claims 9-14 are newly filed in Applicant’s amendment filed February 4, 2025.
Therefore, claims 7-14 are currently under examination to which the following grounds of rejection are applicable.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Japanese Patent Application Nos. 2022-008746 filed on January 24, 2022 and 2022-173215 filed on October 28, 2022. The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/JP2023/001663 filed on January 20, 2023. Receipt is acknowledged of untranslated certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application
Thus, the earliest possible priority for the instant application is January 24, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 23, 2024 and January 27, 2026 were filed. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
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.
Claims 7-10, 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bader et al. (International journal of stem cells 12.3 (2019): 388-399; see IDS filed July 23, 2024; hereinafter ‘Bader’).
Regarding claims 7-8, Bader discloses a method comprising culturing sperm in a solution comprising culture medium derived from cultured mesenchymal stem cells (“sperm groups were cultured with CM”; “The incubation of non-stressed and stressed sperm samples with AD-MSCs-CM for 24 h was found to have the optimum impact on sperm vacuolization, DNA fragmentation and OS levels in comparison to other incubation timings, while preserving motility, viability and morphology of cells.” (abstract; pg. 388)).
Regarding the limitation of the “culture supernatant of mesenchymal stem cells”, this limitation is encompassed by the “AD-MSCs conditioned medium (CM)” taught by Bader based on the CM not including the MSCs, and secondly based on the Specification stating “In the present invention, the mesenchymal stem cell culture supernatant is a culture supernatant obtained when mesenchymal stem cells are cultured.” (par 0036). Therefore, the CM taught by Bader reads on the claimed supernatant.
Regarding the preamble of claims 7-8, Bader discloses the method preserved motility, viability and morphology of cells, improved all sperm parameters except morphology in comparison to the non-treated group, improves sperm quality, and can be used in treating infertility (abstract) and therefore meets the preambles of “improving sperm motility”(instant claim 7) and “retaining sperm fertility” (instant claim 8). Furthermore, Bader discloses the active method steps of the instantly claimed method and therefore the functional results of the preambles of “improving sperm motility”(instant claim 7) and “retaining sperm fertility” (instant claim 8) would inherently follow the recitation of the disclosed steps.
Regarding claims 9 and 12 (similar to claim 9), further to the discussion of claims 7 or 8 above, as stated above (see claims 7-8 rejection above) Bader discloses culturing the sperm in the solution improves sperm motility and retains sperm fertility and therefore the AD-MSCs conditioned medium is meets the structural requirements of a solution “a solution for improving sperm motility” or “a solution for retaining sperm fertility” and subsequently meets the instant claims.
Regarding claims 10 and 13, further to the discussion of claims 7 or 8 above, Bader discloses the supernatant is derived from Adipose-derived mesenchymal stem cells (AD-MSCs) (abstract).
Regarding claims 11 and 14, further to the discussion of claims 7 or 8 above, Bader discloses the medium is a serum-free medium (“cells were washed twice with PBS, and re-incubated with serum-free medium”; pg. 390 col. 2, last paragraph).
Accordingly, Bader anticipates instant claims 7-14.
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.
Provisional Non-Statutory Double Patenting
Claims 7-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19 of copending Application No. 19/125,521 (claims filed on April 29, 2025).
In relation to 19/125,521, claim 14 is directed to a method for an artificial insemination, comprising treating sperm with a composition comprising mesenchymal stem cell culture supernatant. Claim 17 is directed to a method for improving an implantation rate of a fertilized ova, comprising treating a uterus, sperm, or embryo (fertilized ova) with a composition comprising mesenchymal stem cell culture supernatant. Claims 15 and 18, dependent on claims 14 and 17 respectively, recite wherein the mesenchymal stem cells are derived from adipose tissue, derived from umbilical cord tissue, or derived from bone marrow tissue. Claims 16 and 19, dependent on claims 14 and 17 respectively, recite wherein the mesenchymal stem cell culture supernatant is a mesenchymal stem cell culture supernatant obtained through culture of mesenchymal stem cells with a serum-free medium.
Instant claim 7-14 are identical to these claims as claims 7 and 8 recite culturing sperm in a solution comprising a culture supernatant of mesenchymal stem cells (MSCs). Claims 10 and 13, dependent on claims 7 and 8 respectively, recite wherein the mesenchymal stem cells are derived from adipose tissue, umbilical cord tissue, or bone marrow tissue. Claims 11 and 14, dependent on claims 7 and 8 respectively, recite wherein the mesenchymal stem cell culture supernatant is obtained by culturing the mesenchymal stem cells in a serum-free medium.
The only difference between these claims is between the preambles, in which the instant claim 7 recites a method for improving sperm motility and for claim 8 a method for retaining sperm fertility, as opposed to 19/125,521 reciting a method for an artificial insemination and a method for improving an implantation rate of a fertilized ova. Regardless, the active method steps between the claim sets are identical, and therefore the functional results of these preambles would inherently follow the recitation of the disclosed steps. The preamble is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention. Therefore, the instant application is similar to 19/125,521 for reciting identical method steps.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 7-14 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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