DETAILED ACTION
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 Status
Claims 7-14 are pending.
Claims 7-14 are under examination.
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.
Claims 7-14 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 relative terminology of “improving sperm motility” and claim 8 recites the relative terminology “retaining sperm fertility.” A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989).
In the instant case, claim 7 recites “improving sperm motility,” which is dependent on some reference value of sperm motility which is not sufficiently defined (see MPEP 2173.05(b)).
Similarly, claim 8 recites “retaining sperm fertility,” which is dependent on some reference value of sperm fertility which is not sufficiently defined (see MPEP 2173.05(b)).
By nature of their dependency on claims 7 or 8, claims 9-14 are also rejected because they do not clarify the issue.
Claim Rejections - 35 USC § 102
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 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bader et al. (Int J Stem Cells. 2019 Nov 30;12(3):388-399.; see IDS filed 23rd, July, 2024; henceforth “Bader”).
Regarding claims 7-8, Bader discloses a method comprising culturing sperm in a solution comprising a medium for mesenchymal stem cells (“sperm groups were cultured with CM” and “AD-MSCs conditioned medium (CM)” abstract; pg. 388).
Regarding claims 7-8, it is noted that the claimed limitation of “for mesenchymal stem cells” recites and intended use of the claimed medium. In the instant case, the “AD-MSCs conditioned medium (CM)” previously hosted mesenchymal stem cells and is therefore capable of meeting this intended use.
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, 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 meets instant claims.
Regarding claims 10 and 13, further to the discussion of claims 7 or 8 above, Bader discloses the medium is a serum-free medium (serum-free medium; “Generation of conditioned medium” pg. 390 col. 2).
Accordingly, Bader anticipates instant claims.
Claims 7-9, 11-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saucedo et al. (Reproduction . 2018 Aug;156(2):163-172. Epub 2018 Jun 4.; see IDS filed 27th, January, 2026; henceforth “Saucedo”).
Regarding claims 7-8, Saucedo discloses a method comprising culturing sperm in a solution comprising a medium (“When indicated, sperm (at a concentration of 1–10 × 106/mL) were resuspended in medium supplemented with 0.3% bovine serum albumin (BSA) and incubated at 37°C in an atmosphere of 5% CO2 in air to promote capacitation” pg. 164 col. 2).
Regarding claims 7-8, it is noted that the claimed limitation of “for mesenchymal stem cells” recites and intended use of the claimed medium. In the instant case, the culture medium disclosed by Saucedo is capable of meeting the intended use of being “for mesenchymal stem cells” and therefore meets the limitations of instant claims.
Regarding the preamble of claims 7-8 and regarding claims 11 and 14, Saucedo discloses the medium comprises bFGF (instant claims 11 and 14) (“sperm were incubated under capacitating conditions in the presence or absence of rFGF2 for different periods of time” pg. 165 col. 1; see also Title; abstract) and that sperm incubation in the medium led to increased sperm motility and velocity and to enhanced intracellular Ca2+ levels and acrosomal loss compared to the control” abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170). Because the method of Saucedo results in increased sperm motility and velocity and to enhanced intracellular Ca2+ it is capable of meeting the intended use of the preambles of “improving sperm motility”(instant claim 7) and “retaining sperm fertility” (instant claim 8). Furthermore, Saucedo 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, further to the discussion of claims 7 or 8 above, Saucedo discloses culturing in the medium “to promote capacitation”( pg. 164 col. 2) and therefore this medium is capable of meeting the intended use of a sperm conditioning solution, a sperm dilution solution and a sperm preservation solution. Furthermore, as discussed above (see claims 7-8, 11 and 14 rejection above), Saucedo discloses culturing the sperm in a medium that comprises bFGF which led to increased sperm motility and velocity and to enhanced intracellular Ca2+ levels and acrosomal loss compared to the control (abstract) and therefore the medium including bFGF (rFGF2) is capable of meeting the intended use of a solution for improving sperm motility and a solution for retaining sperm fertility.
Accordingly, Saucedo anticipates instant claims.
Claim Rejections - 35 USC § 103
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.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Saucedo et al. (Reproduction . 2018 Aug;156(2):163-172. Epub 2018 Jun 4.; see IDS filed 27th, January, 2026; henceforth “Saucedo”) in view of Peirce et al. (Asian Pacific Journal of Reproduction 2015; 4(3): 222–227; henceforth “Peirce”).
The teachings of Saucedo above are hereby incorporated in their entirety.
Regarding claims 10 and 13, further to the discussion of claims 7 and 8 above, Saucedo is silent to serum-free medium.
Nevertheless, regarding claims 10 and 13, Peirce teaches a method comprising culturing sperm in serum-free medium (PF supplemented culture media; abstract; see also pg. 223; “Sperm preparation and culture”). Peirce teaches the use of serum-free media to produce biopharmaceutical products free of infectious agents (pg. 223 col. 1). Peirce teaches the use of a commercially-available protein-free suite of media can result in good preparations of washed sperm (pg. 226 col. 1).
Therefore, regarding claims 10 and 13, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Saucedo, and simply substitute the serum-free PF of Peirce for the BSA of Saucedo to obtain the predictable result of a media for culturing sperm. One of ordinary skill would have been motivated to do so as taught by Peirce to produce biopharmaceutical products free of infectious agents (pg. 223 col. 1) and because Peirce teaches the use of a commercially-available protein-free suite of media can result in good preparations of washed sperm (pg. 226 col. 1). Regarding the reasonable expectation of success, Peirce evidences successful culture of sperm in serum-free media (pg. 223; “Sperm preparation and culture”).
Hence, the claimed invention as a whole was prima facie obvious.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bader et al. (Int J Stem Cells. 2019 Nov 30;12(3):388-399.; see IDS filed 23rd, July, 2024; henceforth “Bader”) in view of Liu et al. (Ann Clin Lab Sci. 2019 Jan;49(1):63-71.; henceforth “Liu”).
Regarding claims 11 and 14, further to the discussion of claims 7 and 8 above, Bader does not teach the medium comprises ITS supplement, which includes transferrin and insulin.
Nevertheless, regarding claims 11 and 14, Liu teaches culturing MSCs with Insulin-Transferrin-Selenium (ITS) supplement as a serum-free media (Materials and Methods pg. 64-65 “Cell Culture”). Liu teaches culturing MSCs in the defined serum-free media that contained ITS was successful and supported culture proliferation, migration and differentiation capacity of the cells (pg. 70 col. 2). Liu teaches that the ITS medium has the potential to be used for the expansion of mesenchymal stem cells before clinical application (abstract).
Therefore, regarding claims 11 and 14, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Bader, and combine the know prior art element of the ITS supplement which includes insulin and transferrin, of Liu to obtain the predicable result of a media for culturing mesenchymal stem cells. One of ordinary skill would have been motivated to do so as taught by Liu to support culture proliferation (pg. 70 col. 2). Regarding the reasonable expectation of success, Liu evidences culturing MSCs in a media comprising ITS (Figures 1-2; pg. 66).
Hence, the claimed invention as a whole was prima facie obvious.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bader et al. (Int J Stem Cells. 2019 Nov 30;12(3):388-399.; see IDS filed 23rd, July, 2024; henceforth “Bader”) in view of Saucedo et al. (Reproduction . 2018 Aug;156(2):163-172. Epub 2018 Jun 4.; see IDS filed 27th, January, 2026; henceforth “Saucedo”).
The teachings of Bader above are incorporated herein in their entirety.
Regarding claims 11 and 14, further to the discussion of claims 7 and 8 above, Bader does not teach the medium comprises bFGF.
Nevertheless, regarding claims 11 and 14, Saucedo teaches incubating sperm in a medium comprising bFGF led to increased sperm motility and velocity and to enhanced intracellular Ca2+ levels and acrosomal loss compared to the control (abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170).
Therefore, regarding claims 11 and 14, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Bader and combine the known prior art element of the bFGF in the medium of Saucedo to obtain the predictable result of a media for culturing sperm. One of ordinary skill would have been motivated to do so as taught by Saucedo to increase sperm motility and velocity and enhance intracellular Ca2+ levels (abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170). Regarding the reasonable expectation of success, Saucedo evidences culturing sperm in a solution comprising a medium that comprises bFGF (“sperm were incubated under capacitating conditions in the presence or absence of rFGF2 for different periods of time” pg. 165 col. 1; see also Title; abstract) and that sperm incubation in the medium led to increased sperm motility and velocity and to enhanced intracellular Ca2+ levels and acrosomal loss compared to the control” abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170).
Hence, the claimed invention as a whole was prima facie obvious.
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
U.S. Co-pending Application No. 18/832341
Claims 7-10 and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-14 of copending application No. 18/832341(claims filed 4th, February, 2025).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for improving sperm motility and method for retaining sperm fertility anticipates the methods of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claim 7, U.S. Co-pending App ‘ 341 claims a method for improving sperm motility, comprising culturing sperm in a solution comprising a culture supernatant of mesenchymal stem cells (claim 7).
Regarding claim 8, U.S. Co-pending App ‘ 341 claims a method for retaining sperm fertility, comprising culturing sperm in a solution comprising a culture supernatant of mesenchymal stem cells (claim 8).
Regarding claims 7-8, the “culture supernatant of mesenchymal stem cells” meets the instantly claimed limitation of “a medium for mesenchymal stem cells” because the culture supernatant includes media that was previously used to culture mesenchymal stem cells and is therefore capable of meeting this intended use.
Regarding claims 9 and 12, further to the discussion of claims 7 and 8 above, U.S. Co-pending App ‘ 341 claims the medium is a sperm conditioning solution, a sperm dilution solution, a sperm preservation solution, an artificial insemination solution, an in vitro fertilization solution, a solution for improving sperm motility, or a solution for retaining sperm fertility (claims 9 and 12).
Regarding claims 10 and 13, further to the discussion of claims 7 and 8 above, U.S. Co-pending App ‘ 341 claims the medium is a serum-free medium (claims 11 and 14).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 11 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-14 of copending application No. 18/832341 (claims filed 4th, February, 2025) as applied to claims 7-8 above, and in further view of Saucedo et al. (Reproduction . 2018 Aug;156(2):163-172. Epub 2018 Jun 4.; see IDS filed 27th, January, 2026; henceforth “Saucedo”).
The teachings of U.S. Co-pending App ‘ 341 are incorporated herein in their entirety.
Regarding claims 11 and 14, further to the discussion of claims 7 and 8 above, U.S. Co-pending App ‘ 341 does not claim the culture supernatant comprises bFGF.
Nevertheless, regarding claims 11 and 14, Saucedo teaches incubating sperm in a medium comprising bFGF led to increased sperm motility and velocity and to enhanced intracellular Ca2+ levels and acrosomal loss compared to the control (abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170).
Therefore, regarding claims 11 and 14, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as claimed by U.S. Co-pending App ‘ 341 and combine the known prior art element of the bFGF in the medium of Saucedo to obtain the predictable result of a media for culturing sperm. One of ordinary skill would have been motivated to do so as taught by Saucedo to increase sperm motility and velocity and enhance intracellular Ca2+ levels (abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170). Regarding the reasonable expectation of success, Saucedo evidences culturing sperm in a solution comprising a medium that comprises bFGF (“sperm were incubated under capacitating conditions in the presence or absence of rFGF2 for different periods of time” pg. 165 col. 1; see also Title; abstract) and that sperm incubation in the medium led to increased sperm motility and velocity and to enhanced intracellular Ca2+ levels and acrosomal loss compared to the control” abstract see also “Sperm exposure to the recombinant protein led to a significant increase in the percentage of total and progressive motility”; pg. 170).
Since the instant application claims are obvious over cited application claims, in view of Saucedo, said claims are not patentably distinct.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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