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.
Withdrawn Claim Rejections - 35 USC § 112(b)
The rejection of claims 7-8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 7-9, 11-12 and 14 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2018 Jun 4.; see IDS filed 27th, January, 2026; henceforth “Saucedo”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Examiner’s Remark
It is noted that Applicant’s amendments necessitated the addition of an evidentiary reference to the rejection of claims 7-10 and 12-13 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”). Because the claims are still anticipated by Bader and the added reference merely evidences an inherent feature, this is not a new rejection.
Similarly, it is noted that Applicant’s amendments necessitated the addition of an evidentiary reference to the rejection of claims 11 and 14 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”) and the rejection of claims 11 and 14 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”). Because the added reference merely evidences an inherent feature, this is not a new rejection.
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 remain 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”) as newly evidenced by Noverina et al. (Clinical Nutrition Experimental 24 (2019) 34-44; henceforth “Noverina”).
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, although Bader is silent to whether the medium for mesenchymal stem cells comprises at least epidermal growth factor (EGF), the conditioned medium disclosed by Bader is from human adipose-derived mesenchymal stem cells.
Regarding claims 7-8, Noverina evidences conditioned medium (CM) from human adipose tissue-derived MSCs comprises EGF (summary; Results; Figure 1).
Therefore, regarding claims 7-8, the AD-MSCs conditioned medium (CM) disclosed by Bader inherently comprises EGF and anticipates instant claims.
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) as well as the thereby clauses of “improving sperm motility as compared with sperm cultured in the solution without the medium for mesenchymal stem cells” (instant claim 7) and “retaining sperm fertility as compared with sperm cultured in the solution without the medium for mesenchymal stem cells” (instant claim 8).
Furthermore, Bader discloses the active method steps of the instantly claimed method and therefore the functional results of the preambles and thereby clauses of “improving sperm motility”(instant claim 7) and “retaining sperm fertility” (instant claim 8) relative to sperm cultured in the solution without the medium for mesenchymal stem cells 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.
Response to Arguments
Applicant’s argument’s, filed 22nd, September, 2022, have been fully considered but are not found persuasive.
Applicant argues Bader does not teach the medium comprise EGF (pg. 4).
In response, this is not found persuasive because, as set forth above, Noverina evidences conditioned medium (CM) from human adipose tissue-derived MSCs comprises EGF.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claims 10 and 13 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”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
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.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over 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”) as newly evidenced by Noverina et al. (Clinical Nutrition Experimental 24 (2019) 34-44; henceforth “Noverina”) in view of Liu et al. (Ann Clin Lab Sci. 2019 Jan;49(1):63-71.; henceforth “Liu”).
The teachings of Bader and Noverina above are incorporated 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 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 as evidenced by Noverina, 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 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”) as newly evidenced by Noverina et al. (Clinical Nutrition Experimental 24 (2019) 34-44; henceforth “Noverina”) 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 and Noverina above are incorporated 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 as evidenced by Noverina 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.
Response to Arguments
Applicant’s argument’s, filed 22nd, September, 2022, have been fully considered but are not found persuasive.
Applicant argues Bader does not teach the medium comprise EGF (pg. 5) and therefore the combinations do not teach or make obvious the medium.
In response, this is not found persuasive because, as set forth above, Noverina evidences conditioned medium (CM) from human adipose tissue-derived MSCs comprises EGF and therefore the combinations suggested above still meet all the requirements of instant claims.
Withdrawn Double Patenting
Withdrawn Provisional Non-Statutory Double Patenting
U.S. Co-pending Application No. 18/832341
The provisional rejection of claims 7-10 and 12-13 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 set forth in the previous office action is withdrawn in view of Applicant’s filing of a terminal disclaimer.
The provisional rejection of claims 11 and 14 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”) as set forth in the previous office action is withdrawn in view of Applicant’s filing of a terminal disclaimer.
Conclusion
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.
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
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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