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 .
Response to Amendment
Applicant’s amendment filed on 01/28/2026 is entered. Claims 1-8 are amended and claim 9 is added. Claims 1-9 are currently pending and under examination.
Prior rejections not repeated in this Action are withdrawn in view of amendment to the claims and/or Applicant’s persuasive arguments.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive. In particular, Applicant’s arguments in regard to rejection of claims 1-8 under 35 U.S.C. 103 (see Applicant remarks 01/28/2026, pgs. 9-10) that the cited combination of references fail to teach or provide any articulated reasoning, with rational underpinning, to arrive at the critical negative limitation now added to claim requiring that “the sperm sample has not been subjected to acrosome reaction” are not persuasive. The reasons are expounded under the 35 U.S.C. 103 rejection section.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see pg. 5, filed 01/28/2026, with respect to rejection of claims 1-8 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of 11/26/2025 has been withdrawn.
Applicant’s arguments, see pg. 5, filed 01/28/2026, with respect to rejection of claims 2, and 5-7 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of 11/26/2025 has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pgs. 6-7, filed 01/28/2026, with respect to rejection of claim 8 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. The rejection of 11/26/2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive. Claims 1-9 remain rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al. and Silva et al. in view of Ohashi et al and further in view of Hancock et al. (cited in previous Office Action dated 11/26/2025).
The teachings of Edwards, Silva, Ohashi, and Hancock were discussed in Office Action dated 11/26/2025 but are again summarized here briefly.
Edwards teaches improving the quality of a mammalian semen sample, including a human semen sample, by contacting the sample with a carrier bound ligand, such as an antibody, that binds an indicator of impaired sperm membrane or acrosome integrity, thereby forming bound and unbound sperm populations, and separating the carrier-bound unhealthy sperm from the unbound healthier sperm. Edwards further teaches using fresh, neat, diluted, cooled, or frozen thawed semen samples, removing seminal plasma before separation, and employing magnetic beads and magnetic separation (Detailed Description).
Edwards does not specifically teach using an anti-CD46 antibody as the ligand. However, Silva teaches that anti-CD46 antibodies discriminate sperm having intact acrosomes from sperm having disrupted, deteriorated, or reacted acrosomes (Fig. 2). Silva explains that CD46 is inaccessible to antibody in sperm having intact acrosomes, whereas acrosomal disruption or deterioration permits anti-CD46 binding. Silva further recognizes that premature acrosome reaction renders sperm infertile and that acrosome integrity should be assessed before assisted reproduction (Section 2.2).
Ohashi teaches that an anti-CD46 monoclonal antibody may be attached to paramagnetic immunobeads, contacted with human sperm, and used to capture CD46 presenting sperm, with the antibody bound sperm subsequently recovered by magnetic separation. Thus, Ohashi demonstrates the operability of a carrier bound anti-CD46 antibody for immunomagnetic separation of human sperm.
Therefore, it would have been obvious to one of ordinary skill in the art to substitute the anti-CD46 antibody taught by Silva and Ohashi for the ligand used in Edwards, because Silva identifies CD46 as a known marker of acrosomal disruption, and Ohashi demonstrates that CD46 presenting human sperm can predictably be captured using the anti-CD46 coated magnetic beads. One would have been motivated to perform this separation on a sperm sample that had not been subjected acrosome reaction so that anti-CD46 antibody would selectively bind sperm already having damaged or disrupted heads while avoiding the unnecessary exposure of CD46 on otherwise intact sperm. Inducing an acrosome reaction would have been contrary to Edwards’ objective of retaining sperm having intact acrosomes. Hancock further reaches antibody-based panning in which antibody coated sperm are retained on the antibody coated inner surface of a vessel while unbound sperm are removed by washing, thereby rendering obvious the coated vessel embodiments of claims 6 and 9.
Applicant’s arguments (see Applicant remarks 01/28/2026, pgs. 9-10) that the cited combination of references fail to teach or provide any articulated reasoning, with rational underpinning, to arrive at the critical negative limitation now added to claim requiring that “the sperm sample has not been subjected to acrosome reaction” are not persuasive. In regard to Applicant’s argument that Ohashi is premised on and affirmatively promotes acrosome reaction, Examiner asserts that Ohashi is not relied upon to teach the claimed non acrosome reacted starting condition. Edwards supplies the ordinary semen sample and the objective of removing sperm having impaired acrosomal integrity; Silva teaches that acrosomal damage or disruption, independently of a physiological acrosome reaction, exposes CD46; and Ohashi supplies an operable anti CD46 immunoseparation technique. Ohashi’s use of follicular fluid to increase the number of reacted sperm serves Ohashi’s different objective of collecting reacted sperm and does not discredit or otherwise discourage using the same known CD46 binding system to remove damaged sperm from a non-induced sample (See MPEP 2141, 2143, and 2145).
Accordingly, the combination provides an articulated reason with rational underpinning and a reasonable expectation of successfully separating CD46 positive damaged sperm, somatic cells, and cellular debris from CD46 negative sperm having intact heads. The remaining limitations of the dependent claims are met for the reasons previously set forth in the Office Action dated 11/26/2025. The present application itself recognizes that damaged or disrupted acrosomes expose CD46 even though the sample has not undergone the physiological acrosome reaction.
Conclusion
No claim is allowable.
Regarding claim 3, the phrase "preferably" introduces uncertainty as to whether the listed pre-treatment is mandatory thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). Removing “preferably” would clarify the claim and make the limitations clear.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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