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 .
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 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.
Claim Status
Applicant’s arguments dated 10/17/25 have been received and entered in the application.
Claims 1-6 are currently pending and examined on the merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al., (Sept 2006) Identification of X- and Y-chromosome bearing buffalo (Bubalus bubalis) sperm. Animal Reproduction Science, 95(1-2) pp. 158-164 (cited on IDS dated 7/12/22, hereinafter Lu).
Regarding claims 1-3, Lu discloses methods for identifying X- and Y-chromosome bearing sperm (Abstract). Lu discloses first obtaining a sperm sample from individual animals (Sperm collection). The semen is extended in a Tyrodes, albumin, lactate, and pyruvate (TALP) solution, stained with Hoechst 33342, and sonicated to remove the sperm tails prior to sorting (Sperm staining procedure). Therefore, every limitation of claims 1-3 is present in Lu, and the subject matter is anticipated.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lu as applied to claims 1-3 above, and in view of Srivaidayapong et al., (Feb 2000) Effect of sperm diluents on the acrosome reaction in canine sperm. Theriogenology, 53(3) pp. 789-802 (cited on IDS dated 7/12/22, hereinafter Srivaidayapong).
Regarding claim 5, Lu does not disclose that the aggregation-reducing compound may be egg yolk.
Srivaidayapong compares the effects of TALP solution, egg yolk Tris extender, modified egg yolk Tris extender, and other solutions on the acrosome reaction in sperm (Abstract). As Srivaidayapong discloses that egg yolk containing extenders are known alternatives to TALP solution, it would be obvious to one of ordinary skill in the art that the TALP solution of Lu could be substituted for the egg yolk-containing extender of Srivaidayapong as a simple substitution of one known extender for another with a reasonable expectation that the semen could successfully be stained.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lu as applied to claims 1-3 above, and in view of Quan et al., Effects of Hoechst33342 staining on the viability and flow cytometric sex-sorting of frozen-thawed ram sperm. Cryobiology, 70(1) pp. 23-31 (hereinafter Quan).
Regarding claim 5, Lu does not disclose that the method is completed in 20 minutes or less.
Quan discloses methods of optimizing the effects of Hoechst 33342 staining on the viability and sorting efficiency on sperm (Abstract, Introduction). Quan discloses diluting semen in a in a modified TALP solution and staining for between 0 and 90 minutes (Hoechst33342 staining, Fig. 1). Quan explains that longer staining durations are correlated with detrimental effects on membrane integrity, sperm motility, moving velocity (Discussion). Therefore, Quan discloses that staining time is a results-effective variable, for which optimization requires no more than ordinary skill in the art. A skilled artisan viewing Lu and Quan in combination would understand that the processing method of Lu could therefore be optimized as disclosed by Quan.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu.
Applicant argues that Lu fails to anticipate the claims as it does not disclose utilizing an aggregation-reducing compound as required by claim 1 (Response p3).
In response, Lu discloses extending the semen is extended in a Tyrodes, albumin, lactate, and pyruvate (TALP) solution (Sperm staining procedure). As evidenced by Buranaamnuay, K., (2013) Sperm-TALP: An alternative extender for retrieving and diluting epididymal sperm in the domestic cat. Repro Dom Anim, 48(6): pp. 912-917 (hereinafter Buranaamnuay) the albumin utilized in TALP solution is a bovine serum albumin (BSA) (Introduction). The specification as originally filed indicates that BSA is a known aggregation reducing compound (p6 ¶ 4). Therefore, applicant’s arguments are not considered persuasive.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Srivaidayapong.
Applicant argues that a skilled artisan would not add egg yolk to the TALP medium of Lu as the references are directed to different problems (Response p3-4).
Applicant appears to have misunderstood the rejection. Srivaidayapong discloses that egg yolk containing extenders are known alternatives to TALP solution. Therefore, a skilled artisan would understand that the egg yolk extender could be used in place of (i.e., substituted) for TALP.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Quan.
Applicant argues that the combination fails to disclose a composition comprising an aggregation-reducing compound (Response p4).
As noted above, Lu discloses utilizing a TALP solution which contains the aggregation-reducing compound BSA.
Conclusion
Claims 1-3 and 5-6 are rejected. Claim 4 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached on Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632