DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 2/25/2026 has been entered.
Request for Reconsideration
Applicant's reply filed 2/25/2026 been entered. The claims were not amended. As the instant Application did not issue to a patent, claims 1-31 remain pending of which claims 1-8 are being considered on their merits. Claims 9-31 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
Upon further consideration, claims 1-8 are considered unpatentable at this time for the reasons indicated below.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Moreno (WO 2011/123166; provided in the IDS dated 4/27/2020) in view of Natarajan (Mutation Research (2002), 504(1–2), 3-16; Reference U) and Brind’Amour et al. (Nature Methods (2011), 8(6), 484-486 and appended Online Methods; Reference V), and alternatively in view of Khan (Pakistan J. Zool., epub. Dec. 2017, 50(10):97-103; Reference W).
Moreno teaches a method of analyzing fluorescence emission characteristics in
sperm cells or sperm nuclei comprising: entraining sperm cells or nuclei
stained with a DNA dye in sheath fluid ( Hoechst 33342 ) (page 31, lines 21-
22); exposing the entrained sperm cells or sperm nuclei to an electromagnetic
radiation; determining a forward fluorescence characteristic and a side
fluorescence characteristic of individual events associated with the exposed
sperm cells or nuclei; gating the individual events based on the forward
fluorescence characteristic and the side fluorescence characteristic with a
criterion ; and determining the presence and absence of DNA aberration from
the gated individual events (page 12, line 19-22) (the sperm in the dead and
dying sperm population present a higher frequency of DNA fragmentation
(aberration), while the sperm separated into the viable subpopulation
presents reduced level DNA aberration including damage and fragmentation
(page 10, lines 25-27), reading in-part on claim 1. Moreno teaches that sex-sorted sperm are of great interest for assisted reproduction in the livestock breeding industry and that damaged and/or dead sperm lack the viability for producing offspring through methods of artificial insemination (AI), in vitro fertilization (IVF), Intracytoplasmic
Sperm Injection (ICSI), embryo transfer (ET), or other assisted reproductive procedures (p1, lines 18-22), reading in-part on the culling step of claim 1. Moreno teaches bisbenzimide as a species of DNA selective dye (p8, lines 29-33), reading on claim 2. Moreno teaches orienting and exposing sperm labeled with a DNA selective dye to a laser during flow cytometry to distinguish between sperm having an X-chromosome and Y-chromosome (p9, lines 24-28, p34, lines 5-19, and Fig. 7A), reading on claims 3 and 4. Moreno teaches viable subpopulations of sorted sperm (p10, lines 24-33), reading on claim 5. Moreno teaches obtaining sperm from a plurality of mammalian species (p5, lines 7-14), reading on claim 6. Moreno teaches detecting a peak-to-valley ratio (Fig. 8A and 8B, and p34, lines 20-26), reading on claim 7 and 8.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further cull and remove a male from a breeding program in view of Moreno, because Moreno teaches sorting the sperm based on desired characteristics and separating dead/damaged DNA and because Moreno teaches that teaches that sex-sorted sperm are of great interest for assisted reproduction in the livestock breeding industry and that damaged and/or dead sperm lack the viability for producing offspring, and so the combination would be predictably advantageous to remove male livestock from breeding programs based upon the detection non-viable sperm obtained from said male livestock. See M.P.E.P. § 2143(A).
Regarding claim 1, Moreno does not specify DNA aberration and damage as a species of deletion and/or translocation. Alternatively regarding claim 1, Moreno does not teach culling/removing a male from a breeding program.
Natarajan teaches chromosomal aberrations include deletions, translocations, inversions and duplication. (subheading 1.1 on p3-4), reading on claim 1. Natarajan teaches the state of the art that detection of theses anomalies are now known by fluorescent in situ hybridization (FISH) (subheading 9. on p-8-9), reading on claim 1.
Brind’Amour teaches that flow karyotyping uses fluo-rescent dyes specific for DNA on isolated chromosomes to cluster specific chromosomes based on their size and DNA content, and can detect chromosomal abnormalities (p484, left column, paragraph starting “The chromosomal makeup of cells…” and Figure 1), reading in-part on claim 1.
Khan teaches method of determining DNA integrity in different breed of bulls (page 99, left column, 2" full paragraph “Determination of sperm DNA integrity”), alternatively reading on claim 1. Khan teaches culling the crossbred bulls from semen production station(s) based on poor semen quality (page 100, the paragraph spanning the left and right columns underneath Table I), reading on claim 1.
Regarding the chromosomal translocations or deletions of claim 1, it would have been obvious to modify the teachings of Moreno to detect further detect deletions and translocations in view of Natarajan and Brind’Amour. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Natarajan teaches that chromosomal aberrations included deletions and translocations, because both Natarajan and Brind’Amour teach that the detection of these aberrations is known to those skilled in the art, and because Brind’Amour teaches that methods of flow karyotyping (e.g. the combination of methods of fluorescent in situ hybridization (FISH) and flow cytometry) would predictably detect chromosomal abnormalities (e.g. deletions and translocations). The skilled artisan would have been motivated to do so because Moreno teaches sorting based on DNA characteristics and removing sperm with DNA aberration including damaged sperm, and so the modification would be predictably advantageous to sort the sperm composition of Moreno based upon known chromosomal aberrations such as deletions and translocations taught by Natarajan according to the flow karyotyping methods of Brind’Amour. See M.P.E.P. § 2143(A).
Alternatively regarding the culling step of claim 1, it would have been prima facie obvious for one of ordinary skill in the art to further cull the male subjects from a breeding program of Moreno in view of Khan. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Moreno and Khan are in-part directed towards methods of obtaining sperm from male animal subjects and determining the quality of said sperm. The skilled artisan would have been motivated to do so because Khan teaches that it would be predictably advantageous to cull said male subjects based upon the determination of poor semen quality.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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