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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Group I (claims 1-4, 8, 10, 13, 16-17, 19-20, 22-27, and 36) in the reply filed on 03/30/2026 is acknowledged.
2. Claims 1-4, 6-8, 10, 13, 16-17, 19-20, 22-27, and 36 are pending. Claims 1-4, 8, 10, 13, 16-17, 19-20, 22-27, and 36 are currently under consideration. Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed on 08/28/2024 and 12/20/2022 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 12/20/2022 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
5. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
6. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 20 recites the broad recitation “with a spermatozoa number between about 20 % and about 60 % of the total spermatozoa number” (line 5; also see line 10), and the claim also recites “preferably about 35% of the total spermatozoa number measured per sample”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
7. Claims 1-4, 8, 10, 13, 16-17, 19-20, 22-27, and 36 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the language “between about 4% DFI to about 75% DFI” (lines 15-16), which should be amended to “between 4% DFI and 75% DFI” or “from 4% DFI to 75% DFI”. Claims 2-3 are rejected on the same ground.
Claim 20 recites the language “between about 20% DFI to about 60% DFI” (line 4), which should be amended to “between 20% DFI and 60% DFI” or “from 20% DFI to 60% DFI”.
Claims 4, 8, 10, 13, 16-17, 19, 22-27, and 36 are rejected as dependent claims.
Claim Rejections under 35 USC § 103(a)
8. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
9. Claims 1-4, 8, 10, 13, 16-17, 19-20, 22-24, 25-27, and 36 are rejected under 35 U.S.C. 103(a) as being unpatentable over Moskovtsev et al., Archives of andrology, Journal of Reproductive Systems 51:(1), pages 33-40, 2005) in view of Hossain et al (Asian Journal of Andrology 13:406-419, 2011) and Al-Essawe et al. (Cryobiology, ACADEMIC PRESS INC, US, vol. 81, 15 February 2018, pages 145-152).
Moskovtsev et al. teach a method wherein human sperm cells are stratified according to a DNA fragmentation index as determined by acridine orange (AO) staining analysed by flow cytometry and a determination of the membrane integrity as determined by hypo-osmotic swelling (HOS) test (page 34, last paragraph-page 37, last paragraph) which leads to a determination of the sperms' functionality as derivable from the sperms' motility and vitality (see, e.g. Table 1).
Moskovtsev et al. do not teach (i). stratification criteria and consequences derived therefrom recited in claim 1; (ii). the using a fluorescent test for determining membrane stability and the processing of the data obtained by these tests as recited in claims 8, 16, and 19; (iii). The routine and non-inventive data processing steps recited in claims 13, 17, and 20; (iv). The limitations of claims 25-27.
Hossain et al and Al-Essawe et al. teach a SYBR-14/PI based assay for determining sperm plasma membrane integrity and an AO-based assay for determining DNA fragmentation in sperm cells and the limitations of claims 25-27 (see, e.g., Abstract; Figures;Tables).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply the stratifications and criteria for determine the functionality of sperm cells with a reasonable expectation of success. One would have been motivated to do so because the stratifications and criteria for determine the functionality of sperm cells recited in claim 1 are routine variations of the method of Moskovtsev et al.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply SYBR-14/PI-based tests for determining membrane integrity (MI) as alternative of the HOS and the routine and non-inventive data processing steps recited in claims 13, 17, 20, and 25-27with a reasonable expectation of success. One would have been motivated to do so because these tests and the processing of the data obtained by the DNA fragmentation test and the fluorescent-based MI test are well-known in the art as taught by Hossain et al and Al-Essawe et al.
Conclusion
10. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
May 19, 2026
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