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
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 08/21/2026 has been entered. 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 Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Withdrawn Objections and/or Rejections
The rejection of claims 1-4, 8, 10, 13, 16-17, 19-20, 22-27, and 36 under 35 U.S.C. 112(b) is withdrawn in view of amended claims.
Claim Rejections under 35 USC § 103(a)
(i). 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.
(ii). 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 determining 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 25-27 with 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.
Response to Applicant’s argument
Applicant argues that the subject matter of claim 1 particularly differs from the teachings of Moskovtsev by at least the features of four categories recited in claim 1. Moskovtsev does not analyze the four categories "membrane non-intact spermatozoa, having low levels of fragmented DNA, membrane non-intact spermatozoa, having high levels of fragmented DNA, membrane intact spermatozoa, having low levels of fragmented DNA, and membrane intact spermatozoa, having high levels of fragmented DNA ". There is no teaching or suggestion in Moskovtsev that one of skill should look at those specific categories.
Applicant’s argument has been fully considered but is not deemed to be persuasive for the following reasons. First, category (i) recite “membrane non-intact spermatozoa, having a DNA fragmentation index (%DFI) portion of at most about 5%”, whereas category (ii) recites “membrane non-intact spermatozoa, having a DNA fragmentation index (%DFI) portion of at least about 1%. There is 5% overlap in scope of DNA fragmentation index (%DFI) portion (Category (i):<=5%); Category (ii): >=1). Likewise, there is 5% overlap in scope of DNA fragmentation index (%DFI) portion in Category (iii) and Category (iv). Thus, Applicant’s argument about the stratification does not hold.
Second, in view of the teachings of the cited art, 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 determining the functionality of sperm cells recited in claim 1 are routine variations of the method of Moskovtsev et al.
Finally, claim 1 recites two active steps: (a) assaying spermatozoa comprised by said sample for membrane integrity; and (b) assaying spermatozoa comprised by said sample for DNA fragmentation. Moskovtsev et al. teach the two steps. The “wherein” clauses and the stratification criteria recited in the “wherein” clauses do not represent an active step; they simply represent a mental process. Thus, they do not limit claim 1.
Applicant argues that the teachings of Hossain and Al-Essawe do not rectify the deficiencies of Moskovtsev, nor do the teachings of Hossain and Al-Essawe render the missing features obvious.
Applicant’s argument has been fully considered but is not deemed to be persuasive because 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 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 25-27 with 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
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.
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 September 26, 2026
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