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 .
It is noted that Examiner for the present application has been changed. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Examiner Masudur Rahman.
Claim status
In the reply on 16 December 2025, Applicant has withdrawn claim 1-5. Claim 8-13 have been cancelled. Therefore, claims 1-7 and 14-25 are herein pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 6, 7, and 14-25, drawn to a method of culturing sperm, an egg, or fertilized egg comprising culturing sperm, an egg, or fertilized egg in a medium that includes an agent comprising selenoneine or ergothioneine in the reply filed on 16 December 2025 is acknowledged.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 6-7 and 14-25 are under current examination.
Priority
This application was filed 06/24/2022 and is a 371 application of PCT/JP2020/048973 filed on 12/25/2020, which claims benefit to the foreign application 2019-238352 filed on 12/25/2019.
Filing of a certified untranslated copy of the JP 2019-238352, filed 06/24/2022 is acknowledged. MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 12/25/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/03/2022, 10/10/2023, 02/14/2024 are is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 06/24/2022 is objected to because the abstract is only 45 words in length, therefore, submitted abstract is considered non-compliant.
Applicant is reminded of the proper language and format for an abstract of the disclosure. MPEP §608.01(b) states that the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
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 6-7 and 14-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hausman et al., (US20100227307A1; cited in IDS filed 10/03/2022; herein after “Hausman”).
With respect to claims 6-7 and 14-18, Hausman teaches relates to cell, tissue or derivatives thereof, preserving compositions for cells in culture, storage, or lyophilization [0006-0007]. Wherein the ergothioneine is added as a supplement to such extender or preservative compositions in the medium [0052]. Sperm cells so treated showed increased motility when thawed compared to cells that were not treated with ergothioneine (abstract, [0030]-[0031] and claims 1-19).
Regarding claims 19-25, Hausman teaches in vitro fertilization, and embryo transfer technology are also used in humans to aid in the conception process, and/or as a solution to various physiological problems relating to infertility. Clearly, maintaining the viability of reproductive cells for these uses is also very important Accordingly, Hausman discloses a safe and relatively inexpensive cell preservative compounds which improve cell viability after cell culture, long term storage, cryopreservation, and even short term suspensions [0012], [0014]-[0015].
Accordingly, Hausman anticipates the instant claims 6-7 and 14-25.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 6-7 and 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over Coyan et al., (Small Ruminant Research, 2012, vol. 106, pp. 165-167; cited in IDS filed 10/03/2022; herein after “Coyan”).
Regarding claims 6-7 and 14, Coyan indicates that when freezing ram sperm, post-thaw damage to sperm DNA was suppressed by freezing after adding the antioxidant ergothioneine to a liquid (e.g., medium) to be frozen. Additionally, Coyan indicates that sperm DNA damage was inspected using single cell gel electrophoresis (COMET), and that in comparison with a control, fragmentation of DNA was suppressed, and DNA damage was significantly suppressed (abstract, p. 166 section 2.3, and section 3 and 4).
However, the claims 6-7 and 14 pertain to a substance that contains a fertilized egg fragmentation inhibitor comprising ergothioneine, and because the substance is actually ergothioneine itself, it is not possible to distinguish between antioxidant ergothioneine disclosed by Coyan and the invention as in claims 6-7 and 14 of the present application as substances.
Nevertheless, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to prepare said nucleic acid because each of the individual elements of the instant claims are independently presented by Coyan as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the elements into a single embodiment would be apparent to an artisan skilled in culturing sperm, egg or fertilized egg in light of the Supreme Court’s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements were known in the prior art and one skilled in the art could have combined the element as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Each of the elements culturing sperm, egg or fertilized egg, comprising selenoneine or ergothioneine, or a tautomer or dimer thereof, or a pharmaceutically acceptable salt thereof in medium are taught by Coyan. It would be therefore predictably obvious to use a combination of these elements in said a sperm culturing method.
Therefore, it is obvious that Coyan disclose the invention as in claims 6-7 and 14 of the present application. In addition, a person skilled in the art could have easily arrived at the invention as in claim 25 of the present application on the basis of the invention disclosed by Coyan. Similarly, the invention as in claims 15-24 is a matter that a person skilled in the art could have easily arrived at on the basis of the invention disclosed by Coyan.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684