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 .
Request for Continued Examination
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 19, 2025 has been entered.
Claims 21,23-28,30,33,72-80 are under examination.
The following art rejection was provided in the last office action dated March 31, 2025. Because of applicants’ persuasive arguments, the examiner has decided to drop the art rejections and has added new rejections. The arguments will be specifically addressed 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 21, 23-28,30,33,72-74,76-80 are rejected under 35 U.S.C. 103 as being unpatentable over Du (US 20130157362) in view of Yamashita (JP2016154466)
Claims 21,73-75 are rejected under 35 U.S.C. 103 as being unpatentable over Du (US 20130157362) in view of Yamashita (JP2016154466) and Revazova (AU 2016203682)
Response to Applicants Arguments
The examiner considered applicants arguments regarding the instant set of claims. The examiner was persuaded by applicants arguments that although vitrification and freezing processes like those of Yamashita occur under very low temperatures, there are important distinctions between vitrification and Yamashita’s freezing processes as explained by applicant. The examiner was persuaded by applicants’ arguments that Yamashita was not appropriate for teaching use of a phytochemical protective covering on droplets for vitrification purposes since Yamashita taught using phytochemicals coverings for non-vitrification purposes and there was cracking in the protective oil when exposed to low temperatures. Because of applicants’ persuasive arguments, examiner is withdrawing the art rejections. Examiner carried out additional searching and found art that raises issues about enablement and written description using phytochemicals in vitrification processes.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21,23-28,30,33,72-80 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. Applicants are claiming that the droplets used for vitrification are coated with a protective layer coating (phytochemical was the elected species). One limitation of claim 21 recites, “protecting said droplet containing said vitrification medium and said specimen with said separate protective layer coating during said vitrification process from freezing damage.” This mean that the protective layer must cause this protective result (protection from freezing damage). Applicants’ specification does not provide specific examples of phytochemicals that can be used to coat droplets that are subsequently vitrified and effectively protected from damage. Plants and their phytochemicals in general cannot induce vitrification on their own (Introduction of Zamecnik, 2nd paragraph) according to Zamecnik “Vitrification Solutions of Plants Cryopreservation: Modification and Properties”. Therefore, plants and their chemicals would be unable to provide adequate protection during vitrification. The specification fails to provide specific examples of phytochemical compounds that facilitate protective vitrification themselves and which can successfully coat the droplets recited in the instant claims to provide protection from freezing.
Claim 21,23-28,30,33,72-80 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc. 8 USPQD2d 1217 (Fed. Cir. 1988). Whether undue experimentation is required is a conclusion reached by weighing several factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQQ2d 1400 (Fed. Cir. 1988).
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirements, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experiment to make and use the invention based on the content of the disclosure is undue.
Nature of the Invention:
The claims recite a method of protecting in vitro samples from vitrification. The method recites a preparing a specimen for vitrification by first placing it in a holding medium, then placing the specimen in a vitrification medium, forming a droplet containing the specimen and vitrification medium, and then coating this droplet with a protective layer composed of phytochemicals (phytochemicals was the protective layer species chosen by applicant). The claim further recites “protecting said droplet containing said vitrification medium and said specimen with said separate protective layer coating (composed of phytochemicals) during said vitrification process from freezing damage.”
Breadth of the Claims:
Applicants have already elected that the protective layer covering the droplets is composed of phytochemicals. The species elected includes any type of phytochemical. The breadth of the claims includes a protective layer that only includes phytochemicals. Any phytochemical in the protective layer can be used to successfully protect a specimen and the vitrification medium during freezing.
Teachings from the Prior Art:
Zamecnik “Vitrification Solutions for Plant Cryopreservation: Modification and Properties” Plants 2021 teaches specifically, “most plants cannot vitrify themselves because they lack glassy state inducing substances and/or have a high water content (Introduction, 2nd Paragraph).” If plants and/or their plant products cannot induce vitrification, then phytochemicals cannot be effectively used in a protective layer coating to protect specimens and/or vitrification medium during the vitrification process.
Applicants Specification/Guidance/Working Examples:
The specification lists many components that can be used in a protective layer coating composition. One species among many are phytochemicals. A phytochemical is a substance produced by a plant. The specification states that phytochemicals can be used in either the vitrification medium or as a protective coating/layer in a summary paragraph which is not connected to actual data/experimentation. Working example 6 of the specification only states that extract I was used as the protective layer. In Page 25, Table 1 of applicants’ specification, Extract I is listed as being composed of unsaturated fatty acids, saturated fatty acids, polar lipids, phospholipids, and palmitoleic acid. Extract I does not incorporate the phytochemicals which are used in the other extracts such as quercitin. The specification discusses covering the droplets with Extract I, not with the other extracts that contain phytochemicals.
Conclusion
Applicants and the prior art have not demonstrated that phytochemicals can be effectively used to coat droplets so that such droplets can be successfully protected during vitrification.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638