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 .
Claims 21,23,25-28,30,33,72-80 are under examination.
Response to Applicants’ Arguments/Amendments
The claims of 9/19/2025 recite that the phytochemical coating (elected species) is able to successfully prevent freezing damage. This resulted in a written description rejection and enablement rejection because phytochemicals are not known to protect cells from freezing during vitrification. Therefore, applicants amended the claims to state that the phytochemical covering just protects the droplets from contamination. The former rejections have been withdrawn and new rejections put forward.
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, 23-28,30,33,72-74,76,78-80 are rejected under 35 U.S.C. 103 as being unpatentable over Du (US 20130157362) in view of Tran (US 20150299516)
Du discloses a method of protecting in vitro samples from temperature depression comprising the steps of:
- providing a specimen in a holding medium (Paragraph 28);
- removing said specimen from said holding medium (Paragraph 29);
- placing said specimen in a vitrification medium (Paragraph 30);
- forming a droplet comprising said specimen and said vitrification medium (Paragraph 30);
- creating a protective layer coating around said droplet containing said vitrification medium and said specimen (Paragraph 31 and 36); and
- subjecting said droplet with said protective layer coating to a vitrification process (Paragraph 38) as in instant Claim 21.
The Du reference does not specifically teach a phytochemical protective coating layer that can be placed over the vitrification medium and specimen to provide protection during a freezing process. However, Tran teaches that trehalose can be used as a protective coating in a vitrification process (Paragraph 66 of Tran). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used trehalose as a protective coating when vitrifying a sample. An artisan would have been motivated to have coated a sample with trehalose (a phytochemical) because trehalose is able to remain stable and protect the sample within (Paragraph 66 of Tran). Because Tran teaches that trehalose can cover specimens and provide protection during vitrification, there would have been a high expectation for success (Paragraph 66 of Tran). as in instant Claims 21 and 30.
Dependent Claims taught by Tran
Du teaches a step of protecting said specimen during increase or decrease of temperature of said specimen as it transitions between an unstable zone of temperature transitions (Paragraph 38) as in instant Claim 23. Du teaches the protective layer coating comprises a physical barrier (Paragraph 38) as in instant Claim 25. Du teaches a step of providing cellular benefits to said specimen with said supplemented vitrification medium and said protective layer (the reduction of the formation of ice crystals described in paragraph 38 provide cellular benefits to the specimen) as in instant Claim 27. Du teaches that the cellular benefits are chosen from providing membrane stability, maintaining DNA quality, decreasing cellular reorganization, and decrease organellular reorganization (Paragraph 38) as in instant Claim 28. Du teaches after said step of removing said specimen from said holding medium, placing said specimen in an equilibrium medium; and removing said specimen from said equilibrium medium before said step of placing said specimen in said vitrification medium (Paragraph 10 states that when vitrifying oocytes, the oocytes can be placed directly into an equilibration medium before the vitrification step) as in instant Claim 33. Du teaches loading said droplet with said protective layer coating onto a vitrification device and plunging said device with said droplet into liquid nitrogen (Paragraph 54) as in instant Claim 72. Du teaches a step of thawing said droplet with said protective layer coating in a warming medium after said step of subjecting said droplet with said protective layer coating to said vitrification process (Paragraph 62) as in instant Claim 73. Figure 4 of Du shows that the vitrified droplets containing samples are placed into the following medium types which at least consist of four medium types (warming medium, rehydration medium, base medium, and a rinse medium) as in instant Claim 74. Du teaches that the specimens are gametes (Paragraphs 13, 22) as in instant Claim 76. Du teaches wherein said step of forming said droplet comprising said specimen and said vitrification medium comprises a step of forming said droplet comprising a single specimen and said vitrification medium. (Paragraph 29 states that “at least one embryo or oocyte” may be used which means that just one can be used). Paragraph 30 further details how such specimens are able to mix with vitrification medium in order to form droplets as in instant Claim 80.
Dependent Claims taught by Tran
Tran teaches a step of protecting said specimen during decrease of temperature of said specimen as it transitions between unstable zone of temperature transitions (Paragraph 66 of Tran) as in instant Claim 23. Tran teaches wherein said separate protective layer coating comprises a physical barrier which is capable of keeping many physical contaminants listed in claim 26 out (Paragraphs 61-64,66-68 of Tran) as in instant Claims 25 and 26. Tran’s coating would provide membrane stability (Paragraphs 61-64,66-68 of Tran) as in instant Claims 27 and 28. Tran teaches trehalose which is a phytochemical (Paragraphs 61-64,66-68 of Tran) as instant Claim 30. Tran teaches applying a protective layer substance to said droplet comprising said specimen and said vitrification medium (Paragraphs 61-64,66-68 of Tran) as in instant Claim 78. Tran teaches layering said droplet containing said vitrification medium and said specimen with said protective layer substance (Paragraphs 61-64,66-68 of Tran) as in instant claim 79.
Du teaches a method of vitrification which can result in the vitrification of gametes. Du does not teach that such vitrified samples can be successfully coated with a phytochemical such as trehalose. However, Tran teaches that biological samples can be successfully coated in order to provide further protection. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and P.h.Ds. they will be medical doctors, scientists, or engineers. Thus, these people most likely will have the practical knowledge and be well-read in the relevant literature. These people will have the practical knowledge in molecular biology, supercooling, and vitrification. Therefore, the level of ordinary skill in this art is high.
Claims 21,23,25-28,30,33,72-76,78-80 are rejected under 35 U.S.C. 103 as being unpatentable over Du (US 20130157362) in view of Tran (US 20150299516) and Revazova (AU 2016203682)
Du and Tran apply as above to teach claims 21,23,25-28,30,33,72-74,76,78-80. Du teaches that the biological specimens in the vitrification droplets can be further processed using multiple warming solutions after vitrification (a freezing process). However, Du fails to go into detail concerning the osmolarity of all the mediums that specimens with oocytes should be exposed to during the thawing. Revazova specifically states, “after recovery of cells from a frozen or dried state, any external preservation agent may be optionally removed from the culture medium. For example, the media (which can be considered a warming medium) may be diluted by the addition of corresponding media with a lower concentration of preservation agent. For example, the recovered cells may be incubated for approximately five minutes containing a lower concentration of sugar than used for cell storage....To minimize any osmotic shock induced by the decrease in osmolarity of the media, the concentration of the extracellular preservation agent may be slowly decreased. These dilution steps may be repeated (using multiple warming mediums) until there is no extracellular preservation agent present or until the concentration of the preservation agent or the osmolarity of the media is reduced to a desired level (Paragraph 98).”
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the protective thawing measures of Revazova with the vitrified droplets during thawing. An artisan would have been motivated to have used such a method in order to protect cells that were thawed. Furthermore, it would be expected for an artisan to optimize the amount of warming solutions needed in which the amount of preservation agent was slowly reduced.
MPEP § 2144.05 (II) states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”): In re Williams, 36 F.2d 436, 438 (CCPA 1929) (‘It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’ | Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
A review of the specification fails to provide evidence that the claimed concentration are critical. Absent such evidence it would have been obvious to an artisan of ordinary skill at the time of effectively filing Revazova to try a finite number of possible concentrations for each of the warming mediums to predictably arrive at the claimed concentration through routine optimization. An artisan would have a reasonable expectation of success in optimizing the concentration of cryopreservative/osmolality because such optimization was long established in the art as demonstrated by Revazova. Furthermore, Revazova teaches that it was known to decrease the osmolality of such solutions. Thus, Revazova renders obvious the instantly claimed concentration, osmolality, and number of mediums in instant claim 75.
Du teaches a method of vitrification which can result in the vitrification of gametes. Du does not teach that such vitrified samples can be successfully coated with a phytochemical such as trehalose. However, Tran teaches that biological samples can be successfully coated in order to provide further protection. An artisan would have been further motivated to have included the thawing teachings of Revazova in order to successfully preserve the biological specimens during thawing. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and P.h.Ds. they will be medical doctors, scientists, or engineers. Thus, these people most likely will have the practical knowledge and be well-read in the relevant literature. These people will have the practical knowledge in molecular biology, supercooling, and vitrification. Therefore, the level of ordinary skill in this art is high.
Claims 21,23,25-28,30,33,72-74,76-80 are rejected under 35 U.S.C. 103 as being unpatentable over Du (US 20130157362) in view of Tran (US 20150299516) and Takemasa (JP 6238186)
Du and Tran apply as above to teach 21,23,25-28,30,33,72-74,76,78-80. Du focuses on creating vitrification drops that contain either oocytes and/or embryos. Du does not teach that such droplets contain sperm cells. However, Takemasa states that sperm cells can be preserved by vitrification (Placement device Section). It would have been obvious to an artisan of ordinary skill in the art to have preserved sperm cells taught in Takemasa using the method of Du. Since sperm cells can be preserved by vitrification (Placement of Device Section—Takemasa), it would have been obvious to have preserved sperm cells using the vitrification method taught in Du. Because Takemasa teaches that sperm cells can be vitrified, there would have been a high expectation for success (Placement Device Section) as in instant Claim 77.
Du teaches a method of vitrification which can result in the vitrification of gametes. Du does not teach that such vitrified samples can be successfully coated with a phytochemical such as trehalose. However, Tran teaches that biological samples can be successfully coated in order to provide further protection. An artisan would have been further motivated to have preserved sperm cells using the process of Du since Takemasa teaches that sperm cells can be successfully vitrified. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and P.h.Ds. they will be medical doctors, scientists, or engineers. Thus, these people most likely will have the practical knowledge and be well-read in the relevant literature. These people will have the practical knowledge in molecular biology, supercooling, and vitrification. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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