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 .
Status of Claims
Claims 8, 9, 11, 13-16, and 18-29 are pending.
Claims 8, 15, 16 and 18 are amended.
Claims 1-7, 10, 12, and 17 are cancelled.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/JP2019/040145, filed 10/11/2019. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 10/15/2018. It is noted, however, that applicant has not filed a certified copy of the JP2018-194380 application as required by 37 CFR 1.55.
Information Disclosure Statement
All references from IDS(s) received 04/14/2021, 08/04/2022, and 09/12/2023 have been considered unless marked with a strikethrough.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/12/2025 has been entered.
Response to Arguments
Applicant's arguments filed 7/15/2025 have been fully considered but they are not persuasive. In a final dated 4/16/2025, Claims 8, 9, and 11-29 were examined upon their merits.
In a final dated 4/16/2025, Claims 8 and 12-17 were rejected 35 U.S.C. 112(a) and claims 8, 9, and 11-29 were rejected under 35 U.S.C. 103. In response, Applicant cancelled claims 12 and 17, amended claims 8, 15, 16 and 18. Therefore, in view of Applicants cancellation of claims 12 and 17, the 103 rejections for these claims is moot.
With respect to the 112 rejection, the Applicant has amended the claim where it no longer reads “configured to suppress formation and/or proliferation of undesired cells derived from stem cells…” and therefore, the 112 rejection is moot and withdrawn.
With respect to the 103 rejection, Claim 8 has been amended to the following:
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In the previous response and in this current one, the applicant admits that although Fukuda does not teach valine-free DMEM, Chen does teach L-valine free DMEM. The applicant argues that Chen teaches in favor of L-valine presence in the media as L-valine is reported to have an antibacterial effect. The Examiner maintains the argument that Chen does not teach away from the composition of the current claims because the instant application has no motivation for antibacterial properties. The Examiner shifts the burden to the applicant to show the criticality of valine having an antibacterial effect and its bearing on the instant claims.
The Applicant argues that neither Fukuda or Chen teach a solid food, a semi-solid food, or a beverage and therefore a person skilled in the art would not be motivated to use valine-free composition and apply it to the teachings of Fukuda.
In light of this argument, the Examiner presents new art. Yonekubo (JPS5953429A) teaches a composition that is caline-free for diabetic instants but contains phenylalanine, lysine, methionine, threonine, tryptophan, histidine, arginine, asparagine, cysteine, glutamate, glycine, proline, serine, and tyrosine, as required by the instant claims. Yonekubo teaches the composition as a nutritional supplement that is administered orally, therefore it would be obvious that this would include a food, semi-solid food, or beverage. Therefore, a person skilled in the art would be motivated to extract the teachings of Yonekubo and modify them with the teachings of Fukuda. Therefore, a new 103 rejection is added.
NEW REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 8, 9, 11, 13-16, and 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda et al. (US20170327787A1; Nov 2017; cited in the IDS filed 04/14/2021; “Fukuda”) in further view of Yonekubo et al. (JPS5953429A; 1984) and Chen et al. (Front. Immunol., 2017; cited in the IDS filed 04/14/2021; “Chen”).
Fukuda teaches a culture media, as required by instant claim 23, that can be used for elimination of undifferentiated stem cells (SCs) and purification and refinement of cardiomyocytes (CMs) (Page 1, p. 0001). Fukuda analyzes multiple different compositions of culture media, with different specific non-essential and essential amino acids, to investigate which composition best enables the elimination of undifferentiated SCs. In one example, Fukuda teaches a DMEM culture media, which usually contains glutamine, cysteine, methionine, and threonine (Page 9, p. 0134), as required by instant claim 18 and 24. Further, Fukuda does not describe any composition in which valine is present, so it is presumed that valine is not present in any of the media compositions. Fukuda further teaches a method/use of the culture media composition to eliminate undifferentiated SCs (Claims 6 and 19), as required by instant claims 9 and 11.
Fukuda teaches a culture media that is free of glutamine (Claims 1, 6, 11, 19), free of serine and glycine (Claims 3, 8, 14, 23), and free of arginine (Claims 4, 9, 15, 24). Fukuda teaches a DMEM solution free of all four amino acids (Page 9, p. 0132). Further, high glucose DMEM is known in the art to not contain asparagine. Therefore, Fukuda teaches a composition which comprises no non-essential amino acids, as required by instant claim 13, 19, and 25. Fukuda also teaches a culture media each free from each of the amino acids individually (Page 9, p. 0132). For example, in one embodiment the DMEM would be free of glutamine but would still contain serine, glycine, and arginine. Therefore, instant claim 14, 20, and 26, which calls for the composition to consist of at least one non-essential amino acid, is taught by Fukuda.
With respect to Claims 15, 21, and 27, Fukuda teaches a cell culture medium comprising supplemental lactate, pyruvate, fatty acid, ascorbate, or albumin (Claims 11 and 18-19), as required by instant claim 15’s limitation of the composition further comprising a nutrient other than the amino acid.
Fukuda does not teach a “kit” or explicitly a composition without valine, as described by Claim 8.
However, under the Examiner’s BRI, a kit would be any implicit container holding components or reagents together along with the components/reagents themselves. More specifically, since the instant claims require a kit to have a culture medium and a cell population in a “kit”, the teaching of Fukuda in the use of the cardiomyocytes (cell population) with DMEM (cell medium), would implicitly imply the use of a “kit.”
Fukuda fails to teach the composition without valine or it as a food, semi-solid food, or beverage.
Yonekubo teaches a composition that is valine-free for diabetic instants but contains phenylalanine, lysine, methionine, threonine, tryptophan, histidine, arginine, asparagine, cysteine, glutamate, glycine, proline, serine, and tyrosine, as required by the instant claims. Yonekubo teaches the composition as a nutritional supplement that is administered orally, therefore it would be obvious that this would include a food, semi-solid food, or beverage. Therefore, a person skilled in the art would be motivated to extract the teachings of Yonekubo and modify them with the teachings of Fukuda.
Fukuda and Yonekubo fail to teach the administration of the composition for at least 7 days, as described by Claim 16, 22, and 28.
Chen teaches a method of culturing macrophages (a cell population that has undergone differentiation from stem cells) and a reagent for a quantitative phagocytosis assay, in the same capacity. This teaching of Chen implies that something must hold the reagents. Under the Examiner’s BRI, that something holding the reagents along with the reagents themselves is considered a “kit.” More specifically, since the instant claims require a kit to have a culture medium and a cell population in a “kit”, the teaching of Chen in the use of the macrophages (cell population), with DMEM (cell medium), and a reagent would implicitly imply the use of a “kit.”
Chen also teaches the use of a DMEM culture medium that does not contain valine (Page 3, “Cell Culture and Quantitative Phagocytosis Assay”). Further, Chen teaches the use of the medium in mice (mammals) for up to 15 days (Figure 1B). Although Chen does not directly describe a nutritional composition used for the suppressing the formation and/or proliferation of undesired stem cells, Chen does teach a composition that is indistinguishable from the composition claimed in the instant application as well as the composition taught by Fukuda. Therefore, through the combination of teachings of Fukuda and Chen, it would have been obvious to someone skilled in the art at the time to administer the composition designed for suppressing stem cell differentiation in a kit variation, as well as for at least 7 days to an in vivo mammal population, as required by instant claims 16, 22, and 28.
With respect to instant claim 29, both Fukuda and Chen teach culture media, which is a liquid.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to apply the composition to eliminate undifferentiated stem cells, as taught by Fukuda, to the methods taught by Chen, which include the use of a kit and administration of the composition for at least 7 days to mammals (mice). It would have also been obvious to include a valine-free composition in the form of a food or beverage since this is a known nutritional composition in the treatment of metabolic diseases, as taught by Yonekubo.
Conclusion
Claims 8, 9, 11, 13-16, and 18-29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached on (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621