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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Claims 3 and 52 have been amended.
Claims 55 and 56 are new.
In view of Applicant’s amendments to claim 3, the 102 rejection is withdrawn, however a new 103 rejection is set forth.
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.
Claim(s) 3, 32-36, 41, 42, 45, 46 and 48-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda M. (WO 2016/111377, published 7/14/2016, effective filing date 1/12/2016, English Translated attached) in view of Varga et al. (1987, Biochem J., Vol. 247, pgs. 597-604) and further evidenced by the teachings of Natunen et al. (2010, Glycobiology, Vol. 21(9), pgs. 1125-1130).
The claims are drawn to a product by process (i.e. “that has been used for the maintenance” or “obtained by”); the process of making carries little patentable weight. In the instant case, the process of producing a supernatant does not impart any specific property or function to the claimed composition that would distinguish it from the prior art. It is only the product, which is anticipated by the prior art and not the process, by which the product was made. This is because the final product, a composition comprising a supernatant is not distinguished by any particular features or characteristics resulting from the process by which it is made. Thus, the method of making the composition does not impart any specific property or function to the claimed composition. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making the product.
Regarding claims 3, 36 and 48, Ueda teaches “The present invention relates to a pharmaceutical composition comprising an iPS cell culture supernatant and a method for producing the same, a cosmetic and a method for producing the same, an anti-aging composition, a method for suppressing the onset of a disease, a method for treating a disease, a method for treating tissue abnormalities, and a cosmetic method.” (parags. 1 and 17).
Specifically, Ueda teaches a composition comprising a supernatant that has been used for the maintenance culture of iPS cell in an undifferentiated state, which is free of a supernatant of a medium that has been used maintenance culture of stem cells other than pluripotent stem cells and the composition promotes collagen production (parags. 6, 44, 71).
Ueda continues to teach “The inventors of the present invention have made an unprecedented attempt to use iPS cell culture supernatant for medical, cosmetic, and other purposes. As a result, the inventors have surprisingly discovered that iPS cell culture supernatant has a wide range of repair capabilities for tissues in general, and that this repair capability is
superior to that of culture supernatants of somatic stem cells such as mesenchymal stem cells and hematopoietic stem cells. This is because, compared with secretions (including growth factors, cytokines, and the like) secreted from somatic stem cells, the substance composition of secretions secreted from pluripotent iPS cells is significantly different, and as a result, it is presumed that the iPS cell culture supernatant has a wide range of repair capabilities for tissues in general, regardless of the tissue, and that the degree of repair capability is also high. Specifically, it is believed that the content of many growth factors and cytokines in the iPS cell culture supernatant is higher than that in the somatic stem cell culture supernatant, or that certain growth factors and cytokines are contained in the iPS cell culture supernatant but are not substantially contained in the somatic stem cell culture supernatant. In addition, the culture supernatant of iPS cells contains anti-aging substances (e.g., specific types of proteins) that are not contained in the culture supernatant of somatic stem cells, and as a result, the culture supernatant of iPS cells is considered to have an excellent anti-aging effect that is not seen in the culture supernatant of somatic stem cells.” (parag. 12 lines 1-14).
While Ueda teaches that the iPS cells expressed Oct3/4 and NANOG (parag. 15), Ueda does not teach the expression of TRA 1-60. However, the expression of TRA 1-60 on iPS cells would be inherent in view of the teachings of Natunen et al. who teaches that iPS cells express TRA 1-60 (see Abstract).
Regarding claims 32 and 45, Ueda teaches that the supernatant is obtained via centrifugation if media comprising iPS which are removed (parag. 26).
Regarding claim 33, Ueda teaches using ultra centrifugal filters to concentrate iPS cell culture supernatant (parag. 37).
Regarding claim 34, Ueda teaches using 4 ng/ml bFGF (parags. 84-85).
Regarding claim 35, Ueda teaches that supernatant was obtained from iPS colonies (parags. 19, 20 and 22).
Regarding claim 41, Ueda teaches using culture medium suitable for culturing human iPS cells (parag. 18).
Regarding claim 42, Ueda teaches that the supernatant may further comprise a supernatant of a medium used for maintenance of ES cells in an undifferentiated state (parag. 18).
Regarding claim 46, the maintenance culture of the iPS cells is a process by which the supernatant is obtained, i.e. performed, and does not impart any structural or functional limitations to the claimed composition that would distinguish it from the teachings of Ueda.
Regarding claim 49, the process of obtaining the supernatant does not impart any structural or functional limitations to the claimed supernatant that would distinguish it from the teachings of Ueda.
Regarding claim 50, Ueda teaches that the composition comprises 1% of the supernatant (parag. 86).
Regarding claim 51, Ueda teaches that the composition comprises emulsifiers, stabilizing agents and buffers (parag. 30).
Regarding claim 52, Ueda teaches that the supernatant comprises non-essential amino acids (parag. 18).
Regarding claim 53, as set forth above, Ueda taken with the evidence of Natunen, the iPS cells of Ueda would be NANOG, OCT 3/4, and TRA 1-60 positive.
Regarding claim 54, Ueda teaches that the medium does not comprise an EB formed from the iPS cells (parag. 0085).
Ueda does not teach:
TGFβ.
Regarding TGFβ, Varga et al. teach that TGFβ stimulates fibroblast collagen
biosynthesis and leads to persistent collagen biosynthesis after exposure to TGFβ (see Abstract, Fig.3 and Table 2, reproduced below).
PNG
media_image1.png
268
380
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Greyscale
PNG
media_image2.png
187
364
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Greyscale
Thus at the time of filing the ordinary artisan would have found it prima facie to combine the teachings of Ueda regarding a composition that promotes collagen production with the teahings of Varga regarding the role of TGFβ and collagen biosynthesis to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to combine the teachings of Varga with the teachings of Ueda since the composition of Ueda promotes collagen production and Varga teaching that TGFβ stimulates collagen biosynthesis, thus adding TGFβ to the composition of Ueda would facilitate increased collagen production.
There would have been a reasonable expectation of success that the composition of Ueda could comprise TGFβ since it is a composition comprising a supernatant.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda M. (WO 2016/111377, published 7/14/2016, effective filing date 1/12/2016, English Translated attached) in view of Varga et al. (1987, Biochem J., Vol. 247, pgs. 597-604) and further evidenced by the teachings of Natunen et al. (2010, Glycobiology, Vol. 21(9), pgs. 1125-1130) as applied to claims 3, 32-36, 41, 42, 45, 46 and 48-54 above, and further in view of Kuroda et al. (2001, J. Dermatological Sci., Vol. 26, pgs. 156-160).
Ueda and Varga are relied upon above in teaching a composition comprising a supernatant comprising TGFβ.
Ueda and Varga do not teach:
That the supernatant comprises bFGF.
Regarding bFGF and claim 55, Kuroda et al. teach that bFGF upregulates
expression of hyaluronan synthase (see Abstract and Discussion). It was well known and obvious at the of filing that hyaluronan synthase is the enzyme that synthesizes hyaluronic acid from its precursor molecules (UDP-GlcNAc and UDP-GlcUA).
Thus at the time of filing the ordinary artisan would have found it prima facie to combine the teachings of Ueda and Varga regarding a composition that promotes hyaluronic acid production with the teahings of Kuroda regarding the role of bFGF to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to combine the teachings of Ueda/Varga with the teachings of Kuroda since Kuroda teaches that bFGF is known to increase hyaluronan synthase expression and since the composition of Ueda is drawn to promoting hyaluronic acid production, it would have been obvious to add bFGF to the composition of Ueda since this will increase expression of the enzyme that produces hyaluronic acid from its precursors.
There would have been a reasonable expectation of success that the composition of Ueda could comprise bFGF since it is a composition comprising a supernatant.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda M. (WO 2016/111377, published 7/14/2016, effective filing date 1/12/2016, English Translated attached) in view of Varga et al. (1987, Biochem J., Vol. 247, pgs. 597-604) and further evidenced by the teachings of Natunen et al. (2010, Glycobiology, Vol. 21(9), pgs. 1125-1130) as applied to claims 3, 32-36, 41, 42, 45, 46 and 48-54 above, and further in view of Ku et al. (2013, 35th Annual Int. Conf. of the IEEE EMBS, pgs. 6667-6670).
Ueda and Varga are relied upon above in teaching a composition comprising a supernatant comprising TGFβ.
Ueda and Varga do not teach:
That the supernatant comprises gellan gum.
Regarding gellan gum and claim 56, Ku et al. teach that gellan gum can
work with collagen I to improve collagen I’s mechanical strength (pg. 6667 col. 2 parag. 3).
Specifically, Ku teaches “Collagen I is the main component of protein in bone
and exhibits many excellent applications in biomedical fields. Gellan gum possesses good biocompatible, biodegradable and good mechanical property, and shows great potentials as tissue
engineering scaffold or cell culture substrate.” (Abstract lines 1-5).
Thus at the time of filing the ordinary artisan would have found it prima facie to combine the teachings of Ueda and Varga regarding a composition that promotes hyaluronic acid production with the teahings of Ku regarding the role of gellan gum in cell culture to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to combine the teachings of Ueda/Varga with the teachings of Ku since Ku teaches that gellan gum possesses good biocompatible, biodegradable and good mechanical property, and shows great potentials as a cell culture substrate.
There would have been a reasonable expectation of success that the composition of Ueda could comprise gellan gum since Ku teaches that gellan gum can be a cell culture substrate.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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