DETAILED ACTION
Applicant’s response filed January 30, 2026, Supplemental Response of February 23, 2026 and Declaration under 37 CFR 1.132 of February 23, 2026, have been received and entered into the application file. All arguments have been fully considered. Claims 1-16 are currently pending.
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 .
REJECTION(S) WITHDRAWN
Claim Rejections - 35 USC § 102
RE: Rejection of Claim(s) 1-4, 6, 11-12 and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Guan; and
Rejection of Claim(s) 1-4 and 11-12 under 35 U.S.C. 102(a)(1) as being anticipated by Heidari-Moghadam:
Applicant has amended claims 1 and 11 to specifically require bovine fat-derived stem cells are cultured in the presence of 5-20% of horse serum.
Applicant’s arguments, see Remarks, pages 6-7, filed January 30, 2026, with respect to the teachings of Guan and Heidari-Moghadam have been fully considered, in combination with the Declaration provided by Dr. Matsusaki.
The Declaration provided by Dr. Matsusaki sets forth experimental data showing culturing of human ADSCs in the presence of 10% human serum (without presence of horse serum) did not produce a vascular construct. The Declaration further shows that, in terms of the presence or absence of gene expression, rat and mouse ADSCs exhibit a significantly higher similarity to human ADSCs than to bovine ADSCs.
The Declaration asserts that, based on the gene expression results, one skilled in the art would infer that rat ADSCs would likely exhibit the same outcome as human ADSCs-that is, a failure to form a vascular network.
Applicant’s Declaration is persuasive in showing that the claimed bovine fat-derived stem cells (adipose-derived stem cells) are distinct from the prior art rat and human ADSCs.
Applicant has amended claims 1 and 11 to specifically require bovine fat-derived stem cells are cultured in the presence of 5-20% horse serum. Applicant’s experimental data shown in FIG.6 illustrates the improved differentiation effect (CD31 expression) when greater than 5% horse serum is present in the culturing of the bovine fat-derived stem cells.
Thus, Applicant’s arguments, and Declaration showing that the claimed bovine fat-derived stem cells (adipose-derived stem cells) are distinct from the prior art rat and human ADSCs, are persuasive in overcoming the previous rejections of record.
Claim Rejections - 35 USC § 103
RE: Rejection of Claim(s) 5 and 11 under 35 U.S.C. 103 as being unpatentable over Guan, in view of Lu;
Rejection of Claim(s) 5 and 11 under 35 U.S.C. 103 as being unpatentable over Moghadam, view of Lu;
Rejection of Claim(s) 6 and 14 under 35 U.S.C. 103 as being unpatentable over Moghadam, and further in view of Guan;
Rejection of Claim(s) 7-10 and 15-16 under 35 U.S.C. 103 as being unpatentable over Guan, and further in view of WO 2020/203369; and
Rejection of Claim(s) 7-10 and 15-16 under 35 U.S.C. 103 as being unpatentable over Moghadam, and further in view of WO 2020/203369:
For the reasons discussed above, the anticipation rejections over Guan and Moghadam have been withdrawn, and thus the obviousness rejections that is based on the same basis are likewise withdrawn.
REJECTION MAINTAINED/UPDATED
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 1-16 remain 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 now recites:
A method for producing a tissue construct comprising vascular cells, comprising incubating cells comprising at least bovine fat-derived stem cells in a culture medium comprising horse serum in an amount of 5 to 20% of the culture medium.
Claim 11 now recites:
A method for promoting differentiation of fat-derived stem cells, comprising incubating cells comprising at least bovine fat-derived stem cells in a culture medium comprising horse serum in an amount of 5 to 20% of the culture medium.
Dependent claims 2-10 either depend directly from claim 1, or incorporate the method of claim 1. Dependent claims 12-16 either depend directly from claim 11, or incorporate the method of claim 11.
Although the claims have been amended to require specific amounts of horse serum, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of a method for producing a tissue construct comprising vascular cells, comprising incubating cells comprising at least bovine fat-derived stem cells for any period of time (e.g., one minute) in the presence of the recited amount of horse serum.
Applicants have not provided sufficient description of the invention to support they were in possession of a method for promoting differentiation of fat-derived stem cells, comprising incubating cells comprising bovine fat-derived stem cells for any period of time (e.g., one minute) in the presence of the recited amount of horse serum.
In the instant case the only references in the specification to:
producing a tissue construct comprising vascular cells from bovine fat-derived stem cells is by incubating the bovine fat-derived stem cells in the presence of 5-20% horse serum; and
promoting differentiation of bovine fat-derived stem cells in the presence of 5-20% horse serum,
are directed to culturing for at least 7 days in the presence of the recited amounts of horse serum to achieve the CD31 positive vascular cells (Fig. 3, Fig. 6, [0098], [0101], [0104], [0106] and [0117]).
A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of producing vascular cells by incubating the bovine fat-derived stem cells for any period (e.g., 10 minutes) in the presence of 5-20% horse serum. Applicants have not provided sufficient description of the invention to support they were in possession of promoting differentiation of fat-derived stem cells by incubating the bovine fat-derived stem cells for any period of time (e.g. 10 minutes) in the presence of 5-20% horse serum.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
Response to Remarks:
Applicant has traversed the rejection of record, with respect to the "incubation period" aspect, on the grounds the claim requirement of "producing a tissue construct" places practical upper and lower limits on the incubation period, so that the claim does not embrace the infinitely short and infinitely long periods, or even periods in which tissue construct is not produced.
Applicant’s remarks have been carefully considered, but are not found persuasive precisely because the claims require that a mature tissue construct comprising vascular cells is produced from a starting cell population of bovine fat-derived adipose stem cells, which are not yet mature vascular cells, however the claims as currently drafted encompass an open-ended time period, that is the claims encompass any time period including one that is as brief as a few minutes. Applicant’s specification does not support such a brief time period for producing a tissue construct comprising vascular cells.
As discussed above, Applicant’s disclosure shows culturing for at least 7 days in the presence of the recited amounts of horse serum is required to achieve the CD31 positive vascular cells (Fig. 3, Fig. 6, [0098], [0101], [0104], [0106] and [0117]).
NEW GROUND(S) OF REJECTION, NECESSITATED BY AMENDMENT
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 7, 10, 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 11 have been amended to now recite the limitation “bovine fat-derived stem cells”.
Claims 3, 7, 10 and 15 recite the limitation “…comprising at least fat-derived stem cells…”, and thus render claims 3, 7, 10 and 15 indefinite since it is unclear if the recited fat-derived stem cells are the same or different from the amened “bovine fat-derived stem cells”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 12, 13 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 1 and 11 have been amended to now recite the limitation “bovine fat-derived stem cells”.
Claims 5 and 13 recite the following:
5. The method according to claim 1, wherein the fat-derived stem cells are bovine-derived.
13. The method according to claim 11, wherein the fat-derived stem cells are bovine-derived.
Claims 5 and 13 fail to further limit the subject matter of the claims upon which they depend.
Claims 12 and 15 recite the following:
12. The method according to claim 11, wherein the incubating in the presence of horse serum is incubating in a culture medium comprising the horse serum.
15. The method according to claim 11, further comprising incubating cells comprising at least fat-derived stem cells and a fragmented extracellular matrix component in the presence of horse serum.
Claims 12 and 15 fail to further limit claim 11 since claim 11 has been amended to now recite the phrase “in a culture medium comprising horse serum in an amount of 5 to 20% of the culture medium.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claim is allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633