DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election without traverse of Group I, presently claims 1-5, 9, 10, 12, 17, 19, 24, and 27 in the reply filed on 8/12/2026 is acknowledged.
Claims 31-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/16/2026.
Claims 1-5, 9, 10, 12, 17, 19, 24, and 27 are under consideration on the merits.
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 1-5, 9, 10, 12, 17, 19, 24, and 27 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.
The term “about” in claims 1-4, 17, and 19 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree (such as but not limited to a controlling definition), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Correction is required.
In so much that claims 5, 9, 10, 12, 24, and 27 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 9, 10, 12, 17, 19, 24, and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recites a product of nature, i.e. generic canine progenitor cells and product-by-process limitations to being “culture-expanded”. This judicial exception is not integrated into a practical application because at least two embodiments of the claims are directed towards naturally-occurring canine progenitor cells that do not possess any markedly different characteristic as compared to the nearest natural counterpart. See M.P.E.P. § 2106.04(c). Enciso teaches a composition comprising canine bone marrow-derived or adipose-derived mesenchymal stem cells obtained from adult (e.g. post-natal) subjects (Abstract, and the paragraph spanning pages 30-31; pages 30-31, subheading “Animals” for cell isolating and culturing methods), which are capable of doubling in less than about 24 hours (Fig. 2, lower panel), which are defined as having osteoblast, adipocyte, and chondroblast differentiation potential (page 30, left column, sentence starting “In 2006…” ), which inherently comprising a normal karyotype as evidenced by Ock (see Ock at page 2320, left column, paragraph starting "Chromosomal stability..."), and which inherently express telomerase at 197 population doublings as evidenced by Seruya (page 95, subheading “Telomerase Repeat Amplification Protocol (TRAP) Assay” and Fig. 2), thus reading on claims 1, 2, 9, 17, and 19. Enciso teaches that the canine bone marrow-derived or adipose-derived mesenchymal stem cells are Oct4+ (Fig. 4), thus reading on claim 3. Enciso teaches that the canine bone marrow-derived or adipose-derived mesenchymal stem cells are CD90+, CD45-, CD34-, and CDMHCII- (page 33, subheading “Flow Cytometry”), thus reading on claims 10 and 12. Enciso does not teach that culture-expanded mesenchymal stem cells are tumorigenic, form teratomas, are genetically transformed, and are not immortalized and thus reading on the negative limitations of claim 24.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the product-by-process limitations to claim 1 to culture-expanded canine progenitor cells is routine and conventional in this art. Enciso as cited above teaches a composition comprising culture-expanded canine bone marrow-derived or adipose-derived mesenchymal stem cells obtained from adult (e.g. post-natal) subjects. Regarding claims 4 and 5, Enciso teaches that the adult canine bone marrow-derived or adipose-derived mesenchymal stem cells undergo at least 40 population doublings (Fig. 2: 1) BMMSC starting at about 9 x 104 cells -SCF and yielding 2 x 106 cells -SCF after 3 passages, 2) ASC starting at about 1 x 107 cells and yielding about 1 x 109 cells after 3 passages). Regarding claim 27, Enciso as cited above teaches formulating the canine mesenchymal stem cells in aqueous medium.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 9, 10, 12, 17, 19, 24, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enciso et al. (Veterinary Research Communications (2018) 42:29-38; provided in the IDS dated 8/19/2026) as evidenced by Ock et al. (Cell Transplantation (2013), 22(12), 2311-2321) and Seruya et al. (Cell Transplantation (2004), 13, 93–101; Reference U).
Enciso teaches a composition comprising culture-expanded canine bone marrow-derived or adipose-derived mesenchymal stem cells obtained from adult (e.g. post-natal) subjects (Abstract, and the paragraph spanning pages 30-31; pages 30-31, subheading “Animals” for cell isolating and culturing methods), which are capable of doubling in less than about 24 hours (Fig. 2, lower panel), which are defined as having osteoblast, adipocyte, and chondroblast differentiation potential (page 30, left column, sentence starting “In 2006…” ), which inherently comprising a normal karyotype as evidenced by Ock (see Ock at page 2320, left column, paragraph starting "Chromosomal stability..."), and which inherently express telomerase at 197 population doublings as evidenced by Seruya (page 95, subheading “Telomerase Repeat Amplification Protocol (TRAP) Assay” and Fig. 2), anticipating claims 1, 2, 9, 17, and 19, and the embodiment of aqueous culture medium for the carrier of claim 27. Enciso teaches that the canine bone marrow-derived or adipose-derived mesenchymal stem cells are Oct4+ (Fig. 4), anticipating claim 3. Enciso teaches that the adult canine bone marrow-derived or adipose-derived mesenchymal stem cells undergo at least 40 population doublings (Fig. 2: 1) BMMSC starting at about 9 x 104 cells -SCF and yielding 2 x 106 cells -SCF after 3 passages, 2) ASC starting at about 1 x 107 cells and yielding about 1 x 109 cells after 3 passages), anticipating claims 4 and 5. Enciso teaches that the canine bone marrow-derived or adipose-derived mesenchymal stem cells are CD90+, CD45-, CD34-, and CDMHCII- (page 33, subheading “Flow Cytometry”), anticipating claims 10 and 12. Enciso does not teach that culture-expanded mesenchymal stem cells are tumorigenic, form teratomas, are genetically transformed, and are not immortalized and thus anticipating the negative limitations of claim 24.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
