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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claim 13, in the reply filed on 06/15/2026 is acknowledged.
Claims 14-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/15/2026.
Status of the Claims
Claims 13-27 are currently pending.
Claims 14-27 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-12 are cancelled.
Claim 13 has been considered on the merits.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 includes capitalization of words throughout the claim which is grammatically incorrect. “Providing”, “Culturing”, “Freezing”, and “Thawing” should not be capitalized. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the dashes used in the claim as bullet points should be deleted. If applicant desires they may be amended to “i)” or “1)”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the term “UCBP” is used at line 12, but the acronym is defined twice at lines 14 and 15. The first instance of UCBP should be defined and the subsequent recitations should be amended to “USBP”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 13 reads “Thawing the cells of e)” however step e) does not exist within the claims and it appears applicant meant to recite “Thawing the cells of c)”. Appropriate correction is required.
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.
Claim 13 is 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.
Claim 13 recites the phrase “also expressing CD105, CD73, and CD90 and lacking the expression of CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR surface molecules”, which is indefinite. This phrase is unclear as to which CD markers the cells must lack the expression of. It is not clear if the phrase is meant to be read as the cells must lack the expression of (i) CD45/CD34/CD14 or (ii) CD11b/CD79alpha or (iii) CD19/HLA-DR or if the phrase is meant to be read as the cells must lack (i) CD45/CD34 and (ii) one of CD14 or CD11b and (iii) CD79alpha or CD19/HLA-DR. For the sake of compact prosecution, the claim is being interpreted to require that the cells are negative for the expression of CD45 and CD34 and that the cells may be negative for any of the additional listed markers since it is unclear which may be required by the claim. Appropriate clarification is required.
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Truncale et al (US 8883210 B1, 2014) in view of Mitchell et al (Stem Cell Research and Therapy, 2015).
Regarding claim 13, Truncale teaches a process for preparing a MSC composition for the intended use of implanting for tissue repair (abstract) comprising providing two different types of MSCs collected and isolated from a mammal body tissue, more specifically from umbilical cord matrix/stroma MSCs (UC-MSCs) of the Wharton’s jelly, the two cell types being human amniotic MSCs and human chorionic MSCs (See col. 38, last para). Truncale teaches that the cells are positive for the expression of CD105, CD73 and CD90 (See Table 7 within col. 39). Truncale teaches that the cells are negative for the expression of CD45, CD34, CD14, and HLA-DR (See Table 7 within Col. 39 and Col. 39, para 2-3). Further, Truncale teaches culturing conventionally culturing the cells (See Col. 39, para 2-3) and that their invention comprises a viable expanded population of cells (Col. 116, para 2). Truncale teaches that the cells can be cryopreserved (col. 214, para 4, lines 30-40). Further, Truncale teaches that the cells can be cryopreserved in a solution consisting of 90% FBS and 10% DMSO (Col. 206, para 2). Truncale teaches thawing the cells (col. 214, para 4, lines 30-40).
Truncale does not teach that the thawing step d) specifically employs one of the following solutions: 90% UCBP: 10% DMSO, 100% UCBP, or an autologous serum solution as required by claim 13.
However, Mitchell teaches a method of cryopreserving and thawing MSCs using various media/solutions. Mitchell teaches testing cryopreservation/thawing solutions including: 20% FBS/10% DMSO/70% media, 95% FBS/5% DMSO, 20% autologous serum/10% DMSO/70% media, 95% autologous serum/5% DMSO, 20% allogenic serum/10% DMSO/70% media, 95% allogenic serum/5% DMSO. Mitchell teaches that “there were no significant differences in post-thaw viability, total cell number, morphology scores or growth kinetics among the 6 solutions” however, “Prior to clinical use, clinicians may prefer autologous serum and a lower concentration of DMSO” (abstract).
Regarding claim 13, Mitchell teaches cryopreserving and thawing in an autologous serum solution of 95% autologous 5% DMSO (Fig. 1 and abstract).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of making a MSC composition for the intended use of clinical tissue repair implanting taught by Truncale with the step of cryopreserving/thawing MSC compositions within an autologous serum solution taught by Mitchell to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because the composition of Truncale has the intended use of implanting for tissue repair in a clinical setting and Mitchell teaches that “there were no significant differences in post-thaw viability, total cell number, morphology scores or growth kinetics among the 6 solutions” however, “Prior to clinical use, clinicians may prefer autologous serum and a lower concentration of DMSO” (abstract), specifically the 95% autologous serum 5% DMSO solution (see pg. 11, col. 1, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Truncale with Mitchell because Truncale teaches the cryopreservation of the MSC composition, and Mitchell teaches that for clinical applications it is desirable to use a xenogeny-free product, the 95% autologous serum 5% DMSO (see pg. 11, col. 1, para 1). Therefore, Truncale and Mitchell teach the necessary information to perform the method successfully.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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