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 .
Claims 1, 2 and 4-14 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1, 2, 4-6 and 10-14) in the reply filed on 07/24/2026 is acknowledged. Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse.
Claims 1, 2, 4-6 and 10-14 were examined on their merits.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted.
Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Alternatively, Applicant may choose to delete references to color in the Description of Figures 2, 4, 11, 13 and 14.
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, 4-6 and 10-14 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 “similar or comparable size” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure does not specifically define the size of the MSC spheroids to which the spherical materials must be compared. Therefore, whether the spherical materials sizes are “similar” or “comparable” to the MSC spheroids cannot be determined. For purposes of examination, any size spherical material is construed as being “similar” or “comparable” to any MSC spheroids. Claims 4-6 and 10-14 are rejected as being dependent upon rejected Claim 1 and for failing to rectify the indefiniteness thereof.
Claims 6 and 13 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. Claim 6 recites the limitation "the subject for administering". There is insufficient antecedent basis for this limitation in the claim.
For purposes of examination, the Examiner has interpreted the limitation as the prepared agent being suitable for injection into any human or non-human animal. Claim 13 is rejected as being dependent upon rejected Claim 6 and for failing to rectify the indefiniteness thereof.
Claim Interpretation
The preamble of Claim 1, “…an intravenous injection agent” has been construed consistent with the MPEP at 2111.02, II., as a non-limiting statement of purpose or intended use which will be evaluated to determine whether or not the recited purpose or intended use results in a structural difference between the claimed invention and the prior art. Further, Claim 1 contains the limitation of “at least one” meaning that either alternative of “spherical MSC” or “spherical materials formed by biomaterials” meets the claim.
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, 2, 4, 6, 10, 12, 13 and 14 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Ezquer et al. (2018), cited in the IDS.
Ezquer et al. teaches providing spheroidal primary human adipose (a somatic tissue)-derived MSC with a diameter of about 500 µm (Pg. 2, 2nd paragraph and Pg. 3, Fig. 1A), and reading on Claims 1, 2, 4 and 12.
With regard to Claims 1, 6, 10 and 14, Ezquer et al. teaches injection of the spheroids with saline and rat serum (additives) into rats (Pg. 12, 3rd paragraph).
With regard to Claim 13, consistent with the above interpretation under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as the spheroid composition is suitable for injection into rats it would also be suitable for injection into a sheep, horse, cow, rabbit, monkey or camel.
Claims 1, 2 and 11 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Xu et al. (US 2019/0112573 A1).
Xu et al. teaches providing MSC spheroids formed by differentiation of pluripotent stem cells into trophoblast-like cells then into MSC, wherein the spheroids have an average diameter of 228 µm (Pg. 4, Paragraphs [0060]-[0061] and Figs. 1C-D), reading on Claims 1, 2 and 11.
Claims 1 and 5 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Zhao et al. (2016).
Zhao et al. teaches gelatin (collagen) methacrylate microspheres having a diameter of 163-165 µm (construed as being “similar” or “comparable” to any MSC spheroids), and reading on Claims 1 and 5.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 4, 6, 10, 11, 12, 13 and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Ezquer et al. (2018), cited in the IDS, as applied to Claims 1, 2, 4, 6, 10, 12 and 14 above, and further in view of Xu et al. (US 2019/0112573 A1).
The teachings of Ezquer et al. were discussed above.
Ezquer et al. did not teach providing MSC spheroids formed by differentiation of trophoblast-like cells, as required by Claim 11.
Xu et al. teaches providing MSC spheroids formed by differentiation of pluripotent stem cells into trophoblast-like cells then into MSC, wherein the spheroids have an average diameter of 228 µm (Pg. 4, Paragraphs [0060]-[0061] and Figs. 1C-D). The reference further teaches that while MSC isolated from adult tissues (primary) have good effects, they have disadvantages of requiring volunteer donors and MSC are produced in small amounts, take a long time, have high cost and are difficult to quality control (Pg. 1, Paragraph [0004]). The reference teaches that pluripotent stem cells have a stronger proliferative ability and broader differentiation potential than MSC and can be directionally differentiated into MSC under specific conditions (Pg. 1, Paragraph [0005]).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of providing spheroidal primary human adipose (a somatic tissue)-derived MSC of Ezquer et al. to use MSC spheroids formed by differentiation of pluripotent stem cells into trophoblast-like cells than into MSC as taught by Xu et al. because both methods provide sources of MSC to form spheroids. Those of ordinary skill in the art would have been motivated to make this modification because Xu et al. teaches that MSC derived from pluripotent stem cells have a stronger proliferative ability and broader differentiation potential than (primary) MSC and can be directionally differentiated into MSC under specific conditions. There would have been a reasonable expectation of success in making this modification because both references are drawn to the same field of endeavor, that is, MSC spheroids.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 08/05/2026
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