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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 4/14/26. Claims 1-16 are pending. Claims 1 and 9-16 are withdrawn. Claims 2-8 are considered on the merits.
Election Restriction
Applicant's response, with traverse, to the Restriction/Election requirement filed on 4/14/26 is acknowledged. The applicant elected Group II which includes claims 2-8. New claims 15 and 16 are drawn to methods of treatment and are including in non-elected Group IV.
The Applicant argues that the Lack of Unity relied on a combination and disparate disclosures in Deschaseaux et al. However, the culture media ingredients listed in the Restriction Requirement on 1/14/26 are all optional ingredients listed for the differentiation media. Paragraph 210 discloses nearly all of the ingredients of claim 1 except ascorbic acid and VEGF. However these are expressly listed as possible ingredients in differentiation media in [0085] and [0072] respectively, so are obvious to add to the composition. Therefore all of the ingredients listed in the Deschaseaux et al. are obvious components of differentiation media.
Therefore, the Restriction/Election requirement is therefore made FINAL and the elected species and the claims they include will now be examined 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 2-8 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.
In claim 2, the phrase "such as a culture medium such as defined in claim 1" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Interpretation
Claims 3 and 4 contain wherein clauses that limit the result of the method steps: These include:
wherein one portion of the mesenchymal stem cells is differentiated into osteoblasts and another portion of the mesenchymal stem cells is differentiated into adipocytes simultaneously, in a single step, in the same medium and in the same culture container, without posterior assembling of cells; and
wherein endothelial progenitor cells and endothelial cells organize themselves into vessels in the culture medium, at the same time as said mesenchymal stem cells differentiate
MPEP 2111.04 state:
a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’"
Therefore these limitations are not afforded significant patentable weight and art reading on the method steps of the claim will also read on the intended results since the same steps should obviously yield the same results. However if these results are an unexpected improvement, then this should be pointed out by the Applicant and the claims made commensurate in scope with the results shown. Applicant is encouraged to contact the Examiner if any questions about this arise.
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.
Claim(s) 2-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deschaseaux et al. (US 2018/0216070 in IDS 9/15/23) in light of support by PubChem (Fetal serum, Bovine), Lander et al. (J. Stem Cell Res Dev 2018), and NIH-NCI Drug Dictionary (Adipose-derived stromal vascular fraction cells).
Deschaseaux et al. teach a method of culturing stromal vascular fraction (SVF) cells with the following steps:
Seeding the SVF cells in a standard 24 well plate;
Differentiating the SVF cells by culturing for 10 days with a differentiation media comprising α-MEM media supplemented with the following:
BMP7 (50 ng/mL),
Insulin (5 μg/mL),
apotransferrin (10 μg/mL),
intralipids 0.2% (v/v), and
2% fetal bovine serum.
Deschaseaux et al. teach the differentiation media may also comprise ascorbic acid at 0.2-10 μg/mL (1.1 -57 μM) [0085] and VEGF at 0.5-10 ng/mL [0070-0072].
SVF cells comprise both mesenchymal stem cell and endothelial progenitor cells as supported by NIH-NCI Drug Dictionary (Adipose-derived stromal vascular fraction cells) and Lander et al. (pg. 2, Content of SVF). These cells can be primary cells obtained from the subject [0060-0061]. The cells can be seeded on a 3-D substrate and the resulting endothelial cells were able to self-organize into a tubular morphology resembling lumina (e.g. vessels) while the MSCs differentiated into adipocytes [0215-0216]. While Deschaseaux et al. does not teach a portion of the MSCs are differentiation into osteoblasts, this is an intended result of the method steps. Since they perform the same method steps on the same cells as claimed, then they will also achieve the same results (MPEP 2111.04).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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