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 11/24/25. Claims 12-20 are pending and considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 102/103 rejections are withdrawn:
Claim(s) 1-12 were rejected under 35 U.S.C. 102(a)(1) or under 35 U.S.C. 103 as being anticipated by or obvious over Cai et al. (Stem Cell Research & Therapy, 2020, in IDS 2/3/23).
The following 35 USC § 101 rejections are withdrawn:
Claims 1-10 were directed to non-statutory subject matter. These claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they are written as “Use” claims, which do not purport to claim a process, machine, manufacture, or composition of matter to comply with 35 U.S.C. 101 (MPEP 2173.05(q)).
The following 35 USC § 112 rejections are withdrawn:
Claims 1-12 were 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The following Double Patenting rejections are withdrawn:
Claims 1-12 were provisionally rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-14 of copending Application No.
18/001259 which does not teach treating pulmonary fibrosis.
Claim 9-11 were provisionally rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 14-15 of copending Application No.
18252254 which does not teach treating pulmonary fibrosis.
The Applicant’s cancellation of claim 1-11 and substantial amendments to claim 12 including a product-by-process limitation for the cell-free fat extract necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
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) 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al. (Stem Cell Research & Therapy, 2020, in IDS 2/3/23) in view of Rathinasabapathy et al. (British Journal of Pharmacology (2016) 173 2859–2879).
Claim 16 Claim Interpretation
New claim 16 contains a wherein clause that limits the result of the method to the symptoms improved in pulmonary fibrosis. This reads as an intended result of the method steps. 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.
Cai et al. teach a series of three compositions prepared from adipose cells (Fig 1). These include:
ADSC-CM which is condition media (CM) from adipose derived stem cells (ADSCs);
ADSC-Exo which are the exosomes from the culture media of ADSCs;
ATE (Adipose tissue extract) which is adipose cells that have been emulsified and filtered into a cell-free fat extract.
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Fig. 1 shows the ATE is made with steps that match claim 12 steps (1)-(6) including a freeze-thaw step before centrifugation in step (6) of claim 20 (See cropped excerpt of Fig. 1 below). Lipoaspirate reads on crushed fatty tissue raw material. While Cai et al. does not expressly state the lipoaspirate is human, this would be obvious since they intend to harvest their stem cells from humans so it would be obvious to obtain the lipoaspirate form the same source (Cia, Background). Since Cai et al. teach their ATE is made by the same method as claimed, then it will obviously have all of the claimed properites, including the concentrations of growth factors limited in the claims (MPEP 2112.01 II) including claim 12, and 17-19.
Cai et al. teach that i)-iii) share wound healing properties (see Fig 1, far right) but only expressly teach ADSC-CM is suitable for treating pulmonary fibrosis (PF) and not ATE (Cai, pg. 10, col 1, middle). However it would be obvious to try ATE to treat PF in view of the teachings of Rathinasabapathy et al.
Rathinasabapathy et al. teach treating PF in rats that was induced by bleomycin and then administered ADSCs or ADSC-CM (Rathinasabapathy pg. 2859, Experimental Approach). This is supported by both Figs. 7 and 8 on PF induced by bleomycin (an anti-tumor drug and cytotoxic antibiotic) where ADSCs (labeled BAD3 or BAD7) and ADSCs-CM (labeled BCM3 or BCM7) are administered, both showed significantly lower symptoms in lung tissue. One of ordinary skill in the art would conclude from Rathinasabapathy et al. that the active agent to treat PF is produced by the ADSC and secreted into the surrounding media. This supports why both whole ADSCs and their condition medium were nearly equally effective in treating PF. Therefore one of ordinary skill would think it obvious to administer the ATE of Cai et al. to treat PF because:
Both ADSC-CM and ATE already have common wound healing properites;
The healing property to treat PF is both present in the whole adipose stem cell and the conditioned medium, meaning that a living, intact cell is not required to treat PF, just the component it secretes; and
A cell secretes what is produced inside its cytoplasm, therefore lysing the cells by emulsification will also release the contents intended for secretion.
In short, the healting property to treat PF that is secreted by the cell will also be released when the cell is lysed by emulsification. Therefore the ATS will contain the same healing components for PF as would be secreted into conditioned medium. Therefore it would be obvious to try the ATS to treat PF since it would contain the same components as CM to treat PF (MPEP 2141 III (E)).
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.
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.
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.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699