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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/25 has been entered.
Applicant's amendments and arguments filed 10/10/25 have been fully considered they are not persuasive to overcome the anticipation rejection of claims 4-6 or obviousness rejection of claims 1-6.
It should be noted that applicant’s amendment/formatting has resulted in odd spacing of the words of the claims and should be corrected.
Applicant has amended independent claim 1 to indicate that the oxygen concentration is 1% or less and applicant argues:
As noted, currently amended Claim 1 now recites culturing mesenchymal stem cells in a serum-free medium at an oxygen concentration of 1% or less. The specification describes that, as compared with the case where the oxygen concentration is more than 1%, culturing at 1% or less yields advantageous effects including: (i) an enhanced effect of suppressing the progress of kidney fibrosis (paragraph [0113]); (41) more strongly suppressing fibrosis induction caused by TGF-B1 stimulation (paragraph [0124]); Gi) heightening the VEGF secretion property and HGF secretion property (paragraph [0153]); Gv) increasing the expression amount of specific genes at least threefold (paragraph [0178]); (v) enhancing the capacity for growth of human bone marrow-derived mesenchymal stem cells (paragraph [0188]); and (vi) recovering the VEGF and HGF expression amounts that decrease upon subculture (paragraph [0196]). Accordingly, the oxygen concentration of 1% or less is a critical feature that provides advantageous and unexpected effects.
Applicant's arguments have been considered however a showing to overcome a prima facie case of obviousness must be clear and convincing ( In re Lohr et al. 137 USPQ 548) as well as commensurate in scope with the claimed subject matter ( In re Lindner 173 USPQ 356; In re Hyson, 172 USPQ 399 and In re Boesch et al., 205 USPQ 215 (CCPA 1980). As with the previous amendment. It is noted that the “at least a portion thereof” allows for the repair agent to be (or a singular) growth factor from the medium either there as part of the medium components or produced by the MSCs and as such cannot be considered novel or unobvious.
It is noted that although the claims require 1% or less, such a concentration would be considered obvious over possible minute difference between 1% and more than 1% and any alleged unexpected results would not be extrapolated to the “at least a portion of” for eth reasons of record.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4-6 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by
WO 2014/200068.
068 teaches a method of culturing MSCs and the cells produced (cells per se)to be used as in repair (regenerative medicine) in a serum-free medium at an oxygen concentration of about 1-5%, the medium containing factors including an FGF and a PDGF [0002-3], [0017]. The cells and methods are the same in the prior art as are claimed and as such the gene products claimed in claim 4 would have inherently been produced in the cells of 068 and as such the cells (agent) must be considered the same. The intended use of the cells (agent) does not alter the product per se and as such all claims are anticipated by 068.
Note that MPEP § 706.3(e) states that:
"[w]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 35 U.S.C. 102 or 35 U.S.C. 103 of the statute is appropriate. As a practical matter, the Patent and Trademark Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972) ; In re Fessmann, 180 USPQ 324 (CCPA1974)."
It is noted that the “at least a portion thereof” allows for the repair agent to be (or a singular) growth factor from the medium either there as part of the medium components or produced by the MSCs and as such cannot be considered novel. The claims are anticipated by the reference.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over
WO 2014/200068 and WO 2018/123968.
068 teaches a method of culturing MSCs and the cells produced (cells per se)to be used as in repair (regenerative medicine) in a serum-free medium at an oxygen concentration of about 1-5%, the medium containing factors including an FGF and a PDGF [0002-3], [0017]. The cells and methods are the same in the prior art as are claimed and as such the production of the gene products claimed in claim 4 would have inherently been produced in the cells of 068 and as such the cells (agent) must be considered the same.
068 does not clearly recite all the iterations of applicant’s culturing process however, enerally, differences in concentration and use of known components of serum free media will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such a difference is a distinction that is critical.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Further 968 teaches another method of culturing MSCs for tissue repair which would appear to further teach using a medium that contains an FGF, a PDGF, an EGF, at least one phospholipid, and at least one fatty acid [0071-9]. Subculturing is also a notoriously old and well known method for cell multiplication.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657