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 .
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.
(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 1, 3, 10-12 & 15 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Teixeira et al (U).
Teixeira teaches a method of making a secretome from MSCs and the use thereof to treat Spinal Cord Injury vis injection (see Spinal Cod Injury). The cells are described in the reference to be plastic adherent in standard culture conditions; and
express CD105, CD73 and CD90 markers; and are negative for CD45, CD34, CD14, CD11b, CD79 and HLA-DR markers; and are capable to differentiate to osteoblasts, adipocytes and chondroblasts.
The cells used and ultimate secretome would appear to be the same in Teixiera as such the proteins contained therein and functional properties would be inherent to the Teixeira secretome.
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)."
See also MPEP § 2112, disclosing that once a proper holding of anticipation is made, the burden shifts to applicant to demonstrate an unobvious difference between the claims and the prior art. See also, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (“the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product”). Because applicant has not demonstrated any difference between the claimed products used in the claimed methods and the prior art products, the rejection of record clearly must be maintained.
The references anticipates the claim subject matter.
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.
Claim(s) 1-3 and 5-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira et al (U) and Gangaraju (WO 2017/139795)
Teixeira teaches a method of making a secretome from MSCs and the use thereof to treat Spinal Cord Injury vis injection (see Spinal Cod Injury). The cells are described in the reference to be plastic adherent in standard culture conditions; and
express CD105, CD73 and CD90 markers; and are negative for CD45, CD34, CD14, CD11b, CD79 and HLA-DR markers; and are capable to differentiate to osteoblasts, adipocytes and chondroblasts.
The cells used and ultimate secretome would appear to be the same in Teixiera as such the proteins contained therein and functional properties would be inherent to the Teixeira secretome.
Teixiera does not teach all of the specific dosages used or exactly conditions to product the secretome as are claimed however those differences would have been obvious to one of ordinary skill in teha rt at thet time of filing because "[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, Gangaraju provides further guidance to use the claimed parameters to make a therapeutic secretome because Gangaraju teaches a composition comprising a human mesenchymal stem cell (MSC) preparation (secretome) comprising MSC growth factors, MSC extracellular vesicles, MSC exosomes, and/or MSC extracts [0002], compositions comprising stem cell secretions derived from conditioned media as well as methods of making and using the same to treat many conditions including many disorders [0114]. Adult stem cells can be harvested from a variety of adult tissues, including bone marrow, fat, and dental pulp tissue. MSC are suitable stem cells [0059] using multiple culturing methodologies (i.e. , culturing in serum free media in the presence of TNFa and/or IFNy) can synergistically increase the amounts of certain growth factors, cytokines, and/or other proteins present in the secretions of the cells. The resultant medium includes growth factor wherein the growth factors, exosomes, extracts, and extracellular vesicles[0124].
Gangaraju further teaches cells cells cultured under standard hypoxic culturing conditions and cells cultured under artificial wound healing conditions. Cell Care does however discloses the amount of CO2 in the culture conditions (para [0313] .. 50x103 HRMVEC cells were cultured with 250u CSC complete media (10% serum; Cell Systems Inc) on the coated (with attachment factor, Thermo Fisher Scientific) upper chamber (0.4 ul polycarbonate transwell, Corning, Inc.) and 500 ul CSC complete media (10% serum) was filled in the bottom chamber at 37C, 5% CO2..).
Gangaraju teaches a wide variety of useful culture conditions, additives, dosages and pharmaceutical additives (see entire document) that establish the claimed limitation would have been obvious to the skilled artisan at the time of filing.
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