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 .
Status of the Claims
Claims 1-8 are pending.
Claims 1-8 have been examined on their merits.
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 1-8 rejected under 35 U.S.C. 103 as being unpatentable over Honda et al. (WO2016013352A1, on IDS 09/26/2024) in view of Cowper et al. (Cells, 2019) and Hildner et al. (J Tissue Eng Regen Med, 2015).
In regards to claims 1 and 5, Honda teaches methods for dedifferentiating human mature adipocytes (fat cells) (claim 1; second page, last paragraph).
While in embodiments, Honda teaches that the media may contain serum (Example 1, third page), as taught by Cowper, human platelet lysate (HPL) is a known functional substitute for FBS in the culturing of human adipose derived stromal/stem cells (of which dedifferentiated adipocytes are a type (specifically, “HPLs is an effective substitute for FBS in the culture, expansion and differentiation of human ASCs suitable for pre-clinical studies”, Title, Abstract, p1), and therefore, HPL is an art-recognized equivalent for FBS, and it is prima facie obvious to substitute equivalents known for the same purpose (see MPEP 2144.06(II)).
Furthermore, a person of ordinary skill in the art would have been motivated to specifically replace FBS with HPL, and establish a culture medium that does not contain a serum derived from an animal other than a human (or specifically, a culture medium that does not contain a component derived from an animal other than a human), in order to eliminate xenoproteins or other xenogeneic proteins which would make the cells safer for clinical application (see Cowper, p2, “Due to the presence of bovine spongiform encephalopathy (BSE) in many herds worldwide, their remains considerable regulatory concern for potential use of FBS as a cell culture nutrient to introduce xenogeneic material . . . FBS use introduces xenoproteins that bind to isolated ASCs, thereby increasing the risk of immune rejection) (p2, top paragraphs).
They would have been further motivated to replace serum with platelet lysate because Hildner teaches that human platelet lysate promotes dedifferentiation of adipose stem cells (“in ASCs, [human platelet lysate] completely inhibits the expression of AGC1 and COL2A1 . . . This indicates that . . . ASCs undergo some kind of dedifferentiation” (p816; Title, Abstract, p808).
Furthermore, because HPL is a known substitute for FBS, and because Hildner explicitly teaches that HPL promotes dedifferentiation of adipose cells, a person of ordinary skill in the art could have made the substitution with predictable results and a reasonable expectation of success.
In regards to claim 2, Cowper teaches that concentrations of at least 0.75% or 1% HPL can replace FBS (Fig. 1, p6). A concentration of 0.75% HPL overlaps with the claimed range of 0.5 w/v% or greater and 20.00 w/v% or less.
In regards to claim 3, while 0.75% or 1% HPL is less than the claimed range of 5.0 w/v% or greater and 15.0 w/v% or less, as further taught by Hildner, adipose stem cells can be cultured in 5% or 10% HPL (PL strongly promotes proliferation of ASCs, p811; Fig. 1, p811), which overlaps with the claimed range. Therefore, a person of ordinary skill in the art could have at least arrived at a concentration of 5.0 w/v% or greater and 15.0 w/v% or less by routine optimization, and the disclosure does not point to a criticality in this range (see MPEP 2144.05(II)(A), differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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 regards to claim 4, Honda teaches that the adipocytes are cultured by ceiling culture (Example 1, third page).
In regards to claim 6, Honda teaches that the dedifferentiated far cells proliferate (Example 1, third page; Figs. 1-3).
As above, while in embodiments, Honda teaches that the media may contain serum (Example 1, third page), as taught by Cowper, human platelet lysate (HPL) is a known functional substitute for FBS in the culturing of human adipose derived stromal/stem cells (of which dedifferentiated adipocytes are a type (specifically, “HPLs is an effective substitute for FBS in the culture, expansion and differentiation of human ASCs suitable for pre-clinical studies”, Title, Abstract, p1), and therefore, HPL is an art-recognized equivalent for FBS, and it is prima facie obvious to substitute equivalents known for the same purpose (see MPEP 2144.06(II)).
Furthermore, a person of ordinary skill in the art would have been motivated to specifically replace FBS with HPL, and establish a culture medium that does not contain a serum derived from an animal other than a human (or specifically, a culture medium that does not contain a component derived from an animal other than a human), in order to eliminate xenoproteins or other xenogeneic proteins which would make the cells safer for clinical application (see Cowper, p2, “Due to the presence of bovine spongiform encephalopathy (BSE) in many herds worldwide, their remains considerable regulatory concern for potential use of FBS as a cell culture nutrient to introduce xenogeneic material . . . FBS use introduces xenoproteins that bind to isolated ASCs, thereby increasing the risk of immune rejection) (p2, top paragraphs).
They would have been further motivated to replace serum with platelet lysate because Hildner teaches that human platelet lysate promotes dedifferentiation of adipose stem cells (“in ASCs, [human platelet lysate] completely inhibits the expression of AGC1 and COL2A1 . . . This indicates that . . . ASCs undergo some kind of dedifferentiation” (p816; Title, Abstract, p808).
Furthermore, because HPL is a known substitute for FBS, and because Hildner explicitly teaches that HPL promotes dedifferentiation of adipose cells, a person of ordinary skill in the art could have made the substitution with predictable results and a reasonable expectation of success.
Furthermore, it is noted that as taught by Hildner, proliferation of adipose stem cells is a property of being cultured in HPL (PL strongly promotes proliferation of ASCs and HACs, p811).
In regards to claim 7, as above, Cowper teaches of at 0.75% or 1% HPL can replace FBS (Fig. 1, p6) for culturing adipose stem cells, which overlaps with the claimed ranges. Furthermore, as above, Hildner, teaches that HPL concentrations of 5% or 10% strongly promotes proliferation of ASCs (PL strongly promotes proliferation of ASCs, p811; Fig. 1, p811), which also overlaps with the claimed range. In regards to claim 8, Honda teaches that the cells were cultured by adhesion culture (Example 1, third page).
Therefore, the combined teachings of Honda, Cowper, and Hildner render the invention unpatentable as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Matsubara et al. (20190269732A1); Kakudo et al. (Cells, 2019); Phetfong et al. (Bone and Joint Research, 2017).
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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