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
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 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.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-11, in the reply filed on Feb. 13, 2026 is acknowledged.
Claims 1-12 remain pending in the current application, claim 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I and II is still deemed proper and is therefore made FINAL.
Claims 1-11 have been considered on the merits.
Status of the Claims
Claims 1-12 currently pending.
Claim 12 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-11 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: PlasmaLyte® in 0006; Stemulate® in 0021, 0026; PLTMax® in 0021, 0026; UltraGRO™ in 0021, 0026; PLUS™ in 0021, 0026; Ultrapure™ water in 0036; SpectraMax® i3x in 0036; Albuminar® in 0038; Amplite® Universal Fluorimetric Protease Activity assay kit in 0038, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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 and 7-11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gothelf et al. (US 2016/0334392 A1) as evidenced by Farahani et al. (Stem Cells International, 2015) (ref. of record).
With respect to claim 1, Gothelf teaches a method for producing a cell preparation (abstract, 0014 and 0111). With respect to claim 1 step (S1), Gothelf teaches culturing cells which adhere to a flask (a base material) (0219). With respect to claim 1 step (S2), Gothelf teaches contacting the cells with trypsin so that the cells are released from the flask (the base material) to form an initial cell preparation (0219). With respect to claim 1 step (S3), Gothelf teaches stopping the trypsin by adding culture medium to the cells and would provide a cell preparation (0220). Gothelf teaches the cell culture medium contains human platelet lysate (hPL) (0114-0116).
With respect to claim 2, Gothelf teaches the human platelet lysate (hPL) is centrifuged to following lysing by freeze/thaw cycles to remove platelet particles and membrane fragments (the hPL is clarified) (0113). With respect to claim 3, Gothelf teaches that the hPL is not diluted (0113). With respect to claim 7, Gothelf teaches the cells may be incubated with the dispersing agent for about 5-30 minutes, at a temperature of about 37°C (0145). With respect to claim 8 Gothelf teaches that in (S1) the cells are culture in a liquid culture medium containing hPL (0114-0116). With respect to claim 10, Gothelf teaches that the cells are mesenchymal stem cells (abstract and 0014). With respect to claim 11, Gothelf teaches that the MSCs are from the placenta which includes the amnionic membrane and, therefore, includes amnion-derived MSCs (0107-0108).
Gothelf is silent with respect to whether the cells express a platelet-derived growth factor receptor (PDGFR) and does not teach the method where the cells express a PDGFR as recited in claim 9. However, this appears to be an inherent characteristic of MSCs, which Gothelf teaches, as evidenced by Farahani. Farahani reports that platelet‐derived growth factor receptor alpha is a marker of mesenchymal stem cells (abstract and pg. 2 para. 1).
Therefore, the reference anticipates the claimed subject matter.
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.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gothelf et al. (US 2016/0334392 A1) as evidenced by Farahani et al. (Stem Cells International, 2015) (ref. of record) and as further evidenced by Ikebe et al. (BioMed Research International, 2014).
With respect to claim 1, Gothelf teaches a method for producing a cell preparation (abstract, 0014 and 0111). With respect to claim 1 step (S1), Gothelf teaches culturing cells which adhere to a flask (a base material) (0219). With respect to claim 1 step (S2), Gothelf teaches contacting the cells with trypsin so that the cells are released from the flask (the base material) to form an initial cell preparation (0219). With respect to claim 1 step (S3), Gothelf teaches stopping the trypsin by adding culture medium to the cells and would provide a cell preparation (0220). Gothelf teaches the cell culture medium contains human platelet lysate (hPL) (0114-0116).
With respect to claim 2, Gothelf teaches the human platelet lysate (hPL) is centrifuged to following lysing by freeze/thaw cycles to remove platelet particles and membrane fragments (the hPL is clarified) (0113). With respect to claim 3, Gothelf teaches that the hPL is not diluted (0113). With respect to claim 7, Gothelf teaches the cells may be incubated with the dispersing agent for about 5-30 minutes, at a temperature of about 37°C (0145). With respect to claim 8, Gothelf teaches that in (S1) the cells are culture in a liquid culture medium containing hPL (0114-0116). With respect to claim 10, Gothelf teaches that the cells are mesenchymal stem cells (abstract and 0014). With respect to claim 11, Gothelf teaches that the MSCs are from the placenta which includes the amnionic membrane and, therefore, includes amnion-derived MSC (0107-0108).
Gothelf is silent with respect to whether the cells express a platelet-derived growth factor receptor (PDGFR) and does not teach the method where the cells express a PDGFR as recited in claim 9. However, this is an inherent characteristic of MSCs, which Gothelf teaches, as evidenced by Farahani. Farahani reports that platelet‐derived growth factor receptor alpha is a marker of mesenchymal stem cells (abstract and pg. 2 para. 1).
With respect to claims 4-6, Gothelf teaches an exemplary concentration of trypsin that may be used is 0.005-0.5% (50-5,000 µg/mL) trypsin-EDTA (0145) and teaches platelet lysate is at a concentration of 10% in medium (0040). Gothelf does not teach the method where the amount of hPL is 1.44 µL or more per µg of trypsin as recited in claim 4 or where the amount of hPL is 2.4 µL per µg of trypsin as recited in claim 5, or the range of concentration of trypsin is 0.9-83.3 µg/mL. Although Gothelf is silent with the ratio of trypsin to hPL and does not teach the ranges recited in claims 4-6, one of ordinary skill in the art would recognize that the ratio of trypsin to hPL in a step of neutralizing the trypsin with hPL is a result effective variable and that the ratio would be matter of routine optimization as evidenced by Ikebe. Ikebe teaches that the optimal trypsinization conditions may be different among flask types used and cell/density confluence and that the conditions should be determining case-by-case (pg. 7 Col. 2 para. 1). Ikebe teaches that excessive trypsinization can damage cells and insufficient trypsin-treatment will reduce the yield of cells (pg. 7 Col. 2 para. 1). Additionally, Ikebe reports that concentrations of trypsin-EDTA that has been widely been used is 0.25, 0.05 and 0.025% (pg. 7 Col. 2 para. 1). Additionally, one of ordinary skill in the art would readily recognize that the amount hPL added to the cells following the addition of the trypsin would be adjusted to ensure the neutralizing of the trypsin. Furthermore, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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) -MPEP § 2144.05.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wagner et al. (US 2014/0170663 A1)
Wagner teaches a method for producing a cell preparation by culturing cells which adhere to a flask, contacting the cells with trypsin so that the cells are released from the flask (the base material) to form an initial cell preparation stopping the trypsin by adding culture medium containing hPL to the cells and would provide a cell preparation (0116, 0136-0146).
Siemionow (US 2022/0160783 A1, priority Mar. 14, 2019)
Siemionow teaches a method for producing a cell preparation by culturing cells which adhere to a flask, contacting the cells with trypsin so that the cells are released from the flask (the base material) to form an initial cell preparation stopping the trypsin by adding culture medium containing hPL to the cells to inactivate the trypsin and would provide a cell preparation (0065)
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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