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 .
Response to Argument and Argument
The response filed on 8/6/26 has been entered.
Applicant’s arguments filed 8/6/26 have been fully considered but they are not deemed to be persuasive.
Claims 1-4, 11, 14, 29, 40, 44, 50, 55, 73, 79, 80, 87, 108, 112, 120, 175, and 176 are pending in this office action. Claims 108, 112, 120, 175, and 176 are currently withdrawn.
Maintained 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)(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.
Claim(s) 1-4, 11, 14, 29, 40, 44, 55 and 73 is/are rejected under 35 U.S.C. 102 (a2) as being anticipated by Harel et al. (US 2013/0296165).
With regards to instant claim 1, Harel teaches a dry stabilizing composition (see abstract) comprising a eukaryotic cell (see 0048, intrinsically a mammalian cell, thus anticipated a mouse or a human cell), a sugar i.e., non-reducing sugar disaccharide (see 0053, as required by instant claims 1 and 11), an antioxidant i.e., vitamins (see 0048, as required by instant claim 1 and 14), a polymer (i.e., polyvinylpyrrolidone (see 0173, as required by instant claim 15) and a polysaccharide (see0060 and claim 1, as required by instant claim 29) and protein (see 0063, as required by instant claim 40), wherein the sugar is from 10% (see 0067, as required by instant claim 44), and the concentration of the polymer is 0.01% (see 0173 as required by instant claim 55) and comprises a buffer (see 0115, as required by instant claim 73).
Therefore the claims are anticipated by Harel.
Applicant argues that Harel generally relates to the preparations of probiotic, enzymatic, or multivitamin formulations for use in a variety of different applications. The Action has identified a series of distinct teachings from the reference and combined them together to arrive at the presently claimed invention. For example, the Action points to paragraph 48, which notes that this method can be applied to both prokaryotic and eukaryotic cells among a list of multiple different options including such disparate potential components as viruses, vaccines, hormones, peptides, enzymes, vitamins, minerals, fungicides, herbicides, antibodies, and lipid vesicles. Nothing in Harel et al. suggests or teaches the formation of a dry powder composition comprising a eukaryotic cell that is either a plant or animal cell as claimed.
In response Applicant’s argument is found unpersuasive for the following reason. Harel specifically teach that animal protein (see 0063, 0067) which is eukaryotic cell (see also claim 10). Animal protein as known in the art are composed of eukaryotic cells. It is an inherent property of an animal cell, Therefore the rejection is maintained. The newly added limitation
Claim(s) 1-4, 11, 29, 40, 44, 55, 73, 80 and 87 is/are rejected under 35 U.S.C. 102 (a2) as being anticipated by Guangzhou (CN 109593124)
With regards to instant claim 1, Guangzhou teaches a pharmaceutically dry powder formulation comprising one or more eukaryotic cell i.e., an umbilical cord mesenchymal stem (see Abstract) trehalose ie., a sugar (see abstract, a nonreducing sugar, as required by instant claim 11) and a polymer (see abstract) wherein the umbilical cord mesenchymal stem is a eukaryotic cell that is an animal or mammalian cell (i.e., a mouse cell as required by instant claims 2-4), wherein the trehalose is 1-15g i.e., 1-15 % (as required by instant claim 44) poloxomer from 1-5g (as required by instant claim55) and a protein (as required by instant claim 40), culture cell medium as required by instant claim 73) and excipient such as carboxymethyl cellulose (see abstract as required by instant claim 80). With regards to instant claim 87, the composition is the same and therefore the characteristic of showing a decrease of less than 10% change in viability within an hour will be the same because as stated in the MPEP 2112.01 "products of identical chemical composition cannot have mutually exclusive properties."
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.
Claim(s) 1-4, 11, 14, 29, 40, 44, 55, 73, 79, 80 and 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guangzhou (CN 109593124) in view of Cohen et al. (US 2012/0071483)
With regards to instant claim 1, Guangzhou teaches a pharmaceutically dry powder formulation comprising one or more eukaryotic cell i.e., an umbilical cord mesenchymal stem (see Abstract) trehalose ie., a sugar (see abstract, a nonreducing sugar, as required by instant claim 11) and a polymer (see abstract) wherein the umbilical cord mesenchymal stem is a eukaryotic cell that is an animal or mammalian cell (i.e., a mouse cell as required by instant claims 2-4), wherein the trehalose is 1-15g i.e., 1-15 % (as required by instant claim 44) poloxomer from 1-5g (as required by instant claim55) and a protein (as required by instant claim 40), culture cell medium as required by instant claim 73) and excipient such as carboxymethyl cellulose (see abstract as required by instant claim 80). With regards to instant claim 87, the composition is the same and therefore the characteristic of showing a decrease of less than 10% change in viability within an hour will be the same because as stated in the MPEP 2112.01 "products of identical chemical composition cannot have mutually exclusive properties."
Guangzhou fails to teach instant claim 79
Cohen is added because the reference teaches a dry formulation (see 0138) comprising epigallocatechin-gallate (see 0113), polyvinylpyrrolidone.
Therefore it would have been obvious to one of ordinary skill in the art to combine agent known in the art to produce a dry formulation that will reasonably result in success of when the cited references are combined.
No claims are allowed.
Applicants’ 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 9/9/2026
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