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 .
Election/Restrictions
Claims 1-9 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 1-4 in the reply filed on 12 June 2025 is acknowledged. Claims 5-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 June 2025.
Claims 1-4 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification (e.g., page 3, lines 29-31; page 4, lines 4-5 and 13-14) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Please note, however, that this ground may be overcome, by reciting in the claim a generic providing step and either (i) further reciting of the optional sourcing in the claim (e.g. “providing isolated mammalian cells, optionally comprising isolating the cells from a mammal”) and/or (ii) further expressly reciting a required the isolating step in a dependent claim (e.g. “wherein in step (a) the providing comprises isolating the cells from a mammal”), or by other appropriate amendment.
Regarding Claims 1-3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Regarding Claim 1, the parenthetical phrase “(relative to the total weight of the regulating composition)” renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis are part of the claimed invention.
Claim 1 recites the limitations "the mammalian cells.” Since the first recitation of “mammalian cells” is optional, there is insufficient antecedent basis for this limitation in the claim.
Claims 1, 3, and 4 recite the limitation “the regulating composition.” There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claims 2 and 3 recite numerous broad limitations, followed by “preferably,” “most preferably,” and “more preferably” followed narrower limitations (e.g., 1 wt% to 10 wt%, preferably 2% to 6%). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Xu (US 2003/0021850 A1).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to a method for regulating the expression of Musashi 1 in cells comprising exposing mammalian cells to a regulating composition.
Xu teaches compositions and methods for promoting cell growth, tissue repair, and organ regeneration in vivo and in situ wherein the composition comprises a sterol, a fatty-acid containing oil (vegetable or animal oil), beeswax, and baicalin (Xu, [0024]-[0030], [0051], page 5; as required for instant Claim 1). The sterol is present dissolved in a fatty-acid containing oil in a concentration of 0.5 to 40 wt% (Xu, [0026], page 3) and can be stigmasterol, β-sitosterol, brassicalsterol, poriferasterol, daucosterol, or natural, synthesized, or isomeric forms and derivatives thereof (Xu, [0043], page 4; as required for instant Claims 1 and 2). The fatty-acid containing oil can be a vegetable oil such as corn oil, peanut oil, safflower oil, sesame oil, olive oil, or soybean oil (Xu, [0042], page 4; as required for instant Claim 1). The beeswax is present at a concentration ranging from 1 to 20 wt% (Xu, [0070], page 6) and baicalin at a concentration ranging from 0.001 to 2 wt% (Xu, [0105], page 7; as required for instant Claims 1 and 2). The composition is administered at the site of a dysfunctional tissue or organ of an adult mammal (exposing mammalian cells) wherein the dysfunctional tissue resulted from physical trauma (mechanically injured skin cells), a thermal injury (e.g., burn, see [0263]), or due to a diabetic ulcer and wherein the tissues can be skin (skin cells; Xu, [0073]-[0080], page 6; as required for instant Claim 1). Physiologically functional tissues and organs such as skin can thus be regenerated (promotion) at the site of injury (Xu, [0080], page 6; as required for instant Claim 1) when applied for 15 to 30 days (at least 10 days; Xu, [0162], page 9; [0191], page 10; as required for instant Claim 1).
The composition can further comprise propolis at a concentration from 0.1 to 30 wt% (Xu, [0430], page 28); obaculatone at a concentration from 0.1 to 2 wt% (Xu, [0053], page 6); obabenine (obaberine) at a concentration from 0.001 to 2 wt% (Xu, [0055], page 6); berberine at a concentration from 0.001 to 2 wt% (Xu, [0459], page 31); papaverine (Xu, [0475], page 32); and an extract of earthworm at a concentration from 2 to 60 wt% (Xu, [0061]-[0062], page 5; as required for instant Claim 3). The papaverine is extracted from dry capsules of poppy and the composition can be substantially free of papaverine, which is described as less than 0.01% and falls within the claimed range of 0.001 to 2 wt% (Xu, [0475]-[0476], page 32; Claim 42, page 43; as required for instant Claim 3).
Although Xu teaches each of the active steps in the claimed method, they are silent regarding the intended use of the method recited in the preamble i.e. regulating the expression of Musashi 1 in cells. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine the mechanism of action resulting from cell exposure to a composition. The single-step method of exposing mammalian cells to a composition for a given duration of time is the same in both the prior art and instant application as described above, and thus the properties of regulating the expression of Musashi 1 (Claims 1 and 4) are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the method is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses a composition identical to that of the claimed invention which is applied to the same cell types for the same duration of time and thus appears to be identical to the presently claimed method since it is formulated and/or obtained from the same component materials and is administered/administrable to a mammalian cells. Consequently, the claimed process (and compositions provided therein) appears to be anticipated by the reference. In the alternative, even if the process (and compositions therein (with respect to an intended therapeutic effect of regulating the expression of Musashi 1) is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration). Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent 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.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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