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 Status
Applicant’s remarks/arguments and amendment to the claims, specification, and corrected drawings filed on July 7, 2025 in response to the non-final rejection mailed March 5, 2025, are acknowledged and have been fully considered.
Claim(s) 1-10 is/are pending. Claim(s) 1-10 are amended. Claim(s) 1-10 are being examined on the merits.
Response to Amendment
Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action.
Drawings
The objection to the drawings for failing to clearly and unambiguously convey information about the invention (i.e. Figs. 3 and 5-12; multiple charts/tables referencing distinct data sets are referenced and described in a single figure and/or description, however the figures contain multiple graphs/drawings) is rendered moot in view of the corrected drawings, thus the objection is withdrawn.
However, the drawings remain objected to as failing to comply with 37 CFR 1.84(t) because the sheets of the drawings lack the required numbering.
Specification
The objection to the specification for an embedded hyperlink is rendered moot in view of the corrected drawings (i.e. the addition of (A), (B), and (C) in the description of the FIGs; amendment to delete the prefix http:// in paragraph [0011]), thus the objection is withdrawn.
Claim Rejections- 35 USC § 101 and/or 35 USC § 112
The rejection of claim(s) 1-10 under 35 USC § 101 and/or 35 USC § 112 for
improperly written as “Use of…” claims (USC § 101) and for indefiniteness (35 USC § 112) is/are rendered moot in view of the amendment(s) to claim(s) 1-10, thus the rejection is withdrawn.
Claim Rejections- 35 USC § 112(b)
The rejection of claim(s) 1-10 under 35 USC § 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regards as the invention is/are rendered moot in view of the amendment(s) to claim(s) 1-10, thus the rejection is withdrawn in favor of the new rejection set forth below.
Claim 1 is 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.
The term “comprises” should be amended to “comprising” or “wherein the method comprises”. Appropriate correction is required.
The term(s) “providing a therapeutically effective amount…to a subject in need” is vague and unclear. The term “providing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required.
Claim Rejections- 35 USC § 102
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.
(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) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hitoshi (JP 2002104989A, machine translation obtained from Espacenet on February 19, 2025).
With regard to claim 1, Hiroshi teaches use of basidiomycete mycelium extract for reducing side effects, such as nephrotoxicity and hematotoxicity, of anticancer drug(s), including cisplatin, wherein the basidiomyocete in certain embodiments is Enokitake (Flammulina velutipes) (Abstract; Claims 1-3; Specification, [0001], [0008]- [0011], [0018] [0021], [0040]-[0050]). Thus, Hitoshi anticipates the use of brown Flammulina velutipes extract for inhibiting an acute kidney injury caused by cisplatin, wherein the brown Flammulina velutipes extract includes water extract obtained by extraction from brown Flammulina velutipes using water as a solvent.
With regard to claim(s) 2-10, Hiroshi teaches that in performing the active step (i.e. administration of brown Flammulina velutipes extract to a subject with acute kidney injury caused by cisplatin), the use would necessarily result in reduction of the effects of cisplatin-induced acute kidney injury (e.g. weight loss, increase in blood urea nitrogen and creatine, increase expression of inflammatory factors, etc.).
In regard to "wherein” clauses, MPEP 2111.04 states:
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. In the instant case, the wherein clause is directed to the intended result (i.e. reduction in the effects of cisplatin-induced acute kidney injury, i.e. reduction in weight loss, reduction in the increase in blood urea nitrogen and creatine, reduction in the increase expression of inflammatory factors, etc.) of the process step positively recited (i.e. use of brown Flammulina velutipes extract).
Moreover, as set forth in the 101/112 rejection set forth above, the instant claims can be interpreted as both a product or a method. As set forth above, Hiroshi teaches a brown Flammulina velutipes extract and teaches the intended use of the instant claims. Thus, when the claims are construed as a product for purposes of applying art, Hiroshi would anticipate the claimed brown Flammulina velutipes extract wherein the “use” are an intended use of the claimed composition.
Response to Arguments
Applicant’s arguments/remarks filed July 7, 2025 have been fully considered but they are not persuasive.
Please note, the listing of references in Applicant’s arguments/remarks 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.
Applicant argues that the present invention is different from the mycelium extract described in Hitoshi in terms of preparation method and specific mechanism of inhibiting cisplatin-induced acute kidney injury, where by there are differences in the preparation methods and differences in the specific mechanisms for inhibiting cisplatin-induced kidney injury.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In response to Applicant’s argument that Hitoshi fails to show certain features of the invention (i.e. differences in the preparation methods of the extracts and differences in the specific mechanisms for inhibiting cisplatin-induced kidney injury), it is noted that the feature upon which Applicant relies are not recited in the rejected claim(s), and accordingly, Applicant’s argument is not found persuasive. Claim 1 broadly recites a method comprising inhibiting an acute kidney injury caused by cisplatin “…wherein the extract includes water extract obtained by extraction from brown strain Flammulina velutipes using water as a solvent.” Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004).
In response to Applicant’s argument that while Hitoshi lists Flammulina velutipes as an option for the extraction process disclosed therein, Hitoshi did not show any specific example of using Flammulia velutipes, Applicant’s argument is not found persuasive. In the instant case, Hitoshi expressly teaches Flammulia velutipes as a preferred embodiment; working examples are not required. See 35 U.S.C. 102(a)(1).
In response to Applicant’s argument that there are differences in the specific mechanisms for inhibiting cisplatin-induced kidney injury, Applicant’s argument is not found persuasive. 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. In the instant case, Hitoshi expressly teaches use of basidiomycete mycelium extract for reducing side effects, such as nephrotoxicity and hepatotoxicity, of anticancer drug(s), including cisplatin, wherein the basidiomyocete in certain embodiments is Enokitake (Flammulina velutipes) (Abstract; Claims 1-3; Specification, [0001], [0008]- [0011], [0018] [0021], [0040]-[0050]); detailed teaches regarding the mechanism of action is not required.
Please further note, the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the compositions are markedly different. The method of use is the same to treat hepatoxicity induced by cancer drugs is the same, and thus the properties of the disclosed composition is/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 of administration is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
Conclusion
No claim(s) is/are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at (571) 272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655