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
Responsive to claim-set of 7AUG2023
Claims pending 1-21
Claims currently under consideration 1-21
Priority
This application has a filing date of 08/07/2023 and has
PRO 63/395,849 of 08/07/2022
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.
Claims 1-7,11-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bedi et al (2019 Medicines 6,51).
As in claims 1,2,4,6,11,12 & 14, Bedi et al teach throughout the document and especially the first page and sections 2.5, 2.6 & 3.3, by: determining the effect of the small molecule drug camptothecin on the release of a plurality of immunomodulating factors such as cytokines, chemokines and/or growth factors by various kinds of colon cancer cells with an immunoassay; treating a human with a therapeutically effect amount of the drug if the effect of the drug on the release of immunomodulating factors indicates that the drug promotes anti-tumor immunity; plus selecting a different drug for treating colon cancer if the effect of the drug on immunomodulating factor release indicates that the drug does not promote anti-tumor immunity; and/or as in claims 15,16,17,18,19 & 20, determining the effect of the small molecule drug on the release of a plurality of immunomodulating factors such as cytokines or growth factors by various kinds of colon cancer cells with an immunoassay; continuing to treat a subject if the effect of the drug on the release of immunomodulating factors indicates that the drug promotes anti-tumor immunity, or changing treatment to a different drug for treating colon cancer if the effect of the drug on immunomodulating factor release indicates that the drug does not promote anti-tumor immunity. In the passages, Bedi et al further discloses a kit therefor of claim 21 or at least all elements of the kits set forth in claims 13 and 21.
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.
Claims 1-7,11-21 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bedi et al (2019 Medicines 6,51) in view of Greer et al (2016 Science Signaling vol 9 issue 415 fs1 two pages).
Bedi et al is relied on as above.
Bedi et al do not teach an imipridone MEK tyrosine kinase inhibitor such as per claims 8-10.
Like claims 8,9, and 10, Greer et al teach throughout the document and especially figure 1, the imipridone ONC201 as a MEK tyrosine kinase inhibitor.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to test ONC201 of Greer et al for release of immunomoldulating factors by colon cancer in the manner of Bedi et al.
One of ordinary skill in the art would have been motivated to test ONC201 of Greer et al for release of immunomoldulating factors by colon cancer in the manner of Bedi et al for the benefit of stressing tumors to death as put by Greer in the title and abstract, that is, inhibiting multiple (as many as three) cancer cell survival pathways by apoptosis (programmed cell death) -- as well as further inducing apoptosis via camptothecin the topoisomerase inhibitor of Bedi et al.
One would have had a reasonable expectation of success in assaying for immunosuppressive factors released from colon cancer cells like Bedi et al treated with ONC201 as advocated by Greer et al, since adding another drug or switching one for another requires little change in protocol, whereas such combining and substituting are both are well within reach of the skilled artisan.
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 3,5,7 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 pre-AIA the applicant regards as the invention.
Each of said claims are lacking grammatical articles, therein rendering each claim’s metes and bounds unascertainable.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2,4,8-21 are rejected under 35 U.S.C. 101 because the claimed invention is drawn to an abstract idea without significantly more. Claims 1,11,14 are directed to “determining the effect of the small molecule drug on the release of a plurality of immunomodulating factors by various colon cancer cells; and selecting a different drug for treating colon cancer of a human subject if the effect of the drug on immunomodulating factor release indicates that the drug does not promote anti-tumor immunity”; and claims 15 and 19 are similarly directed to “determining the effect of the small molecule drug on the release of a plurality of immunomodulating factors by various colon cancer cells; and changing treatment to a different drug for treating colon cancer if the effect of the drug on immunomodulating factor release indicates that the drug does not promote anti-tumor immunity”, processes further described in dependent claims 2,4,6,16,17,18 wherein said factors are naturally occurring cytokines, chemokines or growth factors; per claims 8-10 wherein said drug being is an imipridone class mitogen-activated protein kinase kinase (MAP2K aka MEK) tyrosine kinase inhibitor; and claims 12,13,20,21 as an immunoassay or kit. Determination, selection and change constitute mental process(es).
MPEP 2106 eligibility step 1 & 2A prong 1: statutory but a judicial exception ?
While the presently claimed process falls under the four categories of statutory subject matter, as interpreted in MPEP 2106.04(a) particularly at pp 2100-37, the courts have held methods that can be performed mentally are judicial exceptions to patent eligible subject matter.
MPEP 2106.04(d)(2) eligibility step 2A prong 2: is the judicial exception integrated ?
In accordance with the immediate aforementioned MPEP section, since the claimed method does not require treatment with a particular imipridone the judicial exception is not integrated into a practical application by claim 8,9 nor 10.
MPEP 2106 eligibility step 2B: do the additional elements provide an inventive concept with significantly more ?
Regarding claims 2,4,6,12,13,16,17,18,20 & 21, in accordance with MPEP 2105,2106.05(g)(3) and/or (d)(2)(II), clinically testing for a biomarker is merely data gathering, or alternatively, determining the level of a (assaying for) a biomarker by any means constitutes well understood, routine conventional molecular biology technique(s). However, neither of which said data gathering nor assaying furnishes an inventive concept
As such, considered separately and in combination, the additional elements recited in claims 1-2,4,8-21 lack integration and/or an inventive concept significantly more than the mental process(es) identified above and therefor represent patent ineligible subject matter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
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