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
Applicant’s election without traverse of claims 1, 5-8, and 12 in the reply filed on 04/20/2026 is acknowledged. The most recent claim set submitted on 07/30/2024 is considered with the claims 1, 5-8, and 12 examined below and claim 14-23 and 26-29 as withdrawn without traverse.
Drawings
The drawings are objected to because Figure 3, Figure 4a, Figure 4b, and Figure 4c are blurry and hard to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 and 12 objected to because of the following informalities:
Claim 5 recites "a candidate drug that has been confirmed to be a mitochondrial F1Fo ATP Synthase c-subunit leak channel opener", however, it should recite "a candidate drug that has confirmed to promote proton (H+) leakage through a mitochondrial F1Fo ATP Synthase c-subunit leak channel".
Claim 5 recites “… a method …”, however, it should recite “… the method…”.
Claim 12 recites “… a glioma patient when: the drug….”, however, it should recite “… a glioma patient when the drug….”.
Appropriate correction is required.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
1. Step 1: Claim 1 recites at least one step or act. Thus, the claim is to a method, which is one the statutory categories of invention. Claim 5 is dependent on Claim 1. (Step 1: Yes).
2. Step 2A Prong One: Claim 1 recites a judicial exception and identify the abstract idea/law or nature/natural phenomenon. Claim 1 recites “detecting” and “comparing” H+ of the sample with and without the drug. This would be considered an evaluation (mental step) and therefore an abstract idea. Claim 5 also recites a “detecting” the presence of glioma suppression. This would be considered an evaluation (mental step) and therefore an abstract idea. (Step 2A -Prong 1: Yes)
3. Step 2A Prong Two: The judicial exception is not integrated into a practical application because claim 1 does not impose any meaningful limits on practicing the abstract idea. There appears to be no additional steps which are significantly more than the abstract idea. It only generally describes detecting and comparing H+ but does not indicate how that is done in a practical step. Once the abstract ideas are complete, nothing is done. Therefore, there appears to be no integration much less a particular practical application. Claim 5 also does not add any practical application for the detection step and afterwards (Step 2A -Prong 2: No)
4. Step 2B: Claim 1 does not have any steps or feature which are significantly more and are well known in the art as taught in the prior art. Claim 1 is ineligible. Claim 5 does not appear to have ‘significantly’ more and all steps in the method in Claim 1 are well understood routine and conventional. Claim 1 and 5 are ineligible because, the step of comparing the difference is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article. Claim 6-8 recite parameters of the method in claim 1, however, that does not include any practical application for the detecting and comparing steps recited in claim 1. Claim 12 recite a step of administering the identified candidate drug from claim 1, however, that does not include any practical application for the detecting and comparing steps recited in claim 1. (Step 2B: No).
Thus, claim 1 and 5 are ineligible. Claims 6-8 and 12 a dependent on Claim 1, therefore are objected to.
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, 5, 7, 8 and 12 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.
Claim 1 recites the limitation "SMV membrane" in step b. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites the limitation "a " in step a which reads as a singular preparation, however, in step b and c ‘SMV’ are plural. Claim 1 recites “SMV(s)” in step b and c, however, it is unclear ‘SMV’ is referring to SMV membrane recited in step b or the SMV preparation in step a. There is insufficient antecedent basis for these limitations in the claim.
Furthermore, Claim 1 recites the limitation "H+ level" in step d. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 5 step a, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites the limitation "the glioma" which is not mentioned in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the glioma" which is not mentioned in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the leak channel opener". That limitation is not mentioned in claim 1. There is insufficient antecedent basis for this limitation in the claim. For examination purpose the claim 12 was reads as “… comprising administering the candidate drug to a…”.
Claim Rejections - 35 USC § 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 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, 5, 6, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature "Antiinfectives targeting enzymes and the proton motive force" by Feng et al. and further in view of Gribkoff et al. (US20130273557).
Regarding claim 1, Feng teaches a method for identifying a candidate anti-glioma drug that promotes proton (H+) leakage through an ATP Synthase ion channel (pg E7075, Section: Results and Discussion and Table 1), the method comprising:
a. providing an admixture comprising:
i. a candidate drug (pg E7076, left column);
ii. membrane vesicles (pg E7075, Section: Results and Discussion);
iii. an H+ probe (pg E7075, Section: Results and Discussion);
b. contacting the admixture with adenosine triphosphate (ATP), wherein the presence of ATP promotes translocation of protons across the membrane and into the internal space of the membrane vesicle (pg E7075, Section: Results and Discussion).
c. detecting H+ external to the member vesicles with the H+ probe, and determining a value of H+ external to the membrane vesicle (pg E7075, Section: Results and Discussion).
d. comparing the H+ level determined at step c) with that of a corresponding reference H+ level for a control admixture that lacks the candidate drug (pg E7075, Table 1); and
i. identifying the drug as a candidate anti-glioma drug that promotes H+ leakage, when the H+ level is higher compared to the reference H+ level for the control admixture (pg E7075, Table 1); or
ii. identifying that the drug is not a candidate anti-glioma drug that promotes H+ leakage, when the H+ level is the same or lower compared to the reference H+ level for the control admixture (pg E7075, Table 1).
Although Feng teaches ATP synthase ion channel and membrane vesicles, Feng does not teach a mitochondrial F1Fo ATP Synthase c-subunit leak channel and submitochondrial vesicles and their preparation.
However, Gribkoff teaches a method of identifying compound including drugs that can bind to an ATP synthase complex for increasing the bioenergetic efficiency (Abstract). Gribkoff teaches a mitochondrial F1Fo ATP Synthase c-subunit leak channel (para 0052-0058) and submitochondrial vesicles (para 0060) and their preparation (para 0210). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Feng with the a mitochondrial F1Fo ATP Synthase c-subunit leak channel and submitochondrial vesicles and their preparation as taught by Gribkoff because F1Fo ATP Synthase c-subunit leak channel has binding specificity with certain compounds (para 0048) and submitochondrial vesicles have similar membrane current to membrane in mitochondria (para 0200).
Regarding claim 5, Feng further in view of Griboff teaches claim 1. Feng furth teaches screening method for identifying an anti-glioma drug, the method comprising:
a. obtaining a candidate drug that has been confirmed to be a mitochondrial F1Fo ATP Synthase c-subunit leak channel opener preferably by a method according to claim 1 (pg E7075, Section: Results and Discussion);
b. contacting an isolated glioma sample with the candidate drug, and incubating the sample (pg E7080, Fig. 5);
c. detecting the presence or absence of glioma suppression when compared to a control glioma sample incubated in the absence of the candidate drug (pg E7080, Fig. 5); and
i. identifying the candidate drug as suitable for use as an anti-glioma drug when suppression is detected (pg E7080, Fig. 5 and left column); or
ii. identifying the candidate drug as unsuitable for use as an anti-glioma drug when suppression is not detected.
Regarding claim 6, Feng teaches the H+ probe is 9-Amino-6- chloro-2-methoxyacridine (ACMA) (pg E7075, Section: Results and Discussion).
Regarding claim 8, Feng teaches the glioma is glioblastoma multiforme (GBM) (pg E7079, Section: Targeting Prenyl Synthases).
Regarding claim 12, Feng teaches administering the candidate drug to a glioma patient when: the drug is identified as a candidate anti-glioma drug that promotes H+ leakage (pg E7081, Section: Conclusion).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature "Antiinfectives targeting enzymes and the proton motive force" by Feng et al. and Gribkoff et al. (US20130273557) as applied to claim 1 above, and further in view of Towner (US20200215015).
Regarding claim 7, Feng in view of Gribkoff teaches the instant invention in claim 1.
Feng does not teach the glioma is temozolomide (TMZ) resistant.
However, Towner teaches a drug treatment for the treatment of temozolomide drug resistant gliomas. Temozolomide is commonly used as an anti-glioma agent (para 0018), however, glioblastoma may be temozolomide resistant (para 0027). Towner teaches TMZ-resistant glioblastoma cells (para 0044). Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify Feng in view of Gribkoff with the glioma being temozolomide resistant as taught by Towner for the benefit of identifying a candidate drug that that works on glioblastomas that are TMZ-resistant (para 0027).
Conclusion
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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