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 .
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.
Previous Rejections
Applicant’s arguments, filed March 26, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 14-16, 18, and 21-37 are cancelled.
Claim 38 is newly added.
Claims 1-13, 17, 19-20, and 38 are pending.
Claims 10-12 are withdrawn.
Claims 1-9, 17, 19-20, and 38 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Venditti (US 8,721,988; of record).
Venditti teaches a device including a chamber wherein the chamber including a rigid enclosure; a rigid lid for the enclosure; a gasket between the lid and the enclosure to allow for an airtight seal between the enclosure and the gasket upon closure of a latch connecting the enclosure and the lid; a port for airtight attachment of a syringe, and a port for airtight insertion of a gas sensor, and methods of use of the device (Abstract; Title). Venditti teaches the method can be used to study patients who might receive gene or cell based therapies or enzyme replacement therapy as a treatment for their underlying disorder (col 8: 10-13). Venditti teaches a method utilizing administration of labeled and unlabeled organic acids, such as propionate, lactate, and acetate (col 7: 1-8).
Venditti teaches the method steps in a mouse experiment (Example) as follows:
-Step (i) of claim 38: “The mouse was then injected intraperitoneally with 2 millimoles of 1-13C-sodium propionate” (col 12: 29-30).
-Step (ii) of claim 38: “Upon closing the chamber, a timer was started, and samples were obtained at five-minute intervals using the same method as that used to collect the control samples prior to injection” (col 12: 32-35).
-Steps (iii) and (iv) of claim 38: “After sample collection was complete, the isotope ratio (13C/12C) of the expired gas was determined with a gas isotope ratio mass spectrometer” (col 12: 36-38).
-Step (v) of claim 38: “two rare untreated Mut-/- mice … received a single intraperitoneal injection of 3x 1011 GC of rAAVS-mMut.” (col 12: 65 to col 13: 4).
-Steps (vi) to (viii) of claim 38: Venditti teaches steps (i) to (iv) are extended and reused in the post
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Venditti. However, the claimed combination of steps is taught as known and used for administration to a subject with in the treatment of organic acidemia. Further, Venditti teaches administration with the same isotope-labeled tracer oral administration or administration by gastric gavage. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the claimed combination of ingredients, including the tracer and the treatment, to a subject with organic acidemia through a gastric or oral route of administration with a reasonable expectation of success that the treatment would be efficacious, as taught by Venditti.
Allowable Claims
Claims 1-9, 17, and 19-20 are considered allowable for the following reason: Claim 1, as presently amended, recites the limitation from previous claim 13, namely “wherein isotope-labeled propionate is administered in the amount of less than or equal to about 10 µmol/kg body weight.” The prior art of Venditti, cited above, teaches a dosage in mice of 200 micrograms (col 6: 15-19). Given the average weight of a laboratory mouse is about 20 grams, the Examiner calculates the dosage as 133 µmol isotope labelled propionate/kg body weight, given the molecular weight of the isotope-labelled propionate is 75.07 gm/mol. As such, the dosage taught in the prior art is more than 13-fold greater than the claimed range, a range neither taught or suggested by the cited prior art.
Examiner’s Reply to Attorney Arguments dated 3/26/2025
1. Rejection of claims 1, 5-9, 17, and 19-20 under 35 U.S.C. § 103 as over Venditti
This rejection is withdrawn in view of the amendment to claim 1 reciting “wherein isotope-labeled propionate is administered in the amount of less than or equal to about 10 mmol/kg body weight.”
2. Rejection of claims 2-4 under 35 U.S.C. § 103 as over Venditti and Carrillo-Carrasco
Applicant’s arguments have been fully considered and are persuasive in view of the cited amendment to claim 1.
3. Rejection of claim 18 under 35 U.S.C. § 103 as over Venditti and Hauser
CONCLUSION
Applicant's 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 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 MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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