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 .
Priority
This application is a Continuation of and claims the benefit of US17190018 with an effective filing date of 02 March 2021 as reflected in the filing receipt mailed on 08 June 2023.
Status of the Claims
Claims 27-46 are pending.
Claims 1-26 were previously cancelled.
Response to Amendments
Applicant’s amendments filed 05 March 2026 are acknowledged.
Claims
Applicant’s new version of the claims filed 05 March 2026 is acknowledged. No claims have been amended.
Abstract
Applicant’s amendments to the abstract are not apparent. The substitute abstract filed 05 March 2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because a marked-up copy showing the mark-ups of the substitute abstract has not been supplied (in addition to the clean copy).
Drawings
Applicant’s amendments to the drawings is sufficient to overcome the objection of the drawings. The drawings have been amended to comply with 37 CFR 1.84 (u)(1). The objection is withdrawn.
Specification
Applicant’s amendments to the specification have been acknowledged.
Applicant’s amendments to the specification is sufficient to overcome the
objection of the specification. The specification has been amended to correct the typographical mistake of “genofibrate” to “fenofibrate”. The objection is withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 05 March 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US10940125 has been reviewed and is accepted. The terminal disclaimer has been recorded. As a result, the rejection of claims 27-46 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 8-10 of U.S. Patent No. 10940125 to Koeberl et al. (hereinafter Koeberl) in view of Yen et al. (WO2017049157, hereinafter Yen) is withdrawn.
Response to Arguments
Applicant’s arguments filed 05 March 2026 have been fully considered but they are not persuasive or moot.
Applicant’s argue that Yen is not prior art to the limitations as recited in the claims. These arguments have been considered but are not persuasive for the reasons set forth in the maintained grounds of rejection below and the response to arguments below.
In response to applications arguments throughout the remarks filed on 05 March 2026 that “Yen is the parent PCT application of the present application. Because Applicant properly claimed priority to Yen, which the Office acknowledged in the Filing Receipt, and which is consistent with Para. [0002] of the present application, Yen cannot be prior art”.
Under MPEP 201.07 and 211.01(b), instant application, US18200156, filed on 22 May 2023 claims the benefit of US15760156 patented as US10940125 on 09 March 2021. 37 CFR 1.78(d) states “[a]n applicant in a nonprovisional application … may claim the benefit of one or more prior-filed copending nonprovisional applications” [emphasis added]. “Copendency is defined in the clause which requires that the later-filed application must be filed before: (A) the patenting of the prior application; (B) the abandonment of the prior application; or (C) the termination of proceedings in the prior application” [emphasis added], see MPEP 211.01(b). Instant application, US18200156, the later filed application, filed on 22 May 2023 cannot claim the benefit of US15760156 patented as US10940125 on 09 March 2021. US15760156, the prior application, was not “copending” on 22 May 2023 because US15760156 was patented on 09 March 2021.
Therefore, this application is incorrectly claiming the benefit of prior-filed application No. 15760156 under 35 U.S.C. 120, 121, 365(c), or 386(c). As stated above, in order to claim the benefit of a prior-filed application copendency between the current application and the prior application is required. Since the applications are not copending, the benefit claim to the prior-filed application is improper. Applicant is required to delete the claim to the benefit of the prior-filed application, unless applicant can establish copendency between the applications.
As stated above, “[t]his application is a Continuation of and claims the benefit of US17190018 with an effective filing date of 02 March 2021 as reflected in the filing receipt mailed on 08 June 2023” [emphasis added]. WO2017049157 to Yen et al. was published 23 March 2017 which is before the effective filing date of the instant application. Therefore, Yen is prior art under “a family of patents”, see MPEP 901.05.
For the reasons indicated above, applicant’s above arguments are not persuasive.
Double Patenting
As stated above, due to the filing of the terminal disclaimer, the rejection of claims 27-46 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 8-10 of U.S. Patent No. 10940125 to Koeberl et al. (hereinafter Koeberl) in view of Yen et al. (WO2017049157, hereinafter Yen) is withdrawn. Applicant’s argument is moot.
The rejections of:
Claims 27-29, 36-38, and 41-45 under 35 U.S.C. 102(a)(1) as being anticipated by Yen et al. (WO2017049157, hereinafter Yen); and,
Claims 30-35, 39, 40, and 46 under 35 U.S.C. 103 as being unpatentable over Yen et al. (WO2017049157, hereinafter Yen), as applied to claims 27-29, 36-38, and 41-45 in the 35 USC 102 rejection above, are maintained.
Maintained Rejections Based on the reply filed on 05 March 2026
In the Spirit of Compact Prosecution
Throughout prosecution the examiner has attempted to identify all objections and clarity issues amongst the claims, applicant is advised that some objections and clarity issues may still remain. Going forward, the examiner respectfully requests applicant to perform a detailed review of the claims regarding clarity, grammar, antecedent basis, word spacing, and spelling issues.
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 27-29, 36-38, and 41-45 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yen et al. (WO2017049157, published 23 March 2017, hereinafter Yen).
The various single embodiments of the claims of Yen expressly disclose the instant application claims 27-29, 36-38, and 41-45 limitations of a method of treating a subject, the method comprising: administering to a subject having a steatosis-associated disorder, such as Glycogen Storage Disease Type I (GSD I), non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), or a combination thereof, a therapeutically effective amount of an autophagy-inducing agent, wherein the autophagy-inducing agent comprises a thyroid hormone, such as thyroxine (T4), triiodothyronine (T3), an analog thereof, or a combination thereof, and/or an AMPK activator, such as quercetin, in combination with administering to the subject a therapeutic lysosomal enzyme, such as glucocerebrosidase, acid alpha-glucosidase, alpha-galactosidase, alpha-n-acetylgalactosaminidase, acid sphingomyelinase, alpha-iduronidase, or a combination thereof, see claims 1, 2, 4, 6, 8, 10-17, 19, 21, and 23-26, where treating as claimed by Yen is defined as “amelioration of one or more symptoms associated with the disease, prevention or delay of the onset of one or more symptoms of the disease, and/or lessening of the severity or frequency of one or more symptoms of the disease”, see Para. [0044], and a therapeutic agent administered in order to treat as claimed by Yen is defined as “therapeutically effective amount”, see Paras. [0046]-[0048];[0094]-[0095];[0102], meeting:
The limitations in instant application claim 27, in instant application claim 28, instant application claim 29, in instant application claim 36, in instant application claim 37, in instant application claim 38, in instant application claim 41, in instant application claim 42, in instant application claim 43, in instant application claim 44, and in instant application claim 45.
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.
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 30-35, 39, 40, and 46 stand rejected under 35 U.S.C. 103 as being unpatentable over Yen et al. (WO2017049157, published 23 March 2017, hereinafter Yen), as applied to claims 27-29, 36-38, and 41-45 in the 35 USC 102 rejection above.
Yen teaches the instant application claims 30-35, 39, 40, and 46 limitations of a method of reversing glycogen storage in a subject in need thereof by administering an autophagy-inducing agent, a lysosomal enzyme, or a combination thereof, in order to induce autophagy in a subject having a steatosis-associated disorder, such as GSD I, NASH, or NAFLD, and reversing glycogen storage and steatosis in the subjects; thus, treating to improve long-term GDS I complications, such as chronic liver disease, metabolic syndrome, cirrhosis, and fibrosis and liver symptoms, particularly in the reduction or prevention of GSD (e.g., GSD-Ia)-associated hepatosteatosis, abdominal discomfort, elevated liver enzyme levels, fatigue, malaise, hepatomegaly, hyperlipidemia, hypoglycemia, hypertension, iron-resistant anemia, kidney stones, growth delay, lactic academia, nephropathy, hepatic/renal glycogenosis, pancreatitis, hepatic adenomata, hepatocellular carcinoma, osteopenia/osteoporosis, platelet dysfunction, spider angiomata, ascites, splenomegaly, hard liver border, palmar erythema, or asterixis, see Paras. [0002];[0040];[0044]-[0046], meeting:
The limitations in instant application claim 30, in instant application claim 39, in instant application claim 40, and in instant application claim 46; and,
Metabolomic analysis of blood and urine is performed to provide noninvasive monitoring of therapeutic effects in GSD I by demonstrate the correction or improvement of biochemical abnormalities of GSD I, where the blood levels of glucose, plasma acylcarnitines, amino acids, triglycerides, lactate are measured and urine organic acids are analyzed for lactate, methylglutaconate, and 3-hydroxybutyric acid, in order to determine the abnormality correction in hypoglycaemia, lactic acidemia and lactic aciduria, elevated urine ketones, and increased long-chain acylcarnitine, see Paras. [0121]-[0125], meeting,
The limitations in instant application claim 31, in instant application claim 32, in instant application claim 33, in instant application claim 34, and in instant application claim 35.
Yen does not specifically teach the above claim limitations in one express single embodiment.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified
the differing embodiments of Yen to treat and test the blood and urine of the patient in order to treat the specific disease and/or disorder with a reasonable predictability of success. By applying “routine optimization” and “predictable results” to select the optimal diagnosis, treatment, and metabolic testing, one of ordinary skill in the art would have been motivated to make these modifications because Yen provides a finite number of identified, predictable solutions, and a person of ordinary skill in the art has good reason to select the appropriate methods of diagnosis, treatment, and metabolic testing, for the benefit of ameliorating one or more symptoms associated with a steatosis-associated disorder, preventing or delaying the onset of one or more symptoms of the disease, and/or lessening of the severity or frequency of one or more symptoms of the disease, see Yen, Paras. [0002]-[0003];[0044]-[0048];[0121]-[0125], and MPEP 2141.
Further, In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) states “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions”, see MPEP 2144.05 II.A.
Conclusion
No claims 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 Y. Lynnette Kelly-O'Neill whose telephone number is (571) 270-3456. The examiner can normally be reached Tuesday-Friday, 8:30 a.m. - 6:30 p.m., EST, with Flex Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Yen-Ye Goon can be reached at (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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