DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined
under the first inventor to file provisions of the AIA .
2. 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.
Election/Restrictions
3. Applicant’s election of Group I (claims 1-10), in the reply filed on March 17, 2026, is acknowledged. Because applicant did not distinctly and specifically point out
the supposed errors in the restriction requirement, the election has been treated as an
election without traverse (MPEP § 818.01(a)).
4. Search of Group I retrieved prior art (see Search 6 of the attached search notes).
5. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected invention of Group II, there being no allowable
generic or linking claim. Election was made without traverse in the reply filed on March 17, 2026.
Current Status of 18/413,542
6. This Office Action is responsive to the claims of January 16, 2024.
7. Claims 1-10 have been examined on the merits. Claims 1-10 are original.
Priority
8. Acknowledgement is on receiving the Certified Copy of Foreign Application filed on 3/04/2024.
9. The effective filing date is January 16, 2024.
Information Disclosure Statement
10. The information disclosure statements (IDS) submitted on May 9, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
11. Claim 7 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.
Claim 7 recites the limitation "the effective dosage". There is insufficient antecedent basis for this limitation in the claims.
As drafted, “the effective dosage” renders the metes and bounds of claim 7 undefined (hence rendering claim 7 indefinite under 35 USC 112(b)) since the artisan does not know where antecedent basis can be found for “effective dosage” within claim 5. Claims 5 is silent as to “an effective dosage” or “effective dosage”.
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.
12. 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.
13. Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over:
MA (“Oxidative Stress Is a Key Modulator in the Development of Nonalcoholic Fatty Liver Disease” Antioxidants 2022, 11, 91. https://doi.org/10.3390/antiox11010091. Published: 30 December 2021),
in view of
QAIS (“Antioxidant Activity of Lumichrome and Its Reduced Form, 5,10-Dihydro-7,8-dimethyl Alloxazine” IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS), Volume 15, Issue 3 Ser. II (May –June 2020), PP 50-53; cited in IDS of 05/09/2026 and provided by Applicant),
and further in view of
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
Determining the scope and contents of the prior art
MA teaches studies to identify the role of antioxidants in the treatment of NAFLD and the use of antioxidants as therapeutic agents for NAFLD, including flavanols (flavan-3-ols), vitamin E, Coenzyme Q10, and diet.
QAIS teaches the antioxidant activity of lumichrome even stronger than the standard of ascorbic acid used in the study.
ANSEL teaches the safe and effective dose of a drug depends on a number of
factors including characteristics of the drug, the dosage form, and a variety of patient
factors (para 2, Left Col, p 48) and the effective dose may be different for different
patients (para 4, Left Col, p 48). ANSEL further teaches the schedule of dosage or the
dosage regimen is determined based on a drug’s duration of action, pharmacokinetics,
and characteristics of the dosage form (para 2, Left Col. p 53).
Ascertaining the differences between the prior art and the claims at issue
MA teaches antioxidants in the treatment of NAFLD, but doesn’t explicitly teach lumichrome.
QAIS only teaches the antioxidant activity of lumichrome, but not treatment of NAFLD.
ANSEL does not teach the instant method.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has
sufficient background in the development of method useful for treatment of NAFLD and
possesses the technical knowledge necessary to make adjustments to the administered
composition to optimize/enhance the treatment outcomes. Said artisan has also
reviewed the problems in the art regarding medical dosage forms and understands
the solutions that are widely-known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
MA’s teachings are not just regarding antioxidants in the treatment of NAFLD, they also inherently include, but not limited to, a medical composite (such as vitamin E, Coenzyme Q10 treatment) or a food composite (e.g. diet), a treatment subject of human, and a pharmaceutically acceptable carrier in making compositions in these treatments.
An artisan would be motivated to combine MA’s teachings with QAIS’s teaching to reach the instant claims, as MA teaches the role of antioxidants in the treatment of NAFLD and the use of antioxidants as therapeutic agents for treatment of NAFLD, and QAIS teaches lumichrome is a strong antioxidant. Moreover, the artisan would have a reasonable expectation of success of such combination with a motivation of finding new drug treatment of NAFLD.
Thus, instant claims 1-5 and 10 are obvious over by combination of MA’s and QAIS’ teachings.
Regarding claims 6-9 of effective dosage and dosage regimen. In view of ANSEL, the artisan would recognize the relationship between a drug’s dosage and the drug’s effect on the target disease. Thus, the artisan would recognize the efficacy of a drug as an outcome of the dosage/dosing regimen and would recognize the dosage/ dosing regimen as a results-effective variable, i.e., a variable that achieves a recognized result. In the instant case, since the optimization of the lumichrome dosage/dosing regimen is obvious, the optimization of the drug’s efficacy at treating NAFLD would naturally follow.
Moreover, patent law views differences in concentration (herein, finding effective dosage ranges and dosage regimen of lumichrome) as not supporting the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) (Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874)
(a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36
F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It 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 also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based
on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Thus, the prior art references MA and QAIS in view of ANSEL teach instant claims 6-9.
Conclusion
15. No claims are allowable as presently written.
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/B.T./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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