DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 04/28/2025 has been entered. Claims 7-32 and 39 are cancelled. Claim 43 is newly added. Claims 1-6, 33-38, and 40-43 are pending in this application. Claims 4-6, 33-37, and 40-42 are withdrawn. Claims 1-3, 38, and 43 are currently under examination.
Priority
This application is a CON of 17/256,406 filed on 12/28/2020, now PAT 12011452, which is a 371 of PCT/US2019/039631 filed on 06/27/2019 and claims benefit of US PRO 62/830,850 filed on 04/08/2019 and PRO 62/690,718 filed on 06/27/2018.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/830,850 or 62/690,718, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-3, 38, and 43 recite “probucol”, which is not disclosed or supported by the prior-filed Application No. 62/690,718. Claims 1-3, 38, and 43 recite “cysteamine bitartrate”, which is not disclosed or supported by the prior-filed Application No. 62/830,850 or 62/690,718. Thus, the priority date of claims 1-3, 38, and 43 is 06/27/2019.
Election/Restrictions
Applicant's election without traverse of Group I invention (claims 1-3) in the reply filed on 04/28/2025 is acknowledged. Amended claim 38 and new claim 43 depend from claim 2 and claim 1, respectively. Claims 4-6, 33-37, and 40-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-3, 38, and 43 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 08/02/2024 has been considered.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: In claim 1, change the incorrect recitation “acipmox” (line 3) to “acipimox”. In claim 3, insert the missing phrase “the effective amounts are” immediately after the recitation “wherein” (line 2) and delete the excessive recitation “are administered” because the claim is directed to a composition. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 38, and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for amelioration of mitochondrial disease, does not reasonably provide enablement for the treatment of mitochondrial disease. The term “treatment” is defined “Accordingly, "treatment" refers to both therapeutic treatment and prophylactic or preventative measures” in the specification (p. 21, lines 3-5). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or to use the invention commensurate in scope with these claims. Claims 2, 3, 38, and 43 depend from claim 1.
Applicants claim a composition having efficacy for the treatment (encompassing of prophylactic or preventative measures) mitochondrial disease recited in claim 1. However, no limiting definition of “prophylactic or preventative measures” is given in the instant Specification. In the absence of a limiting definition by the Applicants, "prevention" as described according to the Institute for International Medical Education (pages 15 and 16), is a preventive measure, such as preserving physical fitness in primary prevention and effective intervention to correct departures from good health in secondary prevention. More specifically, tertiary prevention, which is most relevant as used in the context of the instant invention, "consists of the measures available to reduce or eliminate long-term impairments and disabilities, [and to] minimize suffering caused by existing departures from good health". Thus, the claimed composition having efficacy for the treatment (encompassing of prophylactic or preventative measures) mitochondrial disease as interpreted by a skilled practitioner of the medical or pharmaceutical arts would be to reduce for long-term the occurrence of or to eliminate mitochondrial disease by the composition.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The rejected invention is drawn to A composition having efficacy for the treatment of mitochondrial disease, comprising effective amounts of one or more of glucose, N-acetylcysteine, nicotinic acid, probucol, lithium chloride, resveratrol, folinic acid, nicotinamide riboside, acipimox and cysteamine bitartrate, in a pharmaceutically acceptable carrier.
Relative skill of those in the art: The relative skill of those in the art is from biomedical field (see the cited reference below).
Breadth of claims: The claim is extremely broad in that it encompasses the prevention of mitochondrial disease using the instantly claimed composition.
State of the prior art/Predictability or unpredictability of the art: There is no teaching or suggestion in the state of the prior art that application of certain pharmaceutical composition can prevent mitochondrial disease. Falk et al. (National Academies of Sciences, Engineering, and Medicine. 2018) disclosed that no proven effective therapies or cures for mitochondrial disease are available, mostly because it consists of so many individually rare, highly heterogeneous disorders. More than three dozen antioxidants, metabolic modifiers, and signaling modifiers have been tested in a well-validated Caenorhabditis elegans (C. elegans) worm model of genetic-based primary mitochondrial disease. The lead signaling modifiers were nicotinic acid and probucol, and glucose was an effective metabolic therapy, as were the antioxidants N-acetylcysteine and vitamin E. Some combined therapy combinations, or cocktails, appear to have synergistic effects (page 24, para. 5; page 28, para. 4; page 30, para. 1). One of skilled artisan would understand that contemporary treatment or management of mitochondrial disease is to ameliorate mitochondrial disease symptoms, not to prevent, mitochondrial disease.
Amount of guidance/Existence of working examples: It is worth noting that there are no working examples in the instant application to show that the claimed composition is effective for preventing mitochondrial disease as recited in the claim. The exemplary embodiments of the Specification merely present: (i) Cysteamine bitratrate and N-acetylcysteine rescue brain death and neuromuscular activity in a novel SURFJ-knockout zebrafish animal model of Leigh syndrome; (ii) "Mitochondrial cocktail" combinatorial compound screening in C. elegans and zebrafish models of mitochondrial Complex I disease and identification of combinations having efficacy for the treatment of Mitochondrial Disorders; (iii) Identification of Mitochondrial cocktails from lifespan analyses that significantly improved the short lifespan gas-1(fc21) NDUFS2 mutant worms; (iv) Changes in mitochondrial physiology observed as a result of administration of cocktails; (v) Significant reduction in alanine levels representative of mitochondrial complex I dysfunction; and (vi) Global pattern of gene expression shows NAC+NA and NAC+Glu had the best reversing effect (pages 59-69).
Quantity of experimentation: In order to practice the full scope of the invention, one skilled in the art would need to undertake a novel and extensive research program to show that a preventive measure can be achieved after applying the claimed composition. Furthermore, one of ordinary skill in the art would need to test a representative number of animals before one of ordinary skill in the art would be able to conclude that any composition can be used to prevent mitochondrial disease. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of use in prevention of mitochondrial disease, it would constitute an undue and unpredictable experimental burden.
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164. Genetech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Therefore, in view of the Wands factors as discussed above, including the amount of guidance provided and the predictability of the art and the lack of working examples to practice the full scope of the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
Claim 38 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 pre-AIA the applicant regards as the invention.
Claim 38 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: The “probucol” and “a pharmaceutically acceptable carrier” of claim 38 have been recited in preceding claim 1. The recitation “further” of claim 38 would introduce duplicated “probucol” and “a pharmaceutically acceptable carrier”. Applicant is advised to change the recitation “further comprising effective amounts of probucol in a pharmaceutically acceptable carrier” (lines 1-3 of claim 38) to “wherein the effective amount of probucol is present in the pharmaceutically acceptable carrier”.
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 1-3, 38, and 43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1-3, 38, and 43 recite a composition comprising one or more of glucose, N-acetylcysteine, nicotinic acid, probucol, lithium chloride, resveratrol, folinic acid, nicotinamide riboside, and cysteamine in a pharmaceutically acceptable carrier (for example, water), which are products of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that mixing them in the recited concentrations (i.e., 5-11 mM glucose, 0.1-10 mM N-acetylcysteine, and 0.1-10 mM nicotinic acid) changes the structure, function, or other properties of the one or more of glucose, N-acetylcysteine, nicotinic acid, probucol, lithium chloride, resveratrol, folinic acid, nicotinamide riboside, and cysteamine in a pharmaceutically acceptable carrier in any marked way. Instead, the one or more of glucose, N-acetylcysteine, nicotinic acid, probucol, lithium chloride, resveratrol, folinic acid, nicotinamide riboside, and cysteamine in a pharmaceutically acceptable carrier retains its naturally occurring structure and properties (e.g., antioxidant activity or mitochondrial energy substance). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, mixing of one or more of glucose, N-acetylcysteine, nicotinic acid, probucol, lithium chloride, resveratrol, folinic acid, nicotinamide riboside, and cysteamine in a pharmaceutically acceptable carrier was well-understood, routine and conventional in the field, as evidenced by the reference under the 102 and 103 rejections below. The recitation of specific concentration of one or more of glucose, N-acetylcysteine, and nicotinic acid, or additional acipimox does not affect this analysis, because it was also well-understood, routine and conventional at the time of filing, e.g., to achieve commercially acceptable chemical complex for different purposes. Thus, the mixing of different amounts of one or more of glucose, N-acetylcysteine, nicotinic acid, probucol, lithium chloride, resveratrol, folinic acid, nicotinamide riboside, and cysteamine in a pharmaceutically acceptable carrier, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
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.
(I) Claims 1, 2, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falk et al. (A public workshop of National Academies of Sciences, Engineering, and Medicine, April 2–3, 2018, hereinafter referred to as Falk ‘2018).
With regard to structural limitations “a composition comprising effective amounts of one or more of glucose, N-acetylcysteine, nicotinic acid, and probucol in a pharmaceutically acceptable carrier for ameliorating mitochondrial disease” (claims 1, 2, and 38):
Falk ‘2018 disclosed that antioxidants, metabolic modifiers, and signaling modifiers have been tested in a well-validated Caenorhabditis elegans (C. elegans) worm model of genetic-based primary mitochondrial disease. The lead signaling modifiers were nicotinic acid and probucol, and glucose was an effective metabolic therapy, as were the antioxidants N-acetylcysteine and vitamin E. Some combined therapy, or cocktails, appear to have synergistic effects (page 28, para. 4; page 30, para. 1).
Thus, these teachings of Falk ‘2018 anticipate Applicant’s claims 1, 2, and 38.
(II) Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lehmann (ZA200109677B, 2002-06-25, hereinafter referred to as Lehmann ‘677) as evidenced by Niacin (Fact sheet for health professionals, NIH, Updated: November 18, 2022, hereinafter referred to as Niacin ‘2022).
With regard to structural limitations “a composition comprising effective amounts of one or more of glucose (or 5-11 mM), N-acetylcysteine (or 0.1-10 mM), and nicotinic acid (or 0.1-10 mM) in a pharmaceutically acceptable carrier for ameliorating mitochondrial disease” (claims 1-3):
[AltContent: rect][AltContent: rect]Lehmann ‘677 disclosed Example 1: A first premixture was prepared by mixing
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. A [AltContent: rect]second premixture was prepared by mixing:
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. A third premixture was prepared by mixing:
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. The first premixture was added to water (200 mL) and thoroughly mixed. The second premixture was added to water (200 mL) and thoroughly mixed. The first and second premixture suspensions were combined and mixed. The third premixture was added to the combined first and second premixture suspensions and the resulting mixture mixed for about 5 minutes. Water (2 L) was then added and mixed well for 20 minutes to produce a concentrate. The concentrate should be diluted (1 part concentrate in 3 parts water) before ingestion. A total of 487 people complaining of tiredness were given the composition. Of this group, 485 reported a significant improvement in their energy levels. The result is of research with people with mitochondrial defects, chronic fatigue and fibromyalgesia. The anti-oxidants in the formulation remove waste products formed during the energy producing process before damage can be done to the cell and cell organelles membranes. The B complex vitamin is selected from thiamin (Vitamin B1) and its derivatives, riboflavin (Vitamin B2) and its derivatives, nicotinamide (niacin) (Vitamin B3) and its derivatives, pyridoxine (Vitamin B6) and its derivatives, pantothenic acid (Vitamin B5) and its derivatives, folic acid (Vitamin Bc) and its derivatives, cyanocobalamin (Vitamin B12) and its derivatives, carnitine (Vitamin Bt) and its derivatives, 1-mandelonitrile-ß-glucoronic acid, (Vitamin B17) (amygdalin) and mixtures of any two or more thereof (pages 13/28, lines 14-25; page 14/28, lines 1-26; page 15/28, lines 1-29; page 16/28, lines 1-3 and 22; page 17/28, lines 1 and 14-19; page 19/28, lines 3-5; page 5/28, lines 10-16). Niacin ‘2022 (cited here as evidence only) disclosed that niacin (also known as vitamin B3) is one of the water-soluble B vitamins. Niacin is the generic name for nicotinic acid (pyridine-3-carboxylic acid), nicotinamide (niacinamide or pyridine-3-carboxamide), and related derivatives, such as nicotinamide riboside (page 1/22, para. 1).
Thus, these teachings of Lehmann ‘677) as evidenced by Niacin ‘2022 anticipate Applicant’s claims 1-3 because the calculated concentrations: glucose is 10.1 mM [= ((17500 mg/180 dalton)/2.4 L)/4 parts)}, N-acetylcysteine is 0.3 mM [= ((500 mg/163 dalton)/2.4 L)/4 parts)}, and nicotinic acid is 0.1 mM [= ((78 mg/123 dalton)/2.4 L)/4 parts)], and the mixture would carry the same properties, including “act synergistically when administered separately or together”, required by claim 2.
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 1-3, 38, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Lehmann (ZA200109677B, 2002-06-25, hereinafter referred to as Lehmann ‘677) in view of Shapiro (US 6,746,678, Jun.8, 2004, hereinafter referred to as Shapiro ‘678) and Barzilay et al. (US 2017/0290768, Oct. 12, 2017, hereinafter referred to as Barzilay ‘768). Claims 1-3 are rejected here because they have been rejected by the primary reference under 102 above. Thus, the above disclosure of Lehmann ‘677 is incorporated in its entirety here.
Lehmann ‘677 did not explicitly disclose the limitations (a) effective amount of probucol, folinic acid and cysteamine, required by claims 38 and 43; and (b) effective amount of resveratrol, required by claim 43.
With regard to structural limitation (a) above, Shapiro ‘678 disclosed a closed group of antioxidant co-agents; a closed group of vitamin co-agents; a closed group of co-agent metabolites at risk of depletion; and a closed group of sulfhydryl agents co-agents, is included in combination with use of various additional effective medicament co-agents which have been shown to contribute to the alleviation of symptomology of the diseases. Vitamins include folic acid (vitamin Bc), dosage range from 0.5 mg daily to 50 mg daily; folinic acid, dosage range from 0.5 mg daily to 50 mg daily; niacinamide, dosage range from 100 mg daily to 10 gm daily; nicotinic acid (vitamin B3), dosage range from 100 mg daily to 10 gm daily. Antioxidant agents which may be used in combination, such as ascorbic acid, dosage range from 1 mg daily to 60 mg daily; N-acetylcysteine, dosage range from 100 mg daily to 1 gm daily; penicillamine, dosage range from 25 mg daily to 2 gm daily; cysteamine, dosage range from 200 mg daily to 4 gm daily; and deferoxamine mesylate. Anti-hyperlipidemia agents include dextrothyroxine sodium, dosage range from 0.25 mg daily to 8 mg daily; probucol, dosage range from 100 mg daily to 1 gm daily; nicotinic acid, dosage range from 500 mg daily to 6 gm daily; acipimox, dosage range from 1 mg/kg daily to 500 mg/kg daily; or bile acid sequestrants such as choles tyramine resin, dosage range from 400 mg anhydrous cholestyramine resin daily to 20 gm anhydrous cholestyramine resin daily (page 6/33, col. 9, lines 45-54; page 15/33, col. 28, lines 60-67; page 16/33, col. 29, lines 1-4; page 22/33, col. 41, lines 40-55; page 23/33, col. 43, lines 10-23).
With regard to structural limitation (b) above, Barzilay ‘768 disclosed a dietary supplement being an upregulator of NAD+ activity selected from the group consisting of Resveratrol, Quercetin, Caffeine, Theophylline, Betaine/TMG, Choline, N-Acetyl-Cysteine, Alpha Lipoic Acid, Acetyl-L-Carnitine, Pyruvate, Co-Enzyme A and Fructose. The active ingredients are in powder form, and the other for containing water and optionally dissolved components such as Fructose, Glucose, Betaine, Choline salt, and Creatine (page 12/26, [0044]; page 21/26, [0165]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine the antioxidants and vitamins as taught by Lehmann ‘677 with vitamins, antioxidants, anti-hyperlipidemia agents, and an upregulator of NAD+ activity in view of Shapiro ‘678 and Barzilay ‘768 to prepare a composition for alleviating symptoms of mitochondrial defects or improving health, because benefits of specific vitamins, antioxidants, anti-hyperlipidemia agents, and an upregulator of NAD+ activity are taught, as described above. Thus, one of skill in the art would have a reasonable expectation that by combining the antioxidants and vitamins as taught by Lehmann ‘677 with vitamins, antioxidants, anti-hyperlipidemia agents, and an upregulator of NAD+ activity in view of Shapiro ‘678 and Barzilay ‘768 to prepare a composition for alleviating symptoms of mitochondrial defects or improving health, one would achieve Applicant’s claims 1-3, 38, and 43 and would carry the same properties, including “act synergistically when administered separately or together (or upon administration)”, required by claims 2 and 43. “In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). See MPEP § 2144.06 [R-01.2024] [I].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(I) Claims 1, 2, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/713,342 (Falk et al., the claim set of 05/24/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘342 claims “A composition for the treatment of mitochondrial disease, comprising an effective amount of at least one agent selected from (+) epicatechin, (-)-epicatechin, 11-Phydroxypregnenolone, 11-hydroxyprogesterone, probucol, glucose, N-acetylcysteine, cysteine bitartrate, and nicotinic acid, niacin, or niacinamide, in a pharmaceutically acceptable carrier administered separately or in combination” (claim 1), overlapping with the scope of claims 1, 2, and 38 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(II) Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/871,587 (Falk et al., the claim set of 12/04/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘587 claims “A composition which modulates at least one of mitophagy mitochondrial stress level, and mtDNA heteroplasmy level having efficacy for the treatment of mitochondrial disease, comprising effective amounts of one or more agents selected from hemin, tripterin, folinic acid, lithium chloride, metformin, N-acetylcysteine, nicotinamide, resveratrol, valproic acid, dexamethasone, etoposide, vorinostat, quercitin, hydralazine, thiamine, lipoic acid, pfithrin-alpha, ginsenoside, sulfonsuccinimidyl oleate, carnitine, AICAR, GSK2578215A, an inhibitory nucleic acid and an activating genetic construct targeting a mitophagy modulator protein encoding nucleic acid in a pharmaceutically acceptable formulation” (claim 1), overlapping with the scope of claim 1 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691