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 .
Claim of Foreign Priority
Applicant’s claim of foreign priority and certified copy of foreign priority documents are acknowledged by the Office.
Status of the Claims
Claims 1-13 are pending and examined.
Note: The examiner did not reject claim 4 as improperly broadening claim 1 for adding prevention of muscle fatigue to claim 4 because the Specification defines treatment to include prevention. Thus, while the word “prevention” with respect to muscle fatigue is first used in claim 1, the content is already considered included in claim 1.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
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 1-13 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for preventing a calcium deficiency disorder, muscle fatigue from exercise, treating or mitigating all forms of cancer, neurodegenerative diseases, stress, aging, metabolic rate, trauma, and many other conditions listed in claims 12 and 13.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Prevention of diseases nor treatment of all claimed conditions, including those listed in claim 13.
“Treatment” and “treat” are defined by the Specification to include prevention as well as curing the claimed conditions. See par. 25.
The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below
Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the instant case, the claimed invention pertains to compounds of Formula (I-1), which are alleged by the Specification to prevent and treat all forms of cancer, autoimmune disorders, and others.
The State of the Prior Art and the Relative Skill of those in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
Marchi et al., High mitochondrial Ca2+ content increases cancer cell proliferation upon inhibition of mitochondrial permeability transition pore (mPTP),” Cell Cycle 2019, Vol. 18, No. 8, 914-916 teaches:
“Thus, it is unclear if increased mitochondrial Ca2+ content could sustain cancer progression or augment the susceptibility to apoptosis. Here, we show that high mitochondrial [Ca2 + ] with concomitant mPTP inhibition could potentiate migratory capacity and invasiveness of cancer cells.”
Further, Marchi states: “In conclusion, although elevated mitochondrial Ca2+ entry generally predisposes to cell death, it could potentiate tumor cell proliferation and invasion when mPTP properties appear altered….”
Calvo-Rodriguez et al., “Increased mitochondrial calcium levels associated with neuronal death in a mouse model of Alzheimer’s disease,” Nature Communications, 2020, 11:2146 teaches:
“Excessive Ca2+ taken up by mitochondria could lead to cell death.” “We find increased mitochondrial Ca2+ levels associated with plaque deposition and neuronal death in a transgenic mouse model of cerebral β-amyloidosis.” Abstract.
Thus, it appears from the state of the art that cancers and certain neurodegenerative conditions will not be prevented or treated, but will be made worse, potentially significantly by administration of an agent that increases mitochondrial calcium.
As discussed above, the instantly claimed invention pertains to natural compounds that are alleged to increase intra-mitochondrial Ca2+ levels in a cell. At the time the instant application was filed, it would have been known by those of ordinary skill in the art that - compounds, in the vast majority of cases, demonstrate a remarkably high correlation between their structure, specificity and ability to produce a pharmacological effect. At the same time, it would have also been generally assumed that two compounds with similar chemical properties would exhibit similar biological effects. Thus, given a series of compounds that are shown to exert an activity of interest (or given a target of interest), the ordinarily skilled artisan would have expected that a limited genus of related compounds (e.g., compounds exhibiting near equal molecular shapes and volumes, approximately the same distribution of electrons, and similar physical properties such as hydrophobicity, etc.) would interact with the given target to elicit a related biological response.
Accordingly, at the time the invention was made, the relative skill of those in the art tasked with identifying compounds exerting an activity of interest would have been high, as the ordinarily skilled artisan would have had, at minimum, a Ph.D. and experience with screening techniques including computer assisted virtual screening techniques such as ligand-based and structure-based design methods. Deciding which technique to use would have been determined by the skilled artisan’s knowledge regarding the compound and target of interest. Ligand based drug design relies on knowledge of a compound or compounds of interest (i.e., ligands) to derive new compounds that will, in theory, similarly interact with the target of interest to elicit the activity of interest. Conversely, structure based drug design relies on knowledge of the three dimensional structure of the target of interest (i.e., receptor, ion channel, or enzyme) to derive new compounds that will, in theory, interact with the target of interest to elicit the activity of interest. In either case, the compounds derived from these techniques (applied alone or in combination) are then subjected to in vitro testing for validation.
The Level of Predictability in the Art: Once a compound has been identified by ligand based and/or structure based drug design methods as potentially binding to the target molecule, it must be evaluated. However, as discussed by Anderson (Chem and Biol 10:787-797, 2003), “it is important to consider that the ranking assigned by the scoring function is not always indicative of a true binding constant, since the model of the target:ligand interaction is inherently an approximation. Usually, several molecules which scored well during the docking run are evaluated in further tests since even the top scoring molecule could fail in vitro assays… Finally, leads are brought into the wet lab for biochemical evaluation” (Page 794, Column 1). By that point, as noted by Thiel (Nature Biotechnol 2:513-519, 2004), “libraries are small and hit rates are on the order of one in ten” (Page 517, Column 2). This low level of predictability is not surprising considering that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme.
The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification provides a single example. More particularly, Example 1 on pages 19-20 of the instant Specification showed an increase in mitochondrial Ca2+ rise in HeLa cells. This is shown in Figures 2 and 3. These measurements were performed in vitro using HeLa cells infected with adenovirus as a single example. Cultures of cells were contacted for 2 hours prior to measuring calcium levels. Luminescence data was converted into calcium concentration obtained by stimulating the cells with histamine. There is no data or showing on the treatment or prevention or pharmacokinetics of any compound in vivo.
Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use” (emphasis added). Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added).
At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims". Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
As to the first inquiry, as discussed above, the claims are drawn to preventing and treating conditions including thousands of distinct cancers, neurodegenerative conditions, infections, viruses, and more, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses a single example in vitro wherein Ca2+ levels are increased in HeLa cells infected with adenovirus wherein cells were directly contacted for 2 hours before a luminescence model and algorithm was used to indirectly calculate calcium levels.
Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to “derivatives” and prevention and treatment, as well as contacting cells including brain cells. There is no pharmacokinetic data, dosing data, route of administration, nor treatment or prevention of any kind shown. It would require undue experimentation to understand each of these variables and to determine which conditions under which conditions can be treated and if any can be prevented.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to definitively determine the specific population of individuals who would need to be treated and would furthermore have to determine which of the claimed compounds would provide for the prevention and treatment of cancer, neurodegenerative conditions, infections, and others. To prevent and treat cancer, e.g., in any patient population, as the instant claims are drawn to, would require undue experimentation to both develop an animal model which would reasonably correlate with all forms of cancer and also to identify the portion of the population in which the instantly claimed compounds would need to necessarily be administered.
Thus, factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
The court in Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, 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 and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated or prevented by the compound encompassed in the instant claims, with no assurance of success.
To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Claim Rejections - 35 USC § 112 (Written Description)
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 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims of the present application are drawn to methods of (i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, and (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (iv) treating or preventing a calcium deficiency/depletion disorder in an individual comprising administering to the individual a composition comprising a combination of fisetin and/or a metabolite thereof and quercetin and/or a derivative, in a therapeutically effective amount. Dependent claims limit the cells, the dosing, define the metabolites and derivatives of the compounds, add additional agents and limit the form of the composition. Also claimed are methods of reducing an incidence of, and/or reducing a severity of a mitochondria-related disease or a condition associated with altered mitochondrial function in an individual in need thereof or at risk thereof, wherein the mitochondria-related disease or condition is selected from the group consisting of stress, physiological ageing, obesity, reduced metabolic rate, metabolic syndrome, diabetes mellitus, complications from diabetes, hyperlipidemia, neurodegenerative disease, cognitive disorder, stress-induced or stress-related cognitive dysfunction, mood disorder, anxiety disorder, age-related neuronal death or dysfunction, musculoskeletal disorder, frailty, pre-frailty, chronic kidney disease, kidney failure, trauma, infection, cancer, hearing loss, macular degeneration, myopathies and dystrophies, and combinations thereof. Also claimed are methods for delaying off-set of metabolic decline, maintaining muscle mass and/or muscle function, decreasing oxidative stress, maintaining immune function and/or maintaining cognitive function in a healthy older adult comprising administering a composition comprising a combination of fisetin and/or a metabolite thereof and quercetin and/or a derivative in a therapeutically effective amount. As such, the claims are drawn to treating a wide variety of diseases embracing thousands of disorders with a very large group of compounds embraced by fisetin and/or a metabolite thereof and quercetin and/or a derivative thereof which each embrace thousands of different compounds.
The specification however showed that mitochondrial calcium levels increased with either a combination of fisetin and quercetin or fisetin aglycone and quercetin. This very limited display of results – synergism of fisetin and quercetin to increase calcium levels/uptake in mitochondria, is not seen to support the tremendously large group of diseases/disorders/activities with the various derivatives and metabolites thereof as in the claims.
The data presented shows very limited synthetic variation to the compounds tested and the activities produced therefrom. An adequate representation of a species requires that the species which are expressly described are recognized in the art as representative of the entire genus. Various conditions/activities claimed can occur without a requirement for mitochondrial calcium uptake to be improved – such as treating or preventing a calcium depletion disorder, as this would require increased calcium levels in the blood, not the mitochondria. Currently, one of skill in the art would not recognize the limited disclosure as representative of the genus claimed.
It is noted that a single species is seldom, if ever, sufficient to support a generic claim. See In re Shokal, 242 F.2d 771, 113 USPQ 283, 285 (CCPA 1957). See also, In re Grimme, 274, F.2d 949, 124 USPQ 499, 501 (CCPA 1960).
More particularly, Example 1 on pages 19-20 of the instant Specification showed an increase in mitochondrial Ca2+ rise in HeLa cells. This is shown in Figures 2 and 3. These measurements were performed in vitro using HeLa cells infected with adenovirus as a single example. Cultures of cells were contacted for 2 hours prior to measuring calcium levels. Luminescence data was converted into calcium concentration obtained by stimulating the cells with histamine. There is no data or showing on the treatment or prevention or pharmacokinetics of any compound in vivo.
Claim Rejections - 35 USC § 112 – 2nd paragraph
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 1-13 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 is indefinite wherein the claims is drawn to a method from (i), (ii), and (iii), (iv). It is unclear if these are alternative embodiments or all must be accomplished at once since there is an “and” between (ii) and (iii) and nothing between (iii) and (iv).
All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claims 12 and 13 are directed towards treating metabolic rate. Metabolic rate is merely a parameter and does not appear to be something to be improved per se.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 9-13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhao-Wilson, (US2015/0104393).
Zhao-Wilson teaches a method for affecting an aging process by administering an effective amount of a combination of mitochondria nutrients. They can reverse complex dysfunction, attenuate skeletal muscle impairment, and more. Formula A shown below in Table 2 comprises 60-500 mg quercetin and 30-50 mg fisetin. See Example 2 below.
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The composition can be in the form of a capsule, powder, solution, food bar, drink, or in grains, fruits, and more. See par. 41. The composition can be administered once daily, once weekly, once monthly, etc. See par. 40.
As such, claims 1-5 and 9-13 are anticipated by the prior art.
Claims 1-5, 8, 9, and 11-13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ramarao et al., (WO2008120221) (cited in ISR).
Ramarao teaches a preferred composition comprising fisetin, resveratrol, and quercetin which are natural polyphenols that can be used. Fisetin and quercetin are synergistic when combined and are contemplated in a yogurt composition. Fisetin and quercetin are found in fruits and have significant antioxidant properties. Fisetin has the ability to enhance memory by protecting neural cells from degeneration whilst promoting new connectivity between nerve cells. Quercetin has remarkable antioxidant, anti-histamines and anti-inflammatory properties. It also helps in the prevention of cataracts, cancers, heart, and respiratory diseases and problem related with anxiety and depression. In one composition, 6 mg fisetin and 9 mg quercetin are combined. See Example. The examiner notes that the food product is contemplated for oral administration. It is also included in a product comprising protein. Daily consumption is taught to be advantageous.
As such, claims 1-5, 8, 9, and 11-13 are anticipated by the prior art.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hammerstone et al., (US2008/0227829), as evidenced by Nagarkatti et al., “Cannabinoids as novel anti-inflammatory drugs,” Future Med Chem. 2009 Oct;1(7):1333-49.
Hammerstone teaches compounds for contacting neural progenitor cells to treat damage associated with the hippocampus. See Abstract. Those compounds can be a composition comprising a compound of formula II or a metabolite thereof. See par. 26. Examples of metabolites include glucuronidated, sulfated, or methylated metabolites. See par. 33. Specific metabolites include quercetin-3,4-diglucoside, among others. See par. 36. Further examples include fisetin hydrate. See par. 35. These metabolites can each be glucuronidated, sulfated, or methylated. The methods of treatment include at least one compound from each group, meaning that combination therapy is contemplated. See prior art claim 1. Conditions that can be treated include PTSD, depression, AD, a neurodegenerative disease. See prior art claims 1, 4, 10, and 14, e.g. Combination treatment is taught. See par. 12. This includes combination with agents including cannabinoids. See par. 81. As evidenced by Nagarkatti, “Cannabinoids are potent anti-inflammatory agents and they exert their effects through induction of apoptosis, inhibition of cell proliferation, suppression of cytokine production and induction of T-regulatory cells (Tregs).” See p2, 2nd par. The compound can be a food, dietary supplement, pharmaceutical or other form. See par. 89. It can be a liquid, capsule, powder, other form for oral administration See par. 90.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to administer the claimed combination to a subject with a neurodegenerative disorder. Combinations are taught to include glucuronidated, sulfated, or methylated metabolites of quercetin and fisetin hydrate and combinations can be used. Moreover, the compositions can be in an oral form as a food, dietary supplement, or pharmaceutical. Further, compounds can be administered daily. The claimed compounds are taught for use in administration to a claimed subject population. Such administration would have claimed effect, absent evidence to the contrary. As presently claimed, such effect only needs to include prevention. Thus administration to any subject capable of having a condition qualifies. Moreover, the claimed agents are taught treat neurodegenerative conditions in the hippocampus.
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.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/866,220. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘220 application are directed to administration of an effective amount of fisetin or a derivative and quercetin or a derivative. Claims are directed to the same glucuronidated and sulfated forms, as well as secondary therapeutic agents. Further, such compositions are claimed in same form. In both the instant application and the ‘220 application, the subject population includes prevention. This means that each subject is merely capable of having another condition and the main distinction among the claims is the intent to prevent or treat cartilage degeneration in the ‘220 application whereas the instant application includes preventing muscle fatigue, calcium deficiency, and improving things that would also be improved if administered to a subject that has or is in need of prevention of cartilage degeneration. Thus, the subject populations as presently drafted include substantial overlap and the compositions are identical. As such, it would be obvious to arrive at each of the claimed methods in view of the other methods. It would be obvious to arrive at the instant claims in view of those of the ‘220 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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