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
Examiner acknowledges that, according to the Filing receipt received 06/07/2022, that the instant application 17/639,649 filed 03/02/2022 is a 371 of PCT/US2020/049005 filed 09/02/2020 which claims benefit of 62/895,338 filed 09/03/2019. Therefore, all of the instant claims have been awarded the effective filing date of 09/03/2019.
Information Disclosure Statement
The Information Disclosure Statements filed on 03/02/2022 and 03/18/2022 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the instant specification does not provide support for "drowning" as in claim 6.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because the abstract does not adequately describe the general nature of the compound or Polymorph SP. Examiner additionally suggests adding an exemplary structure to the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
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 1-15 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 recites the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim. Claims 2-7 and 12-15 are rejected for requiring and not clarifying the limitation at issue.
Claims 1 and 8 are directed toward a “stable” polymorph. However, it is unclear what properties are required for the polymorph to be considered “stable”. The scope of the claims is therefore indefinite. Claims 2-7 and 9-15 are rejected for requiring the limitation at issue.
Claim 4 is directed toward a composition comprising the polymorph of claim 1. However, the scope of the compositions includes liquid compositions (specification, p. 13, par. [0054]). In solution, the crystalline form CuATSM and gluconic acid (as in claim 1) would not necessarily be maintained. It is therefore unclear how the polymorph of claim 1 could be present in a liquid composition. Clarification is required.
Claim 4 recites that the composition comprises a “salt”. It is unclear what is mean by “salt”. Is this a salt of the polymorph of claim 1? A salt of the pharmaceutically acceptable excipient? Any ionic compound? Clarification is required.
Claim 12 recites the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim. Claims 13-15 are rejected for requiring and not clarifying the limitation at issue.
Claim Rejections - 35 USC § 112(a)
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 5-7 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 alleviating or ameliorating a neurodegenerative disease selected from Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), Menkes disease, multiple sclerosis, neuropathies, motor neuron disease (MND), Parkinson's disease, Huntington disease, frontotemporal dementia, acrodermatitis enteropathica, Lewy body dementia, synucleinopathies, tauopathies, mild cognitive impairment (MCI), progressive supranuclear palsy (PSP) and prion disease, does not reasonably provide enablement for preventing any of the aforementioned diseases, or treating or preventing (prophylaxis) a condition in a mammal in which copper delivery prevents, alleviates, or ameliorates the condition generally. 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.
In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The claims are directed toward a method of treatment or prophylaxis of a condition in a mammal in which copper delivery prevents, alleviates or ameliorates the condition comprising administering a polymorph of CuATSM and gluconic acid. This genus of diseases is incredibly broad and reads on an array of conditions, ranging from inflammatory to neurodegenerative. The full scope of the claims cannot possibly be considered enabled.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “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, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
The scope of "neurodegenerative disorder" cannot be deemed enabled. The term "neurodegenerative disorder" covers a broad array of different disorders that have different modes of action and different origins. The term covers such diverse disorders as Alzheimer's Disease; Parkinson's Disease; ALS and variants such as forms of ALS-PDC; Gerstmann-Straussler-Scheinker Disease (GSS); Pick's Disease; Diffuse Lewy Body Disease; Hallervordon-Spatz disease; progressive familiar myoclonic epilepsy; Corticodentatonigral degeneration; progressive supranuclear palsy (Steele-Richardson-Olszewski); Huntington's disease; more than a dozen dementias collectively called "frontotemporal dementia and Parkinsonism linked to chromosome 17" (FTDP-17); Tourette's syndrome; Shy-Drager syndrome; Friedrich's ataxia and other spinocerebellar degenerations; Olivopontocerebellar atrophy (OPCA); spasmotic torticollis; Striatonigral degeneration; various types of torsion dystonia; certain spinal muscular atrophies, such as Werdnig-Hoffmann and Wohlfart-Kugelberg-Welander; Hereditary spastic paraplegia, Primary lateral sclerosis; peroneal muscular atrophy (Charcot-Marie-Tooth); Creutzfeldt-Jakob Disease (CJD); Hypertrophic interstitial polyneuropathy (Dejerine-Sottas); retinitis pigmentosa; Leber's Disease; and Hypertrophic interstitial polyneuropathy. These exhibit a very broad range of effects and origins. For example, some give progressive dementia without other prominent neurological signs, such as Alzheimer's disease, whereas other dementias have such signs, such as Diffuse Lewy Body Disease. Some give muscular wasting without sensory changes, e.g., ALS, and some do have the sensory changes such as Werdnig-Hoffmann. Some are abnormalities of posture, movement or speech, such as Striatonigral degeneration, and other are progressive ataxias, such as OPCA. Some are linked to tau mutations, such as Alzheimer's disease and FTDP-17, and other such as Parkinson's clearly do not. Some affect only vision such as retinitis pigmentosa. Even within those that fall into the same category of effects, there are often striking differences. For example, Alzheimer's disease and Pick's disease both give progressive dementia without other prominent neurological signs. But the characteristic Alzheimer's neurofibrillary tangles are not seen in Pick's Disease, which has straight fibrils, as opposed to the paired helical filaments of Alzheimer's disease. Pick's Disease gives lobal atrophy, not seen in Alzheimer's disease. There are differences in origins, even with what little is known. Thus, among progressive dementias, CJD is definitely caused by an infectious agent; so far as can be determined, this is not so for Huntington's disease. Even among the hereditary disorders, the origins are different. Thus, FTDP-17 comes from chromosome 17, Huntington's disease from 4, and the neurodegenerative disorder that people with Down's syndrome develop later in life is presumably connected in some way to 21.
The great majority of these have no treatment at all, and of those that do, none or virtually none have been treated with such inhibitors as are disclosed here. The great diversity of diseases falling within the "neurodegenerative disorder" category means that it is contrary to medical understanding that any agent (let alone a genus of trillions of compounds) could be generally effective against such diseases. The intractability of these disorders is clear evidence that the skill level in this art is low relative to the difficulty of the task. Further, what little success there has been does not point in this direction. Thus, what very few treatments that the massive research effort on Alzheimer's disease has produced are means of providing Acetylcholinesterase inhibition, unrelated to the mechanism of action in this case.
No screening protocol(s) are ever described. Thus, no evidence of in vitro effectiveness is seen in the specification for one of the instantly claimed compounds. In general, pharmacological activity is a very unpredictable area. In cases involving physiological activity "the scope of the enablement obviously varies inversely with the degree of unpredictability of the factors involved." In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970). Since this case involves unpredictable in-vivo physiological activities, the scope of the enablement given in the disclosure presented here was found to be low.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
Claims 8-15 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 preparing the polymorph of CuATSM and gluconic acid of claim 1, wherein the solvent is heptane, isopropyl acetate, or a heptane/isopropyl acetate mixture and the slurry is heated from 40⁰C to 80⁰C, does not reasonably provide enablement for a polymorph generally, a solvent generally, or heating generally. 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 the invention commensurate in scope with these claims.
Claim 8 is directed toward a method of preparing a stable polymorph of CuATSM and gluconic acid generally. Claim 12 is directed toward the polymorph of claim 1 made by a particular method. The claims are additionally directed toward solvents generally, and heating generally. However, the working examples only demonstrate successfully forming a polymorph within the scope of claim 1 wherein the ATSMH2 and copper gluconate are slurried in a solvent that is heptane, isopropyl acetate, or a mixture of heptane and isopropyl acetate, and wherein the slurry is heated from 40⁰C to 80⁰C. One would not be able to predict whether, if another solvent or temperature for heating were used, the polymorph of claim 1 would form. In fact, Example 2 (paragraph [0058]) demonstrates that the polymorph of claim 1 does not form when the solvent is IPA. The preparation of crystalline forms, or polymorphs, is generally considered unpredictable in the art despite a high level of skill. MPEP 2164.03, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).” Given the lack of guidance and in view of the level of unpredictability in the art, one of ordinary skill in the art would not be able to make the polymorph of claim 1 via the method of claims 8-15 without undue experimentation.
Claim Rejections - 35 USC § 102/103
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.
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.
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.
Claim(s) 1-4 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, claims 1-7 and 12-15 are rejected under 35 U.S.C. 103 as obvious over Warner et al. (US 2016/0271175 A1; IDS filed 03/02/2022).
Warner et al. discloses a crystalline form of CuATSM and gluconic acid (p. 21, pars. [0202]-[0206]). Warner et al. teaches that the CuATSM and gluconic acid is formed by solvent-free ball milling of ATSMH2 and Cu(II) D-gluconate, wherein the product obtained was a pale tan color (p. 21, pars. [0202]-[0204]) and has an XRPD pattern as in Figure 5.
Warner et al. additionally teaches that the CuATSM complexes can be used to treat neurological and neurodegenerative disorders, including those of instant claims 5-7 (p. 8, pars. [0052]-[0053]).
MPEP 2112 states:
“SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
In this case, the “unknown property” is the particular crystalline form. This is unknown because the reference is silent on this property. MPEP 2112 goes on to state:
“A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection.”
Again, the “CHARACTERISTIC” which the prior art is silent on is the crystalline form (crystalline form is considered to be in the category of chemical properties; see Zenith Laboratories Inc. v. Bristol-Myers Squibb Co. 30 USPQ2d 1285, 1288).
This is not an ordinary inherency situation where it is not explicitly stated what the product actually is. In every reference applied, the reference explicitly teaches exactly what the compound is. In fact, it is the opposite. In a normal inherency situation, the claim is of known structure, and the reference is of unknown structure. Here, the latter is not true, and hence the legal circumstances of inherency in the prior art do not apply. The only difference is the property about which the reference happens to be silent. Recitation of a property, inherently possessed by the prior art thing, does not distinguish a claim drawn to those things from the prior art, In re Swinehart, 169 USPQ 226, 229.
See for example Ex parte Anderson, 21 USPQ 2d 1241 at 1251, discussion of Rejection E. The claims had “numerical or functional values for certain properties which [the authors of the references] did not measure”. The PTO presented no reasoning as to why the prior art material would have been expected to have those properties. Instead, the decision states, “There is ample precedent for shifting the burden to an applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture.” (page 1253).
In another example, certain claims of Ex parte Raychem Corp. 25 USPQ2d 1265 required a linearity ratio of less than 1.2. The decision notes that neither reference discloses any values of the linearity ratio. The PTO presented no reasoning as to what the ratio would be expected to be in the references. The Decision states: “However, this does not end the inquiry since, where the Patent and Trademark Office is not equipped to perform the needed testing, it is reasonable to shift the burden of proof to Raychem to establish that (1) the argued difference exists….”
And indeed, there have been a number of cases in which applicants have pointed to silence of the prior art with regard to this or that property: In re Pearson, 181 USPQ 641; In re Zierden 162 USPQ 102; In re Lemin, 140 USPQ 273; Titanium Metals Corporation of America v. Banner, 227 USPQ 773; In re Benner, 82 USPQ 49; In re Wilder, 166 USPQ 545; Ex parte Kucera, 165 USPQ 332; General Electric Co. v. Jewel Incandescent Lamp Co., 67 USPQ 155; In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607; In re Parker, 43 USPQ 457. Such efforts to avoid anticipation on that basis invariably failed. Going further, if silence about properties of prior art compounds could be relied on, then one could not reject over references with no utility (see In re Schoenwald, 22 USPQ2d 1671), since applicants could always insert the utility into the claim as a property.
It is well settled that the PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . Whether the rejection is based on ‘inherency' under 35 U.S.C. § 102, or ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products (footnote omitted).
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the claimed characteristic does not appear at all in the product, or if on repetition, it sometimes does not appear in the product, then the rejection is overcome.
If applicants reasoning were accepted, an old compound could always be re-patented, by the simple expedient of isolating the compound in a different manner. All such would be patentee would need to do is attach some parameter which the original patent had been silent about, and there will almost always be such a parameter. For example, suppose a person were to use some solvent anti-solvent pair which applicants didn’t happen to use, and obtained one of applicants’ forms. The person would then write the claim for the compound, using some parameter which applicants didn’t happen to mention, such as density. According to applicants reasoning, the different method of crystallization, along with the instant specification’s silence on density, should prevent any anticipation rejection. The next person could come around with yet another solvent/anti-solvent pair (or some other method) which happened to produce the same form, and this time label it with the gross crystalline habit (e.g. flakes, needles, dendritic, cubic, etc.), which neither of the previous two patentees had mentioned. The fourth inventor could again re-patent the same material, this time tacking on a melting point limitation, pointing to the different method and silence on this characteristic, and the fifth inventor could label the form by refractive index (or dielectric constant), and the sixth could use the enthalpy of melting (i.e. latent heat of melting or “heat of fusion”). Yet another person could specify the maximum level of water or some other solvent, unreacted starting material, or indeed any impurity, previously known or unknown, which the reference happened to be silent about.
Claims 12-15 are directed toward the polymorph of claim 1 as made by a particular process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As the polymorph of claim 1 is anticipated by or obvious over the crystalline form of Warner et al., the process by which the polymorph is made does not distinguish it over the prior art.
Moreover, it would have been prima facie obvious for one of ordinary skill in the art to administer the crystalline form of CuATSM and gluconic acid for the treatment of diseases such as Alzheimer’s disease, prion disease, ALS, neuropathies, etc. One would have been motivated to do so, with reasonable expectation of success, as Warner et al. suggests that the disclosed complexes can be used to treat said diseases and disorders.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al. (US 2016/0271175 A1; IDS filed 03/02/2022) as applied to claims 1-7 and 12-15 above, and further in view of Karimi-Jafari et al. (Crystal Growth & Design; 2018).
Warner et al. discloses as above. Warner et al. additionally discloses methods of synthesizing the co-crystals, such as CuATSM: malic acid (1:1) via stoichiometric solution in hot solvent, comprising dissolving CuATSM and the selected ligand in 15 mL of acetone or acetonitrile, then heating the mixture in a water bath at 74⁰F until the solids dissolved and isolating the co-crystal by slow evaporation (p. 20, par. [0187]).
Warner et al. does not teach a method of making the crystalline form of CuATSM and gluconic acid by slurrying ATSMH2 and copper gluconate. This limitation is obvious over Karimi-Jafari et al.
Karimi-Jafari et al. teaches that co-crystals can be formed by slurry conversion, often using a fixed molar ratio, by suspending a target molecule and its coformer in a solvent (p. 6376). Karimi-Jafari et al. also teaches that slurrying is a preferred cocrystal screening technique due to its high efficiency (p. 6376).
It would have been prima facie obvious for one of ordinary skill in the art to use a method of slurrying ATSMH2 and copper gluconate in a solution, heating the slurry, and isolating the co-crystal. One would have been motivated to try, with reasonable expectation of success, as slurrying is a known preferred method of cocrystal formation. Moreover, one would be guided by the slow evaporation method of Warner et al. in order to arrive at a proper stoichiometric ratio and temperature at which the slurry should be heated.
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 1-7 and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,266,686 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘686 patent are directed toward a non-covalent derivative of a compound of Formula I, wherein the non-covalent derivative is CuATSM: gluconic acid, and compositions thereof.
When making obviousness-type double patenting decisions, the Federal Circuit has stated, “[O]bviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound”. Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010).
The reference patent discloses that the non-covalent derivatives can be used to treat conditions such as Alzheimer’s disease, neuropathies, ALS, and mild cognitive impairment (cols. 24-25).
For the same reasons as in the above prior art rejections, the CuATSM: gluconic acid of the ‘686 patent is anticipated by, or in the alternative, obvious over the instantly claimed polymorph of CuATSM: gluconic acid. Moreover, it would have been prima facie obvious for one of ordinary skill in the art to administer the CuATSM: gluconic acid for the treatment of conditions such as Alzheimer’s disease, neuropathies, ALS, and mild cognitive impairment, as the specification of the ‘686 patent discloses that the claimed non-covalent derivatives can be used for such treatments.
Conclusion
No claims are allowed.
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/M.E.B./Examiner, Art Unit 1624 09/09/2025
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624