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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-8 and 10-12, drawn to a method for treating.
Group II, claim(s) 15, drawn to a composition.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of a chloropentaammine cobalt(III)chloride (CPACC), this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kucharski et al. (Journal or Biological Chemistry, 2000) Kucharski et al. disclose a composition comprising CPACC. In view of this document, the common technical feature linking Groups I-II does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over prior art for the reasons set forth above.
During a telephone conversation with Charles Landrum on March 6, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8 and 10-12. Affirmation of this election must be made by applicant in replying to this Office action. Claim 15 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims
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 1-8 and 10-12 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 ameliorating obesity, cardiovascular disease and diet-induced hepatocellular carcinomas with CPACC, does not reasonably provide enablement for preventing metabolic syndrome in general with variants/derivatives. 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.
To be enabling, the specification of the patent 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 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the 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 quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1) The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method of ameliorating or preventing a metabolic disorder. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Patial et al. (Arch Intern Med. Res. 2024). Patial et al. disclose Metabolic Syndrome (MetS) is a complex cluster of metabolic irregularities that significantly increase the risk of developing chronic conditions, such as hypertension, type 2 diabetes, cardiovascular diseases, and other related disorders. This review aims to provide a comprehensive overview of the current understanding of MetS, its etiology and underlying pathogenesis, and the management strategies. MetS is characterized by central obesity, high blood pressure, insulin resistance, hyperglycemia, hypertriglyceridemia, and low high-density lipoprotein cholesterol levels. The prevalence of MetS is remarkably high, affecting approximately 25% of the global population, particularly in developed nations with inactive lifestyles and high-calorie diets. The development of MetS involves genetic and acquired factors, resulting in an inflammatory state that enhances the risk for cardiovascular disease. The biochemical alterations observed in MetS establish pathological connections between MetS, diabetes, and cardiovascular and neurodegenerative conditions (Abstract). Considering all the facts and the causes of metabolic syndrome, it would be difficult to “prevent” a metabolic syndrome.
2) The breadth of the claims
The claims are broadly drawn to ameliorating and preventing metabolic syndrome.
3) The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful protocols for carrying out the invention as claimed, other than using CPACC for treating conditions such as obesity. The latter is corroborated by the working examples.
4) The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Indefiniteness
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 1-8 and 10-12 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.
1) The claims recite a variant or derivative of chloropentaammine cobalt(III) chloride. However it is not clear what is encompassed by variant. One would conclude that variant would be a cobalt having five amine groups present on the compound, however the claims encompass compound where no amines are present. This encompasses known compounds and therefore would not appear to be considered a variant. A search of variants does not appear to yield results. The only variants appear to be disclosed by the instant specification, at paragraphs 0010 to 0012. The “variants/derivatives” encompass known compounds. Therefore the claims are indefinite because it is not clear when the variant/derivative becomes its own compound.
2) Claim 2-8 recites the limitation "CPACC derivative". There is insufficient antecedent basis for this limitation in the claim because the claim from which they depend recite variant.
Claim Rejections - 35 USC § 102 - Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh (J. Environ Pathol Toxicol Oncol., 2007).
Singh discloses hexaammine cobalt (III) chloride has been advocated as a potential anticarcinogenic compound. The present study looks at the effects of administration of hexaammine cobalt (III) chloride in drinking water to balb/c male mice at doses of 25, 50, and 100 ppm for 14 weeks were examined. The tissue distribution of the compound was seen in liver, kidney, lung, intestine, blood, and spleen. The results suggest an antioxidant potentiating effect of the hexaammine cobalt (III) chloride besides nontoxicity to liver and kidney. It also increases GSH and GST activity. Since the ability to induce an increase of glutathione (GSH) and GST along with other detoxifying enzymes by anticarcinogenic agents has been reported to correlate with the inhibition of tumorigenesis, the cobalt complex might qualify as a potential cancer chemopreventive agent.
The instant claims recite a variant/derivative of CPACC. It is not clear what compounds are encompassed by variant/derivative because a derivative includes a compound where no amines are present. Therefore it is reasonable to conclude that it also encompasses a compound where all the groups are amines.
Therefore, Singh anticipates the instant claims insofar as they disclose a CPACC variant, hexamminecobalt(III) (HAC) chloride, to ameliorate or prevent a metabolic syndrome. Also see indefinite rejection above.
Claim Rejections - 35 USC § 103 - Obviousness
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.
1) Claims 1-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (WO 2018160772) in view of Singh (J. Environ Pathol Toxicol Oncol., 2007).
Gonzalez et al. disclose treatment for obesity, insulin resistance, non¬ alcoholic fatty acid disease and non-alcoholic steatohepatitis in a subject, comprising selectively decreasing the expression or inhibiting the activity of HIF-2a in the intestine, thereby decreasing obesity, insulin resistance, and non-alcoholic fatty acid disease in the subject (Abstract). Conditions associated with insulin resistance include diabetic conditions, which include pre-diabetes and diabetes (paragraph 00109). Body Mass Index is used to assess obesity. A BMI of 25.0 kg/m^2 to 29.9 kg/m^2 is overweight (also called grade I obesity), while a BMI of 30 kg/m^2 or more is truly obese (also called grade II obesity). A pathway of treating the disclosed conditions include targeting hepatic fat accumulation and the resultant metabolic stress. Oxidative stress follows metabolic stress. An approach for targeting oxidative stress, inflammation and injury that follow the metabolic stress include antioxidants. The compositions are formulated into tablets and injectable fluids (paragraph 00118).
Gonzalez differs from the instant claims insofar as it does not disclose using a chloropentaammine cobalt(III) chloride to treat the disclosed conditions.
Singh discloses hexaammine cobalt (III) chloride has been advocated as a potential anticarcinogenic compound. The present study looks at the effects of administration of hexaammine cobalt (III) chloride in drinking water to balb/c male mice at doses of 25, 50, and 100 ppm for 14 weeks were examined. The tissue distribution of the compound was seen in liver, kidney, lung, intestine, blood, and spleen. The results suggest an antioxidant potentiating effect of the hexaammine cobalt (III) chloride besides nontoxicity to liver and kidney. It also increases GSH and GST activity. Since the ability to induce an increase of glutathione (GSH) and GST along with other detoxifying enzymes by anticarcinogenic agents has been reported to correlate with the inhibition of tumorigenesis, the cobalt complex might qualify as a potential cancer chemopreventive agent.
The instant claims recite a variant/derivative of CPACC. It is not clear what compounds are encompassed by variant/derivative because a derivative recited by the instant claims includes a compound where no amines are present. Therefore it is reasonable to conclude that it also encompasses a compound where all the groups are amines, such as those found in Singh et al.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used hexamminecobalt (III) chloride as the antioxidant in the treatment of the conditions of Gonzalez et al. because they have an antioxidant potentiating effect and have nontoxicity to liver and kidney.
In regards to the method steps and patient population of the instant claims 8 and10-12, the compositions are used to treat obesity and insulin resistance which is also associated with pre-diabetes and a BMI of 30 or greater. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have administered hexamminecobalt (III) chloride to a patient having a BMI of 30 or greater and/or pre-diabetes because this is the patient population disclosed by Gonzalez. The dosage regimen is a result effective variable and determines therapeutic effect. Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have taken the composition of the combined references once a day motivated by the desire to achieve the desired therapeutic effect. See MPEP 2144.05.
2) Claims 1-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (WO 2018160772) in view of Saker et al.(Amer. Physiology Soc., 1998) in further view of Heffern et al. (2013).
Gonzalez et al. disclose treatment for obesity, insulin resistance, non¬ alcoholic fatty acid disease and non-alcoholic steatohepatitis in a subject, comprising selectively decreasing the expression or inhibiting the activity of HIF-2a in the intestine, thereby decreasing obesity, insulin resistance, and non-alcoholic fatty acid disease in the subject (Abstract). Conditions associated with insulin resistance include diabetic conditions, which include pre-diabetes and diabetes (paragraph 00109). Body Mass Index is used to assess obesity. A BMI of 25.0 kg/m^2 to 29.9 kg/m^2 is overweight (also called grade I obesity), while a BMI of 30 kg/m^2 or more is truly obese (also called grade II obesity). A pathway of treating the disclosed conditions include targeting hepatic fat accumulation and the resultant metabolic stress. Oxidative stress follows metabolic stress. An approach for targeting oxidative stress, inflammation and injury that follow the metabolic stress include antioxidants. The compositions are formulated into tablets and injectable fluids (paragraph 00118).
Gonzalez differs from the instant claims insofar as it does not disclose using a cobalt(II) chloride.
Saker et al. disclose cobalt chloride has a glycemia-lowering effect in diabetic rats. Treatment with cobalt chloride resulted in a significant decrement in serum glucose. The cobalt chloride was added to drinking water for 14 days. Those not treated with the cobalt chloride gained weight during the 14 day treatment.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used a cobalt(II)chloride to treat the conditions of Gonzalez et al. because they lower serum glucose. This would in turn treat diabetics and those suffering from obesity.
Gonzalez et al. in view of Saker et al. differs from the instant claims insofar as it does not disclose a compound of the instant claims.
However, Heffern et al. disclose Co(III) complexes can be used as prodrugs that are capable of undergoing bioreduction, a process whereby intracellular reduction produces a bioactive agent. Reduction of inert d6 Co(III) complexes yields labile d7 high-spin Co(II) complexes which rapidly undergo ligand substitution. The stability of the inert Co(III) complex offers improved bioavailability.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." See MPEP. Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made the amine cobalt(III)chloride derivative compounds (which includes CoCl6 chloride, see Indefiniteness Rejection above) and then used them in the method of Gonzalez in view of Saker et al. motivated by the desire to use a prodrug that would remain inert and stable, and would be converted to the active Co(II)chloride compound. One would reasonably conclude that the resultant Co(II)chloride would lower glucose serum levels due to the presence of the Co(II)chloride.
In regards to the method steps and patient population of the instant claims 8 and 10-12, the compositions are used to treat obesity and insulin resistance which is also associated with pre-diabetes and a BMI of 30 or greater. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have administered a cobalt (III) chloride of the instant claims to a patient having a BMI of 30 or greater and/or pre-diabetes because this is the patient population disclosed by Gonzalez. The dosage regimen is a result effective variable and determines therapeutic effect. Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have administered the compositions of the combined reference
Claims 1-8, 10-12 are rejected.
Claim 15 is withdrawn.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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