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 .
Status of Claims
Claims 1-21 are pending in the instant application. Claims 8-10, 12 and 14-16 are amended via the amendment filed May 1st, 2024.
Priority
This is a 35 U.S.C. 371 National Stage filing of Application No. PCT/US2022/048596 filed November 1st, 2022, which claims priority to provisional Application No. 63274674, filed November 2nd, 2021.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 05/01/2024, 09/25/2024 and 04/09/2026 have been considered by the Examiner.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claims 1-17 include prophylactic treatment because the claims do not require that a patient actually has the condition or is “in need thereof”. As a courtesy to the Applicant, the Examiner has also addressed patients “in need thereof” in some rejections set forth below. Further, the claims 1, 20 and 21 recite “for treating…” and “for improving…”, which is an intended use and presumed met by the administration of the composition to a subject.
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 1-7, 10-14, 16-17 and 19-21 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 methods of treating obesity, ischemic acute kidney injury or nephrotoxin-induced kidney injury comprising administering a therapeutic agent according to claim 1, the specification does not reasonably provide enablement for the treatment of fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorder, lactic acidosis, metformin toxicity, improving exercise performance and fibrosis. 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. This is a scope of enablement rejection.
To be enabling, the specification of the patent application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
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 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). 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".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 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:
5A. The nature of the invention, state and predictability of the art, and relative skill of those in the art
The invention relates to methods for the treatment of obesity, fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, ischemic acute kidney injury, or nephrotoxin-induced kidney injury, improving exercise performance and treating fibrosis in chronic kidney disease.
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity.); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain).
As illustrative of the state of the art, the examiner cites art below showcasing the utility of the therapeutic agent of the instant invention, which is merely treating obesity.
5B. The breadth of the claims
Claim(s) 1-21 are very broad: the treatment of obesity, fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, ischemic acute kidney injury, or nephrotoxin-induced kidney injury, improving exercise performance and treating fibrosis in chronic kidney disease with a therapeutic agent comprising carious dicarboxylic acids and compositions thereof.
5C. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides data merely determining if DC12 would prove bioenergetically favorable in the kidney during ischemic injury.
The specification provides no particular direction or guidance for determining the particular administration regimens (e.g., timing, administration routes, etc.) necessary to prevent the diseases encompassed by the claims, particularly in humans. There is no experimentation or mechanism of action presented or discussed in the specification regarding the treatment of obesity, fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, or nephrotoxin-induced kidney injury, improving exercise performance and treating fibrosis in chronic kidney disease.
5D. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that any therapeutic agent of instant claims 1 and 20-21 could be predictably used as treatment for fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, improving exercise performance and treating fibrosis in chronic kidney disease.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent 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" (42 USPQ 2d 1001, Fed. Circuit 1997).
As noted above, none of the experimentation provided is drawn to the treatment for fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, improving exercise performance and treating fibrosis in chronic kidney disease.
A review of the state of the art fails to reveal that the therapeutic agent can treat fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, improving exercise performance and treating fibrosis in chronic kidney disease.
Determining if any particular claimed therapeutic agent would treat fatty liver, rhabdomyolysis, Leigh syndrome, mitochondrial Complex I deficiency, fatty acid oxidation disorders, lactic acidosis, metformin toxicity, improving exercise performance and treating fibrosis in chronic kidney disease would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants. As noted supra, even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 1-21 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.
Claims 1 and 18 recite the term “metabolic intermediate”, which is vague and unclear. The term “metabolic intermediate” includes a number of compounds obtainable in vivo through hepatic and non-haptic metabolism. Further, there is no clear definition of the term in the instant specification. As such, claims 1 and 18 are indefinite as the term “metabolic intermediate” leaves the metes and bounds of the claims unclear. Claims 2-17 and 19-21 ultimately depend from claim 1 and do not resolve the issue of indefiniteness and, as such, are also rejected under 112(b).
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 8-12, 13-17 and 20-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lee et al (US 2018/0207120 A1, published July 26th, 2018).
Regarding claims 1 and 9, Lee teaches a method of treating or alleviating obesity , the method comprising administering to a subject azelaic acid , or a pharmaceutically acceptable salt thereof (claim 1).
Lee teaches that azelaic acid is of the following formula (Fig. 1):
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As seen above, azelaic acid is a straight-chain saturated dicarboxylic acid of 9 carbons.
Regarding claims 2, Lee teaches that the chemical name of azelaic acid is nonanedioic acid.
Regarding claims 8, 10-12, 20 and 21, the claims recite limitations on the disease/disorder to be treated. As stated above, the instant claims include prophylactic treatment because the claims do not require that a patient actually has the condition or is “in need thereof”. Further, recite “for treating…” and “for improving…”, which is an intended use and presumed met by the administration of the composition to a subject.
Regarding claims 13 and 17, Lee teaches that the composition can be formulated as a health supplement (paragraph [0079]). The “for enhancing performance during exercise” recitation of claim 13 is an intended use.
Regarding claim 14, the claim recites “wherein the fatty acid oxidation disorder is a mitochondrial long-chain fatty acid oxidation disorder”. As the method taught by Lee is in the utility of treating obesity and the claim places limitations on the fatty acid oxidation disorder, the method of Lee reads on the claim.
Regarding claim 15, Lee teaches that the method reduces body weight (paragraph [0155]).
Regarding claim 16, Lee teaches that the azelaic acid is administered orally (paragraph [0144]).
Claims 1-4, 8-12, 14 and 20-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tamarkin et al (US 2004/0191196 A1, published September 30th, 2004).
Regarding claims 1 and 9, Tamarkin teaches a method of treating obesity comprising administering to a subject having obesity dodecanedioic acid or suberic acid (claims 1, 12 and 31).
Regarding claims 2-4, as seen above, Tamarkin teaches that the method includes administering dodecanedioic acid or suberic acid (octanedioic acid).
Regarding claims 8, 10-12, 20 and 21, the claims recite limitations on the disease/disorder to be treated. As stated above, the instant claims include prophylactic treatment because the claims do not require that a patient actually has the condition or is “in need thereof”. Further, recite “for treating…” and “for improving…”, which is an intended use and presumed met by the administration of the composition to a subject.
Regarding claim 14, the claim recites “wherein the fatty acid oxidation disorder is a mitochondrial long-chain fatty acid oxidation disorder”. As the method taught by Lee is in the utility of treating obesity and the claim places limitations on the fatty acid oxidation disorder, the method of Lee reads on the claim.
Claims 1, 5-6, 8, 10-12, 20 and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Heller et al (US 2006/0141047 A1, published June 29th, 2006).
Regarding claims 1 and 9, Heller teaches a method of treating obesity in subject in need of such treatment comprising the step of administering tricaprylin in a therapeutically effective amount to treat the obesity.
Regarding claims 5-6, tricaprylin is the triglyceride of octanedioic acid.
Regarding claims 8, 10-12, 20 and 21, the claims recite limitations on the disease/disorder to be treated. As stated above, the instant claims include prophylactic treatment because the claims do not require that a patient actually has the condition or is “in need thereof”. Further, recite “for treating…” and “for improving…”, which is an intended use and presumed met by the administration of the composition to a subject.
Claims 8, 10-12 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bharathi et al (Biochemical and Biophysical Research Communications 527 (2020) 162-166, as cited on the IDS dated 09/25/2024).
Regarding claims 18-19, Bharathi teaches the administration of DC12, dodecanedioic acid, to mice (Materials and Methods, page 163). Bharathi further teaches that dodecanedioic acid stimulates the peroxisomal fatty acid oxidation but not the mitochondrial fatty acid oxidation pathway (Figure 4, page 165, right column, paragraph 1). Bharathi also teaches that Peroxisomal succinyl-CoA is released from peroxisomes as succinate, which can transfer into mitochondria, i.e., bypasses the mitochondrial fatty oxidation (page 165, right column, paragraph 3). Bharathi then teaches that dicarboxylic acids such as dodecanedioic acid may prove to be useful anaplerotic therapies for mitochondrial long-chain fatty acid oxidation disorders and other inborn error of metabolism and that oral dodecanedioic acid could potentially provide energy to the heart and muscles, which are often severely affected in mitochondrial fatty acid oxidation (page 165, right columns, paragraph 3).
Regarding claims 8, 10-12, 20 and 21, the claims recite limitations on the disease/disorder to be treated. As stated above, the instant claims include prophylactic treatment because the claims do not require that a patient actually has the condition or is “in need thereof”. Further, recite “for treating…” and “for improving…”, which is an intended use and presumed met by the administration of the composition to a subject.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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