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
This application is a 371 of PCT/US2022/026294 (04/26/2022)
PCT/US2022/026294 has PRO 63/179,777 (04/26/2021).
Claim Rejections - 35 USC § 112
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, 3-12 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 uses the language “the method comprising administering a therapeutically effective amount of a ketogenic composition comprising a ketogenic compound.” This language is ambiguous as to whether the claim requires administering the composition to the subject or somewhere else. One of skill in the art would find such unclear language confusing and ambiguous such that it renders the claim indefinite. Thus, the claim and those that depend therefrom are rejected as indefinite.
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, 3-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjornsson et al. (US20170100354).
Bjornsson teaches treating Kabuki syndrome in a human subject by administering a ketogenic composition comprising a medium chain triglyceride and beta-hydroxybutyrate (claims 1, 4, 11, and 17; [0109]).
Regarding claims 4 and 5, Bjornsson teaches Kabuki syndrome for treatment is caused by either of KMT2D or KDM6A ([0006]: “KS is caused by heterozygous loss-of-function mutations in either of two genes … (KMT2D) on human chromosome 12 … or KDM6A”) which corresponds to Type 1 and Type 2 as defined in the instant specification at [0053].
Regarding claim 6, Bjornsson teaches KS associated symptoms treated include a variety of features including long eyelashes and short stature ([0077]).
Regarding claims 7 and 8, Bjornsson teaches administering a salt of BHB ([0014]: “ at least one agent is selected from the group consisting of: i) D-β-hydroxybutyrate; ii) a salt of D-β-hydroxybutyrate; iii) a metabolic precursor of D-β-hydroxybutyrate; iv) an ester or polyester of D-β-hydroxybutyrate; and v) combinations thereof.”).
Regarding claim 9, Bjornsson teaches administering a medium chain triglyceride (claim 11, [0012]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bjornsson et al. (US20170100354).
Bjornsson anticipates claims 1, 3-9 as applied above and the claims are also rendered obvious.
Regarding claims 10-12, Bjornsson teaches each of the elements of a ketogenic compound and an MCT and combinations thereof ([0097], claims 11 and 17, [0012], [0014]) for treating KS but does not teach the specific ratio. One of ordinary skill in the art would have considered formulating the composition to include ratios of ingredients to improve therapeutic effect as is routine in the art and the result would have been predictable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”); MPEP 2144.05. Thus, the claims are obvious.
Regarding claim 13, Bjornsson teaches treating Kabuki syndrome in a human subject by administering a medium chain triglyceride and beta-hydroxybutyrate (claims 1, 4, 11, and 17; [0109]) but does not teach a specific embodiment with both. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 126 USPQ 186 (CCPA 1960) (the “joint use [of magnesium oxide and calcium carbide] is not patentable” where the prior art teaches “that both magnesium oxide and calcium carbide, individually, promote the formation of a nodular structure in cast iron, and it would be natural to suppose that, in combination, they would produce the same effect and would supplement each other”); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
See also Merck & Co., Inc. v. Biocraft Labs, Inc., 874 F.2d 804, 808 (Fed. Cir. 1989) (“Given the prior art teaching that both amiloride and hydrochlorothiazide are natriuretic, it is to be expected that their coadministration would induce more sodium excretion than would either diuretic alone”); In re Diamond, 360 F.2d 214, 217 (CCPA 1966) (where the evidence showed that synergy was expected because combined drugs targeted different cellular mechanisms, and no evidence to the contrary was produced, “[w]e are not convinced of [the] non-obviousness of the combination of two drugs, A5MP and a glucocorticoid . . . particularly since Appeal the record supports the [PTO' s] contention that the drugs selected are two of the commonly used drugs in the treatment of such collagen diseases”).
Bjornsson teaches the two compounds for the very same purpose and thus the combination is prima facie obvious. “[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claims 14, 20 and 21, Bjornsson renders obvious the combination of BHB and MCT for treating KS but does not teach the specific ratio. One of ordinary skill in the art would have considered formulating the composition to include ratios of ingredients to improve therapeutic effect as is routine in the art and the result would have been predictable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”); MPEP 2144.05. Thus, the claims are obvious.
Regarding claims 15-16, Bjornsson renders obvious the combination of BHB and MCT for treating KS in a human subject by administering a ketogenic composition comprising a medium chain triglyceride and beta-hydroxybutyrate (claims 1, 4, 11, and 17; [0109]) and one of ordinary skill in the art would have considered treating one of the corresponding symptoms in a human.
Regarding claims 17-18, Bjornsson renders obvious the combination of BHB and MCT for treating KS and further teaches that KS is caused by either of KMT2D or KDM6A ([0006]: “KS is caused by heterozygous loss-of-function mutations in either of two genes … (KMT2D) on human chromosome 12 … or KDM6A”) which corresponds to Type 1 and Type 2 as defined in the instant specification at [0053] and one of ordinary skill in the art would have considered treating both of the types and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 19, Bjornsson renders obvious the combination of BHB and MCT for treating KS and further teaches associated symptoms treated include a variety of features including long eyelashes and short stature ([0077]).
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626