DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-19 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. Independent claims 1 and 16 recite “Rc is CH2H2O”. The group is missing a carbon atom. Examiner will interpret the claim as being directed to “Rc is CH2CH2O”.
Claim 4 recites the limitation "hexanoyl-ethyl-3-hydroxybutyrate” and “octanoyl-ethyl-3-hydroxybutyrate" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 limits Rd to O-C4-30 alkyl. In the above compounds Rd is an O-C2 alkyl which is outside of the scope of claim 1.
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.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verdin et al (US 10,562,839).
In column 46, lines 5-19, Verdin exemplifies a composition comprising C6 diesters of β-hydroxy butyrate and C6-diesters of butanediol which have the following structure and correspond to hexanoyl-hexyl-3-hydroxybutyrate and bis-hexanoyl-1,3-butanediol, respectively:
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hexanoyl-hexyl-3-hydroxybutyrate
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bis-hexanoyl-1,3-butanediol
Verdin teaches food compositions prepared by mixing the compounds in ground chow and administering them to mice. Mice meet the limitations directed to mammal. The compounds themselves meet the limitation directed to food additive because they are added to food. The mixture of compound and ground chow meets the limitation directed a non-human mammal food and a non-human mammal food supplement.
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.
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verdin et al (US 10,562,839).
Scope of prior art
Verdin teaches increasing ketone body concertation in a subject comprising administration of β-hydroxyester compounds (column 12, lines 48-56).
Increasing ketone body concentration meets the limitation directed to inducing ketosis. (claim 1)
Verdin defines the term subject to include mammals including canines, felines and equines. (column 4, lines 48-52; limitation of current claims 12-15)
β-hydroxyester compounds include the currently claimed “hexanoyl-hexyl-3-hydroxybutyrate” and “bis-hexanoyl-1,3-butanediol” (current claims 2-4)
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hexanoyl-hexyl-3-hydroxybutyrate (column 18, lines 20-25)
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bis-hexanoyl-1,3-butanediol (column 15, lines 10-15)
Verdin teaches administration of the active agent as a food supplement in combination with one or more components of a ketogenic diet. (column 20, lines 40-42; current claims 5, 10 and 11)
With regards to dosage and frequency of administration, Verdin teaches that the dose will vary depending on the compound administered, clinical goals, specifics of the subject and the disorder to be treated. Verdin provides wide ranges that encompass the claimed doses and states that a proper dosages are readily determined by those skilled in the art. (column 22, lines 31-46; column 28, lines 53-67). Regarding frequency of administration, Verdin teaches twice daily and daily administration (column 22, lines 47-51; column 29, lines 10-13).
Ascertaining the difference
Verdin teaches ranges that encompass the claimed 125mg/kg – 500mg/kg range (column 29, line 1) but does not exemplify administration of a 125mg/kg, 250mg/kg or 500mg/kg dose.
Verdin teaches subjects to include canines, felines, and equines but only exemplifies administration to mice.
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to practice the invention as described by Verdin within the stated parameters. Verdin teaches administration of hexanoyl-hexyl-3-hydroxybutyrate and bis-hexanoyl-1,3-butanediol to mammals to increase ketone body concertation and exemplifies the method in Example 11 by administrating mice. It would have been obvious for a skilled artisan to increase ketone body concentration in mammals such as felines canines or equines by administration of the same active agent because Verdin teaches these mammals to be within the scope of subjects for whom treatment is intended. A skilled artisan would have found it obvious to determine the optimal dose and frequency of administration. Verdin teaches that such determinations can readily be determined by skilled practitioners. It would have been obvious to experiment within the ranges disclosed by Vermin to arrive at the optimal safe and effective dosage and administration frequency.
Conclusion
Claims 1-19 are pending
Claims 1-19 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
