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 Status
Claims 1-16 are pending in the application.
Claim Interpretation
Claims 1 and 13 recite “reducing a rate of disease progression”. It is unclear if this recitation requires the calculations of Example 2 and 3 in the Applicant’s specification as recited in claims 8 and 9 or merely represent an intended outcome. In order to advance prosecution, the recitations of “reducing a rate of disease progression” in claims 1 and 13 are interpretated as intended outcomes.
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 8-12 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.
Claim 8 recites that the “reduction in the rate of progression” is determined by comparison of treated patients to placebo-treated patients “employing the formula of Example 2”. Similarly claim 9 recites determining the reduction using “the formula of Example 3”. The claims do not recite the formula or calculation used, but instead rely on incorporation by reference to specific examples in the specification. Claim scope must be defined by the claim language itself, rather than by reference to examples. As such, the metes and bounds of the claims cannot be determined with reasonable certainty. Furthermore claims 10-12 depend on claims 8 and 9, therefore claims 8-12 are not being further assessed (see MPEP 2173.05(s)).
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.
Claims 1, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shchepinov (US-10058522-B2, Published 2018-08-28).
Claim 1 of the instant application recites a method of reducing the rate of progression of an oxidative retinal disease by administering deuterated docosahexaenoic acid (DHA) or an ester thereof in specified daily amounts to achieve a therapeutic concentration in the retina. Shchepinov teaches a method of treating or inhibiting the progression of oxidative retinal diseases (column 2 lines 60-61 and column 65 claim 1) by administering a deuterated polyunsaturated fatty acid (PUFA) or ester thereof (column 2 lines 5-22). Shchepinov also teaches that the PUFA is DHA or an ester thereof (column 66, claim 16) and that the PUFA is deuterated at “one or more bis-allylic positions” (column 3 lines 10-22 and column 65 claim 1). Furthermore, they recite administration of the substances in amounts of 0.1 mg/kg to about 100 mg/kg per day (column 66 claim 20), overlapping with the dosage ranges of claim 1 in the instant application. Shchepinov additionally teaches monoglyceride, diglyceride, triglyceride and ethyl esters of PUFAs (column 3 lines 5-10, columns 15 lines 64-67, and 16 line 1) in addition to DHA esters (column 16 lines 5-13).
Accordingly, the teachings of Shchepinov anticipate claims 1, 14 and 15
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.
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.
Claims 2 -7, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shchepinov (US-10058522-B2, Published 2018-08-28) as applied to claims 1, 14 and 15. The teachings of Shchepinov as set forth above with respect to claims 1, 14 and 15 are relied upon and incorporated herein.
Shchepinov further teaches at least one deuterium atom is present at a level greater than 0.02% and at least two deuterium atoms at one or more bis-allylic positions in the PUFA. (column 3 lines 15-17, and column 65 claim 2). They also teach that deuteration level affects stability (column 3 lines 10-15) and further disclose embodiments where heavy isotope enrichment at said positions is between 50%-99% deuterium (column 15 lines 55-63) as required by Applicant’s claims 3 and 4. Thus, it would have been obvious to one of ordinary skill in the art at the time, to routinely optimize the DHA ester to achieve an average deuteration at bis-allylic sites of at least about 80-90 percent and average deuteration at mono-allylic sites from about 1 percent to about 35 percent because selection of particular degrees of deuteration within the same compound constitutes optimization of a result-effective variable and no structural distinction in kind is introduced.
Claim 2 of the instant application recites administration of DHA according to claim 1 for at least 5 days per week and claims 5-7 recite achieving therapeutic concentration of DHA in the retina within 50, 40, or 30 days. These limitations describe a result of administration of the same composition as Shchepinov for the same purpose. Shchepinov recites “over the treatment period the deuterated polyunsaturated fatty acid or fatty acid ester comprises between about 10% and 50% of the total amount of fatty acids or fatty acid esters in the patient's eye” (Column 65, claim 3). Furthermore, Examples 19-24 detail testing of tissue specific deuteration, deuterated PUFA (D-PUFA) incorporation in tissues, and D-PUFA efficacy in oxidative retinal diseases (columns 60-64). Within these examples, the D-PUFA is administered at least 5 days per week (column 61 lines 38-45). Therefore, it would have been obvious to one of ordinary skill in the art at the time to use the known method of D-PUFA administration for oxidative retinal disease to yield the predictable result of a therapeutic DHA concentration over time as required by claims 2, and 5-7.
Shchepinov also teaches measuring changes in biological outcomes over time using time-course analysis that includes a baseline measurement such as untreated controls and subsequent time points (Figure 4). This analysis demonstrates determining changes in a condition relative to an initial baseline over time. It would have been obvious to determine reduction in the rate of disease progression by comparing post-treatment progression to a pre-treatment baseline in the same subject, as recited in claim 13, since such baseline comparisons are a routine method for evaluating treatment effects over time.
Claim 16 of the instant application recites placing the patient on a diet that restricts intake of non-deuterated PUFA. Shchepinov teaches “the amount of deuterated polyunsaturated fatty acid or fatty acid ester administered to or ingested by the patient is in the range of about 5% to about 75% of the total amount of polyunsaturated fatty acid or fatty acid ester administered to or ingested by the patient” (Column 65, claim 1). In this recitation 51% to 75% of the total PUFA ingested by a patient being deuterated restricts the intake of non-deuterated PUFA thereby necessarily reducing the proportion of non-deuterated fatty acids in the patient’s diet.
Accordingly, it would have been prima facie obvious to one of ordinary skill, in the art at the time, to modify the teachings of Shchepinov to arrive at the claimed method of the instant application because such modifications represent routine optimization of result-effective variables expressly disclosed by Shchepinov. These modifications would have been expected to yield the predictable result of achieving effective concentrations of D-PUFA, such as deuterated DHA, in retinal tissues over time, thereby reducing progression of oxidative retinal disease as taught by Shchepinov.
Conclusion
No claims are allowed in the action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH JAIPRASHAD whose telephone number is (571)272-1049. The examiner can normally be reached Monday-Friday 8AM-5PM.
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/RAJESH JAIPRASHAD/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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