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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
Assuming that the working examples in the specification reflect the actual invention - as opposed to the text description of the invention and its diagramed compound formulas – then there is no proper antecedent basis for the claimed subject matter. This lack of antecedent basis arises because the diagramed formulas, in particular any diagramed formula with the [-HC=CH-]m moiety in the claims, do not encompass the compounds of the working examples. In fact, there appears to be a systematic error throughout the disclosure and the claims with respect to this diagrammatic description of the instant compounds. That is, the repeating moiety must be [-CH=CH-CH2-]m, in one form or another, in order to accurately describe/define the compounds of the working examples (e.g. compound 7-a, page 16).
Correction/clarification of this error/discrepancy is required.
Claim Objections
Claims 10 and 11 are objected to because of the following informalities: for grammatical reasons, the indefinite article an before the term “…linolenic fatty acid…”, should properly be the indefinite article: a.
Appropriate correction is required.
Claim 17 is objected to because of the following informalities: for grammatical reasons, a comma should appear between the verb “reducing” and the verb “treating.”
Appropriate correction is required.
Inventor’s assistance is respectfully requested in correcting any other minor grammatical and/or spelling errors which may be present in the claim set.
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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As noted above, assuming that the working examples in the specification reflect the actual invention - as opposed to the text description of the invention and its diagramed compound formulas – then there is no proper antecedent basis for the claimed subject matter. This lack of antecedent basis arises because the diagramed formulas, in particular any diagramed formula with the [-HC=CH-]m moiety in the claims, do not encompass the compounds of the working examples. In fact, there appears to be a systematic error throughout the disclosure and the claims with respect to this diagrammatic description of the instant compounds. That is, the repeating moiety must be [-CH=CH-CH2-]m, in one form or another, in order to accurately describe/define the compounds of the working examples (e.g. compound 7-a, page 16).
Claim 17 is 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 a method of treating or reducing some or all of the listed diseases, does not reasonably provide enablement for a method of preventing some or all of the listed diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (MPEP 2164.01(a)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a) The claim is extraordinarily broad: “A method of reducing[,] treating or preventing any of the following in a patient: heart failure,…cognitive decline, cancer…”.
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as, for instance, cognitive decline (e.g. Alzheimer’s disease) or cancer, can be said to be prevented.
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation.
Cancer, for instance, is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific compounds, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor provides no working examples which demonstrate, for instance, the efficacy of the instant compounds in the prevention of cognitive decline or cancer. The working examples are, in fact, drawn only to compound synthesis.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation (multi-phase clinical trials, etc.) in order to determine if, in fact, the instant compounds are actually efficacious in the prevention of, for instance, cognitive decline or cancer.
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, 7-13, 15 and 20 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.
The instant specification explicitly defines very long chain fatty acids as having 24-40 carbon atoms (page 1, [0001]). Yet the claims teach fatty acids – described as very long chain fatty acids in the preamble of the claims – which encompass fatty acids having as few as 16 carbon atoms. That is, the definition of the limitation very long chain fatty acids appears to differ significantly between the teachings of the specification and that of the claims. And that being the case, the limitation in the claims is unclear.
Clarification is in order.
Claim 14 is 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.
There is insufficient antecedent basis for the limitation “The long chain fatty acid of claim 12…” in the claim. Claim 12 teaches a very long chain fatty acid.
Claims 8, 9, 10, 11 and 20 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.
There is insufficient antecedent basis for the limitations “…alpha-linolenic fatty acid…” or “…linolenic fatty acid…” in the claims. The diagramed compounds of claim 1, the claim from which claims 8, 9, 10, 11 and 20 ultimately depend, do not encompass alpha-linolenic fatty acid or linolenic fatty acid. (Note the related 112(a) rejection above with respect to the diagramed [-HC=CH-]m moiety.)
Claims 2-6 and 16-19 are also 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.
The claims all depend, or ultimately depend, upon claims which are indefinite yet do not relieve the indefiniteness. Claim 2-6 and 16-19 are also, therefore, indefinite.
Notes On the Search/Examination
The claimed subject matter has been searched as per MPEP 2143.03, although because of the systemic diagraming error, which appears in the both the disclosure and claims, this claimed subject matter is not enabled and does not, in fact, even appear to be the subject matter that inventor actually intended as claimed subject matter – based upon the working examples (i.e. the best available evidence of what inventor actually intended as claimed subject matter).
The closest prior art, if it can be truly be called that given the 112 issues in the application, appears to be US 2013/0190399 A1 which teaches the synthesis and uses of omega-3 and omega-6 very long chain polyunsaturated acids (VLC PUFAs) (abstract). A representative synthesis is outlined on pages 8-9 for compound C28:6n3. However, these prior art compounds are not closely structurally related to the compounds comprising the instantly claimed methods of synthesis, compositions and methods of use. And that being the case, the claimed subject matter does not read on this art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 8/20/2025