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 .
Election/Restriction
Inventor’s election, without traverse, of the compound 306-HB7b2 (B3) (3rd diagramed structure of Fig. 1F) as the compound elected to begin prosecution is acknowledged. The election/restriction is hereby made FINAL.
Information Disclosure Statement
The lined-through references are either improperly formatted citations of electronic documents, or have no date. With respect to the improper format, see MPEP 707.05(e)(IV) for examples of proper citation format for electronic documents.
Claim Objections
Claim 15 is objected to because of the following informalities: for grammatical reasons, in the second text line of part (d) of the claim, the first tandem repeat of the phrase “…optionally wherein,…” should be deleted.
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 52 and 53 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 a method of treating or ameliorating a disease or disorder which may be treated or ameliorated by delivery of a mRNA to a cell, does not reasonably provide enablement for a method of treating, ameliorating or, in particular, preventing the universe of 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 claims are extraordinarily broad: “A method of treating, ameliorating, and/or preventing at least one disease or disorder…comprising administering…at least one biodegradable LNP of claim 14…” (claim 52). Dependent claim 53 further defines the disease or disorder (liver disease or disorder, pulmonary disease or disorder,…cancer,…). That is, inventor claims nothing less than a ‘magic bullet’ efficacious in the treatment, amelioration and/or prevention of any and all diseases and disorders in any and all hosts.
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 a single therapy is efficacious in the treatment, amelioration and/or prevention of the universe of diseases and disorders. Nor have the medicinal arts advanced to the point where complex diseases with a significant genetic component, such as cancer, can be said to be prevented. Or, indeed, that the universe of liver diseases and disorders, pulmonary diseases and disorders, etc. 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 or therapies, 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’s examples are drawn to the delivery of mRNA. Inventor’s data do not demonstrate that the instant method is efficacious in the treatment, amelioration and/or prevention of the universe of diseases and disorders.
h) It would clearly require an absolutely extraordinary – and thus undue – amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant compounds of Formula I are actually efficacious in a method for the treatment, amelioration and/or prevention of the universe of diseases and disorders.
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.
Claim 2 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.
It is unclear if the diagramed structures of part c of the claim are intended to be simply a subset of possible structures for variable A of instant Formula (I), and/or some other portion of the structure of the compounds defined by Formula (I).
Clarification is in order.
Claims 26 and 32 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 term “…suitable…” (claim 26 part (c); claim 32 penultimate text line) is a relative term which renders the claims indefinite. The term is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What might be, or not, a suitable biodegradable LNP for delivering a nucleic acid to a liver cell would appear to be a wholly subjective determination.
Clarification is very much in order.
Claims 35 and 45 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 term “therapeutically effective amount” is indefinite because the claims fail to state the function which is to be rendered therapeutically effective. Note MPEP 2173.05(c)(III). The mere delivery of an unknown and unknowable agent (the claims’ preamble limitation) cannot reasonably be considered a therapy without knowing what therapeutic benefit delivery of the agent is seeking to accomplish.
Clarification is in order.
Claim 54 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.
The term “therapeutically effective amount” is indefinite because the claim fails to state the function which is to be rendered therapeutically effective. Note MPEP 2173.05(c)(III). The mere induction of an immune response (the claim’s preamble limitation) cannot reasonably be considered a therapy without knowing what therapeutic benefit such an induction is seeking to accomplish.
Clarification is in order.
Claims 36 and 46 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 depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 36 and 46 are also, therefore, indefinite.
Markush Search
The elected species has been searched and is deemed free of the prior art.
The search was therefore expanded as called for under Markush examination practice, a compound-by-compound search, to include a single additional species. That species is defined when, using Formula (I): x=y=0; L= an amino alkyl.
All claimed but as yet unexamined subject matter which does not read on the above species is hereby withdrawn from consideration, for purposes of this Office Action. This subject matter will be rejoined as appropriate as the Markush examination progresses.
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.
Claims 1, 2, 4 and 9, in so far as they read on the species defined above, are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Journal of the American Chemical Society (1905), 27(7), pp. 851-865.
The reference teaches an old and well-known alkyl amine: methyl amine (page 859).
Allowable Subject Matter
The elected species being free of the prior art, any claim or portion of a claim, drawn exclusively to this species constitutes allowable subject matter. That being the case, claims 6-8, 10, 12 and 14 are objected to as being drawn to both allowable subject matter (the elected species) and subject matter which has not yet been completely searched.
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 9/14/2026
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