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 claims of Group I (claims 1, 4-12 and 14-25) is acknowledged. However, in light of inventor’s latest amendment (such that all pending claims are now dependent upon, or ultimately dependent upon, independent claim 1), the election/restriction requirement is now unnecessary and is hereby withdrawn. All pending claims will be examined.
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 18-21, 23 and 25 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 for in vivo delivery of a DNA vector to a bodily site to treat a disease or disorder in a mammalian subject comprising administering the lipid nanoparticle of claim 1, does not reasonably provide enablement for a method for the prevention of such diseases or disorders. 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 for in vivo delivery of [a] DNA vector to a bodily site to treat or prevent a disease or disorder in a mammalian subject, the method comprising administering to the mammalian subject a lipid nanoparticle of claim 1” (claim 18). Dependent claims 19 and 21 (both from claim 18) further define the bodily site. Dependent claim 20 (from claim 18) further defines the mammalian subject. Dependent claim 23 (from claim 18) teaches that the disease or disorder is cancer. Dependent claim 25 (from claim 18) teaches that the disease or disorder is congenital.
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, 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 and methods, 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 data do not demonstrate that administration of the instant lipid nanoparticles prevents, for instance, cancer.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant lipid nanoparticles are actually efficacious in the prevention of, for instance, 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 and 8-10 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 dense in the limitation “…electron dense region…” 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 is, or is not, considered electron dense - even utilizing the instant technique of cryogenic transmission electron microscopy - would appear to be an ambiguous, subjective determination.
Clarification is in order.
Claims 1 and 3 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 claims contain the trademark/trade name ONPATTRO® (“…Onpattro-type formulation…”). Note that where a trademark or trade name is used in a claim as a limitation to describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product not only renders a claim indefinite, but also constitute an improper use of a trademark or trade name. (Note the discussion at MPEP 2173.05(u)).
The examiner respectfully suggests deleting the trademark name.
Claim 11 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 elongate in the limitation “…elongate in shape…” is a relative term which renders the claim indefinite. The term is not defined by the claim, 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 is, or is not, considered an elongate shape, and in comparison to what exactly, would seem to be an ambiguous, subjective determination.
Clarification is in order.
Claim 21 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 how specifying that the lipid nanoparticle is for delivery to spleen, bone marrow or liver further modifies the method of claim 18 (the claim from which claim 21 immediately depends). Is there some formulation difference intended by this claim?
The examiner respectfully suggests a slight rewording, something along the lines of: The method of claim 18 where the lipid nanoparticle is delivered to the spleen, bone marrow or liver.
Claims 2, 4-7, 12, 14-20 and 22-25 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.
Claims 2, 4-7, 12, 14-20 and 22-25 all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 2, 4-7, 12, 14-20 an 22-25 are also, therefore, indefinite.
Allowable Subject Matter
The subject matter of the instant claims would be allowable once the 112 rejections outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter:
The key to the instant invention is the lipid nanoparticle composition of independent claim 1. WO 2010/014895 A2 appears to be the closest prior art. The reference teaches nanoparticle compositions, utilized in nucleic acid delivery, comprising mixtures of a cationic lipid, a fusogenic lipid and a PEG lipid (abstract; page 2, line 8ff; Examples beginning at page 56). The reference does not teach, show, suggest or make obvious the instant lipid nanoparticle composition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: WO 2020/241679 A1 is cited to show a related lipid nanoparticle formulation. (US 12,365,921 B2 is this reference’s English language equivalent.)
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 EST.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 2/20/2026