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 a nucleotide, poly(β-amino ester) and a positively charged amino acid as the drug, polymer and positively charged group, respectively, is acknowledged. However, upon reconsideration, and given the subsequent prior art searches, the election/restriction requirement is hereby withdrawn. All claimed subject matter 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 31, 33, 36, 40 and 49-63 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 the instant nanoparticle composition comprising pBAEs as the polymer, does not reasonably provide enablement for the instant nanoparticle composition comprising the universe of polymers. 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 nanoparticle composition comprising: a polymer conjugated to a drug by a linker to form a polymer compound, the polymer further conjugated to at least one positively charged group such that the polymer compound having [sic] a net positive charge, and the polymer compound interacting electrostatically to form a nanoparticle” (independent claim 31). Dependent claims 33, 49 and 50 further define the drug. Dependent claims 36 and 51-53 further define the linker. Dependent claims 40 and 54 further define the positively charged group. Dependent claims 55-58 further define the nanoparticle. Dependent claim 59 teaches a pharmaceutical composition of the nanoparticle. Dependent claims 60-63 teach methods of cancer treatment utilizing the nanoparticle.
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 pertinent prior art makes clear, the prior art is directed to particular biocompatible polymers utilized in the formulation of compositions useful as non-viral vectors for the delivery of nucleotides.
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.
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 single synthetic working example of nanoparticle formation (Example 2, page 29) encompasses a single class of biocompatible polymers: pBAEs.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation in order to determine if, in fact, the universe of polymers would be efficacious in the synthesis of the instant nanoparticle composition. Inventor’s extrapolation from a single class of end-modified biocompatible polymers to the universe of polymers is unreasonable.
The examiner respectfully suggests limiting the polymer to pBAEs.
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 31 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 nature of the nanoparticle composition is unclear. That is, claim 31 appears to teach a nanoparticle composition comprising a single chemical compound which is comprised of 4 elements: a polymer, a drug, a linker and at least one positively charged group, where the polymer is conjugated to the drug by a linker, and where the polymer compounds interacts electrically to form the nanoparticle. Is this correct? The examiner notes that the specification teaches that the electrostatically complexed polymeric nanoparticles comprise a first polymer conjugated to a drug via a linker and which has a net negative charge, and a second polymer compound comprising a polymer conjugated to at least one positively charged group and which has a net positive charge (page 1, BRIEF SUMMARY OF THE INVENTION; page 11, [38]; Fig. 1a).
Clarification is in order.
Claim 59 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 ‘effective amount’ is indefinite where the claim fails to state the function which is to be rendered effective. Note MPEP 2173.05(c)(III).
Claims 32, 33, 36, 40, 49-58 and 60-63 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, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 32, 33, 36, 40, 49-58 and 60-63 are also, therefore indefinite.
Allowable Subject Matter
The instant subject matter 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 closest prior art appears to be Molecular Systems Design & Engineering (2018), 3, pp. 677-689, cited in the IDS (and inventor Dosta’s own work). The reference teaches the synthesis of stable pBAEs for efficient RNAi delivery which have been end-modified with oligopeptides (abstract; page 680, Results and discussion; page 681, Fig. 1). The reference does not, however, teach, show, suggest or make obvious the instant nanoparticle composition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Acta Biomaterialia 20 (2015), pp. 82-93 (inventor Dosta’s own work) is cited to show the surface charge tunability of tailored oligopeptide-modified pBAEs as a strategy to control electrostatic interaction in a method of high efficiency gene silencing.
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 4/19/2026
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