DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Per amendment filed on 4/26/26, claims 1-11, 13-17, 42-44 and 61-64 are currently pending in the application, with claims 17, 42-44 being withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Amended claim 1 includes limitations from previously presented claims 59 and 60 (dt. 10/15/2). However, limitation in the previously presented claim 60, now recite din claim 1, is not supported by the disclosure as originally filed. In an effort to maintain compact prosecution, examiner contacted the attorney of record to discuss and resolve the new matter issue (cf. attached Interview Summary). However, the issues could not be resolved in a timely manner necessitating the mailing of an office action. Examiner regrets the delay in prosecution as a result of mailing this second nonfinal office action.
Claim Rejections - 35 USC § 112
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 1-11, 13-16 and 61-64 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Paragraph [0191] in the original disclosure is as follows:
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Paragraphs [0191]-[0201] of the disclosure, at best, include qualitative discussions on the Hill coefficient parameter but are silent on absolute values of the Hill coefficient, and specifically, a lower limit as recited in amended claim 1.
Claims 2-11, 13-16 and 61-64 are subsumed by rejected base claim 1 and are therefore included in this rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites a pKa range of about 8 to about 10, which is broader in scope than that of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-4, 6-8, 11, 13-16, 62-64 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (US 20050163743 A1).
Regarding claims 1-4, 6, 7, 16, Lewis teaches compositions comprising polymers and biologically active compounds, e.g., nucleic acid, such as DNA, especially plasmid DNA (Ab., [0001], ref. claims). Disclosed polymers are block copolymers, e.g., (tertiary amine group-containing monomer) block-(zwitterionic monomer) block copolymers. Suitable cationic monomers include dialkyl aminoalkyl(alk)acrylates and acrylamides and suitable zwitterionic monomers include phosphorylcholine group containing acrylate monomers, such as 2-methacyloyloxyethyl-2.sup.1-t- trimethyl ammonium ethyl phosphate salt (MPC) (Ab., ref. claims). The zwitterionic and/or ionic blocks may include comonomers, for instance to provide control over pKa [0067], [0091]-[0100], and the degree of polymerization in each may range from 5 to 500, preferably 10 to 100 [0130].
Disclosed A-B block copolymers in Table 1 are formed MPC and DEA (diethylaminoethyl methacrylate), and those of Table 2 are formed from MPC and DMA (dimethylaminomethyl methacrylate) (Fig. 4-6), i.e., include monomer units within the scope of claim 1.
Lewis is silent on the pKa and Hill coefficient values as claimed, and the capability of the copolymers to undergo cooperative deprotonation for rapid intracellular unpackaging of the biological agent.
At the outset, it is noted that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05.
Given the teaching in Lewis on A-B block copolymers comprising claimed monomer units sufficient, it would have been obvious to one of ordinary skill in the art, as of the effective filing date of the claimed invention, to provide for copolymers of MPC and DEA/ DMA, having a degree of polymerization of each unit at 10-100, and reasonably expect the copolymers to include those having the claimed pKa and Hill coefficient, absent evidence of criticality for the claimed ranges. Additionally, a skilled artisan would reasonably expect copolymers of overlapping scope to be capable of cooperative deprotonation for rapid intracellular unpackaging of the biological agent, and the copolymers associated with a nucleic acid to have the claimed N/P ratio (claim 64), absent evidence to the contrary.
When the prior art discloses all limitations of a claim except a property or function, and the Examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention, basis exists for shifting the burden of proof to the Applicant. In re Fitzgerald et al., 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980). See MPEP 2112-2112.02. Additionally, as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons.
Regarding claim 8, Lewis teaches that either or both the zwitterionic and ionic blocks may include comonomers that can control pKa [0091], such as monohydroxy-C1-6-alkyl(alk)-acrylate (encompasses HEMA) [0100].
Regarding claim 11, disclosed copolymer has a wt. average molecular wt. of less than 500,000 (Tables 1 and 2).
Regarding claim 13, a skilled artisan would reasonably expect block copolymers comprising claimed monomers having charged functional groups in prescribed mol% amount and degree of polymerization, and including HEMA comonomer units to include those having the claimed z potential, absent evidence to the contrary.
Regarding claims 14, 15, Lewis teaches that the polymer and the biologically active compound are electrostatically bound to one another [0013]. A skilled artisan would reasonably expect such an association of a nucleic acid and copolymers of overlapping scope to be entangled as in the claimed invention, absent evidence to the contrary.
Regarding claim 62, Lewis teaches an average diameter of the particles comprising the polymer and the biological active compound as preferably less than 200nm [0013], and that the particle varies depending on the molecular size of the biologically active compound and of the copolymer. The preferred embodiment does not teach away claimed ranges, absent evidence of criticality. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are sufficiently close that one of ordinary skill in the art would expect the ranges to yield products having the same properties. See MPEP 2144.05(I).
Regarding claims 16 and 63, Lewis teaches that the biologically active compound may be DNA or RNA (Ab., [0011]).
Response to Arguments
In view of the amendment dated 4/23/26, the rejections of record are withdrawn. Applicant’s arguments with respect to claim rejections and applied art have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Satya Sastri at (571) 272 1112. The examiner can be reached Monday-Friday, 9AM-5.30PM (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Mr. Robert Jones can be reached at (571)-270-7733. The fax phone number for the organization where this application or proceeding is assigned is (571) 273 8300.
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/Satya B Sastri/
Primary Examiner, Art Unit 1762
Prosecution Insights