DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 19 June 2026, in the matter of Application N° 18/250,121. Said documents have been entered on the record. The Examiner further acknowledges the following:
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 19 June 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3, 5, 7-13, 15, and 16 are pending, where claims 11-13, 15, and 16 remain withdrawn from consideration.
No claims have been added or canceled.
Claims 1 and 7 have been amended to alter the recited definition of the R11 group.
No new matter has been added.
Thus, claims 1, 3, 5, and 7-10 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 112
Applicants’ amendment to claim 1 is considered to overcome the indefiniteness rejection based on the previously raised grounds. Said rejection is withdrawn.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
Claim Rejections - 35 USC §112
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, 3, 5, and 7-10 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 R11 variable in claim 1 has been amended to remove “methyl”, but add the limitation “substituted or unsubstituted C1-C21 alkyl selected from the group consisting of” ethyl, propyl, etc., which the Examiner notes as being conflicting in its definition. Therein, it appears to both include and exclude “methyl”.
Claims 3, 5, and 7-10 each depend directly from or include limitations of claim 1 and therefore are rendered indefinite as a result.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 19 March 2026 since the art that was previously cited continues to read on the amended and previously recited limitations.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hori et al. (US Pre-Grant Publication Nº 2012/0076836 A1; of record).
The instantly amended composition is directed to a copolymer represented by Formula (I):
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Variable ‘A’ is defined in one of two ways as defined in the claim as (i) or (ii). Option (i) is pendant groups such as hydrogen, while option (ii) is represented by the following formula:
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The limitations for L and L’ are recited as being directed to a “linking group”, the definitions for which are set forth within ¶[0018] of the originally-filed disclosure.
The limitations of Y and Y’ remain the same as previously recited.
The limitations for R10 and R10’, are recited as being R11-(C=O)-.
The variables: m, m’, and n, remain unchanged.
Hori discloses polyion complexes having an average particle size of less than 50 nm, and from 10-20 nm (see e.g., Abstract; claim 1, 3, and 4). The polyion complex particles are further defined as having a block copolymer component employing one of the two following core structures:
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The variables of R1a and R1b are defined such that they meet the limitations of option (i) of variable ‘A’, specifically that they may be hydrogen or an unsubstituted or substituted C1-12 alkyl group.
The variables L1 and L2 are defined as being a generic linking group and read on the instantly recited ‘L’ variable.
The R2 variable of formula (I) reads on the instantly claimed ‘Y’ variable as hydrogen.
The pendant methyl group -(CH2)x-is defined as having ‘x’ repeating units ranging from 1-5, and therefore encompasses the instantly recited propyl group (x=3).
Variables R4a and R4b disclose being defined as being embodied by a protecting group for an amino group (i.e., the amino to which R4a and R4b are directly attached), which is further defined in ¶[0065] as being exemplified by such groups as a Z group, Boc group, acetyl group, and the like.
A ‘Z group’ is also known as a benzyloxy carbonyl group having the following structure:
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A Boc group has the following structure:
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An acetyl group has the following structure:
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Each of the foregoing disclosed structures contains the recited definition for R10 and definitions of the ensuing R11-(C=O)- group that follows.
Lastly, the R1a variable of formula (I) reads on the instantly claimed ‘A’ variable as a hydrogen atom or an unsubstituted or substituted linear or branched C1-12 alkyl group.
The foregoing is considered to teach and suggest the mono- or di-C1-4 alkylamino limitation of claims 1 and 7.
The reference discloses that the PEG unit will have ‘m’ repeating units ranging from 5-20,000 units which encompasses the instantly recited 2-1,000 repeating ‘n’ units.
The reference also discloses that the ornithine unit will have ‘n’ repeating units ranging from 2-5,000 units which encompasses the instantly recited 2-300 repeating ‘m’ units.
The foregoing is considered to teach the limitations of instant claims 1, 3, 7, and 10.
Claim 5 discloses a pharmaceutical composition comprising the polyion complex of claim 1 and a pharmaceutically acceptable carrier. Such is considered to teach the limitations of instant claims 8 and 9.
Thus, based on the teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. The sole difference between the recited and disclosed copolymers is the length of the PEG and ornithine subunits; the reference simply discloses a broader range for both components. However, the reference’s disclosure clearly encompasses the instantly claimed ranges, thereby rendering the instant invention obvious. See MPEP §2144.05(I).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 3, and 7-10 under 35 USC 103(a) as being unpatentable over the combined teachings of Hori et al. have been fully considered, but they are not persuasive.
Applicants’ remarks address the Examiner’s previous citation of ¶[0060] and ¶[0061] as defining variables R4a and R4b as “inappropriate,” since the cited paragraphs are directed to defining variables R1a and R1b.
The Examiner agrees with this observation and has corrected the language and citations in the above maintained rejection to reflect this change.
Applicants next address the Examiner’s discussion of the protecting group as set forth in ¶[0065].
Here, it is stated that claims 1 and 7 have been amended to remove “methyl” from the groups defining R10 such that an acetyl group would not read on the R11 group.
The Examiner submits that in view of the filed amendment, as discussed in the newly presented indefiniteness rejection, the acetyl group disclosed by the reference continues to read.
Lastly, Applicants simply assert “that R10 as defined in claims 1 and 7 is not any one of Z group, Boc group and trifluoroacetyl group disclosed by Hori.”
The Examiner respectfully disagrees and maintains the rejection for the reasons discussed above, noting the structures of each of those groups.
Applicants’ response, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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