DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 15 January 2026, in the matter of Application N° 18/250,121. Said documents have been entered on the record. The Examiner further acknowledges the following:
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Claims 1, 3, 5, 7-13, 15, and 16 are pending, where claims 11-13, 15, and 16 remain withdrawn from consideration.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 with respect to the R10 and R10’ variables. Therein, both the R10 and R10’ have had the hydrogen definition removed and are narrowed to be R11-(C=O)-. The R11-(C=O)- variable is also amended to recite alkyl definitions (i.e., methyl, ethyl, etc.), but have been narrowed by removing the language directed to substituted or unsubstituted alkyls, aryls, and alkoxy groups. The be R11 group is also narrowed to remove the definition for it being substituted, a substituent being a C1-C21 alkyl, C1-C21 alkoxy, or aryl. The amendments are supported by the originally-filed disclosure.
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 Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 102
Applicants’ amendments to claims 1 and 7 above are considered to overcome the previously raised anticipation rejection. Said rejection is withdrawn.
Rejection under 35 USC 103
Applicants’ amendments to claims 1 and 7 removing hydrogen as an option for R10 and R10’ as discussed above are considered to overcome the previously raised obviousness rejection. Said rejection is withdrawn in its current form and remade below.
New Rejections
Applicants’ amendments have necessitated the following grounds 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.
As amended, claims 1 and 7 narrow the definition for the R11 variable, removing the language that recited “substituted or unsubstituted C1-C21 alkyl, substituted or unsubstituted aryl, or substituted or unsubstituted C1-C21 alkoxy”.
Claims 1 and 7 continue to recites the limitation “when the C1-C21 alkyl and the aryl and the aryl are substituted, substituents are C1-C4 alkyl, C1-C4 alkoxy, or aryl, and when the C1-C21 alkoxy is substituted, a substituent is C1-C4 alkyl, or C1-C4 alkoxy;” following the removed language. Due to the amendment, there is now insufficient antecedent basis for this limitation in the claims.
Claims 1 and 7 now also recite “optionally branched” as parenthetical limitations ahead of several alkyl structures. The manner in which this is recited renders the claims indefinite since it is unclear if these are part of the recited compositions, as amended.
The remaining claims are similarly rendered indefinite since they either depend from or independently include the limitations of claims 1 and 7.
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’, as amended are discussed above at length.
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, which is further defined as including a -C(=NH)NHR5 group where R5 is a hydrogen. See e.g., ¶[0020]. Protecting groups are additionally defined as being represented by C1-6 alkyl and C1-6 alkoxycarbonyl groups. See ¶[0060] and ¶[0061]. 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 amendments and remarks directed to the redefinition of the R10 and R10’ variables are acknowledged.
The Examiner, in response, respectfully submits that definitions provided in the reference directed to the protecting groups species continue to read on the instantly amended limitations.
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 remaining claims have been rejected; no claims are allowed.
Conclusion
Applicants’ amendments necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP §706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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