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 .
Applicants' arguments, filed March 9, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Comments and Notes
When a claim is canceled, such as previously pending claim 21, no claim text shall be presented for any claim in the claim listing with the status of “canceled”. Therefore the claim amendments filed March 9, 2026 are not properly formatted, which can result in the mailing of a Notice of Non-Compliant Amendment. Please ensure that future claim amendments are properly formatted to avoid that scenario.
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 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. Applicant is 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.
Claim(s) 1, 3, 4, 11, 13 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US 2017/0143852) in view of Rosiuk et al. (Langmuir, May 13, 2019. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that Gao lacks any separate acetic acid group in the polymer. The instant specification at ¶ 263 discloses a synthesis procedure involving acetic anhydride that is lacking in Gao. The rationale provided by the Examiner of various monomers influencing that nature of the polymer by systematically varying the hydrophobicity and charge would modify one of the major moieties of the claimed compounds given the rationale to influence the properties of the polymer. This overlooks the fact that the claims are directed to a polymer with x = 50 – 200 and z = 1 – 3. Following the examiner’s rationale, one would have sought to replace the PDBA [polydibutyl amine] moiety with the MEMA [methyl ether methacrylate] moiety of Rosiuk but that would not have led to the claimed invention and not the particularly claimed values of x and z.
These arguments are unpersuasive. The instant claims are drawn to a product and are not even product-by-process claim. In such a claim, the claimed production process is considered but does not necessarily have to be taught by the prior art in order to render the claim obvious but no product-by-process limitations are present in the claims. The rationale does not argue the addition of the MEMA monomer but rather MAMA (2-acetamidoethyl methacrylate) as shown in scheme 1 of Rosiuk et al., and MEMA was mentioned in the Office Action because data was presented as to the effect of amount of hydrophilicity and fluorescent quantum yield for that specific monomer in the publication. MAMA is also disclosed by Rosiuk et al. as a hydrophilic monomer that can be used in the same manner of MEMA even if not exemplified in the examples. The pH sensitive property of the materials of Gao et al. requires the presence of pH sensitive groups such as the amine of whose hydrophilicity/hydrophobicity changes as the pH changes. The amide containing MAMA would have a different pKa the amine of the matierals disclosed by Gao et al. and would retain a constant charge over the pH range as the amine could change protonation states, allowing for the modulation of the pH insensitive overall log P and also the fluorescent quantum yield but still being pH sensitive to permit changes in fluorescence as a function of pH as discussed in paragraph bridging p 9 and 10 of the Office Action mailed September 8, 2025. Applicants have not pointed to evidence of record as to the criticality of the claimed subscripts and therefore the arguments are unpersuasive as one would seek to optimize the log P and fluorescent quantum yield as a function of pH.
Claim(s) 23, 24, 29, 30, 32 and 40 were rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. and Rosiuk et al. further in view of Ogawa et al. (US 2004/0253315). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
Applicants state that Ogawa is addressed to different claim elements and does not cure the above-noted deficiencies.
As discussed in greater detail above, Gao et al. and Rosiuk et al. are not deficient as alleged by Applicants so Ogawa et al. need not cure the alleged deficiencies of Gao et al. and Rosiuk et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Applicants only mention the nonstatutory double patenting rejection based on US’971 and not the other 4 rejections that are also reiterated below.
Applicants state that the rejection based on US’971 is overcome for the same reasons as above.
As discussed in greater detail above, the arguments regarding Gao et al. and Rosiuk et al. were not persuasive.
Applicant' s failure to argue the rejection on the grounds of non-statutory double patenting over US Patent Nos. 11,013,818 and 11,723,990 is noncompliant with the regulations under 37 C.F.R. 1.111. The instant rejection is not a provisional rejection as the claims of US Patent Nos. 11,013,818 and 11,723,990 have been issued. In the interest of compact prosecution, the Examiner has examined the instant application. However, in order for the response to the instant Office Action to be fully responsive and in compliance with the regulations under 37 C.F.R. 1.111, the Applicant should either file a terminal disclosure or traverse the rejection based on US Patent Nos. 11,013,818 and 11,723,990. Because applicant did not distinctly and specifically point out the supposed errors in the instant non-statutory double patenting rejection based on US Patent Nos. 11,013,818 and 11,723,990 and no Terminal Disclaimer has been filed, the rejection is maintained.
Claims 1, 3, 4, 11, 13, 16, 23, 24, 29, 30, 32 and 40 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 13 of U.S. Patent No. 10,098,971 (this is the patent to issue from the Gao et al. reference used in the obviousness rejections above) in view of Rosiuk et al. (Langmuir, May 13, 2019) optionally further in view of Ogawa et al. (US 2004/0253315). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
Claims 1, 3, 4, 11, 13, 16, 23, 24, 29, 30, 32 and 40 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 25 of U.S. Patent No. 11,013,818 in view of Rosiuk et al. (Langmuir, May 13, 2019) optionally further in view of Ogawa et al. (US 2004/0253315). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
Claims 1, 3, 4, 11, 13, 16, 23, 24, 29, 30, 32 and 40 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 4 of U.S. Patent No. 11,723,990 in view of Rosiuk et al. (Langmuir, May 13, 2019) optionally further in view of Ogawa et al. (US 2004/0253315). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
Claims 1, 3, 4, 11, 13, 16, 23, 24, 29, 30, 32 and 40 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5 - 14 of copending Application No. 17/614,638 in view of Rosiuk et al. (Langmuir, May 13, 2019) optionally further in view of Ogawa et al. (US 2004/0253315). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 4, 11, 13, 16, 23, 24, 29, 30, 32 and 40 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, 10, 12, 13, 23, 26, 28, 51, 52, 55, 58, 74, 78, 80 and 81 of copending Application No. 17/755,671 optionally in view of Rosiuk et al. (Langmuir, May 13, 2019) optionally further in view of Ogawa et al. (US 2004/0253315). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed September 8, 2025 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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