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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the requirement of b is 0,1 to 50, should be corrected as noted in the specification (page 2, line 15) which is 0.1 to 50.
Appropriate correction is required.
Claim Interpretation
The claim 1 requirement of b is interpreted to be 0.1 to 50 mol%
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.
Claims 1, 3-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bartholomew et al. US 2018/0163054 A1 (present on IDS).
Bartholomew discloses polymeric dyes which include a conjugated segment of aryl or heteroaryl co-monomers (abstract).
Regarding claims 1, 3, 6 and 9, Bartholomew teaches (para [0148]) multichromophore comprising conjugated segments having the structure of formula (IIa) as shown below, and where the repeat units can be in a random arrangement (para [0061]).
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Where
Z1 can be fluorescein (para [0225]), and meets claimed FL.
L1 located within the polymer backbone can be an aryl or heteroaryl group and meets the claimed L1.
Both M1 and M2 can be independently aryl or heteroaryl monomers, which correspond to applicant’s MU and AR respectively.
G1 and G2 are independent terminal groups and correspond to applicant’s G1 and G2 (para [0148]).
Bartholomew discloses that G1 and G2 end groups can be a halogen (para [0227] and para [0229]). Bartholomew adds that one of the G1 or G2 can be represented as (end of para [0228]):
-Ar-L3-Z
and at least one end group can terminate in an antibody (Z) (para [0233]), which is an antigen recognizing moiety (instant claim 9).
L3 is the linking group and is depicted as the formula below (paras [0228], [0229], [0429] and [0431]), where q can be 1. Ar-L3 unit situated at the polymer end meets the L2 limitation, and reads on the first structure of instant claim 6.
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Bartholomew adds that mole% of each repeat unit (x, y, w and z) can be 5 mol% or more, overlapping the claimed requirement, where y= required a, z=required b and w +x= required c, and further notes that the monomer repeat units total 100 mol% (para [0148]). Bartholomew discloses that the total number of repeat units can be 2 to 1,000 (para [0053]), meeting the claimed requirement of d.
Bartholomew teaches that both the monomers M1 and M2 can be selected to be the following (para [0190], page 34; claim 25, page 94):
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M1 M2
Where M1 corresponds to the required MU which is a phenylene unit substituted with a C1 haloalkyl (instant claim 3), and M2 corresponds to the required binaphthyl group. Bartholemew differs from the claims in that does not specify connection of its M2 groups through the positions as claimed. However, connection through the aromatic group is disclosed (para [0190], page 34; claim 25, page 94) and it has been held that a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities {see MPEP 2144.09 I.}. Accordingly, it would have been obvious for one having ordinary skill in the art to have attached the M2 groups of Bartholemew to the polymer of Bartholemew through any position in the aromatic group beyond the specifically identified 4,4’ arrangement for the purpose of achieving acceptably developed and useful dyes in order to arrive at the products of applicants’ claims with the expectation of success and that compounds similar in structure will have similar properties in the absence of a showing of new or unexpected results.
Bartholomew recognizes the polyethylene glycol based polymers as water soluble groups (WSG) which provide for increased water-solubility (para [0103]) to the overall polymer. As discussed above, Bartholomew teaches 1,1-binaphthyl monomer which is substituted at the 2,2’ position with polyethylene glycol oligomer, with n=11 via a -CH2- linking group.
Bartholomew further notes that in some cases the water soluble group can be (CH2)3(OCH2CH2)11OCH3 (para [0134]). Bartholomew provides additional structures of aryl based monomers where the water soluble group is connected to the aromatic ring via an ether -O- group, as depicted below (para [0190], page 34; claim 25, page 94).
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Bartholomew further notes that those skilled in the art will be able to devise various arrangements, modifications and changes, which are within the scope of the invention (paras [0524] and [0525]). Thus, for one having ordinary skill in the art an obvious water soluble group derived from the teaching of the Bartholomew would have been where (CH2)3(OCH2CH2)11OCH3 are connected to the 1,1’-binaphthyl monomer at the 2,2’ positions via an ether -O- group (the 2,2’ positions as shown for the M2 structure above). Such a residue meets the structural requirement of formula (III).
Therefore, the invention as claimed is fully within the purview of the Bartholomew and choosing the polymer repeat units corresponding to the required structural configurations would have been obvious with reasonable expectation of achieving adequate results.
Regarding claim 4, Bartholomew teaches (reference claim 18, page 85) that L1, can be aryl or heteroaryl comonomer which can be substituted, and shows that one of the structures can be where a substituted pendant chain is attached to a dye, which meets the claimed requirement.
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Regarding claim 5, as discussed when addressing claim 1, one of end groups G1 or G2 can be Ar-L3-Z or Ph-L-Z (Bartholomew: paras [0228] and [0234], page 49, structure 21) where Ar-L3 has aryl group located at the end of the polymer chain (shown below) and which terminates with an amine functional group.
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Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bartholomew, as applied to claim 1 above and further in view of Wu et al. Macromol. Chem. Phys. 2012, 213, 2238−2245 (present on IDS).
Regarding claim 2, as discussed when addressing claim 1, Bartholomew teaches the recited binaphthyl monomer M2, corresponding to AR, but does not explicitly provide its chirality. Bartholomew notes that changes and modifications may be made by those of ordinary skill in the art (para [0524]), thus encouraging a skilled artisan to look to analogous art such as Wu for further optimization of the conjugated polymer system. Wu teaches
π
conjugated chiroptical polymer which comprise S stereo isomer of the binaphthyl units (abstract). Advantageously Wu provides the motivation to create chiral polymers based on (S) 1,1’-Binaphthyl derivatives, since they provide excelled NIR (near infrared) fluorescence emission and show good anisotropic fluorescence property (Conclusion, page 2243).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have substituted Bartholomew’s 1,1’-Binaphthyl monomer with the S-stereo isomer of 1,1’-Binaphthyl monomer as taught by Wu for the same application of creating a chiral conjugated polymer which has improved fluorescence property.
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.
Claims 1-6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/097,244 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they refer to almost identical conjugated polymer system, where reference application’s MU, MU*, and L correspond to the required MU, L1 and L2 respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on 02/18/2026 have been fully considered, please see the response below.
Applicant’s explanation of the terms: conjugate, polymer modifying unit MU, band gap modifying unit, fluorescent moiety and antigen recognizing moiety is acknowledged and the 112(b) rejection is withdrawn.
With respect to arguments against the 103 rejection over Bartholomew, applicant notes that the reference discloses a vast number of suitable subunits including a 4,4' Binaphthyl group, and the reference provides no technical reason or hint for modifying the 4,4' substitution pattern of the binaphthyl group to a different one.
In response, it is recognized that Bartholomew discloses a number of subunits along with a 4,4’ binaphthyl group, the reference does not limit the connection to the depicted 4,4’ position. Bartholomew highlights that those skilled in the art will be able to devise various arrangements and that structural and functional equivalents are within the scope of the invention (para [0525]). Applicant is reminded that the "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344.
Applicant adds that Bartholomew does not disclose a 1,1’-binaphthyl repeating unit (AR) connected in the polymer main chain, or the fluorescent moieties (FL) or at least two positions of a binaphthyl core substituted with the side chains according to formula (III), or a polymer-modifying unit that is a thiophene or phenylene unit; and L1 and/or L2 and the limitations of G1 and G2 as required by the amended claims.
Examiner disagrees, while Bartholomew does not provide a single embodiment with all the required structural units and configurations, as discussed in the main rejection the claimed limitations are embraced within Bartholomew’s disclosure. The claims are met by simply operating within the broadest teachings of Bartholomew, everything within the reference’s teachings are prima facie obvious. Bartholomew renders the required binaphthyl repeating unit AR, FL, side chains corresponding to formula (III), M1 which can be selected to be substituted phenylene, L1/L2 and G1/G2, obvious. Additionally, Bartholomew discloses light harvesting multichromophore having a conjugated segment of aryl or heteroaryl co-monomers which include branched two or more water soluble polymers, where the signaling choromophores can be fluorescent dyes such as fluorescein (abstract, para 225) which are the same features as discussed by the instant specification.
In the absence of a showing of new or unexpected results, applicant’s arguments against reference Bartholomew are not convincing and applicant’s attention is brought to the following case laws:
If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56.
The rejection of amended claims 1, 3-6 and 9 over reference Bartholomew and of claim 2 over Bartholomew and Wu are maintained.
Conclusion
Applicant's amendment 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 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 Surbhi M Du whose telephone number is (571)272-9960. The examiner can normally be reached M-F 9:00 am to 5:00pm.
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/S.M.D./
Examiner
Art Unit 1765
/JOHN M COONEY/Primary Examiner, Art Unit 1765