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 .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Restriction/Election
Applicant’s election of Group I, claims 1-10, in response to restriction/election requirement is acknowledged. Applicant’s election of single species for the components of formula (I) is also acknowledged. Since Applicant did not traverse the restriction/election requirement, the election has been treated as an election without traverse.
Therefore, claims 11-12 are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1-10 are examined on merits in this office action.
Claim Objections
Claims 1, 5, 7 and 10 are objected to for not being in proper Markush format. A Markush claim is commonly formatted as: “selected from the group consisting of A, B, and C”. When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper (MEPP § 2173.05).
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 1-10 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.
Claim 1 recites Mu is a band gap modifying unit that is evenly or randomly distributed along the polymer main chain. MU has not been clearly defined in the specification and the structure and connectivity of Mu to Ar has not been clearly defined in the claim and the drawn line from Ar to Mu does not provide any clear indication regarding the types of connection and bonding to Ar capable of functioning as band gap modifying unit.
Claim 6 and 7 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. Claims 6 and 7 are dependent on claim 1 and are directed to the nature of “L”. However, claim 1 from which the claims are dependent on, does not recite “L” or the general formula (I) as drawn, do not disclose L. Thus, it is unclear what structure the claims are intended to refer by “L” in the claims.
Claim 5 discloses compounds with star symbol on either side. It is unclear what that star symbol indicates. It they are intended for attachment point to Ar and G2, the claim should clearly recite so to particularly pointing out an distinctly claiming the subject matter which the applicant regards as his invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 9 and 10 are rejected under 35 U.S.C. 102(a1) as being anticipated by Odaka et al. (Chem. Lett. 2017).
Odaka disclosed a conjugate comprising anti-BN antibody (i.e. an antigen recognition moiety) and a binitrophenyl derivative :
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wherein
the binitrophenyl derivative
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is
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. The conjugate reads on the general formula (I) of claims 1-3, 9 and 10, with the followings:
G1 is antigen recognition moiety (that above antibody reads on this), Ar is binaphthayl as claimed, Mu is absent (when b=0 mol%, a=100mol%, c=1), L is present and comprising alkyl (see claim 2), and G2 is hydrogen.
In regards to claims 4 and 5, the claims do not limit the conjugate comprising at least one MU unit but only described regarding the structures of MU and thus still can be absent (when b is 0). Thus, claim 4 and 5 are rejected based on b=0 as described above.
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 1-2 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bartholomew et al (US 20180163054).
Bartholomew discloses polymeric dyes which include a conjugated segment of aryl or heteroaryl co-monomers (abstract).
Regarding claims 1-2, 4-5 and 7-10, 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]), 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 7.
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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 does not teach the conjugate comprising ethylene oxide moiety as claimed in claims 1 and claim 8 having the compound having formula (III).
However, Bartholomew teaches 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 6, 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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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bartholomew et al (US 20180163054), as applied to claims 1-2 and 4-10 above and further in view of Wu et al. (Macromol. Chem. Phys. 2012, 213, 2238−2245).
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 1-10 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.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/015351 (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.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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