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 without traverse of Group I, claims 1-16, in response to restriction requirement is acknowledged. In response to election of species requirements, Applicant elected the followings:
A polymer comprising monomer units of formula A and monomer units of formula B; wherein the monomer units of formula A is
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wherein X is the number of monomer units of formula A in the polymer wherein the monomer units of formula A are consecutive or nonconsecutive and X is from 10 to 200, and A is N; SG1 and SG2 are each methyl; R1 is non-existent; and R2 is
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, and wherein the monomer units of formula B is
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Y is the number of monomer units of formula B in the polymer wherein the monomer units of formula B are consecutive or nonconsecutive and Y is from 0 to 100, and SG3 and SG4 are each independently a PEG, a fluoro a linker (L), or an acceptor; R3 and R4 are each hydrogen, such that the elected polymer species comprises units of formula B that are selected from
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and more specifically, the polymer has a structure comprising the following combinations of formulas A and В:
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Note that SG3 and SG4 are elected as independently a PEG, a fluoro, a linker or an acceptor. But however, claim 1 recites SG3 and SG4 independently a hydrogen, a halogen, an amino, a PEG, a linker (L) and/or a biological substrate conjugated via a linker (L-BS) and “an acceptor” has not recited for SG3 and SG4. Therefore, recited acceptor of claim 16 is directed to SG1, SG2, or R1, for which Applicant elected alkyl and non-existence. Therefore, claim 16 does not read on the elected specie. Moreover, the above election also does not read on claims 8-9, 11 and 14. Therefore, claims 1, 3-7, 10, 12, 13 and 15 of the elected group read on the elected species.
Examiner searched prior arts with the scope of the elected species and found arts that renders the claimed polymer obvious when the search was expanded beyond the scope of the elected species and therefore, claims 8-9, 11, 14, 16 and non-elected subject matter of claims 1-7, 10, 12, 13, and 15 (i.e. all other non-elected substitution groups) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention. See MPEP 803.02. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1, 3-7, 10, 12, 13 and 15 are examined on merits in this office action.
Claim Objections
Claims 6, 13, and 15 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, 3-7, 10, 12, 13 and 15 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 “X is from 10 to 200” and also recites X+Y=Z is 15 to 50. It is unclear when X is 50 or more than 50 (the range 10-200, allows 50 or more), how can X+Y be within the range of 15-50 as the polymer comprises one or more monomer units of formula B. Further, the recitation “one or more monomer of formula B” requires Y to be at least 1 but however, claims 1 and 10 recites Y is from 0 to 100, which is conflicting with the recitation “one or more monomer units of formula B” because when Y is 0, formula B unit will be absent.
Claim 1 recites R1 is …….an acceptor”. It is unclear what is intended to encompass by the term :acceptor”? Acceptor of what?
Claim 4 recites “wherein the monomer units of formula A, B and C, if present are directly connected to each other. It is unclear what is intended by the recitation “if present” because from the recitation of claim 1, both formula A and formula B must be present and only formula C is optional. Thus the “if present” recitation makes it confusing as to whether the formula A or formula B can be absent or not.
Claim 7, step (v) recites “a hydrogen, an alkyl, a halogen, a boronyl, an aryl, a heteroaryl group or a L-BS”. It is unclear the recited groups are intended for what substitution group in the polymer?
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 of this title, 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, 3-7, 10 and 13 are rejected under 35 U.S.C. 103 as obvious over Diwa et al. (US 2017/0275418A1).
In regards to claim 1, Diwa discloses a polymer having the formula
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The above formula makes obvious of the polymer comprising monomer units of formula A and one or more monomer units of formula B of claim 1. In the above formula, y and z can be 0 (paragraph [0014]) and when z is 0, the formula reads on
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where x is an integer from 6-100 (para [0014]). Diwa teaches that HG1 and HG2 independently represent aryl among other substitution (para [0014] and [0024]), which provides the units
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linked to one or more aryl. Diwa teaches that “aryl” includes phenyl (para [0177]). Diwa teaches that the SG1 and SG1 independently represent an alkyl, and R1-R4 independently represent hydrogen, an alkyl, a PEG of a linker (para [0014). Diwa teaches that the ratio of x/(y+z) is >1 and x+y+z is >10 (para [0014]). Therefore, from the above selection of the substitution groups, the polymer of claim 1 would be in the possession of public at the time of the invention and would be obvious to one of ordinary skilled in the art.
In regards to claim 4, as described above , the formula of Diwa provides directly connected monomer units.
In regards to claims 3 and 5, Diwa teaches various fluorophores, as for example, fluorescein, rhodamines, cyanines, bodipy or other polycyclic aromatics ([0046], [0058-0061]) with the polymeric composition and teaches one or more fluorophores (para [0106]) and thus polymers with various excitation peak including close to 350nm and various polymer to fluorophore ratio would be obvious to one of ordinary skilled in the art. Moreover, it has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971 ). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 6 and 7, Diwa teaches that R1-R4 con be a biological substrate conjugated via a linker L-BS wherein the linker may comprise PEG, carboxamide or a thioether (para [0010]).
In regards to claim 10, Diwa teaches that “aryl” includes phenyl (para [0177]) and as described above, Diwa teaches HG1 and HG2 independently represent aryl among (para [0014] and [0024]), which provides the units
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linked to one or more phenyl. The formula B differs from “aryl” by having alkyl substitution (when SG3, SG4, R3 and R4 are all alkyl) in place of hydrogen . However, It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963).
In regards to claim 13, Diwa teaches SG6 is fluorophore (FP) (para [0013]) and the fluorophores can be selected from various fluorophores such as fluorescein, cyanine and others (para [0058-0061]).
Claims 1, 3-7, 10, 13 and 15 are rejected under 35 U.S.C. 103 as obvious over Diwa et al. (US 2017/0275418A1) in view of Gaylord et al (WO 2008/100344; cited in the IDS filed 7/15/2022).
Diwa has been applied above that provides obviousness of the polymers recited in claims 1, 3-7, 10, and 13.
Diwa as described above teaches aryl, as for example a phenyl group for formula B but however, does not disclose PEG linker with the phenyl group as claimed in claim 15.
However, Diwa teaches PEG linkers with the bridged fluorene group.
Gaylord throughout the reference, teaches conjugated polymer comprising fluorene and phenyl group wherein the phenyl group comprises PEG linker having a functional group useful for conjugation (pages 53-56).
Therefore, it would be obvious to one of ordinary skilled in the art to easily envisage providing PEG linker having functional group to aryl group of the conjugated polymer of diwa with the expectation of providing diwa with a linker useful for conjugation with a reasonable expectation of success. One of ordinary skilled in the art would consider the linker having PEG group because Gaylord teaches the PEG linker for conjugation and the linker having PEG would provide water solubility to the polymer.
Allowable Subject Matter
Claim 12 is free of prior art but are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678