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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Status of Claims
Claims 1-2 and 4-19 and 37 are pending. Claim 37 is withdrawn. Claims 3, 20-36 and 38-94 are canceled. Claims 1-2 and 4-19 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 6, recites “residues each” (emphasis added) should be – residue –, as it only has a single residue. Appropriate correction is required.
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.
Claims 1-2, 4-5 and 10-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bartholomew et al. (US20200392346A1, published 12/17/2020, IDS submitted 7/25/2023, cite no. 14).
Bartholomew teaches polymeric tandem dyes based on the subject multichromophores are provided that further include an acceptor fluorophore linked to a non-conjugated repeat unit of the polymeric backbone and configured in energy-receiving proximity to a pendant donor chromophore group and also provided labelled specific binding members (see abstract). Bartholomew teaches formulas (VI) and (VII) (see paras. [0180]-[0187]). Note that the instant specification indicates that donor and acceptor fluorophores can both be BODIPY group (see pgs. 24 and 26). Because Bartholomew’s pendant donor fluorophores (BOPDIY) have all the chemical structures of the donor and acceptor fluorophores, formulas (VI) and (VII) would read on the claimed pendant fluorophores. Bartholomew also teaches in formula (VIa) a polymeric tandem dye includes a dye comprising a peptidic scaffold comprising two pendent donor chromophore groups, an acceptor chromophore (see para. [0375]). Bartholomew teaches D1 can be linked to an amino acid sidechain linker L1 (see second para. [0187] and para. [0191]). Bartholomew teaches the polymeric backbone of the multichromophore with the following poly-peptide sequence segments wherein X is a first amino acid residue having a sidechain-linked first chemoselective tag, or a sidechain-linked pendant donor chromophore and Y is a second amino acid residue having a sidechain-linked second chemoselective tag, or a sidechain-linked pendant acceptor fluorophore (see paras. [0189]-[0192]), which would also read on donor and acceptor fluorophores of the fluorescently labeled molecular entity are in energy transfer relationship. Bartholomew further teaches the addition of a third type of amino acid residue (Z) can be incorporated into the polymeric backbone wherein the residue having a chemoselective functional group suitable for selective installation of an additional moiety of interest such as a linked biomolecule (see para. [0194]). Because the pendant sensor has not been defined in the specification, the chemoselective functional group or linked biomolecule reads on the structure of a pendant sensor.
With respect to claim 2, Bartholomew teaches the polypeptide sequence segments (see table of paras. [0187] and [0189]), which would read on the peptidic scaffold comprises donor-fluor amino acid residues. Bartholomew also teaches said formula (VIa) having n and p are each independently an integer from 1 to 20 and m is 1 (see para. [0379]).
With respect to claim 3, Bartholomew teaches the polypeptide sequence segments (see table of para. [0189]), which would read on the peptidic scaffold comprises a single acceptor-fluor amino acid residue. Bartholomew also teaches said formula (VIa) having m is 1 (see para. [0379]).
With respect to claim 4, Bartholomew teaches the polypeptide sequence segments (see table of para. [0189]), which would read on the number of donor-fluor amino acid residues within the claimed range.
With respect to claim 5, Bartholomew teaches the polypeptide sequence segments (see table of para. [0189]), which are within the range of 2 to 1000.
With respect to claim 10, Bartholomew further teaches the addition of a third type of amino acid residue (Z) can be incorporated into the polymeric backbone wherein the residue having a chemoselective functional group suitable for selective installation of an additional moiety of interest such as a linked biomolecule (see para. [0194]).
With respect to claims 11-13, Bartholomew teaches the biomolecules of interest are polypeptides and antibody or fragment thereof (see para. [0427]).
With respect to claim 14, Bartholomew teaches D1 is a pendant BODIPY donor chromophore.
With respect to claim 15, Bartholomew teaches in formula (Xa) WSG is a water solubilizing group indirectly covalently bonded to a donor fluorophore (see para. [0398]). Note that the WSG would also read on pendant sensor.
With respect to claim 16, Bartholomew teaches acceptor fluorophore is dipyrromethene borondifluoride (i.e., BODIPY) (see paras. [0328]-[0329]).
With respect to claim 17, Bartholomew teaches in formula (Xa) WSG is a water solubilizing group indirectly covalently bonded to an acceptor fluorophore (see para. [0398]). Note that the WSG would also read on pendant sensor.
With respect to claim 18, Bartholomew teaches the polypeptide sequence segments (see table of para. [0189]) which may include o and p as zeros. Because the polymeric backbone is a peptide backbone (as claimed) and the tandem dye is open-ended (having), the peptide segments would read on Bartholomew’s peptide segments with chemoselective tag, donor chromophore and acceptor chromophore. Note that the instant specification indicates that donor and acceptor fluorophores can both be BODIPY group (see pgs. 24 and 26).
With respect to claim 19, Bartholomew teaches l is greater than n (see paras. [0379]-[0380]).
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 1-2 and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bartholomew et al. (US20200392346A1, published 12/17/2020, IDS submitted 7/25/2023, cite no. 14).
Bartholomew teaches polymeric tandem dyes based on the subject multichromophores are provided that further include an acceptor fluorophore linked to a non-conjugated repeat unit of the polymeric backbone and configured in energy-receiving proximity to a pendant donor chromophore group and also provided are labelled specific binding members (see abstract). Bartholomew teaches formula (VI) and formula (VII) (see paras. [0180]-[0187]). Bartholomew further teaches in formula (VIa) a polymeric tandem dye includes a dye comprising a peptidic scaffold comprising two pendent donor chromophore groups, an acceptor chromophore (see para. [0375]) which would also read on donor and acceptor fluorophores of the fluorescently labeled molecular entity are in energy transfer relationship. Bartholomew teaches L1 and L2 are linkers (see para. [0378]). Bartholomew teaches D1 can be linked to an amino acid sidechain linker L1 (see second para. [0187] and para. [0191]). Bartholomew teaches the polymeric backbone of the multichromophore wherein K is lysine residue covalently linked via to the pendant donor chromophore group (see para. [0196]). Note that the instant specification indicates that donor and acceptor fluorophores can both be BODIPY (see pgs. 24 and 26).
Additionally, Bartholomew teaches the water-soluble polymer can include one or more spacers or linkers (see para. [0298]). Bartholomew teaches the light harvesting multichromophore includes a modular scaffold that has a linear polymeric backbone of non-conjugated repeat units and the modular scaffold can have a polymeric backbone including a particular defined sequence of non-conjugated repeat units, e.g., amino acid residues of a polypeptide sequence and by non-conjugated is meant that at least a portion of the repeat unit includes a saturated backbone group and extended delocalized electronic structure along the polymeric backbone from one repeat unit to the next (see paras. [0071]-[0072]). Bartholomew teaches the light harvesting multichromophore includes a polymeric backbone of non-conjugated repeat units wherein S1 and S2 are spacer units and independently has a PEG spacer (see para. [0083]). Bartholomew teaches the specific binding member is a polypeptide or IgG antibody (see para. [0421]). Bartholomew teaches in formula (VII) that Z1 groups can be further conjugated to a molecule of interest via a second chemoselective tag (Z2) to install a pendant group such as a linked biomolecule (see para. 2 of para. [0187]). Bartholomew teaches the polymeric backbone of the multichromophore with the following poly-peptide sequence segments wherein X is a first amino acid residue having a sidechain-linked first chemoselective tag, or a sidechain-linked pendant donor chromophore and Y is a second amino acid residue having a sidechain-linked second chemoselective tag, or a sidechain-linked pendant acceptor fluorophore (see paras. [0189]-[0192]). Bartholomew further teaches the addition of a third type of amino acid residue (Z) can be incorporated into the polymeric backbone wherein the residue having a chemoselective functional group suitable for selective installation of an additional moiety of interest such as a linked biomolecule (see para. [0194]). Bartholomew teaches the biomolecules of interest are polypeptides and antibody or fragment thereof (see para. [0427]).
Bartholomew does not exemplify the peptide segments or formulas (VI), (VIa), (VII), and (VIIa) comprising a non-amino acid spacer (claims 6-9) with the pendant sensor (claims 18-19, L4, p is 1).
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated an antibody sensor and PEG spacer together in the polypeptide segments because Bartholomew teaches the sidechains have chemoselective tags for conjugation biomolecules of interest through the spacer (Z) linking peptide segments and PEG spacer has been recognized by Bartholomew as a saturated spacer that precludes pi-conjugation and has an extended delocalized electronic structure along the polymeric backbone from one repeat unit to the next.
Claims 2-5 and 10-17 have been discussed in the above rejection.
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 1-2 and 4-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-20 of U.S. Patent No. 10844228B2 (‘228) in view of Bartholomew et al. (US20200392346A1, published 12/17/2020).
Patent No. ‘228 recites the formula:
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322
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Note that Z is a chemoselective tag which would read on the claimed pendant sensor. Patent claim 14 further recites that the polymeric tandem comprises pendant donor chromophore groups and an acceptor fluorophore linked to a non-conjugated repeat unit of the polymeric backbone.
Patent No. ‘228 does not explicitly recite a pendant acceptor fluorophore in the formula (claim 1) and a non-amino acid spacer with pendant sensor (claims 6-9 and 18-19).
Bartholomew has been discussed above. It would have been obvious to the person at the time of the filing date to have replaced a donor fluorophore of the Patent with an acceptor fluorophore of Bartholomew because Bartholomew teaches the polymeric tandem dyes include an acceptor fluorophore to configure in energy-receiving proximity to a pendant donor chromophore group. Additionally, it would have been obvious to have incorporated an antibody sensor and PEG spacer together in the polypeptide segments because Bartholomew teaches the sidechains have chemoselective tags for conjugation biomolecules of interest through the spacer (Z) linking peptide segments and PEG spacer has been recognized by Bartholomew as a saturated spacer that precludes pi-conjugation and has an extended delocalized electronic structure along the polymeric backbone from one repeat unit to the next.
With respect to instant claims 2-5, Patent claim 11 recites n and p each independently an integer from 1 to 20 which is within the claimed ranges.
With respect to instant claims 18-19, the Patent formula does not recite R1 and R3 which are polymer segments. However, it would have been obvious to have added a polymer segment having a peptide backbone because Patent claim 13 recites different amino acid sequences having polymer segments.
Claims 1-2 and 4-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11214688B2 (‘688) in view of Bartholomew et al. (US20200392346A1, published 12/17/2020).
Patent No. ‘688 recites a multichromophore comprising a polypeptide backbone and a plurality of pendant donor chromophores each independently linked to an amino acid residue of the polypeptide backbone. Patent claim 6 recites the polypeptide comprises first, second, and third amino acid residues. Patent claim 7 recites the first amino acid residue is linked to a donor chromophore, the second amino acid residue comprises a sidechain-linked second chemo-selective tag and the third amino acid residue comprises a spacer residue.
Patent No. ‘688 does not explicitly recite a pendant acceptor fluorophore in the formula (claim 1) and a non-amino acid spacer with pendant sensor (claims 6-9).
Bartholomew has been discussed above. It would have been obvious to the person at the time of the filing date to have replaced a donor fluorophore of the Patent with an acceptor fluorophore of Bartholomew because Bartholomew teaches the polymeric tandem dyes include an acceptor fluorophore to configure in energy-receiving proximity to a pendant donor chromophore group. Additionally, it would have been obvious to have incorporated an antibody sensor and PEG spacer together in the polypeptide segments because Bartholomew teaches the sidechains have chemoselective tags for conjugation biomolecules of interest through the spacer (Z) linking peptide segments and PEG spacer has been recognized by Bartholomew as a saturated spacer that precludes pi-conjugation and has an extended delocalized electronic structure along the polymeric backbone from one repeat unit to the next.
With respect to instant claims 2-5, Patent claim 2 recite the polypeptide backbone comprises 2 to 200 amino acid residues. Because the Patent claim 2 recites a range of amino acid residues that overlaps with the claimed range, it would be prima facie obvious to have a tandem dye having the claimed amino acid range.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive.
35 U.S.C. 102(a)(1) rejection:
Applicant argues at pages 7-8 that when paragraph 194 discussed the Z amino acid residue, it is the context of incorporating it between two segments references in the previous paragraph. As can be seen above, each of the disclosed segments includes an acceptor (Y residue), As such, when cited paragraph 194 discusses inclusion of a Z residue, it is the context of embodiments with two segments and therefore at least two acceptor fluorophores, since each segment includes at least one Y residue.
The arguments are not found persuasive for the following reasons. First, paragraph 192 recites that Y can either be a chemoselective tag or an acceptor fluorophore. Although there are two segments, Y does not have to be exclusively acceptor fluorophore as disclosed by paragraph 192 (reproduced at page 8 of Remarks). Second, paragraph 194 is one of many embodiments in the reference. Thus, the compound does not be restricted to only paragraph 194. Third, as stated in the rejection above, Paragraph 187 the reference teaches that at Z1 group it can be further conjugated to molecule of interest via a second chemoselective tag (Z2) to install a pendent group such as acceptor fluorophore. Therefore, the rejection is maintained.
35 U.S.C. 103 rejection:
Applicant argues that Bartholomew fails to disclose at least the claim elements of an internal amino acid residue conjugated to a pendant sensor and a single acceptor fluorophore. Nor does Bartholomew suggest this claim element because Bartholomew only discloses the Z amino acid residue in the context of backbones made up of two or more segments each having at least one acceptor fluorophore.
The arguments are not found persuasive because a pendant sensor does not have to exclusively be a biomolecule. As stated in the rejection above, Paragraph 187 the reference teaches that at Z1 group it can be further conjugated to molecule of interest via a second chemoselective tag (Z2) to install a pendent group such as acceptor fluorophore. Thus. A molecule of interest via a second chemoselective tag would read on a pendant sensor. Therefore, the rejection is maintained.
Non-statutory double patenting rejection:
Applicant argues that Patent ‘228 and ‘668 lack at least the elements of an internal amino residue conjugated to a pendent senor and a single acceptor fluorophore.
The arguments are not found persuasive for the reasons stated above. Bartholomew does teach a pendent senor and a single acceptor fluorophore.
Conclusion
No claim is allowed.
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.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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