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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/2026 has been entered.
Status of Claims
Claims 1-2, 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 Claim 37 is withdrawn.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.
Withdrawn Objection
In light of the amendments, the objection is hereby withdrawn.
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 10-17 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.
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, Fig. 4 and Fig. 7B). 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]-[0193]). 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 teaches amino acids such as lysine, ornithine have sidechain amino groups suitable for conjugation with an amino-reactive group such as an activated carboxyl acid and cysteine includes a sidechain thiol group suitable for conjugation with a thiol-reactive group such as a maleimide or a haloacetyl (see para. [0188]).
Bartholomew does not exemplify Fig. 4 with an internal pendant sensor (claim 1), Fig. 4 with a non-amino acid spacer (claims 6-9), and the claimed formula of claims 18-19.
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 modified Fig. 4 with an internal pendant sensor because Bartholomew teaches X (i.e., D) is also a sidechain-linked first chemoselective tag (i.e., a pendant sensor). Also, it would have been obvious to have an antibody or chemoselective tag sensor with PEG spacer together in the polypeptide segments because Bartholomew teaches in Fig. 7B to incorporate PEG spacer as part of the backbone to the donors and acceptors.
Additionally, it would have been obvious to have modified Fig. 4 to produce the claimed formula of claim 18 with the recognition that 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]-[0193]), as taught by Bartholomew because Bartholomew recognizes suitable conjugate at specific amino acid residues (see para. [0188]) and teaches different combinations of species with chemoselective tags, donor chromophores, and acceptor fluorophores on a tandem dye for assays.
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) (of record) in view of Bartholomew et al. (US20200392346A1, published 12/17/2020).
Patent No. ‘228 recites the formula:
PNG
media_image1.png
322
446
media_image1.png
Greyscale
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) (of record) 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 08/11/2026 have been fully considered but they are not persuasive. In view of the amendments, the rejections have been modified.
Arguments under 102 rejection, Applicant argues pages 7-8 that claim is amended to state that the peptidic scaffold comprises a single internal amino acid residue conjugated to a pendant sensor. Meanwhile, Applicant contends that the cited passages in Bartholomew fail to teach a tandem dye as recited in claim 1.
The arguments are not found persuasive because paras. 189-193 of Bartholomew disclose different combinations of species which would read on the claimed invention. Bartholomew teaches all of its species for tandem dyes. Meanwhile, a list of species would be anticipated if one or more species have all the claimed structures as the instant claims. For example, the species of a XY(X)nYX segment wherein n is 2, wherein Xs are sidechain linked pendent donor chromophores, one (1) Y is a sidechain linked pendent acceptor chromophore, and the other Y is a chemoselective tag (i.e., reads on the structure of a pendant sensor). Meanwhile, the claimed phrase "pendant sensor" is not explicitly defined in the specification. Additionally, the claim recites that the peptidic scaffold is COMPRISING and the tandem dye is COMPRISING (open-ended recitations). Therefore, the claim encompasses a plurality of segments.
Arguments under 103 rejection, Applicant argues on pages 11-12 that the present claims would not been obvious in view of the cited embodiments in Bartholomew because it is clear the size of the genus must be considered in making an obviousness determination.
The arguments are not found persuasive because paras. 189-193 and Fig. 4 of Bartholomew are NOT a genuses but rather species that have different combinations of a single acceptor-fluor conjugated to a pendant acceptor fluorophore, a plurality of donor-fluor amino acid, and implies an addition of a pendent sensor (e.g., chemoselective tag).
For example, the species of a XY(X)nYX segment wherein n is 2, wherein Xs are sidechain linked pendent donor chromophores, one (1) Y is a sidechain linked pendent acceptor chromophore, and the other Y is a chemoselective tag (i.e., reads on the structure of a pendant sensor). Meanwhile, the claimed phrase "pendant sensor" is not explicitly defined in the specification.
Arguments under nonstatutory double patenting rejections, Applicant argues on pages 12-13 that the rejections should be withdrawn for '228 and '688 in view of the arguments above. The arguments are not found persuasive for the reasons stated above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAM P NGUYEN whose telephone number is (571)270-0287. The examiner can normally be reached Monday-Friday (8-4).
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, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
