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 .
Election/Restrictions
Applicant’s election without traverse of the species containing boron nitride and carbon nanotubes in claims 1-2 and 4-20 in the reply filed on 11/21/2025 is acknowledged.
Status of the Claims
Claim 3 is withdrawn in response to Applicant’s Election filed 11/21/2025. Claims 1-2 and 3-20 are pending and examined herein.
Priority
This application, filed 02/21/2022, is a 371 of PCT/US2020/047378, filed 08/21/2020, which claims benefit of 62/889,691, filed 08/21/2019, and is a CIP of PCT/US2020/035568 and PCT/US2020/035574, both filed on 06/01/2020. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 08/21/2019.
Information Disclosure Statement
The Information Disclosure Statements filed 02/21/2022, 03/16/2022, and 06/24/2025 are acknowledged and have been considered.
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 1-2 and 4-11 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 “a second linker having a second end connected to the nanomaterial carrier” and “a biomolecule connected to the second end of the second linker”. It is not clear how two separate components of the claimed compound, the nanomaterial carrier and the biomolecule, would be connected to the same end of the second linker. For purposes of compact prosecution, the claims will be interpreted to mean that the carrier is connected to the first end of the linker and the biomolecule is connected to the second end of the linker, consistent with Figure 1A of the application; however, appropriate correction is required.
Claim 1 further recites “the biomolecule is configured to connect to a cluster of differentiation”; however, it is not clear how the generic biomolecule “is configured to connect to” its target. There are a variety of mechanisms by which a biomolecule could be configured to connect to a target, including van der waals interaction, polar/non-polar interactions, covalent interaction, non-covalent interaction, physical interaction, protein-ligand interaction, etc. For purposes of compact prosecution, this will be interpreted to mean antibody or aptamer-based ligand interaction, consistent with embodiments in the specification; however, appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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.
Claim 1-2, and 4-11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2010/0069606 A1, “TUBULAR NANOSTRUCTURE TARGETED TO CELL MEMBRANE” (published 03/18/2010, referred to herein as Bangera).
Regarding claim 1, “configured to connect to a cluster of differentiation of an extracellular vesicle” is considered an intended use of the biomolecule. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and a further limitation merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then that limitation is not considered a limitation of significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, for example, any antibody would be considered to be capable of binding to a cluster of differentiation of an extracellular vesicle, regardless of whether it is explicitly disclosed whether it is being used to bind to a cluster of differentiation of an extracellular vesicle.
Regarding claims 1, 2, and 9-11, Bangera teaches a compound comprising a boron nitride nanotube carrier (para. 0024, lines 1-5). Bangera teaches the compound comprises a fluorescent entity (para. 0090, lines 1-4) and an antibody (para. 0067, lines 1-2). Bangera teaches that the nanotube is functionalized by linkers, such as DSPE-PEG2000 (para. 0046, lines 15-27), to connect components to the nanotube.
Regarding claims 4 and 5, Bangera teaches that the nanotube is functionalized by linkers via covalent binding (para. 0047, lines 1-4) through the use of functional groups (para. 0048, lines 1-3).
Regarding claim 6, Bangera teaches the covalent binding of biomolecules to the nanotube (para. 0048, lines 8-9).
Regarding claims 7 and 8, Bangera teaches non-covalently binding the linker to the nanotube (para. 0046, lines 1-5). Bangera teaches the linker is amphiphilic and that the hydrophobic region is non-covalently bound to the surface of the nanotube (para. 0046, lines 1-5).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bangera in view of Ciravolo et al., “Potential Role of HER2-Overexpressing Exosomes in Countering Trastuzumab-Based Therapy” Journal of Cellular Physiology (published 04/04/2011, referred to herein as Ciravolo).
Regarding claim 12, Bangera teaches a method of detecting tumor cells comprising linking a fluorescent marker and an antibody configured to target HER-2 to a nanotube (para. 0179, lines 1-6), connecting the nanotube compound to the target cells, and detecting the marked target with fluorescent imaging (para. 0178, lines 3-10).
Regarding claim 13, Bangera teaches that the nanotube is a boron nitride nanotube (para. 0024, lines 1-5).
Regarding claim 14, Bangera teaches that the nanotube is functionalized by linkers via covalent binding (para. 0047, lines 1-4) through the use of functional groups (para. 0048, lines 1-3).
Regarding claim 15, Bangera teaches the covalent binding of biomolecules to the nanotube (para. 0048, lines 8-9).
Regarding claims 16 and 17, Bangera teaches non-covalently binding the linker to the nanotube (para. 0046, lines 1-5). Bangera teaches the linker is amphiphilic and that the hydrophobic region is non-covalently bound to the surface of the nanotube (para. 0046, lines 1-5).
Regarding claims 18-20, Bangera teaches that the boron nitride nanotube is functionalized by linkers, such as DSPE-PEG2000 (para. 0046, lines 15-27), to connect components to the nanotube.
However, Bangera does not teach a method of using the nanotube compound to detect extracellular vesicles (claim 12).
Ciravolo teaches that HER-2 is expressed on extracellular vesicles released from cancer cells (p. 659, col. 1, para. 1, lines 24-26). Ciravolo teaches that measuring HER-2 exosome levels is important to determine whether a HER-2 positive breast cancer patient is likely to benefit from Trastuzumab treatment (p. 664, col. 1, para. 2, lines 13-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of HER-2 expressing tumor cell detection taught by Bangera by detecting HER-2 expressing exosomes as taught by Ciravolo. An artisan would have been motivated to make this modification because, as taught by Ciravolo, measuring HER-2 exosome levels is important to determine whether a HER-2 positive breast cancer patient is likely to benefit from Trastuzumab treatment (p. 664, col. 1, para. 2, lines 13-17). An artisan would have had a reasonable expectation of success in making this change because, as taught by Ciravolo, the target exosomes express HER-2 and the nanotube compound taught by Bangera is intended to detect HER-2 on lipid membranes, such as those of exosomes.
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 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11 of U.S. Patent No.12,544,462 (referred to herein as ‘462). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound claimed by ‘462 is a species of the genus claimed by the instant application. In this case, the compound of ‘462 anticipates the claimed compound in the instant application.
Regarding instant claim 1, ‘462 claims a compound comprising a nanomaterial carrier (claim 1, line 2), a first linker connected to the carrier (claim 1, line 3), a second linker connected to the carrier (claim 1, line 4), a fluorescent entity connected to the first linker (claim 1, line 7), and a biomolecule configured to connect to a cluster of differentiation, i.e. a biomarker, connected to a linker (claim 1, lines 14-15).
Instant claim 2 is disclosed by ‘462 claim 2.
Instant claim 3 is disclosed by ‘462 claim 3.
Instant claim 4 is disclosed by ‘462 claim 4.
Instant claim 5 is disclosed by ‘462 claim 5.
Instant claim 6 is disclosed by ‘462 claim 6.
Instant claim 7 is disclosed by ‘462 claim 7.
Instant claim 8 is disclosed by ‘462 claim 8.
Instant claim 9 is disclosed by ‘462 claim 9.
Instant claim 11 is disclosed by ‘462 claim 11.
Claims 1-2 and 4-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17,615,441 (referred to herein as ‘441) in view of Bangera.
Regarding claims 1-2 and 4-6 of the instant application, ‘441 claims a compound comprising a boron nitride nanotube, a fluorescent entity covalently linked to the nanotube with a linker, and a second linker covalently attached to the nanotube (‘441 claim 1).
‘441 does not disclose a biomolecule configured to connect to a CD attached to the second linker.
Bangera teaches attaches a biomolecule configured to connect to a CD to a boron nitride nanotube (para. 0067, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound disclosed by ‘441 by attaching a biomolecule to the linker as taught by Bangera. An artisan would have been motivated to make this modification with a reasonable expectation of success because, as taught by Bangera, compounds with fluorescent moieties and biomolecules covalently attached to boron nitride nanotubes are useful for the detection of biomarkers (Bangera para. 0178, lines 1-10).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 February 18, 2026