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
Claims 2-3, 10, 13, and 19 are cancelled by Applicant. Claims 1, 4-9, 11-12, 14-18, and 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.
Withdrawn Rejections/Objections
The rejection of claims 1-2 and 4-11 under 35 U.S.C. 112(b) has been withdrawn in response to Applicant’s amendments.
The rejection of claims 1-2 and 4-11 under 35 U.S.C. 102(a)(1) and (a)(2) is withdrawn in response to Applicant’s amendments.
Amended 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 1, 4-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0069606 A1, “TUBULAR NANOSTRUCTURE TARGETED TO CELL MEMBRANE” (published 03/18/2010, referred to herein as Bangera).
Regarding claim 1, “selected to interact with a cluster of differentiation (CD) 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, 9, and 11, Bangera teaches a compound comprising a boron nitride nanotube carrier (para. 0024, lines 1-5). Bangera teaches that the nanotube has a diameter between about 0.5 nm – about 5 nm, which overlaps with the claimed range, and a length between about 1 nm to about 1500 nm, which is encompassed by the claimed ranges (p. 2, col. 1, para. 1, lines 1-10). 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 the recitation of “wherein the BNNT carrier is detectable by laser light scattering”, this is considered to be a functional limitation describing a characteristic of the nanotubes. The nanotubes taught by Bangera are considered capable of this function, i.e. are detectable by laser light scattering, because they comprise all of the claimed physical characteristics of the claimed nanotubes.
Bangera does not teach the full claimed diameter range of 1 and 80 nm; however, it does teach a range of about 0.5 nm to about 5 nm, which overlaps with the claimed range (p. 2, col. 1, para. 1, lines 1-10). It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to pick a diameter value within the range taught by Bangera that overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I): Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions”).
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).
Claims 12, 14-18, and 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). Bangera teaches that the nanotube is a boron nitride nanotube (para. 0024, lines 1-5). As described above regarding claim 1, the nanotubes taught by Bangera are considered capable being detected by laser light scattering because they comprise all of the claimed physical characteristics of the claimed nanotubes. Bangera teaches that the nanotube has a diameter between about 0.5 nm – about 5 nm, which overlaps with the claimed range, and a length between about 1 nm to about 1500 nm, which is encompassed by the claimed ranges (p. 2, col. 1, para. 1, lines 1-10).
Bangera does not teach the full claimed diameter range of 1 and 80 nm; however, it does teach a range of about 0.5 nm to about 5 nm, which overlaps with the claimed range (p. 2, col. 1, para. 1, lines 1-10). It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to pick a diameter value within the range taught by Bangera that overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I): Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions”).
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). Ciravolo teaches detecting the marked EVs with light scattering (p. 659, col. 2, para. 4, lines 11-12).
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.
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 and 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.
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, 4-9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,544,462 in view of Bangera.
Regarding instant claim 1, ‘462 claims a compound comprising a boron nitride 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). ‘462 claims a boron nitride nanotube (claim 2, lines 1-2).
However, ‘462 does not disclose the diameter and length of the boron nitride carrier.
Bangera teaches a boron nitride nanotube with a diameter between about 0.5 nm – about 5 nm, which overlaps with the claimed range, and a length between about 1 nm to about 1500 nm, which is encompassed by the claimed ranges (p. 2, col. 1, para. 1, lines 1-10) for use in affinity-based detection.
It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to make boron nitride nanotubes, as taught by ‘462, of the length and diameter taught by Bangera. This is considered to be Combining Known Elements According to Known Methods to Yield Predictable Results (See MPEP 2143(I)(A)). An artisan would recognize that nanotubes of the size taught by Bangera were predictably usable as linker-bound nanotubes like those that are claimed in ‘462.
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). Bangera teaches that the nanotube has a diameter between about 0.5 nm – about 5 nm, which overlaps with the claimed range, and a length between about 1 nm to about 1500 nm, which is encompassed by the claimed ranges (p. 2, col. 1, para. 1, lines 1-10).
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 on nanotubes of the size 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.
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on page 6 on the rejection under 35 U.S.C. 112, the rejection is withdrawn in response to Applicant’s amendment.
Regarding the remarks on page 6 on the rejections under 35 U.S.C. 102 and 103, Applicant argues that Bangera nor Ciravolo teach the newly claimed features added by Applicant’s amendment.
This argument is not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. In this case, Applicant did not describe how the claimed nanotubes are distinguishable from the nanotubes in the prior art. Further, Bangera in view of Ciavolo does teach the claimed features, as described above under 35 U.S.C. 103.
Regarding the remarks on page 7 over the Double Patenting Rejection, the rejection is being maintained and has been amended in order to account for Applicant’s amendment.
Conclusion
THIS ACTION IS MADE FINAL. 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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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 31, 2026
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