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
Summary
This is the Final Office action based on the 17/615411 election response filed 03/04/2026.
Claims 1, 3, 5, 7-8 & 11-25 are pending.
Claims 1, 3, 5, 7-8 & 21-25 are pending and have fully been fully examined.
Claims 11-20 are withdrawn.
Claims 2, 4, 6, 9-10 are cancelled.
Claims 21-25 are newly added.
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, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No 17/637018. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘018 application claims:
A compound, comprising: a nanomaterial carrier; a first linker having a first end connected to the nanomaterial carrier; a second linker having a second end connected to the nanomaterial carrier; a fluorescent entity connected to a second end of the first linker; and a biomolecule connected to a second end of the second linker, wherein the biomolecule is configured to connect to a cluster of differentiation (CD) of an extracellular vesicle (EV). (See Claim 1). It further claims that the nano material is a boron nitride nanotube (Claim 2). This anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No 17/765310. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘310 application claims:
A compound, comprising: a boron suites Carrier; a first linker having a first end connected to the carrier; a second linker having a first end connected to the carrier; a third linker having a first end connected to the carrier; a linker having a first end connected to the carrier, a first fluorescent entity connected to a second end of the first linker; a second fluorescent entity different from the first fluorescent entity connected to a second end of the second linker, wherein the biomolecule is configured to connect to biomarker. Claims 4-6, require that the bonding is covalent. This anticipates instant claims 1-2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 non-obviousness.
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, 3, 5, 7-8 & 21-25 are rejected under U.S.C. 103 as being obvious over BANGERA in US 20100069606 in view of in view of LUNDORF in US 20180298154.
With respect to Claim 1, BANGERA is used to remedy this and teaches of tubular nanostructures/methods of forming them (abstract & paragraph 0006).
BANGERA further teaches of a compound comprising a boron nitride nanotube carrier (paragraph 0007, 0011, 0024), and that the nanotubes can include a fluorescent marker attached to the nanostructure/nanotube (paragraph 0009, 0012, 0028), and further that the nanotube is functionalized with linkers to connect components to the nanotube (paragraph 0046).
More specifically, BANGERA teaches that the tubular nanostructures/the boron nitride nanotubes may be functionalized with small chemical compounds or biomolecules such as fluorescent dyes, and that any number of any of a number of homobifunctional, heterofunctional, and/or photoreactive cross linking agents may be used to bind biomolecules to tubular nanostructures. Examples of homobifunctional cross linkers include, but are not limited to, primary amine/primary amine linkers. Examples of heterofunctional cross linkers include, but are not limited to, primary amine/sulfhydryl linkers (paragraph 0027-0028). Therefore, this reads on the claimed attachment of a boron nitride nanotube to any number of linkers/linking agents, which would include the claimed number of 4.
BANGERA further teaches that the nanotube bound to fluorescent marker structures can be functionalized using covalent or non-covalent methodologies (paragraph 0044, 0047-0048, 0052-0053). BANGERA give a specific example wherein the nanotubes (including the boron nitride nanotubes) have multiple covalently tethered pyrene linkers (plural) and fluorescent chromophores (BANGERA states “fluorescence emitted by chromophores,”) (paragraph 0111). BANGERA also teach of binding the fluorescent molecules to a linker (functional group of a linker) (paragraph 0027, 0056, 0121).
BANGERRA further teaches that the linkers can be hetero-functional/heterobifunctional, which means that they use bioconjugation to join two different biomolecules through their respective, different, functional groups Hetero-functional linkers have two distinct reactive ends (paragraph 0027, 0052).
Specifically, BANGERRA teaches of adding a heterobifunctional crosslinker by covalently adding amino groups to the nanotube via azomethine ylide cycloaddition or alkyne azide cycloaddition, followed by derivatization of the amino groups with a heterobifunctional crosslinker, e.g., succiminidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxy-(6-amidocaproate) (LC-SMCC) (paragraph 0052). Therefore, just in this example, BANGERRA is teaching that the carbon or boron nanotube is covalently attached to amino groups, and then the amino groups attach to the heterobifunctional cross linker, which would then attach to the protein (paragraph 0052-0053 or other biomolecule which can also be derivatized itself to include other linking/reactive groups). Therefore- this teaches of the claimed 2 linkers, with the first linker having a first and second functional group and the 2nd linker having a 3rd and fourth functional group, as broadly claimed.
Further—again, the examiner notes that BANGERA further teaches that the nanotube bound to fluorescent marker or dye structures can be functionalized using covalent or non-covalent methodologies (paragraph 0044, 0047-0048, 0052-0053), and also of using “any number,” of linking agents that can be used to bind biomolecules to the tubular nanostructures (paragraph 0027-0028). Therefore, this again in the very least makes obvious the claimed 2 linkers, with the first linker having a first and second functional group and the 2nd linker having a 3rd and fourth functional group, with all the claimed groups having covalent bounds/interactions, as broadly claimed.
BANGERA teaches of the claimed linkages between the nanotube, first linker, second linker, and fluorescent moiety as shown above. Though BANGERA teaches and makes obvious the linking in series, in case this is not apparent to one of ordinary skill in the art, LUNDORF is used to remedy this.
LUNDORF teaches of a composite material of which the general structure is ligand-Linker1-Linker2, which is then a unit between a matric and additive, and then binds covalently to a structural entity such as a nanotube (abstract).
LUNDORF further teaches that structural entity the linker structure can bind to can be a boron nitride nanotube(paragraph 0260-0261, 0463, 0494), and that the linkers are arranged in series (paragraph 0644). LUNDORF further teaches that LINKER1 and LINKER2 can each have sublinkers, making the total amount of linkers at least 4 linkers as instantly claimed (paragraph 0641-0642).
Even further, LUNDORF teaches that all linking between all the molecules can be covalent (paragraph 0027, 0088-0091). Even further, LUNDORF teaches that the number of ligands in series can be over 100,000 ligands (paragraph 0069) and that the number of the linkers is proportional to the number of ligands and therefore the number of covalent or disulfide bonds which are also covalent is also proportional to this (paragraph 0642., 0639, 0666, 0672).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to link the linkers together in series using covalent bonds as is done in LUNDORF in the composition of BANGERA due to the advantage changing linker size and composition has for changing properties of the composite molecules (LUNDORF, paragraph 0666-0667).
With respect to Claim 3, BANGERA teaches of the nanotube length being between 1 nm to 1500nm (paragraph 0011). This includes and therefore reads on the claimed range of “between about 100 and 2000nm.”
With respect to Claim 5, BANGERA teaches that the carrier can be a multi-walled nanotube (paragraph 0007).
With respect to Claim 7, BANGERA teaches of the nanotube carrier/ BNNT having at least one polar group (which is OH), and wherein the first functional group can covalently linked to the nanotube carrier at the at least one polar OH group- see claim 1 rejection (paragraph 0057).
With respect to Claim 8, BANGERA teaches of the nanotube carrier/ BNNT having at least one polar group (which is OH), and wherein the first functional group can covalently linked to the nanotube carrier at the at least one polar OH group- see claim 1 rejection (paragraph 0057).
With respect to Claim 21, BANGERA teaches that the diameter of the nanotube can be about 0.5 nm to about 5 nm (paragraph 0007).
With respect to Claim 22, BANGERA teaches of the invention as shown above, but does not teach of the claimed linker size. LUNDORF is used to remedy this and teaches that the linker/s can have a length of less than 200 nm, as claimed (paragraph 0066-0667). See reason for combination from Claim 1.
With respect to Claim 23, BANGERA further teaches that the nanotube bound to fluorescent marker structures can be functionalized using covalent or non-covalent methodologies (paragraph 0044, 0047-0048, 0052-0053). BANGERA give a specific example wherein the nanotubes (including the boron nitride nanotubes) have multiple covalently tethered pyrene linkers (plural) and fluorescent chromophores (BANGERA states “fluorescence emitted by chromophores,”) (paragraph 0111). BANGERA also teach of binding the fluorescent molecules to a linker (functional group of a linker) (paragraph 0027, 0056, 0121).
BANGERRA further teaches that the linkers can be hetero-functional/heterobifunctional, which means that they use bioconjugation to join two different biomolecules through their respective, different, functional groups Hetero-functional linkers have two distinct reactive ends (paragraph 0027, 0052).
Specifically, BANGERRA teaches of adding a heterobifunctional crosslinker by covalently adding amino groups to the nanotube via azomethine ylide cycloaddition or alkyne azide cycloaddition, followed by derivatization of the amino groups with a heterobifunctional crosslinker, e.g., succiminidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxy-(6-amidocaproate) (LC-SMCC) (paragraph 0052). Therefore, just in this example, BANGERRA is teaching that the carbon or boron nanotube is covalently attached to amino groups, and then the amino groups attach to the heterobifunctional cross linker, which would then attach to the protein (paragraph 0052-0053 or other biomolecule which can also be derivatized itself to include other linking/reactive groups). Therefore- this teaches of the claimed 2 linkers, with the first linker having a first and second functional group and the 2nd linker having a 3rd and fourth functional group, as broadly claimed.
Further—again, the examiner notes that BANGERA further teaches that the nanotube bound to fluorescent marker or dye structures can be functionalized using covalent or non-covalent methodologies (paragraph 0044, 0047-0048, 0052-0053), and also of using “any number,” of linking agents that can be used to bind biomolecules to the tubular nanostructures (paragraph 0027-0028). Therefore, this again in the very least makes obvious the claimed 2 linkers, with the first linker having a first and second functional group and the 2nd linker having a 3rd and fourth functional group, with all the claimed groups having covalent bounds/interactions, as broadly claimed.
Even further, LUNDORF teaches that all linking between all the molecules can be covalent (paragraph 0027, 0088-0091). Even further, LUNDORF teaches that the number of ligands in series can be over 100,000 ligands (paragraph 0069) and that the number of the linkers is proportional to the number of ligands and therefore the number of covalent or disulfide bonds which are also covalent is also proportional to this (paragraph 0642., 0639, 0666, 0672). See reason for combination from Claim 1.
With respect to Claim 24, BANGERA further teaches that the nanotube bound to fluorescent marker structures can be functionalized using covalent or non-covalent methodologies (paragraph 0044, 0047-0048, 0052-0053). BANGERA give a specific example wherein the nanotubes (including the boron nitride nanotubes) have multiple covalently tethered pyrene linkers (plural) and fluorescent chromophores (BANGERA states “fluorescence emitted by chromophores,”) (paragraph 0111). BANGERA also teach of binding the fluorescent molecules to a linker (functional group of a linker) (paragraph 0027, 0056, 0121).
BANGERRA further teaches that the linkers can be hetero-functional/heterobifunctional, which means that they use bioconjugation to join two different biomolecules through their respective, different, functional groups Hetero-functional linkers have two distinct reactive ends (paragraph 0027, 0052).
Specifically, BANGERRA teaches of adding a heterobifunctional crosslinker by covalently adding amino groups to the nanotube via azomethine ylide cycloaddition or alkyne azide cycloaddition, followed by derivatization of the amino groups with a heterobifunctional crosslinker, e.g., succiminidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxy-(6-amidocaproate) (LC-SMCC) (paragraph 0052). Therefore, just in this example, BANGERRA is teaching that the carbon or boron nanotube is covalently attached to amino groups, and then the amino groups attach to the heterobifunctional cross linker, which would then attach to the protein (paragraph 0052-0053 or other biomolecule which can also be derivatized itself to include other linking/reactive groups). Therefore- this teaches of the claimed 2 linkers, with the first linker having a first and second functional group and the 2nd linker having a 3rd and fourth functional group, as broadly claimed.
Further—again, the examiner notes that BANGERA further teaches that the nanotube bound to fluorescent marker or dye structures can be functionalized using covalent or non-covalent methodologies (paragraph 0044, 0047-0048, 0052-0053), and also of using “any number,” of linking agents that can be used to bind biomolecules to the tubular nanostructures (paragraph 0027-0028). Therefore, this again in the very least makes obvious the claimed 2 linkers, with the first linker having a first and second functional group and the 2nd linker having a 3rd and fourth functional group, with all the claimed groups having covalent bounds/interactions, as broadly claimed.
Even further, LUNDORF teaches that all linking between all the molecules can be covalent (paragraph 0027, 0088-0091). Even further, LUNDORF teaches that the number of ligands in series can be over 100,000 ligands (paragraph 0069) and that the number of the linkers is proportional to the number of ligands and therefore the number of covalent or disulfide bonds which are also covalent is also proportional to this (paragraph 0642., 0639, 0666, 0672). See reason for combination from Claim 1.
With respect to Claim 25, BANGERA teaches of using two dye molecules, which is a tandem dye and using dye/ fluorophore pairs like the cyanine dyes (paragraph 0107, 0108, 0110, 0102).
Response to Arguments
Applicant's arguments filed 02/10/2026 and amendments dated 03/04/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, a different reference is used for the primary reference than was before, completely changing the grounds of rejection, and a new reference was used in support of this. In the instant amendments dated 03/04/2026, prior Claim 2, subject matter from prior Claim 9, and prior Claim 10 was added to Claim 1. All of these claims 2, 9 & 10 were dependent on Claim 1 before, so the combination of them together was not claimed- therefore allowing for a new grounds of rejection to be presented in this Final Office Action.
With respect to the Double Patenting Rejections, applicant makes no substantive arguments. Therefore, they are maintained.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CIOFANI in A simple approach to covalent functionalization of boron nitride nanotubes
CIOFANI teaches of functionalization of boron nitride nanotubes (BNNTs)/ the nanotube carrier, obtained after oxidation with HNOs3 (abstract, pages 308-309).
CIOFANI teaches of using 3-aminopropyl-triethoxysilane (APTES) as a silanizing agent for the BNNT surface (Page 308, column 2, last paragraph), and that the APTES is linked to the BNNT surface (see Figure 1, and Page 309, column 1, paragraph 1). The APTES is referred to as functionalized BNNTs or f-BNNTs. THE APTES in CIOFANI reads on the instantly claimed, “linker,” compound which has a first and second functional groups (one of which is shown as covalently linked to the BNNT/nanotube carrier, in Figure 1).
CIOFANI further teaches of covalently binding a further molecule to their surface (at a separate functional group of the linker), by labeling with a fluorescent dye (which reads on the instantly claimed moiety) to produce fluorescent f-BNNTs (Page 309, column 1, paragraph 1 & Page 311, column 2, paragraph 2).
BUZATU in US 20090022655
BUZATU teaches of using boron nitride nanotubes (paragraphs 0009-0010, 0034, 0040), of functionalizing the nanotubes (paragraph 0045), and of further binding multiple linkers with the boron nitride nanotube (wherein the linkers would have different functional groups as claimed) (paragraph 0046, 0062, 0037, 0040).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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