DETAILED ACTION
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.
Examiner’s Note
Examination of this application has passed to Fred Reynolds from Brendan Oliss.
Claim 8 requires a non-cleavable linker “derived from” suberic acid or PEG. Applicants have not defined “derived,” so the dictionary definition, something that can be made from another substance (Merriam Websters online dictionary) is used (MPEP 2111.01(I)). Given what a skilled chemist can accomplish, it is suspected that this is broader than applicants intended.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because fig 4 is illegible. Fig 4 shows a large number of lines in greyscale, but the gradations in greyscale are not sufficient to distinguish one line from another. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election without traverse of group I (PSMA targeting compounds) and the compound SBPD-1 in the reply filed on 19 Feb, 2026 is acknowledged.
Applicants have elected compound SBPD-1. A search was conducted for this compound, and references rendering it obvious were found. As a result, claims 1-6, 8-16, and 18-22 were examined, and claims 7, 17, and 23-31 have been withdrawn from consideration. Applicants have stated that they believe claims 7 and 17 also read on the elected compound, but claim 7 has an aromatic ring attached to the Lys residue that is not found in applicant’s elected species, and claim 17 requires a spacer moiety/linker not found in applicant’s elected species. Thus, these claims are properly withdrawn.
During examination, a reference was found that anticipated at least one non-elected species. This reference is discussed below.
Claims Status
Claims 1-31 are pending.
Claims 7, 17, and 23-31 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 Feb, 2026.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 8, 9, 11-16, and 18-21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure(MPEP 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure and (d) representative number of samples.
(a and b) actual reduction to practice and disclosure of drawings or structural chemical formulas: All examples use a Lys-Glu urea pseudodipeptide as a PSMA binding agent. There is no discussion of what structural features are required to bind to PSMA. Furthermore, claim 20 requires a compound selected from a Markush group comprising topoisomerase inhibitors and PARP inhibitors. No examples are given of these compounds.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure: The rejected claims all require a PSMA targeting moiety. This is a functional limitation that the moiety binds to PSMA with sufficient affinity to be useful in targeting a PSMA expressing cell or tissue. However, applicants have not described what structural features are required to meet this functional limitation. A person of skill in the art would not know what sequence/charge/hydrophobicity requirements are necessary to meet this functional limitation. In essence, applicants have defined a component of their invention by function. That is not sufficient to meet the written description requirement.
Furthermore, claim 20 requires cytotoxic agents that work by inhibiting specific proteins, a functional limitation. Likewise, applicants have provided no explanation of what structural features are required to both bind and inhibit these proteins.
As a matter of law, an inventor does not generally have written description of an antibody by defining what it binds to (MPEP 2163 (II)(A)(3)(a)). The targeting moiety of the rejected claims is broad enough to include antibodies, but no information other than the binding target is given in the claims.
As of applicant’s priority date, it was not possible to predict if a given molecule bound to a receptor. Lowe (blog “In the pipeline” entry of 7 Sept, 2022) describes an experiment where that was attempted. 39K compounds, including known antibiotics, were screened against E. coli for growth inhibition, finding 218 active compounds (1st page, 3d paragraph). These were computer docked to a set of 296 essential bacterial proteins by multiple docking procedures (1st page, 3d paragraph), along with 100 random inactive compounds (2nd page, 1st paragraph). The number of strong binders predicted were essentially the same between the active compounds and the controls, and out of 142 compound/target interactions previously known, the methodology found only 3 (2nd page, 2nd paragraph). While a given docking program may accurately predict if compound A binds to protein B, it is impossible to a priori know if the prediction is accurate. In other words, several years after applicant’s priority date, it was not possible to predict if a given compound and target bound to each other.
(d) representative number of samples: Both of applicant’s examples use the Lys-Glu urea pseudodipeptide as the PSMA targeting agent. Given that there are no structural limitations on the rejected claims for this moiety, the universe of compounds that meet the structural limitations of the claims is infinite, making it impossible to extrapolate from the examples in the spec to all compounds that meet the functional limitations of the claim. There are no examples of PARP or topoisomerase inhibitors. Thus, the claims lack written description.
Claim Rejections - 35 USC § 112(b)
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.
first rejection
Claims 1-6, 8-15, and 18-21 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.
The rejected claims require a cleavable linker, a non-cleavable linker, and/or a spacer. Any bond will cleave if enough energy is put into it, and most bonds are stable under at least some conditions. Without describing the conditions under which the cleavage does or does not occur, it is not possible to define a linker as cleavable or non-cleavable. Some of the rejected claims have a spacer; a term which is not defined. This means that the cutoff between a linker and a linker/spacer is not defined. For example, applicants have claimed Val-Cit-PABA as a cleavable linker-spacer combination (claim 16). However, the system is cleaved by cathepsin B; the whole thing could reasonably be interpreted as just a cleavable linker, without a spacer.
second rejection
Claim 20 is 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 20 lists a number of cytotoxic compounds, including “plant derived natural phenols.” Derived means can be chemically modified, but natural means it cannot.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19, from which claim 20 depends, requires the cytotoxic agent be a tubulin inhibitor. However, a number of the compounds of claim 20 are not tubulin inhibitors, making the claim broader in this respect. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-4, 8, 9, 11-16, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) with evidentiary support from Mondal et al (Tetrahedron Lett. (2018) 59(40) p3594-3599).
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page). Thus, the reference anticipates claims 1-4, 8, 9, 15, and 16. As evidenced by Mondal et al, Val-Cit is cleavable by cathepsin B (abstract), so this species in the construct of Wang et al anticipates claims 11-14. Monomethylauristatin E is a cytotoxic tubulin inhibitor (p1730, 1st column, 2nd paragraph), anticipating claims 18-21.
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.
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.
Claim(s) 1-6, 8-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) in view of Banerjee et al (J. Med. Chem. (2008) 51 p4504-4517).
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page). Note that this construct is very similar to applicant’s elected species, with the same cytotoxic agent, cleavable linker, and spacer.
Please note that this reference anticipates claims 1-4, 8, 9, 11-16, and 18-21.
The difference between this reference and the remaining claims is that this reference uses a different PSMA binding agent, with a different connection to a (slightly shorter) non-cleavable linker.
Banerjee et al discuss using a Lys-Glu urea pseudodipeptide to target radiation to PSMA expressing cancers for imaging (abstract). Note that this is the same PSMA binding agent in applicant’s elected species. Most examples attach the material to the chelating agent via a suberic acid attached via an amide bond to the Lys side chain of the pseudodipeptide (chart 2, p4505, 2nd column, top of page). The compounds are synthetically accessible and have high affinity for PSMA (p4514, 1st column, 2nd paragraph). This reference discusses targeting compounds to tumors with a PSMA binding agent.
Therefore, it would be obvious to use the Lys-Glu pseudodipeptide of Banerjee et al for the antibody of Wang et al, to provide a synthetically accessible therapeutic with high affinity for PSMA. As Banerjee et al successfully used this material to target a tumor cell, an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to use an amide to attach the pseudodipeptide to the linker as a simple substitution of one element (the maleimide of Wang et al, which uses chemistry not available to the amine of the compound of Banerjee et al) for another (the amide bond of Banerjee et al) yielding expected results (connection of the targeting agent to the linker). As this is a very common chemistry, and Banerjee et al shows how to make the linkage, an artisan in this field would attempt this modification with a reasonable expectation of success.
Banerjee et al renders obvious the Lys-Glu pseudodipeptide, rendering obvious claims 5 and 6.
Banerjee et al attach the targeting agent via an amide bond. While Wang et al uses a slightly shorter alkyl chain, this is a homologous series, which is not considered a patentable distinction (MPEP 2144.09). Alternatively, Banerjee et al connects to the payload using a suberic acid linker, rendering that obvious to connect to the Val-Cit cleavage point. Thus, the combination of references renders obvious claims 10 and 22.
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.
first rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 11 of copending Application No. 19/006,486 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) with evidentiary support from Wibowo et al (ACS Chem. Biol. (2017) 12(7) p1737-1742).
Competing claim 7 describes a method of treating a PSMA expressing tumor, comprising administering a therapeutic comprising a chelated radiometal, a linker, and a urea pseudodipeptide. Competing claim 11 describes specific compounds, including
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. Note, as evidenced by Wibowo et al, ROS compounds can react with the thiourea (abstract), making this a cleavable bond. Thus, this compound anticipates claims 1-6, 9, and 18.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
second rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 19/505,332 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes compounds with a Lys-Glu urea pseudodipeptide attached via an amide bond to the Lys side chain to a DOTA via a linker with a Lys residue. Note that this will be cleaved by trypsin, making it a cleavable linker. Competing claim 9 is a method of treating a PSMA expressing tumor or cell, comprising administering a compound of claim 1.
Thus, this compound anticipates claims 1-6, 9, and 18.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
third rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 9 of copending Application No. 18/807,333 (US 20250230135) in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) with evidentiary support from Wibowo et al (ACS Chem. Biol. (2017) 12(7) p1737-1742).
Competing claim 1 describes chemical compound with a radiochemical chelating group. Competing claim 3 describes a handful of compounds, including
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Note, as evidenced by Wibowo et al, ROS compounds can react with the thiourea (abstract), making this a cleavable bond. Competing claim 9 is a method of treating a PSMA expressing tumor. Thus, this compound anticipates claims 1-6, 9, and 18.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
fourth rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 18/966,839 (US 20250177580) in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes compounds with a Lys-Glu urea pseudodipeptide attached via an amide bond to metal chelator via a linker. Competing claim 9 is a method of treating a PSMA expressing tumor or cell, comprising administering a compound of claim 1.
The difference between the competing claims and the examined claims is that the examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
fifth rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 7 of copending Application No. 18/979,841 (US 20250195700) in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) with evidentiary support from Wibowo et al (ACS Chem. Biol. (2017) 12(7) p1737-1742).
Competing claim 1 describes chemical compound with a radiochemical chelating group. Competing claim 6 describes a handful of compounds, including
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Note, as evidenced by Wibowo et al, ROS compounds can react with the thiourea (abstract), making this a cleavable bond. Competing claim 7 is a method of treating a PSMA expressing tumor. Thus, this compound anticipates claims 1-6, 9, and 18.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
sixth rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of copending Application No. 17/622,060 (US 20250177580) in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes compounds with a Lys-Glu urea pseudodipeptide attached via an amide bond to metal chelator via a linker. Competing claim 9 is a method of treating a PSMA expressing tumor or cell, comprising administering a compound of claim 1.
The difference between the competing claims and the examined claims is that the examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
seventh rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, and 20 of copending Application No. 17/312,548 (US 20250177580) in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes compounds with a Lys-Glu urea pseudodipeptide or equivalent attached via an amide bond to metal chelator via dendrimeric linker. Competing claim 18 requires the Lys-Glu urea pseudodipeptide. Competing claim 20 is a method of treating a PSMA expressing tumor or cell, comprising administering a compound of claim 1.
The difference between the competing claims and the examined claims is that the examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
This is a provisional nonstatutory double patenting rejection.
eighth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of U.S. Patent No. 9,776,977 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) with evidentiary support from Wibowo et al (ACS Chem. Biol. (2017) 12(7) p1737-1742).
Competing claim 1 describes chemical compound with a radiochemical chelating group. Competing claim 3 describes a handful of compounds with a Lys-Glu urea pseudodipeptide, attached to a chelator group via linker, some of which have thiurea or peptide moieties in the linker.
Note, as evidenced by Wibowo et al, ROS compounds can react with the thiourea (abstract), making this a cleavable bond. Peptides can be digested (cleaved), making that a cleavable linker. Competing claim 5 is a method of treating a PSMA expressing tumor. Thus, this compound anticipates claims 1-6, 9, and 18.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
ninth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7 of U.S. Patent No. 10,232,058 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 5 describes a method of treating a PSMA expressing tumor, comprising administering a therapeutic comprising a photosensitizer, a linker, and a urea pseudodipeptide. Competing claim 7 describes specific compounds, a Lys-Glu urea pseudodipeptide, with the linker attached via an amide bond to the Lys side chain
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
tenth rejection
Claims 1-6, 8-16, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 11 of U.S. Patent No. 9,884,132 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants) with evidentiary support from Wibowo et al (ACS Chem. Biol. (2017) 12(7) p1737-1742).
Competing claim 7 describes a compound:
PNG
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191
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. This compound has a Lys-Glu urea pseudodipepitde, attached via a linker with a thiourea to a metal chelator. Note, as evidenced by Wibowo et al, ROS compounds can react with the thiourea (abstract), making this a cleavable bond. Thus, this compound anticipates claims 1-6, 9, and 18. Competing claim 11 specifies using this compound to treat cancer.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
eleventh rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 9 of U.S. Patent No. 10,683,272 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 8 describes a method of treating a PSMA expressing tumor, comprising administering a therapeutic comprising a chelator, a linker, and a urea pseudodipeptide. Competing claim 8 describes specific compounds, a Lys-Glu urea pseudodipeptide, with the linker attached via an amide bond to the Lys side chain
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
twelfth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 10,653,806 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes a therapeutic comprising a chelator, a linker, and a urea pseudodipeptide. Competing claim 6 describes a method of treating a cancer, comprising administering the agent.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
thirteenth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 11,458,213 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes a compound comprising a chelator, a linker, and a urea pseudodipeptide. Competing claim 4 describes specific compounds, a Lys-Glu urea pseudodipeptide, with the linker attached via an amide bond to the Lys side chain. Competing claim 5 describes a method of treating PSMA expressing tumors, comprising administering one of these compounds.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
fourteenth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 4 of U.S. Patent No. 11,478,558 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 3 describes a method of treating a PSMA expressing tumor, comprising administering a therapeutic comprising a chelator, a linker, and a urea pseudodipeptide. Competing claim 4 describes specific compounds, a Lys-Glu urea pseudodipeptide, with the linker attached via an amide bond to the Lys side chain
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
fifteenth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 15 of U.S. Patent No. 11,813,340 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 5 describes a therapeutic comprising a chelator, a linker, and a urea pseudodipeptide. Competing claim 7 describes specific compounds, a Lys-Glu urea pseudodipeptide, with the linker attached via an amide bond to the Lys side chain. Competing claim 15 describes a method of treating a PSMA expressing tumor, comprising administering a compound of competing claim 1.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
sixteenth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 18 of U.S. Patent No. 11,661,402 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes chemical compound with a radiochemical chelating group. Competing claim 11 describes a handful of compounds with a Lys-Glu urea pseudodipeptide, attached to a chelator group via linker, some of which have peptide moieties in the linker. Peptides can be digested (cleaved), making that a cleavable linker. Competing claim 18 is a method of treating a PSMA expressing tumor. Thus, this compound anticipates claims 1-6, 9, and 18.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
seventeenth rejection
Claims 1-6, 8-16, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No.12,233,137 in view of Wang et al (Mol. Canc. Ther. (2011) 10(9) p1728-1739, cited by applicants).
Competing claim 1 describes chemical compound with a radiochemical chelating group attached via a linker to a Lys-Glu urea pseudodipeptide. Competing claim 4 is a method of treating a PSMA expressing tumor, comprising administering a compound of claim 1.
The difference between the competing claims and the remaining examined claims and applicant’s elected species is that the remaining examined claims use a different linker and chemotherapeutic agent.
Wang et al discuss an auristatin conjugated to an antibody to PSMA (title). The structure of the construct is the PSMA binding antibody (PSMA targeting moiety) conjugated to a C6 carboxylic acid via a maleimide (non-cleavable linker) attached to a Val-Cit dipeptide (cleavable linker), attached to a PBAC moiety (spacer) attached to monomethylauristatin E (cytotoxic drug) (fig 1, p1730, top of page).
Therefore, it would be obvious to use the linker/chemotherapeutic of Wang et al, for the linker/therapeutic of the competing claims, as a substitution of one known element for another yielding expected results. As both the competing claims and Wang et al target the same protein for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
Please note that the attachment of Wang et al would have to be modified to attach to the pseudodipeptide of the competing claims, as that compound will not react with a maleimide. An obvious way to do this is the chemistry of the competing claims; an amide bond.
Conclusion
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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