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 .
This is the First Office Action on the Merits of US 18/248,137 filed on 04/06/2023 which is a 371 of PCT/EP2021/077931 filed on 10/08/2021 which claims Foreign priority of EP 20201040.1 filed on 10/09/2020.
The Applicants Amendment to the Claims filed on 01/15/2026 is entered.
Election/Restrictions
Applicant’s election without traverse of invention Group II (e.g., claim 2 drawn to a method for treating lichen sclerosis) in the reply filed on 01/15/2026 is acknowledged.
In view of the applicants’ present claim amendments, Group II now includes present claims 2-10.
Applicant’s election without traverse of the following species in the reply filed on 01/15/2026 is acknowledged.
A. The type of nucleophilic compound being a dipeptide, a tripeptide, or a tetrapeptide: Applicant elects a dipeptide;
B. The type of nucleophilic compound from among those listed in claim 6: Applicant elects Ala-Gln;
C. The type of formula I versus formula II: Applicant elects Formula I;
D. The type of R1: Applicant elects CH3;
E. The type of R2: Applicant elects COOH;
F. The type of R5: Applicant elects H;
G. The type of H or OH: With reference to R3 & R4, Applicant elects H;
H. The type of n (1, 2, or 3): Applicant elects 2; and
I. The type of compound selected in claim 9: Applicant elects Ala-Gln.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/15/2026.
Claim status
Claims 1-10 are pending.
Claim 1 is withdrawn to non-elected invention group.
Claims 2-10 are under examination in this office action.
Information Disclosure Statement
The IDS statements filed on 10/16/2025, 05/13/2025, and 08/30/2023 have been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See pages 5, line 29; page 13, last row; page 18, line 7, present claim 6.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 3, 6, and 9 are objected to because of the following informalities:
Regarding claim 3, for improved clarity, amend line 2: ..said pharmaceutical composition…
Regarding claim 6, for improved clarity, amend line 2: …selected from the group consisting of:… Also, add the term “and” before the last element of this group, specifically add the “and” after the term “Gly-Gly-Gly-Gly”.
Regarding claim 7, the term “the” is repeated in line 1.
Regarding claim 9, for improved clarity, amend line 3: ..said pharmaceutical composition…
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4, 5, and 8, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 is indefinite because there is insufficient antecedent basis in the claims for the phrase: “as measured by the in vitro protein carbamylation assay provided herein”. Specifically, claim 4 depends from claim 2 which does not recite an in vitro protein carbamylation assay. For purpose of applying prior art the claim is construed to require that the nucleophile is capable of inhibiting carbamylation of a protein.
In addition, regarding claims 4, 5, and 8, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 4 recites the broad recitation “a degree of BSA carbamylation of less than 80%”, and the claim also recites “preferably less than 70%, more preferably less than 60%, even more preferably less than 50%” which is the narrower statement of the range/limitation.
In addition, claim 5 recites the broad recitation “the nucleophilic compound is a dipeptide, a tripeptide or a tetrapeptide”, and the claim also recites “preferably a dipeptide” which is the narrower statement of the range/limitation.
In addition, claim 8 recites the broad recitation “the lichen sclerosus is genital lichen sclerosus”, and the claim also recites “preferably vulvar lichen sclerosus” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Written Description
Claims 2-10 are 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.
Claims are drawn to a method of treating a subject for lichen sclerosus by administering a pharmaceutical composition comprising a nucleophilic compound capable of inhibiting carbamylation. Thus claims require the critically essential element of a pharmaceutical composition comprising a genus of nucleophilic compounds capable of inhibiting carbamylation and which function in the pharmaceutical composition for treating lichen sclerosus.
The instant specification and instant claim 4 defines a nucleophile capable of inhibiting carbamylation by measuring the degree of carbamylation of the nucleophile against the degree of a control BSA carbamylation to be less than 80% as performed in an in vitro protein carbamylation assay. The number of nucleophilic compounds encompassed by the present claim language is extremely large. However, while showing the degree of inhibition of carbamylation for a set of nucleophilic compounds in Table 1, the specification does not provide a representative set of the enormous genus of nucleophiles which would meet the required property of at least 80 % inhibition as presently claimed and as defined in the specification. While showing possession of the screening assay to determine whether a given nucleophilic compound meets the functional requirement of the claimed method, it is noted that the Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as be structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXlS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original). While the basic structure of a nucleophile is known in the art, a skilled artisan would need to perform a trial and error assay to determine if a particular nucleophile possessed the function/activity required of the claimed method.
Further, in Example 4, the specification shows possession of pharmaceutical compositions comprising Ala-Gln, acetylcysteine, phenelzine sulfate, His, or Sitagliptin which showed positive results in an assay using reconstructed human skin cultures. The specification shows no other examples having these required properties of the claims. However, such assay using reconstructed human skin cultures does not provide sufficient evidence for treating lichen sclerosis in a human patient.
The state of the art shows unpredictability in whether a nucleophilic compound encompassed by the present claim language would have the required property of being capable of treating lichen sclerosis. For example, the state of the prior art shows that topical creams for treating lichen sclerosus were known. See prior art rejections below. However, the prior art teaches that not only albumin but also other proteins can be carbamylated such as for instance hemoglobin, fibrinogen, alpha-1-anti-trypsin, enolase, vimentin etc. (See Favoino et al: "Anti-carbamylated protein antibodies and skin involvement in patients with systemic sclerosis: An intriguing association", (PloS one, 1 January 2018, pages 1-13; IDS reference.) (See especially Favoino et al page 2, para 3.) Presently any nucleophilic compound capable of inhibiting carbamylation of any protein is claimed for use in treating lichen sclerosus. However, it is not plausibly shown in the patent application that an inhibition of the carbamylation of e.g. fibrinogen, enolase or hemoglobin is causally linked to a treatment of the claimed conditions.
It is considered that without trial and error experimentation, one of ordinary skill in the art would not be able to predict whether a given nucleophilic compound would possess the property of being capable of treating lichen sclerosis.
The specification provides one working example showing possession of one embodiment of the claimed pharmaceutical composition. Specifically, the pharmaceutical topical cream comprising the active ingredients of instant claim 10, formulated as a topical cream (“an oil-in-water cream base, well-known to a person skilled in the art”; page 10, Example 1), the formulation comprising (in w/w% of the entire pharmaceutical composition): L- Histidine 0.50 %, L-Arginine 0.75%, and L-Lysine 0.70% . (See Example 1 & 2).
However, neither the specification as originally filed nor the state of the art before the effective filing date show a sufficient correlation of nucleophilic compounds correlated to the required property of being capable of treating lichen sclerosis.
To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
While having written description of the claims drawn to the pharmaceutical comprising the a pharmaceutical topical cream comprising the active ingredients of instant claim 10, formulated as a topical cream (an oil-in-water cream base, well-known to a person skilled in the art”; page 10, Example 1), the formulation comprising (in w/w% of the entire pharmaceutical composition): L- Histidine 0.50 %, L-Arginine 0.75%, and L-Lysine 0.70% . (See Example 1 & 2), the specification does not provide sufficient descriptive support for the myriad of embodiments embraced by the claims. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Given this lack of description of representative species encompassed by the genus of the claim, the specification does not sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the entire scope of the claimed invention.
For inventions in an unpredictable art, adequate written description of a genus, which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph.
In the instant case, the unpredictability of the art is evidenced by the cited references, above. Adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of isolating a compound. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Scope of enablement
Claims 2-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating lichen sclerosus in a patient by administering a pharmaceutical topical cream comprising the active ingredients comprising a nucleophilic compound recited in claim 10, does not reasonably provide enablement for treating by administering any pharmaceutical composition comprising any nucleophilic compound capable of inhibiting carbamylation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Many factors are to be considered when determining if sufficient evidence exists to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue". These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is a method of treating lichen sclerosus by administering a pharmaceutical composition comprising a nucleophilic compound capable of inhibiting carbamylation.
The breadth of the claims: Except for instant claims 6 and 9-10, the claims are broad to any nucleophilic compound capable of inhibiting carbamylation. Except for claims 3 and 9-10, the claims are broad to compositions other than topical.
The state of the prior art: The state of the prior art shows that topical creams for treating lichen sclerosus were known. See prior art rejections below. However, the prior art teaches that not only albumin but also other proteins can be carbamylated such as for instance hemoglobin, fibrinogen, alpha-1-anti-trypsin, enolase, vimentin etc. (See Favoino et al: "Anti-carbamylated protein antibodies and skin involvement in patients with systemic sclerosis: An intriguing association", (PloS one, 1 January 2018, pages 1-13; IDS reference.) (See especially Favoino et al page 2, para 3.) Presently any nucleophilic compound capable of inhibiting carbamylation of any protein is claimed for use in treating lichen sclerosus. However, it is not plausibly shown in the patent application that an inhibition of the carbamylation of e.g. fibrinogen, enolase or hemoglobin is causally linked to a treatment of the claimed conditions.
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833,166 USPQ18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is unpredictable because the claims are broad to any nucleophilic compound capable of inhibiting carbamylation and methods of administering other than topical. Further, even if a nucleophile meets the definition of instant claim 4 regarding the degree of carbamylation inhibition required, such compounds must further be tested for treating a skin disorder as shown in the instant specification using some of the compounds listed in instant claims 6 and 9-10, specifically comprising Ala-Gln, acetylcysteine, phenelzine sulfate, His, or Sitagliptin. However, even these compounds must further be shown to treat lichen sclerosis beyond an in vitro skin assay. In the instant case, the specification provides evidence of unpredictability in Example 3 which shows that ectoine results in a high degree of carbamylation relative to HBSS control but is not considered to be a nucleophilic compound within the meaning of presently claimed invention.
The amount of direction or guidance present and The presence or absence of working examples: The compounds of the instant invention shown in claims 6 and 9-10, specifically comprising Ala-Gln, acetylcysteine, phenelzine sulfate, His, or Sitagliptin which showed positive results in an assay using reconstructed human skin cultures. However, only the Example 2 shows a working embodiment of a pharmaceutical for treating lichen sclerosus. Specifically, the guidance present in the specification supports a method of treating lichen sclerosus using a pharmaceutical topical cream comprising the active ingredients of claim 10, formulated as a topical cream (an oil-in-water cream base, well-known to a person skilled in the art”; page 10, Example 1), the formulation comprising (in w/w% of the entire pharmaceutical composition): L- Histidine 0.50 %, L-Arginine 0.75%, and L-Lysine 0.70% . (See Example 1 & 2).
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine which nucleophilic compounds would be capable of inhibiting carbamylation and further which of such compounds would be successful in treating lichen sclerosus. Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which nucleophilic compounds would be capable of inhibiting carbamylation and further which of such compounds would be successful in treating lichen sclerosus, with no assurance of success.
This rejections under 35 U.S.C. 112(a) can be overcome by limiting the claims to the embodiment of instant claim 10, further limited to the concentrations of: L- Histidine 0.50 %, L-Arginine 0.75%, and L-Lysine 0.70%.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-4, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0275577 to Priebe et al November 10, 2011; IDS ref).
Regarding claim 2, Priebe et al discloses a method of treating lichen sclerosis by administering caffeic acid analog compounds to a patient in need thereof. (see entire document; Abstract; para 2; para 20; para 35; ref claims 1-29.)
Regarding claim 3, Priebe et al disclose the pharmaceutical compositions can be formulated for topical use (para 186, 191) in the treatment of lichen sclerosus (para 21).
Regarding claim 4, given the fact that these compounds comprise at least one secondary amine these compounds are capable of inhibiting carbamylation of a protein. (See Priebe et al para 0025-0027; para 0174 listing an embodiment with a dimethylamine.) See above 112 (b) rejection of claim 4 for claim interpretation.
Regarding claim 7, caffeic acid analog compounds of Priebe et al are not the compound of claim 7 formula (I).
Regarding claim 8, Priebe et al disclose treating for genital lichen sclerosus. See Abstract.
Claims 2-4, and 7, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wulf (WO-00/37071, published 06/29/2000; IDS reference).
Regarding claims 2-4, Wulf discloses administering topical creams containing lysine for treating skin conditions including sclerosis, scleroderma, lichen symplex, and lichen nitidus to patients in need thereof. (See entire document; page 8, para 1-2; para bridging pages 9-10; ref claims). Regarding claim 4, lysine is a nucleophilic compound that inherently meets the limitation of carbamylation inhibition activity as evidenced by the instant specification (e.g., see instant specification page 5).
Regarding claim 3, Wulf discloses topical creams. (See Title, Abstract, ref claims).
Regarding claim 7, the nucleophilic compound lysine is not the compound of claim 7 formula (I).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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