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
Priority
The present application is a continuation of U.S. Patent Application No., 17/825,737, filed on May 26, 2022, which is a continuation of International Application No. PCT/US2022/026117, filed on April 25, 2022, which claims the benefit of U.S. Provisional Application No. 63/179,065, filed on April 23, 2021, U.S. Provisional Application No. 63/188,930 filed on May 14, 2021, and U.S. Provisional Application No. 63/189,492, filed on May 17, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 04/04/2024 is acknowledged. Claims 72-101 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/30/2023 and 04/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 04/04/2024 are acknowledged and accepted by the Examiner.
Claim Objections
Claim 99 is objected to for the following informalities:
Claim 99 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
(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 72-87 and 91-97 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manoharan et al. “Manoharan” (WO2009/073809, IDS of record dated 08/30/2023).
Mitchell et al. “Mitchell” (WO2021/055892, IDS of record dated 08/30/2023).
The claims are directed to a pharmaceutical composition comprising: a) a glyconucleic acid or salt thereof, the glyconucleic acid comprising: i) a short interfering RNA (siRNA); and ii) at least one oligosaccharide moiety comprising a hybrid type N-glycan comprising a trimannose core, at least one GlcNAc residue on the terminal end of the α1,3 mannose (Man α1,3) arm of the trimannose core and zero or more mannoses on the α1,6 mannose (Man α1,3) arm of the trimannose core, covalently bound to the siRNA; and b) a pharmaceutically acceptable carrier.
Regarding claims 72-76, 80-81, 83, 85 and 89, Manoharan discloses iRNA agents comprising at least one subunit of the formula (I):
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wherein: A and B are each independently for each occurrence O, N(RN) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, -P(Z')(Z")0- nucleoside, -P(Z' )(Z")O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, -P(Z' )(Z")O-Linker-OP(Z'")(Z"")O-oligonucleotide, a nucleotide, an oligonucleotide, - P(Z')(Z")-formula(I), -P(Z' )(Z")- or -Linker-R; R is LG, -Linker-LG, or has the structure shown below: LG is independently for each occurrence a carbohydrate, e.g., monosaccharide, disaccharide, trisaccharide, tetrasaccharide, oligosaccharide, polysaccharide; RN is independently for each occurrence H, methyl, ethyl, propyl, isopropyl,butyl, or benzyl; and Z', Z", Z"' and Z"" are each independently for each occurrence O or S (Abstract; and Fig 1 embodiments, pages 30-39); and their invention provides methods of making these compositions, as well as methods of introducing these iRNA agents into cells using these compositions, e.g., for the treatment of various disease conditions (page 1 second para). Manoharan discloses a pharmaceutical composition comprising a glycol-ligand, wherein the glycol-ligan comprises one or more glycan moieties operably linked to one or more sites on a synthetic scaffold domain comprising a synthetic ribonucleic acid (RNA) polymer, whereby the RNA can be siRNA and can be modified with groups such as phosphorothioate groups (page 59 to page 65; claims 1-20 of Manoharan). Manoharan discloses in another embodiment, the iRNA agent includes at least one (e.g., two or three or more) N-Acetyl-Galactosamine (GalNAc), N-Ac-Glucosamine (GluNAc), or mannose (e.g., mannose-6-phosphate). In one embodiment, iRNA agent comprises at least one mannose ligand (page 6 first para; Figure 1). Manoharan discloses in embodiments that the mannose can be D-mannose (i.e. Man α1,3). Manoharan also discloses the glycoligand can be bi-antennary or tri-antennary and can include mannose terminal groups or GalNAc terminal groups, including options wherein all of the groups are mannose or all of the groups are GalNAc (Figures 19 and 36) (instant claims 72-76, 78, 80, 81, 83, 85, 86 and 94).
Regarding claims 77, 82 and 95-96, Manoharan also discloses the glycoligand can be bi-antennary or tri-antennary and can include mannose terminal groups or GalNAc terminal groups, including options wherein all of the groups are mannose or all of the groups are GalNAc (Figures 19 and 36).
Regarding claims 79, 84, Manoharan discloses embodiments whereby the saccharides include neuraminic acid (i.e. sialic acid) (page 26 last para).
Regarding claims 87, 91 and 97, Manoharan discloses the oligosaccharide moiety comprises at least 8 monosaccharides (“about 4-9 monosaccharide units”, page 25 first para).
Regarding claim 92, Manoharan discloses the siRNA can be bound to a terminus of the siRNA (page 60 second para).
Therefore, the cited prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 88-90 and 98, 100-101 are rejected under 35 U.S.C. 103(a) as being unpatentable over Manoharan et al. “Manoharan” (WO2009/073809, IDS of record dated 08/30/2023) as applied to claims 72, 82 and 91 above. The teachings of Manoharan et al. are outlined above and incorporated herein.
Regarding claims 88 and 98, Manoharan discloses “Representative carbohydrates include the sugars (mono-, di-, tri- and oligosaccharides containing from about 4-9 monosaccharide units), and polysaccharides such as starches, glycogen, cellulose and polysaccharide gums” (page 25 first para).
Manoharan does not explicitly disclose at least 10 monosaccharide units.
However, it is not inventive and considered routine and obvious to one of ordinary skill in the art to use at least 10 monosaccharide units. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the knowledge that Manoharan discloses about 4-9 monosaccharide units leads one of ordinary skill in the art that an optimum range of monosaccharide units are within the purview of a skilled artisan. Moreover, the specification does not discredit or discourage a particular amount of monosaccharides that would impede the functions of the method. Thus, it would be obvious and merely routine to a skilled artisan to add at least 10 monosaccharide units suitable for having the desired function of pharmaceutical composition comprising the oligosaccharide moiety.
Regarding claims 89-90 and 100-101, Manoharan discloses iRNA agents comprising at least one subunit of the formula (I): wherein: A and B are each independently for each occurrence O, N(RN) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, -P(Z')(Z")0- nucleoside, -P(Z' )(Z")O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, -P(Z' )(Z")O-Linker-OP(Z'")(Z"")O-oligonucleotide, a nucleotide, an oligonucleotide, - P(Z')(Z")-formula(I), -P(Z' )(Z")- or -Linker-R; R is LG, -Linker-LG, or has the structure shown below: LG is independently for each occurrence a carbohydrate, e.g., monosaccharide, disaccharide, trisaccharide, tetrasaccharide, oligosaccharide, polysaccharide; RN is independently for each occurrence H, methyl, ethyl, propyl, isopropyl,butyl, or benzyl; and Z', Z", Z"' and Z"" are each independently for each occurrence O or S (Abstract); and their invention provides methods of making these compositions, as well as methods of introducing these iRNA agents into cells using these compositions, e.g., for the treatment of various disease conditions (page 1 second para). Manoharan discloses a pharmaceutical composition comprising a glycol-ligand, wherein the glycol-ligan comprises one or more glycan moieties operably linked to one or more sites on a synthetic scaffold domain comprising a synthetic ribonucleic acid (RNA) polymer, whereby the RNA can be siRNA and can be modified with groups such as phosphorothioate groups (page 59 to page 65; claims 1-20 of Manoharan). Manoharan discloses in another embodiment, the iRNA agent includes at least one (e.g., two or three or more) N-Acetyl-Galactosamine (GalNAc), N-Ac-Glucosamine (GluNAc), or mannose (e.g., mannose-6-phosphate). In one embodiment, iRNA agent comprises at least one mannose ligand (page 6 first para; Figure 1). Manoharan discloses in embodiments that the mannose can be D-mannose (i.e. Man α1,3). Manoharan also discloses the glycoligand can be bi-antennary or tri-antennary and can include mannose terminal groups or GalNAc terminal groups, including options wherein all of the groups are mannose or all of the groups are GalNAc (Figures 19 and 36) (instant claims 89 and 100).
Manoharan does not explicitly disclose a method of making the glyconucleic acid whereby L comprises a linker formed by a biorthogonal click chemistry reaction between [A] and a first click-chemistry handle and [B] and second click chemistry handle.
However, the glyconucleic acid composition disclosed by Manoharan appears to be the same as the present invention, thus, a method of how the glyconucleic acid is made is not inventive and considered obvious such that a skilled artisan would readily be able to use molecular techniques to perform the method with the siRNA, hybrid type N-glycan or high-mannose type N-glycan, and click chemistry formed in vitro that is suitable for their specific application. Further, it appears that the desired functional characteristics of the glyconucleic acid would also be the same. Moreover, the specification does not discredit or discourage any method steps that would impede the functions of the method. With respect to claims 90 and 101, the claims are a product-by-process claim. According to the MPEP (2113), PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 Langi, 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 72-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13-14, 18-27 and 29 of U.S. Patent No. 11766481 B2.
The patented claims are directed to:
1. A pharmaceutical composition comprising:
a) a glyconucleic acid or salt thereof, the glyconucleic acid comprising:
i) a short interfering RNA (siRNA); and
ii) at least one oligosaccharide moiety comprising at least 6 monosaccharides, covalently bound to the siRNA; and
b) a pharmaceutically acceptable carrier;
wherein the at least one oligosaccharide moiety comprises a multiple antennary complex type N-glycan comprising at least one GlcNAc residue attached to the Manal-3 arm and at least one GlcNAc attached to the Manal-6 arm of a trimannose core (instant claims 72, 82).
2. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises at least 8 monosaccharides (instant claim 87).
3. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises at least 10 monosaccharides (instant claim 88).
4. The pharmaceutical composition of claim 1, wherein at least one terminal residue of the multiple antennary complex type N-glycan comprises a monosaccharide selected from sialic acid, fucose, GlcNAc, mannose, and galactose (instant claims 73, 78, 83, 86).
5. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety is covalently bound to the siRNA via a click-chemistry reaction.
6. The pharmaceutical composition of claim 1, wherein the siRNA is covalently bound to the oligosaccharide moiety via a linker group covalently bound to a terminus of the-siRNA (instant claim 74).
7. The pharmaceutical composition of claim 1, wherein the siRNA is covalently bound to the oligosaccharide moiety via a linker covalently bound to a chemically modified nucleotide in the middle of the siRNA (instant claim 75).
8. The pharmaceutical composition of claim 1, wherein the siRNA is covalently bound to the oligosaccharide moiety via a chemical handle inserted between two nucleotides of the siRNA (instant claim 75).
13. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a bisecting complex type N-glycan (instant claims 77, 82).
14. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a fucose linked to a GlcNAc residue in a core or a base region of the complex type N-glycan (instant claim 76).
18. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a bi-antennary complex type N-glycan comprising a first terminal residue and a second terminal residue (instant claim 77).
19. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises a monosaccharide selected from sialic acid, GlcNAc and galactose (instant claims 73, 78, 81).
20. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises sialic acid (instant claims 79, 84).
21. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises GlcNAc (instant claim 80).
22. The pharmaceutical composition of claim 18, wherein at least one of the first terminal residue and the second terminal residue comprises mannose (instant claim 73).
23. The pharmaceutical composition of claim 18, wherein the at least one oligosaccharide moiety comprises a fucose linked to a GlcNAc residue in a core or a base region of the bi-antennary N-glycan (instant claim 76).
24. The pharmaceutical composition of claim 1, wherein the at least one oligosaccharide moiety comprises a tri-antennary complex type N-glycan comprising a first terminal residue, a second terminal residue, and a third terminal residue (instant claim 82).
25. The pharmaceutical composition of claim 24, wherein at least one of the first terminal residue and the second terminal residue comprises a monosaccharide selected from sialic acid, GlcNAc, and galactose (instant claims 73, 78, 81).
26. The pharmaceutical composition of claim 24, wherein at least one of the first terminal residue, the second terminal residue, and the third terminal residue comprises sialic acid (instant claims 79, 84).
27. The pharmaceutical composition of claim 24, wherein at least one of the first terminal residue, the second terminal residue, and the third terminal residue comprises GlcNAc (instant claim 85).
29. The pharmaceutical composition of claim 24, wherein the at least one oligosaccharide moiety comprises a fucose linked to a GlcNAc residue in a core or a base region of the tri-antennary complex type N-glycan (instant claim 82).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 18/363,050 discloses a pharmaceutical composition comprising:
a) a glyconucleic acid or salt thereof, the glyconucleic acid comprising:
i) a short interfering RNA (siRNA); and
ii) at least one oligosaccharide moiety comprising at least 6 monosaccharides, covalently bound to the siRNA; and
b) a pharmaceutically acceptable carrier;
wherein the at least one oligosaccharide moiety comprises a multiple antennary complex type N-glycan comprising at least one GlcNAc residue attached to the Manal-3 arm and at least one GlcNAc attached to the Manal-6 arm of a trimannose core. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 72, 73, 76, 77, 82 and 83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 22, 23, 39, 57 and 59 of co-pending Application No. 18/602,962. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The co-pending claims are directed to:
1.A pharmaceutical composition comprising a glyco-ligand, wherein the glyco-ligand comprises one or more glycan moieties operably linked to one or more sites on a synthetic scaffold domain comprising a synthetic ribonucleic acid (RNA) polymer; wherein a) the synthetic RNA polymer comprises small interfering RNA (siRNA); and b) at least one of the one or more glycan moieties comprises an oligosaccharide structure comprising: i. a bi-antennary glycan comprising a first terminal residue, and a second terminal residue; ii. a tri-antennary glycan comprising a first terminal residue, a second terminal residue, and a third terminal residue; or iii. a tetra-antennary glycan comprising a first terminal residue, a second terminal residue, a third terminal residue and a fourth terminal residue; wherein at least one of the first terminal residue, second terminal residue, third terminal residue, if present, or fourth terminal residue, if present, comprises GalNAc (instant claims 72, 77 and 82).
7. The pharmaceutical composition of claim 1, wherein the one or more glycan moieties comprise a bi-antennary glycan, wherein the biantennary glycan comprises a first terminal residue and a second terminal residue (instant claim 77).
22. The pharmaceutical composition of claim 7, wherein both the first terminal residue and second terminal residue of the bi-antennary glycan comprises GalNAc (instant claim 73).
23. The pharmaceutical composition of claim 1, wherein the one or more glycan moieties comprise a tri-antennary glycan, wherein the tri-antennary glycan comprises a first terminal residue, a second terminal residue, and a third terminal residue (instant claim 82).
39. The pharmaceutical composition of claim 23, wherein all of the first terminal residue, the second terminal residue and the third terminal residue of the tri-antennary glycan comprises GalNAc (instant claim 83).
57. The pharmaceutical composition of claim 1, wherein the one or more glycan moieties comprise a fucose linked to a GlcNAc residue in a core or a base region of the glycan (instant claim 76).
59. The pharmaceutical composition of claim 1, wherein the one or more glycan moieties comprise a bisecting glycan (instant claims 77 and 82).
There is no patentable difference between the claimed composition and the patented composition in that the co-pending application No. 18/602,962 discloses a pharmaceutical composition comprising a glyco-ligand, wherein the glyco-ligand comprises one or more glycan moieties operably linked to one or more sites on a synthetic scaffold domain comprising a synthetic ribonucleic acid (RNA) polymer; wherein a) the synthetic RNA polymer comprises small interfering RNA (siRNA); and b) at least one of the one or more glycan moieties comprises an oligosaccharide structure comprising: i. a bi-antennary glycan comprising a first terminal residue, and a second terminal residue; ii. a tri-antennary glycan comprising a first terminal residue, a second terminal residue, and a third terminal residue; or iii. a tetra-antennary glycan comprising a first terminal residue, a second terminal residue, a third terminal residue and a fourth terminal residue; wherein at least one of the first terminal residue, second terminal residue, third terminal residue, if present, or fourth terminal residue, if present, comprises GalNAc. The composition of the instant claims would anticipate the compositions herein. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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