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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-23 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 10-12, 14-21, and 23-26 of copending Application No. 18024628 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of instant claim 1 are present in claim 1 (dated 09/10/2025) of the reference application. Claim 1 of the reference application claims additional features that are not claimed in the instant claim 1.
Limitations of instant Claim 2 are also present in claim 1 (dated 09/10/2025) of the reference application.
Regarding instant claim 3, the hydraulic permeability (about 200 x 10-12 cm2 to about 700 x 10-12 cm2) overlaps the hydraulic permeability (about 100 x 10-12 cm2 to about 500 x 10-12 cm2) of claim 1 (dated 09/10/2025) of the reference application. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Limitations of instant Claim 4 are present in claim 4 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 5 are present in claim 5 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 6 are present in claim 6 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 7 are present in claim 7 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 8 are present in claim 8 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 9 are present in claim 1 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 10 are present in claim 10 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 11 are present in claim 11 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 12 are present in claim 12 (dated 09/10/2025) of the reference application.
Limitations of instant Claim 13 are present in claim 1 (dated 09/10/2025) of the reference application.
Limitations of instant Claims 14, 15, 16, 17, 18, 19, 20, 21 are present in claim 14, 15, 16, 17, 18, 19, 20, 21 (dated 09/10/2025) of the reference application.
Limitations of instant Claims 22 and 23 are present in claim 23 and 24 (dated 09/10/2025) of the reference application.
Limitations of instant Claims 25 and 26 are present in claim 25 and 26 (dated 09/10/2025) of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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.
Claims 1-23 and 25-26 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.
Regarding claim 1, the limitation “a particle size distribution has a D90/D10 less than or equal to 3” doesn’t clearly specify that the limitation is claiming particle size distribution for the claimed inorganic particles rendering the claim indefinite. Since the claim do not recite any particles other than the inorganic particles, examiner has interpreted that the intent of the applicant was to claim “the inorganic particles having a particle size distribution has a D90/D10 less than or equal to 3”.
Regarding claim 2, the limitation “wherein the targeted molecule is a protein, antibody, viral vector and combinations thereof” appear to require all four options. If this is not the case, then examiner suggests “or a combination thereof” or “wherein the targeted molecule is selected from…”.
Regarding claim 17, the limitation “wherein the fibrillated polymer membrane has a wound configuration, a stacked configuration, and a combination thereof” appear to require all three options. If this is not the case, then examiner suggests “or a combination thereof” or “wherein configuration of the fibrillated polymer membrane is selected from…”. For purpose of claim rejection, examiner has interpreted the limitation as “or combination thereof” since the instant figures do not disclose an embodiment of combination of wound and stacked membrane within a device.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McManaway (US 2017/0021286A1), in view of Minor et al. (US 6015610).
Regarding claims 1 and 5-6, McManaway teaches an article (refer fig. 4, fig. 8) comprising:
an affinity chromatography device (refer abstract, [0027] disclosing device being affinity chromatography device) including:
a fluid inlet (80);
a fluid outlet (85) fluidly connected to the fluid inlet;
a fibrillated heat treated polymer membrane (refer [0038] disclosing expanded PTFE, expanded PTFE is known to have fibrillated structure (providing heat in making of PTFE is also known) positioned between the fluid inlet and fluid outlet (refer fig. 4, fig. 8) and containing therein inorganic particles (refer [0034]) and a nominal particle size from about 5 microns to about 20 microns (refer [0004]);
a housing (50) encompassing the fluid inlet, the fluid outlet and the fibrillated heat treated polymer membrane (refer fig. 4, fig. 8),
wherein a particle size distribution has a D90/D10 less than or equal to 3 (refer [0028] disclosing particles being monodisperse, i.e uniform in size), and
wherein at least one of the fibrillated heat treated polymer membrane and the inorganic particles has covalently bonded thereto an affinity ligand that reversibly binds to a targeted molecule (refer [0004]).
Regarding the inorganic particles having a spherical shape, McManaway teaches (refer [0028] that the inorganic particles may be either solid or porous and may have a variety of sizes and shapes. McManaway does not disclose that the particles have a spherical shape, however, selecting spherical shape would have been an obvious matter of choice to one of ordinary skill in the art because McManaway discloses that particles can have a variety of shapes. Furthermore, Minor discloses ePTFE comprising titanium dioxide particles (Abstract). Minor also discloses that particles have a size from about 1 nm to 1mm, and can be any shape, such as speres, rods, needle-like, or irregular (C5/L54-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to select particle shape as sphere in the membrane of McManaway because Minor establishes that use spherical shaped inorganic particles in PTFE membranes is known in the art.
Regarding claim 2, modified McManaway teaches limitations of claim 1 as set forth above. , McManaway teaches that the targeted molecule is a protein or antibody (refer abstact). The claim is directed to an article (i.e. an apparatus/device/structure). A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 3, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the device has permeability of about 133 x 10-12 cm2 to about 303 x 10-12 cm2 (Refer table 4, table 5). The permeability disclosed by McManaway overlaps the claimed hydraulic permeability. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4 , modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the inorganic particles are selected from silica, zeolites, hydroxyapatite, metal oxides and combinations thereof (refer [0028]).
Regarding claim 7 , modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches affinity ligands for use in the affinity chromatography device include, but are not limited to, Protein A, Protein G, Protein L, human Fc receptor protein, antibodies that specifically bind to other proteins, and heparin (refer [0029]).
Regarding claim 8 , modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the inorganic particles comprise at least a first inorganic particle having a spherical shape and a first nominal particle size and a second inorganic particle having a spherical shape and a second nominal particle size, the first and second nominal particle sizes being different from each other. Refer [0032] disclosing “the polymer membrane 20 may contain at least first inorganic particles and second inorganic particles where the first inorganic particles are different from the second inorganic particles in nominal particle size and/or type. For example, the polymer membrane 20 may include a mixture of a first particle size (e.g., 20 microns) and a second particle size (e.g., 10 microns) of the same or different inorganic particle (e.g., porous silica). The mixture of inorganic particles within the polymer membrane 20 may be any mixture, such as a 50/50 blend, a 30/70 blend, a 60/40 blend, a 25/75, or a 20/80 blend.”
Regarding claim 9, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the nominal particle size is selected from about 5 microns, about 10 microns, about 15 microns, about 20 microns, and combinations thereof (Refer [0028]).
Regarding claim 10, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the inorganic particles having a spherical shape comprise a blend of 10 micron spherical particles and 20 micron spherical particles, and wherein the blend is from 10:90 to 90:10. Refer [0032] disclosing “the polymer membrane 20 may contain at least first inorganic particles and second inorganic particles where the first inorganic particles are different from the second inorganic particles in nominal particle size and/or type. For example, the polymer membrane 20 may include a mixture of a first particle size (e.g., 20 microns) and a second particle size (e.g., 10 microns) of the same or different inorganic particle (e.g., porous silica). The mixture of inorganic particles within the polymer membrane 20 may be any mixture, such as a 50/50 blend, a 30/70 blend, a 60/40 blend, a 25/75, or a 20/80 blend.” "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 11, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the inorganic particles having a spherical shape comprise a blend of 5 micron spherical particles and 10 micron spherical particles, and wherein the blend is from 10:90 to 90:10. Refer [0032] disclosing “the polymer membrane 20 may contain at least first inorganic particles and second inorganic particles where the first inorganic particles are different from the second inorganic particles in nominal particle size and/or type. For example, the polymer membrane 20 may include a mixture of a first particle size (e.g., 20 microns) and a second particle size (e.g., 10 microns) of the same or different inorganic particle (e.g., porous silica). The mixture of inorganic particles within the polymer membrane 20 may be any mixture, such as a 50/50 blend, a 30/70 blend, a 60/40 blend, a 25/75, or a 20/80 blend.” "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 12, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the inorganic particles having a spherical shape comprise a blend of 5 micron spherical particles and 20 micron spherical particles, and wherein the blend is from 10:90 to 90:10. Refer [0032] disclosing “the polymer membrane 20 may contain at least first inorganic particles and second inorganic particles where the first inorganic particles are different from the second inorganic particles in nominal particle size and/or type. For example, the polymer membrane 20 may include a mixture of a first particle size (e.g., 20 microns) and a second particle size (e.g., 10 microns) of the same or different inorganic particle (e.g., porous silica). The mixture of inorganic particles within the polymer membrane 20 may be any mixture, such as a 50/50 blend, a 30/70 blend, a 60/40 blend, a 25/75, or a 20/80 blend.” "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches that the affinity chromatography device has a dynamic binding capacity (DBC) of at least 35 mg/ml at a residence time of 20 seconds. Refer [0053] disclosing “affinity chromatography devices described herein have a dynamic binding capacity (DBC) of at least 30 mg/ml at 10% breakthrough at a residence time of 20 seconds or less where an Fc binding protein is the affinity ligand”. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, modified McManaway teaches limitations of claim 1 as set forth above. McManaway discloses comprising a cycling durability of at least 50 cycles (Figure 10). However, modified McManaway is silent to comprising a cycling durability of at least 100 cycles at an operating pressure less than 0.3 MPa.
Figure 10 shows that the dynamic binding capacity for articles that have alternating 10 micron and 20 micron inorganic particles are constant or slightly improved over 50 cycles, suggesting that there is no increase in operating pressure or loss of dynamic binding capacity over 50 cycles (Figure 10, [0024], [0058]).
It would have been obvious to one of ordinary skill before the effective filing date of the invention for the cycling durability of the article of modified McManaway to be at least 100 cycles at an operating pressure less than 0.3 MPa, in order to maintain the same dynamic binding capacity for the articles over many cycles and reduce the number of times the articles need to be replaced.
Regarding claims 15-17, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches a wound or stacked configuration of the membrane (refer abstract, fig. 8).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McManaway (US 2017/0021286A1), in view of Minor et al. (US 6015610) as applied to claim 1 above, and further in view of WO 2017/176522.
Regarding claims 18-20, modified McManaway teaches limitations of claim 1 as set forth above. McManaway teaches an intermediate layer film is positioned on the polymer membrane and is wrapped with the polymer membrane such that upon winding, the intermediate film is situated between the wound layers of the polymer membrane (refer [0047]). McManaway discloses wherein the intermediate material is selected from a porous fluoropolymer film and a porous non-fluoropolymer film (refer [0047]). However, modified McManaway is silent to wherein an inner intermediate material is circumferentially positioned on an outer surface of the core, and wherein the fibrillated polymer membrane is circumferentially positioned around the inner intermediate material, wherein an outer intermediate material is circumferentially positioned on the fibrillated polymer membrane.
WO ‘522 teaches an affinity chromatography device wherein an intermediate film is positioned on the polymer membrane and is wrapped with the polymer membrane around a core such that upon winding, the intermediate film is situated between the wound layers of the polymer membrane (refer [0048]), and that that an inner intermediate film is circumferentially positioned on an outer surface of a core (refer [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide an inner intermediate material is circumferentially positioned on an outer surface of the core of modified McManaway, and wherein the fibrillated polymer membrane is circumferentially positioned around the inner intermediate material, wherein an outer intermediate material is circumferentially positioned on the fibrillated polymer membrane, as taught by WO ‘522 to force the flow of the aqueous mixture containing the targeted protein or antibody laterally through the membrane layers.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McManaway (US 2017/0021286A1), in view of Minor et al. (US 6015610) and WO 2017/176522 as applied to claim 19 above, and further in view of Heller et al. (US 2019/0284321).
Regarding claim 21, modified McManaway teaches limitations of claim 19 as set forth above. McManaway discloses that the intermediate material is a polypropylene material ([0047]). However, modified McManaway is silent to wherein at least one of the inner intermediate material and the outer intermediate material is a non-woven material.
Heller teaches nonwoven membranes capable of use for various separation methods, such as separation of proteins from certain solutions using ion exchange or affinity chromatography, capturing biomolecules from biological fluids, capturing ionic species from gases, water, and other solvents, or any other separation process that utilizes a stationary phase for target capture (refer [0074]). Heller discloses that nonwoven membranes controllable porosities, fiber diameters, and pore sizes with low cost materials using high-rate manufacturing technologies (refer [0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to use non-woven material for the inner intermediate material and the outer intermediate material in the article of modified MacManaway because Heller discloses that it is advantageous to use nonwoven membranes due to controllable porosities, fiber diameters, and pore sizes.
Claim(s) 22-23 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over McManaway (US 2017/0021286A1), in view of Minor et al. (US 6015610) as applied to claim 1 above, and further in view of Gebauer et al. (US 2017/0361245).
Regarding claims 22-23 and 25-26, modified McManaway teaches limitations of claim 1 as set forth above. Modified McManaway does not teach a manifold comprising at least two of the affinity chromatography devices of claim 1 arranged in a parallel configuration (Claim 22), wherein the manifold is enclosed within a housing (Claim 23), comprising a first manifold and a second manifold in a parallel configuration, wherein each of the first manifold and the second manifold includes at least two of the affinity chromatography devices of claim 1 (Claim 25), wherein the first manifold and the second manifold are enclosed within a housing (Claim 26).
Gebauer teaches a device for chromatographic separations comprising a manifold comprising a plurality of connectors for connecting to one or more chromatographic separation columns and/or feed or extraction tubing, or even to a mating connector on another manifold (refer abstract, [0013]). Gebauer teaches that one or more columns connected in parallel and/or in series (refer [0032]). Gebauer also teaches that the valves on the manifolds are controlled in such a way that the columns are subsequently subjected to the loading, washing, elution and all other steps involved in the process cycle (refer [0074]).
It would be obvious to one of ordinary skill that each manifold or multiple manifolds are enclosed within a housing to protect the manifolds from the surrounding environment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for modified McManaway to comprise a manifold comprising at least two of the affinity chromatography devices of claim 1 arranged in a parallel configuration (Claim 23), wherein the manifold is enclosed within a housing (Claim 24), comprising a first manifold and a second manifold in a parallel configuration, wherein each of the first manifold and the second manifold includes at least two of the affinity chromatography devices of claim 1 (Claim 25), wherein the first manifold and the second manifold are enclosed within a housing (Claim 26), as taught by Gebauer, as part of a continuous countercurrent purification of complex proteins using affinity chromatography, enabling a more efficient process and leading to significant savings in chemicals, solvents, and water. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that each manifold or multiple manifolds are enclosed within a housing to protect the manifolds from the surrounding environment.
Conclusion
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/PRANAV N PATEL/Primary Examiner, Art Unit 1777