DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-20 are pending.
The election of adalimumab as the species of antibody in the reply filed on 12/1/25 is acknowledged. Applicants indicate claims 1-20 read on the elected species.
Claims 1-20 are under consideration.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent application 16/477,187.
Specification
The disclosure is objected to because of the following informalities:
The title of the invention, "Stable Liquid Formula", is not descriptive because it is directed to a stable liquid formula comprising any components, but the claimed formula is limited to specific components. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Stable Liquid Formula comprising an Anti-TNFα Antibody, Acetate Buffer and Glycine.
Appropriate correction is required.
Claim Objections
Claims 2-3, 7 and 17-18 are objected to because of the following informalities:
In claim 2, line 2, “measured to through” should be “measured through”.
In claim 2, line 3, the acronym “SE-HPLC” should be accompanied by the full terminology the first time it is used in a series of claims; e.g., “high performance liquid chromatography (SE-HPLC)”. See the specification at ¶ 95, and compare with claim 1.
In claim 3, line 5, “measured to be through” should be “measured through”.
In claim 3, line 14, the acronym “NR CE-SDS” should be accompanied by the full terminology the first time it is used in a series of claims; e.g., “non-reduced capillary electrophoresis-sodium dodecyl sulfate (NR CE-SDS)”. See the specification at ¶ 111.
In claim 7, line 1, “the acetate buffer 1 to 30 mM” should be “the acetate buffer has a concentration of 1 to 30 mM”. Compare with claim 9.
In claims 17 and 18, in part (b) of each, “an acetate” should be “acetate” and in part (c) of each, “a glycine” should be “glycine”. Compare with claim 19.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
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.
Claims 1-20 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 pre-AIA the applicant regards as the invention.
Independent claim 1 is directed to a liquid formulation, which is a product, but lines 8-10 limit the composition by way of a method step to be performed, i.e., “which is measured through micro flow imaging (MFI) after storage at a temperature of 40°C±2°C”. This limitation renders the claim a single claim which claims both a product and a method step of using said product, which per MPEP 2173.05(p) is indefinite under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Per MPEP 2173.05(p):
See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to "[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited "an input means" and required a user to use the input means was found to be indefinite because it was unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.")
In the instant claim, the claim limitations directed to making a measurement of the formulation using MFI after storing it for a period of time, is not directed to the product itself but rather to an active step (“is measured”) taken by a practitioner, which creates confusion as to when direct infringement occurs. It is unclear whether the claims are limited to the formulation in and of itself without the measurement being taken.
Claim 2 limits the formulation of claim 1 to one having a high-molecular-weight component content of 0 to 1.4%, measured by SE-HPLC after storage at a temperature of 45°C±2°C for 3 weeks. However, parent claim 1 already limits the formulation to one that has a measurement taken after storage at a different temperature, 40°C±2°C, for 6 weeks. It is unclear how the formulation can be store at both 45°C±2°C and 40°C±2°C during the same time period.
Claims 2 and 3 are indefinite for the same reasons as claim 1 with respect to including a measuring limitation that renders the claim a single claim which claims both a product and a method step of using said product, which per MPEP 2173.05(p) is indefinite under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Claim Rejections - 35 USC § 112(a), written description
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 1-18 and 20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Per MPEP 2163, 35 U.S.C. 112(a) requires, “separate and distinct from the enablement requirement”, that the “specification shall contain a written description of the invention…” (Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010)). In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a), it is necessary to understand what Applicants are claiming and what Applicants have possession of.
The instant claims are directed to a product that is a liquid formulation having four components: (A) an antibody; (B) an acetate buffer; (C) the amino acid glycine; and (D) a surfactant. The following components are also excluded from being present in the formulation: sucrose, trehalose, mannitol, sorbitol and NaCl. Additionally, the formulation is limited by a physical property related to the stability of the antibody during storage at a warm temperature; specifically, the formulation is limited to having 0-10,000 sub-visible particles, as measured through micro flow imaging (MFI), following storage at a temperature of 40°C±2°C for 6 weeks. The instant specification defines sub-visible particles as between 1.00-100.00 µm in size (¶ 103, published application).
Independent claim 1 broadly encompasses a formulation having any concentration of the four components, and also exhibiting the required storage stability. Dependent claims 2 and 3 recite further required physical properties reflecting stability. Claim 4 limits the antibody to one selected from a group including adalimumab, and claim 5 limits the antibody to one having the CDRs, defined by amino acid sequence, that are found in adalimumab. Claims 6, 7, 9, 13, 17 and 18 limit the concentrations of the four components to various ranges, including 50-150 mg/mL for the antibody, 1 to 30 mM for the acetate, 100 to 300 mM for the glycine, and 0.01 to 1% (w/v). Claims 8, 10, and 16 further exclude specific buffering agents, amino acids, preservatives or chelating agents. Claims 11 and 12 limit the type of surfactant. Claim 15 limits the osmolality of the formulation. Claim 20 recites an intended use for the formulation, that it is for subcutaneous administration.
Thus, the claims are genus claims because they encompass a genus of formulations having varying concentrations of four components, and also have the required physical property. In the instant case, the physical property is a functional result of the stability of the antibody in the formulation, and thus this result is analogous to a functional limitation. A product defined by a a physical property resulting from a function (i.e., storage stability) is not in and of itself sufficient to describe the product because it is only an indication of how the product behaves, rather than what it is; i.e., the specific structure of the product. It is only a definition of a useful result rather than a definition of what achieves that result. Per MPEP 2124, "describing a composition by its function alone typically will not suffice to sufficiently describe the composition".
Written description for a genus may also be satisfied through sufficient description of a relevant number of species. This is dependent on whether one of skill in the art would recognize necessary common attributes or features possessed by the members of the genus. Generally, in an unpredictable art, adequate description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Also, “[w]hen a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)). “[A] sufficient description of a genus … requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69).
In support of the claimed genus, the specification provides only two examples of formulations stored at 40°C for 6 weeks, and exhibiting sub-visible particles in the specified range. These are the formulations labeled Example 1 (E1) and 2 (E2), which are described in Table 1 as having 100 mg/mL of the antibody adalimumab; 10 mM of sodium acetate; 250 mM (Example 1) or 280 mM (Example 2) of glycine; and 0.1% (w/v) of the surfactant Polysorbate 80. After storage at the specified conditions, these formulations had 4,973 (Example 1) or 7,115 (Example 2) sub-visible particles. Other tested formulations, including “Comparative Example” (CE) 6 and 7 had far more sub-visible particles, i.e., 51,914 and 37,751. CE 6 had less antibody (50 mg/mL) completely different components (C) and (D), i.e., (C) was NaCl and Mannitol, and (D) was sodium phosphate and sodium citrate, but CE7 was identical to E1 and E2 except for having 310 mM glycine. This demonstrates that a formulation of claim 1 having 310 mM glycine does not exhibit physical property required by the claims. The specification does provide any evidence showing, or teaching describing, how lower amounts of glycine, i.e., below 250 mM, affect the number of sub-visible particles. There is no description of the minimum amount of glycine that is required to provide the requisite storage stability. Furthermore, there is no description of how the changing the concentrations of antibody, acetate buffer or surfactant from those used in Example 1 will affect the stability. Instead, the specification merely states that the concentrations of the antibody (¶ 51), acetate buffer (¶ 54) or surfactant (¶ 60) “may be freely adjusted within a range that has substantially no adverse influence on the stability and viscosity of the stable liquid formulation according to the present invention” (¶ 51, 54, 60). The specification further teaches that glycine “may act as a stabilizer” and states that when the amount of glycine is in a range of 100 mM to 300 mM, “the osmolality, stability (sub-visible particles) and viscosity of the formulation may become superior”, but fails to provide any evidence of this outside of the exemplary formulations having 250 and 280 mM. The observation that 310 mM of glycine, which is just 30 mM more than one of the examples, provides evidence that even relatively small changes in the concentration of one of the components may drastically affect the stability of the composition.
A description of a physical property of two species of formulations having particular concentrations of four components is not representative of the physical properties of the entire genus of formulations having any concentration of any of the four components. The description does not correspond in scope to what is claimed. Per MPEP 2163, "A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (pg 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (pg 1116).
Therefore, only a liquid formulation: (A) 100 mg/ml of an antibody; (B) 10 mM acetate; (C) 250-280 mM glycine; and (D) 0.1% (w/v) of a surfactant, wherein the liquid formulation does not comprise sucrose nor trehalose nor mannitol nor sorbitol nor NaCl, and wherein the formulation has 0-10,000 sub-visible particles, as measured through micro flow imaging (MFI) after storage at a temperature of 40°C±2°C for 6 weeks, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112(a). Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (pg 1115).
Claim Rejections - Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,986,523, issued 3/6/21, and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation from application 17/202,982, from which the ‘523 patent issued.
Instant claim 1 encompasses a liquid formulation, comprising an antibody, an acetate buffer, glycine, a surfactant, wherein the liquid formulation does not comprises sucrose, trehalose, mannitol, sorbitol or NaCl, and wherein a number of sub-visible particles in the formulation is 0 to 10,000, which is measured through micro flow imaging (MFI) after storage at a temperature of 40°C±2°C for weeks.
Claim 1 of ‘523 also encompasses a liquid formulation, comprising an antibody, an acetate buffer, glycine and a surfactant, wherein the liquid formulation does not comprises sucrose, trehalose, mannitol, sorbitol or NaCl, but where the antibody is at a concentration of 50-150 mg/mL, the glycine is at a concentration of 210-300 mM, and the formulation has an osmolality ranging from 200 to 400 mmol/kg. Thus, claim 1 of ‘523 meets all of the limitations of instant claim 1, except for the final “wherein” clause directed to sub-visible particles. However, the formulation of claim 1 of ‘523 would include compositions having this property, as evidenced by the working examples of the specification, which demonstrate that a solution having antibody and glycine concentrations in this range have sub-visible particle numbers under 10,000 when stored as specified; see the results for in Table 11 in column 19. As such, claim of ‘523 anticipates instant claim 1, and the two sets of claims are not patentably distinct.
Instant claim 3 encompasses a formulation of claim 1 having one of five other properties, including a high-molecule weight component content in the formulation of 0 to 0.9%, which is measured through SE-HPLC after storage at a temperature of 40°C±2°C for weeks. Again, the formulation of claim 1 of ‘523 would inherently have this property, as evidenced by the working examples of the specification, which demonstrates that a solution having antibody and glycine concentrations in this range would have this property; see Table 6 in column 18.
Claim 4 encompasses a formulation of claim 1 wherein the antibody comprises adalimumab. Claim 2 of ‘523 further limits the antibody to one comprising a set of CDRs that are from adalimumab. As such, the two sets of claims are not patentably distinct.
Instant claims 6, 9 and 15 recite further limitations directed to the concentration of the antibody being at 50-150 mg/ml (claim 6), the concentration of glycine being at 100-300 mM (claim 9), or the osmolality of the formulation being at 200-400 mmol/kg. Each of these limitations are met by further limitations found in independent claim 1 of ‘523, and thus these claims are also not patentably distinct from those of ‘523.
Instant claims 5, 7-16 and 20 depend from claim 1 and further limit the respective parent claim to embodiments that correspond to the further limitations of the antibody of the dependent claims of ‘523 as follows:
Instant Claim
Claim of ‘523
5
2
7
3
8
4
10
5
11
6
12
7
13
8
14
9
16
10
20
12
As such, the method of these instant dependent claims are also anticipated by the corresponding claims of the ‘523 patent, and as such these instant claims are also not patentably distinct from the claims of ‘523.
Instant claims 17 and 18 each depend from claim 1 and further limit the formulation to a combination of limitations that represent embodiments that are also encompassed by the claims of ‘523, as evidenced by each these limitations corresponding to dependent limitations expressly recited in the claims of ‘523. Specifically, instant claim 17 combines the limitations of claims 1, 3, and 8 of ‘523, and claim 18 combines the limitations of claims 1, 2, 3 and 8 of ‘523.
Instant claim 19 recites the same further limitations as instant claim 18, except that each component is limited to a specific concentration in the recited range; specifically; 100 mg/mL of the antibody; 10 mM of acetate in the acetate buffer; 250 mM of glycine, and 0.1.% (w/v) of the surfactant. While ‘523 does not include claims directed to these specific concentrations, each falls within the ranges recited in the claims of ‘523, and it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use 100 mg/ml adalimumab; an acetate buffer comprising 10 mM acetate, 250 mM glycine, and 0.1% (w/v) surfactant. Per MPEP 2144.05, "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). As further set forth in MPEP 2144.05, “[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).
Claims 1 and 3-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,980,881, issued 4/20/21 (cited on the 4/17/24 IDS), and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation from application 17/202,982, which in turn claims priority as a continuation to application 16/477,187, from which the ‘881 patent issued.
Instant claim 1 encompasses a liquid formulation, comprising an antibody, an acetate buffer, glycine, a surfactant, wherein the liquid formulation does not comprises sucrose, trehalose, mannitol, sorbitol or NaCl, and wherein a number of sub-visible particles in the formulation is 0 to 10,000, which is measured through micro flow imaging (MFI) after storage at a temperature of 40°C±2°C for weeks.
Claim 1 of ‘881 also encompasses a liquid formulation, comprising an antibody, an acetate buffer, glycine and a surfactant, wherein the liquid formulation does not comprises sucrose, trehalose, mannitol, sorbitol or NaCl, but where the antibody is an antibody that binds to TNFα, the glycine is at a concentration of 210-300 mM, and the formulation has an osmolality ranging from 200 to 400 mmol/kg. Thus, claim 1 of ‘881 meets all of the limitations of instant claim 1, except for the final “wherein” clause directed to sub-visible particles. However, the formulation of claim 1 of ‘881 would include inherently have this property, as evidenced by the working examples of the specification, which demonstrate that a solution having glycine concentrations in this range have sub-visible particle numbers under 10,000 when stored as specified; see the results in Table 11 in columns 19. Specifically, the composition of dependent claim 15 having 100 mg/ml of antibody; acetate buffer comprising 10 mM acetate; 250 mM glycine and 0.1% (w/v) of surfactant, would have this property as evidenced by the results for the formulation labeled “Example 1” that are shown in Table 11 of the specification. As such, claim of ‘881 anticipates instant claim 1, and the two sets of claims are not patentably distinct.
Instant claim 3 encompasses a formulation of claim 1 having one of five other properties, including a high-molecule weight component content in the formulation of 0 to 0.9%, which is measured through SE-HPLC after storage at a temperature of 40°C±2°C for weeks. Again, the formulation of claim 1 of ‘881 would inherently have this property, as evidenced by the working examples of the specification, which demonstrates that a solution having antibody and glycine concentrations in this range would have this property; see Table 6 in column 18.
Instant claims 9 and 15 recite further limitations directed to the concentration of glycine being at 100-300 mM (claim 9), or the osmolality of the formulation being at 200-400 mmol/kg. Each of these limitations are met by further limitations found in independent claim 1 of ‘881, and thus these claims are also not patentably distinct from those of ‘881.
Instant claims 4, 5-8, 10-14 and 16-20 depend from claim 1 and further limit the respective parent claim to embodiments that correspond to the further limitations of the antibody of the dependent claims of ‘881 as follows:
Instant Claim
Claim of ‘881
4
2
5
3
6
4
7
5
8
6
10
7
11
8
12
9
13
10
14
11
16
12
17
13
18
14
19
15
20
16
As such, the method of these instant dependent claims are also anticipated by the corresponding claims of the ‘881 patent, and as such these instant claims are also not patentably distinct from the claims of ‘881.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674