DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. The Amendment filed January 15, 2026 in response to the Office Action of September 16, 2025 is acknowledged and has been entered. Claims 2, 4, 6, 7, 11, 12, 17 and 20 have been cancelled. Claims 1 8-10, 13, 14, and 16 have been amended. New claims 22 and 23 have been added.
2. Claims 1, 3, 5, 8-10, 13-16, 18, 19, and 21-23 are currently being examined.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
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.
3. Claims 1, 3, 5, 8-10, 13-16, 18, 19, and 21-23 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. This is a new matter rejection.
Claim 1 has been amended to recite “wherein the antibody formulation is substantially free of lactate, lactic acid, and methionine”.
Applicant argues that this amendment is supported by the fact that all exemplified inventive formulations omit methionine, lactate, and lactic acid.
Applicant’s argument has been considered, but has not been found persuasive. MPEP 2173.05(i) teaches that “[a]ny negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) . . . The mere absence of a positive recitation is not basis for an exclusion.” Only methionine is disclosed in the specification as filed. See, e.g., Tables 1 and 7. Thus new limitation of “wherein the antibody formulation is substantially free of lactate, lactic acid, and methionine” is new matter because the use of lactate and lactic acid in the formulations was not previously disclosed.
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.
4. Claims 1, 3, 5, 8-10, 13-16, 18, 19, and 21-23 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 1 has been amended to recite “wherein the antibody formulation is substantially free of lactate, lactic acid, and methionine”.
The term "substantially free of lactate, lactic acid, and methionine" in claim 1 is a relative term which renders claim 1 and its dependent claims indefinite. The term "substantially free of lactate, lactic acid, and methionine" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not teach at what point the formulation is considered to be substantially free of lactate, lactic acid, and methionine
Section 2171 of the M.P.E.P. states
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of applicant or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
In the instant case of “substantially free of lactate, lactic acid, and methionine”, one of skill in the art could find representative examples in the art which have been defined in such terms, however, it is unclear at what point one of skill in the art would be infringing on the claims without limitations as to the metes and bounds of “substantially free of lactate, lactic acid, and methionine”, and the amount of deviation acceptable under the term “substantially free of lactate, lactic acid, and methionine.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
5. Claim(s) 1, 3, 5, 8-10, 13-16, 18, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0239970 A1 (Bee et al. Aug. 27, 2015), “Bee” in view of WO 2019/105450 A1 (Lin et al June 6, 2019, of record), “Lin-450” or in view of US 2022/0071901 A1 (Lin et al March 10, 2022, of record)-Lin-901.
US 2022/0071901 A1 (Lin et al March 10, 2022, of record)-Lin-901 is the English language publication of the national stage of Lin-450 and will be cited for both Lin-450 and Lin-901. The rejection below applies to both Lin-901 and Lin-450.
Bee teaches a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of anti-IL6 antibody. Bee teaches the invention is directed to a stable, low viscosity antibody formulation comprising about 50 mg/mL to about 400 mg/mL of an anti-IL6 antibody, and arginine, wherein the antibody formulation is in an aqueous solution and has a viscosity of less than 20 cP at 23°C. See abstract and ¶¶ 0001, 0009 and 0010.
Bee teaches the anti-IL6 antibody can be tocilizumab. See ¶¶ 0047.
Tocilizumab comprises SEQ ID NOs: 1 and 2, See p. 2-2nd paragraph of the instant specification.
Bee teaches various concentrations of arginine can be used. In some embodiments, the antibody formulation comprises greater than 200 mM arginine. In some embodiments, the antibody formulation comprises greater than 220 mM arginine. In some embodiments, the antibody formulation comprises 150 mM to 400 mM arginine. See ¶¶ 0014 and 0018-0020.
Bee teaches using greater than 100 mM arginine, greater than 125 mM arginine, greater than 150 mM arginine, greater than 175 mM arginine, greater than 200 mM arginine. See ¶¶ 0067.
Bee teaches arginine includes arginine hydrochloride. See ¶¶ 0065.
Bee teaches the formulations include about 20 mM to about 30 mM histidine/histidine hydrochloride or about 5 mM to about 100 mM histidine/histidine hydrochloride. See ¶¶ 0015, 0018-0024, 0035, 0092 and 0094.
Bee teaches the formulations include about 0.01% (0.1mg/ml) to about 0.1% (1.0 mg/ml) polysorbate 80 or about 0.07% (0.7 mg/ml). polysorbate 80. See ¶¶ 0015, 0018-0020 and 0087.
Bee teaches the formulations include sucrose at various concentrations. See ¶¶ 0086, 0130 and 0134. See Table 3
Bee teaches the formulations include trehalose/trehalose dihydrate at about 10 mM to about 1000 mM, about 50 mM to about 500 mM, or about 100 mM to about 350 mM or 400 mM. See ¶¶ 0015, 0022-0023, and 0090. See Table 3.
Bee teaches the viscosity and stability was acceptable over the pH range of 5 to 6 with all combinations tested with pH 6.0 being optimal. See Example 3 and ¶ 0133.
Bee teaches increased arginine levels resulted in lower viscosity profiles. See ¶ 0136 FIG. 3 and FIG. 4.
Bee teaches the viscosity of the formulations decrease as the temperature increases. See Fig. 8.
Bee teaches administration by subcutaneous injection.
Bee teaches making pharmaceutical formulations. See ¶¶ 0061-0062 and 0065.
Bee teaches treating disease with the formulations like rheumatoid arthritis . See ¶¶ 0025, 0096, and 0098.
Bee teaches as set forth above but does not teach sucrose at 15-25 mg/ml or using sodium acetate buffer.
Lin-901 teaches the invention relates to a liquid formulation of humanized antibody for treating IL-6 related diseases. The liquid formulation contains 2-100 mg/ml recombinant humanized anti-human interleukin 6 receptor monoclonal antibody, 5-20 mM histidine salt buffer (or a buffer of a combination of 5-20 mM histidine salt and 5-20 mM sodium acetate), 0.025-0.075% (by volume) surfactant, and 3-5% (by mass to volume) stabilizer and water for injection. The antibody formulation enhances the stability of the recombinant anti-human interleukin 6 receptor monoclonal antibody, prevents the monoclonal antibody from aggregation, degradation, and acidic isomer increases. See abstract.
Lin-901 teaches an antibody formulation, characterized by comprising: (1) an antibody: 2-100 mg/mL humanized anti-IL-6 receptor antibody; (2) a buffer; (3) a surfactant: 0.1-1.0 g/L; (4) a stabilizer: 30-400 mM; (5) water for injection; a pH of the antibody formulation being 5.0-7.0; wherein a buffer system is formed in the formulation by a buffer, the buffer system being a buffer of 5-20 mM histidine salt, or a combination of 5-20 mM histidine salt and 5-20 mM sodium acetate; preferably, the concentration of the humanized anti-IL-6 receptor antibody is 10-90 mg/mL; more preferably, the concentration of the humanized anti-IL-6 receptor antibody is 15-50 mg/mL; particularly preferably, the concentration of the humanized anti-IL-6 receptor antibody is 18-25 mg/mL; preferably, the pH of the antibody formulation is 5.5-6.5; more preferably, the pH of the antibody formulation is 6.0-6.4; still more preferably, the pH of the antibody formulation is 6.2. See claim 1.
Lin-901 teaches the antibody formulation according to claim 1, characterized in that, the stabilizer is selected from a combination of arginine hydrochloride and sucrose, or mannitol, or sodium chloride; preferably, the stabilizer is selected from a combination of 40-200 mM arginine hydrochloride and 15-70 g/L sucrose; or preferably, the stabilizer is selected from 30-70 g/L mannitol; or yet preferably, the stabilizer is selected from 100-300 mM sodium chloride; preferably, the surfactant is selected from one or more of polysorbate-20, polysorbate-80 and poloxamer 188; more preferably, the surfactant is selected from polysorbate-80; more preferably, the surfactant is selected from 0.1-0.7 g/L polysorbate-80. See claim 3.
Lin-901 teaches the antibody formulation according to claim 1, comprising the following ingredients: (1) 18-22 mg/mL humanized anti-IL-6 receptor antibody; (2) 8-15 mM histidine salt buffer solution; (3) 0.45-0.65 g/L polysorbate-80; (4) 40-60 mM arginine hydrochloride; (5) 15-25 g/L sucrose; (6) water for injection; a pH being 6.0-6.4. See claim 4.
Lin-901 teaches the antibody BAT1806 comprises two heavy chains shown in SEQ ID NO. 1 and two light chains shown in SEQ ID NO. 2. See ¶ 0017. BAT1806 comprises the claimed SEQ ID NO: 1 and 2. See p. 2-2nd paragraph of the instant specification.
Lin-901 teaches the antibody formulation according to claim 1, characterized in that, the pharmaceutical dosage form of the antibody formulation is an injection formulation; preferably, the formulation is a subcutaneous injection formulation or an intravenous injection formulation. See claim 7.
Lin-901 teaches the antibody formulation according to claim 1, characterized in that, the formulation remains stable for at least one month at room temperature; preferably, the formulation remains stable for at least 36 months at 2-8° C.; preferably, the formulation remains stable after at least 5 freeze-thaw cycles. See claim 8.
Lin-901 teaches measuring the stability of the antibody, including antibody fragments thereof, can be assessed by measuring the degree of aggregation, degradation or fragmentation and the like of the formulation by techniques such as SEC-HPLC, IEC-HPLC, CE-SDS, etc. See ¶ 0140.
Lin-901 teaches the antibody formulation according to claim 1, characterized in that, wherein the antibody formulation is a pharmaceutical formulation for treating IL-6 related diseases; preferably, the IL-6 related diseases include: adult rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, giant lymph node hyperplasia, cytokine storms caused by immunotherapy, adult Still's disease, recurrent polychondritis, type II diabetes, ankylosing spondylitis, thyroid-associated ophthalmopathy, cardiovascular disease caused by rheumatoid arthritis, polymyalgia rheumatica, acute graft-versus-host disease, non-ST-segment elevation myocardial infarction, systemic lupus erythematosus, schizophrenia, uveitis, ovarian cancer, anti-neutrophil cytoplasmic antibody-associated vasculitis, neuromyelitis optica, chronic glomerulonephritis, and colorectal cancer; more preferably, the IL-6 related diseases include: adult rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and giant lymph node hyperplasia. See claim 9.
Lin-901 teaches a method to prepare the antibody formulation according to claim 1, characterized by comprising the steps of: (1) dissolving a weighed buffer, a stabilizer and a surfactant in water for injection; (2) adjusting the liquid prepared in the step (1) with an aqueous sodium hydroxide until the pH is 5-7; preferably, the concentration of aqueous sodium hydroxide is 1 M; (3) filtering the liquid prepared in the step (2) into an aseptic container; preferably, the pore size of the filter membrane is 0.22 um; and (4) adding the liquid prepared in the step (3) into an antibody solution. See claim 10.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Bee and Lin modify the components of the formulation taught by Bee and Lin concentrations thereof to optimize the viscosity and stability of the tocilizumab for various conditions and uses such as at different temperatures. Additionally, one would have been motivated to optimize the order of combining and mixing tocilizumab with the components of the formulations of Bee and Lin to optimize the dissolution of all of the components into the diluent of the formulation.
Response to Arguments
In the remarks Applicant argues:
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Applicant’s arguments have been considered, but have not been found persuasive. The description of contents the Formulations used in the Examples, other than Formulation 3, are not clearly describe. Additionally Formulation 3 appears to comprise 900 mM arginine hydrochloride, 200 mg/mL sucrose (see p. 10-2nd paragraph), which is outside of the claimed ranges for those components. Thus, relevance of the formulation data in the Examples for determining the non-obviousness of the claimed invention cannot readily be determined given the lack of description of the formulations used.
Additionally, the evidence of nonobviousness must be commensurate in scope with the claims to rebut the prima facie case of obviousness. See MPEP 716.02 (d). The claims encompass a large genus of IL-6 antibody formulations with various concentrations of different components of the formulation. However, only three antibody formulations were examined and compared in the specification. Further, the evidence in the Examples does not clearly show significant differences in properties amongst the different formulations examined. The presented evidence is not commensurate in scope with the claimed invention and is not sufficient to support Applicant’s assertion of non-obviousness of the claimed invention. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. Thus, the rejection is maintained.
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.
6. Claims 1, 3, 5, 8-10, 13-16, 18, 19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/045,946 (published as US 2023/0190649 A1) in view of US 2015/0239970 A1 (Bee et al. Aug. 27, 2015), “Bee” and in view of WO 2019/105450 A1 (Lin et al June 6, 2019, of record), “Lin-450”.
This is a provisional nonstatutory double patenting rejection.
The ‘946 claims are drawn to:
1. An antibody formulation, characterized by comprising:
(1) an antibody:-2-100 mg/mL of a humanized anti-IL-6 receptor antibody comprising a heavy chain shown in SEQ ID NO. 1 and a light chain shown in SEQ ID NO. 2;
(2) a buffer system comprising 5-20 mM histidine salt;
(3) a surfactant comprising 0.45-0.65 g/L polysorbate-80:
(4) a stabilizer comprising a combination of 40-200 mM arginine hydrochloride and 15-
70 g/L sucrose; (5) water for injection; and having a pH of 6.0-6.4.
4. The antibody formulation, according to claim 1 comprising: (1) 18-22 mg/mL humanized anti-IL-6 receptor antibody; (2) 8-15 mM histidine salt buffer solution; (3) 0.45-0.65 g/L polysorbate-80; (4) 40-60 mM arginine hydrochloride; (5) 15-25 g/L sucrose; (6) water for injection; and having a pH being 6.0-6.4.
5. The antibody formulation according to claim 1 comprising the following ingredients: (1) 20 mg/mL humanized anti-IL-6 receptor antibody; (2) 10 mM histidine salt buffer; (3) 0.5 g/L polysorbate-80; (4) 50 mM arginine hydrochloride; (5) 20 g/L sucrose; (6) water for injection; and a pH being 6.2;.
6. The antibody formulation according to claim 1, characterized in that, wherein the formulation also comprises a base.
7. The antibody formulation according to claim 1, characterized in that, the pharmaceutical dosage form of the antibody formulation is an injection formulation.
8. The antibody formulation according to claim 1, characterized in that, the formulation remains stable for at least one month at room temperature.
9. A method for treating an IL-6-related disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the antibody formulation according to claim 1, wherein the IL-6-related disease is selected from adult rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine storms caused by immunotherapy and adult Still's disease.
12. The antibody formulation according to claim 1, wherein the concentration of the humanized anti-IL-6 receptor antibody is 10-90 mg/mL.
13. The antibody formulation according to claim 1, wherein the concentration of the humanized anti-IL-6 receptor antibody is 15-50 mg/mL.
14. The antibody formulation according to claim 1, wherein the concentration of the humanized anti-IL-6 receptor antibody is 18-25 mg/mL.
15. The antibody formulation according to claim 1, wherein the pH of the antibody formulation is 5.5-6.5.
The ‘946 SEQ ID NOs: comprise the claimed SEQ ID NO: 1 and 2. See Appendix of the Office Action of September 16, 2025
The ‘946 claims teach as set forth above, does not teach making and using the humanized anti-IL-6 receptor antibody at a concentration of 160-200 mg/ml.
Bee and Lin-450 teach as set forth above
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘946 claims, Bee and Lin-450 and use a dose of tocilizumab in the range of about 50 mg/mL to about 400 mg/mL taught by Bee because Bee teaches that stable, low viscosity antibody formulation can be made with these concentrations of antibodies. One would have been motivated to modify the components of the formulation taught by the ‘946 claims Bee and Lin-450 and concentrations thereof to optimize the stability and viscosity of the humanized anti-IL-6 receptor antibody for various conditions and uses such as at different temperatures.
Conclusion
7. All other objections and rejections recited in the Office Action of September 16, 2025 are withdrawn in view of Applicant’s amendments and arguments.
8. No claims allowed.
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch, can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter J Reddig/
Primary Examiner, Art Unit 1642