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 Acknowledgement is hereby made of receipt and entry of the communication filed on Dec. 07, 2023. Claims 1-15 are pending and are examined. 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 1-15 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. These claims recite a term “about” that renders the claims indefinite. It is unclear what the concentration range of “about” is. The instant specification discloses that “a s used herein, "about" means within a statistically meaningful range of a value or values such as, for example, a stated concentration, length, molecular weight, pH, sequence identity, time frame, temperature or volume. Such a value or range can be within an order of magnitude typically within 20%, more typically within 10%, and even more typically within 5% of a given value or range. The allowable variation encompassed by "about" will depend upon the particular system under study, and can be readily appreciated by one of skill in the art ”. However, this disclosure indicates “about” varies under different conditions such as pH, concertation, different system, etc. Accordingly, t he specification does not clarify and define the “ about ” such that one of ordinary skill in the art would know what the claimed “about” is. Therefore, one of ordinary skill in the art will not know the metes and bounds of the claims. Claim Rejections - 35 USC § 112 (Enablement) 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 14-15 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Claims 14-15 contain subject matter which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Enablement is considered in view of the Wands factors (MPEP 2164.01(a)) (1) the nature of the invention, (2) the state of the prior art, 3) the breadth of the claims, (4) the amount of guidance in the specification, (5) the presence or absence of working examples, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and 8) and the quantity of experimentation necessary. A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Claims 14-15 are directed to a method of treating 2019 novel coronavirus (2019-nCoV) infection or COVID-19 ( claim 14 ) and a method of preventing 2019 novel coronavirus (2019-nCoV) infection or COVID-19 in an individual ( claim 15 ) through administration of the pharmaceutical formulation as claimed. The instant specification teaches that “a s used herein, "treat," "treatment" or "treating" means managing and caring for an individual having or suspected of having a condition for which formulation administration is indicated for the purpose of combating or alleviating symptoms and complications of its infection. Treating includes administering a compound, composition or formulation including the active ingredient herein (e.g., an Ab) to such an individual to prevent the onset of symptoms or complications, alleviating the symptoms or complications, or eliminating the infection. Treating includes administering a compound, composition or formulation including the active ingredient herein (e.g. , an Ab) to an individual in need thereof to result in an attenuated or blocked 2019-nCOV infection. The individual to be treated is an animal, especially a human being ” (See [0046]). Also, the instant specification discloses that “as used herein, "patient," "subject" and "individual," are used interchangeably herein, and mean an animal, especially a human. In certain instances, the individual is a human and is further characterized with an infection that would benefit from administration of the formulation herein ” (See [0047]) , and “i n other instances, the individual is at risk for exposure to 2019-nCOV. In other instances, the individual is recently exposed to 2019-nCoV infection (i.e., but not yet having a confirmed 2019-nCoV infection) ” (See [0022]). However, the instant specification does not provide any evidence for supporting the treatment and prevention including the administration step and treatment evaluation and prevention assessment. In their two examples, the instant specification only discloses the formulation preparation (See [0075]- [0084]) and the formulation stability studies including the Freeze/Thaw Stability tests (See e.g., [0085] – [ 0088]), where there is no evidence /experiments to support the claimed method using the claimed pharmaceutical formulation to treat and prevent the Covid-19 infection diseases. Also, b ased on the instant specification, it discloses that the subject can be animal or human , or individual at-risk for exposure or exposed to 2019-nCoV , however, there is no experimental support if the claimed formulation and administration can work on the different subjects the same or differently. Thus, the instant specification does not provide evidence to support a method for treating and preventing 2019 novel coronavirus (2019-nCoV) infection or COVID-19 in an individual . Accordingly, when all the aforementioned factors are considered in total, it would require undue experimentation for one skilled in the art to practice the full scope of claimed invention as defined by instant claims. Therefore, claims 14-15 were rejected under 35 USC § 112 (Enablement). 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. Claims 1-3, 5 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over EMA (Assessment report, 16 March 2021, https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/eli-lilly-company-limited-antibody-combination-bamlanivimab-etesevimab-covid19-article-53-procedure-assessment-report_en.pdf ) . The base claim 1 is directed to a pharmaceutical formulation comprising: a 2019 novel coronavirus (2019-nCoV) antibody at a concentration from about 30mg/ml to about 150 mg/ml; a histidine buffer at a concentration from about 5 mM to about 40 mM; sucrose at a concentration from about 8.0% (w/v) to about 8.5% (w/v); and a polysorbate 80 at a concentration from about 0.02% (w/v) to about 0.08% (w/v), wherein the pharmaceutical composition has a pH from about 5.5 to about 7.0. EMA teaches two antibodies that can treat SRAS-COV-2, bamlanivimab and etesevimab. Bamlanivimab is a neutralizing immunoglobulin (IgG)-1 monoclonal antibody (mAb) to the Spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is being evaluated for treatment and prophylaxis for COVID-19 and etesevimab is a fully human IgG1 antibody that shows potent neutralization of live virus in vitro, high binding affinity to the viral S protein, and will be manufactured employing a similar Chemistry, Manufacturing, and Control (CMC) strategy to bamlanivimab . Bamlanivimab and etesevimab bind different but overlapping epitopes in the RBD region of the S protein. (See bridging pages 3 and 4). EMA teaches that Bamlanivimab and Etesevimab finished products are presented as concentrates for solution for infusion in separate vials. Each vial contains 700 mg of each monoclonal antibody in 20 mL, corresponding to a concentration of 35 mg/mL) that is in a range of the claimed antibody concentration “from about 30 mg/ml to about 150 mg/ml ” and also teaches claims 2 and 3 . Bamlanivimab and Etesevimab are formulated with a L-histidine buffer, sucrose, polysorbate 80, sodium chloride and water for injection. The formulations do not contain preservatives (See page 62, 2.4.1 Introduction) . EMA further teaches that the excipients - L-histidine and L-histidine hydrochloride monohydrate in a buffer with target pH 6.0 (See page 65, 2.4.3. Finished Medicinal Product) , where the pH is in the range as claimed pH is from about 5.5 to about 7.0 , and also teaches claim 5 that requires the pH is about 6.0 . Although EMA does not explicitly point out the concentrations of histidine, sucrose and polysorbate 80 present in the formulation, according to section 2144.05 of the MPEP, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). See also Peterson , 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”). Since EMA teaches that the histidine, sucrose and polysorbate 80 are the components in the formulation with a claimed antibody concentration and pH, one of ordinary skills would be able to test for an optimal concentration for the histidine, sucrose and polysorbate 80 through routine experimentation. Therefore, the claimed concentration values of histidine, sucrose and polysorbate 80 would have been obvious unless there is evidence showing that they produce unexpected results. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Regarding claim 13, it requires the pharmaceutical formulation of Claim 1 further comprising one or more additional 2019-nCoV antibodies. EMA teaches that in more recent results, the effects of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate Covid-19 were presented. The treatment with a combination of bamlanivimab and etesevimab significantly decreased SARS-CoV-2 viral load at day 11 compared with placebo (between-group difference, –0.57 [95% CI, –1.00 to –0.14], P = 0.01) (See page 4 , paragraph 4). Regarding claim 14, it requires a method of treating 2019 novel coronavirus (2019-nCoV) infection or COVID-19 comprising the step of administering to an individual having a 2019-nCoV infection an effective amount of the pharmaceutical formulation of claim 1. EMA teaches that the study population including female and male patients, aged ≥ 18 years, who tested positive for SARS-COV-2 infection (See page 9) and Bamlanivimab was administered to these patients in doses of 700 mg (101 patients), 2800 mg (107 patients), or 7000 mg (101 patients). Dose levels were fixed, and either bamlanivimab or placebo was administered within 3 days after positive results on SARS-CoV-2 testing (See page 10). Regarding claim 15, it requires that a method of preventing 2019 novel coronavirus (2019-nCoV) infection or COVID-19 in an individual comprising the step of administering to an individual at-risk for exposure or exposed to 2019-nCoV an effective amount of the pharmaceutical formulation of claim 1. Based on the description above, EMA teaches a pharmaceutical formulation containing antibody that are neutralizing immunoglobulin (IgG)-1 monoclonal antibody (mAb) to the Spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is being evaluated for treatment and prophylaxis for COVID-19 (See page 3), and discloses that the treatment and prevention of SARS - COV-2 infection is through the administration at “ each patient received a single intravenous infusion of bamlanivimab or placebo monotherapy over approximately 1 hour. Bamlanivimab was administered to these patients in doses of 700 mg (101 patients), 2800 mg (107 patients), or 7000 mg (101 patients)” (See page 10), where the patients are tested positive for SARS-COV-2 infection (exposed) ( See page 9, paragraph 2), and discloses that in the phase-3 part of the study, treatment with etesevimab and bamlanivimab combination therapy reduced the percentage of participants with persistent high viral load (PHVL) compared to placebo (See page 39). Ema also teaches the high-risk individual being include in the study at “ according to the latest protocol version (Amendment L), the following inclusion criteria were used in order to characterize the higher risk population that was included in the phase 3 portion of the study PYAB (treatment arms 7 and 8) ” (See page 9). Claims 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over EMA as applied to claims 1-3, 5 and 13-1 5 above and further in view of Strickley et al. (J Pharm Sci. 2021 Jul;110(7):2590-2608.e56. Epub 2021 Mar 28, hereinafter “Strickley”) and Liu et al. (WO2021249548A1, published on Dec. 16, 2021, Prior Filing Date June 12, 2020, hereinafter Liu) and Westendore et al. (WO2021183195A1, published on Sep. 16, 2021, international filling date Dec. 09, 2020). Claims 4 and 6-7 require a specific concentration for histidine buffer concentration is about 20 mM ( claim 4 ), sucrose concentration is at a concentration of about 8.05% (w/v) ( claim 6 ) and polysorbate 80 is at a concentration of about 0.05% (w/v) ( claim 7 ). Based on the description above, EMA teaches the reagents of histidine, sucrose and polysorbate 80 in the pharmaceutical formulation. However, it does not point out a specific concentration. Liu teaches a pharmaceutical composition of novel coronavirus antibody and their use (Se Abstract) and discloses that different concentrations of histidine, sucrose and polysorbate 80 used in the composition like: “(a) About 40 mg/mL humanized monoclonal antibody or its antigen-binding fragment; (b) About 20 mM histidine buffer, pH about 6.0; (c) About 235 mM or about 247 mM mannitol ; (D) and about 0.02% of polysorbate 80” (See page 2, paragraph 1), where the 20 mM histidine buffer teaches claim 4 and the concentration of sucrose and polysorbate 80 are varies. Liu also teaches the pharmaceutical composition can treat and prevent COVID-19 infection by injection (See e.g., page 5). Strickley reviewed the formulations of commercially available antibodies and teaches Casirivimab and imdevimab are available in separate vials and were approved in 2020 for the emergency use authorization treatment of mild to moderate COVID-19 (See page 2597, left column, paragraph 3). Strickley teaches an intravitreal administration formula at 120 mg/mL brolucizumab-dbll, 58 mg/mL sucrose, 0.2 mg/mL polysorbate 80, and pH 7.2 sodium citrate 0.01M buffer. Lucentis is a solution with 10 mg/mL ranibizumab, 100 mg/mL trehalose, 0.1 mg/mL polysorbate 80, and pH 5.5 histidine 0.01M buffer (See page 2597, left column). Westendorf teaches antibodies that binding SARS-Co V spike protein, SARS-Co V-2 spike protein, and methods of using same for treating or preventing conditions associated with SARS or COVID-19 (See Abstract) and discloses pharmaceutical composition comprises histidine, sodium chloride, sucrose, and polysorbate 80. In particular embodiments, the pharmaceutical composition has a pH of about 6.0. In particular embodiments, the pharmaceutical composition comprises 5 mM histidine, 50 mM NaCl, 6% sucrose, 0.05% polysorbate 80 and has a pH of about 6.0 (See [0074]). Based on the description above, each of Liu, Strickley and Westendorf teaches the concentrations of histidine, sucrose and polysorbate 80 even though the amounts of the concentrations vary, and some of the teachings match the histidine buffer concentration at about 20 mM and polysorbate 80 at a concentration of about 0.05% as claimed in the claims. It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from EMA, Liu, Strickley and Westendorf to arrive at an invention as claimed. Based on the description above, the concentration of histidine, sucrose and polysorbate 80 in a pharmaceutical formula varies based on different antibody, pH, administration route and etc. One of skill in the art would have been motivated to combine the teaching s of Liu, Strickley and Westendorf with EMA’s formula to develop a specific concentration as claimed. There would be a reasonable expectation of success to develop such pharmaceutical formulation based on the teachings from EMA, Liu, Strickley and Westendorf. In addition, according to section 2144.05 of the MPEP, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”). Here, based on the combination teachings of EMA, Liu, Strickley and Westendorf for the claims 4, 6 and 7, one of ordinary skills would be able to test for the claimed concentration for the histidine, sucrose and polysorbate 80 through routine experimentation. Therefore, the claimed concentration values of histidine, sucrose and polysorbate 80 would have been obvious unless there is evidence showing that they produce unexpected results. Claims 9-10 a re rejected under 35 U.S.C. 103 as being unpatentable over EMA as applied to claims 1-3, 5 and 13-1 5 above and further in view of Yan et al. (US 2023/0073067 A1, published on Mar. 09, 2023, PCT filed on Feb. 23, 2021, hereinafter “Yan”). The claims 9-10 require a 2019-nCoV antibody comprises a heavy chain variable region (HCVR) comprising SEQ ID NO:7, and a light chain variable region (HCVR) comprising SEQ ID NO:8. Based on the description above, EMA teaches a pharmaceutical formulation comprising Bamlanivimab that is a neutralizing immunoglobulin (IgG)-1 monoclonal antibody (mAb) to the Spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is being evaluated for treatment and prophylaxis for COVID-19. However, it is silent on the SEQ ID NOs: 7 and 8. Yan teaches a humanized monoclonal antibody for 2019 novel coronavirus and their use for treat and prevent the infection caused by 2019-nCOV (See Abstract). Yan discloses that the human monoclonal antibody or antigen binding fragment thereof comprises a heavy chain variable region and a light chain variable region: (I) the heavy chain variable region comprises an amino acid sequence as shown in SEQ ID NO: 7, or an amino acid sequence having at least 95%, 96%, 97%, 98% or 99% sequence identity to the amino acid sequence as shown in SEQ ID NO: 7; and the light chain variable region comprises an amino acid sequence as shown in SEQ ID NO: 8, or an amino acid sequence having at least 95%, 96%, 97%, 98%, or 99% sequence identity to the amino acid sequence as shown in SEQ ID NO: 8 (See [0015]), where the SEQ ID NO: 7 of Yan is identical to the SEQ ID NO: 7 as claimed (See Table A below ), and the SEQ ID NO: 8 of Yan is identical to the SEQ ID NO: 8 as claimed (See Table B below ). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known SEQ ID NOs of Yan into EMA’s report. One of skill in the art would be motivated to substitute one antibody variable region for another (See MPEP 2144.06: Substituting equivalents known for the same purpose). There would be a reasonable expectation of success to develop such pharmaceutical formulation comprising the HCVR and LCVR as claimed. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over EMA as applied to claims 1-3, 5 and 13-1 5 above and further in view of Liu et al. (WO2021249548A1, published on Dec. 16, 2021, Prior Filing Date June 12, 2020, hereinafter Liu) The claim 11 require a 2019-nCoV antibody comprises a heavy chain comprising SEQ ID NO: 9. Based on the description above, EMA teaches a pharmaceutical formulation comprising Bamlanivimab that is a neutralizing immunoglobulin (IgG)-1 monoclonal antibody (mAb) to the Spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is being evaluated for treatment and prophylaxis for COVID-19. However, it is silent on the SEQ ID NO: 9. Liu teaches a pharmaceutical composition of novel coronavirus antibody and their use (Se e Abstract) and discloses a humanized monoclonal antibody has a heavy chain amino acid sequence as shown in SEQ ID NO: 9 (See page 1), where the SEQ ID NO: 9 is identical to the claimed SEQ ID NO: 9 (See Table C below ). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known SEQ ID NO: 9 of Liu into EMA’s report. One of skill in the art would be motivated to substitute one antibody heavy chain for another (See MPEP 2144.06: Substituting equivalents known for the same purpose). There would be a reasonable expectation of success to develop such pharmaceutical formulation including an antibody heavy chain comprising SEQ ID NO:9. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over EMA as applied to claims 1-3, 5 and 13-1 5 above and further in view of Schepens et al. (WO2021156490A2, published on Aug. 12, 2021, international filling date Feb. 05, 2021, herein after “Schepens”). The claim 12 require a 2019-nCoV antibody comprises a light chain comprising SEQ ID NO:10. Based on the description above, EMA teaches EMA teaches a pharmaceutical formulation comprising Bamlanivimab that is a neutralizing immunoglobulin (IgG)-1 monoclonal antibody (mAb) to the Spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is being evaluated for treatment and prophylaxis for COVID-19. However, it is silent on the SEQ ID NO: 10. Schepens teaches the invention relates to compositions comprising antibodies capable of specifically binding and neutralizing SARS-Corona viruses. The compositions are useful in the diagnosis of Sarbecoviruses, and specifically SARS-CoV-2 virus, and in prophylactic and/or therapeutic treatment of a condition resulting from infections with Sarbecoviruses, specifically SARS-Corona or SARS-CoV-2 virus, or mutants thereof (See Abstract). Schepens teaches the light chain sequence of mAb CB6 is SEQ ID NO: 64 (See page 112), where the SEQ ID NO: 64 is identical the SEQ ID NO: 10 as claimed (See Table D below) . It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known SEQ ID NO: 64 of Schepens into EMA’s report. One of skill in the art would be motivated to substitute one antibody light chain for another (See MPEP 2144.06: Substituting equivalents known for the same purpose). There would be a reasonable expectation of success to develop such pharmaceutical formulation including an antibody light chain comprising SEQ ID NO:10. Allowable Subject Matter The HCDR sequence containing SEQ ID NOs 1-3 and the LCDR sequence containing SEQ ID NOs 4-6 are free of prior art. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT RUIXUE WANG whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7960 . 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