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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/5/2026 has been entered.
Applicant’s remarks, filed 1/5/2026, are acknowledged and entered into the record. Applicants amended claims 51, 56-57, 64, 66-67 and 69, and canceled claims 62, 70 and 72-73, in the remarks of 1/5/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) or under 35 U.S.C. 120, 121, 365(a) or (b), or 386(a) is acknowledged. The present application is drawn from PCT/EP2019/066217, filed 6/19/2019; and claims benefit under 35 U.S.C. (119(a)-(d) to foreign application EP 18178526.2, filed 6/19/2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group II, encompassing claims an immunoglobulin or fragment thereof that binds tumor in vivo but does not significantly cross-react with normal cells, in the reply filed on 9/7/2023 is acknowledged. Applicants have since canceled claims 1-50, subject to the restriction of 8/1/2023, and added new claims 51-75, in the amended claims of 1/26/2024, 10/31/2024, and 7/22/2025. Currently claims 51-60, 63-69 and 71 are pending; and encompass the immunoglobulin and compositions of Group II (claims 51-60, 63, 66 and 71), the methods of Group III (claims 64-65), and the nucleic acids, vectors and host cells of Group IV (claims 67-69), of the restriction of 8/1/2023.
In view of applicant’s amendments to the claims (of 1/5/2026), examiner interview summary (of 12/9/2025), and applicant remarks (of 1/5/2026), the restriction between the inventions of Groups II, III and IV, is withdrawn. Claims 64-65 (Group III) and 67-69 (Group IV) are rejoined to claims 51-60, 63, 66 and 71 (Group II), for examination.
Status of Claims
Claims 51-60, 63-69 and 71 are pending and are being examined on the merits.
Claim Objections – Withdrawn
The objections to claim 51 for minor informalities are withdrawn in view of applicant’s amendments to the claims, wherein the minor informalities were corrected.
Claim Rejections – Withdrawn
Claim Rejections - 35 USC § 112
The rejection of claim 70 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, is withdrawn. Applicants canceled claim 70, thus the rejection is moot.
The rejection of claims 51-60, 63, 66, and 70-71 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for antibody molecules comprising six complete parental CDRs, does not reasonably provide enablement for similar molecules with fewer than six parental CDRs, mutated CDRs, or incomplete/truncated parental CDRs, is withdrawn. Applicants amended the claims to be limited to a single antibody species, with a VH and VL, defined by SEQ ID NOs: 22 and 25, respectively, which has 6 corresponding CDRs as a set. Thus, applicant’s amendments have obviated the rejection.
The rejection of claims 51-60, 63, 66, and 70-71 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, is withdrawn. Applicants amended the claims to be limited to a single antibody species, with a VH and VL, defined by SEQ ID NOs: 22 and 25, respectively, which has 6 corresponding CDRs as a set. Thus, applicant’s amendments have obviated the rejection.
The rejection of claims 51-60, 63, 66, and 70-71 on the judicially-created basis that they contain an improper Markush grouping of alternatives, is withdrawn. Applicants amended the claims to be drawn to a single species of antibody, and thus removed the Markush grouping. Therefore the rejection for an improper Markush grouping is moot.
Claim Rejections – New
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.
Claims 51-60, 63-69 and 71 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 51 recites an isolated monoclonal antibody or a fragment thereof wherein each monoclonal antibody or fragment comprises a VH having SEQ ID NO: 22 and a VL having SEQ ID NO: 25. Use of the terminology “having SEQ ID NO:” is unclear, as “having” is not defined in the specification. That is, it is not clear if, for example, the VH comprises or consists of SEQ ID NO: 22, or even requires the full sequence of SEQ ID NO: 22. A VH comprising SEQ ID NO: 22 is open-ended; thus while it requires the amino acid sequence of SEQ ID NO: 22 in full, it encompasses amino acid sequences that have SEQ ID NO: 22 and additional amino acid sequences. A VH consisting of SEQ ID NO: 22 is close-ended, and thus requires the amino acid sequence of SEQ ID NO: 22, and excludes any other amino acids beyond that of SEQ ID NO: 22. In the instant claim, “having SEQ ID NO: 22” or “having SEQ ID NO: 25” is open for interpretation as to the scope of the claim. Therefore, as the metes and bounds of the claim limitations are unclear, claim 51 is rendered indefinite. As claims 52-60, 63-69 and 71, ultimately depend from claim 51, but fail to rectify the issue of indefiniteness, they are also rejected. It is suggested that applicants use definitive language such as “comprising the amino acid sequence of SEQ ID NO:”, when referencing the required amino acid sequences that encode the domains of the claimed product.
Claim Rejections - 35 USC § 112(a)
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.
Claims 64 is 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.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 64 recites a method of treating cancer in a subject by administering an antibody comprising the VH of SEQ ID NO: 22 and the VL of SEQ ID NO: 25; which corresponds to the IEOmAB2 of SEQ ID NO: 4 (scFv) or SEQ ID NO: 38 (scFv-hIgG); see specifications pg. 57, lines 33-38; and pg. 63, lines 108. However, the specifications fail to disclose the antigen/target to which the IEOmAB2 antibody has binding specificity. Further, the specifications teach that IEOmAB2 has tumor killing properties against hT-ALL cancer cells (specs. pg. 49, lines 2-10; Fig. 2) and melanoma (pg. 50, lines 28-31; Fig. 4). However, in each case, the IEOmAB2 was fused to TNFα, which is not required of the antibodies of the method of claims 64-65. One skilled in the art would readily appreciate that an antibody fused to TNFα, whereby the antibody specifically binds a tumor-associated antigen (TAA), could be used to treat a cancer that expresses the specific TAA for which the antibody is directed, whereby the TAA provides a target for the TNFα-mediated cytotoxicity. However the claims are drawn to a method of treating any cancer by administering IEOmAB2. Absent empirical determination one skilled in the art would be unable to envision which cancers that do not express the TAA target of IEOmAB2 could be treated with the claimed antibody. This is further complicated when the TAA target (or any antigen target) of IEOmAB2 is unidentified. The scope of the claim encompasses all cancers, and thus includes a vast number of TAAs; therefore the method of treating cancer, of claim 64, are drawn to a genus of cancers to be treated by IEOmAB2. Section 2163(II)(A)(3)(a)(ii) of the MPEP states that the written description for a claimed genus may be satisfied through either a) a representative number of species, or b) disclosed correlation between function and structure. Here the applicants teach only hT-ALL and melanoma tumor cells are effectively treated with IEOmAB2, and do not disclose or describe the correlation between structure and function that results in the effect on hT-ALL and melanoma tumor cells, because they do not describe the antigen to which the structure binds, much less if the antigen is common to both species of cancer. Specifically the properties of the antibody to bind specific TAAs, or the genus of cancers which express the IEOmAB2-specific antigen, should be described. Such a description would be essential in determining the degree of cancers that may be allotted in methods of using the antibody for treating cancers. This lack of definition complicates the determination of the boundaries of the claimed genus of any cancers with regard to which species of cancers would be anticipated, a priori, by one skilled in the art, to fall within the scope of the claims. Without identification of the necessary cancer target antigen, shared by all species of cancer that fall within the scope of the claimed method, it may be that IEOmAB2 would not bind to some cancers and would thus be ineffective. For example, consider mesothelioma; the specifications (pg. 52, Table 1) teach that IEOmAB2 does not bind mesothelial cells. Accordingly, Figure 8 teaches IEOmAB2 was ineffective against the mesothelioma tumor cell line IstMes1. Therefore, it is difficult to imagine that applicants were in possession of a method for treating mesothelioma with IEOmAB2. The specifications do not describe the antigen to which IEOmAB2 binds and do not describe that mesothelioma tumors express the necessary antigen by which IEOmAB2 could target TNFα-mediated tumor cell killing activity to mesothelioma cancer cells.
In view of this uncertainty, and the lack of a representative number of examples, or adequate description of the structure/function relationship between the agent and the method for treating any cancer type, claim 64 is rejected for lack of adequate written description support.
Claims 64-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering hIgG-IEOmAB2-scFv-hTNFα for treating hT-ALL or melanoma, does not reasonably provide enablement for treatment of any cancer type by administering the IEOmAB2-scFv of claim 51. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (reversing the PTO’s determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement). In Wands, the court noted that there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known." 858 F.2d at 740, 8 USPQ2d at 1406. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention." Id., 8 USPQ2d at 1407.
Breadth of claims and nature of invention
The claimed subject matter pertains to a method of treating cancer in a subject comprising administering the monocolonal antibody of claim 51, wherein the antibody, or antigen binding fragment thereof, comprises the VH amino acid sequence of SEQ ID NO: 22 and a VL amino acid sequence of SEQ ID NO: 25; which is identified as IEOmAB2 (Specs., pg. 22, line 7; SEQ ID NO: 4 comprises SEQ ID NOs: 22 and 25). The antibody is directed at various cancer cell lines and tissues, and comprises a TNF-α domain (see claim 71), such that the antigen binding domain targets the cancer cell and the TNF-α domain mediates cytotoxicity. The nature of the invention is to target TNF-α to tumor cells for cell death, and relies on the antibody having at least 1.5 fold greater affinity for tumor cells versus normal cells, to limit the TNF-α-mediated inflammatory response to the tumor tissue (specs, pg. 20, lines 9-13). As the required tumor associated antigen (TAA) binding domain will restrict binding of the antibody to the tumor microenvironment, the TNF-α mediated cytotoxicity will also be local to tumors. Thus, the invention is enabled for targeting a cancer via the tumor-directed antibody, or antigen binding fragment, of claim 51. However, the specifications fail to disclose the antigen/target to which the IEOmAB2 antibody has binding specificity. Further, the scope of claim 64 includes administering the antibody for treatment of any cancer in a subject. This encompasses the full cohort of different cancers, unlimited by what antigens are expressed on the tumor cells, what tissues contain the malignancy, or what caused the malignancy. Applicant’s specifications describes many different types of cancers (pgs. 13, lines 15-20) that may be treated by the instant invention.
State of art and level of ordinary skill
At the time of the effective filing date, the level of ordinary skill to treat cancer was high, requiring advanced knowledge of medicine and cell biology, and typically requiring an advanced degree and years of experience. One of skill in the art is well-aware that cancer is difficult to prevent and treat, and there are numerous molecular mechanisms which may drive cells to become cancerous, from genetic abnormalities to environmental factors. The variety of molecular mechanisms for cancer require highly personalized treatment for each type of cancer, depending on the patient. However, the instant disclosure does not provide sufficient in vitro or in vivo evidence showing that the instantly claimed method can counter-act the cause or the manifestation of any cancer as defined above in order to prevent or ameliorate the disease. For example, Fidler (Human Vaccines & Immunotherapeutics 8:8, 1141-1142) teaches that cancer is a highly heterogenous disease, driven by genomic variability, which presents challenges to therapy. Specifically, Fidler describes “a targeted therapy requires a target,” and “a heterogenous disease cannot be treated by a homogenous therapy.” One skilled in the art would appreciate that a single specific therapy would be unlikely to treat all types of cancers equally.
The level of predictability of the art
Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, e.g. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissue where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment.
The amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure
The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in the area of cancer treatment, the skilled artisan would need significant guidance in treating any and every conceivable type of cancer by practicing the claimed method. The skilled artisan recognizes that keeping individuals free of cancer indefinitely is an intractable proposition, if not now wholly impossible, given, for example, that cancers are widely heterogeneous diseases, having widely varying pathologies and etiologies, and with causes that are multifactorial and as yet only partially characterized and poorly understood.
The specification does not adequately teach how to effectively treat the breadth of all cancers or reach an appropriate beneficial therapeutic endpoint by administering the antibody. The specification does not teach how to extrapolate data obtained from various in vitro or in vivo observations as well as clinical experience with the antibody to the development of effective methods of preventing or treating the plethora of cancers broadly encompassed by the claimed invention. Applicant’s specification offers no data to indicate that administration of the recited antibody would be successful in treating every conceivable cancer.
There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art (i.e. treating any cancer) to which the invention pertains, undue experimentation would be required to practice the claimed method of treating any cancer with a reasonable expectation for success, absent a specific and detailed description in applicant’s specification of how to effectively use the claimed agent and absent working examples providing evidence which is reasonably predictive that the claimed agent is effective for treating any cancer commensurate in scope with the claimed invention. An antibody directed to a single tumor associated antigen (TAA) will be limited in its therapeutic effectiveness to only tumor cells that express the antigen target of the single embodiment. Here the applicants do not identify the TAA for which the claimed antibody has binding specificity. Instead, applicants rely on trial-and-error confirmation of the effectiveness of IEOmAB2 (conjugated to TNF-α) against various cancer cell lines, in vitro and in vivo. For example, the specification teaches when IEOmAB2 is fused with TNF-α, it offered an effective, in vivo, immunotherapy of hT-ALL and melanoma (pgs. 47-50). Controls whereby only TNF-α was applied were ineffective, resulting in the applicant’s conclusion that the effective immunotherapy “depends upon tumor binding of the immune-cytokine,” (pg. 48, line 23; pg. 50, lines 5-6). Therefore it is clear that the TAA or ligand to which IEOmAB2 binds is critical in determining which cancers a IEOmAB2-TNF-α fusion construct would have therapeutic efficacy, such that only cancer types that express the specific ligand target of the IEOmAB2 antibody would be enabled for treatment by administering the antibody. Here the applicants do not disclose what ligand/TAA the IEOmAB2 antibody binds to. Applicants provide a table of various human tumor cell lines for which the antibody/TNFα fusion construct showed binding, in vitro (Fig. 8). However, this list of ~30 cell lines does not encompass all types of cancer (of claim 64), and also includes some cancer cell lines whereby the antibody treatment appears to be ineffective. For example, mesothelioma, specifically the cell line IstMes1, does not appear to be bound or treated by the claimed antibody. Further, the claims include language directed at various genera of cancer types, such as “brain cancer” (of claim 65) which includes many different species of cancer. Take for example, Pineal cancer, which is a brain cancer characterized by tumors of the pineal gland. Without description of what ligand IEOmAB2 antibody binds to, an artisan would have no teaching regarding whether or not such a ligand is expressed by pineal gland tissue, or tumors thereof; even if they knew the TAAs of pineal gland tumors, they would not have a reasonable expectation for success to practice the methods, given that the ligand target of the IEOmAB2 antibody is not disclosed. Further, while applicants claim wherein the antibody has at least 1.5 fold greater affinity to cancerous tissue versus normal cells, the ligand specificity and affinity are necessary to determine the effective and appropriate doses for a cancer treatment. This is especially true when the antibody is conjugated to TNF-α, which may cause systemic inflammatory responses, and the concentrations of which would need to be considered for potential adverse effects of the treatment strategy. That is, if the pineal gland tumor expresses a very low level of the ligand for which IEOmAB2 binds, then a larger concentration of the antibody/TNFα fusion construct may need to be administered, compared to treatments of a different cancer type which may highly express the IEOmAB2-specific ligand/TAA. A skilled artisan may generally be able to find effective doses for a taught cancer treatment, but would rely in part on the relevant biology of the ligand which the treatment targets and its expression across various cancer types. Without providing such data, a skilled artisan faces undue experimentation in determining whether the IEOmAB2 antibody would target any particular cancer type specifically, and to what degree, so as to design tolerable doses for administration. Determining the antigen associated with the tumors, generating the appropriate and functional antibody-cytokine construct, and determining both the pharmacokinetic profile and cell killing effectiveness of the generated embodiment, as well as management of potential adverse effects of administering said antibody must all be considered for each embodiment of cancer species. Instead, there is insufficient guidance provided to practice a method of treating, which encompasses the broad scope of any conceivable cancer type (i.e., re. claim 64), or even any “brain cancer” (re. claim 65), without even a basic description of the ligand to which the antibody of the invention binds, leaving an undue amount of experimentation in the hands of the skilled artisan to practice the method as directed for any cancer.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. MPEP 2164.02. In view of the quantity of experimentation necessary, the lack of working examples, the nature of the invention, the state of the prior art, and the unpredictability of the art and breadth of the claims, it would take undue trial and error to practice the claimed invention.
Allowable Subject Matter
An antibody, or antigen-binding fragment thereof, comprising a VH with the amino acid sequence of instant SEQ ID NO: 22 and a VL with the amino acid sequence of SEQ ID NO: 25 has been searched and is free of the art. Thus the antibody, methods of making the antibody, antibody conjugates, and methods of using the antibody in a treatment are novel over the art. Therefore, patentability would be based on a sufficient descriptive support and enablement, under 35 U.S.C. 112(a), of the use of the antibody in said methods.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642