Notice of Pre-AIA or AIA Status
1. 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
Status of Claims
2. Applicant's preliminary amendment of the instant application, which was originally submitted on 05/22/2023 and later amended on 11/20/2023, then 01/28/2026, is acknowledged by the Examiner. The cancellation of claims 7, 14 – 20, 27 – 29, 31, and 32 pursuant to the amendment on 11/20/2023 is acknowledged. Claims 1 – 6, 8 – 13, 21 – 26, 30, and 33 were previously examined and restricted in the Office Action mailed on 11/28/2025.
Election/Restrictions
3. Applicant’s election without traverse of a binding agent that specifically binds to a flavivirus NS1, i.e., Group I, in the reply filed on 01/28/2025 is acknowledged. Claims 30 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/28/2025. Claims 1 – 6, 8 – 13, and 21 – 26 are pending.
Priority
4. The instant application is a National Stage Entry of International Patent Application No. PCT/US21/60468 filed on 11/23/2021, which claims priority to United States Provisional Application No. 63/117222 filed on 11/23/2020. Priority is granted to the U.S. Provisional Application for claims 1 – 6, 8 – 13, and 21 – 26 of the instant application.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 07/18/2024 has been considered by the Examiner. However, the IDS fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references have been considered, except where lined through. Additionally, the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Thus, unless the references have been cited by the Examiner on form PTO-892, they have not been considered.
Specification
6. The use of the terms Dengvaxia® on page 2; Humab-Mouse™ on page 25; Kirin TC Mouse™ on page 25; Kyowa Kirin KM-Mouse on page 25; Anticalin® on page 27; Affibody® on page 27; Afflin™ on page 27; Atrimer™ on page 27; SIMP™ on page 27; Avimer™ on page 27; and possibly others in the specification, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, ℠, or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant is required to properly annotate all trade names and/or marks that are present in the specification.
7. The disclosure is objected to for failing to adhere to the requirements of the sequence rules set forth in 37 CFR 1.821(a)–(d) and MPEP § 2422. Sequences are described by reference to NCBI Accession No. on pages 2 – 5, 21, and 22, rather than to sequences set forth in the specification. Furthermore, since the sequences associated are not irrevocably fixed, but are corrected and updated as additional sequence information becomes available, the accession numbers may refer to sequences which change after the application filing date. Applicant is reminded that the incorporation of essential material, i.e., NCBI Accession No., as recited in claim 13, in the specification by reference to a foreign application or patent, or to a publication, is improper under 37 CFR 1.57. Applicant must append SEQ ID NOs to all mentions of specific sequences comprising four or more amino acids and ten or more nucleic acids in the specification. Appropriate correction is required. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated herein by reference. Furthermore, if the recited materials in claim 13 was not set forth in the specification as filed, and was not publicly available at the time that the application was filed, the amendment will be treated as an attempt to introduce new matter. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973). Applicant should also note that an amendment introducing an additional sequence corresponding to the intended sequence will likely require a replacement Sequence Listing (CRF) and a statement indicating that the paper and CRF sequence submissions are identical.
8. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
9. The drawings are objected to because the instant specification refers to Fig. 9F on page 10, but there is no Fig. 9F disclosed in the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
10. The instant application contains at least on drawing executed in color. At a minimum, FIGs. 1E, 1H, 2A – D, 3A, 4A, 4E, 6B, 6E, 7A, 7B, 8A, 8B, 9A – E, 12A, 12B, 14B, 15, 16D, and 17C all have multiple parts that refer to and are differentiated by various colors. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
11. Claims 1, 9, 12, and 26 are objected to because of the following informalities:
In claim 1, line 1, the acronym “NS1” is recited, but not defined in the claim. An acronym should be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For the purposes of examination, “NS1” is interpreted to mean “nonstructural protein 1”;
In claim 9, line 2, the acronym “scFV” is defined as being “single chain variable fragment”. However, the acronym has previously been defined in claim 8. An acronym should only be defined the first time it appears in an independent claim or in the group of claims under an independent claim;
There is a typographical error in line 2 of claims 12 and 26. There is a missing comma after “serotype 3”, wherein the phrase should read “serotype 3, or serotype 4”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
12. 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.
13. Claim 13 is 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.
14. Claim 13 recites “(NCBI Accession No. X)”, wherein X is a different number for parts (a) – (m). Due to the presence of parentheses, it cannot be determined whether or not the phrase is a recited limitation. If the parenthetical phrase is intended to be a limitation, then the NCBI Accession No. fails to clearly identify the sequence of the specific region of the flavivirus protein that the binding agent is intended to bind. No precise structural information regarding the NCBI Accession No. can be gleaned as the sequences are not irrevocably fixed, but rather corrected and updated as additional sequence information becomes available.
Moreover, without a reference to a sequence identifier, all residues of claim 13 are indefinite. An N-terminal tag, including natural signaling peptides, would be considered part of a recombinant virus under the genera recited, but would shift all position labels. There are multiple interpretations of each position as no reference sequence is provided to define them. The presence of multiple very different interpretations of the same claim language also renders the claim indefinite.
Additionally, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation of Dengue virus 1, and the claim also recites NCBI Accession No. X, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
15. It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection(s) and art may be applied in a subsequent Office Action.
35 USC § 112(a)
16. 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.
35 USC § 112(a) – Enablement
17. Claims 1, 2, 5, 8, 10 – 13, and 21 – 26 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 the tested antibody shown to function, including the six defined parental CDRs, does not reasonably provide enablement for merely any binding agent, including a human antibody, domain antibody, or antibody fragment, or a non-antibody polypeptide, i.e., an alternative protein scaffold, that has function against a flavivirus NS1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
18. In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit has developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors, to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." The factors considered include, but are not limited to: (A) the breadth of the claims; (B) the nature of the invention; (C) the state of the prior art; (D) the level of one of ordinary skill in the art; (E) the level of predictability in the art; (F) the amount of direction provided by the inventor; (G) the existence of working examples; and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the claims and nature of the invention: Claim 1 of the claimed invention is drawn to a binding agent that specifically binds to a flavivirus NS1 protein, which is comprised of three CDRs of the heavy chain variable region, drawn to SEQ ID NOs: 1 – 3, and three CDRs of the light chain variable region, drawn to SEQ ID NOs: 4 – 6. Further limitations to the method include that the frameworks of the heavy and light chain variable regions have at least 95% sequence identity to SEQ ID NOs: 7 and 8, respectively, and that the flavivirus is yellow fever virus (YFV), dengue virus (DENV) serotypes 1 – 4, Japanese encephalitis virus (JEV), West Nile virus (WNV), Zika virus (ZIKV), or St. Louis encephalitis virus (SLEV). The binding agent itself can be an antibody, whether that be a monoclonal antibody, chimeric antibody, humanized antibody, human antibody, whole antibody, or a fragment thereof, including a F(ab')2, Fab', Fab, Fv, single chain variable fragment (scFv), a disulfide-stabilized Fv fragment (dsFv), a domain antibody (dAb), and a single chain binding polypeptide, or a non-antibody polypeptide, i.e., an alternative protein scaffold.
Those with relevant skill in the art: The level of skill in the art is that of Ph.D.-level scientists and
medical doctors (D.O. and/or M.D.).
Amount of direction, existence of working examples: The instant application teaches two working examples, which does not represent an example for the innumerable combinations of different binding agents, antibody types, and flaviviruses. Thus, the instant application offers no reasonable guidance or direction to use the claimed binding agent with six defined CDRs to bind and, thus protect against, any flavivirus.
The closest working example is in paragraphs 0051 and 0073 – 0075 on pages 23, 31, and 32, referred to as example 1. Example 1 teaches that a mouse monoclonal antibody with heavy chain variable regions of SEQ ID NOs: 1 – 3 and light chain variable regions of SEQ ID NOs: 4 – 6, referred to as 2B7, protects against lethal DENV infection. It is further taught that 2B7, as well as its Fab and single chain variable fragment (scFv), were sufficient to block binding of NS1 to human pulmonary microvascular endothelial cells. In the second working example in paragraphs 0080 – 0083 on pages 35 – 37, referred to as example 3, it is taught that 2B7 is cross-reactive and binds with NS1 from multiple flavivirus species. This includes DENV1-4, ZIKV, SLEV, WNV, JEV, USUV, and WSLV. However, minimal binding was detected for YFV, POWV, and TBEV. It is further taught that the strength of 2B7 binding for other flavivirus species correlated with the degree of conservation with the DENV NS1. Additionally, single point mutations of the residues involved with 2B7 binding to the DENV NS1 resulted in weaker binding.
The instant application only recites one mouse monoclonal antibody with six CDRs, 2B7, which can only bind DENV1-4, ZIKV, SLEV, WNV, JEV, USUV, and WSLV, wherein the strongest binding was for DENV. However, the ability to bind to all flaviviruses is not disclosed. There are no binding agents, i.e., antibodies, described that bind to the NS1 protein for YFV, POWV, and TBEV, or the other 60+ flaviviruses that are known in the art. Aside from the seven residues within the NS1 that cannot be perturbed at without losing binding affinity, there is no guidance as to what other mutations would be tolerated in the NS1 to still allow binding of 2B7. Moreover, non-antibody binding agents and different types of antibodies, aside from the mouse monoclonal antibody, are not recited.
State of the prior art and unpredictability in the art: It is taught by Paul, W. E., (Fv structure and diversity in three dimensions, Fundamental Immunology, 3, 292-295; Published 1993), hereby Paul, that an intact antigen-binding site of antibodies generally requires the association of the complete heavy and light chain variable regions of a given antibody (page 293, left column, lines 3 – 8; right column, lines 1 – 9 and 27 – 30). It is further taught that both the heavy and light chain variable regions are comprised of three CDRs or hypervariable regions, for a total of six CDRs per antibody, which provide the majority of the contact residues for the binding of the antibody to its target epitope (page 293, left column lines 3 – 8 and 19 – 22). The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin (page 293, left column, lines 8 – 22). It is expected that all of the heavy and light chain CDRs are required in their proper order in the context of framework sequences which maintain their required conformation in order to produce a protein having antigen-binding function. Moreover, the proper association of the CDRs for both the heavy and light chain variable regions is required in order to form functional antigen-binding sites.
PNG
media_image1.png
366
527
media_image1.png
Greyscale
Paul teaches that the “humanization” of antibodies involves grafting the antigen-binding loops from rodent monoclonal antibodies into human Fv frameworks (page 293, right column, lines 9 – 26). Similarly, Bendig M. M., (Methods: A Companion to Methods in Enzymology, 8, 83-93; Published 1995), hereby Bendig, teaches that the general strategy for “humanizing” antibodies involves the substitution of all six CDRs from a rodent antibody and grafting these regions into human regions (page 83, abstract and right column, second paragraph; page 84). It is noted that Bendig used Kabat CDRs in their humanization process (page 86, right column, second paragraph). It is further taught that the “humanization” can be partial or full. Partial humanization involves joining the entire variable domain from the rodent antibody to the constant domain from a human antibody, creating rodent-human “chimeric” antibody, whereas full involves joining only the CDRs from the rodent variable domains with the human variable domains, yielding a fully humanized antibody (see figure 2 as reproduced above).
Quantity of experimentation needed: At a minimum, the art teaches that a skilled artisan would consider the predictive function of an antibody if the six CDRs are defined, wherein there are three each for the heavy and light chain variable regions, in the context of the framework sequences with the correct spatial orientation. Thus, one of skill in the art would neither expect nor predict the appropriate function of any binding agent of the instant claims for a flavivirus NS1 as broadly as claimed, as such an agent would not need to be an antibody and, thus, would not provide the framework required by the six parental CDRs to bind an antigen. There is also no art for the fusion of the three heavy CDRs or three light CDRs, as disclosed by SEQ ID NOs: 1 – 3 and 4 – 6, respectively.
Any and all enablement of the claimed agents must therefore come from the instant disclosure. However, the instant disclosure only teaches a mouse monoclonal antibody with the six recited CDRs. The claims are clearly not enabled to their full scope. Moreover, claims not containing elements critical or essential to the practice of the invention, such as antibodies or antibody fragments not having all of the relevant functional CDRs in the proper site on an appropriate antibody heavy or light chain framework, are not enabled by the disclosure. Claims that contain materials demonstrated not to bind to the critical element of the invention are also not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
For the reasons discussed above, undue experimentation would be required to practice
the claimed invention commensurate with the scope of the claims. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. It would take undue trials and errors to practice the claimed invention in view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims.
Conclusion: The instant disclosure is not enabling for any and all binding agents as presently written, but rather the mouse monoclonal antibody with the six recited CDRs and a framework that has the highest binding for the DENV1 NS1. Thus, any claim that does not further limit the “binding agent” as presently written to an antibody is not enabled. This includes claims 1, 2, 10 – 13, and 21 – 26. Regardless, tt is recommended that all iterations be of “[A] binding agent” be replaced with “[A] monoclonal antibody”. The following claims are also not enabled:
Claim 5 recites a human antibody. The CDRs of claim 1 are derived from mice, as discussed above, and so cannot be used to make a human antibody, which requires human CDRs. Therefore, a human antibody is not enabled and should be deleted.
Claim 8 includes a dAb, which would only have three CDRs. This is not enabled as all six CDRs are required for antigen binding function of a mouse or humanized antibody, as discussed above. It is recommended that this iteration be removed.
Claim 10 encompasses an alternative protein scaffold. This is not enabled as only an antibody has been adequately described by the instant disclosure. There is no evidence disclosed that the binding agent can be a non-antibody polypeptide, i.e., an alternative protein scaffold. It is recommended that this iteration be removed.
Claim 11 and 25 define the flavivirus as YFV. This is not enabled as the mouse monoclonal antibody was demonstrated to have no affinity for YFV, as discussed above. Thus, YFV is not enabled and should be deleted.
35 USC § 112(d)
19. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. — Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
20. Claims 4, 8, 11 – 13, 25, and 26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
21. Claim 4 requires a “monoclonal antibody”. Claim 1 and 3, wherein claim 4 is dependent on claim 3, which is dependent on claim 1, both recite “a binding agent”. The binding agent is defined as a proteinaceous molecule (instant specification, page 21, paragraph 0048), i.e., a single molecule. However, a monoclonal antibody is not one molecule – it is a solution of multiple antibody molecules that are all the same. Thus, not all embodiments of claim 4 would include all of the limitations of the claims upon which it depends, i.e., claims 1 and 3.
22. Claim 8 requires a “domain antibody (dAb)”. Claim 1, which claim 8 is dependent upon, recites “three complementarity determining regions (CDRs) of an antibody heavy chain variable region (VH) and three CDRs of an antibody light chain variable region (LH)”. Six CDRs are recited in claim 1, which a domain antibody would not contain. Thus, not all embodiments of claim 8 would include all of the limitations of the claim upon which it depends, i.e., claim 1.
23. Claims 11 – 13, 25, and 26 require that “the binding agent specifically binds to a region of a flavivirus NS1 protein”, wherein the flavivirus is a dengue virus of serotype 1, serotype 2, serotype 3, or serotype 4. Claim 1, which claims 11 – 13, 25, and 26 are dependent upon, recites “a binding agent that specifically binds to a flavivirus NS1 protein”, wherein the binding agent is an antibody with six defined CDRs. There are no additional limitations in claims 11 – 13, 25, and 26 that are not recited in claim 1. Every enabled portion of the antibody defined in claim 1 will bind to whatever it binds. In other words, the claims as currently written only recite inherent properties of the claimed antibody. Thus, claims 11 – 13, 25, and 26 fail to further limit the subject matter of claim 1.
24. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form so long as no duplicates are made, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
25. Claims 3, 4, 6, and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. There is no art for an antibody with the fusion of the three heavy CDRs or three light CDRs, as disclosed by SEQ ID NOs: 1 – 3 and 4 – 6, respectively.
Conclusion
26. Claims 1 – 6, 8 – 13, and 21 – 26 are rejected. No claims are allowed.
27. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hallie N. Pennington, Ph.D. whose telephone number is (571)272-6781. The examiner can normally be reached M-Th 7:30-5:30 ET.
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, Michael Allen can be reached at (571)270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HALLIE N. PENNINGTON, PH.D./Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671