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 .
Applicant’s amendment, filed on 2/11/2026, is acknowledged.
Claims 21-23 are cancelled.
Claims 1-20 are currently pending.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-14 and 19, directed to a TCR having activity to bind a SEQ ID NO: 26-HLA A0201 complex; and the Species of: i) a TCR with CDRα1-3 of SEQ ID NO: 20-22 respectively and CDRβ1-3 of SEQ ID NO: 17-19 respectively; and ii) Thr48 of TRAC*01 exon 1 and Ser57 of TRBC1*01 or TRBC2*01 exon 1, filed on 2/11/2026, is acknowledged.
Claims 15-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Claims 1-14 and 19 are under examination as reading on a TCR having activity to bind a SEQ ID NO: 26-HLA A0201 complex with CDRα1-3 of SEQ ID NO: 20-22 respectively and CDRβ1-3 of SEQ ID NO: 17-19 respectively.
Priority
Applicant’s claim for the benefit of a prior-filed Chinese Patent Application No. 202011349425. 5, filed on November 26, 2020, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/26/2023 and 2/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Figures 8 and 10 contain amino acid sequences without the corresponding identifiers disclosed in the Drawings or the “Brief Description of the Drawings” section of the specification.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the terms: BugBuster® (¶[0145]), HiTrap™ (¶[0146]), HiPrep™ (¶[0146]), Biacore™ (¶[0148], [0149]), IncuCyte™ (¶[0168], [0170]), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , 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.
Claim Objections
Claim 7 is objected to because “SEQ ID NO: 178” and should most likely recite “SEQ ID NO: 17” to correct a typographical error. There is no SEQ ID NO: 178 in the instant application.
Claims 8 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.
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.
Claims 1-7, 10-14, and 19 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 TCRs with the 6 CDR sets recited in claim 8 or the Vα and Vβ combinations recited in claim 9 and the function of “bind to TIHDIILECV-HLA A0201 complex”, does not reasonably provide enablement for a broad genus of TCRs with a partial structure at best and the function of “bind to TIHDIILECV-HLA A0201 complex”. 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.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Breadth of claims and nature of invention:
Claims 1-3, 10-14, and 19 encompass a broad genus of TCR structures with up to 10% sequence variation in each of the recited Vα and Vβ sequences, including in the CDR regions that are critical for antigen binding, and the recited function “bind to TIHDIILECV-HLA A0201 complex”. For example, SEQ ID NO: 1 has 113 residues, allowing for up to 11 substitutions in the CDR regions, and SEQ ID NO: 5 has 114 residues, allowing for 11 substitutions in the CDR regions as well. There are 25 residues that make up the three CDRs in SEQ ID NO: 1, and 24 residues that make up the three CDRs in SEQ ID NO: 5.
The total number of variants of a polypeptide having a specific number of amino acid substitutions can be calculated from the formula:
N
!
*
19
A
N
-
A
!
A
!
Where N is the length in amino acids of the reference polypeptide and A is the number of allowed substitutions. For the 25 CDR residues in the TCRVα region of SEQ ID NO: 1 with 11 allowed substitutions, there would be
25
!
*
19
(
11
)
25
-
11
!
11
!
Which is approximately 1.48x1024 variants for the Vα, and approximately 8.31x1023 variants for the Vβ.
Claim 4 recites a sufficient TCRVβ CDR1-3 structure with the function of “bind to TIHDIILECV-HLA A0201 complex”, however still encompasses a broad genus of 1.48x1024 TCRVα variants with the function of “bind to TIHDIILECV-HLA A0201 complex”
Claim 5 encompass a broad genus of TCR structures with up to 5% sequence variation in each of the recited Vα and Vβ sequences, including in the CDR regions that are critical for antigen binding, and the recited function “bind to TIHDIILECV-HLA A0201 complex”, which is a genus of approximately 7.26x1010 Vα variants and 5.81x1010 Vβ variants with CDR amino acid substitutions with the recited function.
Claim 6 recites a sufficient TCRVβ chain structure with the function of “bind to TIHDIILECV-HLA A0201 complex”, however still encompasses a broad genus of 1.48x1024 TCRVα variants with the function of “bind to TIHDIILECV-HLA A0201 complex”.
Claim 7 recites a sufficient TCRVβ CDR1-3 structure with the function of “bind to TIHDIILECV-HLA A0201 complex”, however still encompasses a broad genus of 7.26x1010 TCRVα variants with the function of “bind to TIHDIILECV-HLA A0201 complex”.
The specification discloses the generation of TCRs directed to HPV16 E6 antigen (Example 1). Four TCRVα and one TCRVβ were generated that formed TCRs that bound to SEQ ID NO: 26 when complexed with HLA*A0201 (Tables 1 and 2).
Amount of direction and existence of working examples:
The TCRs directed to SEQ ID NO: 26 when complexed with HLA*A0201 (i.e., with the function of “bind to TIHDIILECV-HLA A0201 complex”) are disclosed in Tables 1 and 2:
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614
1270
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379
856
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Greyscale
Level of predictability, state of prior art, and quantity of experimentation needed:
The claims are directed to a broad classes TCRs defined by its function “bind to TIHDIILECV-HLA A0201 complex” with a partial structure at best.
However, the specification did not give the skilled in the art enough information to choose candidate antigen binding structures from the vast number of options of millions of candidates, and therefore required scientists to engage in a great deal of experimentation and failure. “That is not enablement”—it is a “hunting license.”
The specification only discloses four TCRs with the function of “bind to TIHDIILECV-HLA A0201 complex”, all of which have the same TCRVβ of SEQ ID NO: 5 but with varying TCRVα sequences (SEQ ID NO: 1-4).
In Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). The Supreme Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the function of binding to specific amino acid residues on PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR. This decision reaffirmed the prior decision made by the Federal District Court in Amgen Inc. v. Sanofi, Aventisub LLC., 987 F.3d 1080 (Fed. Cir. 2021).
The Court clarified that the specification does not always need to "describe with particularity how to make and use every single embodiment within a claimed class." Id. at 610-11. However, "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class….The more one claims, the more one must enable." Id.
The specification may require a reasonable amount of experimentation to make and use the invention and what is reasonable will depend on the nature of the invention and the underlying art. For example, "it may suffice to give an example (or a few examples) if the specification also discloses some general quality … running through the class that gives it a peculiar fitness for the particular purpose" and "disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset." Id. at 611 (internal quotations omitted). However, the Supreme Court found that Amgen failed to enable all that it claimed, even if allowing for a reasonable degree of experimentation. Id. at 613; see also Baxalta Inc. v Genentech, Inc., 81 F.4th 1362, 1367, 2023 USPQ2d 1103 (Fed. Cir. 2023) ("[t]he facts of this case are more analogous to—and are, in fact, indistinguishable from—those in Amgen. We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors."). Moreover, "[w]e see no meaningful difference between Wands' ‘undue experimentation’ and Amgen's ‘[un]reasonable experimentation’ standards. Id. at footnote 4. See also Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024), which explains that regardless of the technology the Wands factors should be used when assessing enablement.
However, while the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class which included "a ‘vast’ number of additional antibodies" that Amgen had not described by their amino acid sequences. Id. at 613. The Court found that Amgen sought to monopolize an entire class by their function, even though that class was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. Id. at 613.
In Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed, the Federal Circuit explicitly applied the Wands factors to assess whether the specification of Amgen’s patent provided sufficient enablement, for purposes of 35 U.S.C. 112(a), to make and use the full scope of the claimed invention. The court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Id. at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. See also the following cases across various technology areas: McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019).
Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification. The two processes, the “roadmap” and “conservative substitution” did not save Amgen. According to the Court, these amounted to “little more than two research assignments” which forced scientists to conduct “painstaking experimentation” to see what worked. (citing Incandescent Lamp). The Court therefore held that Amgen’s specification did not enable the claims.
This case is akin to the issue in Amgen Inc. v. Sanofi, Aventisub LLC, in which the court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Sanofi-Aventisub at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. While the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class that included “a ‘vast' number of additional antibodies” that Amgen had not described by their amino acid sequences. Id. at 1256. The Supreme Court found that Amgen sought to monopolize an entire class of antibodies by their function, which was much broader than the 26 exemplary antibodies disclosed by their amino acid structure.
In the instant case, while the claims are not directed to antibodies, they are directed to TCRs that specifically bind epitopes using a set of 6 CDRs, which is analogous to an antibody. The specification discloses four TCRs, one TCRVβ, and four TCRVα structures defined by their amino acid sequences, especially in the CDR regions critical for antigen binding, that performs the recited function of “bind to TIHDIILECV-HLA A0201 complex”.
The instant claims are directed to a class of TCRs, that include “a ‘vast’ number” of additional TCRs in which the instant specification fails to describe the amino acid sequences of. It would be necessary to first generate and then screen each candidate TCR to determine whether it met the functional limitations of “bind to TIHDIILECV-HLA A0201 complex”. The Federal Circuit concluded that there was a lack of enablement, which was affirmed by the Supreme Court in Amgen.
The instant specification does not disclose any common structural feature delineating which TCRs will have the function of “bind to TIHDIILECV-HLA A0201 complex”, or how to distinguish TCR structures with this function from structures without. The only structure-function relationship guidance the specification provides is to disclose the one TCR sequences with this function.
The instant claims simply direct skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the TCR structures they elected to disclose and that “[u]nder Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Id. at *8, *10.
The Supreme Court’s 2023 decision in Amgen v. Sanofi, which mainly involves the enablement requirement, states that “where a patentee purports to invent an entire genus, it must enable the entire genus”; “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies – and it is the latter that petitioners claim as their invention”; S. Ct.
Additionally, in its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023) the Federal Circuit found the facts of this case to be "materially indistinguishable from those in Amgen." Baxalta, 2023 WL 6135930, at *4. According to the Federal Circuit, claim 1 covers "millions of potential candidate antibodies" (id.) that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa. The court, however, noted that the specification discloses the amino acid sequence of just 11 of those antibodies. And like the roadmap in the patents at issue in Amgen, "the '590 patent's roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the [11] antibodies they elected to disclose." (Id.) Missing from the specification, according to the Federal Circuit, was "'a quality common to every functional embodiment' ... that would allow a skilled artisan to predict which antibodies will perform the claimed functions" (id.; quoting Amgen Inc. v. Sanofi., 598 U.S. 594, 614 (2023)), such as a common structural or other feature that would allow the antibodies to perform the claimed functions, or an explanation as to why the 11 antibodies do so and others do not. (Baxalta, 2023 WL 6135930, at *4). And the Federal Circuit was not persuaded by Baxalta's argument that its disclosed hybridoma-and screening process "predictably and reliably generates new claimed antibodies every time it is performed" (id.), because "it is undisputed that to practice the full scope of the claimed invention, skilled artisans must make candidate antibodies and screen them to determine which ones perform the claimed functions." (Id.).
The specification does not reasonably provide enablement to make and use the invention of instant claims 1-7, 10-14, and 19. The specification does enable one with ordinary skill to make the antibody clone discussed supra.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
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 2 and 11 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.
Claims 2 and 11 is indefinite because the claim recites amino acid positions in TCR exons, for example “TRAC*01” in claim 2 and “TRAC*01 exon 1” in claim 11.
The instant specification discloses the naming nomenclature (¶[0075]): “In the IMGT system, alpha chain constant domain is represented by a symbol TRAC*0l, where "TR" represents T cell receptor gene; "A" represents alpha chain gene; C represents constant region; "*0 l" represents allele gene 1. Beta chain constant domain is represented by a symbol TRBCl *01 or TRBC2*01, where "TR" represents T cell receptor gene; "B" represents beta chain gene; C represents constant region; "*0l" represents allele gene 1. The alpha chain has a uniquely defined constant region, while the beta chain has two possible forms of constant region genes "Cl" and "C2".”
It is currently unclear how the T cell receptor recited in claim 1, which is a polypeptide, have the constant chain gene sequences recited in claims 2 and 11, which are nucleotides.
Claim 11 is additionally indefinite because the claim recites amino acid position numbers (i.e., “Thr48”) without a corresponding reference amino acid sequence in the claims. It is currently unclear which amino acid sequences the recited residue numbers refer to. It is recommended to amend the claims to recite a sequence in the claims, or to recite an established antibody amino acid residue numbering system, to overcome this issue.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sissons et al. (U.S. Patent No 11,072,660, provisional application filed on 10/3/2016) teaches TCRs that bind to SEQ ID NO: 233 complexed with HLA A0201. SEQ ID NO: 233 is 100% identical to instant SEQ ID NO: 26. Sissons et al. teaches TCRs that bind this epitope complex (Col. 17, lines 17-45). Sissons et al. teaches TCRs comprising the Vα of SEQ ID NO: 532, which is 98% identical to instant SEQ ID NO: 1; and the Vβ of SEQ ID NO: 560, which is only 89.9% identical to instant SEQ ID NO: 5. This is the closest prior art that was found that teaches similar subject matter to the instantly claimed invention.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641