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 .
Information Disclosure Statement
The IDSs dated 15 February 2023 and 31 July 2023 have been considered except where lined through. The lined through references have not been considered because they appear to be in entirely different fields of endeavor not even related to biotechnology. The examiner would also like to note that although Hiepe et. al. NPL 018 IDS dated 15 February 2023 has been considered to the best of the examiner’s ability, the provided copy has disruption to the text of the titles, subtitles, and Figure legends as shown below:
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Therefore, only the text of the body of the reference has been considered.
Claim Objections
Claims 108-12 are objected to because of the following informalities: In claim 108, IgG is used as a parenthetical abbreviation for immunoglobulin. As described in the specification, IgG is subtype of a class of immunoglobulins that corresponds to the heavy-chain con Appropriate correction is required.
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.
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 109 and 114 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 109 is indefinite for the recitation of “wherein the heavy chain variable domain comprises an IgG1, IgG2, IgG3, or IgG4 heavy chain”. It is unclear whether the claim requires a heavy chain constant domain because the claim recites “heavy chain variable domain”. However, the subclasses IgG1, IgG2, IgG3, and IgG4 all refer to particular characteristics of a heavy chain constant domain or Fc domain. Thus, an artisan would not understand whether the metes and bounds require a IgG1, IgG2, IgG3, or IgG2 heavy chain constant region or how the classification alters the heavy chain variable domain.
Claim 114 is indefinite for the recitation of “wherein the light chain variable domain comprises a variable domain of an IgG1, IgG2, IgG3, or IgG4 light chain”. It is unclear what the claim is referring to because light chains do not get defined by the IgG class or subclass. As described in the specification, there are two types of human light chain constant domains, lamda and kappa [0060], and these refer to light chain constant domains rather than light chain variable domains. An artisan would therefore not understand the metes and bounds of the claim.
Claim Rejections - 35 USC § 112(a)- Written Description
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 108-112, 124-126 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 108, the claims recites an anti-CD38 immunoglobulin binding domain comprising 3 heavy chain CDRs without any defined light chain CDRs, but the art and genus of known species does not allow for predictable binding of the recited function of binding CD38.
Scope of the claimed genus
Claim 108 recites a genus of polypeptides comprising an antibody binding fragment which specifically binds to CD38 and comprises a VH with HC-CDRs of SEQ ID NO: 9, 10, and 11, respectively with any light chain.
State of the Relevant Art
It is well established in the art that the formation of an intact antigen-binding site in an antibody usually requires the association of the complete heavy and light chain variable regions of a given antibody, each of which comprises three CDRs (or hypervariable regions) which provide the majority of the contact residues for the binding of the antibody to its target epitope. E.g., Almagro et. al., Front. Immunol. 2018; 8:1751 (see Section “The IgG Molecule” in paragraph 1 and Figure 1). While affinity maturation techniques can result in differences in the CDRs of the antibody compared to its parental antibody (page 3 “The IgG Molecule, second and third paragraphs), those techniques involve trial-and-error testing and the changes that maintain or improve affinity are not predictable a priori. E.g., id., (page 6 ending paragraph onto page 7). Chiu ML et al. (Antibodies 2019 8, 55, 1-80) taught the antigen binding of antibodies often results in conformational changes in the contact surface areas of both the antibody and the antigen (page 5, first paragraph). Thus, the prediction of CDR binding to the epitope is difficult to predict. Chiu further taught antibody modeling has been shown to be accurate for the framework region sequences, but CDR modeling requires further development and improvements (page 6, second paragraph). Prediction of the structure of HCDR3 could not be accurately produced when given the Fv structures without their CDR-H3s (page 6, second paragraph). Chiu taught the quality of antibody structure prediction, particularly regarding CDR-H3, remains inadequate, and the results of antibody–antigen docking are also disappointing (page 11, paragraph 2).
Further, a recitation of “percent identity” does not limit the differences in amino acid sequence to residues outside the CDRs. And while it is possible to screen for variants that retain antigen binding, it is respectfully submitted that the number of possible substitutions permitted by “95% percent identity” language (as in claim 126, for example) does not allow the skilled artisan to envisage those variants not yet made which would retain the required function.
Additionally, 95% identity to the scFv-Fc sequences of claim 126 would allow for exchange of up to 24 amino acids in the light chain CDRs of SEQ ID NOs: 169, 222, or 223, which encompasses complete exchange any two of the LC-CDRs.
In regards to anti-CD38 antibodies, other anti-CD38 antigen binding sites are known in the art. For example, WO2019035938 to Loew et. al. (Of record, IDS 2/15/2023 FOR005) teaches multispecific molecules that bind to CD38 and BCMA among a group, wherein the anti-CD38 antibody comprises CDRs that differ from the instant H-CDRs SEQ ID NO: 9, 10, and 11, respectively and L-CDRs SEQ ID NOs: 67, 68, and one of 69, 188, or 193, respectively (Table 3, p. 41-42). Thus, an artisan would not be able to envision from the instant specification whether the light chain CDRs of Loew et. al. could pair with the instant H-CDRs to make a functional anti-CD38 antibody.
Summary of Species disclosed in the original specification
The instant specification discloses three bispecific antibodies comprising the instantly claimed heavy and light chain CDRs that binds to CD38 (CD38 x anti-BCMA.BMK2, CD38med x BCMA.BMK2, and CD38low x BCMA.BMK2); see Table 9 and Figs. 6 and 7.
One of skill in the art would reasonably conclude that applicant was not in possession of the required genus of variants to allow complete substitution of the light chain or any of the light chain CDRs of the anti-CD38 antibody portion while maintaining the anti-CD38 binding function.
Summary
A genus of species is not present in the instant specification or prior art that would demonstrate a structure/activity relationship would be known for antibody CDR residues for the recited function of binding the protein CD38. There is a lack of an appropriate number of species with identical or alternative amino acid residues within the CDR binding determinant region that indicate which amino acid residues: i) are essential for binding; ii) can be changed and still allow protein target binding; or iii) disrupt protein target binding. One of skill in the art would reasonably conclude that the applicant was not in possession of the genus of substitutions and deletions of the antibodies of claim 108 at the time of filing. Regarding claims 109-112 and 124-126, the claims are ultimately dependent on the rejected claim 108 without narrowing the claimed subject matter and thus are also rejected.
Claim Rejections - 35 USC § 112(a)- Scope of Enablement
Claims 108-112, 124-126 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:
An antibody that comprises a CD38 binding domain wherein the CD38 binding domain comprises a heavy chain variable domain comprising CDRs SEQ ID NOs: 9, 10, and 11 respectively and a light chain variable domain comprising CDRs CDR-1: SEQ ID NO: 67, CDR-2: SEQ ID NO: 68, and CDR-3: SEQ ID NO: 69, 188, or 193.
does not reasonably provide enablement for:
An antibody that comprises a CD38 binding domain wherein the CD38 binding domain comprises a heavy chain variable domain comprising CDRs SEQ ID NOs: 9, 10, and 11 and no light chain or no defined light chain CDRs
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit 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." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. In In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) eight factors included for determining enablement:
(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;
(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.
The following is an analysis of these factors in relationship to this application
Scope of the claimed genus and nature of the invention
Claim 108 recites a genus of polypeptides comprising an antibody binding fragment which specifically binds to CD38 and comprises a VH with HC-CDRs of SEQ ID NO: 9, 10, and 11, respectively with any light chain.
State of the Relevant Art ; level of one of ordinary skill; and level of predictability in the art
It is well established in the art that the formation of an intact antigen-binding site in an antibody usually requires the association of the complete heavy and light chain variable regions of a given antibody, each of which comprises three CDRs (or hypervariable regions) which provide the majority of the contact residues for the binding of the antibody to its target epitope. E.g., Almagro et. al., Front. Immunol. 2018; 8:1751 (see Section “The IgG Molecule” in paragraph 1 and Figure 1). While affinity maturation techniques can result in differences in the CDRs of the antibody compared to its parental antibody (page 3 “The IgG Molecule, second and third paragraphs), those techniques involve trial-and-error testing and the changes that maintain or improve affinity are not predictable a priori. E.g., id., (page 6 ending paragraph onto page 7). Chiu ML et al. (Antibodies 2019 8, 55, 1-80) taught the antigen binding of antibodies often results in conformational changes in the contact surface areas of both the antibody and the antigen (page 5, first paragraph). Thus, the prediction of CDR binding to the epitope is difficult to predict. Chiu further taught antibody modeling has been shown to be accurate for the framework region sequences, but CDR modeling requires further development and improvements (page 6, second paragraph). Prediction of the structure of HCDR3 could not be accurately produced when given the Fv structures without their CDR-H3s (page 6, second paragraph). Chiu taught the quality of antibody structure prediction, particularly regarding CDR-H3, remains inadequate, and the results of antibody–antigen docking are also disappointing (page 11, paragraph 2).
Further, a recitation of “percent identity” does not limit the differences in amino acid sequence to residues outside the CDRs. And while it is possible to screen for variants that retain antigen binding, it is respectfully submitted that the number of possible substitutions permitted by “95% percent identity” language (as in claim 126, for example) does not allow the skilled artisan to envisage those variants not yet made which would retain the required function.
Additionally, 95% identity to the scFv-Fc sequences of claim 126 would allow for exchange of up to 24 amino acids in the light chain CDRs of SEQ ID NOs: 169, 222, or 223, which encompasses complete exchange any two of the LC-CDRs.
In regards to anti-CD38 antibodies, other anti-CD38 antigen binding sites are known in the art. For example, WO2019035938 to Loew et. al. teaches multispecific molecules that bind to CD38 and BCMA among a group, wherein the anti-CD38 antibody comprises CDRs that differ from the instant H-CDRs SEQ ID NO: 9, 10, and 11, respectively and L-CDRs SEQ ID NOs: 67, 68, and one of 69, 188, or 193, respectively (Table 3, p. 41-42).
Summary of Species disclosed in the original specification ; the amount of direction provided by the inventor; existence of working examples; and quantity of experimentation needed to make and use the invention based on the content of the disclosure
The instant specification discloses three bispecific antibodies comprising the instantly claimed heavy and light chain CDRs that binds to CD38 (CD38 x anti-BCMA.BMK2, CD38med x BCMA.BMK2, and CD38low x BCMA.BMK2); see Table 9 and Figs. 6 and 7. The light chain CDRs each differ only by a single residue in L-CDR3 at two different positions as underlined:
SEQ ID NO: 69QGYYSGGSYA
SEQ ID NO: 188AGYYSGGSYA
SEQ ID NO: 193QGYYSAGSYA
There are no other examples for direction or alternate light chains shown to couple with the instant heavy chain CDRs in order to make a complete anti-CD38 binding domain. Therefore, it would take undue experimentation to determine which of the potentially thousands of additional antibodies comprising any light chain CDRs or with individual complete CDR swaps or changes in individual amino acids residues of the instant light chain CDRs maintains binding to CD38.
Conclusion
The applicant does not have enablement for the complete scope of the genus of antibodies binding to CD38 comprising a heavy chain with CDRs of SEQ ID NOs: 9, 10, and 11 as recited in claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 108-117, 124, 126, and 127 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by WO2021222595 to Chen et. al. effectively filed 30 April 2020.
Chen et. al. teaches a multispecific antibody comprising a CD38 binding domain and an EpCAM binding domain, wherein the anti-CD38 binding domain comprises SEQ ID NO: 271 (100% identical to instant SEQ ID NO: 169). SEQ ID NO: 271 comprises an anti-CD38 scFv comprising CDRs identical to instant HC-CDRs SEQ ID NOs: 9, 10, and 11 and LC-CDRs SEQ ID NOs: 67, 68, and 69 and identical to VH of SEQ ID NO: 114 and VL of SEQ ID NO: 137.
Regarding claims 109 and 114, Chen et. al. teaches the antibody may comprise and IgG1, IgG2, IgG3, or IgG4 heavy or light chain variable domain [0005].
Regarding claim 124, the antibody comprises an scFv or a Fab [0005].
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 125 is rejected under 35 U.S.C. 103 as being unpatentable over WO2021222595 to Chen et. al. effectively filed 30 April 2020 as applied to claim 108 above, and further in view of WO2019035938 to Loew et. al (Of record, IDS).
The teachings of Chen et. al. in regards to claim 108 are in the 102 rejection above.
Chen et. al. does not teach the multispecific antibody further comprises an anti-BCMA binding domain.
This deficiency is resolved by Loew et. al.
Loew et. al. teaches a bispecific antibody comprising an anti-CD38 binding domain and an anti-BCMA binding domain: “In some embodiments, the multispecific molecule includes a) a first targeting moiety that binds to BCMA, and b) a second targeting moiety that binds to CD38” (p. 2 top paragraph) (also see for example p. 41-42, p. 35-38, Fig. 3A). Loew et. al. teaches that the antibodies are for treating cancer such as a hematologic cancer (p. 89). Also see “Targeting moieties” section starting on p. 34).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date, to substitute the anti-CD38 binding domain of the bispecific antibody of Chen et. al. for then anti-CD38 binding domain of the anti-CD38/anti-BCMA bispecific of Loew et. al. in order to benefit from the dual anti-CD38/anti-BCMA binding for targeting cancer as taught by Loew et. al. This would have a predictable effect because both anti-CD38 binding domains are taught to be effective anti-CD38 targeting domains for therapeutic cancer antibodies.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 108-124, 126, and 127 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 77-93 of copending Application No. 17998481 (reference application), effectively filed 14 May 2020. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '481 make obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The ‘481 application teaches a bispecific antibody comprising a CD38 binding domain comprising SEQ ID NO: 40 (identical to instant SEQ ID NO: 114 and comprising CDRs identical to instant SEQ ID NOs: 9, 10, and 11) (claim 90). The claims disclose a humanized CD38 binding domain comprising a sequence at least 90% identical to SEQ ID NOs: 50-55, which are identical to the instant CDRs SEQ ID NOs: 9, 10, and 11 and 67, 68, and 69, respectively. To determine the scope of the claimed anti-CD38 antibodies, the specification was consulted (MPEP 804.II.B.1). The specification teaches SEQ ID NO: 271, which is 100% identical to instant SEQ ID NO: 169 comprises an anti-CD38 scFv comprising CDRs identical to instant HC-CDRs SEQ ID NOs: 9, 10, and 11 and LC-CDRs SEQ ID NOs: 67, 68, and 69 and identical to VH of SEQ ID NO: 114 and VL of SEQ ID NO: 137; SEQ ID NO: 210, which is 100% identical to instant SEQ ID NO: 210, and SEQ ID NO: 215, which is 100% identical to instant SEQ ID NO: 215. Therefore, the claims of ‘481 make obvious the instantly claimed anti-CD38 antibody.
Claim 125 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 77-93 of copending Application No. 17998481 (reference application) effectively filed 14 May 2020 as applied to claim 108 above and in further view of WO2019035938 to Loew et. al.
The teachings of the ‘481 claims in regards to claim 108 are in the NSDP rejection above.
The ‘481 claims do not teach the bispecific antibody wherein the antibody further comprises a BCMA binding domain.
This deficiency is resolved by Loew et. al.
Loew et. al. teaches a bispecific antibody comprising an anti-CD38 binding domain and an anti-BCMA binding domain: “In some embodiments, the multispecific molecule includes a) a first targeting moiety that binds to BCMA, and b) a second targeting moiety that binds to CD38” (p. 2 top paragraph) (also see for example p. 41-42, p. 35-38, Fig. 3A). Loew et. al. teaches that the antibodies are for treating cancer such as a hematologic cancer (p. 89). Also see “Targeting moieties” section starting on p. 34).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date, to substitute the anti-CD38 binding domain of the bispecific antibody of the ‘481 claims for the anti-CD38 binding domain of the anti-CD38/anti-BCMA bispecific of Loew et. al. in order to benefit from the dual anti-CD38/anti-BCMA binding for targeting cancer as taught by Loew et. al. This would have a predictable effect because both anti-CD38 binding domains are taught to be effective anti-CD38 targeting domains for therapeutic cancer antibodies.
Conclusion
No claims are allowed.
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/KATHLEEN CUNNINGCHEN/ Examiner, Art Unit 1646
/ANAND U DESAI/ Primary Examiner, Art Unit 1656