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 .
Response to Amendment
The amendment filed 06/11/2026, amending claim(s) 1, 28, 44, cancelling claims 12, 14, 15, 17, 30, 46, and newly adding claims 47-50 is acknowledged.
Applicant's amendments to the claims have overcome each and every 112(a) written description rejection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 3/11/2026.
The rejection of claims 1, 3, 12-15, 25, 28, and 44-46 under 35 U.S.C. § 102(a)(1) as allegedly being anticipated by Minnesota, claims 28, 44, and 46 as allegedly being anticipated by, or in the alternative, obvious over Minnesota as evidenced by Chmielowiec et al., and claims 4-5 and 27 as allegedly being obvious over Minnesota further in view of Juno are withdrawn. Applicant added the new limitations of “wherein the engineered cell is a beta cell”, and “the one or more exogenous secreted proteins are inserted into the C-peptide-encoding region of an insulin gene of the cell such that the beta cell co-secretes insulin and the one or more exogenous secreted proteins” to newly amended claim 1, which are not disclosed by Minnesota.
Claims 1, 3-9, 11, 13, 20, 21, 23, 25, 27, 28, 31-34, 36, 37, 43-45, and 47-50 are pending.
Claims 1, 3-5, 13, 25, 27, 28, 44, 45, and 47-50 are pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application PCT/US2018/019763 filed 04/01/2020 and provisional application 62/827,772 filed on 04/01/2019 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. The effective filing date of the claims is granted as the filing date of provisional application 62/827,772 filed on 04/01/2019.
Claim Rejections - 35 USC § 112(a) – New, necessitated by amendment
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.
Claim 50 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.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
Newly added claim 50 recites “The engineered cell of claim 1, further comprising one or more polynucleotides encoding an exogenous co-expressed protein that enhances the expression, stability or biological activity of the one or more exogenous secreted proteins.”
The exogenous co-expressed protein of the claimed engineered cell is recited at a high level of generality. There are a wide variety of proteins that work at distinct levels of expression/stability/activity (e.g., proteins to enhance transcription start, proteins to enhance pre-mRNA splicing, proteins to start translation, proteins that degrade the mRNA, proteins that help with folding, proteins that help with targeting the protein to the correct location, proteins that degrade the protein, and proteins and compounds that increase/decrease the activity of a protein). How would an artisan determine what level will enhance the expression, stability, or biological activity of the exogenous secreted protein, for example?
The claim is considered to lack adequate written description for failing to recite the structure that is necessary and sufficient to cause the recited functional language (i.e., enhances the expression, stability or biological activity). The claim limitations recited above merely state functional characteristics without providing any indication about how the functional characteristic is provided.
The specification fails to disclose what structures of the co-expressed protein in the claimed engineered cell is necessary and sufficient to cause the recited functions, and thus the ordinary artisan would not know what modification(s) must be made or what structure must be present in order to fulfill the instant recitation. For example, how would an artisan know whether a co-expressed protein will enhance the expression, stability or biological activity of the one or more exogenous secreted proteins? A search of the specification for “co-express[ed]” only returned re-iterations of the claim language and the following related to anti-fibrillating polypeptides:
[0092] The polynucleotide may encode an anti-fibrillating polypeptide. The anti- fibrillating polypeptide can be the secreted polypeptide. In some aspects the anti-fibrillating polypeptide is co-expressed with one or more other polynucleotides and/or polypeptides described elsewhere herein. The anti-fibrillating agent can be secreted and act to inhibit the fibrillation and/or aggregation of endogenous proteins and/or exogenous proteins that it may be co-expressed with.
The claims fail to recite, and the specification fails to disclose, the structure/function nexus between the genus of co-expressed proteins and the functional properties of enhancing the expression, stability or biological activity of the secreted protein.
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function…does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
Claim Rejections - 35 USC § 112(b) – New, necessitated by amendment
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.
Claim 1, 3-5, 13, 25, 27, 28, 44, 45, and 47-50 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.
Claim 1 recites the limitation "the inserted polynucleotide" in the second-to-last line. There is insufficient antecedent basis for this limitation in the claim. The recitation is indefinite because there is no prior reference to an inserted polynucleotide in claim 1, and there is nothing implicit in claim 1 that would inherently require an inserted polynucleotide to be present. Is the inserted polynucleotide intended to refer to one of the one or more polynucleotides encoding one or more exogenous secreted proteins? Claim 1 also refers to the one or more exogenous secreted proteins being inserted into the C-peptide-encoding region of an insulin gene, but not a polynucleotide. The metes and bounds of the claim is not clearly and precisely defined. It would be remedial to amend claim 1 to clarify what the “inserted polynucleotide” is referring to.
Similarly, claim 48 recites “The engineered cell of claim 1, wherein the one or more polynucleotides are inserted in the middle of the C-peptide-encoding region of the insulin gene.” It is unclear in view of claim 1 whether the polynucleotides inserted in claim 48 is/are the same as the inserted polynucleotide of claim 1. If so, it is unclear which polynucleotide is being referred to, as claim 1 recites a singular inserted polynucleotide, while claim 48 recites one or more. Additionally, how do the inserted polynucleotide(s) relate to the inserted exogenous secreted proteins of claim 1? It would be remedial to clarify the relationship between the inserted exogenous secreted proteins and inserted polynucleotide recited in claim 1 and the inserted one or more polynucleotides of claim 48.
Claim 28 recites “wherein the one or more polynucleotides comprise a protease cleavage site on each end”. It is unclear how a nucleic acid can comprise a protein sequence, as nucleic acids encode proteins. It would be remedial to amend the claim to recite that the one or more polynucleotides encode a protease cleavage site on each end. For examination purposes, prior art teaching the one or more polynucleotides encoding a protease cleavage site on each end is interpreted to read upon the claim limitations.
Claim Rejections - 35 USC § 103 – New, necessitated by amendment
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) 1, 3-5, 13, 28, and 47-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. (Burns, Sean M., et al. "High-throughput luminescent reporter of insulin secretion for discovering regulators of pancreatic Beta-cell function." Cell metabolism 21.1 (2015): 126-137.; cited in IDS) and further in view of Carter et al. (Carter, Jeffrey D., et al. "Viral IL-10-mediated immune regulation in pancreatic islet transplantation." Molecular Therapy 12.2 (2005): 360-368.; cited in IDS).
Regarding claims 1 and 49, Burns et al. teaches:
An engineered cell comprising one or more polynucleotides encoding:
(a) one or more exogenous secreted proteins (e.g., Gaussia luciferase),
wherein the engineered cell is a beta cell; and wherein the one or more exogenous secreted proteins are inserted into the C-peptide-encoding region of an insulin gene (e.g., proinsulin) of the cell such that the beta cell co-secretes insulin and the one or more exogenous secreted proteins, and wherein the inserted polynucleotide comprises one or more protease cleavage sites (e.g., PC2- claim 49) (e.g., Abstract; pg. 127, col 1, “Creating a Luminescent Insulin Secretion Reporter”).
Burns et al. does not teach the one or more exogenous secreted proteins being an immunomodulatory protein, an anti-fibrotic protein; a hormone; anti-microbial protein; a protein or peptide that promotes tissue regeneration.
An artisan, interested in secreting exogenous genes in beta cells, would be aware of Carter et al. for teaching interleukin-10 gene transfer into insulin-producing β cells (e.g., islets).
Carter et al. teaches an injecting diabetic mice with an AAV vector encoding IL-10 (claims 3-5, 47), then evaluating beta cell function (e.g., pg. 361, Results). Following AAV IL-10 delivery, Carter et al. still observed insulin secretion in the islets (e.g., pg. 365, col 2, para 2; Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the luciferase protein taught by Burns et al. with the cytokine IL-10 taught by Carter et al. with a reasonable expectation for success. An artisan would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06.
Further, replacing a protein with another has long been done in the molecular biology art and would be routine. One would be motivated to replace the lucierase protein taught by Burns et al. because as taught by Carter et al., the AAV vIL-10 can protect grafted islets from autoimmune mediated destruction (e.g., Abstract). Additionally, cytokines such as IL-10 are well known to play vital roles in autoimmunity, immune cell regulation, and transplantation rejection, with previous studies showing beneficial effects from exogenous IL-10 gene therapy (e.g., pg. 366, col 1, last para).
Regarding claim 13, Burns et al. teaches the beta cell being a human cell (e.g., pg. 132, “Validating Compounds on Human Islets”).
Regarding claim 28, Burns et al. teaches the one or more polynucleotides comprising a protease cleavage site at each end (e.g., Fig. 1A).
Regarding claim 48, Burns et al. teaches the polynucleotide being inserted into the middle of the c-peptide encoding region of the insulin gene (e.g., Fig. 1A).
Claim(s) 1, 3-5, 13, 25, 27, 28, 44, 45, and 47-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. and Carter et al., further in view of Juno (previously cited).
As shown above, the base claims are obvious over the base art.
An artisan, interested in engineered cells, would be aware of Juno for teaching engineered beta cells comprising exogenous secretory polypeptides.
Regarding claims 25, 27, and 45, Burns et al. and Carter et al. do not teach the engineered cell further comprising one or more polynucleotides encoding interference RNA.
Juno teaches engineering beta cells to comprise one or more coding sequences encoding an exogenous protein under the control of one or more elements to effect secretion of the exogenous protein from the cell (e.g., claim 1 of Juno). Juno also teaches inserting the nucleic acid encoding the exogenous protein into an endogenous locus, such as an immunoglobulin locus (e.g., [0136]). The engineered cell further comprising one or more polynucleotides encoding interference RNA, optionally wherein the interference RNA is siRNA (claim 45) (e.g., [0256; 0261-0268]).
Juno teaches achieving gene repression using antisense techniques, such as by RNA interference (RNAi) to selectively suppress or repress expression of a gene [0387; 0439-440]. Additionally, Juno teaches the engineered cell comprising a recombinant receptor comprising a ligand binding domain (claim 7 of Juno). This ligand may be a colony stimulatory factor (CSF) or TGF-beta [0229; 0234]. Juno also teaches the signal sequence in the engineered cell comprising TGF-beta [0195]. TGF-beta and/or CSF may be a stimulating agent or growth factor for the engineered cell [0162; 0303, 0305]. While Juno does not explicitly disclose the RNAi suppressing TGF-beta, CSF-1, or a combination thereof, Juno does teach using RNAi to repress a variety of genes, such as OCT2 and ETS1 [0261-0268]. Additionally, Juno teaches that gene repression achieved using RNAi is known in the art [0387; 0439].
Therefore, at the time of effective filing of the instant case, an artisan would have known that one can use RNAi to suppress the expression of a gene of their choice. One would be motivated to use RNAi for gene suppression because as taught by Juno, RNAi can selectively suppress or repress expression of a targeted gene [0439-0441].
Further, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the engineered cell taught by Burns et al. and Carter et al. by Juno to suppress the recited genes and yield predicable results. Adding the RNAi taught by Juno would not alter the co-expression of a protein that enhances the biological activity of the secreted protein. Juno teaches that gene repression via RNAi is known in the art [0387]. One would be motivated to add the RNAi to the engineered cell of Burns et al. and Carter et al. because as taught by Juno, RNAi can be used to selectively suppress or repress expression of a gene [0439].
Regarding claim 44, Burns et al. and Carter et al. do not teach the beta cells being differentiated from a progenitor in vitro.
Juno teaches that the engineered beta cells may be differentiated in vitro from progenitor cells such as hematopoietic stem cells (e.g., [0311-0312]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the beta cells taught by Burns et al. and Carter et al. with the beta cells taught by Juno with a reasonable expectation for success. An artisan would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06.
Further, replacing the origin of a cell type with another has long been done in the molecular biology art and would be routine. One would be motivated to replace the substitute for a beta cell differentiated from a progenitor in vitro because as taught by Juno, the secretory capacity of B cells is related to their differentiation state. Normally, B cells develop from hematopoietic stem cells (HSCs) that originate from bone marrow (e.g., [0117]). Additionally, modifying the input cell to increases the capacity of the engineered B cell to produce and/or secrete the exogenous protein (e.g., [0313]).
Regarding claim 50, Burns et al. and Carter et al. do not teach the engineered cell further comprising one or more polynucleotides encoding an exogenous co-expressed protein that enhances the expression, stability or biological activity of the one or more exogenous secreted proteins.
Juno teaches the enhancement of the expression, activity, and/or function of the exogenous gene may be carried out by modifying the expression of the endogenous gene, by introducing an exogenous copy of the gene (e.g., [0445]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the engineered beta cells taught by Burns et al. and Carter et al. with the engineered beta cells taught by Juno by adding one or more polynucleotides encoding an exogenous co-expressed protein that enhances the expression, stability or biological activity of the one or more exogenous secreted proteins as taught by Juno. Because their combination would require nothing more than employing well known gene activation techniques, an artisan would have a reasonable expectation of success in making the engineered cell as claimed. One would be motivated to add the one or more polynucleotides taught by Juno because as taught by Juno, the polynucleotide(s) would enhancement of the expression, activity, and/or function of the gene (e.g., [0445]).
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
Regarding the 112(a) written description rejection of the recitation “an exogenous co-expressed protein that enhances the expression, stability or biological activity of the one or more exogenous secreted proteins”, the Applicant argues:
“The specification satisfies the written description requirement by disclosing, for the recited co-expressed protein limitation, a defined structural class, design methodology for generating members of that class, representative species with disclosed amino acid sequences, and an identified mechanism that ties structure to the recited enhancement function. Paragraph [0092] of the specification provides one such demonstration, in the form of an "anti-fibrillating polypeptide" that "act[s] to inhibit the fibrillation and/or aggregation of endogenous proteins and/or exogenous proteins that it may be co-expressed with." (Spec. [0092].) Inhibition of fibrillation and aggregation is a recognized mechanism for enhancing the stability of a co-expressed protein, and paragraph [0092] thereby identifies the structure/function nexus between the disclosed class and the recited "stability" function: members of the anti-fibrillating polypeptide class enhance stability by suppressing the fibrillation and aggregation pathways through which co-expressed proteins lose stability. The specification incorporates by reference U.S. Patent No. 8,754,034, which provides design methodology for anti-fibrillating peptides, and U.S. Patent No. 8,343,914, which discloses fibrillation-resistant variants. (Id.) Within that methodology, paragraph [0092] identifies representative species including the peptides designated P4 (VITYF), P5 (VVVVV), KR7 (KPWWPRR), NK9 (NIVNVSLVK), iAb5p (Leu-Pro-Phe-Phe-Asp), D-(PGKLVYA),
LVEALYL, and RGFFYT (SEQ ID NOs: 1-8), along with additional named anti-fibrillating peptides (KLVF, indolicidin, carnosine, RI-OR2-TAT, SEN304, SEN1576, D3, HGD, poly- lysine, poly-aspartate, and poly-L-glutamate) and three defined structural sub-classes (D-peptides, L-peptides, and retro-inverso peptides). (Id.) The anti-fibrillating polypeptide class of paragraph [0092] is one illustration of how the specification places the inventor in possession of the recited co-expressed protein limitation under MPEP § 2163(II)(A)(2), through the combination of a disclosed mechanism, incorporated design methodology, named structural sub-classes, and representative species with disclosed sequences.”
This argument is not persuasive because the claim language and specification do not clearly define the structure of the exogenous secreted proteins. The Applicant fails to expand upon how a recognized mechanism for enhancing stability of an exemplary secreted protein, for example, defines the structure of the generically claimed genus of polynucleotides encoding exogenous co-expressed proteins with the function of enhancing the expression, stability, or biological activity of the secreted protein. The functional relationship between the exogenous secreted protein and co-expressed exogenous protein also does not clearly define/limit the structure(s) of the protein(s). How would one measure this criteria? What structure leads to this function? What modification(s) to the protein(s) would still result in this function? Limiting the co-expressed exogenous protein functionally does not provide clear guidance for an artisan on what proteins are included in this genus, nor provide evidence of possessing the claimed cell.
Further, [0092] of the specification, which was cited in the rejection, only provides an example of a polypeptide/exogenous co-expressed protein that may be encoded by a polynucleotide in the claimed engineered cell. Anti-fibrillating polypeptides are not recited in the claims, and it is unclear how examples of anti-fibrillating polypeptides provide enough guidance for possession of the genus of “exogenous co-expressed protein[s]” recited in claim 50.
In addition, the Applicant argues:
“…the specification answers the possession question directly. For example, it identifies a defined structural class (anti-fibrillating polypeptides), discloses the mechanism by which that class enhances stability of a co-expressed protein (inhibition of fibrillation and aggregation), provides design methodology through incorporation of U.S. Patent No. 8,754,034, and names representative species with disclosed sequence”.
Again, anti-fibrillating polypeptides are not recited in the claims, nor does the claim language recite inhibition of fibrillation and aggregation as a function of the co-expressed protein. The Examiner also notes that based on the claim language, the exogenous co-expressed protein is recited to enhance the expression/stability/activity of the exogenous secreted proteins, not the other way around as quoted above in the Applicant’s remarks.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M JOHNSON whose telephone number is (703)756-1396. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ALLISON MARIE JOHNSON/Examiner, Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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