DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 21, 2026 has been entered.
Claims 1-4, 6, 8-10, 12-15, 17-24 are pending and being examined. Claims 1 and 13 are amended. The species of host cells and targeted loci sequences (SEQ ID NOs:1-7) have been rejoined for examination.
Claim Objections
2. Claim 13 is objected to because of the following informalities: In part b) of claim 13, the claim recites “introducing into the host cells provided in (a)”, however, the step “a)” recited in claim 13 contains a single parenthesis “a)” and not double parenthesis “(a)”. Examiner suggests amending them to be the same.
Claim 13 recites the acronym “SOI” in part b) without indicating what the acronym means. Examiner suggests inserting “(SOI)” after the first mention of “sequence of interest” in part a) of claim 13.
Claim 13 recites the acronym “RRSs” in part b) of claim 13 without indicating what the acronym means. Examiner suggests amending the claim to recite “recombination recognition sequences” before the first mention of RRSs.
Appropriate correction is required.
New Rejections
Claim Rejections - 35 USC § 112
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.
3. Claims 1-4, 6, 8-10 and 12 are 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: “wherein the targeted integration of the nucleic acid SOI encoding said first polypeptide of interest and said first selection marker was integrated within the targeted locus by an exogenous nuclease.” There is insufficient antecedent basis for this limitation in the claim because there is no previous mention of a targeted integration step of the nucleic acid SOI.
Examiner suggests amending claim 1 to recite and conclude with: “wherein the targeted integrated exogenous nucleic acid SOI encoding a first polypeptide of interest and a first selection marker was integrated within the targeted locus by an exogenous nuclease”.
Dependent claims are rejected for encompassing the rejected limitation of claim 1.
4. Claim 6 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 6 recites the limitation "the first targeted integrated exogenous nucleic acid SOI". No SOI was previously identified as the “first targeted integrated nucleic acid SOI”. There is insufficient antecedent basis for this limitation in the claim.
5. Claims 13-15, 17-24 are 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 13 recites:
A method of expressing a polypeptide of interest comprising:
a) providing host cells comprising an exogenous nucleotide sequence of interest and a first selection marker integrated at a targeted locus of the genome of the host cells, wherein said targeted locus is at least 95% homologous to a sequence selected from SEQ ID NOs: 1-7, wherein the exogenous nucleotide sequence of interest comprises two RRSs flanking the first selection marker;
b) introducing into the host cells provided in (a) a nucleic acid comprising two RRSs matching the two RRSs of the integrated exogenous nucleotide sequence and flanking a first exogenous SOI encoding a first polypeptide of interest and a second selection marker;
c) introducing into the host cells a recombinase or a nucleic acid encoding a recombinase, wherein the recombinase recognizes the RRSs;
d) selecting for host cells expressing the second selection marker;
e) introducing into the host cells, via random integration, a second exogenous SOI encoding a second polypeptide of interest and a third selection marker into the genome of the host cell;
f) selecting for host cells expressing the third selection marker; and
g) culturing the host cells under conditions sufficient to express the first and second polypeptides of interest wherein each of said first polypeptide of interest and second polypeptide of interest is a single chain antibody, an antibody light chain, an antibody heavy chain, a single-chain Fv fragment (scFv), or an Fc fusion protein; and wherein the targeted integration of the nucleic acid SOI encoding a first polypeptide of interest and a first selection marker was integrated within the targeted locus by an exogenous nuclease.
Claim 13 recites plural host cells in steps a)-d), f), and g), however, step e) recites a singular host cell, and it is unclear which singular host cell the claim is referencing. See suggested amendment to claim 13 below.
Claim 13 recites in the last phrase: “wherein the targeted integration of the nucleic acid SOI encoding a first polypeptide of interest and a first selection marker was integrated within the targeted locus by an exogenous nuclease”. There is insufficient antecedent basis for this limitation in the claim because there is no previous mention of a “nucleic acid SOI encoding a first polypeptide of interest and a first selection marker” or the targeted integration thereof. There is only previous mention of “an exogenous nucleotide sequence of interest and a first selection marker” that was already (previously) integrated at a targeted locus in the host cells provided in step a).
Step b) is grammatically unclear as to what is being introduced into the host cells and where and what the RRSs are. It is unclear if the phrase in step b): “flanking a first exogenous SOI encoding a first polypeptide of interest and a second marker” refers to the two RRSs of the exogenous nucleotide sequence described in step a) or refers to the introduced nucleic acid in step b). It is unclear if the nucleic acid introduced in step b) comprises two RRSs that flank a first exogenous SOI encoding a first polypeptide of interest and a second marker, or if the nucleic acid introduced in step b) comprises only two RRSs and a second selection marker. It is unclear how the two RRSs “match” the other two RRSs. Are they the same RRSs or do they “match” in a different manner?
Claims dependent on claim 13 are rejected or encompassing the rejected limitations of claim 13.
Examiner Suggestion: Amend claim 13 to recite:
A method of expressing a polypeptide of interest comprising:
a) providing host cells comprising a first exogenous nucleotide sequence of interest (SOI) and a first selection marker integrated at a targeted locus of the genome of the host cells, wherein said targeted locus is at least 95% homologous to a sequence selected from SEQ ID NOs:1-7, wherein a first set of two recombination recognition sequences (RRSs) flank the first selection marker;
b) introducing into the host cells provided in a), a nucleic acid sequence comprising a second set of two RRSs and a second selection marker, wherein the second set of RRSs are identical to the first set of RRSs and flank the second selection marker;
c) introducing into the host cells a recombinase or a nucleic acid encoding a recombinase, wherein the recombinase recognizes the first and second sets of RRSs;
d) selecting for host cells expressing the second selection marker;
e) introducing into the host cells selected in d), via random integration, a second exogenous nucleotide SOI encoding a second polypeptide of interest and a third selection marker into the genome of the host cells;
f) selecting host cells expressing the third selection marker; and
g) culturing the host cells selected in f) under conditions sufficient to express the first and second polypeptides of interest wherein each of said first polypeptide of interest and second polypeptide of interest is a single chain antibody, an antibody light chain, an antibody heavy chain, a single-chain Fv fragment (scFv), or an Fc fusion protein; and
wherein the first exogenous nucleotide SOI and first selection marker integrated at the targeted locus were integrated within the targeted locus by an exogenous nuclease.
6. Claims 18-20 are 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 18-20 all depend ultimately from claim 13 and all recite “the host cell”. Claim 13 recites plural host cells as well as a singular host cell (see rejection in section 5 above), therefore, it is unclear which singular host cell claims 18-20 are referring to.
Examiner suggestion: Change all references to a singular cell to plural cells.
7. Claims 21-22 are 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 21 recites:
“wherein the targeted integration of any of the SOIs is promoted by an exogenous nuclease”.
It is unclear what “targeted integration” step is being referenced because there is no step of targeted integration recited in the method of claim 13. Further, there are two SOIs recited in claim 13, wherein the first SOI was already integrated into the host cells’ genome at a targeted locus when the host cells were provided in step a), therefore there is no active step of targeted integration and, and wherein the second SOI is integrated randomly and not by not targeted integration.
8. Claim 23 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 23 recites the limitation "the SOI”. Claim 23 is dependent upon claim 13, and claim 13 recites “an exogenous nucleotide sequence of interest”, “a first exogenous SOI”, “a second exogenous SOI”, and “the nucleic acid SOI encoding a first polypeptide of interest”, therefore it is unclear which SOI claim 23 is referring to.
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.
9. Claim 17 is 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. Claim 17 depends from claim 13. Claim 13 was amended to recite that each of the first and second polypeptide of interest is a single chain antibody, an antibody light chain, and antibody heavy chain, a single-chain Fv fragment (scFv), or an Fc fusion protein. Dependent claim 17 also recites that the first and second polypeptide of interest are selected from the group consisting of a single chain antibody, an antibody light chain, and antibody heavy chain, a single-chain Fv fragment (scFv), and an Fc fusion protein, which was already recited in claim 13. Therefore, claim 17 fails to further limit claim 13. 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, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
10. Claims 21 and 22 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. Claim 21 depends from claim 13. Claim 13 recites that one SOI was integrated at a targeted locus, and a second SOI is randomly integrated. Claim 21 recites “the targeted integration of any of the SOIs is promoted by an exogenous nuclease”. Given claim 13 limits the second SOI to being integrated randomly, it cannot be integrated by targeting. Therefore, claim 21 fails to properly further limit claim 13. Claim 22 is rejected for depending on claim 21 and encompassing the rejected limitation. 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, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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11. Claims 1-4, 6, 8-10, 12-15, 17-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 10-13, 21-25, 28-31, 33 of copending Application No. 18/510,297 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application is claiming a species of the host cell and method instantly claimed, wherein random integration is performed by transposon-mediated integration, thereby rendering obvious the instantly claimed genus of host cell and method. The copending application claims:
1. A host cell capable of expressing a polypeptide of interest comprising:
a) a targeted integrated exogenous nucleic acid sequence of interest (SOI) encoding a first polypeptide of interest and a first selection marker flanked by two recombination recognition sequences (RRSs), wherein the targeted integrated exogenous SOI is integrated within a targeted locus of the genome of the host cell;
b) a transposon-mediated genomically integrated exogenous nucleic acid SOI
encoding a second polypeptide of interest and a second selection marker, wherein the transposon-mediated genomically integrated exogenous nucleic acid SOI is integrated at least once in the genome of the host cell; and
c) wherein the targeted integrated exogenous nucleic acid SOI is constitutively or inducibly expressed, and the transposon-mediated genomically integrated exogenous nucleic acid SOI is constitutively or inducibly expressed.
2. The host cell of claim 1, wherein:
a) the first and the second polypeptide of interest are the same: and/or
b) the first and the second selection marker are the same.
4. The host cell of claim 1, comprising one to ten transposon-mediated genomically integrated exogenous nucleic acid SOIs.
5. The host cell of claim 1, wherein the targeted locus is at least about 90% homologous to a sequence comprising all or a portion of the contig sequence of one of the contigs NW_006874047.1, NW_006884592.1, NW_006881296.1, NW_003616412.1, NW_003615063.1) NW_006882936.1, and NW_003615411.1 or to a sequence selected from SEQ ID Nos. 1-7 [which are identical to instant SEQ ID NOs:1-7].
6. The host cell of claim 1, further comprising a second targeted integrated exogenous nucleic acid SOI encoding a second polypeptide of interest and a second selection marker integrated within a targeted locus of the genome of the host cell, wherein the first targeted integrated exogenous nucleic acid SOI and the first selection marker are flanked by a first and a third RRS and the second targeted exogenous SOI and second selection marker are flanked by a second and the third RRS.
7. The host cell of claim 1, wherein the polypeptides of interest are selected from the group consisting of: a single chain antibody, an antibody light chain, an antibody heavy chain, a single-chain Fv fragment (scFv), and an Fc fusion protein.
10. The host cell of claim 1, wherein the host cell is a CHO host cell, a CHO K1 host cell, a CHO K1SV host cell, a DG44 host cell, a DUKXB-11 host cell, a CHOK1S host cell, or a CHO K1M host cell.
11. The host cell of claim 1, wherein the targeted integration of the SOIs and selection markers are promoted by an exogenous nuclease.
12. The host cell of claim 11, wherein the exogenous nuclease is selected from the group consisting of a zinc finger nuclease (ZFN), a ZFN dimer, a transcription activator-like effector nuclease (TALEN), a TAL effector domain fusion protein, an RNA-guided DNA endonuclease, an engineered meganuclease, and a clustered regularly interspaced short palindromic repeats (CRISPR)-associated (Cas) endonuclease.
13. The host cell of claim 1, wherein:
a) the targeted integrated exogenous nucleic acid SOI is constitutively expressed; b) the targeted integrated exogenous nucleic acid SOI is inducibly expressed;
c) the transposon-mediated genomically integrated exogenous nucleic acid SOI is constitutively expressed;
d) the transposon-mediated genomically integrated exogenous nucleic acid SOI is inducibly expressed;
e) the targeted integrated exogenous nucleic acid SOI is inducibly expressed and the transposon-mediated genomically integrated exogenous nucleic acid SOI is constitutively expressed;
f) the targeted integrated exogenous nucleic acid SOI is inducibly expressed and the transposon-mediated genomically integrated exogenous nucleic acid SOI is inducibly expressed; or
g) the targeted integrated exogenous nucleic acid SOI is constitutively expressed and the transposon-mediated genomically integrated exogenous nucleic acid SOI is inducibly expressed.
21. A method of expressing a polypeptide of interest comprising:
a) providing a host cell comprising an exogenous nucleotide sequence integrated at a targeted locus of the genome of the host cell, wherein the exogenous nucleotide sequence comprises two RRSs flanking a first selection marker;
b) introducing into the cell provided in (a) a nucleic acid comprising two RRSs matching the two RRSs of the integrated exogenous nucleotide sequence and flanking a first exogenous SOI encoding a first polypeptide of interest and a second selection marker;
c) introducing a recombinase or a nucleic acid encoding a recombinase, wherein the recombinase recognizes the RRSs;
d) selecting for cells expressing the second selection marker;
e) introducing, via transposon-mediated genomic integration, a second exogenous SOI encoding a second polypeptide of interest and a third selection marker into the genome of the host cell;
f) wherein the exogenous nucleotide sequence integrated at a targeted locus of the genome of the host cell is constitutively or inducibly expressed, and the transposon- mediated genomically integrated exogenous SOI is constitutively or inducibly expressed;
g) selecting for cells expressing the third selection marker; and
h) culturing the host cell under conditions sufficient to express the first and second polypeptides of interest.
22. The method of claim 21, further comprising recovering the first and second polypeptides of interest from the host cell culture.
23. The method of claim 21, wherein the first and the second polypeptides of interest are the same.
24. The method of claim 21, wherein the targeted locus is at least about 90% homologous to a sequence comprising all or a portion of the contig sequence of one of the contigs NW_006874047.1, NW_006884592.1, NW_006881296.1,NW_003616412.1, NW_003615063.1, NW_006882936.1, and NW_003615411.1 or to a sequence selected from SEQ ID Nos. 1-7.
25. The method of claim 21, wherein the first and second polypeptides of interest are selected from the group consisting of: a single chain antibody, an antibody light chain, an antibody heavy chain, a single-chain Fv fragment (scFv), and an Fc fusion protein.
28. The method of claim 21, wherein the host cell is a CHO host cell, a CHO K1 host cell, a CHO K1SV host cell, a DG44 host cell, a DUKXB-11 host cell, a CHOK1S host cell, or a CHO K1M host cell.
29. The method of claim 21, wherein the targeted integration of any of the SOls is promoted by an exogenous nuclease.
30. The method of claim 29, wherein the exogenous nuclease is selected from the group consisting of a zinc finger nuclease (ZFN), a ZFN dimer, a transcription activator-like effector nuclease (TALEN), a TAL effector domain fusion protein, an RNA-guided DNA endonuclease, an engineered meganuclease, and a clustered regularly interspaced short palindromic repeats (CRISPR)-associated (Cas) endonuclease.
31. The method of claim 1, wherein the expression of the SOIs is controlled by a regulatable promoter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 1-4, 6, 8-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, and 8 of copending Application No. 18/129,976 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a method of preparing a host cell comprising two or more integrated exogenous nucleic acid SOIs, wherein the exogenous nucleic acid SOIs are integrated into loci selected from SEQ ID NOs:1-7; wherein the exogenous nucleic acid SOIs comprise at least two RRSs flanking a selection marker; wherein the exogenous nucleic acid SOIs encode polypeptides selected from a single chain antibody, an antibody light chain, and antibody heavy chain, a single-chain Fv fragment (scFv), or an Fc fusion protein; wherein the host cell is a mammalian cell; wherein one or more SOIs are introduced into the host cells by recombinase-mediated integration; and wherein one exogenous nucleic acid SOI and first selection marker are flanked by a first and third RRS, and another exogenous nucleic acid SOI and second marker are flanked by a second and the third RRS. Given the copending application claims a method of making the host cell and recites all of the host cell’s features, the resulting host cell is rendered obvious.
It is noted that although the copending application claims the exogenous nucleic acid SOI’s are integrated into the host cell genome by targeted integration, the resulting host cell product is indistinguishable from the instantly claimed host cell product comprising both targeted and randomly integrated exogenous nucleic acid SOIs. The host cell of the copending and instant claims both comprise integrated SOIs regardless of the method used to integrate the SOI. MPEP 2113 states: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In the instant claims, the host cell comprising an integrated exogenous nucleic acid SOI that was integrated randomly, is indistinguishable from a host cell comprising an integrated exogenous nucleic acid SOI that was integrated by targeted means.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Conclusion: No claim is allowed. All other rejections in the office action mailed December 5, 2025 are hereby withdrawn in view of amendments. The rejection of claims 13-15 and 17-24 under 35 U.S.C. 103 as being unpatentable over Gaidukov et al (Nucleic Acids Research, May 4, 2018, 46:4072-4086) is withdrawn in view of amendments to claim 13 requiring integration of the exogenous nucleotide SOI and first selection marker with flanking RRSs at a targeted locus at least 95% homologous to any of SEQ ID NOs:1-7. Gaidukov does not teach or suggest this limitation.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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