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 .
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.
Written Description
Claims 1, 3, 5-10, 13, 16-19, 21, 25-26, and 30 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.
Claim 1 allows the CDRs of different anti-CD47 single domain antibody (sdAb) clones to be mixed and matched, yet there is no evidence that said antibodies are variants of a single starting clone such that the resultant antibody retains binding affinity for CD47. With the exception of claims 2, 4, 12, and 13, all claims dependent either directly or indirectly from claim 1 (or incorporates limitations of claim 1) do not cure the deficiencies of claim 1 and are thus also rejected.
Further, claim 13 recites that the HCAbs of claim 12 comprise one or more amino acid substitutions; however, there is no guidance provided in the specification whereby artisans can readily predict which specific amino acids can vary in the CDRs and framework regions of the claimed HCAbs such that the ability of the claimed HCAbs to bind to CD47 is retained. As such, claim 13 is also rejected.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus (MPEP 2163).
In The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F. 3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the court also noted:
“A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin [e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.”
The court has further stated that “Adequate written description requires a precise definition, such as by structure, formula, chemical name or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.” Id. at 1566, 43 USPQ2d at 1404 (quoting at 1171, 25 USPQ2d at 1606). Also see (CAFC 2002). Enzo-Biochem v. Gen-Probe Fiers, 984 F.2d 01-1230.
Claim 1 recites an antibody comprising a single domain antibody (sdAb) that specifically binds to CD47; or an antigen binding fragment thereof, wherein the sdAb comprises CDRs selected from two clones (CD47 Nb#01 and CD47 Nb#02) (see Table 6).
Claim 1 allows the heavy chain CDRs of different anti-CD47 single domain antibody (sdAb) clones to be mixed and matched. While the specification teaches the development of at least two different anti-CD47 sdAb clones, there is no data provided showing that the CDRs from each of the antibody clones can be mixed and matched with each other without substantially impacting the ability of the resulting antibody to bind to CD47 as it does not appear that the clones are variants/mutants of a single starting clone. Therefore, artisans could not readily determine which CDRs of different anti-CD47 sdAb clones can be mixed and matched such that binding affinity for CD47 is maintained in order to treat cancer in a subject or detect the presence of CD47 commensurate in scope of claim 1, 25, and 30.
Further, the HCAbs of claim 12 have fixed or exact amino acid sequences in the CDR domains with no Xaa residues that allow for the incorporation of amino acid mutations, yet claim 13 recites that the HCAbs comprise one or more amino acid substitutions. These HCAbs represent partially defined structures having one or more undefined amino acid substitutions; however, there is no guidance provided in the specification whereby artisans can readily predict which specific amino acids can vary the CDRs and framework regions of the claimed HCAbs such that the ability of the claimed HCAbs to bind to CD47 is retained. Indeed, it is well-known that amino acid substitutions in the antibody in the CDR domains can eliminate binding activity (Piche-Nicholas et al, see in particular, Abstract). The level of skill and knowledge in the art is such that one of ordinary skill would not be able to readily identify without further testing which amino acid mutations can be made in the CDR and/or framework sequences of the claimed HCAbs such that the ability of the HCAbs to bind to CD47 is retained.
Therefore, the claimed genus of anti-CD47 sdAbs lacks adequate written description because there does not appear to be any correlation between the structure of the claimed sdAbs and the function of binding to CD47 in order to, for example, treat cancer in a subject or detect CD47 in a sample. Thus, one of ordinary skill in the art would reasonably conclude that the applicant was not in possession of the full breadth of the claimed genus of anti-CD47 sdAbs at the time the instant application was filed.
Enablement
Claim 1, 3, 5-10, 13, 16-19, 21, 25-26, and 30 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 recites an antibody comprising a single domain antibody (sdAb) that specifically binds to CD47; or an antigen binding fragment thereof, wherein the sdAb comprises CDRs selected from two clones (CD47 Nb#01 and CD47 Nb#02) (see Table 6).
Claim 1 allows the heavy chain CDRs of different anti-CD47 single domain antibody (sdAb) clones to be mixed and matched. While the specification teaches the development of at least two different anti-CD47 sdAb clones (see Examples 1-6 and Tables 5-6), there is no data provided showing that the CDRs from each of the antibody clones can be mixed and matched with each other without substantially impacting the ability of the resulting antibody to bind to CD47 as it does not appear that the clones are variants/mutants of a single starting clone. Therefore, artisans could not readily determine which CDRs of different anti-CD47 sdAb clones can be mixed and matched such that binding affinity for CD47 is maintained in order to treat cancer in a subject or detect the presence of CD47 commensurate in scope of claim 1, 25, and 30.
Further, the HCAbs of claim 12 have fixed or exact amino acid sequences in the CDR domains with no Xaa residues that allow for the incorporation of amino acid mutations, yet claim 13 recites that the HCAbs comprise one or more amino acid substitutions. These HCAbs represent partially defined structures having one or more undefined amino acid substitutions; however, there is no evidence provided in the specification that random, undefined amino acid substitutions can be made in each of the CDRs or framework regions of the claimed HCAbs such that the ability of the claimed HCAbs to bind to CD47 is retained.
Therefore, the specification is not enabled over the full scope of the claims.
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 1 and 8-10 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.
Regarding claim 1, the phrase “or an antigen binding fragment thereof” renders the scope of the claim indefinite because it is unclear whether the “antigen binding fragment” is a fragment of the single domain antibody, a fragment of the antibody, or a standalone antigen-binding fragment that even binds to the target antigen. Thus, the metes and bounds of the claim is unclear.
Regarding claim 8, the phrase "preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 9-10 which depend directly from claim 8 do not cure the deficiencies of claim 8 and are thus also rejected.
Examiner suggestion: Claim 1 can be amended to recite “An antibody comprising a single domain antibody, or antigen-binding fragment thereof, that binds to CD47”
Claim 8 can be amended to recite “obtained by fusing the sdAb to an Fc fragment via a peptide linker”.
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.
Claim 13 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 13, which depends on claim 12, recites that the HCAb comprises at least one or more amino acid substitutions. However, the HCAbs recited in claim 12 have fixed or exact amino acid sequences with no Xaa residues that allow for the incorporation of amino acid substitutions. Thus, claim 13 does not include all the limitations of the claim 12, but instead adds new limitations (i.e. amino acid substitutions) and thus broaden claim scope. 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.
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 1-10, 12, 13, 16-19, 21, 25, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-10, 12-17, 19-20, 23, 25, and 29-30 of copending Application No. 18277931 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims either anticipate or are obvious variants over the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The co-pending claims recite an anti-PD-L1 x CD47 bispecific antibody comprising a first single domain antibody (sdAb) that targets PD-L1 and a second sdAb that targets CD47, wherein the second sdAb comprises CDR1, CDR2, and CDR3 of SEQ ID NOs: 7, 8, and 9, respectively (co-pending claims 1 and 3). The amino acid sequences of SEQ ID NOs: 7, 8, and 9 respectively correspond to the amino acid sequences of SEQ ID NOs: 3, 4, and 5 recited in the instant claims. The anti-CD47 sdAb is defined by the amino acid sequence of SEQ ID NO: 6, corresponding to SEQ ID NO: 1 of the instant claims (co-pending claim 9). The anti-CD47 sdAb or antigen-binding fragment thereof includes the following VHH domain: (1) FR1 consisting of the amino acid sequence of SEQ ID NO: 17 (corresponding to SEQ ID NO: 11 of the instant claims); (2) FR2 consisting of the amino acid sequence of SEQ ID NO: 18 (corresponding to SEQ ID NO: 12 of the instant claims); (3) FR3 consisting of the amino acid sequence of SEQ ID NO: 19 (corresponding to SEQ ID NO: 13 of the instant claims); and FR4 consisting of the amino acid sequence of SEQ ID NO: 20 (corresponding to SEQ ID NO: 14 of the instant claims) (co-pending claim 6). The first and second antigen-binding moieties are fused to each other via a peptide linker (co-pending claim 10). The bispecific antibody comprises at least one or more amino acid substitutions, wherein the at least one or more amino acid substitutions are a) conservative substitutions or b) a substitution of an amino acid with a non-genetically encoded amino acid or a synthetic amino acid (co-pending claims 12-14). The bispecific antibody can also be conjugated to an immunomodulator, cytokine, cytotoxic agent, chemotherapeutic agent, diagnostic agent, antiviral agent, antimicrobial agent, or drug (co-pending claim 23). The bispecific antibody can be a heavy chain only antibody (HCab) wherein the first or second sdAb can be fused to an Fc fragment via a peptide linker (co-pending claim 15), wherein the bispecific antibody of this embodiment can comprise one or more amino acid substitutions (co-pending claim 20). The HCab is monomeric or multimeric (co-pending claim 16); and the Fc fragment is human IgG1, IgG2, IgG3, or IgG4 (co-pending claim 17). The HCab consists of an amino acid sequence of SEQ ID NO: 12 which fully comprises SEQ ID NO: 19 of the instant claims (co-pending claim 19). Further recited is a nucleic acid molecule encoding the bispecific antibody, an expression vector comprising the nucleic acid, and a host cell transformed with the expression vector (co-pending claim 25). Lastly recited is a method for preventing or treating cancer comprising administering the bispecific antibody to an individual (co-pending claim 29), wherein the cancer is selected from the group consisting of melanoma, lung cancer, liver cancer, glioblastoma, ovarian cancer, colorectal cancer, head and neck cancer, bladder cancer, renal cell cancer, stomach cancer, breast cancer, metastatic cancer, prostate cancer, pancreatic cancer, non- Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, leukemia, lymphoma, myelodysplastic syndrome, acute lymphoblastic leukemia, acute myelogenous leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, solitary myeloma and aplastic anemia (co-pending claim 30).
Thus, the co-pending claims meet the limitations of instant claims 1-10, 12, 13, 16-19, 21, 25, and 26.
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-10, 12-17, 19-20, 23, 25, and 29-30 of copending Application No. 18277931, as applied to claims 1-10, 12, 13, 16-19, 21, 25, and 26 above, in view of Sato et al (US20170369572A1), hereinafter Sato.
This is a provisional nonstatutory double patenting rejection.
The teachings of the co-pending claims have been discussed above and differ from the instantly claimed invention in that a method for detecting CD47 or determining the amount of CD47 in a sample is not specifically taught.
However, Sato discloses methods of detecting CD47 or determining the amount of CD47 in a sample comprising (a) contacting a biological sample from the patient with one or more anti-CD47 antibodies or antigen-binding fragments; (b) detecting binding of the antibody or antigen-binding fragment to CD47 to determine a CD47 protein level in the biological sample from the patient; and (c) comparing the CD47 protein level with a standard CD47 protein level (Section 5.4.1: Diagnostic Uses, Para. 0214-0228). For detection, the anti-CD47 antibody can be conjugated to a detectable substrate such as a fluorescent compound, an enzymatic substrate, a radioactive compound or a luminescent compound, or a second antibody which recognizes the first antibody can be conjugated to a detectable substrate) (Para. 0190). The term “antibody” encompasses bispecific antibodies (Para. 0049-0050). Thus, the methods of detecting CD47 or determining the amount of CD47 in a sample can be performed using a bispecific anti-CD47 antibody.
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims to detect CD47 or determine the amount of CD47 present in a biological sample from a subject. One of ordinary skill in the art would have been motivated to do so since anti-CD47 antibodies can be used in methods of detection and diagnosis as taught by Sato. Therefore, one of ordinary skill in the art would expect that the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims can be used to detect CD47 or determine the amount of CD47 present in a sample.
Claims 1-2, 8-10, 16-19, 21, 25, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18277914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims either anticipate or are obvious variants over the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The co-pending claims recite an anti-PD-L1 x CD47 bispecific antibody comprising a first humanized single domain antibody (sdAb) or antigen-binding fragment thereof that targets PD-L1 and a second humanized sdAb that targets CD47, wherein the second sdAb comprises the CDRs of SEQ ID NOs: 9, 10, and 11 (co-pending claims 1 and 3). The amino acid sequences of SEQ ID NOs: 9, 10, and 11 respectively correspond to the amino acid sequences of SEQ ID NOs: 3, 4, and 5 recited in the instant claims. The first and second antigen-binding moieties are fused to each other via a peptide linker (co-pending claim 10). The bispecific antibody can also be conjugated to an immunomodulator, cytokine, cytotoxic agent, chemotherapeutic agent, diagnostic agent, antiviral agent, antimicrobial agent, or drug (co-pending claim 17). The bispecific antibody can be a heavy chain only antibody (HCab) wherein the first or second sdAb can be fused to an Fc fragment via a peptide linker (co-pending claim 12), wherein the bispecific antibody of this embodiment can comprise one or more amino acid substitutions (co-pending claim 16). The HCab is monomeric or multimeric (co-pending claim 13); and the Fc fragment is human IgG1, IgG2, IgG3, or IgG4 (co-pending claim 14). Further recited is a nucleic acid molecule encoding the bispecific antibody, an expression vector comprising the nucleic acid, and a host cell transformed with the expression vector (co-pending claim 18). Lastly recited is a method for preventing or treating cancer comprising administering the bispecific antibody to an individual (co-pending claim 19), wherein the cancer is selected from the group consisting of melanoma, lung cancer, liver cancer, glioblastoma, ovarian cancer, colorectal cancer, head and neck cancer, bladder cancer, renal cell cancer, stomach cancer, breast cancer, metastatic cancer, prostate cancer, pancreatic cancer, non- Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, leukemia, lymphoma, myelodysplastic syndrome, acute lymphoblastic leukemia, acute myelogenous leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, solitary myeloma and aplastic anemia (co-pending claim 20).
Thus, the co-pending claims meet the limitations of instant claims 1-2, 8-10, 16-19, 21, 25, and 26.
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18277914, as applied to claims 1-2, 8-10, 16-19, 21, 25, and 26 above, in view of Sato et al (US20170369572A1), hereinafter Sato.
This is a provisional nonstatutory double patenting rejection.
The teachings of the co-pending claims have been discussed above and differ from the instantly claimed invention in that a method for detecting CD47 or determining the amount of CD47 in a sample is not specifically taught.
However, Sato discloses methods of detecting CD47 or determining the amount of CD47 in a sample comprising (a) contacting a biological sample from the patient with one or more anti-CD47 antibodies or antigen-binding fragments; (b) detecting binding of the antibody or antigen-binding fragment to CD47 to determine a CD47 protein level in the biological sample from the patient; and (c) comparing the CD47 protein level with a standard CD47 protein level (Section 5.4.1: Diagnostic Uses, Para. 0214-0228). For detection, the anti-CD47 antibody can be conjugated to a detectable substrate such as a fluorescent compound, an enzymatic substrate, a radioactive compound or a luminescent compound, or a second antibody which recognizes the first antibody can be conjugated to a detectable substrate) (Para. 0190). The term “antibody” encompasses bispecific antibodies (Para. 0049-0050). Thus, the methods of detecting CD47 or determining the amount of CD47 in a sample can be performed using a bispecific anti-CD47 antibody.
It would have been obvious to one of ordinary skill in the art to use the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims to detect CD47 or determine the amount of CD47 present in a biological sample from a subject. One of ordinary skill in the art would have been motivated to do so since anti-CD47 antibodies can be used in methods of detection and diagnosis as taught by Sato. Therefore, one of ordinary skill in the art would expect that the bispecific anti-PD-L1 x CD47 antibodies of the co-pending claims can be used to detect CD47 or determine the amount of CD47 present in a sample.
Conclusion
No claim is allowable.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641