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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/7/2025 has been entered.
Claim Status
Claims 1-16, 19, 23, 26, 29-31, 33, 36-39, 41-62, and 65-94 were canceled.
Claim 95 was added.
Claims 17-18, 20-22, 24-25, 27-28, 32, 34-35, 40, 63-64 and 95 are pending and under consideration.
Withdrawn Rejections
Objection of claim 17 is withdrawn. Applicant amended the claim 17, thereby obviating this rejection/objection.
Rejection of Claims 17-18, 20-22, 24-25, 27-28, 32, 34-35, 40, and 63-64 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claim 32 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn. Applicant provided a persuasive argument as follows at page 6 of Applicant’s response filed 11/7/2025.
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NEW - Claim Rejections - 35 USC § 112
(based on reconsideration)
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 17-18, 20-22, 24-25, 27-28, 32, 34-35, 40, 63-64 and 95 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Analysis
Instant claims are drawn to a polypeptide comprising a variant Fc domain monomer comprising a serine at amino acid position 220, wherein (i) the polypeptide is between 200 and 300 amino acid residues in length; or (ii) the polypeptide is between about 20 kDa and about 40 kDa in mass, wherein the N-terminus of the polypeptide comprises between 10 and 20 residues of the Fab domain, wherein the variant Fc domain monomer comprises substitutions at positions 252, 254, and 256, and wherein the substitution at position 252 is a methionine to tyrosine (M252Y), the substitution at position 254 is a serine to threonine (S254T), and the substitution at position 256 is a threonine to glutamate (T256E), and the amino acid numbering is according to the EU index as in Kabat.
Instant specification disclosed Conjugate 1 (Fc domain including C220S/M252Y/S254T/T256E mutations) and its Maldi TOF analysis (example 2, page 72). Instant specification disclosed experimental results with this Conjugate 1 (example 4-7, page 73-79). Therefore, instant specification disclosed a single species of polypeptide encompassed by instant claim 17. In contrast, instant claim 17 encompasses infinite number of polypeptide which can comprise any amino acid substitution at any position of the polypeptide except positions 220, 252, 254 and 256 because instant claim recites “wherein the variant Fc domain monomer comprises substitutions at positions 252, 254, and 256, and wherein the substitution at position 252 is a methionine to tyrosine (M252Y), the substitution at position 254 is a serine to threonine (S254T), and the substitution at position 256 is a threonine to glutamate (T256E), and the amino acid numbering is according to the EU index as in Kabat” and the language “comprises” is open-ended and does not exclude other substitutions at other positions. Because Fc domain has about 220 amino acid residues and identity of amino acid residues at four positions are defined by instant claim 17 (i.e. C220S/M252Y/S254T/T256E), all possible variant Fc domain with all possible mutations at 116 positions is 20116 which is practically close to infinite number. Therefore, only a single species disclosed by instant specification cannot be considered as a representative number of species falling within the scope of genus encompassing 20116 variant Fc domains.
Instant claim 32 recites specific SEQ ID NOs, but claim 32 recites “at least 90% identical”. For example, SEQ ID NO: 20 has 247 amino acid residues and 10% of these residues (24 residues) can have mutations. The possible combination of selecting 24 positions out of 247 positions for mutation is (247, 24) = 247! / ((247-24)! X 24!) = (247x246x245x244x … x224) / (24x23x22x … x3x2x1). For each combination, the possible number of mutations at 24 positions are 2024. Therefore, instant claim 32 encompasses practically infinite number of polypeptides. The single species Conjugate 1 disclosed by instant specification cannot be considered as a representative number of species falling within the scope of genus broadly claimed by instant claim 32.
Furthermore, instant specification did not show that all these possible variant polypeptides can still have same functional property as Conjugate 1 disclosed by instant specification. Thus, instant specification does not provide adequate written description for instant claims.
In the field of protein modification technology, a change of a single amino acid residue may change the properties of the protein. Sickle cell anemia, for example, results from a mutation in just one of 574 amino acids. Prengler et al (Ann Neurol 2002;51:543-552; PTO-892) teaches that one amino acid substitution valine for glutamic acid at the sixth position of the beta-globin chain cause sickle cell anemia (page 544, left column, third paragraph). Witkowski et al (Biochemistry 38:11643-11650, 1999; PTO-892) teach that one conservative amino acid substitution transforms a B-ketoacyl synthase into a malonyl decarboxylase and completely eliminates B-ketoacyl synthase activity. Seffernick et al., (Bacteriol. 183(8): 2405-2410, 2001; PTO-892) teach that two naturally occurring Pseudomonas enzymes having 98% amino acid sequence identity catalyze two different reactions: deamination and dehalogenation, therefore having different function. It is not always possible to make variants that retain activity if the regions have been altered.
In sum, because instant specification disclosed only a single species polypeptide and did not show that other possible variant polypeptide encompassed by instant claims also have same functional property as instant invention, instant specification does not provide adequate written description for instant claims.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genus. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Adding specific sequence for variant Fc domain into instant claim 17 will overcome this rejection.
MAINTAINED - 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) 17-18, 20-22, 24-25, 27-28, 32, 34-35, 63-64 and 95 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Balkovec et al (WO2020/051498; effectively filed on 9/6/2018; 5/2/2022 IDS).
The applied reference has a common assignee 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.
Regarding claim 17-18, 21-22 and 34-35, Balkovec teaches a conjugate between Fc monomer and therapeutic agent (claim 1). Balkovec teaches a conjugate wherein each E comprises an Fc domain monomer having the sequence of SEQ ID NO: 68 (claims 1 and 7). As shown below, SEQ ID NO: 68 of Balkovec comprises C220S mutation, 247 amino acid residues, between 10 and 20 residues of the Fab domain at N-terminus, and M252Y, S254T, T256E mutations as instant SEQ ID NO: 1 (result 1 of 1.rag); and is human IgG1 sequence as evidenced by instant SEQ ID NO: 1 at page 31 of instant specification.
result 1 of 1.rag
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Regarding claim 20, as shown above, SEQ ID NO: 68 of Balkovec has 247 amino acid residues. Because average mass of amino acid is 110 Da, SEQ ID NO: 68 of Balkovec is 27.17 kDa in mass.
Regarding claims 24-25, as shown above, SEQ ID NO: 68 of Balkovec comprises NVNHK (residue 201-205) of Fab domain.
Regarding claims 27-28, as shown above, SEQ ID NO: 68 of Balkovec comprises GK (residue 446-447) at C-terminus.
Regarding claim 32, instant SEQ ID NO: 1 has three different residues from instant SEQ ID NO: 20 (see page 31 and 35). Therefore, SEQ ID NO: 68 of Balkovec also has three different residues from instant SEQ ID NO: 20 and has sequence identity of 244/247 = 98.8%.
Regarding claim 63, Balkovec teaches “In some embodiments of the conjugates described herein, E homodimerizes with another E to form an Fc domain”.
Regarding claim 64, Balkovec teaches “In another aspect, the invention provides a pharmaceutical composition comprising any of the conjugates described herein (e.g., a conjugate of any one of formulas (1)-(5), (D-I)-(D-X), (D’-I), (M-I)-(M- X), or (M’-I)), or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient”.
Regarding claim 95, Balkovec teaches “Conjugate 6 and Conjugate 12, analog with Fc mutation at N297A, was evaluated against a lethal IAV H1N1 influenza infection in female BALB/c mice (Charles River Laboratories, 6-8 weeks).”
Response to Arguments
In the response filed on 11/7/2025, Applicant argued at page 7,
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Applicant's arguments have been fully considered but they are not persuasive because Applicant did not make an explicit statement. The MPEP 2154.02(c) states: “A clear and conspicuous statement by the applicant (or the applicant's representative of record) that the claimed invention of the application under examination and the subject matter disclosed in the U.S. patent document applied as prior art were owned by the same person or subject to an obligation of assignment to the same person not later than the effective filing date of the claimed invention will be sufficient to establish that the AIA 35 U.S.C. 102(b)(2)(C) exception applies.” Applicants are advised to make a clear and conspicuous statement the claimed invention of the application under examination and the subject matter disclosed in the U.S. patent document applied as prior art were owned by the same person or subject to an obligation of assignment to the same person not later than the effective filing date of the claimed invention.
NEW - Double Patenting
(based on reconsideration)
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 17-18, 20-22, 24-25, 27-28, 32, 34-35 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,833,213 (hereinafter patent’213; 1/22/2025 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 17-18, 20 and 34-35, claim 1 of patent’213 claims
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SEQ ID NO: 68 claimed by claim 1 of patent’213 comprises C220S/M252Y/S254T/T256E because as shown below in sequence alignment, SEQ ID NO: 68 of patent’213 and instant SEQ ID NO: 1 comprises C220S/M252Y/S254T/T256E as evidenced by instant specification page 31 (see SEQ ID NO: 1 at page 31).
Result 1 of 1.rai
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Therefore, the conjugate of patent’213 includes the polypeptide of instant claims. As shown above in sequence alignment, SEQ ID NO: 68 of patent’213 has 247 amino acids which is between 200 and 300 amino acids in length as claimed by instant claim 17-18. Because average mass of amino acid is 110 Da, 247 amino acids correspond to about 27.17 kDa.
Regarding claim 21-22, because SEQ ID NO: 68 of patent’213 has 99.8 % identity to instant SEQ ID NO: 1 and instant SEQ ID NO: 1 is human IgG1 Fc variant as evidenced by instant specification page 31, SEQ ID NO: 68 of patent’213 is human IgG1 Fc variant.
Regarding claims 24-25, as shown above, SEQ ID NO: 68 of patent’213 comprises NVNHK (residue 201-205) of Fab domain.
Regarding claims 27-28, as shown above, SEQ ID NO: 68 of patent’213 comprises GK (residue 446-447) at C-terminus.
Regarding claim 32, instant SEQ ID NO: 1 has three different residues from instant SEQ ID NO: 20 (see page 31 and 35). Therefore, SEQ ID NO: 68 of patent’213 also has three different residues from instant SEQ ID NO: 20 and has sequence identity of 244/247 = 98.8%.
Regarding claim 63, claim 4 of patent’213 claims that the two Es dimerize with each other to form an Fc domain.
Claims 17-18, 20-22, 24-25, 27-28, 32, 34-35 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11,510,992 (hereinafter patent’992; 1/22/2025 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 17-18, 20 and 34-35, Claim 1 of patent’992 claims
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Claim 16 of patent’992 claims
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SEQ ID NO: 77 claimed by claim 16 of patent’992 comprises C220S/M252Y/S254T/T256E because as shown below in sequence alignment, SEQ ID NO: 77 claimed by claim 16 of patent’992 and instant SEQ ID NO: 1 comprises C220S/M252Y/S254T/T256E as evidenced by instant specification page 31 (see SEQ ID NO: 1 at page 31).
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Therefore, the conjugate of patent’992 includes polypeptide of instant claims. As shown above, SEQ ID NO: 77 of patent’992 has 246 amino acid residues which is between 200 and 300 amino acid as recited by subpart (i) of instant claim 17. Because average mass of amino acid is 110 Da, 246 amino acids correspond to about 27.06 kDa.
Regarding claim 21-22, because SEQ ID NO: 77 of patent’992 has 99.5 % identity to instant SEQ ID NO: 1 and instant SEQ ID NO: 1 is human IgG1 Fc variant as evidenced by instant specification page 31, SEQ ID NO: 77 of patent’992 is human IgG1 Fc variant.
Regarding claims 24-25, as shown above, SEQ ID NO: 77 of patent’992 comprises NVNHK (residue 201-205) of Fab domain.
Regarding claims 27-28, as shown above, SEQ ID NO: 77 of patent’992 comprises G (residue 446) at C-terminus.
Regarding claim 32, instant SEQ ID NO: 1 has three different residues from instant SEQ ID NO: 20 (see page 31 and 35). Therefore, SEQ ID NO: 77 of patent’992 also has three different residues from instant SEQ ID NO: 20 and has sequence identity of 244/247 = 98.8%.
Regarding claim 63, claim 4 of patent’992 claims that the two Es dimerize with each other to form an Fc domain.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674