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 .
Claims 1-3, 5-6, 8-11 and 13-29 are cancelled. Claims 4, 7 and 12 are amended. Claims 30-48 are new. Claims 4, 7, 12 and 30-48 are pending. Claims 39-48 are withdrawn. Claims 4, 7, 12 and 30-38 are under examination.
The information disclosure statement filed 3/18/24 has been considered and an initialed copy is enclosed.
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-15, 17 and 26-29 in the reply filed on 2/23/26 is acknowledged.
Claims 39-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/23/26.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 4, 7, 12 and 30-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. WO 2014097099 6-26-2014 cited in IDS.
Claim 4: Han et al disclose an S. pneumoniae serotype 12F glycoconjugate. As evidenced by the instant specification S. pneumoniae serotype 12F capsular polysaccharide comprises a between about 0.05 to about 25 N-acetyl-D-fucosamine (D- FucNAc) residues and between about 0.05 to about 25 N-acetyl-D-quinovosamine (D-QuiNAc) in every 100 saccharide repeat units of the polysaccharide and wherein said S. pneumoniae serotype 12F capsular polysaccharide comprises between about 99 to about 50 N-acetylgalactosamine residues and between about 1 to about 50 4-keto-N-acetylquinovosamine residues in every 100 saccharide repeat units of said polysaccharide. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8.
The specification on p. 5 of the specification state that the inventor found that the 12F polysaccharide actually contains partial substitution of N-acetyl-galactosamine by 4-keto-N-acetyl- quinovosamine (also referred as Sug, D-Sug, 2-acetamido-2,6-dideoxy-D-xlo-4-hexulose or 4KQ) and the specification discloses the 12F capsular polysaccharide structure on p. 5-6.
Claim 7: Han et al disclose that the carrier protein of the glycoconjugate is TT (tetanus toxoid), DT (Diphtheria toxoid) or aDT mutant wherein said DT mutant is optionally CRM197. See p. 6 first paragraph, p. 13 first paragraph, p. 15 paragraphs 2-3, p. 20 first paragraph.
Claim 12: Han et al disclose that the glycoconjugate is prepared by a process comprising
Claim 30: As evidenced by the instant specification S. pneumoniae serotype 12F capsular polysaccharide comprises between about 99 to about 50 N-acetylgalactosamine residues and between about 1 to about 50 4-keto-N-acetylquinovosamine residues in every 100 saccharide repeat units of said polysaccharide. See p. 5 lines 18-34 and p. 6-14.
Claim 31: Han et al disclose that the step of reacting with an oxidizing agent is performed with the addition of a stable nitroxyl radical compound, wherein said stable nitroxyl radical compound is optionally 2,2,6,6-tetramethylpiperidinyl-1-oxy (TEMPO). See p. 1 first paragraph, p. 2 under summary.
Claim 32: Han et al disclose that the oxidizing agent is periodate. See example 1.
Claim 33: Han et al disclose the step of reacting with an oxidizing agent is carried out in aqueous solvent. See p. 3 paragraph 2.
Claim 34: Han et al disclose the step of reacting with an oxidizing agent is carried out in aprotic solvent, wherein said aprotic solvent is optionally dimethylsulfoxide (DMSO). See p. 3 paragraph 2.
Claim 35: Han et al disclose the reducing agent is sodium cyanoborohydride. See p. 6 first paragraph.
Claim 36: Han et al disclose the step of reacting with a reducing agent is carried out in aqueous solvent. See p. 3 paragraph 2.
Claim 37: Han et al disclose the step of reacting with a reducing agent is carried out in aprotic solvent, wherein said aprotic solvent is optionally dimethylsulfoxide (DMSO). See p. 3 paragraph 2.
Claim 38: Han et al disclose after either of said steps of reacting with an oxidizing agent or reacting with a reducing agent, the step of capping unreacted aldehyde groups with a capping agent, wherein said capping agent is optionally sodium borohydride. See p. 6 first paragraph.
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 4 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10745438 (‘438). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘438 claims disclose:
A S. pneumoniae serotype 12F glycoconjugate comprising a serotype 12F capsular polysaccharide conjugated to CRM197, wherein the glyconjugate is prepared by a process comprising reacting said capsular polysaccharide with an oxidant to produce an activated polysaccharide and reacting said activated polysaccharide with the carrier protein.
As evidenced by the instant specification S. pneumoniae serotype 12F capsular polysaccharide comprises a between about 0.05 to about 25 N-acetyl-D-fucosamine (D- FucNAc) residues and between about 0.05 to about 25 N-acetyl-D-quinovosamine (D-QuiNAc) in every 100 saccharide repeat units of the polysaccharide, wherein the polysaccharide comprises between about 99 to about 50 N-acetylgalactosamine residues and between about 1 to about 50 4-keto-n-acetylquinovosamine residues in every 100 saccharide repeat units of said polysaccharide.. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8.
The specification on p. 5 of the specification state that the inventor found that the 12F polysaccharide actually contains partial substitution of N-acetyl-galactosamine by 4-keto-N-acetyl- quinovosamine (also referred as Sug, D-Sug, 2-acetamido-2,6-dideoxy-D-xlo-4-hexulose or 4KQ) and the specification discloses the 12F capsular polysaccharide structure on p. 5-6.
Claims 12 and 30-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10745438 (‘438) as applied to claims 4 and 7 above, further in view of Han et al. WO 2014097099 6-26-2014.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘438 claims is set forth above.
The ‘438 claims does not disclose reacting the activated polysaccharide with the carrier protein in the presence of reducing agent to form a glycoconjugate; does not disclose the oxidizing agent is periodate; does not disclose the step of reacting with an oxidizing agent is carried out in a aqueous solvent; does not disclose that the step of reacting with an oxidizing agent is carried out in aprotic solvent and does not disclose the reducing agent is sodium borohydride.
Han et al disclose an S. pneumoniae serotype 12F glycoconjugate. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8. Han et al disclose that the carrier protein of the glycoconjugate is TT (tetanus toxoid), DT (Diphtheria toxoid) or aDT mutant wherein said DT mutant is optionally CRM197. See p. 6 first paragraph, p. 13 first paragraph, p. 15 paragraphs 2-3, p. 20 first paragraph.
Han et al disclose that the glycoconjugate is prepared by a process comprisingHan et al disclose that the oxidizing agent is periodate. See example 1.Han et al disclose the step of reacting with an oxidizing agent is carried out in aqueous solvent. See p. 3 paragraph 2.
Han et al disclose the step of reacting with an oxidizing agent is carried out in aprotic solvent, wherein said aprotic solvent is optionally dimethylsulfoxide (DMSO). See p. 3 paragraph 2. Han et al disclose after either of said steps of reacting with an oxidizing agent or reacting with a reducing agent, the step of capping unreacted aldehyde groups with a capping agent, wherein said capping agent is optionally sodium borohydride. See p. 6 first paragraph.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to date of the instant invention to have modified the “438 claims such that the reaction of activated polysaccharide with the carrier protein is carried out in the presence of a reducing agent such as sodium borohydride; the oxidizing agent is periodate; the step of reacting with oxidizing agent or reducing agent is carried out in aqueous solvent or aprotic solvent such as DMSO and the step of capping unreacted aldehyde groups is performed with the capping agent sodium borohydride, as taught by Han et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Han et al disclose that the conjugation reaction of 12F glyconjugate can be carried out in the presence of reducing agent such as sodium borohydride, an oxidizing agent such as periodate and reacting with oxidizing agent can be carried out in the presence of aqueous or aprotic solvent such as DMSO and unreacted aldehydes can be capped with sodium borohydride.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 19-20 of U.S. Patent No. 11603384 (‘384). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘384 claims disclose:
A S. pneumoniae serotype 12F glycoconjugate comprising a serotype 12F capsular polysaccharide, wherein the glyconjugate is prepared by a process comprising reacting said capsular polysaccharide with an oxidant to produce an activated polysaccharide and reacting said activated polysaccharide with the carrier protein.
As evidenced by the instant specification S. pneumoniae serotype 12F capsular polysaccharide comprises a between about 0.05 to about 25 N-acetyl-D-fucosamine (D- FucNAc) residues and between about 0.05 to about 25 N-acetyl-D-quinovosamine (D-QuiNAc) in every 100 saccharide repeat units of the polysaccharide, wherein the polysaccharide comprises between about 99 to about 50 N-acetylgalactosamine residues and between about 1 to about 50 4-keto-n-acetylquinovosamine residues in every 100 saccharide repeat units of said polysaccharide. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8.
The specification on p. 5 of the specification state that the inventor found that the 12F polysaccharide actually contains partial substitution of N-acetyl-galactosamine by 4-keto-N-acetyl- quinovosamine (also referred as Sug, D-Sug, 2-acetamido-2,6-dideoxy-D-xlo-4-hexulose or 4KQ) and the specification discloses the 12F capsular polysaccharide structure on p. 5-6.
Claims 7, 12 and 30-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 19-20 of U.S. Patent No. 11603384 (‘384) as applied to claim 4 above, further in view of Han et al. WO 2014097099 6-26-2014.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘384 claims is set forth above.
The ‘384 claims does not disclose reacting the activated polysaccharide with the carrier protein in the presence of reducing agent to form a glycoconjugate; does not disclose the oxidizing agent is periodate; does not disclose the step of reacting with an oxidizing agent is carried out in a aqueous solvent; does not disclose that the step of reacting with an oxidizing agent is carried out in aprotic solvent and does not disclose the reducing agent is sodium borohydride.
Han et al disclose an S. pneumoniae serotype 12F glycoconjugate. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8. Han et al disclose that the carrier protein of the glycoconjugate is TT (tetanus toxoid), DT (Diphtheria toxoid) or aDT mutant wherein said DT mutant is optionally CRM197. See p. 6 first paragraph, p. 13 first paragraph, p. 15 paragraphs 2-3, p. 20 first paragraph.
Han et al disclose that the glycoconjugate is prepared by a process comprising
Han et al disclose that the oxidizing agent is periodate. See example 1.Han et al disclose the step of reacting with an oxidizing agent is carried out in aqueous solvent. See p. 3 paragraph 2.
Han et al disclose the step of reacting with an oxidizing agent is carried out in aprotic solvent, wherein said aprotic solvent is optionally dimethylsulfoxide (DMSO). See p. 3 paragraph 2. Han et al disclose after either of said steps of reacting with an oxidizing agent or reacting with a reducing agent, the step of capping unreacted aldehyde groups with a capping agent, wherein said capping agent is optionally sodium borohydride. See p. 6 first paragraph.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to date of the instant invention to have modified the ‘384 claims such that the reaction of activated polysaccharide with a carrier protein such as CRM 197 is carried out in the presence of a reducing agent such as sodium borohydride; the oxidizing agent is periodate; the step of reacting with oxidizing agent or reducing agent is carried out in aqueous solvent or aprotic solvent such as DMSO and the step of capping unreacted aldehyde groups is performed with the capping agent sodium borohydride, as taught by Han et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Han et al disclose that the conjugation reaction of 12F glyconjugate with carrier protein CRM197 can be carried out in the presence of reducing agent such as sodium borohydride, an oxidizing agent such as periodate and reacting with oxidizing agent can be carried out in the presence of aqueous or aprotic solvent such as DMSO and unreacted aldehydes can be capped with sodium borohydride.
Claims 4 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11117928 (‘928). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘928 claims disclose:
A S. pneumoniae serotype 12F glycoconjugate comprising a serotype 12F capsular polysaccharide conjugated to CRM197, wherein the glyconjugate is prepared by a process comprising reacting said capsular polysaccharide with an oxidant to produce an activated polysaccharide and reacting said activated polysaccharide with the carrier protein.
As evidenced by the instant specification S. pneumoniae serotype 12F capsular polysaccharide comprises a between about 0.05 to about 25 N-acetyl-D-fucosamine (D- FucNAc) residues and between about 0.05 to about 25 N-acetyl-D-quinovosamine (D-QuiNAc) in every 100 saccharide repeat units of the polysaccharide, wherein the polysaccharide comprises between about 99 to about 50 N-acetylgalactosamine residues and between about 1 to about 50 4-keto-n-acetylquinovosamine residues in every 100 saccharide repeat units of said polysaccharide.. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8.
The specification on p. 5 of the specification state that the inventor found that the 12F polysaccharide actually contains partial substitution of N-acetyl-galactosamine by 4-keto-N-acetyl- quinovosamine (also referred as Sug, D-Sug, 2-acetamido-2,6-dideoxy-D-xlo-4-hexulose or 4KQ) and the specification discloses the 12F capsular polysaccharide structure on p. 5-6.
Claims 12 and 30-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11117928 (‘928) as applied to claims 4 and 7 above, further in view of Han et al. WO 2014097099 6-26-2014.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘928 claims is set forth above.
The ‘928 claims does not disclose reacting the activated polysaccharide with the carrier protein in the presence of reducing agent to form a glycoconjugate; does not disclose the oxidizing agent is periodate; does not disclose the step of reacting with an oxidizing agent is carried out in a aqueous solvent; does not disclose that the step of reacting with an oxidizing agent is carried out in aprotic solvent and does not disclose the reducing agent is sodium borohydride.
Han et al disclose an S. pneumoniae serotype 12F glycoconjugate. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8. Han et al disclose that the carrier protein of the glycoconjugate is TT (tetanus toxoid), DT (Diphtheria toxoid) or aDT mutant wherein said DT mutant is optionally CRM197. See p. 6 first paragraph, p. 13 first paragraph, p. 15 paragraphs 2-3, p. 20 first paragraph.
Han et al disclose that the glycoconjugate is prepared by a process comprising
Han et al disclose the step of reacting with an oxidizing agent is carried out in aprotic solvent, wherein said aprotic solvent is optionally dimethylsulfoxide (DMSO). See p. 3 paragraph 2. Han et al disclose after either of said steps of reacting with an oxidizing agent or reacting with a reducing agent, the step of capping unreacted aldehyde groups with a capping agent, wherein said capping agent is optionally sodium borohydride. See p. 6 first paragraph.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to date of the instant invention to have modified the ‘928 claims such that the reaction of activated polysaccharide with the carrier protein is carried out in the presence of a reducing agent such as sodium borohydride; the oxidizing agent is periodate; the step of reacting with oxidizing agent or reducing agent is carried out in aqueous solvent or aprotic solvent such as DMSO and the step of capping unreacted aldehyde groups is performed with the capping agent sodium borohydride, as taught by Han et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Han et al disclose that the conjugation reaction of 12F glyconjugate can be carried out in the presence of reducing agent such as sodium borohydride, an oxidizing agent such as periodate and reacting with oxidizing agent can be carried out in the presence of aqueous or aprotic solvent such as DMSO and unreacted aldehydes can be capped with sodium borohydride.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 11160855 (‘855). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘855 claims disclose:
A S. pneumoniae serotype 12F glycoconjugate comprising a serotype 12F.
As evidenced by the instant specification S. pneumoniae serotype 12F capsular polysaccharide comprises a between about 0.05 to about 25 N-acetyl-D-fucosamine (D- FucNAc) residues and between about 0.05 to about 25 N-acetyl-D-quinovosamine (D-QuiNAc) in every 100 saccharide repeat units of the polysaccharide, wherein the polysaccharide comprises between about 99 to about 50 N-acetylgalactosamine residues and between about 1 to about 50 4-keto-n-acetylquinovosamine residues in every 100 saccharide repeat units of said polysaccharide.. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8.
The specification on p. 5 of the specification state that the inventor found that the 12F polysaccharide actually contains partial substitution of N-acetyl-galactosamine by 4-keto-N-acetyl- quinovosamine (also referred as Sug, D-Sug, 2-acetamido-2,6-dideoxy-D-xlo-4-hexulose or 4KQ) and the specification discloses the 12F capsular polysaccharide structure on p. 5-6.
Claims 7, 12 and 30-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 11160855 (‘855) as applied to claim 4 above, further in view of Han et al. WO 2014097099 6-26-2014.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘855 claims is set forth above.
The ‘855 claims does not disclose reacting the activated polysaccharide with the carrier protein in the presence of reducing agent to form a glycoconjugate; does not disclose the oxidizing agent is periodate; does not disclose the step of reacting with an oxidizing agent is carried out in a aqueous solvent; does not disclose that the step of reacting with an oxidizing agent is carried out in aprotic solvent and does not disclose the reducing agent is sodium borohydride.
Han et al disclose an S. pneumoniae serotype 12F glycoconjugate. See p. 5 lines 18-34, p. 6-14, p. 5 paragraph 2 and example 1-8. Han et al disclose that the carrier protein of the glycoconjugate is TT (tetanus toxoid), DT (Diphtheria toxoid) or aDT mutant wherein said DT mutant is optionally CRM197. See p. 6 first paragraph, p. 13 first paragraph, p. 15 paragraphs 2-3, p. 20 first paragraph.
Han et al disclose that the glycoconjugate is prepared by a process comprising
Han et al disclose the step of reacting with an oxidizing agent is carried out in aprotic solvent, wherein said aprotic solvent is optionally dimethylsulfoxide (DMSO). See p. 3 paragraph 2. Han et al disclose after either of said steps of reacting with an oxidizing agent or reacting with a reducing agent, the step of capping unreacted aldehyde groups with a capping agent, wherein said capping agent is optionally sodium borohydride. See p. 6 first paragraph.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to date of the instant invention to have modified the “855 claims such that the reaction of activated polysaccharide with a carrier protein such as CRM197 is carried out in the presence of a reducing agent such as sodium borohydride; the oxidizing agent is periodate; the step of reacting with oxidizing agent or reducing agent is carried out in aqueous solvent or aprotic solvent such as DMSO and the step of capping unreacted aldehyde groups is performed with the capping agent sodium borohydride, as taught by Han et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Han et al disclose that the conjugation reaction of 12F glyconjugate can comprise CRM197 as carrier and can be carried out in the presence of reducing agent such as sodium borohydride, an oxidizing agent such as periodate and reacting with oxidizing agent can be carried out in the presence of aqueous or aprotic solvent such as DMSO and unreacted aldehydes can be capped with sodium borohydride.
Status of Claims
Claims 39-48 are withdrawn. Claims 4, 7, 12 and 30-38 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645