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 .
DETAILED ACTION
Claims 1-7, 12, and 15-20 are pending in the instant application.
Claims 2, 5, and 15-20 are withdrawn from consideration.
Claims 1, 3-4, 6-7, and 12 are examined herein.
Priority
The instant application claims benefit of foreign priority to CN202010663949.5, filed on 10 July 2020 and the benefit of priority to PCT/CN2020/113949, filed on 08 September 2020. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 10 July 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 14 February 2023, 02 March 2023, 06 March 2023, 21 November 2023, and 20 August 2024, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, claims 1-7 and 12, without traverse, in the reply filed on 13 October 2025 is acknowledged. In addition the specie election of (S)-2-(4-(ethylsulfonyl)phenyl)-N-(4-(1-(1-(4-fluorophenyl)ethyl)-6-(trifluoromethyl)-1H-benzo[d]imidazol-2-yl)phenyl)acetamide (pictured below), which reads on claims 1, 3, 5-7, and 12, is acknowledged.
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If the elected species is not identified in the art, the search will be expanded to additional species per MPEP 802.03.
The elected species was not found in the art and the search was expanded to additional species. Particularly, example 1, 4-methyl-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide; example 3, 4-fluoro-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide; and example 5, N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-3-nitrobenzenesulfonamide.
The additional species read on claims 1, 3-4, 6-7, and 12. Claims 2, 5, and 15-20 are withdrawn for not reading on the elected group and expanded species.
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.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 recites the pharmaceutically acceptable salt, isomer, racemate, prodrug, co-crystal complex or solvate of a compound of claim 1. The applicant provides no examples of a prodrug.
One of ordinary skill in the art would was not in possession of the full scope as claimed, ie. “prodrug”. The specification only defines a prodrug, it does not establish the applicant was in the possession of the knowledge of which prodrugs would or would not provide the prodrug function. Strickley et al. (Formulation Challenges of Prodrugs. Prodrugs. 2007. Chapter 4.1.2. 383-410) discuss several formulation challenges presented with prodrugs, namely; chemical stability, reactive by-products, solubility, and polymorphism. Experimentation is required to make successful prodrug, or in order to establish a structure/function correlation. The specification does not provide structural definitions of a prodrug, or points of attachment to Formula I; both of which can alter the functionality of the drug. Additionally, the specification does not provide any structure-function correlation to support the bounds of a functional prodrug of Formula I; nor is a representative number of species presented as the specification does not provide any examples. Overall, the lack of a required written description suggests the applicant is not in possession of a functional prodrug of a compound of Formula I.
In conclusion, there is no structure-function correlation between what is and what is not a functional prodrug in the specification. Based on the work of Strickley, prodrugs are unpredictable, without the correlation between structure and function or an adequate representation of species functioning as a prodrug, the instant invention fails to comply with the written description requirement.
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.
Claim 3 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.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1 and 3-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riesz (Revista Facultad de Humanidades y Ciencias.1947;1(1):305-314).
Regarding claim 1, Riesz teaches the compound N-[4-(6-methyl-2-benzothiazolyl)phenyl]-4-nitro-benzenesulfonamide (pictured below from the STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is nitro.
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Regarding claim 3, Riesz teaches the substituent corresponding to the instant R11 is nitro.
Regarding claim 4, Riesz teaches the compound N-[4-(6-methyl-2-benzothiazolyl)phenyl]-4-nitro-benzenesulfonamide (pictured above from the STN search). This is a species of instant Formula (II) when X is –(SO2)-, Y is CR5, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is nitro.
Regarding claim 6, Riesz teaches the fifth listed compound of claim 6, and example 5 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevens et al. (WO2003004479A1).
Regarding claim 1, Stevens discloses the compound 4-methyl-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide (pictured below from page 87, scheme 10). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
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Regarding claim 3, Stevens discloses the substituent corresponding to the instant R11 is C1 alkyl.
Regarding claim 4, Stevens discloses the compound 4-methyl-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide (pictured above from page 87, scheme 10). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
Regarding claim 6, Stevens discloses the first listed compound of claim 6, and example 1 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 349624-72-2, created on 01 August 2001.
Regarding claim 1, RN 349624-72-2 belongs to the compound 4-fluoro-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 halogen.
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706
798
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Regarding claim 3, substituent corresponding to the instant R11 is halogen.
Regarding claim 4, RN 349624-72-2 belongs to the compound 4-methyl-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide (pictured above). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is halogen
Regarding claim 6, RN 349624-72-2 is the third listed compound of claim 6, and example 3 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 909525-53-7, created on 04 October 2006.
Regarding claim 1, RN 909525-53-7 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-4-( trifluoromethoxy) benzenesulfonamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 carbalkoxy substituted with at least one halogen.
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Regarding claim 3, substituent corresponding to the instant R11 is C1 carbalkoxy substituted with at least one halogen.
Regarding claim 4, RN 909525-53-7 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-4-( trifluoromethoxy) benzenesulfonamide (pictured above). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 carbalkoxy substituted with at least one halogen.
Regarding claim 6, RN 909525-53-7 is the fourth listed compound of claim 6, and example 4 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 1116042-18-2, created on 05 March 2009.
Regarding claim 1, 1116042-18-2 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-1-(p-tolyl)methanesulfonamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
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656
824
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Regarding claim 3, substituent corresponding to the instant R11 is C1 alkyl.
Regarding claim 4, RN 1116042-18-2 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-1-(p-tolyl)methanesulfonamide (pictured above). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
Regarding claim 6, RN 1116042-18 is the twelfth listed compound of claim 6, and example 12 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 2199951-86-3, created on 27 March 2018.
Regarding claim 1, RN 2199951-86-3 belongs to the compound 1-(4-fluorophenyl)-N-(4-(6-methylbenzo[d]thiazol-2-yl )phenyl)methanesulfonamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is halogen.
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Regarding claim 3, substituent corresponding to the instant R11 is halogen
Regarding claim 4, RN 2199951-86-3 belongs to the compound 1-(4-fluorophenyl)-N-(4-(6-methylbenzo[d]thiazol-2-yl )phenyl)methanesulfonamide (pictured above). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is halogen.
Regarding claim 6, RN 2199951-86-3 is the thirteenth listed compound of claim 6, and example 13 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 941972-03-8, created on 10 July 2007.
Regarding claim 1, RN 941972-03-8 belongs to the compound 2-(4-(Ethylsulfonyl)phenyl)-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)acetamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, Z is S, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C2 alkyl sulfonyl.
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Regarding claim 3, substituent corresponding to the instant R11 is ethyl sulfonyl.
Regarding claim 4, RN 941972-03-8 belongs to the compound 2-(4-(Ethylsulfonyl)phenyl)-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)acetamide (pictured above). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C2 alkyl sulfonyl.
Regarding claim 6, RN 941972-03-8 is the twenty fifth listed compound of claim 6, and example 25 in the specification.
Claim(s) 1, 4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 546070-51-3, created on 11 July 2003.
Regarding claim 1, RN 546070-51-3 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)heptanamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, Z is S, R1 is C7 alkyl substituted with 0 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, and R9 is H.
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Regarding claim 4, RN 546070-51-3 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)heptanamide (pictured above). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, R1 is C7 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C2 alkyl sulfonyl.
Regarding claim 6, RN 546070-51-3 is the twenty sixth listed compound of claim 6, and example 26 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 599163-10-7, created on 06 October 2003.
Regarding claim 1, RN 599163-10-7 belongs to the compound 2-(4-(Ethylsulfonyl)phenyl)-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)acetamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, Z is S, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
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Regarding claim 3, substituent corresponding to the instant R11 is C1 alkyl.
Regarding claim 4, RN 599163-10-7 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-2-(p-tolyl)acetamide (pictured above). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
Regarding claim 6, RN 599163-10-7 is the twenty seventh listed compound of claim 6, and example 27 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 349440-23-9, created on 29 July 2001.
Regarding claim 1, RN 349440-23-9 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-2-(2-nitrophenyl)acetamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, Z is S, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is nitro.
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Regarding claim 3, substituent corresponding to the instant R11 is nitro.
Regarding claim 4, RN 349440-23-9 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-2-(2-nitrophenyl)acetamide (pictured above). This is a species of instant Formula (I) when X is –(CO)-, Y is CR5, R1 is C6 aryl C1 alkyl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is nitro.
Regarding claim 6, RN 349440-23-9 is the twenty eighth listed compound of claim 6, and example 28 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 349623-23-0, created on 01 August 2001.
Regarding claim 1, RN 349623-23-0 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-2-nitrobenzenesulfonamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is nitro.
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Regarding claim 3, substituent corresponding to the instant R11 is nitro.
Regarding claim 4, RN 349623-23-0 belongs to the compound N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)-2-nitrobenzenesulfonamide (pictured above). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl substituted with 1 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is nitro.
Regarding claim 6, RN 349623-23-0 is the seventh listed compound of claim 6, and example 7 in the specification.
Claim(s) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 3494624-08-4, created on 01 August 2001.
Regarding claim 1, RN 349623-23-0 belongs to the 2,4,6-trimethyl-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide (pictured below from STN search). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, Z is S, R1 is C6 aryl substituted with 3 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl
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Regarding claim 3, substituent corresponding to the instant R11 is C1 alkyl.
Regarding claim 4, RN 349623-23-0 belongs to the compound 2,4,6-trimethyl-N-(4-(6-methylbenzo[d]thiazol-2-yl)phenyl)benzenesulfonamide (pictured above). This is a species of instant Formula (I) when X is –(SO2)-, Y is CR5, R1 is C6 aryl substituted with 3 R11, R2 is H, R3 is H, R4 is H, R5 is H, R6 is H, R7 is H, R8 is C1 alkyl, R9 is H, and R11 is C1 alkyl.
Regarding claim 6, RN 349623-23-0 is the tenth listed compound of claim 6, and example 10 in the specification.
Conclusion
Claims 1, 3-4, 6-7, and 12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621