DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of Application, Amendments and/or Claims
2. The amendment dated 4/8/2025 is fully considered and entered into record. Claims 1, 11 and 12 are amended. Claims 10, 13, 15-17 and 25-30 are cancelled. New claims 31-37 have been added. Claims 1-2, 11-12, 14 and 31-37 are currently pending.
3. Claims 1-2, 11-12, 14 and 31-37 drawn to a method of treating migraine and a chronic sleep disorder in a subject, comprising administering botulinum toxin, are being considered for examination in the instant application.
Rejections Withdrawn
4. Upon consideration of amendment of claim 1 and Applicant’s arguments, the rejections under 35 U.S.C. 103(a) are withdrawn.
Rejections Maintained
Double Patenting
Non-Statutory
5. 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).
6. 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).
7. 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.
8. 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.
9. Claims 1-2, 11-12, 14, 31-37, are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 9-12 and 21-24 of US Patent 7,537,773 in view of Biondi (2001) and Blumenfeld (2004) and Tommaso et al (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendment.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects having pain (a symptom of inflammation) and erythema (atopic condition) comprising administering botulinum toxin type A to said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating migraine headache causing pain in a subject, while claims of the ‘773 patent do not recite treating migraine as an inflammatory or pain condition. However, the ‘773 patent teaches that botulinum toxin treats pain syndromes like migraine (col 2, lines 33-37). It is known that migraine accompanied pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims recite that the subject having migraine also has a chronic sleep disorder, while ‘773 claims do not recite sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Biondi, and Blumenfeld as stated above.
10. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 7,537,773.
11. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 4, 7, 45, 51-54, of US Patent 7,691,394 in view of Biondi (2001) and Blumenfeld (2004), Borodic (2002) and Tommaso et al (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects having inflammation or pain such as migraine, comprising administering botulinum toxin type A to said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite that the migraine subjects have a pain which is responsive to tactile stimulation, while ‘394 patent claims do not have this limitation. However, migraine accompanied pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘394 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
iii) Instant claims recite that the subject having migraine also has chronic sleep disorder, while ‘394 claims do not recite sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Biondi, and Blumenfeld as stated above.
12. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 7,691,394.
13. Claims 1-2, 11-12, 14 and 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-7, 11, 15, 18-20, 22 of US Patent 6,429,189 in view of Biondi (2001) and Blumenfeld (2004) and Tommaso et al (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendment.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects having pain or inflammation caused by migraine headache, eczema (atopic disease) etc., comprising administering botulinum toxin to said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite that the subject having migraine also has chronic sleep disorder like DSPD, while ‘189 claims do not recite sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Biondi, and Blumenfeld as stated above.
ii) Instant claims recite administration of botulinum toxin type A, while the ‘189 claims are generic. However, treating migraine by administering botulinum toxin type A, would be obvious in view of the teachings of Blumenfeld as stated above.
iii) Instant claims recite assessing the subject’s response to tactile stimulation, while ‘189 patent claims do not have this limitation. However, migraine accompanied pain is reduced by tactile stimulation in patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
14. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 6,429,189.
15. Claims 1-2, 11-12, 14 and 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of US Patent 10,441,641 in view of Blumenfeld (2004), Biondi (2001), Tommaso et al (2002), Borodic (2002) and Sheftell et al (Headache 42: 934-944, 2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects having a sleep disorder, and reducing at least one symptom of the disorder comprising administering a pharmaceutical composition comprising botulinum toxin type A by injection (transdermal) to said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating migraine and a sleep disorder in a subject, while claims of the ‘641 patent recite treating sleep disorder and depression. However, this would be obvious in view of the teachings of Blumenfeld, Biondi and Sheftell et al., as migraine headaches coexist with sleep disorders like DSPD (sleep onset insomnia), and which are treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi, as stated above. Additionally, Sheftell et al teach that depression patients also exhibit migraine headaches and the two conditions are comorbid (Background; Conclusions). Therefore, migraine, depression and sleep disorders can co-exist in the same subject. It is known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘641 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
16. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,441,641.
17. Claims 1-2, 11-12, 14 and 31-37 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 5-10, 12-13, 17-18, 22, 25 and 31 of co-pending application number 17/234,690 in view of Blumenfeld (2004), Biondi (2001), Tommaso et al (2002), Borodic (2002) and Sheftell et al (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Upon consideration of current claim amendments, claims 10 and 13 of ‘690 application have been included. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating a subject having a symptom of depression such as insomnia, or treating a subject with myofacial pain (headache), comprising administering botulinum toxin to said subjects, wherein the administration is multifocal, the delivery is by subdermal (subcutaneous) routes, and the toxin blocks acetylcholine.
The only differences between the two sets of claims are:
i) Instant claims recite treating migraine, while the ‘690 claims do not have this limitation.
However, the ‘690 specification teaches that administration of botulinum can be used to treat migraine headache pain (para 0012). It is known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims recite treating migraine and a sleep disorder in a subject, while claims of the ‘690 application recite treating sleep disorder and depression. However, this would be obvious in view of the teachings of Blumenfeld, Biondi and Sheftell et al., as migraine headaches coexist with chronic sleep disorders like DSPD (sleep onset insomnia), and which are treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi, as stated above. Additionally, Sheftell et al teach that depression patients also exhibit migraine headaches and the two conditions are comorbid (Background, Conclusions). Therefore, migraine, depression and sleep disorders can co-exist in the same subject.
iii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘690 application claims. However, as stated above, this would be obvious in view of Borodic teachings.
iv) Instant claims recite administration of botulinum toxin type A, while the ‘690 application claims are generic. However, treating headache etc., by administering botulinum toxin type A, would be obvious in view of the teachings of Blumenfeld as stated above.
18. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
19. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent 8,926,991, in view of Biondi (2001) and Blumenfeld (2004), Borodic (2002) and Tommaso et al (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Upon consideration of current amendments, claims 5-7, 11-12 and 16-18 of ‘991 patent have been included. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects having sleep disorder (sleep onset insomnia or DPSD), comprising administering botulinum toxin type A to said subjects, wherein the administration is multifocal, the delivery is by transdermal or subcutaneous route to different regions like forehead, scalp, neck, etc., and the toxin composition decreases choline acetyltransferase activity and acetylcholine synthesis.
The only differences between the two sets of claims are:
i) Instant claims recite treating a migraine and a sleep disorder in a subject, while claims of the ‘991 patent only recite treating sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. Therefore, headache and sleep disorders co-exist in the same subject. It is also known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘991 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
20. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,926,991.
21. Claims 1-2, 11-12, 14, 31-37 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9, 11-13, 16-17, 20-22, 24-27 of co-pending application number 17/135,938, in view of Tommaso (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Previously considered claims 10, 18, 23 and 28 of the ‘938 application have also been canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects with pain (migraine headache) and (chronic) sleep disorder - delayed sleep phase disorder (sleep onset insomnia), comprising administering an effective amount of botulinum toxin type A to said subjects, wherein: the administration is multifocal and the delivery is by transdermal route.
The only differences between the 2 sets of claims are:
i) Instant claims recite that the migraine subjects have a pain which is responsive to tactile stimulation, while ‘938 claims do not have this limitation. However, migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘938 application claims. However, as stated above, this would be obvious in view of Borodic teachings.
22. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
23. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 8 and 21 of US Patent 9,956,435, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating subjects with migraine headaches by administering a composition comprising botulinum toxin type A.
The only differences between the two sets of claims are:
i) Instant claims recite treating migraine and a sleep disorder in a subject, while claims of the ‘435 patent do not recite treating sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. It is also known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘435 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
24. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,956,435.
25. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 11 of US Patent 8,518,414, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating pain by intradermally administering a composition comprising botulinum toxin type A.
The only differences between the two sets of claims are:
i) Instant claims recite treating migraine, while the ‘414 patent claims do not have this limitation.
However, the ‘414 specification teaches that administration of botulinum can be used to treat reduction or prevention of neurologic pain like migraine headaches (col 9, lines 64-67), thereby suggesting treating migraine as a pain condition. It is known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘414 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
iii) Instant claims recite treating a sleep disorder in the subject, while claims of the ‘414 patent do not recite treating sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with chronic sleep disorders like DSPD (sleep onset insomnia), both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above.
26. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,518,414.
27. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 and 45 of US Patent 10,080,786, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating pain like migraine headaches by administering a composition comprising botulinum toxin.
The only differences between the two sets of claims are:
i) Instant claims recite treating a sleep disorder in the subject, while claims of the ‘786 patent do not recite treating a sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. It is known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) in view of the teachings of Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘786 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
iii) Instant claims recite using botulinum toxin type A, while the ‘786 claims do not recite this limitation and are generic. However, treating headache, by administering botulinum toxin type A, would be obvious in view of the teachings of Blumenfeld as stated above.
28. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,080,786.
29. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims over claims 1-2, 6-10, 16-17, 19-20, of co-pending application number 17/951220, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating pain like headaches by administering a composition comprising botulinum toxin.
The only differences between the two sets of claims are:
i) Instant claims recite migraine headaches, while the ‘220 claims generically recite headache. However, the published specification of ‘220 application teaches that the composition can be used for treating migraine headaches (para 0050).
ii) Instant claims recite treating a sleep disorder in the subject, while claims of the ‘220 application do not recite treating a sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. It is also known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
iii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘220 claims. However, as stated above, this would be obvious in view of Borodic teachings.
iv) Instant claims generically recite a pharmaceutically acceptable carrier, while the ‘220 claims recite a positively charged carrier. However, instant claims are to a genus of carriers.
30. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
31. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-8, 19, 21-24, 26-27, 29,32, 52-54, of co-pending application number 17/912513, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendment.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of administering botulinum toxin A and a carrier intramuscularly, by multifocal injections for treating disorders like migraine headaches.
The only differences between the two sets of claims are:
i) Instant claims recite treating a sleep disorder in the subject, while claims of the ‘513 application do not recite treating a sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with chronic sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. It is also known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘513 claims. However, as stated above, this would be obvious in view of Borodic teachings.
32. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
33. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims over claims 152-157, 160-163, 168-175, of co-pending application number 18/595365, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. All previously considered claims of the ‘365 application have also been canceled. Minor modifications are made to address the amendments.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of administering botulinum toxin A and a carrier, by multifocal injections for treating disorders like migraine headaches.
The only differences between the two sets of claims are:
i) Instant claims recite treating a sleep disorder in the subject, while claims of the ‘365 application do not recite treating a sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with chronic sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. It is also known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
ii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘365 claims. However, as stated above, this would be obvious in view of Borodic teachings.
iii) Instant claims do not have the positively charged carrier limitation of ‘365 clams, rather generically recite a pharmaceutically acceptable carrier, indicating that the instant claims are to a genus.
34. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
35. Claims 1-2, 11-12, 14, 31-37 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4 and 11 of US Patent 8,518,414, in view of Biondi (2001) and Blumenfeld (2004), Tommaso et al (2002) and Borodic (2002). The rejection is maintained for reasons of record in Office Action dated 6/6/2024. It is noted that previously rejected claims 10, 13, 15-17 and 25-30 are now canceled. Minor modifications are made to address the amendment.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to treating pain by transdermal (transcutaneous) administration of botulinum toxin for treating pain.
The only differences between the two sets of claims are:
i) Instant claims recite migraine headaches, while the ‘414 claims do not have this limitation. However, the ‘414 specification teaches migraine headache pain, which can be treated with the inventive composition (col 2, line 45; col 4, line 67; col 9, line 66).
ii) Instant claims recite treating a chronic sleep disorder in the subject, while claims of the ‘414 patent do not recite treating a sleep disorder. However, this would be obvious as migraine headaches (pain) are known to coexist with chronic sleep disorders like DSPD, both of which are shown to be treated using botulinum toxin in view of the teachings of Blumenfeld and Biondi as stated above. It is known that migraine associated pain is reduced by tactile stimulation in migraine patients (i.e., such patients are responsive to tactile stimulation) as taught by Tommaso et al. Tommaso et al also teach that migraine accompanies cutaneous hyperalgesia, and cutaneous pain threshold was significantly reduced after tactile stimulation (para 57 of this action).
iii) Instant claims 2 and 36 recite that the subject has atopic disease, while this is missing from the ‘414 patent claims. However, as stated above, this would be obvious in view of Borodic teachings.
iv) Instant claims recite using botulinum toxin type A, while the ‘414 claims do not recite this limitation and are generic. However, treating headache, by administering botulinum toxin type A, would be obvious in view of the teachings of Blumenfeld as stated above.
36. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,518,414.
Note: It is incumbent on the Applicant to inform the office of all related subject matter and to file all related terminal disclaimers. See 37 CFR 1.56, Duty to disclose information material to patentability.
Applicant’s Remarks:
37. Traversing the double patenting rejections individually, Applicant asserts that based upon present amendment of claim 1 and cancellation of claims 13, 15-17 and 25-30, the rejections are now moot. Applicant submits that there is no basis to combine reference patents/co-pending applications with the cited art for reasons stated in the remarks to 103 rejections. Applicant therefore, requests withdrawal of the rejections over US patents 7537773, 7691394, 6429189, 9956435, 8518414, 10080786, 8518414/co-pending applications 18/455179, 17/951220, 17/912513, 18/595365, 17/472525. Applicant also requests the rejections over US patents 10441641, 8926991/co-pending applications 17/234690, 17/135938, to be held in abeyance until the finding of allowable subject matter.
38. Applicant’s argument is fully considered, and is found to be persuasive in part. However, upon consideration of current amendment, modified rejections have been set forth in this Office Action. Upon consideration of abandonment of application 18/455179, and amendment of 17/472525 claims to recite treating glabellar lines, the obviousness double patenting rejections over these application claims are withdrawn. As stated in the rejections, it is repeated that the conflicting patents or co-pending applications render the instant claims obvious in view of the teachings of the cited art.
39. Applicant’s stating that some of the rejections be held in abeyance until the finding of allowable subject matter, is considered but not found to be persuasive. The rejections have not been overcome by amendment or the filing of an approved terminal disclaimer. Thus, the rejections, as modified, are maintained.
New Rejections – necessitated by current amendment
Claim Rejections - 35 USC § 103
40. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the
basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
41. Claims 1, 11-12, 14, 31-35 and 37 are rejected under 35 U.S.C. 103(a) as being unpatentable over Blumenfeld (USP 8734810, filed 10/12/2004) and Guiloff et al, (J Neurol, Neurosurg Psychiatry 51: 1022-1031, 1988), in view of Biondi, DM (Dent Clin North Amer 45: 685-700, 2001) (IDS), as evidenced by Marcus et al (Clin Rheumatol 24: 595-601, 2005) and Wurts et al, (J Neurosc 20: 4300-4310, 2000).
42. The claims are directed to a method of treating migraine or recurring occurrence of common migraine in a subject having a chronic sleep disorder, comprising identifying a subject with both disorders, administering by injection an effective amount of a pharmaceutical composition comprising botulinum toxin immunotype A of between 5-3000 units with a pharmaceutically acceptable carrier (an aqueous vehicle), thereby reducing at least one symptom of both disorders, wherein the chronic sleep disorder is a delayed sleep phase disorder, (claims 1, 33, 37), wherein: the injection comprises at least at two injection sites and is multifocal (claims 11, 12), is administered to at least one of the regions recited in claim 31, and is transcutaneous, subcutaneous or intramuscular (claim 32); the botulinum toxin A is from a Hall strain Clostridium botulinum (claim 14); and the composition decreases choline acetyltransferase activity and acetylcholine synthesis (claims 34, 35).
43. Blumenfeld teaches treating or preventing a neurological disorder by administering to a trigeminal sensory nerve vicinity (Abstract). The reference teaches that trigeminal nerves are involved in the genesis of migraine headaches and botulinum administration ameliorates chronic migraine progression (col 28, lines 11-15). Blumenfeld teaches treating migraine headache using botulinum toxin or BOTOX® (botulinum toxin type A) (col 15, lines 13-17, 63, 66), wherein the botulinum toxin type A is from the Hall strain of Clostridium botulinum (col 14, lines 20-21; claims 1, 3, 6, 8), and the toxin is present in compositions comprising a pharmaceutically acceptable carrier (col 25, lines 51, 54-56), which can be used for injections including subcutaneous route (col 19, lines 20, 21) at multiple injection sites (or multifocal) in about 1 to about 3000 units (col 20, para 1; col 21, lines 43-44), wherein the injections can be in the head or neck region (col 29, lines 14-18, 26-28) (instant claims 1, 11-12, 14, 32, 33). The reference teaches intramuscular injection (at the level of inferior frontalis muscle) by infiltrating the eyebrow (periocular) (col 35, lines 27-29, 37) (instant claims 31, 32). Blumenfeld also teaches using botulinum for prophylactic (preventing) treatment of migraine, wherein botulinum decreases migraine frequency (recurring) and severity (col 15, lines 13-18) (instant claim 37). The reference teaches that botulinum can ameliorate the progression of chronic (prevents a repetitive occurrence) migraine (col 24, lines 8-12). As pain is a known symptom of migraine headache, and as migraine is relieved upon treatment as taught in the reference, the reference teaches reducing a symptom of migraine. Blumenfeld teaches that botulinum toxin administration in therapeutic amounts reduces secretion of a CNS neurotransmitter acetylcholine (col 29, lines 32-36). It is noted that the wherein clause reciting “wherein the composition decreases….” (instant claims 34, 35) recites a property of the botulinum composition that is administered. Once the composition is administered in effective amounts via subcutaneous mode to different regions, as instantly claimed (as taught by Blumenfeld), the composition will necessarily decrease choline acetyltransferase activity and acetylcholine synthesis, for reasons of being an inherent property of botulinum toxin. It is understood that “a compound and all of its properties are inseparable” In re Papesch, CCPA 137, USPQ 43. Also, the “wherein” limitations of claims 34 and 35 recite a result of the method of claim 1, therefore is an intended outcome, but not a step that is to be performed by the artisan. Upon performing the only step of administering an effective amount of botulinum toxin type A, one will have necessarily decreased choline acetyltransferase activity and acetylcholine synthesis. Additionally, it was well established at the time of the present invention that botulinum toxin decreases acetylcholine synthesis by inhibiting choline acetyltransferase or reducing the substrates.
44. Even though Blumenfeld does not explicitly teach treating a subject having sleep disorder with botulinum toxin, the reference suggests treating pain syndromes like fibromyalgia (known to be a chronic condition) having sleep disorder and headache as symptoms (col 2, lines 41-43; col 37, Example 5). As evidenced by Marcus et al (Abstract), migraine is a part of fibromyalgia and the majority of headache patients with fibromyalgia are migraine sufferers. Blumenfeld also teaches that botulinum toxin type A treatment by trigeminal targeting to a patient with phantom limb pain, and sleep disorder like staying awake all night (not able to get to sleep or DSPD), results in an ability to sleep through the night (Example 8, col 38), thus showing that botulinum toxin treats sleep disorder (decrease a sleep disorder or DSPD symptom as compared to before administration), along with an accompanying pain syndrome in a subject. Here the subject stayed awake all night (a symptom of delayed sleep phase disorder, based upon definition in para 0065 of the instant specification). Since Blumenfeld teaches treating migraine, repetitive migraine occurrence and a symptom of a chronic sleep disorder with botulinum, the reference inherently teaches administering effective amounts of botulinum for treating the same. In considering the disclosure of a reference, it is proper to take into account not only specific teaching of the reference but also the inferences which one skilled in the art would be reasonably be expected to draw therefrom (In re Preda, 401 F.2d 825, 159 USPQ 342, 344 (CCPA 1968)). Also, a reference must be considered, under 35 U.S.C. 103, not only for what it expressly teaches but also for what it fairly suggests; all disclosures of prior art, including unpreferred embodiments, must be considered in determining obviousness (In re Burckel 201 USPQ 67 (CCPA 1979)).
45. Guiloff et al, teach that upper and lower limb (knee) pain (phantom limb pain was reproduced) is closely associated with migraine attacks (Summary; Table 1; page 1028, col 2, para 3), thereby suggesting that the subject having a phantom limb pain and an accompanying sleep disorder also has migraine as a condition, and that botulinum toxin decreases a symptom of DSPD in subjects having migraine.
46. Blumenfeld, or Guiloff et al do not explicitly teach that the subject having migraine also has a chronic sleep disorder.
47. Biondi teaches sleep disorders and sleep physiology on the presentation of headaches including migraine headaches, and states that migraine headaches are associated with sleep pattern irregularities (page 688, para 1), and adds that headache can result in disordered sleep or insomnia (inability to fall asleep or delayed sleep phase disorder (DSPD) symptom) (para spanning pages 685 and 686, page 686, last para) (instant claim 1). Biondi therefore, suggests that pain (migraine) and DSPD result in disrupted sleep "10 or more nights per month" (page 686, para 1), indicating a chronic sleep disorder. Biondi also teaches that headaches like migraine are correlated to rapid eye movement or REM phase of sleep (paragraph on page 688). The art recognizes that the suprachiasmatic nucleus or SCN promotes REM sleep, and that “REM sleep is under strong circadian control”, as evidenced by Wurts et al (Abstract; page 4300, col 2, para 1).
48. Even though Blumenfeld or Biondi does not explicitly teach identifying a subject with migraine and chronic sleep disorder, the references indicate that migraine and sleep disorder are comorbid conditions, i.e., a subject having migraines or recurring migraines also has chronic sleep disturbances. Based upon the teachings in the references, it would be obvious that treating migraine would implicitly include subjects with sleep disorder. Since Blumenfeld teaches a method of treatment of subjects with migraine, it would be obvious that the subject needs to be identified for administering the toxin as part of an efficient treatment protocol.
49. It would therefore, have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the method of administering botulinum toxin in a subject having migraine or fibromyalgia or phantom limb pain and chronic sleep disorder like DSPD symptom as taught by Blumenfeld, wherein the phantom limb pain or lower limb pain is closely associated with migraine attacks as taught by Guiloff et al, by also treating migraine marked by chronic sleep disturbance or disorder like insomnia or inability to fall asleep in view of the teachings of Biondi. The person of ordinary skill in the art would have been motivated to make that modification and would have expected reasonable success as migraine and disorders accompanying migraine are known to have sleep disruptions associated with circadian rhythm or insomnia, and both migraine and chronic sleep disturbances are shown to be effectively treated with botulinum (Blumenfeld, Biondi). The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of the prior art reference.
50. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
51. Claims 1-2, 11-12, 14, and 31-37 are rejected under 35 U.S.C. 103(a) as being unpatentable over Blumenfeld (2004), Guiloff et al, (1988), and Biondi, DM (2001), in view of Borodic GE, US Patent 6,429,189 (2002), and in further view of Tommaso et al (Neurosc Lett 333: 29-32, 2002), as evidenced by Marcus et al (2005) and Wurts et al (2000).
52. Claim 2 recites that the subject further has atopic disease. Claim 36 recites assessing the subject’s response to tactile stimulation.
53. The teachings of Blumenfeld, Guiloff et al, and Biondi are set forth above.
54. Blumenfeld, Guiloff et al, or Biondi do not teach that the subject further has atopic disease.
55. Borodic teaches treating pain and inflammation (Abstract). The reference teaches that botulinum toxin use in a patient having migraine (pain), flushed face and itching with hives (atopic skin disease), resulted in improvement of pain (col 4, lines 7-13) (instant claim 2).
56. Blumenfeld, Guiloff et al, Biondi or Borodic do not teach assessing the response to tactile stimulation.
57. Tommaso et al teach that cutaneous hyperalgesia occurs during migraine episodes and cutaneous pain thresholds were significantly reduced in (chronic or suffering for many years) migraine patients without aura (common migraine) using laser stimuli on skin of hands (tactile stimulation) (Abstract; page 30, col 1; page 31, col 1, para 1; Fig. 1). The reference teaches the presence of increased sensitivity (response) to tactile stimulation in migraine patients (page 29, col 1). The reference also teaches that laser evoked stimulus “may play an important role in migraine maintenance and severity and should be taken into account in the therapeutic approach to migraine attack” (page 32) (instant claim 36).
58. Please note that the limitation of claim 36 reciting "wherein, upon tactile stimulation......composition" is directed to an intended result of the active method step recited in the preamble viz., ".... assessing the subject's response to tactile stimulation", and a prediction derived therefrom, but not a step that is to be performed by the artisan. Upon treating a subject having migraine with botulinum toxin and performing the step of assessing the response to tactile stimulation in a migraine patient (as taught by Tommaso et al), one will necessarily derive at the claimed prediction. As Tommaso teaches migraine accompanies cutaneous hyperalgesia, Borodic teaches atopic skin disease associated with pain and migraine, which can be treated with botulinum toxin, and further since Tommaso teaches cutaneous pain threshold was significantly reduced after tactile stimulation, a person of ordinary skill would obviously understand that such stimulation seemingly "predicts an increased responsiveness to the composition", absent any evidence to the contrary.
59. It would therefore, have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the method for treating a subject with migraine and a chronic sleep disorder comprising administering a composition comprising botulinum toxin as taught by Blumenfeld, Biondi and Guiloff et al, wherein the subject further has an atopic disease as taught by Borodic, by using tactile stimulation in view of the teachings of Tommaso et al. The person of ordinary skill in the art would have been motivated to use laser evoked stimulus (tactile stimulation) in migraine subjects as it “may play an important role in migraine maintenance and severity and should be taken into account in the therapeutic approach to migraine attack” (Tommaso et al, page 32). The person of ordinary skill would also have expected reasonable success because combining therapeutic measures for treating neurological diseases, was under investigation at the time the invention was made.
60. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
Applicant’s Remarks:
61. Traversing the rejections and emphasizing the present amendment, particularly “identifying…..” (step (i)) of claim 1, and “simultaneously treating both migraine and a chronic sleep disorder”, Applicant alleges that the cited teachings do not teach or suggest such method. Applicant argues that Blumenfeld does not teach treating DSPD or ASPD with botulinum toxin. Applicant also argues that Blumenfeld concerns treating pain associated with fibromyalgia or phantom pain. Applicant further argues that Example 8 of Blumenfeld (teaching phantom limb pain) is prophetic, and that neither of the sleep abnormalities discussed in Example 5 (treating fibromyalgia) and Example 8 of the reference “equates to “delayed sleep phase disorder” or “advanced sleep phase disorder””, rather are “too generic”. Applicant asserts that the reference provides “no connection…. between fibromyalgia and migraine”, and does not teach a “subject having both migraine and a chronic sleep disorder”, like DSPD or ASPD.
62. Applicant argues that Guiloff and Tommaso fail to remedy the deficiencies of Blumenfeld. Applicant also argues that Biondi at pages 694-698 teaches headaches which may interrupt sleep (e.g., sleep-disordered breathing, bruxism and temporomandibular disease (TMD)), however, does not teach reducing a symptom of any chronic sleep disorder such as DSPD or ASPD. Applicant argues that Borodic is used for the teaching of treating atopic disease, a limitation of a dependent claim, however, the reference does not remedy the shortcomings of the above-mentioned references.
63. Applicant summarizes that the cited references fail to teach or suggest each and every element of amended claim 1, and there would not have been a reasonable expectation of success of reducing at least one symptom of “both migraine and the chronic sleep disorder” in a subject for reasons stated. Applicant therefore, requests withdrawal of the rejections.
64. Applicant’s arguments that the cited art does not teach or suggest the current amendments particularly “identifying…..” (step (i) of claim 1, and “simultaneously treating both migraine and a chronic sleep disorder”, is considered but not found to be persuasive. New rejections addressing the amendments are set forth above.
65. Applicant’s argument that Example 8 of Blumenfeld does not teach DSPD or circadian rhythm disorders, is considered. Examiner understands that a sleep disturbance associated with phantom limb pain is not the same as a chronic circadian rhythm sleep disorder like DSPD. The example was only cited to show that botulinum is capable of treating inability to sleep, which also happens to be a symptom of instantly claimed sleep disorder. The Office is generally equating the symptoms of the reference sleep disorder with those of the claimed sleep disorder, and not the “sleep disorders” per se. Moreover, diseases like fibromyalgia are known to be chronic and the majority of sufferers from this ailment also have migraine (Marcus), thereby providing “a connection” between fibromyalgia and migraine, and indicating that the sleep disorder associated with such diseases will understandably be chronic. It is noted that the claims recite treating at least one symptom of a chronic sleep disorder.
66. Applicant’s allegation that Biondi teaches three types of headaches associated with sleep disorders including bruxism and TMD, is neither found to be persuasive, nor the Office Action points to such teaching. Agreed, Biondi devotes a separate section on disorders like sleep apnea, bruxism and TMD. However, the reference in its entirety, focuses on various headaches like migraine, tension, etc., and discusses sleep abnormalities coexisting with such headaches, some of which are chronic in nature. In fact, Biondi exclusively dedicates pages 687-694 to various headaches and sleep disorders.
67. Applicant’s arguments that Biondi does not teach chronic sleep disorders like DSPD or ASPD is considered. Biondi however, teaches that chronic pain (including chronic headaches) can cause sleep disorder or nonrestorative sleep, which can lead to chronic disruption in sleep pattern (every month indicating a symptom for months) (para spanning pages 685 and 686). It is noted that instant claim 1 recites “reducing ……at least one symptom of the chronic sleep disorder”, and inability to fall asleep (or sleep onset insomnia) is a symptom of DSPD (or DSPS) (instant specification as-filed, para 0065). Moreover, as stated in the rejection, Biondi teaches that headaches like migraine are correlated to the REM phase of sleep, which is controlled by the SCN and circadian rhythms. Biondi therefore, implicitly teaches symptoms of DSPD associated with headache.
68. The combined cited art therefore, teaches that: disturbed sleep pattern including the onset of sleep is regularly experienced with chronic migraine headache; and REM sleep phase has a high correlation with migraine headaches, wherein REM sleep is under circadian control, suggesting that the sleep disorder associated with headache is a chronic circadian rhythm disorder like DSPD, absent any evidence to the contrary.
69. Applicant’s arguments that the secondary references will not cure the deficiencies of Blumenfeld and Biondi are fully considered, however, are not found to be persuasive. Contrary to Applicant’s allegations, the teachings of Biondi and Blumenfeld are proper, which along with secondary references – Tommaso et al, Guiloff et al, and Borodic, are appropriate to render the claimed method obvious for the above stated reasoning. The person of ordinary skill in the art would have had a reasonable expectation of success based upon the combined prior art teachings. Applicant seems to argue each reference on a standalone basis. Applicant is however, reminded that in a 103 rejection, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the instant invention as recited in amended claims 1-2, 11-12,14, and 31-37 as a whole, was clearly prima facie obvious over the combined teachings of the prior art.
Conclusion
70. No claims are allowed.
14. 71. The art considered pertinent to applicant's disclosure is as follows:
Fibromyalgia <Fibromyalgia: Causes, Symptoms, Diagnosis, and Treatment>
downloaded on 1.24.2026,18 pages.
(Reference teaches that fibromyalgia is a chronic condition with sleep disturbances like
trouble sleeping (a symptom of DSPD) (pages 1, 3)).
72. Applicant’s amendment necessitated the new ground(s) of rejection presented in the Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
73. A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
74. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aditi Dutt whose telephone number is (571)272-9037. The examiner can normally be reached on M-F 9:00am-5:00pm.
75. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
76. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A. D./
Examiner, Art Unit 1675
25 January 2026
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675