Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 May 2025 has been entered.
Status of Application, Amendments and/or Claims
3. The amendment of 21 May 2025 has been entered in full. Claims 18 and 28 have been cancelled. Claims 1 and 16-17 have been amended. Claims 1-9, 11-13, 16-17, 20-22 and 24-27 are currently pending.
4. Claims 1-9, 11-13, 16-17, 20-22 and 24-27, drawn to a method of treating a sleep disorder and a pain syndrome in a subject, comprising administering botulinum toxin, are being considered for examination in the instant application.
Withdrawn Objection/Rejections
5. Upon consideration of proper amendment, the claim objection is withdrawn.
6. Upon consideration of cancellation of claim 18, and amendment of claim 1, the rejection under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
7. Upon consideration of claim amendments, the rejections under 35 U.S.C. 103(a) are withdrawn.
8. Upon consideration of claim amendments, the rejections under nonstatutory obviousness double patenting are withdrawn.
New Rejections – necessitated by amendment
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1-9, 12-13, 17, 20-21 and 24-27 are rejected under 35 U.S.C. 103(a) as being unpatentable over Freund et al (The Clin J Pain 18: S163-S168, 2002), Schlesinger et al (Headache 41:586-589, 2001), and Ferrari et al (Best Practice Res Clin Rheumatology 17: 57-70, 2003), in view of Blumenfeld (USP 8734810, filed 10/12/2004), in further view of Hunt T (US PGPB 20020064536, filed 5/30/2002).
11. The claims are directed to a method of treating sleep disorder and a pain syndrome in a subject comprising identifying a subject with both sleep disorder and pain syndrome and administering a therapeutically effective amount of a pharmaceutical composition comprising botulinum toxin immunotype A and a pharmaceutically active carrier to the subject, thereby reducing a symptom of the sleep disorder and the pain syndrome, wherein the pain syndrome comprises cervical radiculopathy (CR) or whiplash, and the composition further comprises a polycationic protein (claims 1, 17, 21), wherein: the sleep disorder is sleep onset disorder (claim 26) or sleep maintenance disorder (claim 27); the botulinum toxin is from a Hall strain of Clostridium botulinum (claim 2); the administering is by injection (claim 3) at multifocal sites (claim 8), and is transcutaneous, subcutaneous, transdermal or intramuscular (claim 24); the administering is on one or more of the forehead, face, scalp or periocular region (claim 4), neck (claim 5), extra-cranial region of soft tissue (claim 12), nasal or sinus cavity or both (claim 13); the pharmaceutical composition comprises the toxin in an amount of 1.25-3000 units (claim 9), approximately 100 units (claim 20); and the administering of the composition to the subject is in tissues that enhance venous drainage from the administration site to CNS site or that enhances uptake by the portal hypophyseal drainage system of the subject (claim 25). Claim 6 recites that the toxin composition after administration crosses the blood brain barrier (BBB) and affects neurotransmission and decreases choline acetyltransferase activity in the CNS (claim 7).
12. Freund et al teach that whiplash associated disorders (WADs) occur from motor vehicle accidents, resulting in cervical injury, and that botulinum toxin can be used for treating muscle and neck pain in such disorders (Abstract; page S165, col 1, para 3). The reference teaches that WADs are associated with headaches (tension and migraine), which respond well with botulinum toxin injections in different muscles (intramuscular) of the neck (page S164, Table 2; S166, col 1, para 3; col 2, para 2, 3), and muscles of the face, head and neck (e.g., temporalis, masseter) (Table 5). The reference also teaches administering 100 U of botulinum toxin A (Botox – pharmaceutical composition) at doses within the claimed range of 1.25 units to 3000 units (Table 5) (instant claims 1, 3-5, 8-9, 17, 24).
13. Freund et al do not teach a sleep disorder in the same subject.
14. Ferrari et al teach that whiplash injury leads to chronic neck pain (Abstract), which is accompanied with headache (page 58, para 2). Ferrari et al also teach treating neck pain due to motor vehicle collisions with botulinum toxin A (page 66, para 2). Ferrari et al further teach that whiplash patients also report of sleep disorder (page 66, para 3).
15. Schlesinger et al teach sleep patterns in persons with whiplash injury. The reference teaches that sleep-logs maintained by whiplash injured subjects showed a significantly prolonged sleep latency (sleep onset disorder), and significantly impaired sleep quality as compared to controls, wherein the number of arousals (sleep maintenance disorder) in whiplash injured persons positively correlated with the intensity of the injury. It is understood that prolonged sleep latency (longer time to fall asleep) and impaired sleep quality are symptoms of sleep onset and maintenance disorders, which are chronic insomnia symptoms. The reference also teaches that sleep efficiency was inversely correlated with the number of injury findings (Abstract) (instant claims 1, 26-27). The reference further teaches that sleep-logs continued for 3 to 5 months after injury did not show significant difference from those soon after injury (Methods, page 587, col 2, para 2; page 588, col 1, para 1), suggesting chronicity of the sleep disorder. Schlesinger et al therefore, implicitly identify a subject with both – pain disorder and sleep disorder.
16. The references do not explicitly teach identifying a subject with sleep disorder and pain syndrome. However, since both Ferrari et al and Schlesinger et al teach that whiplash is accompanied with sleep disorder, the conditions are expected to be comorbid, and the subject having a pain syndrome like whiplash will reasonably be believed to also have a sleep disorder. Therefore, it would be obvious that the subject identified for treatment of pain syndrome will have a sleep disorder.
17. Even though Freund et al, Ferrari et al and Schlesinger et al do not teach treating sleep disorder using botulinum toxin, the teachings establish that sleep efficiency is inversely correlated with the intensity of whiplash injury (Schlesinger et al), and that whiplash associated pain can be treated with botulinum (Freund et al, Ferrari et al). It would, therefore, be obvious to the person of ordinary skill in the art that reducing whiplash injury and pain would increase sleep efficiency, i.e., reducing at least one symptom of the sleep disorder and of the pain syndrome.
18. Please note that the preamble of claim 1 reciting “a method of simultaneously treating a sleep disorder and a pain syndrome…”, is directed to an intended use of the claimed method steps. MPEP 2111.02(II) states that “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. Here, the body of the claim sets forth all the steps and starting materials, and the preamble of the claim merely sets forth an intended use of the steps. Additionally, the "thereby reducing at least ...of the sleep disorder and …the pain syndrome.." clause in lines 7 and 8 of claim 1 recites a result of the method and is an intended outcome following the term “thereby”, but not a step that is to be actively performed by the artisan (emphasis added). The broadest reasonable interpretation of the claim would be that upon performing the steps of (i) identifying a subject, and (ii) administering botulinum toxin, one will necessarily have reduced at least one symptom of both - the pain syndrome and the sleep disorder. Note that the claim does not recite for example, “(iii) reducing….symptom..” or “determining reduction….”, which would require an active step to be performed.
19. Freund et al, Ferrari et al or Schlesinger et al do not teach botulinum injection specifics.
20. Blumenfeld teaches treating neurological disorders including chronic pain, comprising administering botulinum toxin by peripheral administration (transdermal, subcutaneous) to the vicinity of trigeminal nerves or nerve endings (abstract; col 1, para 1; col 2, para 3; col 20, para 1), wherein: the botulinum toxin type A is from the Hall strain of Clostridium botulinum (col 14, lines 20-21; claims 1, 3, 6, 8), the pharmaceutical composition contains about (approximately) 100 units of the toxin (col 14, lines 31-33), and the toxin is present in compositions comprising a pharmaceutically acceptable carrier (col 25, lines 51, 54-56), which can be used for subcutaneous injections (col 20, lines 1, 2) in the head, face, and neck region (col 29, lines 14-18, 26-28), at multiple injection sites (or multifocal) (col 21, lines 43-44), in amounts of about 1 to about 3000 units (col 20, lines 1-3) (instant claims 1-5, 8-9, 12, 20, 24). 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). Because the trigeminal nerves and its branches have endings in the face, neck scalp, forehead and nasal cavity (col 8, lines 44-50; col 24, lines 66, 67; col 9, line 16), peripheral injections of botulinum to the vicinity of trigeminal nerves and its branches would inherently encompass subcutaneous administration to the scalp and head region including nasal cavity (col 29, para 4; col 9, line 16) (instant claim 13). As the injections are subcutaneous or transdermal, the administration would inherently be to an extracranial region (instant claim 12). The reference further teaches that botulinum toxin administration in therapeutic amounts reduces the secretion of a CNS neurotransmitter acetylcholine (col 29, lines 32-36) (instant claims 6, 7). It is noted that the wherein clause reciting “wherein the pharmaceutical composition after the administering decreases choline acetyltransferase activity” (instant claim 7) recites a result of the method and is an intended outcome, but not a step that is to be performed by the artisan. Upon performing the only step of administering botulinum toxin, one will have necessarily decreased choline acetyltransferase activity. 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. Furthermore, the specification hypothesizes that “botulinum toxin penetrates the blood/brain barrier” (para 0071). The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). On a similar note, even though the reference does not teach that the administering of the pharmaceutical composition results in an enhanced venous drainage or an enhanced uptake by the hypophyseal portal system (as recited in instant claim 25), the clause reciting “wherein the administering …” indicates an intended outcome, which will occur upon administration of the toxin as instantly recited. It is noted that Blumenfeld teaches the step of administration of botulinum toxin to a subject with pain syndrome and sleep disorder to different sites (head, face, neck, nasal cavity), using different modes of administration (subcutaneous), in amounts as recited in instant claims 9 and 20.
21. Freund et al, Ferrari et al, Schlesinger et al, or Blumenfeld do not teach that the pharmaceutical composition comprises a polycationic protein.
22. Hunt teaches that peptides comprising cationic amino acids like polylysine can bind to acidic proteins like botulinum toxin and shield the protein from getting unstable on contact with other ingredients in the composition like sugars, thereby stabilizing the active protein from being degraded. Hunt teaches that this property also provides the “additional advantage of being antibacterial” (para 0121), thereby improving the stability of the composition. It is noted that presence of a polylysine stretch can be considered as a polycationic peptide (instant claims 1, 21).
23. 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 for treating whiplash, and a sleep disorder in the same subject as taught by Freund et al, Ferrari et al and Schlesinger et al, wherein the botulinum is from a Hall strain of Clostridium botulinum, and can be administered to different sites for treating pain syndromes in view of the teachings of Blumenfeld, by using a toxin composition that further comprises a polycationic protein, in view of the teachings of Hunt. The person of ordinary skill in the art would have been motivated to make that modification and would have expected reasonable success to treat both whiplash and sleep disorder in the same subject, as both whiplash associated pain and sleep disorder are known to be present in the same subject, and are inversely correlated. The person of ordinary skill in the art would have also been motivated as botulinum toxin is a protein molecule, and polycationic peptides were known stabilizers of the protein therapeutic (Hunt). 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 references.
24. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
25. Claims 1, 6, 11, 17 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Freund et al (2002), Ferrari et al (2003) and Schlesinger et al (2001), in view of Blumenfeld (2004), and in further view of Royer (US Patent 5783214, dated 7/21/1998).
26. Claims 11 and 22 recite that the pharmaceutical composition with botulinum further comprises hyaluronidase.
27. The teachings of Freund et al, Ferrari et al, Schlesinger et al, and Blumenfeld are set forth above.
28. Freund et al, Ferrari et al, Schlesinger et al, or Blumenfeld does not teach using the toxin composition further comprising hyaluronidase.
29. Royer teaches the preparation of protein therapeutics for controlled drug release (abstract). The reference teaches using a bioerodible matrix that comprises the inclusion of hydrolytic enzymes like hyaluronidase, which is used as a stabilizer and leads to faster release of the protein therapeutic (col 7, lines 26-27, 42-43; col 6, lines 42-46).
30. 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 administering a composition comprising botulinum toxin for treating pain and sleep disorder in a subject as taught by the combined teachings of Freund et al, Ferrari et al, Schlesinger et al, and Blumenfeld, by including hyaluronidase to the toxin composition in view of the teachings of Royer. The person of ordinary skill in the art would have been motivated to make that modification and would have expected reasonable success as botulinum toxin is a protein molecule, and the inclusion of hydrolytic enzymes in protein therapeutics resulted in enhanced release of the therapeutic. The person of ordinary skill would also have expected reasonable success because the making of therapeutic toxin formulations for improved drug delivery was under investigation at the time the invention was made.
31. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
32. Claims 1-9, 12-13, 16, 20-21 and 24-27 are rejected under 35 U.S.C. 103(a) as being unpatentable over Barbanti et al (Neurology 64, 1308-1309, April 2005), Borodic, (US patent 7670608, filed 3/8/2004), Jankovic et al (Neurology 41: 1088-1091, 1991), and Biondi, DM (Dent Clin North Amer 45: 685-700, 2001), in view of Blumenfeld (2004), and in further view of Hunt T (2002).
33. Claim 16 recites that the pain syndrome comprises cervical radiculopathy (CR).
34. Barbanti et al teach that cervical dystonia (CD) patients have pain in the dystonic muscle and headache, which improved after botulinum toxin type A (BoNT/A) treatment (page 1308, col 1, col 2, para 4), wherein the headache frequency in dystonia patients was 56.2% (page 1309, col 1, para 1) (instant claim 1).
35. Barbanti et al do not teach CR.
36. Borodic teaches that botulinum is useful for treating pain syndromes like CD and headaches (Abstract). The reference teaches that the toxin was effective in treating conditions related to cervical muscles and the associated pain component (col 1, para 3). The reference also teaches identifying a subject with a pain syndrome like cervical radiculopathy, and administering a composition comprising botulinum toxin immunotype A (col 3, lines 12-14, 20; col 4, lines 13-15; claims 1, 3).
37. Jankovic et al teach that 32% of CD patients had secondary cervical radiculopathy, and intramuscular botulinum toxin injection relieved the pain associated with the diseases (Abstract).
38. Barbanti et al, Borodic et al and Jankovic et al clearly suggest that CR coexists with CD and headaches, all of which can be treated with botulinum.
39. Barbanti et al, Borodic, or Jankovic et al do not teach sleep disorder in the same subject.
40. Biondi teaches sleep disorders and sleep physiology on the presentation of headaches. The reference teaches that head and neck pain can be caused by sleep disorder, as well as chronic pain and headache can result in normal sleep pattern disruption like nonrestorative or disrupted sleep and various forms of insomnia (i.e., sleep onset/maintenance insomnia) (para spanning pages 685 and 686, page 686, last para; Summary) (instant claims 16, 17, 26-27).
41. The fact that headaches coexist in the same subject having CD and CR (pain syndromes), and headaches can result in sleep disorder and vice versa (Biondi), implies that CR and sleep disorder are comorbid in the same subject. Since the references teach treating CR with botulinum, and since CR coexists with sleep disorder, it would be logical that identification of the subject having CR will result in also identifying sleep disorder in the same subject.
42. Additionally, the "thereby reducing...subject" clause of claim 1 recites a result and an intended outcome of the method, but not a step that is to be performed by the artisan. Upon performing steps (i) and (ii) (identifying a subject….;and administering…), one will necessarily have reduced a symptom of the sleep disorder and of the pain syndrome. It is noted that the only 2 steps are those listed as (i), (ii), in the claim, and that there are no further active steps such as determining or detecting said reduction.
43. Barbanti et al, Borodic, Jankovic et al, or Biondi do not teach the claimed botulinum injection specifics.
44. The teachings of Blumenfeld are set forth above.
45. Barbanti et al, Borodic, Jankovic et al, or Biondi, or Blumenfeld do not teach that the pharmaceutical composition comprises a polycationic protein.
46. The teachings of Hunt are set forth above.
47. 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 for treating CR as a pain syndrome and sleep disorder in the same subject in view of the teachings of Barbanti et al, Borodic, Jankovic et al, and Biondi, wherein the botulinum is from a Hall strain of Clostridium botulinum, and can be administered to different sites for treating pain syndromes as per the teachings of Blumenfeld, by using a toxin composition that further comprises a polycationic protein, in view of the teachings of Hunt. The person of ordinary skill in the art would have been motivated to make that modification and would have expected reasonable success to treat both CR and sleep disorder in a subject, as both CR associated pain and sleep disorder are present in the same subject, and because the toxin can effectively reduce sleep disorder symptoms in pain syndromes (Biondi, Blumenfeld). The person of ordinary skill in the art would have been motivated as botulinum toxin is a protein molecule, and polycationic peptides were known stabilizers of the protein therapeutic (Hunt). 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 references.
48. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
49. Claims 1, 6, 11, 16 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Barbanti et al (2005), Borodic (2004), Jankovic et al (1991), Biondi (2001), Blumenfeld (2004) and in view of Royer (1998).
50. The teachings of Barbanti et al, Borodic, Jankovic et al, Biondi, and Blumenfeld are set forth above.
51. Barbanti et al, Borodic, Jankovic et al, Biondi, or Blumenfeld does not teach using the toxin composition further comprising hyaluronidase.
52. The teachings of Royer are set forth above.
53. 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 administering a composition comprising botulinum toxin for treating pain and sleep disorder in a subject as taught by the combined teachings of Barbanti et al, Borodic, Jankovic et al, Biondi, and Blumenfeld, by including hyaluronidase to the toxin composition in view of the teachings of Royer. The person of ordinary skill in the art would have been motivated to make that modification and would have expected reasonable success as botulinum toxin is a protein molecule, and the inclusion of hydrolytic enzymes in protein therapeutics resulted in enhanced release of the therapeutic. The person of ordinary skill would also have expected reasonable success because the making of therapeutic toxin formulations for improved drug delivery was under investigation at the time the invention was made.
54. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
Applicant’s Remarks:
55. Applicant submits that the person of ordinary skill would not have been motivated to combine the teachings of the cited art to arrive at the method as claimed at the time of the invention. Applicant refers to paragraph 0026 of the PGPB that provides the inventive method.
56. Applicant argues that Freund and Schlesinger do not teach or suggest “identifying a subject with both said sleep disorder and said pain syndrome”, wherein the sleep disorder is sleep onset insomnia or sleep maintenance insomnia, and the pain syndrome is CR or WL. Applicant particularly argues Schlesinger teaching, which report that actigraphic monitoring did not show a significant difference in the sleep characteristics of WL and controls. Applicant also argues that the “prolonged sleep latency and impaired sleep quality” in WL patients of the reference is distinct from the instantly claimed sleep disorders. Applicant further argues that Blumenfeld, Hunt and Royer fail to correct the deficiencies of Freund, and Schlesinger, and there would be no motivation to combine the references to arrive at the claimed method. Applicant, therefore, requests the rejections to be withdrawn.
57. Applicant argues that the references including Biondi fail to teach the newly added limitation of “identifying…”. Applicant further argues that Biondi does not teach that the subject with headache necessarily also has a sleep disorder of the types as claimed, and Blumenfeld fails to correct the deficiency of the earlier cited references. Applicant alleges that as there is no reason or motivation to combine the references at the time of the invention, the method of treating using the cited references cannot be accomplished without using impermissible hindsight. Applicant, therefore, requests the rejections to be withdrawn.
58. Applicant’s arguments pertaining to the amendments of claim 1 are fully considered. All previous rejections are withdrawn and new rejections incorporating the amendments are set forth above.
59. Applicant’s assertion that the actigraphic data of Schlesinger did not show a significant difference between the sleep characteristics of WL and controls, is agreed. The reference however, also included subjective impressions (“sleep-logs”) of the subjects for comparison, which “suggest the opposite conclusion” from the actigraphic one (Abstract). In the concluding paragraph (page 589), the reference implicitly upholds subjective analysis stating that WL injury resulted in “subtle, but clinically important, sleep disturbances ….that cannot be detected by actigraph ….” and “the subjective impressions of the subjects in this instance were closer to the truth than the objective measurements”.
60. Applicant’s argument that “prolonged sleep latency and impaired sleep quality” in WL patients of Schlesinger is distinct from the instantly claimed sleep disorders, is considered, but not found to be persuasive, as both of these are symptoms of sleep onset and sleep maintenance disorders respectively (as evidenced by Copilot Search (Google) Sleep disorder < advanced vs delayed sleep phase disorder and (sleep onset and sleep maintenance) are chronic - Search> (pgs 1-2), downloaded from internet on 8/23/26; page 1 (Sleep Onset vs Sleep Maintenance). Schlesinger even maintained the sleep-logs for 3-5 months after the injury (Methods, page 587, col 2), however, the data (actigraphic, sleep-log) were not significantly different from those soon after the injury (page 588, col 1, para 1), indicating chronicity of the sleep disorder. It is noted that the claimed sleep disorders are chronic (para 0067 of instant PGPB).
61. The claimed method would, therefore, be obvious, and the person of ordinary skill in the art would be motivated in view of the combined references for reasons set forth in the new rejections. Applicants may argue that the examiner's conclusion of obviousness is based on improper hindsight reasoning. However, "[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). Applicants may also argue that the combination of two or more references is "hindsight" because "express" motivation to combine the references is lacking. However, there is no requirement that an "express, written motivation to combine must appear in prior art references before a finding of obviousness." See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP § 2141 and § 2143 for guidance regarding establishment of a prima facie case of obviousness.
Double Patenting
Non-Statutory
62. 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).
63. 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).
64. 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.
65. 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.
66. Claims 1-4, 6-7, 12, 16-17, 21 and 25 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 6-7, 9-12 and 21-24 of US Patent 7,537,773 in view of Jankovic et al (1991), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003), Biondi (2001) and Hunt (2002). 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) comprising administering botulinum toxin type A in a periocular area (extracranial) to said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘773 patent claims do not have this limitation. However, the ‘773 claims are directed to treating pain and inflammation using botulinum; and CR or whiplash are known to be associated with pain and inflammation as taught by Jankovic et al and Freund et al respectively (para 40, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, and identifying a subject with both, while claims of the ‘773 patent do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '773 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include subjects with sleep disorder, and the subjects would require identification of the conditions before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘773 claims do not have these limitations. However, these will amount to an inherent intended outcome, which will occur upon performing the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘773 patent claims. However, as stated in the rejection, this would be obvious in view of Hunt.
67. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 7,537,773.
68. Claims 1-3, 6-7, 9, 12, 16-17, 21 and 25 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 7, 41, 45, 51-54, 56-58 and 63 of US Patent 7,691,394 in view of Jankovic et al (1991), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003), Biondi (2001) and Hunt (2002). 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 pain syndrome (headache, etc.) comprising administering botulinum toxin type A in amounts that fall within instantly recited 1.25 to 3000 units to said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘394 patent claims do not have this limitation. However, the ‘394 claims are directed to treating pain and inflammation using botulinum; and CR or whiplash are known to be associated with pain and inflammation as taught by Jankovic et al and Freund et al respectively (para 40, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘394 patent do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '394 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include subjects with sleep disorder, and the subjects would require identification of the conditions before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘394 claims do not have these limitations. However, these will amount to an inherent intended outcome, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘394 patent claims. However, as stated in the rejection, this would be obvious in view of Hunt.
69. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 7,691,394.
70. Claims 1, 3, 4-7, 12, 16-17, 21 and 25 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-7, 11, 15-19, 22-23 of US Patent 6,429,189 in view of Jankovic et al (1991), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003), Biondi (2001) and Hunt (2002) and Blumenfeld (2004). 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 pain syndrome (headache, etc.) comprising administering botulinum toxin to the head and neck region of said subjects.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘189 patent claims do not have this limitation. However, the ‘189 claims are directed to treating pain and inflammation using botulinum; and CR or whiplash are known to be associated with pain and inflammation as taught by Jankovic et al and Freund et al respectively (para 40, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘189 patent do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Biondi - para 21, 19 of this office action), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '189 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include subjects with sleep disorder, and the subjects would require identification of the conditions before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while the ‘189 claims do not have these limitations. However, these would be an inherent intended outcome, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited. Additionally, the ‘189 patent teaches that botulinum decreases acetylcholine release (col 1, last para).
v) Instant claims recite administration of botulinum toxin type A, while the ‘189 claims are generic. However, treating headache and other pain disorders by administering botulinum toxin type A, would be obvious in view of the teachings of Blumenfeld as stated above (para 24 of this office action).
vi) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘189 patent claims. However, as stated in the rejection, this would be obvious in view of Hunt.
71. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 6,429,189.
72. Claims 1-9, 12, 16-17, 21 and 24-27 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 Schlesinger et al (2001), Ferrari et al (2003), Biondi (2001) and Sheftell et al (2002). It is noted the previously rejected claim 28 is now canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to identifying a subject having sleep disorder, treating subjects having a sleep disorder, sleep onset or sleep maintenance insomnia comprising administering a pharmaceutical composition comprising botulinum toxin type A by injection to the head, forehead, scalp, neck or periocular region, using subcutaneous or intramuscular modes (extracranial) in amounts between 5 to 3000 units of said subjects, wherein the administration is multifocal, and the composition decreases acetylcholine synthesis.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating a pain syndrome 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 Sheftell et al. Sheftell et al teach that depression patients also exhibit pain syndrome, and the two conditions are comorbid (page 938, col 1, para 2; col 2, para 1).
ii) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘641 patent claims do not have this limitation. However, this would be obvious as the ‘641 patent teaches treating CR and whiplash using botulinum toxin (para spanning cols 5 and 6).
iii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘641 patent do not recite treating both conditions in the same subject. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR for reasons stated above, and in view of the teachings of Schlesinger et al, Ferrari et al and Biondi (para 21, 42 of this office action), treating said subject by administration of botulinum toxin would be obvious.
iv) Even though the '641 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
v) Instant claim 25 recites that after administration of botulinum toxin, the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system, while ‘641 claims do not have these limitations. However, this is an intended outcome, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited. Additionally, the ‘641 patent teaches that administration of botulinum to the “forehead, scalp or neck…. or…the periocular region and …face that enhance maximize venous drainage from the site of administration to the central nervous system (CNS)” (col 7, lines 11-16).
vi) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘641 patent claims. However, this is contemplated in the ‘641 patent (col 7, lines 50-53, 63-65).
73. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,441,641.
74. Claims 1-8, 12, 21 and 24-27 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 Schlesinger et al (2001) and Ferrari et al (2000). It is noted the previously rejected claim 28 is now canceled.
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 sleep maintenance insomnia), comprising identifying a subject with the sleep disorder, administering botulinum toxin type A to said subjects, wherein the administration is multifocal in the face, neck and scalp regions and the delivery is by subcutaneous, and intramuscular routes, wherein botulinum toxin decreases choline acetyltransferase activity and synthesis of acetylcholine.
The only differences between the two sets of claims are:
i) Instant claims recite treating a subject with sleep disorder and pain syndrome, while the ‘991 patent claims only recite treating sleep onset insomnia or sleep maintenance insomnia. However, treating a subject having pain and insomnia is obvious in view of the teachings of Biondi (see rejection above), since the two conditions are closely associated in cause-effect manner.
ii) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘991 patent claims do not have this limitation. However, this would be obvious as the ‘991 patent teaches treating pain syndromes like CR and whiplash using botulinum toxin (col 5, line 64).
iii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘991 patent do not recite treating both conditions in the same subject. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR for reasons stated above, and in view of the teachings of Schlesinger et al, Ferrari et al and Biondi (see rejection above), treating said subject by administration of botulinum toxin would be obvious.
iv) Even though the '991 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (WL or CR) (as in instant claims), based upon the teachings of Ferrari et al, Freund et al and Schlesinger et al, both WL and CR are comorbid with sleep disorder. The ‘991 patent claims or teaches treating both conditions using botulinum. It would, therefore, be obvious that treating whiplash or CR derived pain in a subject with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would be required to be identified before administering botulinum for treatment efficacy.
v) Instant claim 25 recites that after administration of botulinum toxin, the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system, while ‘991 claims do not have these limitations. However, these indicate an intended outcome, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
vi) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘991 claims. However, this is contemplated in the ‘991 patent (col 7, lines 40-42, 52-55).
75. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,926,991.
76. Claims 1-3, 5-7, 9, 12, 16-17, 20-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3-5, 7-8, 12, 29-30 of co-pending application number 18/031,861 in view of Graziano et al (1992), Jankovic et al (1991), Biondi (2001), Schlesinger et al (2001), Ferrari et al (2003), and Hunt (2002). It is noted that previously presented claim 28 of instant application, and claims 15-17 of ‘861 application, are now cancelled.
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 a pain syndrome, comprising intramuscularly administering an effective amount of botulinum toxin type A injection to said subjects is 125 or 250 U (1.25 units to 3000 units), wherein the administration is at multifocal muscle sites of the neck.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘861 claims recite treating cervical dystonia. However, the association of CD with whiplash and CR is taught by Graziano et al, and Jankovic et al (see preceding rejection). As both CR and whiplash are closely associated with CD, and all three conditions can be treated using botulinum toxin, instant claims would be rendered obvious over the ‘861 claims.
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘861 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Ferrari et al. Schlesinger et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '861 claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘861 claims do not have these limitations. However, these indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘861 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
77. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
78. Claims 1-9, 16-17, 20-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 and 15-19 of co-pending application number 18/244,279 in view of Biondi (2001), Freund et al (2002), Jankovic et al (1991), Schlesinger et al (2001), Ferrari et al (2003) and Hunt (2002). It is noted that previously presented claims 18 and 28 of instant application, and claims 11-14 of ‘279 application, are now cancelled. 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 syndrome (headache), comprising administering an effective amount of botulinum toxin type A to said subjects in a total dose of 100-450 U (1.25-3000 U), wherein the administration is intramuscular and multifocal in the face and neck muscles (trapezius, masseter).
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘279 claims do not have this limitation. However, the ‘279 claims are directed to treating migraine pain using botulinum; and CR or whiplash are known to be associated with headache as taught by Jankovic et al, Biondi and Freund et al (para 40, 42, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while ‘279 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the ‘279 claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘279 claims do not have these limitations. However, these indicate an inherent intended outcome, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘279 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
79. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
80. Claims 1-9, 16-17, 20-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 4-8, 19, 24, 26-27, 29, 32, 52-54 of co-pending application number 17/912,513 in view of Biondi (2001), Freund et al (2002), Jankovic et al (1991), Schlesinger et al (2001), Ferrari et al (2003), and Hunt (2002). It is noted that previously presented claims 18 and 28 of instant application, and claims 21 and 23 of ‘513 application, are now cancelled. 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 syndrome (headache), comprising administering an effective amount of botulinum toxin type A to said subjects in a total dose of 200-450 U (1.25-3000 U), wherein the administration is intramuscular and multifocal in the face and neck muscles (trapezius, masseter).
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘513 claims do not have this limitation. However, the ‘513 claims are directed to treating headache or migraine pain using botulinum; and CR or whiplash are known to be associated with headache as taught by Jankovic et al, Biondi and Freund et al (para 40, 42, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while ‘513 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '513 claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘513 claims do not have these limitations. However, this indicates an intended outcome, which will obviously occur after completing the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder, as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘513 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
81. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
82. Claims 1-3, 5-9, 12, 16-17, 20-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 and 8-9 of US patent 12,257,293 in view of Graziano et al (1992), Jankovic et al (1991), Biondi (2001), Schlesinger et al (2001), Ferrari et al (2013) and Hunt (2002). (Note that the rejection in the prior office action was over claims 1-9 of application 17/547211, now issued as patent ‘293).
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 syndrome, comprising intramuscularly administering an effective amount of botulinum toxin type A injection to said subjects from 100-300 U (1.25 units to 3000 units), wherein the administration is at multifocal muscle sites.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘293 patent claims recite treating cervical dystonia. However, the association of CD with whiplash and CR is taught by Graziano et al, and Jankovic et al (see preceding rejection). As both CR and whiplash are closely associated with CD, and all three conditions can be treated using botulinum toxin, instant claims would be rendered obvious over the ‘293 claims.
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while the ‘293 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '293 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘293 claims do not have these limitations. However, these would indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘293 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
83. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 12,257,293.
84. Claims 1-2, 16-17 and 26-27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 and 53 of US patent 9,211,248 in view of Biondi (2001), Freund et al (2002), Schlesinger et al (2001), and Ferrari (2003). 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 syndrome (headache), comprising administering an effective amount of botulinum toxin type A to said subjects.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘248 claims do not have this limitation. However, the ‘248 claims are directed to treating headache or migraine pain using botulinum; and CR or whiplash are known to be associated with headache as taught by Biondi and Freund et al respectively (para 42, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘248 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '248 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
85. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,211,248.
86. Claims 1-2, 6-9, 12, 16-17, 20-21 and 24-27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 8-49 of US patent 9,956,435 in view of Graziano et al (1992), Jankovic et al (1991), Biondi (2001), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003) and Hunt (2002). 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 muscle spasm or spasmodic torticollis (CD), comprising administering an effective amount of 1-400 U (1.25-3000 U) of botulinum toxin type A to said subjects.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘435 claims recite treating cervical dystonia. However, as stated above, the association of CD with whiplash or CR is taught by Graziano et al, and Jankovic et al respectively. As both CR and whiplash are closely associated with CD, and all three conditions can be treated using botulinum toxin, instant claims would be rendered obvious over the ‘435 claims.
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while the ‘435 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '435 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘435 claims do not have these limitations. However, these would indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘435 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
87. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,956,435.
88. Claims 1-3, 6-7, 12, 16-17, 21 and 24-27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 7, 11-12 of US patent 8,518,414 in view of Graziano et al (1992), Jankovic et al (1991), Schlesinger et al (2001), Ferrari et al (2003), Biondi (2001) and Hunt (2002). 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, muscle spasm or CD, comprising transdermally administering an effective amount of botulinum toxin to said subjects.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘414 claims recite treating pain or cervical dystonia. However, as stated above, the association of CD with whiplash or CR is taught by Graziano et al, and Jankovic et al respectively. As both CR and whiplash are pain syndromes, are closely associated with CD, and all three conditions can be treated using botulinum toxin, instant claims would be rendered obvious over the ‘414 claims.
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘414 patent do not recite treating both conditions in the same subject. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR for reasons stated above and in view of the teachings of Schlesinger et al, Ferrari et al, and Biondi (see rejection above), treating said subject by administration of botulinum toxin would be obvious.
iii) Even though the '414 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘414 claims do not have these limitations. However, these would indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘414 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
89. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,518,414.
90. Claims 1-2, 6-7, 12, 16-17, 21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 22-23 of US patent 10,080,786 in view of Biondi (2001), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003) and Hunt (2002). 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, muscle spasm or headache, comprising topically (transdermally) administering an effective amount of botulinum toxin to said subjects. Note that para 0035 of instant specification teaches “transdermal or topical”, indicating that topical and transdermal administration are the same.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘786 claims do not have this limitation. However, the ‘786 claims are directed to treating migraine pain using botulinum; and CR or whiplash are known to be associated with headache as taught by Biondi and Freund et al respectively (para 42, 19 of this office action).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘786 patent do not recite treating both conditions in the same subject. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR for reasons stated above and in view of the teachings of Schlesinger et al, Ferrari et al and Biondi (para 21, 42 of this office action), treating said subject by administration of botulinum toxin would be obvious.
iii) Even though the '786 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘786 claims do not have these limitations. However, these would indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘786 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
91. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,080,786.
92. Claims 1-9, 16-17, 20-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 152-156, 163-164, 169-171 of co-pending application number 18/595,365 in view of Biondi (2001), Freund et al (2002), Jankovic et al (1991), Schlesinger et al (2001), Ferrari et al (2003), and Hunt (2002).
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 syndrome (migraine headache, CD), comprising administering into muscles (intramuscular) a therapeutic or treatment dose (10-100 U) of botulinum toxin type A, resulting in reduction of a symptom.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘365 claims do not have this limitation. However, the ‘365 claims are directed to treating pain syndromes like migraine headache using botulinum; and CR or whiplash are known to be associated with headache as taught by Jankovic et al, Biondi and Freund et al (see rejection above).
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while ‘365 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '365 claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘365 claims do not have these limitations. However, this indicates an intended outcome, which will obviously occur after completing the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder, as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘365 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
93. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
94. Claims 1-9, 16-17, 20-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 54-57, 59-62, 65-66, and 69-71 of co-pending application number 19/088478 in view of Graziano et al (Curr Opin Orthopaed 3: 186-192, 1992), Jankovic et al (1991), Biondi (2001), Schlesinger et al (2001), Ferrari et al (2003) and Hunt (2002). 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 syndrome, comprising intramuscularly administering an effective amount of botulinum toxin type A injection to said subjects from 100-300 U (1.25 units to 3000 units), wherein the administration is at multifocal muscle sites.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘478 claims recite treating cervical dystonia. However, Graziano et al teach the association of CD with whiplash, wherein torticollis (cervical dystonia) can be caused by conditions like cervical injury (page 189, col 1, para 1), and post whiplash injury (pg 190, col 1, para 4). Jankovic et al teach that CD patients have secondary CR (para 40 of this office action). As both CR and whiplash are closely associated with CD, and all three conditions can be treated using botulinum toxin, instant claims would be rendered obvious over the ‘478 claims.
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while the ‘478 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the ‘478 claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘478 claims do not have these limitations. However, these would indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘478 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
95. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
96. Claims 1-3, 6-9, 11, 16-17, 21-22 and 25-27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 6-7, 10, 31 and 33 of co-pending application number 17/951,220 in view of Graziano et al (1992), Jankovic et al (1991), Biondi (2001), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003) and Hunt (2002).
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 muscle spasm or spasmodic torticollis (CD), comprising administering an effective amount of botulinum toxin type A injection to said subjects.
The only differences between the two sets of claims are:
i) Instant claims recite treating pain syndromes like CR or whiplash, while the ‘220 claims recite treating cervical dystonia. However, as stated above, the association of CD with whiplash or CR is taught by Graziano et al, and Jankovic et al respectively. As both CR and whiplash are closely associated with CD, and all three conditions can be treated using botulinum toxin, instant claims would be rendered obvious over the ‘220 claims.
ii) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while the ‘220 claims do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
iii) Even though the '220 claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘220 claims do not have these limitations. However, these would indicate intended outcomes, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘220 claims. However, as stated in the rejection, this would be obvious in view of Hunt.
97. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
98. Claims 1-7, 11, 16-17, 21-22 and 25-27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3-8 of US Patent 7,670,608 in view of Thomson et al (Brit J Dermatol 146: 627-630, 2002 – abstract only), Freund et al (2002), Schlesinger et al (2001), Ferrari et al (2003), Biondi (2001) and Hunt (2002). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to identifying a subject with a pain syndrome (headache, CR, WL, etc.) and administering botulinum toxin A to the head or neck region, thereby treating the pain syndrome.
The only differences between the 2 sets of claims are:
i) Instant claims recite treating sleep disorder and a pain syndrome in a subject, while claims of the ‘608 patent do not recite treating sleep disorder. However, as stated above, Biondi teaches that pain syndromes like headache have clinical features like sleep disorder. Since pain and sleep disorder coexist in a subject with both whiplash and CR (Schlesinger et al, Ferrari et al, Biondi), treating said subject by administration of botulinum toxin would obviously treat the sleep disorder.
ii) ‘608 patent claims recite that the subject has a history of atopic disease, while instant claims do not have this limitation. However, this would be obvious in view of Thomson et al., which teach the impact of patch testing in patients with eczema (atopic disease), showing that a borderline improvement in the pain score was observed in said patients (Abstract), indicating that pain and atopic disease can coexist in a subject.
iii) Even though the '608 patent claims do not recite identifying a subject with sleep disorder and pain syndrome (as in instant claims), both WL and CR are shown to be comorbid with sleep disorder, in view of the combined teachings of Ferrari et al, Freund et al and Schlesinger et al. It would, therefore, be obvious that treating whiplash or CR derived pain with botulinum would implicitly include treating the coexisting sleep disorder in said subject, and the subjects would accordingly be required to be identified before administering botulinum for treatment efficacy.
iv) Instant claims 6, 7 and 25 recite that after administration of botulinum toxin, neurotransmission is affected, choline acetyltransferase activity is decreased, and the composition is in tissues that enhance venous drainage or that enhance uptake by the hypophyseal portal system respectively, while ‘608 claims do not have these limitations. However, these will amount to an inherent intended outcome, which will obviously occur after the only active method step of administration of the toxin to a subject having a pain syndrome and a sleep disorder as instantly recited.
v) Instant claims recite that the composition comprises a polycationic protein and no human blood products, while this limitation is missing in the ‘608 patent claims. However, as stated in the rejection, this would be obvious in view of Hunt.
99. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 7,670,608.
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:
100. Applicant comments on each of the double patenting rejections, primarily asserting that the conflicting claims do not teach or suggest the “subject matter presently claimed in the instant case”, i.e. a method of simultaneously treating sleep disorder and pain syndrome in a subject. Applicant requests withdrawal of the rejections. Applicant also requests that the rejections over US patents 10,441,641, 8,926,991 and co-pending application number 17/234,690, be held in abeyance until the finding of allowable subject matter in the present case.
101. Referring to the Kuehl case law, Applicant submits that the present claims are allowable in view of US Patent 8,926,991, to which the instant case claims priority. Applicant points out that the ‘991 claims were to treating sleep disorders with botulinum toxin, and instant claims with additional limitations are like dependent claims of the ‘991 patent claims, which means that the present claims “do not materially increase the scope of protection” that is already present under the ‘991 patent. Associating Kuehl with the present claims, Applicant adds that this “increases the wealth of technical knowledge”. Applicant also uses the Pleuddemann case law asserting that the inventor is “entitled to his method of use claims…..together with the already allowed ….claims”. Applicant, therefore, submits that the present claims should be allowed as a matter of “constitutional principle and in accordance with the constitutional purpose of patent law”.
102. Applicant’s comments are fully considered. Since the amendment has made considerable changes to the scope of independent claim 1, a renewed consideration of the claims was made during the present examination. As such, all previous double patenting rejections were withdrawn, and new rejections have been presented as necessitated by the amendment. Upon consideration of abandonment of applications 17/234690, 18/359633, 18/455179, and 18/521777, the ODP rejections in view of said applications have been withdrawn.
103. Applicant’s reference to the Kuehl case law and associated arguments are fully considered, but not found to be persuasive. Applicant’s showing that instant claim 1 “can be considered a dependent claim of issued claim 1 of the ‘991 patent”, and that dependent claims “do not materially increase the scope of protection”, already present under the ‘991 patent is also considered. It appears that Applicant is conceding that the instant claims are not patentably distinct from the ‘991 patent claims, i.e. the two sets of claims are directed to obvious inventions. Applicant’s argument that because instant claims “can be considered” as dependent claims of the ‘991 patent, they do not materially increase the scope of protection present in the patent, is not found to be persuasive, as the instant claims can only be “considered” to be dependent claims of the ‘991 patent, however, are not actual dependent claims in the same patent. MPEP explains that “nonstatutory-type" double patenting rejection is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent. Since the doctrine of double patenting seeks to avoid unjustly extending patent rights at the expense of the public, the focus of any double patenting analysis necessarily is on the claims in the multiple patents or patent applications involved in the analysis [MPEP 804]. Instant claims are, therefore, obvious over the ‘991 patent claims, and the double patenting rejection is valid.
104. Applicant’s reference to Pleuddemann case is also considered. However, the claims in both referred cases are different in terms of the subject matter as compared to instant claims. The Pleuddemann claims are pertaining to the method of use of new compounds along with the already allowed article of manufacture claims. Applicant’s comparison of instant treatment claims with the compound/method of use/article of manufacture claims of the stated case law is, therefore, not persuasive to show non-obviousness of the instant claims. As noted in Brouwer, 77 F.3d at 425, 37 USPQ2d at 1666, the inquiry as to whether a claimed invention would have been obvious is "highly fact-specific by design." Accordingly, obviousness must be assessed on a case-by-case basis.
105. Applicant also requests that the rejections over US patents 10,441,641, 8,926,991 and co-pending application number 17/234,690, be held in abeyance until the finding of allowable subject matter in the present case.
106. The response requests that the requirement for submission of a Terminal Disclaimer be held in abeyance. The rejection has not been overcome by amendment or the filing of an approved terminal disclaimer. Thus, the rejection is maintained.
NOTE: Application number 17/234,690 is now abandoned.
Conclusion
107. No claims are allowed.
108. 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.
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/A. D./
Examiner, Art Unit 1675
20 August 2026
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
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