DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawal of Rejections
The response and amendments filed on 05/27/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous claim rejections under 35 U.S.C. 112(b) for indefiniteness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below necessitated by Applicant’s amendments. The previous claim rejections under 35 U.S.C. 103 for obviousness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112(b), Indefiniteness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 26-27 rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 26-27 recite comprising language which is open-ended and does not exclude additional, unrecited elements or method steps; however, independent claims 1 and 3-4 recite consisting of language which excludes any additional component. Therefore, the dependent claims cannot have open-ended, comprising language because they depend on independent claims reciting consisting language that excludes additional components.
Examiner’s Response to Arguments
Regarding Applicant’s arguments pertaining to the previous 35 U.S.C. 112(b) rejections (remarks, page 8), as stated above, all previous 35 U.S.C. 112(b) rejections have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth above.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112(a), Scope of Enablement
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 11-13, and 26-27 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for administration of Clostridial neurotoxin, does not reasonably provide enablement for administration of Clostridial neurotoxin by itself (i.e., without a carrier). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In re Wands (858 F2d, 731, 737, 8 USPQ 2d 1400, 1404 (Fed Cir. 1988) the issue of enablement in molecular biology was considered. It was held that the following factors should be considered to determine whether the claimed invention would require of the skilled artisan undue experimentation:
1) Quantity of experimentation necessary;
2) Amount of direction or guidance presented;
3) Presence or absence of working examples;
4) Nature of the invention;
5) State of the prior art;
6) Relative skill of those in the art;
7) Predictability or unpredictability of the art; and
8) Breadth of the claims.
Nature of the invention: The invention is directed towards a method of administering a Clostridial toxin.
Breadth of the claims: As claimed, the method consists of administering a Clostridial neurotoxin by itself (i.e., no carrier, or resuspension in a sterile solution) into at least five muscle regions selected from the frontalis, corrugator, masseter, nasalis, oculi, occipitalis, temporalis, and trapezius muscle regions. Due to the “consisting of” language, the Examiner has interpreted the Clostridial neurotoxin to be administered by itself (i.e., no carrier or resuspension of the neurotoxin prior to administration).
Amount of direction or guidance presented: The instant specification teaches “In an embodiment, botulinum type A is supplied in a sterile solution for injection with a 5- mL vial nominal concentration of 20 ng/mL in 0.03 M sodium phosphate, 0.12 M sodium chloride, and 1 mg/mL HSA, at pH 6.0” (see, e.g., instant specification, [066]). Additionally, the instant specification teaches “A controlled release system can be comprised of a neurotoxin incorporated into a carrier. The carrier can be a polymer or a bio-ceramic material” (see, e.g., instant specification, [0276]). The instant specification teaches “"Pharmaceutical composition" means a formulation in which an active ingredient can be a Clostridial toxin. The word "formulation" means that there is at least one additional ingredient (such as, for example and not limited to, an albumin [such as a human serum albumin or a recombinant human albumin] and/or sodium chloride) in the pharmaceutical composition in addition to a botulinum neurotoxin active ingredient. A pharmaceutical composition is therefore a formulation which is suitable for diagnostic, therapeutic or cosmetic administration to a subject, such as a human patient” (see, e.g., instant specification, [055]). Therefore, the instant specification teaches that the Clostridial neurotoxin is not administered by itself, but instead resuspended in a sterile solution prior to administration.
Presence or absence of working examples: Example 47 teaches “The botulinum type A concentration used for all injections other than the temporalis was 50 U/cc. For the temporalis, 100 U/cc was used. Eight 1-cc syringes were used with 1/2-inch, 32- gauge needles” (see, e.g., instant specification, Example 47, [0445]). One of ordinary skill in the art would readily understand that cc and milliliters are the same size; therefore, in this example, one would be injecting a liquid which would mean that the Clostridial toxin is resuspended in a solution for injection. Moreover, Example 48 teaches “The botulinum type A concentration used for all injections other than the temporalis was 50 U/cc. For the temporalis, 50 U/cc was used” (see, e.g., instant specification, Example 48, [0475]); therefore, one of ordinary skill in the art would readily understand that the Clostridial neurotoxin is resuspended in a liquid solution.
State of the prior art: Blumenfeld (US 2019/0060423 – previously cited) teaches “ In one embodiment, a method is disclosed that utilizes a dose and injection paradigm of 155 units of BOTOX® (typically provided as 100 Units of Clostridium botulinum type A neurotoxin complex, with 0.5 mg of human serum albumin, and 0.9 mg of sodium chloride in a sterile, vacuum-dried state for reconstitution” (see, e.g., Blumenfeld, [0054]). Additionally, Blumenfeld teaches “The lyophilized material can be reconstituted with a suitable liquid such as, for example, saline, water, or the like to create a solution or composition containing the botulinum toxin to be administered to the patient” (see, e.g., Blumenfeld, [0042]). Wheeler (Botulinum Toxin Injection Technique for Treatment of Headaches – previously cited) teaches “1 mL preservative-free normal saline solution per 100 U of botulinum toxin serotype A” (see, e.g., Wheeler, Introduction, pg. 65). McAllister (Improvement of headache symptoms and reduction in headache medication usage in patients treated with botulinum toxin type A – previously cited) teaches “Each vial (100 units [U] botulinum toxin type A) was diluted with 2 ml of 0.9% saline (5 U/0.1 ml)” (see, e.g., McAllister, “Treatment protocol”, pg. 21). Therefore, the prior art teaches that Clostridial neurotoxin is resuspended in a liquid solution, such as saline, prior to administration.
Relative skill of those in the art: Based on the prior art, the relative skill of those in the art for administering a Clostridial neurotoxin by itself (i.e., without a liquid carrier such as saline) is low.
Predictability or unpredictability of the art: The level of unpredictability in the art is high, as the prior art does not teach administration of Clostridial neurotoxin without a liquid carrier, such as saline, as evidenced by Blumenfeld, Wheeler, and McAllister. Moreover, since the prior art does not teach administration without a carrier, it is unpredictable if one would even be capable of administering Clostridial neurotoxin without a carrier, especially since the mode of administration is via injection of the neurotoxin into a patient.
Amount of experimentation necessary: Since the prior art does not teach injection of Clostridial neurotoxin without a carrier, one of ordinary skill in the art would have undue experimentation to determine how to administer Clostridial neurotoxin by itself (i.e., without a carrier).
New and/or Maintained Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim interpretation: Consistent with Applicant’s arguments, prior art has been applied to the instantly claimed invention as it pertains to methods of administering Clostridial toxin to the claimed muscle regions and not any method(s) of assessment prior to administration. Thus, the consisting language excludes any additional components in the composition and any additional steps of treating. If applicant contends that the method claims also exclude any assessment/diagnosis prior to administration, then a enablement rejection will be considered.
Claims 1-2, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenfeld (US 2019/0060423; Date of Publication: February 28, 2019 – cited in the IDS filed on 11/28/2023 – previously cited).
Blumenfeld’s general disclosure relates to “a method for prophylactically treating a headache in a patient suffering from chronic migraine headaches, the method comprises of local administration of a clostridial neurotoxin, such as a botulinum neurotoxin, to the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles of the patient that suffers from the migraine headache” (see, e.g., Blumenfeld, [0005]). Moreover, Blumenfeld discloses that “the dose of a botulinum toxin used according to embodiments of the present invention is less than the amount of botulinum toxin that would be used to paralyze a muscle, because an intent of a method according to embodiments of the present invention is not to paralyze a muscle but to reduce a pain sensory output from sensory neurons located in or on a muscle, or in or under the skin” (see, e.g., Blumenfeld, [0023]).
Regarding claims 1-2 pertaining to administering Clostridial neurotoxin, Blumenfeld teaches a method for prophylactically treating a headache in a patient suffering from chronic migraine headaches, the method comprises “localizing one or more administration target; isolating the one or more administration target; administering a therapeutically effective amount of a clostridial toxin to the isolated one or more administration target; wherein the one or more administration target comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles” (see, e.g., Blumenfeld, [0006]). Therefore, Blumenfeld teaches that one, all, or a combination of muscle regions can be targeted via administration, which can include the claimed at least five muscle regions (i.e., frontalis, corrugator, occipitalis, temporalis, and trapezius). Blumenfeld teaches specific methods of administering Clostridial toxin to muscle regions individually, such as the corrugator (see, e.g., Blumenfeld, [0071]-[0074]), frontalis (see, e.g., Blumenfeld, [0078]-[0085]), temporalis (see, e.g., Blumenfeld, [0086]-[0089]), occipitalis (see, e.g., Blumenfeld, [0090]-[0092]), and trapezius (see, e.g., Blumenfeld, [0097]-[0099]). Additionally, Blumenfeld teaches that inadvertent and undesirable administration of the botulinum toxin to an area adjacent to the administration site and/or too deep injections can cause adverse effects (see, e.g., Blumenfeld, [0065]). Moreover, Blumenfeld teaches “To minimize or prevent unwarranted side effects, in some embodiments, the present method comprises locating the corrugator, isolating the corrugator to eliminate or minimize inadvertent injection to the frontalis and administering a botulinum toxin to the corrugators” (see, e.g., Blumenfeld, [0073]). Blumenfeld teaches “To minimize or prevent unwarranted side effects, including brow weakness, brow elevation, brow ptosis, in some embodiments, the present method comprises locating the frontalis muscle, isolating administration target area within the frontalis and administering a botulinum toxin to the frontalis” (see, e.g., Blumenfeld, [0080]). Additionally, Blumenfeld teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, Blumenfeld teaches that targeting specific muscle regions for injection, while avoiding others, is necessary to reduce unwanted side effects.
Regarding claims 5 and 7 pertaining to the migraine headache, Blumenfeld teaches chronic migraine (see, e.g., Blumenfeld, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer Clostridial neurotoxin to specific muscle regions, while avoiding others, in order to reduce migraine symptoms, as taught by Blumenfeld. One would have been motivated to do so because Blumenfeld teaches that inadvertent and undesirable administration of the botulinum toxin to an area adjacent to the administration site and/or too deep injections can cause adverse effects (see, e.g., Blumenfeld, [0065]). Blumenfeld teaches “To minimize or prevent unwarranted side effects, in some embodiments, the present method comprises locating the corrugator, isolating the corrugator to eliminate or minimize inadvertent injection to the frontalis and administering a botulinum toxin to the corrugators” (see, e.g., Blumenfeld, [0073]). Blumenfeld teaches “To minimize or prevent unwarranted side effects, including brow weakness, brow elevation, brow ptosis, in some embodiments, the present method comprises locating the frontalis muscle, isolating administration target area within the frontalis and administering a botulinum toxin to the frontalis” (see, e.g., Blumenfeld, [0080]). Additionally, Blumenfeld teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, based on the teachings of Blumenfeld, it would have been obvious to target specific muscle groups, such as the frontalis, corrugator, temporalis, occipitalis, and trapezius, while avoiding others, in order to increase the efficacy of botulinum toxin treatment and avoid unwanted side effects. Increasing botulinum toxin efficacy and avoiding unwanted side effects is motivation to only target the muscle groups that are necessary for the treatment of migraines.
Claims 3 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenfeld (cited above) in view of Wheeler (Botulinum Toxin Injection Technique for Treatment of Headaches; 2002 – cited in the IDS filed on 11/28/2023 – previously cited).
Blumenfeld’s general disclosure is discussed above.
Regarding claim 3 pertaining to the dosages of Clostridial neurotoxin, Blumenfeld teaches “the botulinum neurotoxin is administered to the frontalis at about twenty units divided among four sites of injection, to the corrugator at about ten units divided among two sites of injection; to the procerus at about five units to one site of injection; to the occipitalis at about thirty units divided among six sites of injection to about forty units divided among eight sites of injection; to the temporalis at about forty units divided among eight sites of injection up to fifty units divided among ten sites of injection; to the trapezius at about thirty units divided among six sites of injection up to about fifty units divided among ten sites of injection and to the cervical paraspinal muscles at about twenty units divided among four sites of injection, and where the botulinum neurotoxin is injected at 31 to 39 injection sites” (see, e.g., Blumenfeld, [0005]). Additionally, Blumenfeld teaches “To minimize or prevent unwarranted side effects, in some embodiments, the present method comprises locating the corrugator, isolating the corrugator to eliminate or minimize inadvertent injection to the frontalis and administering a botulinum toxin to the corrugators” (see, e.g., Blumenfeld, [0073]). Blumenfeld teaches “To minimize or prevent unwarranted side effects, including brow weakness, brow elevation, brow ptosis, in some embodiments, the present method comprises locating the frontalis muscle, isolating administration target area within the frontalis and administering a botulinum toxin to the frontalis” (see, e.g., Blumenfeld, [0080]). Additionally, Blumenfeld teaches that inadvertent and undesirable administration of the botulinum toxin to an area adjacent to the administration site and/or too deep injections can cause adverse effects (see, e.g., Blumenfeld, [0065]). Therefore, Blumenfeld teaches that targeting regions for injection, such as the corrugator and frontalis muscle, is necessary to avoid side effects.
Regarding claims 11-13 pertaining to the total Clostridial dose, Blumenfeld teaches “The botulinum toxin can be selected from the group consisting of botulinum toxin types A, B, C, D, E, F and G. Botulinum toxin type A is a preferred botulinum toxin. The botulinum toxin can be administered in an amount of between about 1 unit and about 3,000 units, or between about 2 units and about 2000 units, or between about 5 units and about 1000 units, or between about 10 units and about 500 units, or between about 15 units and about 250 units, or between about 20 units and about 150 units, or between 25 units and about 100 units, or between about 30 units and about 75 units, or between about 35 units and about 50 units, or the like” (see, e.g., Blumenfeld, [0053]). Moreover, Blumenfeld teaches “the total amount of BOTOX®, DYSPORT® or MYOBLOC®, suitable for administration to a patient according to the methods of the invention disclosed herein should not exceed about 300 units, about 1,500 units or about 15,000 units respectively, per treatment session” (see, e.g., Blumenfeld, [0050]).
However, Blumenfeld does not teach: administering Clostridial toxin to the oculi muscle wherein the Clostridial toxin is administered to the oculi muscle at a dosage of 3-10 units to each side of the head (claim 3).
Wheeler’s general disclosure relates to administration of botulinum toxin serotype A for “pain treatment and headache prophylaxis by acting at the neuro-muscular junction through several antinociceptive mechanisms” (see, e.g., Wheeler, abstract). Moreover, Wheeler discloses that therapeutic botulinum toxin dosages and injection techniques “vary with the patient and clinical disorders that may affect the same muscle groups” (see, e.g., Wheeler, Introduction, pg. 65). Furthermore, Wheeler discloses that botulinum toxin A clinical effect “is usually apparent at 7 to 10 days and plateaus at 3 weeks. The neuromuscular blocking action of BTX-A lasts 3 to 4 months; however, the reduction of pain can last substantially longer, and an effect for specific for migraine may continue to develop beyond 2 to 3 months after the injection session” (see, e.g., Wheeler, pg. 68).
Regarding claim 3 pertaining to administration of Clostridial toxin to the oculi muscle, Wheeler teaches administration of botulinum toxin serotype A to the oculi muscle at a dose of 3-5 units per site (see, e.g., Wheeler, Table. Technical guidelines for botulinum toxin serotype A: Intramuscular injections for headache treatment, pg. 67). Additionally, Wheeler teaches that the oculi muscle region represents a craniofacial and cervical musculotendinous site that acts as a migraine trigger or gain generator during headache (see, e.g., Wheeler, pg. 65 & Figure, pg. 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer botulinum toxin to treat headaches, as taught by Blumenfeld, wherein the toxin is administered to the oculi muscle, as taught by Wheeler. One would have been motivated to do so because Wheeler teaches that the oculi muscle region represents a craniofacial and cervical musculotendinous site that acts as a migraine trigger or gain generator during headache (see, e.g., Wheeler, pg. 65 & Figure, pg. 66). Moreover, Blumenfeld teaches “a method for reducing the occurrence or alleviating a headache in a patient suffering from chronic migraine headaches in a patient with chronic migraine headaches, the method comprises: localizing one or more administration target; isolating the one or more administration target; administering a therapeutically effective amount of a clostridial toxin to the isolated one or more administration target; wherein the one or more administration target comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscle” (see, e.g., Blumenfeld, [0006]). Blumenfeld teaches that inadvertent and undesirable administration of the botulinum toxin to an area adjacent to the administration site and/or too deep injections can cause adverse effects (see, e.g., Blumenfeld, [0065]). Additionally, Blumenfeld teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, based on the teachings of Blumenfeld and Wheeler, it would have been obvious to administer botulinum toxin to the oculi muscle to treat migraine since the oculi muscle is a region that triggers migraine, as taught by Wheeler, and targeting specific areas with botulinum toxin, while avoiding other muscle areas, increases the efficacy of the treatment and decreases off target effects, as taught by Blumenfeld. One would have expected success because Blumenfeld and Wheeler both teach administration of botulinum toxin to various muscle areas in the head and back in order to treat migraine headaches.
Claim 4 is are rejected under 35 U.S.C. 103 as being unpatentable over Blumenfeld (cited above) in view of Wheeler (cited above) and McAllister (Improvement of headache symptom and reduction in headache medication usage in patients treated with botulinum toxin type A; 2008 – cited in the IDS filed on 11/28/2023 – previously cited).
The teachings of Blumenfeld are discussed above.
Regarding claim 4 pertaining to administration of Clostridial toxin, Blumenfeld teaches “the botulinum neurotoxin is administered to the frontalis at about twenty units divided among four sites of injection, to the corrugator at about ten units divided among two sites of injection; to the procerus at about five units to one site of injection; to the occipitalis at about thirty units divided among six sites of injection to about forty units divided among eight sites of injection; to the temporalis at about forty units divided among eight sites of injection up to fifty units divided among ten sites of injection; to the trapezius at about thirty units divided among six sites of injection up to about fifty units divided among ten sites of injection and to the cervical paraspinal muscles at about twenty units divided among four sites of injection, and where the botulinum neurotoxin is injected at 31 to 39 injection sites” (see, e.g., Blumenfeld, [0005]).
However, Blumenfeld does not teach: administering a Clostridial toxin to the oculi at a dosage of about 3-10 units to one site on each side of the head (claim 4); or administering a Clostridial toxin to the nasalis at a dosage of about 1-5 units to one site on each side of the head (claim 4); or administering a Clostridial toxin to the masseter at a dosage of about 3-10 units to one site on each side of the head (claim 4).
The teachings of Wheeler are discussed above.
Regarding claim 4 pertaining to administration of Clostridial toxin to the oculi muscle, Wheeler teaches administration of botulinum toxin serotype A to the oculi muscle at a dose of 3-5 unites per site (see, e.g., Wheeler, Table. Technical guidelines for botulinum toxin serotype A: Intramuscular injections for headache treatment, pg. 67). Additionally, Wheeler teaches that the oculi muscle region represents a craniofacial and cervical musculotendinous site that acts as a migraine trigger or gain generator during headache (see, e.g., Wheeler, pg. 65 & Figure, pg. 66).
McAllister’s general disclosure relates to a retrospective review of charts for 132 consecutive patients receiving botulinum toxin type A (BoNT-A) for headache prevention (see, e.g., McAllister, Summary, pg. 19). Moreover McAllister discloses that the mean BoNT-A dose was 101.9 units for 99% of patients reported some improvement in their headache symptoms (see, e.g., McAllister, Summary, pg. 19). Additionally, McAllister discloses administering BoNT-A using a “fixed-site” and/or “follow-the-pain” approach in order to treat headaches and/or pain within patients.
Regarding claim 4 pertaining to administration of the Clostridial toxin to the nasalis and masseter muscles, McAllister teaches administering BoNT-A to the nasalis muscle at a dose of 2.5 to 5 units, and administration of BoNT-A to the masseter muscle at a dose of 5.0 to 30.0 units (see, e.g., McAllister, Table 1, pg. 22). Additionally, McAllister teaches that for patients with migraine or headaches, a “fixed-site” treatment method was used (see, e.g., McAllister, “Treatment protocol, pg. 21).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer botulinum toxin to treat headaches, as taught by Blumenfeld, wherein the toxin is administered to the oculi muscle, as taught by Wheeler. One would have been motivated to do so because Wheeler teaches that the oculi muscle region represents a craniofacial and cervical musculotendinous site that acts as a migraine trigger or gain generator during headache (see, e.g., Wheeler, pg. 65 & Figure, pg. 66). Moreover, Blumenfeld teaches “a method for reducing the occurrence or alleviating a headache in a patient suffering from chronic migraine headaches in a patient with chronic migraine headaches, the method comprises: localizing one or more administration target; isolating the one or more administration target; administering a therapeutically effective amount of a clostridial toxin to the isolated one or more administration target; wherein the one or more administration target comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscle” (see, e.g., Blumenfeld, [0006]). Blumenfeld teaches that inadvertent and undesirable administration of the botulinum toxin to an area adjacent to the administration site and/or too deep injections can cause adverse effects (see, e.g., Blumenfeld, [0065]). Additionally, Blumenfeld teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, based on the teachings of Blumenfeld and Wheeler, it would have been obvious to administer botulinum toxin to the oculi muscle to treat migraine since the oculi muscle is a region that triggers migraine, as taught by Wheeler, and targeting specific areas with botulinum toxin, while avoiding other muscle areas, increases the efficacy of the treatment and decreases off target effects, as taught by Blumenfeld. One would have expected success because Blumenfeld and Wheeler both teach administration of botulinum toxin to various muscle areas in the head and back in order to treat migraine headaches.
It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer botulinum toxin to treat headaches and migraines, as taught by Blumenfeld, wherein the toxin is administered to the nasalis and masseter muscle regions, as taught by McAllister. One would have been motivated to do so because McAllister teaches that when administering botulinum toxin to treat headache that the toxin was administered using a “fixed-site” and/or “follow-the-pain” approach used by Blumenfeld, wherein the fixed-site method was used for patients with migraine or headaches with migrainous features and the follow-the-pain approach was used to treat tension-type headaches (see, e.g., McAllister, “Treatment Protocol”, pg. 21). Additionally, McAllister teaches that with both of these approaches, the nasalis and masseter muscle regions were injected with botulinum toxin to treat headaches and migraines (see, e.g., McAllister, “Treatment Protocol”, pg. 21 & Table 1). Moreover, Blumenfeld teaches “a method for reducing the occurrence or alleviating a headache in a patient suffering from chronic migraine headaches in a patient with chronic migraine headaches, the method comprises: localizing one or more administration target; isolating the one or more administration target; administering a therapeutically effective amount of a clostridial toxin to the isolated one or more administration target; wherein the one or more administration target comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscle” (see, e.g., Blumenfeld, [0006]). Additionally, Blumenfeld teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, based on the teachings of Blumenfeld and McAllister, it would have been obvious to administer botulinum toxin to the nasalis and masseter muscle regions to treat migraines since the nasalis and masseter regions are regions that patients have injected for treatment of migraine, as taught by McAllister, and botulinum toxin can be used to treat migraine, as taught by Blumenfeld. Additionally, based on these teachings, it would be obvious to use the fixed-site injection approach, as taught by Blumenfeld and McAllister in order to target specific muscle groups with botulinum toxin, while avoiding other groups, in order to increase efficacy of the botulinum toxin and reduce unwanted side effects. One would have expected success because Blumenfeld and McAllister both teach administration of botulinum toxin to various muscle areas in the head in order to treat migraines.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenfeld as applied to claims 1-2, 5, and 7 above, and further in view of Manack (US 2009/0232850; Date of Publication: September 17, 2009 – previously cited).
Blumenfeld’s general disclosure is discussed above.
However, modified-Blumenfeld-Wheeler does not teach: wherein said migraine headache is an episodic migraine (claim 6).
Manack’s general disclosure relates to “Methods for treating a coronary risk factor (such as hypertension, diabetes, hyperlipidemia and obesity) and/or a respiratory disorder (such as asthma, chronic obstructive pulmonary disease and bronchitis) and/or arthritis by local administration of a botulinum neurotoxin to at least one of a head, neck or shoulder location (for example, by subdermal, subcutaneous or intramuscular administration of the botulinum neurotoxin) of a patient with a coronary risk factor, respiratory disorder or arthritis” (see, e.g., Manack, abstract). Moreover, Manack discloses that the botulinum toxin can be administered to treat headaches and migraines (see, e.g., Manack, [0067]).
Regarding claim 6 pertaining to the migraine being an episodic migraine, Manack teaches administration of botulinum toxin via intramuscular or subdermal administration in order to treat episodic migraine (see, e.g., Manack, [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer botulinum toxin to treat headaches and migraines, as taught by Blumenfeld, wherein the toxin is administered to treat episodic migraines, as taught by Manack. One would have been motivated to do so because Manack teaches that administration of a botulinum toxin, via intramuscular or subdermal administration, to the head and/or neck and/or shoulder muscle of a patient in order to treat episodic migraines, which are migraines at a patient suffers between zero to eight times a month (see, e.g., Manack, [0067]). Moreover, Blumenfeld teaches administration of botulinum toxin in a combined fixed site/fixed dose for patients suffering from headache and chronic migraine (see, e.g., Blumenfeld, abstract). Additionally, Blumenfeld teaches a method for reducing the occurrence or alleviating a headache in a patient suffering from chronic migraine headaches in a patient with chronic migraine headaches, the method comprises: localizing one or more administration target; isolating the one or more administration target; administering a therapeutically effective amount of a clostridial toxin to the isolated one or more administration target; wherein the one or more administration target comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscle” (see, e.g., Blumenfeld, [0006]). Therefore, based on the teachings of Blumenfeld and Manack, it would have been obvious to administer botulinum toxin to treat episodic migraines. One would have expected success because Blumenfeld and Manack both teach administration of botulinum toxin to treat migraines.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenfeld, Wheeler, and McAllister as applied to claim 4 above, and further in view of Schavelzon (Botulinum Toxin in the Nasal Area; 2016 – previously cited) and Menon (WO 2018/200991; Date of Publication: November 1, 2018 – previously cited).
The teachings of Blumenfeld, Wheeler, and McAllister, herein referred to as modified-Blumenfeld-Wheeler-McAllister, are discussed above as it pertains to administration of botulinum toxin for treatment of migraine.
However, modified-Blumenfeld-Wheeler-McAllister does not teach: wherein said injection of the nasalis comprises: instructing the patient to "scrunch" their nose and eyes to identify the nasalis muscle; injecting the muscle parallel to the bone away from the eye at a 90-degree angle to the skin at a minimal depth (claim 26).
Schavelzon’s general disclosure relates to methods of administering botulinum toxin type A in the nasal area for softening dynamic wrinkles and correcting nasal tip ptosis, nasal flutter, hyperhidrosis of nasal dorsum, and multiple eccrine hidrocystomas (see, e.g., Schavelzon, abstract). Moreover, Schavelzon discloses injection of botulinum toxin type A into the nasalis muscle in order to treat nasoglabellar wrinkles and bunny lines, which appear due to constant contraction of the nose, thereby provoking wrinkles (see, e.g., Schavelzon, section 6.1, pg. 104).
Regarding claim 26 pertaining to injection of the nasalis, Schavelzon teaches “The nasoalar lines are produced by the contraction of the alar fibers of the levator labii superioris and must be treated just over the nasal ala. The nasoorbicular and the nasociliar are produced by the contraction of the orbicularis oculi. We inject 2–4 UI of Botulinum toxin in the transverse nasalis belly where it goes over the nasal bone” (see, e.g., Schavelzon, Section 6.1, pg. 105). One of ordinary skill in the art would readily understand that “contraction”, as taught by Schavelzon, is synonymous to “scrunch”, as claimed. Moreover, Schavelzon teaches, as shown in Figures 6 and 7, injection of the muscle parallel to the bone away from the eye at a minimal depth.
Menon’s general disclosure relates to manufacturing botulinum neurotoxin serotype E (BoNT/E) with improved yield and purity (see, e.g., Menon, abstract). Moreover, Menon discloses that BoNT/E can be used within a therapeutic for treatment of migraines (see, e.g., Menon, [0101]), wherein the BoNT/E toxin can be administered to “the following skeletal muscles, for example, the occipitofrontalis, nasalis, orbicularis oris, depressor anguli oris, platysma, sternohyoid, serratus anterior, rectus abdominis, external oblique, tensor fasciae latae, brachioradialis, lliacus, psoas major, pectineus, adductor longus, sartorius, gracillis, vastus lateralis, rectus femoris, vastus medialis, tendon of quadriceps femoris, patella, gastroctnemius, soleus, tibia, fibularis longus, tibialis anterior, patellar ligament, iliotibial tract, hypothenar muscles, thenar muscles, flexor carpi ulnaris, flexor digitorum superficialis, palmaris longus, flexor carpi radials, brachioradialis, pronator teres, brachialis, biceps brachii, triceps brachii, pectoralis major, deltoid, trapezius, sternocleidomastoid, masseter, orbicularis oculi, temporalis, epicranial aponeurosis, teres major, extensor digitorum, extensor carpi ulnaris, anconeus, abductor policis longus, plantaris, calcanel tendon, soleus, adductor magnus, gluteus maximas, gluteus medius, latissimus dorsi, infraspinatus, and combinations thereof” (see, e.g., Menon, [0104]).
Regarding claim 26 pertaining to injection of the nasalis, Menon teaches that BoNT/E can be injected into the nasalis muscle for treatment of migraine in patients (see, e.g., Menon, [0101], [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer botulinum toxin to treat headaches and migraines, as taught by as modified-Blumenfeld-Wheeler-McAllister, wherein the botulinum toxin is administered to the nasalis muscle region, as taught by Schavelzon and Menon. One would have been motivated to do so because Menon teaches that the nasalis muscle is a skeletal muscle that can be injected with botulinum toxin in order to treat migraine (see, e.g., Menon, [0101], [0104]). Moreover, modified-Blumenfeld-Wheeler-McAllister teaches administration of botulinum toxin in a combined fixed site/fixed dose for patients suffering from headache and chronic migraine (see, e.g., Blumenfeld, abstract). Additionally, modified-Blumenfeld-Wheeler-McAllister teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, based on the teachings of modified-Blumenfeld-Wheeler-McAllister, Schavelzon, and Menon it would have been obvious to administer botulinum toxin to the nasalis muscle region in order to treat migraine. One would have expected success because modified-Blumenfeld-Wheeler-McAllister. Schavelzon, and Menon all teach administration of botulinum toxin to head/facial areas for therapeutic purposes.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenfeld, Wheeler, and McAllister as applied to claim 4 above, and further in view of Lee (US 2020/0085923; Date of Publication: March 19, 2020 – previously cited) and Menon (WO 2018/200991; Date of Publication: November 1, 2018 – previously cited).
The teachings of Blumenfeld, Wheeler, and McAllister, herein referred to as modified-Blumenfeld-Wheeler-McAllister, are discussed above as it pertains to administration of botulinum toxin for treatment of migraine.
However, modified-Blumenfeld-Wheeler-McAllister does not teach: wherein said injection of the masseter comprises: visualizing a line between the tragus and the corner of the mouth to avoid the zygomaticus; determining the midpoint of that line; visually drawing a line down to the angle of the jaw; instructing the patient to clench their teeth; palpitating the masseter muscle; administering the injection perpendicular to the skin into the muscle, avoiding the parotid gland at a 90 degree angle as the patient maintains the tightened muscle; and injecting the toxin as the patient relaxes the muscle, one to two finger breadths above the jawline to avoid the submandibular gland (claim 27).
Lee’s general disclosure relates to treating or alleviating masseter muscle hypertrophy by administration of botulinum toxin into the masseter muscle (see, e.g., Lee, abstract). Moreover, Lee discloses identifying the masseter muscle region and injecting botulinum toxin “at a plurality of sites in the regio to administer the botulinum toxin to reduce lower face width within the masseter region” (see, e.g., Lee, [0008]).
Regarding claim 27 pertaining to injection of the masseter, Lee teaches “administering to a region of the masseter muscle a dose of botulinum toxin that reduces prominence of the masseter muscle, where the dose is administered to a plurality of sites in the region of the masseter muscle. The region is identified as a region of maximal bulge in the masseter muscle when the jaw is in a clenched position and the dose is administered with the jaw in a relaxed position” (see, e.g., Lee, [0016]). Moreover, Lee teaches “the administering step is by injection with a needle positioned during the injection to be perpendicular to the masseter muscle” (see, e.g., Lee, [0018]). Lee teaches “The method comprises identifying a line that extends from the lateral commissure of the mouth to the point where the ear lobe attaches to the face; identifying a region of maximal bulge of the masseter muscle with the jaw in a clenched position; determining a treatment area that includes the region of maximal bulge, is positioned at or below the line, is posterior to the risorius muscle and is anterior to the parotid gland; and injecting botulinum toxin at a plurality of injection sites in the treatment area to administer a dose of botulinum toxin that reduces lower face convexity or width” (see, e.g., Lee, [0025]). Lee teaches “the line that extends from the lateral commissure of the mouth to the point where the ear lobe attaches to the face is identified visually as an imaginary line. In other embodiments, the line is visually identified and physically marked on the skin of the patient” (see, e.g., Lee, [0027]). Additionally, Lee teaches “Typically, the subject will maximally clench his/her jaw (mouth closed and teeth together) which allows the masseter muscle to be more visible. In addition to or rather than visual inspection for the maximal bulge of the masseter muscle, the maximal bulge can be identified or confirmed by manually palpating the masseter muscle to feel for the maximal bulge” (see, e.g., Lee, [0083]). Moreover, Lee teaches “ For example, in one embodiment, the most bulky point of the masseter muscle or the maximal bulge of the masseter muscle is identified and is assigned as the first administration site; and subsequent or further administration sites are placed relative to the first administration site. The plurality of administration sites can form a triangle or an inverted triangle in the treatment area. The plurality of administration sites can form a line, where in one embodiment, the administration sites are along a line that extends directionally with the jaw line. In another embodiment, the administration sites are along a line that extends directionally from the shoulder to the eyelid. The administration sites, in one embodiment, are evenly spaced to fill the treatment area” (see, e.g., Lee, [0087]).
The teachings of Menon are discussed above.
Regarding claim 27 pertaining to injection of the masseter, Menon teaches that BoNT/E can be injected into the masseter muscle for treatment of migraine in patients (see, e.g., Menon, [0101], [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer botulinum toxin to treat headaches and migraines, as taught by as modified-Blumenfeld-Wheeler-McAllister, wherein the botulinum toxin is administered to the masseter muscle region, as taught by Lee. One would have been motivated to do so because Menon teaches that botulinum toxin can be injected into the masseter muscle region, which is a skeletal muscle region, in order to treat migraine (see, e.g., Menon, [0101], [0104]). Moreover, modified-Blumenfeld-Wheeler-McAllister teaches administration of botulinum toxin in a combined fixed site/fixed dose for patients suffering from headache and chronic migraine (see, e.g., Blumenfeld, abstract). Additionally, modified-Blumenfeld-Wheeler-McAllister teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, based on the teachings of modified-Blumenfeld-Wheeler-McAllister, Lee, and Menon it would have been obvious to administer botulinum toxin to the nasalis muscle region in order to treat migraine. One would have expected success because modified-Blumenfeld-Wheeler-McAllister. Lee, and Menon all teach administration of botulinum toxin to head/facial areas for therapeutic purposes.
Examiner’s Response to Arguments
Regarding Applicant’s argument that Blumenfeld does not teach amended claim 1 because Blumenfeld teaches injection of the procerus, which should not be included in the rejection due to the amended “consisting of” language (remarks, pages 8-10), this argument is not persuasive for multiple reasons. First, Blumenfeld teaches a method for prophylactically treating a headache in a patient suffering from chronic migraine headaches, the method comprises “localizing one or more administration target; isolating the one or more administration target; administering a therapeutically effective amount of a clostridial toxin to the isolated one or more administration target; wherein the one or more administration target comprises the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles” (see, e.g., Blumenfeld, [0006]). Therefore, Blumenfeld teaches that the administration sites can be one or more selected from the frontalis, corrugator, procerus, occipitalis, temporalis, trapezius and cervical paraspinal muscles, which can include a combination of at least five claimed muscle sites (i.e., frontalis, corrugator, occipitalis, temporalis, and trapezius). Secondly, Blumenfeld teaches motivation for selecting specific muscle regions to target and only targeting muscle regions that are necessary (i.e., regions that require treatment). Blumenfeld teaches “To minimize or prevent unwarranted side effects, in some embodiments, the present method comprises locating the corrugator, isolating the corrugator to eliminate or minimize inadvertent injection to the frontalis and administering a botulinum toxin to the corrugators” (see, e.g., Blumenfeld, [0073]). Blumenfeld teaches “To minimize or prevent unwarranted side effects, including brow weakness, brow elevation, brow ptosis, in some embodiments, the present method comprises locating the frontalis muscle, isolating administration target area within the frontalis and administering a botulinum toxin to the frontalis” (see, e.g., Blumenfeld, [0080]). Additionally, Blumenfeld teaches “To increase efficacy of botulinum toxin treatment for headache/migraine and/or to minimize or eliminate the above-identified adverse effects, the present method comprises locating the administration target, isolating the administration target so that the botulinum toxin is administered only to the isolated target area without inadvertently impacting an adjacent area” (see, e.g., Blumenfeld, [0069]). Therefore, targeting specific regions, such as the frontalis, corrugator, occipitalis, temporalis, and trapezius muscles, while avoiding other regions, such as the procerus muscle, can be effective at reducing off target side effects and increasing efficacy of the botulinum treatment. Based on these teachings, the prior art is obvious in view of Blumenfeld because Blumenfeld provides motivation for targeting specific muscle regions, such as the frontalis, corrugator, occipitalis, temporalis, and trapezius muscle regions, while avoiding other muscle regions, such as the procerus muscle region, for the treatment of migraine. It is within a skilled artisan to administer treatment to required sites especially in light of to side effects of the toxin.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4-11, 14-16, and 29-30 of U.S. Patent No. 11,826,405 (herein referred to as “US’405”).
Although the claims at issue are not identical, they are not patentably distinct from each other because US’405 teaches: a) administering about 10 units of a botulinum neurotoxin into the upper frontalis at the hairline, and further administering the neurotoxin to at least five of the muscle regions selected from the corrugator, masseter, nasalis, oculi, occipitalis, temporalis, and trapezius muscle regions, and wherein the cervical paraspinal muscle and procerus muscles are not administered to; b) thereby treating the migraine headache (see, e.g., US’405, claim 1); wherein said botulinum neurotoxin is further administered to between five six and seven eight of the muscle regions selected from the corrugator, masseter, nasalis, occipitalis, temporalis, trapezius and oculi muscle regions (see, e.g., US’405, claim 3); wherein said botulinum neurotoxin is further administered to the corrugator, occipitalis, temporalis, and trapezius muscle regions (see, e.g., US’405, claim 4); wherein said botulinum neurotoxin is further administered to the corrugator, occipitalis, temporalis, oculi and trapezius muscle regions (see, e.g., US’405, claim 5); wherein said botulinum neurotoxin is further administered to the corrugator, occipitalis, temporalis, oculi, masseter and trapezius muscle regions (see, e.g., US’405, claim 6); wherein said botulinum neurotoxin is further administered to the corrugator, occipitalis, temporalis, oculi, nasalis, and trapezius muscle regions (see, e.g., US’405, claim 7); wherein said botulinum neurotoxin is further administered to the corrugator, occipitalis, temporalis, oculi, nasalis, masseter and trapezius muscle regions (see, e.g., US’405, claim 8); wherein said migraine headache is an episodic migraine or a chronic migraine (see, e.g., US’405, claim 9); wherein said migraine headache is an episodic migraine (see, e.g., US’405, claim 10); wherein said migraine headache is a chronic migraine (see, e.g., US’405, claim 11); wherein the total dose of said botulinum neurotoxin is about 145-200 Units (see, e.g., US’405, claim 14); wherein the total dose of said botulinum neurotoxin is about 195 Units (see, e.g., US’405, claim 15); wherein the total dose of said botulinum neurotoxin is about 150 Units (see, e.g., US’405 claim 16); administering a botulinum toxin to the superior trapezius at a dosage of about 5 units per site at one site on each side of the head and about 10 units per site to the inferior trapezius at one site on each side of the head; and administering a botulinum toxin to the occipitalis at a dosage of about 10 units per site at three sites on each side of the head; and administering a botulinum toxin to the temporalis at a dosage of about 5 units per site at three sites on each side of the head; and administering a botulinum toxin to the oculi at a dosage of about 5 units to one site on each side of the head; and administering a botulinum toxin to the corrugator at a dosage of about 5 units to one site on each side of the head; and administering a botulinum toxin to the upper frontalis at the hairline at a dosage of about 5 units to one site on each side of the head; wherein the botulinum toxin is not administered to the cervical paraspinal or procerus muscles; thereby treating the migraine with a total of about 150 Units (see, e.g., US’405, claim 28); administering a botulinum toxin to the superior trapezius at a dosage of about 5 units per site at one site on each side of the head and about 10 units per site to the inferior trapezius at one site on each side of the head; and administering a botulinum toxin to the occipitalis at a dosage of about 10 units per site at three sites on each side of the head; and administering a botulinum toxin to the temporalis at a dosage of about 10 units per site at three sites on each side of the head; and administering a botulinum toxin to the oculi at a dosage of about 5 units to one site on each side of the head; and administering a botulinum toxin to the corrugator at a dosage of about 5 units to one site on each side of the head; and administering a botulinum toxin to the upper frontalis at the hairline at a dosage of about 5 units to one site on each side of the head; and administering a botulinum toxin to the nasalis at a dosage of about 2.5 units to one site on each side of the head; and administering a botulinum toxin to the masseter at a dosage of about 5 units to one site on each side of the head; wherein the botulinum toxin is not administered to the cervical paraspinal or procerus muscles; thereby treating the migraine with a total of about 195 Units (see, e.g., US’405, claim 29); and administering a botulinum toxin to the superior trapezius at a dosage of about 3-10 units per site at one site on each side of the head and 5-15 units per site to the inferior trapezius at one site on each side of the head; and administering a botulinum toxin to the occipitalis at a dosage of about 7-15 units per site at three sites on each side of the head; and administering a botulinum toxin to the temporalis at a dosage of about 3-15 units per site at three sites on each side of the head; and administering a botulinum toxin to the oculi at a dosage of about 3-10 units to one site on each side of the head; and administering a botulinum toxin to the corrugator at a dosage of about 3-10 units to one site on each side of the head; and administering a botulinum toxin to the upper frontalis at the hairline at a dosage of about 3-10 units to one site on each side of the head; and administering a botulinum toxin to at least one of the nasalis and masseter, wherein said nasalis administration is at a dosage of about 1-5 units to one site on each side of the head; and said masseter administration is at a dosage of about 3-10 units to one site on each side of the head; wherein the botulinum toxin is not administered to the cervical paraspinal or procerus muscles; thereby treating the migraine headache (see, e.g., US’405, claim 30).
Claims 1-2 and 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 13, and 15-17 of copending Application No. 19/008,137 (reference application – herein referred to as “App’137”).
Although the claims at issue are not identical, they are not patentably distinct from each other because App’137 teaches: A method for reducing the severity of a symptom associated with a migraine headache comprising: a) administering a Clostridial neurotoxin into at least five of the muscle regions selected from the frontalis, corrugator, procerus, masseter, nasalis, oculi, occipitalis, temporalis, and trapezius muscle regions; and b) thereby reducing the severity of the symptom associated with migraine headache (see, e.g., App’137, claim 1); wherein said Clostridial neurotoxin is administered to between five and eight of the muscle regions selected from the frontalis, corrugator, procerus, masseter, nasalis, occipitalis, temporalis, trapezius and oculi muscle regions (see, e.g., App’137, claim 3); wherein said Clostridial neurotoxin is administered to the frontalis, corrugator, occipitalis, temporalis, oculi, nasalis, masseter and trapezius muscle regions (see, e.g., App’137, claim 13); wherein said migraine headache is an episodic migraine or a chronic migraine (see, e.g., App’137, claim 15); wherein said migraine headache is an episodic migraine (see, e.g., App’137, claim 16); and wherein said migraine headache is a chronic migraine (see, e.g., App’137, claim 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Response to Arguments
Regarding Applicant’s argument that the double patenting rejection be held in abeyance (remarks, page 10), the Office does not hold any rejections in abeyance. All rejections are maintained until Applicant overcomes them by amendment(s) or files a terminal disclaimer. Therefore, the nonstatutory double patenting rejection is maintained.
Conclusion
Claims 1-7, 11-13, and 26-27 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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