DETAILED ACTION
Examiner acknowledges receipt of the reply filed 9/23/2025, in response to the non-final office action mailed 5/20/2025.
Claims 34-36, 38-40, and 43-55 are pending. Claims 37, 41, and 42 have been cancelled. Claims 54 and 55 are newly added.
Claims 43-53 remain withdrawn for the reasons made of record.
Claims 34-36, 38-40, 54, and 55 are being examined on the merits in this office 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 .
Drawings- withdrawn
The objection to the drawings is withdrawn in view of the amendment filed 9/23/2025.
Claim Objections- withdrawn
The objection of claims 37 and 38 is withdrawn in view of the amendment filed 9/23/2025.
Claim Rejections - 35 USC § 112- withdrawn, in part
The rejection of claims 34-42 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 9/23/2025.
Claim Rejections - 35 USC § 102- withdrawn
The rejection of claims 34-37, 39 and 40 under 35 U.S.C. 102(a)(1) as being anticipated by Ding et al (Exp Thera Med 14:1136-1140 (2017)-cited in IDS filed 6/24/2022), is withdrawn in view of the amendment filed 9/23/2025.
The rejection of claims 34-37, 39 and 40 under 35 U.S.C. 102(a)(1) as being anticipated by Jeong et al (KR 20030018827)-cited in IDS filed 6/24/2022). Examiner refers to the English Machine Translation, pp 1-18, is withdrawn in view of the amendment filed 9/23/2025.
Claim Rejections - 35 USC § 103- withdrawn
The rejection of claims 34-40 under 35 U.S.C. 103 as being unpatentable over Ding et al (Exp Thera Med 14:1136-1140 (2017)-cited in IDS filed 6/24/2022), and further in view of Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- cited in IDS filed 3/18/2025), is withdrawn in view of the amendment filed 9/23/2025.
The rejection of claims 34-41 under 35 U.S.C. 103 as being unpatentable Ding et al (Exp Thera Med 14:1136-1140 (2017)-cited in IDS filed 6/24/2022) and Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- cited in IDS filed 3/18/2025), as applied to claims 34-40 above, and further in view of Popoff et al. (Future Microbiology 4(8):1021-1064 (2009)), is withdrawn in view of the amendment filed 9/23/2025.
The rejection of claims 34-42 under 35 U.S.C. 103 as being unpatentable over Ding et al (Exp Thera Med 14:1136-1140 (2017)-cited in IDS filed 6/24/2022), Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- cited in IDS filed 3/18/2025, and Popoff et al. (Future Microbiology 4(8):1021-1064 (2009)), as applied to claims 34-41 above, and further in view of Jeong et al ((KR 20030018827)-cited in IDS filed 6/24/2022; Examiner refers to the English Machine Translation, pp 1-18) and Pai (Pharmacotherapy 32: 856-868 (2012)), is withdrawn in view of the amendment filed 9/23/2025.
The rejection of claims 34-40 under 35 U.S.C. 103 as being unpatentable over Jeong et al ((KR 20030018827)-cited in IDS filed 6/24/2022; Examiner refers to the English Machine Translation, pp 1-18), and further in view of Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- cited in IDS filed 3/18/2025), is withdrawn in view of the amendment filed 9/23/2025.
The rejection of claims 34-41 is/are rejected under 35 U.S.C. 103 as being unpatentable Jeong et al ((KR 20030018827)-cited in IDS filed 6/24/2022; Examiner refers to the English Machine Translation, pp 1-18) and Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- cited in IDS filed 3/18/2025), as applied to claims 34-40 above, and further in view of Popoff et al. (Future Microbiology 4(8):1021-1064 (2009)), is withdrawn in view of the amendment filed 9/23/2025.
The rejection of claims 34-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al ((KR 20030018827)-cited in IDS filed 6/24/2022; Examiner refers to the English Machine Translation, pp 1-18), Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- cited in IDS filed 3/18/2025, and Popoff et al. (Future Microbiology 4(8):1021-1064 (2009)), as applied to claims 34-41 above, and further in view of Pai (Pharmacotherapy 32: 856-868 (2012)), is withdrawn in view of the amendment filed 9/23/2025.
Response to Arguments
Applicant's arguments and amendment filed 9/23/2025 with respect to the above rejections have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant's arguments and amendment filed 9/23/2025 have been fully considered but they are not persuasive with respect to the maintained rejections.
Upon further consideration, a new ground(s) of rejection is made in view of the amendment filed 9/23/2025.
An action on the merits is set forth herein.
Specification- maintained
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Response to Arguments
The objection to the abstract is maintained. The reply filed 8/20/2025 was not entered, as indicated on 9/04/2025. The amended abstract was omitted in the reply filed 9/23/2025.
Please refile the amended abstract to overcome this objection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 34-36, 38-40, 54, and 55 remain/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating [specifically alleviation or a reduction] the recited disorders PTSD, depression, anxiety, headache, and complex regional pain syndrome (CRPS), does not reasonably provide enablement for preventing the recited disorders. As noted below, the specification defines treating as encompassing preventing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The rejection is maintained from the office action mailed 5/20/2025, but has been amended to reflect claims filed 9/23/2025.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims; (2) The nature of the invention and the level of predictability in the art; (3) The state of the prior art; (4) The level of one of ordinary skill; (5) The amount of direction provided by the inventor; (6) The existence of working examples; and (7) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
Breadth of claims. Claim 34 is directed to a method of treating a neurological or psychological disorder comprising administering a 50-250 units of a type A botulinum toxin into a stellate ganglion in a mammal in need thereof, wherein the neurological or psychological disorder comprises one of post-traumatic stress disorder (PTSD), depression, anxiety, headache, and complex regional pain syndrome (CRPS).
Para. [030] of the as-filed specification states:
“Treat," "treating," or "treatment" means an alleviation or a reduction (which includes some reduction, a significant reduction, a near total reduction, and a total reduction), resolution or prevention (temporarily or permanently) of an symptom, disease, disorder or condition, so as to achieve a desired therapeutic or cosmetic result, such as by healing of injured or damaged tissue, or by altering, changing, enhancing, improving, ameliorating and/or beautifying an existing or perceived disease, disorder or condition.
Accordingly, the instant claim scope is construed as alleviating, reducing, and/or preventing a recited disorder in a mammal [human or non-human (cat, dog, mouse, cow, etc.)], as well as the neurological or psychological disorder itself [including underlying etiology].
(2) The nature of the invention and predictability in the art: The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
(3) The state of the prior art: The following is a selection of the recited diseases for purposes of illustrating the variety of treatment and disorders. This is not intended to be a comprehensive listing.
Popoff et al. (Future Microbiology 4(8):1021-1064 (2009)- previously cited) reviews clostridial toxins and teaches that 15 Clostridium species produce potent toxins (p. 1021, left col., lines 18-21). These toxins include botulinum toxins (BoNT) (from C. botulinum). See the summarized list of clostridial toxins in tables 1, 2, and 4; pp. 1044-1049.
Regarding headaches, Blumenfeld (U.S 2008/0279895- previously cited) teaches that botulinum toxin is used for the treatment of migraine and other forms of headaches (abstract). Headaches include migraines, cluster headaches, Paroxysmal Hemicrania, SUNCT Syndrome, and Hemicrania Continua (paras. [0011]-[0018]). botulinum toxin can also treat various symptoms associated with the headache, including pai, nasal symptoms (rhinorrhea, and post nasal drip), ocular symptoms (conjunctival injection, and tearing) and sinus congestion (pain or pressure around the sinuses) (e.g., para [0010]). Turkel et al. (US 2010/0266638- previously cited) discloses administration of botulinum neurotoxins in the amount of between 5-50 units per muscle to specific muscle groups of patients in a clinical setting (table 20 and table 23). A headache is a pain in the head, such as in the scalp, face, forehead or neck. A headache can be a primary headache or a secondary headache. A primary headache is a headache which is not caused by another condition. Contrarily, a secondary headache is due to a disease or medical condition, such as an illness, infection, injury, stroke or other abnormality. Thus, with a secondary headache there is an underlying disorder that produces the headache as a symptom of that underlying disorder. Tension headache is the most common type of primary headache and tension headaches account for about 90% of all headaches (para. [0019]). Headaches further include sinus headaches, migraines, headaches caused by overmedication, etc (paras. [0020]-[0026]).
Pain (Overview of pain, Merck Manual, accessed 10/14/2023 at URL merckmanuals.com/professional/neurologic-disorders/pain/overview-of-pain, pp. 1-3- previously cited) has sensory and emotional components and is often classified as acute or chronic. Acute pain is frequently associated with anxiety and hyperactivity of the sympathetic nervous system (e.g., tachycardia, increased respiratory rate and blood pressure, diaphoresis, dilated pupils). Chronic pain does not involve sympathetic hyperactivity but may be associated with vegetative signs (e.g., fatigue, loss of libido, loss of appetite) and depressed mood. People vary considerably in their tolerance for pain. Nociceptive pain (pain caused by tissue injury) may be somatic or visceral. Somatic pain receptors are located in skin, subcutaneous tissues, fascia, other connective tissues, periosteum, endosteum, and joint capsules. Stimulation of these receptors usually produces sharp or dull localized pain, but burning is not uncommon if the skin or subcutaneous tissues are involved. Visceral pain receptors are located in most viscera and the surrounding connective tissue.
Treatment of pain includes nonopioid and opioid analgesics are the main drugs used to treat pain. Antidepressants, antiseizure drugs, and other central nervous system (CNS)–active drugs may also be used for chronic or neuropathic pain and are first-line therapy for some conditions. Neuraxial infusion, nerve stimulation, and neural blockade can help selected patients. See Treatment of pain, Merck Manual, accessed 10/14/2023 at URL merckmanuals.com/professional/neurologic-disorders/pain/treatment, pp. 1-17. Cognitive-behavioral interventions may reduce pain and pain-related disability and help patients cope. These interventions include counseling to refocus a patient's thoughts from the effects and limitations of pain to the development of personal coping strategies and may include counseling to help patients and their family work together to manage pain. Nonopioid analgesics include acetaminophen, aspirin, COX-2 inhibitors, and topical NSAIDS. “Opioid” is a generic term for natural or synthetic substances that bind to specific opioid receptors in the central nervous system (CNS), producing an agonist action. Opioids are also called narcotics—a term originally used to refer to any psychoactive substance that induces sleep. Opioids have both analgesic and sleep-inducing effects, but the two effects are distinct from each other.
(4) The relative skill of those in the art:
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(5) The amount of direction or guidance presented and (6) the presence or absence of working examples: That provided is limited.
Examples 1-4 purport treatment of a posttraumatic stress disorder (PTSD patient). Example 1 indicates administration of 35 U botulinum type A. The patient reported “a reduction in stressful dreams”. Example 2 indicates injection of 45 U botulinum type A, and the patient reported “a reduction in stress related headaches”. Example 3 indicates administration of 60 U a botulinum type B, as well as administration of a SSRI [specific drug not identified] and a “reduction in their depression symptoms”. Example 4 indicates administration of 40 U botulinum type 4, and lidocaine. The patient also took an SNRI [specific drug not identified] and a “reduction in their depression symptoms”. Depression symptoms were not expressly defined in the example.
Example 5 indicates administration of 40 U a botulinum type A. Patient reported “a reduction in their anxiety symptoms”. Anxiety symptoms were not expressly defined in the example.
Regarding examples 1-5, each of the examples is limited to a singular patient, and there is no baseline comparison. The data is subjective and qualitative. The statistical relevance is unclear. Moreover, the patients in examples 3 and 4 took drugs that are known antidepressants - SNRI and SSRI. It thus unclear as to the effect of botulinum toxin alone vs botulinum toxin in combination with SNRI/SSRI treatment.
Examiner notes that the specification defines treating as encompassing prevention (temporarily or permanently) of an symptom, disease, disorder or condition (para [0030]). In order to prevent, the skilled artisan must further know what subject is at risk for development of a given neurological or psychological disorder [or a symptom associated therewith], as well as the amount of botulinum toxin and dosing schedule to prevent a neurological or psychological disorder. The specification has not provided any such guidance.
The skilled artisan cannot extrapolate from the limited examples to preventing neurological or psychological disorders recited in the instant claim scope.
(7) The quantity of experimentation necessary: Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: "Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention." Applicant cannot rely on the knowledge of one skilled in the art to supply information on the novel aspects of the claimed invention. Thus, in view of the reasons set forth above, it would take an undue amount of experimentation for one of skill in the art to practice the claimed invention.
Owing the factors listed above, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” Because of the scope of the claim language, one of ordinary skill in the art would be burdened with undue “painstaking experimentation study” to practice the instant claims.
Response to arguments
Applicant traversed the rejection at p. 5-6 of the reply filed 9/23/2025. Applicant asserts “specification does indeed enable the pending claims” (reply at p. 5). Applicant provides an excerpt of the specification, para [0015]: stating “[d]isclosed methods can include the use of both intra-muscular and nerve-rich administration sites, for example injection into the SG to “block” the nerve bundle, establishing an SGB”. Id.
Examiner has reviewed and considered applicants arguments, but is not persuaded.
The instant claim scope encompasses preventing the recited neurological or psychological disorders: PTSD, depression, anxiety, headache, and complex regional pain syndrome (CRPS). The specification does not provide any guidance (amount, dosing regimen, etc) for administering a type A botulinum toxin to prevent the recited disorders. The skilled artisan cannot extrapolate from limited guidance of Examples 1-5 in which a singular patient was assessed. There is no baseline comparison in the examples. The statistical relevance is unclear. The data is subjective and qualitative. Moreover, the patients in examples 3 and 4 took drugs that are known antidepressants - SNRI and SSRI. It thus unclear as to the effect of botulinum toxin alone vs botulinum toxin in combination with SNRI/SSRI treatment.
In order to prevent a recited disease [PTSD, depression, anxiety, headache, or CRPS] the skilled artisan must first be able to identity subjects [any mammal] at risk for developing a recited disorder, and administer an effective amount/dosing regimen to prevent development of a recited disorder. The instant specification has not provided such information.
The rejection is maintained for at least these reasons and those previously made of record.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 remains/is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The rejection is maintained from the office action mailed 5/20/2025.
Claim 38 recites the limitation "the anterior transverse process”. There is insufficient antecedent basis for the limitations in the claim.
Response to Arguments
The rejection of claim 38 was not addressed in the reply filed 9/23/2025.
Claim Rejections - 35 USC § 102- maintained
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 34-36, 40 and 54 remain/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ranoux (WO 2019/068888, published 4/11/2019; earliest effective filing date 10/06/2017 of U.S. Prov. Appl. 62/569304)-previously cited). The rejection is maintained from the office action mailed 5/20/2025, but has been amended to reflect claims filed 9/23/2025.
Ranoux teaches administration of botulinum toxin to treat chronic migraines [construed as reading on headaches] and tinnitus (p. 6, Ex 1-2). Botulinum toxin can be injected into the stellate ganglion (also known as cervical sympathetic ganglion) (e.g., pp. 5-6, 9). Dosages include between 10 U and 200 U, preferably between 10 U and 100 U (p. 8). Ranoux teaches administration of 30 units (Ex. 1). Accordingly, the limitations of instant claims 34, 36, 37 are satisfied.
Regarding claims 35 and 40, Ranoux teaches that botulinum toxin comprises the various strains of Clostridium botulinum produce seven distinct serotypes of botulinum toxin, of which five are pharmacologically active in man (A, B, E, F, and G) and two are inactive (C and D). Two serotypes are used in therapeutics, BT type A (BTX-A- reads on recombinant) and BT type B (BTX-B) (pp.7-8). Regarding claim 54, dosages include between 10 U and 200 U, preferably between 10 U and 100 U (p. 8). Ranoux teaches administration of 30 units (Ex. 1).
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Response to Arguments
Applicant traverse the rejection at p. 6 of the reply filed 9/23/2025. Applicant asserts that claim 34 was amended to incorporate the limitations of claim 37.
Examiner has reviewed and considered Applicants arguments but is not persuaded.
Ranoux teaches administration of a botulinum toxins, e.g., type A botulinum toxin, to a stellate ganglion (also known as cervical sympathetic ganglion) to treat a migraine (reads on headache). Dosages include between 10 U and 200 U, preferably between 10 U and 100 U (p. 8).
The rejection is maintained for at least these reasons and those previously made of record.
Double Patenting- maintained
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 34-36, 38-40, 54, and 55 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/857116 (hereinafter referred to as “the ‘116 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The rejection is maintained from the office action mailed 5/20/2025, but has been amended to reflect claims filed 9/23/2025.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 34, claims 1-6 of the ‘116 application teach a method of treating a neurological, physical, or psychological disorder or symptom thereof comprising administering a neurotoxin into the stellate ganglion (SG) of the subject where in the neurotoxin comprises a botulinum toxin A. The neurological, physical, or psychological disorder comprises PTSD, depression, anxiety, headache, or CRPS. Claims 20-23 of the ‘116 application recite wherein the disorder comprises depression, anxiety, CRPS, and headache. Claim 12 of the ‘116 application recites that the total dose of the neurotoxin is 15-250 units
Regarding instant claims 35 and 40, claims 5 and 6 of the ‘116 application teach that the botulinum toxin comprises type A.
Regarding instant claim 36, claim 11 of the ‘116 application teaches that the botulinum toxin is administered by injection.
Regarding claim 38, claim 18 of the ‘116 application recites that administration does not comprise imaging guidance. Claim 19 of the ‘116 application recites wherein said administration comprises guidance via palpitation of the interior transverse process of C6 or the Chassange tubercle.
Regarding claim 39, claims 16 and 17 of the ‘116 application recite wherein said administration comprises imaging guidance [computed tomography or ultrasound].
Regarding claim 54, claim 13 of the ‘116 application teaches that the total dose of the neurotoxin is 25-150 units.
Regarding claim 55, claim 17 of the ‘116 application teaches that the imagining includes computed tomography or ultrasound.
Accordingly, instant claims 34-36, 38-40, 54, and 55 are obvious in view of claims 1-28 of the ‘116 application.
New Objection/Rejections
Claim Objections
Claim 34 is objected to because of the following informalities: This is a new objection necessitated by the amendment filed 9/23/2025.
Claim 34 should be amended to recite “administering [[a]] 50-250 units of a type A botulinum toxin”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 35, 36, 37-40, 54, and 55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new rejection necessitated by the amendment filed 9/23/2025.
Claims 35, 36, 37-40, and 54 recite the limitation "the botulinum toxin”. There is insufficient antecedent basis for the limitations in the claim.
Because claim 55 depends from indefinite claim 39 and does not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
To overcome this rejection, claims 35, 36, 37-40, and 54 should be amended to recite "the type A botulinum toxin”, for consistency with independent claim 34.
Claim 38 recites the limitation "the anterior transverse process”. There is insufficient antecedent basis for the limitations in the claim.
Claim 54 lacks antecedent basis from claim 34. Claim 34 recites “50-250 units of a type A botulin toxin”. Claim 54 recites “25-150 units”.
Claim 54 recites the limitation "the total dose". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Previously cited Popoff et al. (Future Microbiology 4(8):1021-1064 (2009)) has been removed as subject matter relating to claim 41 has been cancelled.
Claims 34-36, 40, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al ((KR 20030018827)- previously cited; Examiner refers to the English Machine Translation, pp 1-18), in view of Pai (Pharmacotherapy 32: 856-868 (2012)- previously cited). This is a new rejection necessitated by the amendment filed 9/23/2026.
Jeong et al teach a sympathetic ganglion-blocking agent containing botulinum toxin type A for treating disorders including migraine headaches (abstract, pp. 2-3, 10, claims 1-6). The reference further teaches treatment of cancer pain or chronic pain. Id. The sympathetic ganglion includes the stellate sympathetic ganglion (abstract; pp. 3, 9-10). Jeong et al teach injection of botulinum toxin type A (BoNT/A) into the sympathetic ganglion via a stellate ganglion block procedure (e.g., abstract, pp. 7-11, claims 1-7).
Although Jeong et al teach administration of botulinum toxin type A in a dose of 0.5-5 U/kg patient body weight (p 11), the reference does not explicitly teach the recite the botulinum toxin dose amounts of instant claim 34.
Pai is being used for the purpose of its teaching that the average body weight of an adult is 81 kg (p. 861, left column; p. 866 right column).
It would have been obvious to one of ordinary skill in the art to administer 50-250 units or 25-150 units of type A botulinum toxin into the stellate ganglion of a mammal (human subject) in a method for treating a neurological or psychological disorder, e.g., migraine headache. Jeong et al. explicitly taught methods of treating migraine headaches, as well as routes of administration (injection) into the stellate ganglion. Jeong et al further taught a dose of 0.5-5 U/kg patient body weight (p 11). The reference Pai taught that the average body weight of an adult is 81 kg (p. 861, left column; p. 866 right column). Thus, a dosage of 0.5 U/kg patient weight is 45 Units. A dosage of 5 U/kg patient weight is 405 Units. Example 2 of Jeong further assessed administration of 2 U/kg body weight which equates to 162 units.
The optimization of result effect parameters (dosage amount) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, instant claims 34 and 54 are deemed to be obvious.
Regarding claims 35 and 40, Jeong et al teach commercially available botulinum toxin type A (BoNT/A) (e.g., pp. 2 and 12). BoNT/A is produced by Clostridium botulinum. BoNT/A has been isolated and purified and is used clinically (p. 2).
Regarding claim 36, Jeong et al teach injection of botulinum toxin type A (BoNT/A) (e.g., abstract, pp. 7-11, claims 1-7).
Accordingly, claims 34-36, 40, and 54 are obvious in view of the teachings of the cited references.
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Claims 34-36, 38-40, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al ((KR 20030018827)- previously cited; Examiner refers to the English Machine Translation, pp 1-18), and Pai (Pharmacotherapy 32: 856-868 (2012)- previously cited), as applied to claims 34-36, 40, and 54 above, in further view of Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- previously cited). This is a new rejection necessitated by the amendment filed 9/23/2026.
The teachings of Jeong et al and Pai are set forth above. The references do not explicitly teach that the injection of type A botulinum toxin is performed using palpitation or with imaging.
Cha et al is a journal article discussing the use of the neck crease of the human subject as a landmark of Chassaignac’s tubercle for anatomical and radiological purposes in a stellate ganglion block procedure (abstract). The reference teaches that the stellate ganglion is located at the C7 vertebral level. However, the close proximity to the dome of the pleura and the vertebral artery at the C7 level implies risks for pneumothorax and accidental injection into the vertebral artery. Injections at the C6 vertebral level are considered safer for a stellate ganglion block procedure (p. 102). Cha et al teach that the stellate ganglion block is frequently performed at the anterior tubercle of vertebrate C6 transverse process, also known as Chassaignac’s tubercle, which can easily be palpated (p. 100). The reference further teaches that injection for stellate ganglion block can be assessed using radiological guidance (X-rays) for optimal safety and efficacy (abstract, pp. 101-102). Cha et al teach that although palpation for the interior transverse process of C6 is commonly used, this anatomical assessment is more difficult in obese patients or those with a short neck. The reference teaches that in order to avoid procedure related complications, it may be preferable to perform stellate ganglion block under x-ray guidance (p. 102).
It would have been obvious to one of ordinary skill in the art to administer type A botulinum toxin by injection without any imaging by palpitating the anterior transverse process of vertebrate C6, and injecting the botulinum toxin medially for a stellate ganglion block procedure. Alternatively, it would have been obvious to one of ordinary skill in the art to administer type A botulinum toxin by injection imaging the treatment area [for a stellate ganglion], and injecting the botulinum toxin medially into a treatment area for a stellate ganglion block procedure. Cha et al taught methods for assessing location of injection via palpating the cervical vertebrae, or radiological (X-ray) imaging. The reference taught that radiological imaging was more effective to ensure optimal safety and efficacy of the stellate ganglion block procedure.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650. In this case, Jeong et al expressly taught administration of botulinum toxin via injection in a stellate ganglion block procedure. The skilled artisan would have recognized that Cha et al taught anatomical and radiological methodologies for the procedure. Thus, the motivation to safely administer type A botulinum toxin to the stellate ganglion by injection through the cervical vertebrae either by palpating or radiological imaging using the teaching of Cha et al can be found in the common knowledge of the art and common sense of its skilled practitioners.
Accordingly, claims 38 and 39 are rendered obvious.
Claims 34-36, 38-40, and 54 are obvious in view of the teachings of the cited references.
Claims 34-36, 38-40, 54, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al ((KR 20030018827)- previously cited; Examiner refers to the English Machine Translation, pp 1-18), Pai (Pharmacotherapy 32: 856-868 (2012)- previously cited), and Cha et al (Acta Anesthesiol Scand 46:100-102 (2022)- previously cited), as applied to claims 34-36, 38-40, and 54 above, in further view of Soneji et al (Korean J Pain 26:111-124 (2013)). This is a new rejection necessitated by the amendment filed 9/23/2026. This rejection includes new reference Soneji et al.
The teachings of Jeong et al, Pai, and Cha et al are set forth above. Although Jeong and Cha disclose a stellate ganglion block procedure, injection into the stellate ganglion, and assessing stellate ganglion physical location in a subject via palpitating or x-ray imagining, the references do not explicitly teach ultrasound imaging.
Soneji et al teach that ultrasound has emerged to become a commonly used modality in the performance of chronic pain interventions. It allows direct visualization of tissue structure while allowing real time guidance of needle placement and medication administration (abstract, p. 112). Traditionally, procedures in pain medicine were performed using anatomic landmarks, fluoroscopy or CT scan. While these modalities continue to be utilized, there has been a tremendous growth in the use of ultrasound by pain practitioners (p. 111). Stellate Ganglion Block (SGB) is commonly utilized for chronic pain conditions of the head (p. 112). The stellate ganglion is part of the sympathetic chain and is formed by fusion of the inferior cervical and first thoracic ganglion (Fig 1). The classically described technique for SGB is performed at the C6 anterior tubercle (Chassaignac’s tubercle) with anatomic or fluoroscopic guidance (p. 113). Soneji et al disclose that ultrasound guided injection in a SGB procedure allows for precise insertion of the needle and minimizes risk of intravascular injection (pp. 112-114).
It would have been obvious to one of ordinary skill in the art to administer type A botulinum toxin to a subject using ultrasound guided injection in a stellate ganglion block (SGB) procedure. The skilled artisan would have recognized that Cha taught methods for assessing location of injection via palpating the cervical vertebrae, or radiological (X-ray) imaging. The skilled artisan would further have recognized that Soneji et al taught ultrasound guided injection improved accuracy of needle placement. Thus, Soneji et al offered another technique (ultrasound imaging) that could be implemented for ensuring accurate needle position for delivery of botulinum toxin in a in a SBG procedure.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650. In this case, Jeong et al expressly taught administration of botulinum toxin via injection in a stellate ganglion block procedure. The skilled artisan would have recognized that Soneji et al taught ultrasound guided injection techniques for the procedure. Thus, the motivation to safely administer type A botulinum toxin to the stellate ganglion by injection using the ultrasound imaging technique of Soneji et al can be found in the common knowledge of the art and common sense of its skilled practitioners.
Accordingly, claim 55 is rendered obvious.
Claims 34-36, 38-40, 54, and 55 are obvious in view of the teachings of the cited references.
Response to Arguments- as relating to previous 103 rejections of Jeong, Pai, and Cha (withdrawn herein because the Popoff reference doesn’t apply to the instant claim scope)
Applicant traversed the rejections at pp. 6-11 of the reply filed 9/23/2025. Applicant provides excerpts of Jeong et al relating to dosage amounts and diseases to be treated by Jeong (reply at p. 7). Applicant further discloses a list of types of diseases and conditions that were deemed to be treatable [via administration of botulinum toxin type A] in Jeong et al (reply at pp. 7-8 referring to Jeong at pp.2-3 of the machine translation). Applicant asserts that Jeong (at Example 2) reduced to practice administering type A botulinum toxin to an upper cervical sympathetic ganglion injection in a rabbit. Applicant alleges that Jeong is limited to treatment of upper cervical sympathetic ganglion, not the claimed stellate ganglion which have different physical locations in a mammal, referring to anatomical illustration at p. 10.
With regard to the botulinum toxin dose, applicant states that “the reference itself [Jeong] “warns” against applying dosages appropriate to a specific ganglion to a different ganglion”, based on the following quote from Jeong:
[t]he most appropriate dosage of the formulation of the present invention is determined by the clinician in consideration of the severity of the disease, the weight and health of the patient, and in particular the dose in volume of the toxin to be used depending on the location of the target sympathetic ganglion”.
Reply at pp. 10-11. Emphasis added by applicant. Applicant asserts that the cited references do not teach or suggest each element of the pending claims.
Examiner has reviewed and considered applicants arguments but is not persuaded.
Contrary to applicant’s assertions, Jeong discloses specific diseases/disorders to be treated e.g., migraine headache, using botulinum toxin type A injected into a sympathetic ganglion, e.g., stellate ganglion (e.g., Jeong at abstract, p. 10, ll. 419-421; claims 1-6) (numbering as indicated in the machine translation provided 5/20/2025).
Patents and applications are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for ALL they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Nonpreferred embodiments constitute prior art. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). See M.P.E.P. §2123.
It is noted that MPEP guidelines do not require that a claimed disease and administration of a botulinum toxin to the stellate ganglion be reduced to practice in a prior art reference.
Applicants assertion of “warning” is misplaced.
There would have been a reasonable expectation of success in treating a claimed disease, e.g. headache, because, in part, the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ § 2123(I)-(II). Furthermore, it is well-within the ordinary skill in the art to simply optimize or modify a BoNT/A dosage for treating a headache by a skilled clinician, as taught by Jeong, taking into consideration the weight and health of the subject to be treated. The skilled artisan would have known the differences between the stellate ganglion and the upper cervical ganglion. Cited references Cha and Soneji taught methods of palpitating, x-ray, and ultrasound that could be used in a stellate ganglion block procedure to distinguish the two different ganglion. It is further noted that Cha states “Stellate ganglion block (SGB) is most commonly performed at the transverse process of the sixth cervical vertebra” (Cha at abstract). The reference was published in 2002. Thus, the prior art establishes that a SGB procedure- which targets the stellate ganglion – was a known and clinically used procedure for over 20 years.
Please refer to the 103 rejection presented herein for specific details.
Relevant Art Not Relied Upon
Lipov (U.S. 2006/0287687) teaches a method for the treatment of a patient suffering from postpartum depression and other symptoms comprising the step of administering a stellate ganglion block to the patient to alleviate the symptoms (abstract; claim 1). The stellate ganglion block is administered by delivering an anesthetic to the patient's stellate ganglion (e.g., claim 2). Anesthetics, include lidocaine, morphine or other opioids, clonidine, botox, or tetracine, or a combination of anesthetic and epinephrine, may be used and that the dosage range may vary depending on the particular anesthetic and other factors, as are known in the art (para. [0012]).
Carroll et al (U.S. 20070264373- cited in IDS filed 3/18/2025) disclose selective and extended sympathetic nerve block is achieved by administration of a botulinum toxin at and/or around a targeted sympathetic ganglion. The toxin induced sympathetic block finds use for the treatment of sympathetically maintained pain, e.g., chronic pain (abstract, claim 1). The botulinum toxin is botulinum toxin type A (claim 2). The effective dose of botulinum toxin is from about 1 to 300 units (claim 3). The neurotoxin is administered in an amount of at least about 1 U/kg, usually at least about 2.5 U/kg; and not more than about 10 U/kg, usually not more than about 7.5 U/kg, and may be about 5 U/kg. For the purpose of sympathectomy, botulinum toxin A will be administered at the dose range of from about 0.01 to 10 U/kg, usually about 0.1 to about 5 U/kg; more usually about 0.1 to about 1 U/kg, or about 0.2 to about 0.5 U/kg; more usually in the vicinity of a sympathetic ganglion (para. [0036]). The botulinum toxin can be administered to the cervicothoracic (stellate) ganglion (e.g., paras [0021], [0038], [0053], claim 6). Pain is associated with headaches, migraines, and CRPS (e.g., paras [0008], [0016], [0052], [0054]). Treatment with an analgesically effective dose of toxin is performed by injection of the dose in the retroperitoneal space at the border of the ganglion or vertebral body. The injection may be performed with a single or divided dose. Fluoroscopic guidance may be used to aid in the procedure (para. [0056]).
Ding et al (Exp Thera Med 14:1136-1140 (2017)- previously cited) teach results of a clinical study comprising botulinum toxin type A (BTX-A) injection into stel-late ganglion under ultrasound guidance in patients suffering from insomnia [reads on neurological or psychological disorder]. The reference indicates that BTX-A injection effectively treated insomnia without any noticeable adverse reactions (pp.1137-1140, Tables II-V). Ding et al teach all the patients suffered from different levels of insomnia symptoms, including diffi-culty to fall asleep, drowsiness, early awakening, anxiety and physical problems (p. 1136). Administration was performed by imaging the treatment area, in the injecting the botulinum toxin through the sixth vertebral transverse (pp. 1136-1137). Ding et al teach do not explicitly teach or suggest the amount of botulin toxin administered to treat insomnia.
Conclusion
No claims are allowed.
Claims 34-36, 38-40, and 43-55 are pending. Claims 43-53 are withdrawn.
Claims 34-36, 38-40, 54, and 55 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654