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 .
Non-Final Rejection
The Status of Claims:
Claims 1-5, 8-16 are pending.
Claims 1-5, 8-16 are rejected.
DETAILED ACTION
1. Claims 1-5, 8-16 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of PCT/CA2023/050112 01/27/2023, which has a foreign document, EPO EP22154109.7 01/28/2022.
Drawings
3. The drawings filed on 7/22/24 were accepted by the examiner.
IDS
4. The IDS filed on 11/06/24 & 2/12/26 were reviewed by the examiner.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, 8-16 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 pre-AIA the applicant regards as the invention.
In claims 1-4, 6, 11, 14 and 16, the phrases “ an anticholinergic compound ” ,
, “a muscarinic receptor antagonist” are recited. These terms” can be vague and indefinite because the terms can be read on the reach-through claim. A functional definition of a chemical compound ("reach-through" claim) covers all compounds possessing the activity or effect specified in the claim. It would be an undue burden to isolate and characterize all potential compounds, without any effective pointer to their identity or to test every known compound and every conceivable and undiscovered future compound for this activity to see if it falls within the scope of the claims. In effect, the applicant is attempting to patent what has not yet been invented. Therefore, an appropriate correction is required.
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 1-5 ,11, 13, and 15-16 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 ALS, does not reasonably provide enablement for treating any other neuromuscular disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
The specification mentions that it is possible to treat various neuromuscular disorders, such as amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), myasthenia gravis (MG), congenital myasthenia, Lambert-Eaton myasthenic syndrome (LEMS), Lyme disease, poliomyelitis, post-poliomyelitis, heavy metal intoxication, Kennedy syndrome, adult-onset Tay-Sachs disease, hereditary spastic paraplegia, multifocal neuropathy, cervical spondylosis, extramedullary tumor with compressive radiculopathy and myelopathy, inclusion body myositis, progressive bulbar palsy, progressive muscular atrophy, motor neuron syndrome and thyrotoxic myopathy by administering to the subject a therapeutically effective amount of any known or unknown anticholinergic compound.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention in claim 1 is as followed:
A method of treating a neuromuscular disorder in a human subject in need thereof comprising administering to the subject a therapeutically effective amount of an anticholinergic compound.
The State of the Prior art
Fu et al(US 2020/0206220 A1) discloses a method for treating a subject suffering from a disease involving EphA4 signaling, comprising administering to the subject an effective amount of a compound selected from the group consisting of dutasteride, irinotecan, ergoloid, tolvaptan, conivaptan, dihydroergotamine, pimozide, adapalene, amcinonide, maraviroc, cyproheptadine, vecuronium, drospirenone, nilotinib, hexafluorenium, glyburide, abiraterone acetate, danazol, azelastine, ergotamine, eplerenone, retapamulin, spironolactone, trospium, darifenacin, clocortolone pivalate, irbesartan, deferasirox, rocuronium, betamethasone phosphate, buclizine, betamethasone acetate, fluocinonide, pancuronium, difenoxin, paliperidone, diflorasone diacetate, lurasidone, vilazodone, telaprevir, sulfinpyrazone, dexamethasone acetate, and exemestane, wherein the disease is traumatic brain injury, stroke, Parkinson's Disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), spinal cord injury, cancer, inflammation, depression, or anxiety.
Hart et al (WO 2017/218905 A1) discloses a method for treating Spinal Muscular Atrophy (SMA), the method comprising: administering to a subject in need thereof an agent that inhibits a muscarinic acetylcholine receptor, wherein the muscarinic acetylcholine receptor M2 antagonist is selected from the group consisting of: atropine, hyoscyamine, dimethindene, otenzepad, AQRA-741, AFDX-384, dicycloverine, thorazine, diphenhydramine, dimenhydrinate, tolterodine, oxybutynin, ipratropium, methoctramine, tripitramine, gallamine, and chlorpromazine.
However, there are no conclusive data which allow the approval for treating all kinds of neuromuscular disorders comprising administering some compound which is the same as or similar to the claimed anticholinergic compound.
The presence or absence of working examples
In the specification, there are many examples for using only darifenacin in target engaqement: darifenacin successfully reducing PSC muscarinic hyperexcitability,
darifenacin treatment dampening muscarinic hyperexcitability in SOD1 mice beneficial effects of darifenacin treatment at disease onset , darifenacin preserving NMJ innervation status , darifenacin reducing motor neuron death, darifenacin improving neuromuscular contractile muscle force and NMJ efficacy, preserving muscle fatigue properties, improving locomotor function and gait, the general condition and extends mice survival, and darifenacin will be tested in ALS patients for the safety and tolerability. However, there are no other examples for testing any other anticholinergic compounds for the treatment for various neuromuscular disorders, such as spinal muscular atrophy (SMA), myasthenia gravis (MG), congenital myasthenia, Lambert-Eaton myasthenic syndrome (LEMS), Lyme disease, poliomyelitis, post-poliomyelitis, heavy metal intoxication, Kennedy syndrome, adult-onset Tay-Sachs disease, hereditary spastic paraplegia, and other disorders. Also, the specification does not contain any pharmacological data regarding the treatments for all kinds of neuromuscular disorders while using the claimed compound. Thus, the specification fails to provide sufficient working examples as to how the treatment of all kinds of neuromuscular disorders can be treated successfully by the claimed compound without any unexpected negative effects of using the claimed compound.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine whether or not the claimed compounds can be led to exhibit the desired pharmacological activity for treating all the neuromuscular disorders.
Thus, the specification fails to provide sufficient support for the treatment of all neuromuscular disorders. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting claimed neuromuscular disorders suitable for the claimed compounds in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent 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”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test whether or not all the claimed neuromuscular disorders can be treated by the claimed compounds, which is encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 102
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) 1-5, 8-10, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Fu et al(US 2020/0206220 A1).
Fu et al discloses a method for treating a subject suffering from a disease involving EphA4 signaling, comprising administering to the subject an effective amount of a compound selected from the group consisting of dutasteride, irinotecan, ergoloid, tolvaptan, conivaptan, dihydroergotamine, pimozide, adapalene, amcinonide, maraviroc, cyproheptadine, vecuronium, drospirenone, nilotinib, hexafluorenium, glyburide, abiraterone acetate, danazol, azelastine, ergotamine, eplerenone, retapamulin, spironolactone, trospium, darifenacin, clocortolone pivalate, irbesartan, deferasirox, rocuronium, betamethasone phosphate, buclizine, betamethasone acetate, fluocinonide, pancuronium, difenoxin, paliperidone, diflorasone diacetate, lurasidone, vilazodone, telaprevir, sulfinpyrazone, dexamethasone acetate, and exemestane, wherein the disease is traumatic brain injury, stroke, Parkinson's Disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), spinal cord injury, cancer, inflammation, depression, or anxiety. Regardless of the disease involving EphA4 signaling, these are inherently identical with the claims.
Claim(s) 1-5, 8-10, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Hart et al (WO 2017/218905 A1).
Hart et al discloses a method for treating Spinal Muscular Atrophy (SMA), the method comprising: administering to a subject in need thereof an agent that inhibits a muscarinic acetylcholine receptor, wherein the muscarinic acetylcholine receptor M2 antagonist is selected from the group consisting of: atropine, hyoscyamine, dimethindene, otenzepad, AQRA-741, AFDX-384, dicycloverine, thorazine, diphenhydramine, dimenhydrinate, tolterodine, oxybutynin, ipratropium, methoctramine, tripitramine, gallamine, and chlorpromazine.
Regarding the difference between ipratropium and ipratropium bromide, they are the exact same medication. The shorter name is just a simple way to say the full chemical name. Therefore, these are inherently identical with the claims.
Conclusion
Claims 1-5, 8-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAYLOR V OH/ Primary Examiner, Art Unit 1625
7/24/2026
Prosecution Insights