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 .
DETAILED ACTION
STATUS OF THE CLAIMS: Claims 1-11 are pending in this application.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 1-11 (including claims dependent thereon and claims that relate back to claim 1) 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.
(b) Claims 1 and 2 are indefinite because the claims recite the term “analog”, which implies more than what is being positively recited. The term " analog" can differ in one or more atoms, functional groups, or substructures, which are replaced with other atoms, groups, or substructures, and can include any or all organic compounds derived from the core structure, and thus, it is unclear what is included or excluded. The claims are drawn to an analog, but the numerous examples presented all failed to produce an analog. These cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity.” Hence, applicants must show that an analog can be used, or limit the claims accordingly.
(b) Claims 2 and 3 are indefinite for reciting “somatosensory impairment”. Somatosensory impairment refers to dysfunction in the body’s ability to detect and interpret sensory information from the skin, muscles, joints, and internal organs. This includes deficits in proprioception, tactile sensation, thermal sensation, pressure sensation, and pain, and includes, for example, brain disorders (e.g., stroke), autoimmune diseases, spinal cord injuries, and trauma related disorders (crash injuries, carpal tunnel syndrome and sciatica) to name a few. Are all somatosensory impairments treated with amiloride intended? Examiner suggests including the somatosensory impairments intended (e.g., incorporate claims 3 and 4 into claim 1). Correction is required.
Claim Rejections - 35 USC § 112, first paragraph
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 1-11 (including claims dependent thereon and claims that relate back to independent claim 1) are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1-11 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims are directed to “amiloride … and a pharmaceutically acceptable salt” and a composition comprising the amiloride compound. The claims are rejected for lack of enablement because there is an insufficient teaching of how to use the claimed amiloride and pharmaceutically acceptable salt and the composition as claimed. A “compound and a pharmaceutically acceptable salt” and composition specify that at least some therapeutic benefit arise from some property of the composition. Intended use claims do not have patentability weight. A pill, for example, is a pill no matter what it is used for, and thus, intended use are not consider patentable. Therefore, Applicant has not taught how to use the compounds of the invention to therapeutic effect for any condition. Examiner suggests amending the claims or adding method claims. For example, “A method for treating….”.
Claims 1-11 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for “treating”, does not reasonably provide enablement for “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. Applicant is entitled to treatment or treating, not “prevention” or “preventing”.
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims
The breadth of the instant claims is seen to encompass methods for treating and preventing somatosensory impairments by administering to a patient in need of such treatment a therapeutically effective amount of an amiloride compound. Applicant failed to exactly defined how to prevent these disorders. Somatosensory impairment — the loss or reduced ability to process sensory information from the skin and body — can result from damage to the brain’s somatosensory cortex, peripheral nerves, or sensory receptors. Common causes include stroke, traumatic brain injury, spinal cord injury, cerebral palsy, diabetic neuropathy, and nerve injury. Because these conditions often involve structural or neurological damage, complete prevention is not always possible, even though certain measures can reduce the risk or slow progression. Thus, claim is extremely broad.
The nature of the invention
Currently, there are no known agents with the therapeutic efficacy to prevent these disorders. The art does not disclose an active agent or combination of active agents, which is recognized as prevention for the conditions cited supra. The prior art does not teach or disclose a treatment modality wherein healthy subjects are treated with an active agent or agents and there is no evidence that none of the associated symptoms or disease state characteristics are ever manifested. The disclosure does not direct the skilled artisan to an art, which satisfies the requirement for preventing a disease state associated with these disorders.
The level of predictability in the art
Since the art does not disclose any therapeutic preventative agents, the skilled artisan would not predict, in the absence of proof to the contrary, that the active agent(s) instantly claimed are efficacious in preventing the conditions as broadly claimed. The assertion of a broad application, as set forth in the instant method claims, necessarily requires evidence to support Applicant’s asserted methods. The Examiner notes there are no known agents recognized as preventative agents, and one of skill in this art could not predict, from the evidence of record, that the active agents asserted to be useful in the instantly claimed method, can indeed prevent these disorders.
The amount of direction provided by the inventor
The Examiner notes, there is not seen sufficient guidance provided in the form of administration profiles, combination ratios of the active agents or reference to same in the prior art to provide the skilled artisan with sufficient guidance to practice the instant preventative method. Prevention is seen to encompass administering the active agent to a subject in need, and noting the fact that symptoms of conditions such as these disorders never manifest themselves. The data and evidence provided in the instant disclosure leads the examiner to doubt the objective truth of assertions of prevention of any of the conditions.
The existence of working examples
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims of prevention. There is not seen sufficient working examples or data from references of the prior art providing a nexus between that which applicant asserts as proof of a method for preventing these disorders from the data and evidence currently provided on the record to support methods drawn to preventing any condition.
The level of one of ordinary skill
The ordinary skill artisan would not be able to practice the claimed invention of preventing these disorders with the current disclosure.
The quantity of experimentation
A great deal of experimentation is required. In lieu of the fact that no animal models exists which can reasonably suggest successful prevention of these disorders, it may be necessary for an ordinary skilled artisan to have clinical data in order to practice the claimed invention.
Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure for the prevention of somatosensory impairments.
Conclusion
Claims 1-11 are pending. Claims 1-11 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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, James Alstrum-Acevedo can be reached at 571-272-5548. 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.
/PAUL V WARD/ Primary Examiner, Art Unit 1622
Prosecution Insights