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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026 has been entered.
Status of Claims
3. Claims 1-2, 4-10, and 12-43 are pending and under consideration herein.
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.
4. Claims 39-42 are rejected under 35 U.S.C. 112, first paragraph, while being enabling for the treatment of a disease, disorder, or condition of claims 39 and 41, the specification does not reasonably provide enablement for the complete remission/curing of the full scope of the aforementioned claimed conditions. 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.
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) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the claims is drawn to methods for the treatment and curing of various conditions.
(b) Nature of the invention - The nature of the invention is therefore drawn to the pharmaceutical art. These claims cover diseases that are known to exist and those that may be discovered in the future, for which there is no enablement provided.
(c,e) State of the prior art and predictability in the art - The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic or curative regimen on its face.
While a full discussion of each disease which is encompasses by Applicant’s claim language will not be given, the following examples teach that the state of the prior art with respect to the claimed diseases has not advanced to the point of being predictive of the cure of the breadth of diseases instantly claimed.
Treatment as defined in the specification as follows:
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Regarding the total remission, cure, remission is defined as follows: “Remission is the state of absence of disease activity in patients known to have a chronic illness that cannot be cured. It is commonly used to refer to absence of active cancer or inflammatory bowel disease when these diseases are expected to manifest again in the future. A complete remission is defined as complete disappearance of all such manifestations of disease.” As evidenced, total remission includes the disappearance of all such manifestations of disease, also known as curing. The current state of the art is that that full scope of diseases claimed within instant claims is not curable.
With regard to Alzheimer's disease, for example, it is the state of the art that there is no known cure for Alzheimer’s disease. The current drugs for the treatment of Alzheimer’s disease, Aricept, Exelon, Reminyl and Cognex, treat early stages of Alzheimer’s disease by delaying the breakdown of acetylcholine. Memantine, blocks excess amounts of glutamate treats late stage Alzheimer’s disease. (URL: <http://www.cnn.com/HEALTH/mentalhealth/alzheimers/#>)
Furthermore, Layzer, Cecil Textbook of Medicine, states that “some degenerative diseases are difficult to classify because they involve multiple anatomic locations” (see page 2050). Alzheimer’s disease has traditionally been very difficult or impossible to treat effectively with chemotherapeutic agents. See e.g., the Cecil Textbook of Medicine, 20th edition (1996), Vol. 2, wherein it is stated that “[t]here is no cure for Alzheimer’s disease, and no drug tried so far can alter the progress of the disease” (pg. 1994).
The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic or curative regimen on its face.
(d) Level of one of ordinary skill in the art - The artisans using applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
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 or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
(f-g) Amount of direction provided by the inventor and existence of working examples - The only direction or guidance present in the instant specification is the listing of diseases applicant considers as treatable and preventable by the claims.
There are absolutely no working examples present for the cure of any disease encompassed by the claims.
Test assays and procedures are not provided in the specification and the disclosure does not provide how the in vitro data correlates to the cure of the assorted disorders of the instant claims.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous diseases/disorders or conditions claimed herein. That a single compound can be used to treat all diseases/disorders and conditions embraced by the claim is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all of the diseases/disorders or conditions by administering the instant claimed compound.
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases, disorders, or conditions out of all diseases, disorders, or conditions would be benefited by claimed activity and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment and cure of the diseases.
A person having ordinary skill in the art at the time the invention was made would be faced with an undue amount of experimentation to use the pharmaceutical compositions for the full scope of the claimed intended uses.
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)}.
The specification fails to provide sufficient support of the broad use of the methods of administering compounds of the claims in the cure of disorders of the claims as a result necessitating one of skill to perform an exhaustive search for which diseases can be treated or prevented by what compounds of the invention in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “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”.
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 which diseases can be treated by the compounds encompassed in the instant claims, with no assurance of success.
Conclusion
5. Claims 1-2, 4-10, 12-38 and 43 are allowed.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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