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 .
Claims 1-17 are presented for examination.
Applicants’ drawings filed April 28, 2023 and July 12, 2023 have been received and entered.
Applicants’ information disclosure statement filed April 28, 2023 has been received and entered.
Applicants’ preliminary amendment filed July 12, 2023 has been received and entered.
Applicants’ election filed November 5, 2025 in response to the restriction requirement of September 23, 2025 has been received and entered. The applicants elected the invention described in claims 9-17 (Group II) without traverse.
Claims 1-8 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
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 9, 10 and 12-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad terms: CB1 receptor-mediated diseases, one other therapeutic agent. The mere fact that Applicant may have discovered one type of CB1 receptor-mediated disease is treated with a pharmaceutical composition comprising genistein and its phosphate ester derivative and further comprising at least one other therapeutic agent is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of therapeutic agent in combination with genistein and its phosphate ester derivative to treat or prevent a CB1 receptor-mediated disease is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 9, 10 and 12-17 are not allowed.
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 9-17 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 the treatment of CB1 receptor-mediated diseases comprising an effective amount of genistein and its phosphate ester derivative and further comprising at least one other therapeutic agent, does not reasonably provide enablement for the prevention of CB1 receptor-mediated diseases comprising an effective amount of genistein and its phosphate ester derivative and further comprising at least one other therapeutic agent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In this regard, the application disclosure and claims have been compared per factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation.
The factors include:
1) the quantity of experimentation necessary
2) the amount of direction or guidance provided
3) the presence or absence of working examples
4) the nature of the invention
5) the state of the art
6) the relative skill of those in the art
7) the predictability of the art and
8) the breadth of the claims
The instant specification fails to provide guidance that would allow the skilled artisan background sufficient to practice that instant invention without resorting to undue experimentation in view of further discussion below.
The nature of the invention, state of the prior art, relative skill of those in the art and the predictability of the art
The claimed invention relates to a method for the prevention of CB1 receptor-mediated diseases comprising an effective amount of genistein and its phosphate ester derivative and further comprising at least one other therapeutic agent to said subject.
The relative skill of those in the art is generally that of a Ph.D. or M.D.
There are no known preventive therapies for CB1 receptor-mediated diseases in the art.
It is clear the art to which the present invention relates is highly unpredictable and unreliable with respect to conclusions drawn from laboratory data extrapolated to clinical efficacy.
The breadth of the claims
The claims are very broad and inclusive of any “causes” of CB1 receptor-mediated diseases.
The amount of direction or guidance provided and the presence or absence of working examples
There are no examples showing the instant genistein and its phosphate ester derivative, alone or in combination with one other therapeutic agent compound will, in fact, prevent a CB1 receptor-mediated disease in a subject not presently at risk of or predisposed to developing such a disease. No examples showing the instant genistein and its phosphate ester derivative, alone or in combination with one other therapeutic agent is administered to a healthy subject not having a CB1 receptor-mediate disease, and the administration of the instant active agents(s) will prevent the subject from becoming afflicted with a CB1 receptor-mediated disease during its lifetime. Current modes of treatment are known, but there are no known agents, which can be, prevent the causes of a CB1 receptor-mediated disease in a healthy subject.
The quantity of experimentation necessary
Applicants have failed to provide guidance as to which cause would be prevented for an autoinflammatory disease. The skilled artisan would expect the interaction of a particular drug in the prevention of causes of a CB1 receptor-mediated disease to be very specific and highly unpredictable absent a clear understanding of the structural and biochemical basis of the agent. The instant specification sets forth no such understanding nor any criteria for extrapolating beyond the administration of the genistein and its phosphate ester derivative, alone or in combination with one other therapeutic agent. Even for the data presented, no direction is provided to prevent specific causes of a CB1 receptor-mediated disease. Absent reasonable a priori expectations of success, one skilled in the art would have to test extensively many conditions that may lead to a CB1 receptor-mediated disease to discover which cause is prevented. Since each prospective embodiment, as well as future embodiments as the art progresses, would have to be empirically tested, undue experimentation would be required to practice the invention as it is claimed in its current scope. The specification provides inadequate guidance to do otherwise.
Claims 9-17 are not allowed.
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.
Claim 11 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.
Claim 11 is rendered indefinite and vague by the phrases, “preparations for treating sleep disorders, preparations for treating substance abuse or addiction disorders, preparations for treating cognitive disorders, preparations for treating Alzheimer's disease, preparations for treating Parkinson's disease, preparations for treating neurodegenerative disorders, preparations for treating arteriosclerosis, preparations for treating respiratory conditions, preparations for treating intestinal diseases, preparations for treating liver cirrhosis”. Are there steps a subject must prepare for treating these diseases or disorders? Do these steps require lifestyle changes and address underlying conditions?
Claim 11 is not allowed.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 9, 10 and 12-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hendler et al. (6,541,613 B2).
Hendler et al. teach isoflavones, in its aglucone form the includes genistein (see column 1, lines 24-26). Note column 4, Example 1, teaches the mixed phosphate esters of genistein such as the 4’phosphate and the 7’-phosphate (column 5, lines 1-4). Note column 5, Example 2 teaches phosphate ester derivative of genistein is genistein-7-phosphate, same as genistein 7-O-phosphate. Also note column 8, lines 14-27 teaches the genistein and its phosphate ester derivative may be administered alone or in combination with other agents (therapeutic agents). Further note, column 8, lines 28-49 the pharmaceutical composition is prepared with the therapeutically effective amount of the active agent and mixed with pharmaceutically acceptable carriers.
Note that a composition comprising the same agent as the claimed composition will inherently possess the qualities recited herein. Note further that recitation of intended use does not further limit a claim drawn to a composition.
Claim 9, 10 and 12-15 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629