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 .
Status of Claims
Claims 1-4, and 6-8 are pending and under examination
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 8 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 8, which depends on claim 1, recites a method, and the limitation "said disease" in claim 8, line 1. However, there is no prior recitation of a method or any disease, either previously in claim 8, or in claim 1 from which claim 8 depends. There is insufficient antecedent basis for this limitation in the claim.
The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
(OF NOTE: The following rejection is made under the assumption that Applicant intends claim 8 to be dependent on claim 7, instead of claim 1).
Claims 7-8 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 or reducing risk of worsening type-II diabetes in a person suffering from type-II diabetes, does not reasonably provide enablement for treating or reducing risk of any cardiovascular disease or metabolic condition in a person suffering from or at risk of said disease or condition, or reducing the risk of developing type-II diabetes in a person not already afflicted with the disease.
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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: The nature of the invention is complex in that the claims are drawn to a method of treating or reducing risk of any cardiovascular disease or metabolic condition in a person suffering from or at risk of said disease or condition, or reducing the risk of developing type-II diabetes in a person not already afflicted with the disease.
Applicant demonstrates GLP-1 agonism with 23 exemplified compounds in human pancreatic insulinoma cell line, with no demonstration of any effect in any other disease state or condition. Applicant is enabled for treatment of type-II diabetes through experimental data, and literature supporting (see below) that GLP-1 agonism is standard of treatment for type-II diabetes.
Applicant demonstrates PDE3 inhibition with 3 exemplary compounds, and shows much higher IC50 values compared to reference compounds. This provides a nexus between the 3 species of compounds and their potential to avoid exacerbating or inducing cardiovascular mortality. However, merely avoiding a mechanism that is shown to worsen a given outcome, does not reasonably provide treatment for that outcome.
Breadth of the Claims: The claims are broad in that the claims recite a method of treating or reducing risk of any cardiovascular disease or metabolic condition in any person suffering from or at risk of said disease or condition, or reducing the risk of developing type-II diabetes in a person not already afflicted with the disease. The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the Specification and Existence of Working Examples: The specification describes GLP-1 agonism with 23 exemplified compounds, in human pancreatic insulinoma cell line. However, no working example is given for any other disease. Further, Applicant demonstrates PDE3 inhibition with 3 exemplary compounds, and shows much higher IC50 values compared to reference compounds. This provides a nexus between the 3 species of compounds and their potential to avoid exacerbating or inducing cardiovascular mortality, but merely avoiding a mechanism that is shown to worsen a given outcome, does not provide reasonably provide treatment for that outcome.
While it is noted that the applicant has shown some data for activity in relevant cell lines with exemplified species of the Applicant’s formula, the applicant is not enabled for treating or reducing risk of any cardiovascular disease or metabolic condition in any person suffering from or at risk of said disease or condition, or reducing the risk of developing type-II diabetes in a person not already afflicted with the disease.
Predictability and State of the Art: The state of the art at the time the invention was made was unpredictable and underdeveloped. It is known in the art that GLP-1 agonism is a standard of care for type-II diabetes, such that the Applicant’s exemplified compounds shown to agonize GLP-1 would be reasonably expected to treat this disease state.
Cai, Y. (Long-acting preparations of exenatide), Drug Design, Development and Therapy, Vol. 7, pp. 963-970 (Year: 2013), teaches that as a potent agonist of the GLP-1 receptor, exenatide has been widely used as an adjunctive therapy to improve glycemic control in type 2 diabetes mellitus patients who are unable to achieve adequate glucose control using metformin and/or sulfonylurea (See Page 963; Paragraph 2).
However, it is not understood in the art that GLP-1 agonists can be administered to any person to reduce risk of type 2 diabetes. Applicant has not defined “a person at risk of” a given disease, and Examiner is construing this term to include any person, as any person can be considered to be at any risk of any disease.
Ali, O. (Genetics of type 2 diabetes), World Journal of Diabetes, Vol. 4, no. 4, pp. 114-123 (Year: 2013) teaches a strong genetic component of type 2 diabetes, and that while environmental factors can impact the progression the disease, the genetic component remains a strong backbone in terms of risk, such that one having ordinary skill in the art would assume this genetic risk needs to be present in a subject of a treatment, to be able to meaningfully reduce risk. Further, reducing risk in general, and particularly in the context of any person as a subject of the treatment, is undeterminable without commensurate disclosure showing there was a statistical reduction development of type 2 diabetes in any person.
Amount of Experimentation Necessary: The quantity of experimentation necessary to carry out the claimed invention is high, as the skilled artisan could not rely on the prior art or instant specification to teach a method of treating or reducing risk of any cardiovascular disease or metabolic condition in a person suffering from or at risk of said disease or condition, or reducing the risk of developing type-II diabetes in any person not already afflicted with the disease.
In order to carry out the claimed invention, one of ordinary skill in the art would have to administer the Applicant’s compounds to subject populations at risk of or suffering from every cardiovascular disease or metabolic condition, including type 2 diabetes, and determine whether there was effective treatment or risk reduction.
In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 7 and 8 are not considered to be fully enabled by the instant specification.
Claims 1-3, and 6-8 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. In claim 1, “A compound of Formula (I)” is not defined in the specification with reasonable clarity as to what entities the applicant is intending to reference.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of the claim indicates that these claims are drawn to “A compound of Formula (I)”. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Hence, an adequate written description of the ingredients requires more than a mere statement that it is a compound of Formula (I).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984). Accordingly, reciting “a compound of Formula (I), in the absence of knowledge as to what constitutes a compound of Formula (I), is not a description. In the instant case, on page 3; paragraph 30, Applicant discloses “a compound of Formula (I)”. However, other than the mere mention on page 3; paragraph 30 to page 8; paragraph 7, wherein Applicant simply states “a compound of Formula (I)”, Applicant does not provide representative examples of a compound of Formula (I).
There are 23 species of the claimed genus disclosed that is within the scope of the claimed genus, i.e., example compounds 1-23, on pages 49-62 in the specification.
The disclosure of select species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, the present claim encompasses numerous species that are not further described. There is substantial potential for variability among the species.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of what constitutes “a compound of Formula (I).”. The specification does not clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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, Amy L Clark can be reached at (571) 272-1310. 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.
/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights