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 .
This is a Non-Final Office Action.
Claims 1-8, 12-15, 17-21, 24 and 25 are pending and under examination.
Claim Objections
The objection to claim 1 because of the ">" in the definition of R4, is withdrawn based on the amendments.
Claims 12, 13 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewriteten 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(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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 21 is 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 diabetic macular edema, dry and wet age-related macular degeneration, geographic atrophy, and non-exudative choroidal neovascularization, does not reasonably provide enablement for the curing of diabetic macular edema, dry and wet age-related macular degeneration, geographic atrophy, and non-exudative choroidal neovascularization. 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.
The specification on page 12 defines treatment as curative.
The how to use requirement of the enablement statute, when applied to method
claims, refers to operability and how to use the claimed method work. Pursuant to In re
Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the
following factors to determine whether undue experimentation is required: (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, some experimentation is not fatal; the issue is whether the
amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444.
The pharmaceutical art is unpredictable. The specification does not enable any physician skilled in the art of medicine, to make the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The main issue here is the lack of any correlation between a platelet activating factor receptor antagonist and the lack of any pharmacological data, the predictability in the art, the state of the pharmacological arts and the breadth of the claims.
There are several biological assays, drawn to 1) the evaluation of the inhibition of PAFR activation, with data on pages 61-62; 2) evaluation of the inverse agonism mode as a prophetic assay; 3) evaluation of the in vivo efficacy in an animal model of laser-induced choroidal neovascularization in rats, which is prophetic; 4) evaluation of binding of compounds to melanin, which is prophetic; 5) evaluation of chemical stability with data on page 64; 6) evaluation of permeability, which is prophetic; 7) evaluation of metabolic stability in human or rate liver microsomes, which is prophetic; 8) evaluation of metabolic stability in human or rate hepatocytes, which is prophetic; 9) evaluation of plasma protein binding, which is prophetic; 10) evaluation of solubility, with data on pages 66-67; and 11) evaluation of pharmacokinetic characteristics in rodents, which is prophetic.
The scope of the claims involves all of the millions of compounds of claim 1 and the hundreds of diseases and/or conditions embraced by claim 21.
Thus, the scope of the claims is very broad.
Due to the level of unpredictability in the art, the very limited guidance provided, and the lack of working examples, the applicant has shown lack of enablement. MPEP 2164.01 (a) states, "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)." That conclusion is clearly justified here.
Applicant states, “[T]he term "therapeutic treatment" is described in the specification on page 12, lines 13-15 as follows: "Therapeutic treatment may be symptomatic treatment in order to relieve the symptoms of the specific indication or causal treatment in order to reverse or partially reverse the conditions of the indication or to stop or slow down progression of the disease." Thus, as described in the specification, therapeutic treatment may "reverse or partially reverse the conditions of the indication or to stop or slow down progression of the disease."”
Also, on page 12, line 10, the specification states, “The terms "treatment" and "treating" as used herein encompass both therapeutic, i.e. curative and/or palliative…” Therefore, the scope of the claims is not enabled and the rejection is maintained.
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 § 103
The rejection of claims 1-11 and 17-24 under AIA 35 U.S.C. 103(a) as being unpatentable over Weber et al. (US 5532233) in view of and Weber et al. (Medicinal research reviews 9.2 (1989): 181-218) because of the following species:
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, is withdrawn based on the amendments.
The rejection of claims 1-11 and 17-25 under AIA 35 U.S.C. 103(a) as being unpatentable over Weber et al. (US 5532233) because of the following species:
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and
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is withdrawn based on the amendments.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-8, 14, 17-21, 24 and 25 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Weber et al. (US 5532233) in view of and Weber et al. (Medicinal research reviews 9.2 (1989): 181-218).
The present application claims are drawn to compounds of formula (I.1) and methods for treating diabetic macular edema, dry and wet age-related macular degeneration, geographic atrophy, and non-exudative choroidal neovascularization and urticaria, wherein R1= methyl, R2= 2-Cl, n= 1, R3= H, R4= 3-chlorophenyl, and the bond between the nitrogen in the seven-membered ring and the adjacent carbon is a single bond.
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Weber et al. teaches similar compounds, wherein R1= methyl, R2= 2-Cl, n= 1, R3= H, R4= 3-chlorophenyl, and the bond between the nitrogen in the seven-membered ring and the adjacent carbon is a double bond.
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The differences between the claimed compounds and the compounds cited above are 1) the bond between the nitrogen in the seven-membered ring and the adjacent carbon, double versus Applicant’s single; 2) the stereochemistry at the same carbon; and 3) the stereochemistry at the amide bond.
The ‘233 patent and the Weber NPL teach the bond between the nitrogen in the seven-membered ring and the adjacent carbon may be single or double, see column 70, formulas Ia and Ib, and the guidepost shown below in the ‘233 patent. Therefore, the single and double bond are alternatively useable.
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The ‘233 patent teaches racemic mixtures of the compounds. Applicants are requested to note that MPEP § 2144.09 teaches that stereoisomers are prima facie obvious. See also In re May, 574 f.2d 1082, 197 USPQ 601 (CCPA 1978).
The ‘233 patent also teaches phenyl and alkylene-heteroaryl groups at R3 or R4, see columns 57-58, compound 104, and columns 51-52, compound 61.
The ‘233 reference teaches the treatment of inflammation and diabetes, see columns 19-20.
Both references teach the same utility as the present application.
Therefore, said claims are rendered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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