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 .
DETAIL ACTION
This office action is a response to the following:
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As filed, claims 1-25 are pending, wherein claim 1 is an independent claim.
Claim Rejections - 35 USC § 112(b)
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 1-25 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.
Regarding claims 1 and 6-10, the claim recites the phrase, “the optional substituents” for instant variable R4, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “an” optional substituent. Without antecedent basis, the claims are rendered indefinite.
Regarding claim 1, the claim recites instant variable Rk and its definition, but such variable is missing in instant formula (I). Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite.
Regarding claim 10, the claim recites “formula (I-a)” without any structure, and it is unclear to the Examiner whether “formula (I-a)” pertains to instant formula (I) in claim 1. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite.
Regarding claim 19, the claim recites the following cancers, but some examples of cancers are in parenthesis (shown by boxes below) and it is unclear to the Examiner whether the cancers in parenthesis are part of the limitations. With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
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Regarding claim 19, the claim is a dependent claim of claim 18, and the claim recites the phrase, “malignancies and hyperproliferative disorders of the bladder”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” bladder in claim 18 or 19. Without antecedent basis, the claim is rendered indefinite.
Regarding claims 2-25, these claims are dependent of claim 1, and they failed to correct the indefiniteness in claim 1, which rendered these claims indefinite.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to a compound of instant formula (I), pharmaceutical composition thereof, or a method of treatment via the compound thereof.
Claims 1-25 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
9,561,231
1-24 and 28-43
No
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned U.S. patent are drawn to a compound of instant formula (I), pharmaceutical composition thereof, or a method of treatment using the compound thereof.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned U.S. patent described the compound of instant formula (I) in a different Markush structure.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to the same compound having the same therapeutic utility (e.g. treating inflammatory disease, cancer, diabetes, etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned U.S. patent.
As recited above, the compound in the conflicting claims of abovementioned U.S. patent is the compound of instant formula (I). However, these conflicting claims may have different Markush structure of instant formula (I).
Structural similarity is the touchstone of the nonobviousness inquiry for patents claiming a novel chemical compound. Eisai Co. v. Dr. Reddy's Laboratories, 533 F.3d1353,1356-57 (Fed. Cir. 2008). In this case, the compounds are the same; i.e., they have the same atomic composition and the same atomic connectivity. For this reason, one of ordinary skill in the art would anticipate that this is the same compound.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that the structure of the abovementioned U.S. patent is excluded as the compound of instant formula (I) of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant compound forms and that of the conflicting claims of the abovementioned U.S. patent to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities:
Regarding claims 8 and 9, these claims recite the phrase, “The compound of claim 1 of formula (I)”.
For consistency throughout the whole claim set, the expression can be clarified by reciting -- The compound of claim 1 --.
Appropriate correction is required.
Conclusion
Claims 1-25 are rejected.
Claims 8 and 9 are objected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621