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 Final Office Action.
Claims 1, 7, 9, 12, 14, 16, 31, 32, 35, 42-45, 47, 49, 57 and 59-62 are pending and under consideration. Claims 59-62 are new claims.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “C1-6 alkyl” is repeated in the definition of R22. Appropriate correction is required.
Claims 1, 12, 14, 16, 31, 32, 35, 42 and 62 are objected to because of the following informalities: the term “fluorosubstituted” should be replaced with “fluoro-substituted” in said claims. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the term “and” should be added between the “C(O)C1-4 alkyl” and “CO2C1-4 alkyl” in the definition of R22. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the term “PO(OR29)(OR30)” should be replaced with “PO(OR29)(OR29)” in the definition of R22. Appropriate correction is required.
Claims 43-45 and 47 are objected to because of the following informalities: the term Formula “II” should be replaced with “II-D” in each claim. Appropriate correction is required.
Claim 47 is objected to because of the following informalities: the phrase “comprising administering a therapeutically” is repeated in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1, 3-7, 9, 12, 14, 16, 31, 32, 35, 42-45, 47 and 57 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase "disease, disorder or condition that is treatable by inhibiting interactions between Cav3.2 and USP5” is withdrawn based on the amendments.
The rejection of claims 1, 3-7, 9, 12, 14, 16, 31, 32, 35, 42-45, 47, 49 and 57 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 pain, does not reasonably provide enablement for the prevention of pain or “disease, disorder or condition that is treatable by inhibiting interactions between Cav3.2 and USP5,” generally, is withdrawn based on the amendments.
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, 7, 9, 12, 14, 16, 31, 35, 42-44, 47, 49, 57 and 59-62 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.
In claims 1 and 12, the phrase “provided R20 and R21 are not both H,” is vague. The variables R20 and R21 are not defined as H. Thus, claims 1, 7, 9, 12, 35, 42-44, 47, 49, 57 and 59-62 are vague.
In claim 12, the definition of R20 and R21 is vague due to “H, F, Cl, CHO, CN, NO2, OH, SH, NH2, CO2H, C(O)NH2, PO3H, SO2H, SO2NH2, NHSO2H” since these groups lack antecedent basis.
In claim 14, the definition of R20 and R21 is vague due to “CO2H” and “H, F, Cl, CHO, CN, NO2, OH, SH, NH2, CO2H, C(O)NH2, PO3H, SO2H, SO2NH2, NHSO2H” since these groups lack antecedent basis.
In claim 14, the definition of R20 and R21 is substituted with “halo” since this group lacks antecedent basis.
In claim 16, the definition of R20 and R21 is vague due to “CO2H” since this group lacks antecedent basis.
In claim 31, the definition of R20 and R21 is vague due to “C1-4alkyleneC3-10cycloalkyl, C1-4alkyleneC3-10heterocycloalkyl, C1-4alkyleneC3-10aryl, and C1-4alkyleneC3-10heteroaryl” since this groups lack antecedent basis.
In claim 43, the following formula:
PNG
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158
286
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lacks antecedent basis based on the definition of R20 and R21.
In claim 44, the following formulas:
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114
617
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112
612
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lacks antecedent basis based on the definition of R20 and R21.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 49 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 49 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 7, 12, 14, 16, 31, 32, 35, 42, 43, 47, 49, 57 and 59-62 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection. The definition of L’ has been amended from “C1-4alkylene” to “C1-24alkylene” which does not find support in the disclosure. Thus, the amendment is new matter.
Claims 1, 7, 12, 14, 16, 31, 32, 35, 42, 43, 47, 49, 57 and 59-62 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 pre-AIA 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 genus of formula (II) and the treatment of disease, disorder or condition that is treatable by inhibiting interactions between Cav3.2 and USP5. The mere fact that Applicant may have discovered one specific type of disease, disorder or condition that is treatable by inhibiting interactions between Cav3.2 and USP5 that is treated with a limited genus of compounds of the formula (II) 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]."
Thus, the claims are rejected under 35 USC 112, (a) (Written Description).
This rejection is maintained based on the new matter rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624