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 .
DETAILED ACTION
Claims 14, 24-31 and 51-56 are pending in the application. Claims 14 and 54 are rejected. Claims 24-31, 51-53, 55 and 56 are withdrawn from further consideration.
Response to Amendment / Argument
Rejections made in the previous Office Action have been overcome by Applicant's amendments to the claims. Therefore, arguments pertaining to these rejections will not be addressed.
Election/Restrictions
Applicant has amended the instant claims to exclude the elected species. MPEP 803.02(III)(A) notes: “If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.” Since no claims are drawn to the elected species, examination has been limited to Markush claims 14 and 54.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14 and 54 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent PGPub No. 2008/0020994 A1 by Huang in view of Islam et al. Cancer Epidemiol Biomark Prev 2015, 24, 1079-1085.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Huang teaches agents for reducing Gα12 or Gα13 expression (abstract):
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Huang further teaches in paragraph [0055] (page 5): “The antisense nucleic acid molecule may be single or double stranded (e.g. a small interfering RNA (siRNA)), and may function in an enzyme-dependent manner or by steric blocking.” The prior art further teaches examples of siRNA sequences that can hybridize to Gα12 in paragraph [0057] (page 6). The prior art teaches application of reducing Gα12 in mammals as follows on page 2:
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The prior art reiterates treatment of lung cancer on page 10 (paragraph [0080]) and further teach inhibition of tumor growth in Gα12-/- mice in Example 8 (page 15).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art generally teaches administration of a Gα12 inhibitor (including siRNA targeting Gα12) to subjects including those having lung cancer but does not teach that the Gα12 inhibitor should be administered to a subject in need of treating bronchoconstriction (as required by instant claim 14) or that airway smooth muscle cells should be contacted with the Gα12 inhibitor as required by instant claim 54).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Regarding the scope of patients, a person having ordinary skill in the art would expect that patients having lung cancer would significantly be in need of treating bronchoconstriction. Islam et al. teach comorbidities in lung cancer patients as follows in the abstract: “The most common comorbid conditions were chronic pulmonary disease (52.5%), diabetes (15.7%), and congestive heart failure (12.9%).” Islam et al. further refer to an additional study on page 1081 as follows:
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Accordingly, a person having ordinary skill in the art in treating the lung cancer patient population of Huang et al. would expect that a significant percentage of patients would have a disease characterized by bronchoconstriction, in particular COPD. The instant claim 14 places no limitations on dosages, frequency of administration, level of effectiveness, etc. and therefore administering any of the Gα12 siRNA sequences taught by Huang et al. to a lung cancer patient population would meet the limitations of the instant claim 14. Applicant may take the position that the instant disclosure contains evidence of unexpected results based on characterization of disease pathways; however, MPEP 716.02(b)(I) states the following:
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)
Even if the model systems of the specification were considered to be predictive of statistically significant results at the patient level, MPEP 716.02(d) notes:
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)
In this situation, the instant independent claim 14 places no limitation on dosage ranges or the identity of the Gα12 inhibitor siRNA.
Regarding instant claims 14 and 54, the preambles recite intended effects of “treating bronchoconstriction” or “inhibiting contraction of an airway smooth muscle cell or promoting relaxation of an airway smooth muscle cell,” but the active steps of the claims only require administering a therapeutically effective amount of a Gα12 inhibitor or contacting a cell with a Gα12 inhibitor. Accordingly, administering the prior art Gα12 inhibitor siRNA for any purpose (such as treating lung cancer) would still result in the active steps. Regarding “contacting the airway smooth muscle cell” step of instant claim 54, Huang teaches various modes of administration in paragraph [0065] (page 9) including various systemic modes of administration that would be expected to deliver the active compounds to the body, including the diseased tissue, i.e. the lungs.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 14 and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 20-23 of copending Application No. 19/606,463 in view of U.S. Patent PGPub No. 2008/0020994 A1 by Huang and in further view of Islam et al. Cancer Epidemiol Biomark Prev 2015, 24, 1079-1085. Claim 1 of the copending case is generic to reducing or inhibiting invasion or migration of tumor cells in a subject by administering a Gα12 inhibitor, which embraces the subject matter found to be obvious under 35 USC 103. The rationale under 35 USC 103 is incorporated here by reference. For the same reasons as discussed under 35 USC 103, instantly claimed subject matter would have been an obvious embodiment of the claims of the copending case.
This is a provisional nonstatutory double patenting 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 MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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