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 .
Claim Objections
Claim 11 is objected to because of the following informalities: for grammatical reasons, in the third text line of the claim, the indefinite article a should appear before the noun compound (“…comprising a compound…”).
Appropriate correction is required.
Inventor’s assistance is respectfully requested in correcting any other minor grammatical and/or spelling errors which may be present in the claim set.
112(a) Rejections Withdrawn
The rejection of claims 1, 6-9 and 14-22 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 1, 6, 7, 9, 14-17 and 20-22, the amendment cancels the claims. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that it is now enabled.
The rejection of claims 2 and 10 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claim 2, the amendment cancels the claim. With respect to claim 10, the amendment narrows the scope of the claimed subject matter such that it is now enabled.
The rejection of claims 3 and 11-13 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claim 3, the amendment cancels the claim. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that it is now enabled.
112(b) Rejections Withdrawn
The rejection of claims 1-3 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
The rejection of claim 6 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 7 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 8 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 9 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 10 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 11 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 12 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 13 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 14 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 16 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 17 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 18 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 19 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
The rejection of claim 20 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 22 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
The rejection of claim 15 and 21 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
Claim Rejections - 35 USC § 112, NEW
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.
In the penultimate line of the claim, the term “…the pharmaceutical compound…” is unclear. It would appear that the term should properly be: the pharmaceutical composition. (Note the related claim language of claims 10 and 11.)
Clarification is in order.
Claims 8, 10, 11 and 18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The RA substituent in the -NH-RA moiety is undefined.
The examiner respectfully suggests that the parenthetical definition of a variable Ra which immediately follows “-NH-RA” should properly refer to substituent RA (not Ra).
Clarification/correction is in order.
Claim 23 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.
The term “…the pharmaceutical compound…” is unclear. It would appear that the term should properly be: the pharmaceutical composition. (Note the related rejection of claim 8, the claim from which claim 23 immediately depends.)
Clarification is in order.
Claims 27, 30 and 32 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
There is insufficient antecedent basis for the limitation “…the pharmaceutical compound…” in the claims.
The examiner respectfully suggests that the claims should refer to a pharmaceutical composition (not a compound).
Claims 12, 13, 19, 24-26, 28, 29 and 31 are also 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.
The claims all depend, or ultimately depend, upon an indefinite base claim yet do not relieve the indefiniteness. Dependent claims 12, 13, 19, 24-26, 28, 29 and 31 are also, therefore, indefinite.
102 Rejections Withdrawn
The rejection of claims 1-3, 6, 7, 14, 20 and 21 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
Markush Search
Inventor having overcome the outstanding art rejection with respect to the elected species, the search history of record was reviewed and expanded given inventor’s newly amended claim set. This resulted in a new rejection being formulated below which is predicated upon the prior art of record in combination with newly cited art. Thus, the Markush search has still not advanced beyond the elected species (compound BIA).
All claimed but as yet unexamined subject matter which does not read on the elected species remains withdrawn, for purposes of this Office Action, as being drawn to non-elected subject matter. This subject matter will be rejoined as appropriate as the Markush examination progresses.
Claim Rejections - 35 USC § 103, NEW
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 8, 10-12, 23, 24, 27, 28 and 30, in so far as they read on the elected species (compound BIA), are rejected under 35 U.S.C. 103 as being unpatentable over Chemistry of Natural Compounds (2018), 54(1), pp. 158-160, prior art of record, in view of CHEST (2009), 135, pp. 898-903.
Inventor teaches a method of treating a BI-1 related disease, inter alia asthma, comprising administering a pharmaceutical composition comprising a compound of Formula 1, wherein the compound inhibits calcium release from the endoplasmic reticulum through BI-1 (independent claim 8). Dependent claim 23 teaches a list of compounds of Formula 1 which includes BIA (first listed compound). Dependent claim 24 teaches that the asthma is fungal asthma.
Inventor teaches a method of treating a mTORC2 related disease, inter alia asthma, comprising administering a pharmaceutical composition comprising a compound of Formula 1, wherein the pharmaceutical composition inhibits binding of BI-1 to mTORC2 and inhibits activity of mTOR (independent claim 10). Dependent claim 27 teaches a list of compounds of Formula 1 which includes BIA (first listed compound). Dependent claim 28 teaches that the asthma is fungal asthma.
Inventor teaches a method of treating an ATK related disease, inter alia asthma, comprising administering a pharmaceutical composition comprising a compound of Formula 1, wherein the pharmaceutical composition reduces or inhibits ATK phosphorylation (independent claim 11). Dependent claim 12 teaches that the asthma comprises allergic asthma, fungal asthma or steroid resistant asthma. Dependent claim 30 teaches a list of compounds of Formula 1 which includes BIA (first listed compound).
Chemistry of Natural Compounds (2018), 54(1), pp. 158-160, teaches inventor’s compound as a component of an antifungal pharmaceutical composition utilized in the inoculation of microtest plates containing Trichophyton rubrum to test for antifungal activity in the interest of developing new antifungal drug formulations (page 158, compound 15; page 159, Table 1, compound 15; page 160, Antifungal Activity Assay). The antifungal activity of compound 15, as measured by its MIC80, is among the most effective tested (page 159, Table 1).
CHEST (2009), 135, pp. 898-903 teaches that it is known in the art the sensitization to Trichophyton species is associated with asthma (abstract). The reference expands this observation by quantifying a relationship between IgE response to Trichophyton rubrum and asthma severity (abstract).
As shown by Chemistry of Natural Compounds (2018), 54(1), pp. 158-160, inventor’s compound is an excellent candidate as an active ingredient in an antifungal formulation against Trichophyton rubrum. And as shown by CHEST (2009), 135, pp. 898-903, sensitization to Trichophyton rubrum is associated with asthma, and may be associated with the severity of the asthma. That being the case, one of ordinary skill in the art, before the effective filing date of the instant invention, would have been motivated to combine the teachings of the cited art, and with a reasonable expectation of success, in order to arrive at an effective treatment for asthma utilizing inventor’s compound.
With respect to the instant claim limitations drawn to the purpose, or desired use or characteristics of the instant composition in the instant method (“…treating a BI-1 related disease…wherein the pharmaceutical compound inhibits BI-1 and inhibits calcium release from the endoplasmic reticulum through BI-1…” (claim 8); “…treating a mTORC related disease…wherein the pharmaceutical composition inhibits binding of BI-1 to mTORC2 and inhibits activity of mTOR…” (claim 10); “…treating an AKT-related disease…wherein the pharmaceutical composition reduces or inhibits AKT phosphorylation…: (claim 11)), the examiner notes that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the instant case, the instant composition and that of the prior art are the same and thus must necessarily exhibit the same properties when utilized in the treatment of asthma. (MPEP 2112.01 (I).) This is so because a compound and its properties are inseparable (MPEP 2112.01; 2141.02 (V).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Journal of the European Academy of Dermatology and Venereology (1999), 12, pp. 250-253 is cited to show a case study of asthma induced in a patient by allergy to Trichophyton rubrum.
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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 6/23/2026
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