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 .
Shift of Invention
As noted in the previous Office Action, the general policy of the USPTO is that applicants are not permitted to shift to claim another invention after an election is made and an Office Action on the merits is made of record on the elected invention (MPEP 819).
Inventor has added new claims 26-29. New claims 26-29 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
New claims 26-29 are drawn to a method for preventing or inhibiting the formation of intestinal pre-cancerous lesions or intestinal adenoma comprising administering a Wnt agonist. Previously, all pending claims were drawn to a Wnt agonist (i.e. the Wnt agonist itself). These are two different inventions each requiring a different search strategy in order to facilitate the reasonably complete and thorough search to which inventor is entitled. Such differing strategies necessarily require search queries, digital resource searches or differing classification searches, specific to that invention, such that a search of one invention is unlikely to uncover prior art pertinent to the other invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, new claims 26-29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claim Objections Withdrawn
The objection to claims 12 and 23, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
112(a) Rejections Withdrawn
The rejection of claims 13, 16, 17 and 20-25 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 22, 23 and 25, the amendment cancels the claims. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that the claims are now enabled.
112(b) Rejections Withdrawn
The rejection of claims 10, 11, 21 and 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. With respect to claims 11 and 22, the amendment cancels the claims. With respect to the remaining claims, the amendment clarifies the claims 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 25 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 claims 12, 16, 17, 20, 23 and 24 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action (indefinite from indefinite), has been overcome by inventor’s amendment. With respect to claims 12 and 23, the amendment cancels the claims. With respect to the remaining claims, the amendment clarifies the claims as appropriate.
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.
Claims 10 and 21 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.
It is unclear how exactly the formulation of the instant composition might differ with respect to the timing of its administration (“…simultaneously, separately, or sequentially after administration of an anti-inflammatory compound…”). The rational for any particular formulation would logically depend upon its route of administration, would it not? Not its timing in relation to the administration of some other drug.
Clarification is in order.
Claims 24 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.
There is insufficient antecedent basis for the limitation “…wild type cells…” in the claim.
102 Rejections Withdrawn
The rejection of claims 4-6, 10-13, 16, 17 and 20-25 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 11, 12, 22, 23 and 25, the amendment cancels the claims. With respect to the remaining claims, the claims have been amended such that they are now drawn to a particular pharmaceutical composition. The rejection is withdrawn. A new 103 rejection with new art appears below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-6, 10, 13, 16, 17, 20, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Journal of the Chemical Society (1931), pp. 3148-3149.
Inventor claims a pharmaceutical composition comprising LiCl or Li2CO3, as a Wnt agonist, formulated for administration in the bloodstream at a concentration of 0.2 – O.4 mM, for preventing or inhibiting the formation of intestinal pre-cancerous lesions or intestinal adenoma in a subject and wherein the composition prevents the expansion of constitutively Wnt antagonist expressing cells (claim 4). Dependent claims 5 and 6 further define the subject. Dependent claim 10 teaches that the composition is formulated for simultaneous, separate or sequential administration after an anti-inflammatory compound. (Note the also 112(b) rejection of claim 10 above.)
Inventor further claims a pharmaceutical composition comprising LiCl or Li2CO3, as a Wnt agonist, formulated for administration in the bloodstream at a concentration of 0.2 – O.4 mM, for boosting fitness of healthy cells in a subject with a genetic predisposition to a gastrointestinal tract cancer where the cancer is a stomach, intestinal, colon or rectal cancer, and wherein the boosting of fitness of healthy cells comprises limiting the expansion of pre-malignant clones and the transformation of pre-malignant cells into malignant cells (claim 13). Dependent claims 16 and 17 further define the subject. Dependent claim 20 teaches a result of the administration of the composition. Dependent claim 21 teaches that the composition is formulated for simultaneous, separate or sequential administration after an anti-inflammatory compound. (Note the also 112(b) rejection of claim 21 above.) Dependent claim 24 teaches a result of the administration of the composition. (Note also the 112(b) rejection of claim 24 above.)
Journal of the Chemical Society (1931), pp. 3148-3149 is cited as evidence that LiCl is an old and well-known compound whose water solubility across a wide spectrum of temperatures is well-known in the art. That is, the reference teaches a pharmaceutical composition of LiCl (LiCl dissolved in water) across a wide spectrum of temperature/concentration.
The examiner first points out for clarity of the record that the instant limitations with respect to the intended use of the instant composition, or the intended results of its administration, can be given no patentable weight. This is so because all claims are explicitly drawn to a composition of matter: a pharmaceutical composition, formulated for administration to the blood stream, of either LiCl or Li2CO3 at a particular concentration range. The intend use, or result of such use, does not and cannot further limit the composition itself. Likewise, the limitations with respect to the subject’s diagnosis or genetic predisposition cannot be given patentable weight because they do not and cannot further limit the composition itself. And likewise the limitations with respect to the timing of the administration.
As noted in the previous Office Action, 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. (MPEP 2112.01 (I).) This is essentially because a chemical composition and its properties are inseparable. Products of identical chemical composition cannot have mutually exclusive properties. Thus, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (MPEP 2112.01 (II).)
In sum, inventor’s claims distill to: a pharmaceutical composition, formulated for administration to the bloodstream, of either LiCl or Li2CO3, at a concentration of 0.2-0.4 mM.
Furthermore, LiCl, the active agent, dissolved in water, a pharmaceutically acceptable solvent, would intrinsically yield a pharmaceutical composition suitable for administration to the bloodstream (intravenously, for instance).
Inventor principally distinguishes over the cited art in that a particular concentration range is taught. However, one of ordinary skill in the art, before the effective filing date of the instant invention, would have found it obvious to prepare an aqueous solution of LiCl (i.e. a pharmaceutical composition of LiCl suitable for administration to the bloodstream) at any suitable concentration. One of ordinary skill would have been motivated to do so depending upon the use of the resulting composition, and with a reasonable expectation of success, given the solubility data presented in the cited art.
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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 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, 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 1/24/2026