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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/28/2026 has been entered.
Shift of Invention
As outlined in detail in the previous Office Action, once applicant has received an Office Action on the merits for the originally presented invention (in the instant case, claims to a composition), that invention has been constructively elected by original prosecution on the merits. Newly added claims (in the instant case, claims to a method) constitute a shift of invention.
112 Rejections Withdrawn
The rejections of claims 10, 21 and 24 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, have been overcome by inventor’s amendment. The amendment clarifies the claims as appropriate.
Claim Rejections - 35 USC § 103, MAINTATINED
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 remain rejected under 35 U.S.C. 103 as being unpatentable over Journal of the Chemical Society (1931), pp. 3148-3149, prior art of record. Inventor’s amendments and arguments have been carefully considered but are not persuasive.
Inventor claims a pharmaceutical composition comprising LiCl or Li2CO3, as a Wnt agonist, formulated for administration in the bloodstream and which provides a therapeutically effective concentration of 0.2 – 0.4 mM in the bloodstream, for preventing or inhibiting the formation of intestinal pre-cancerous lesions or intestinal adenoma in a human subject and wherein the composition prevents the expansion of constitutively Wnt antagonist expressing cells (independent claim 4). Dependent claims 5 and 6 further define the subject. Dependent claim 10 teaches that the composition is formulated for simultaneous administration with an anti-inflammatory compound.
Inventor further claims a pharmaceutical composition comprising LiCl or Li2CO3, as a Wnt agonist, formulated for administration in the bloodstream and which provides a therapeutically effective concentration of 0.2 – 0.4 mM in the bloodstream, for boosting fitness of healthy cells in a human 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 (independent 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 administration with an anti-inflammatory compound. Dependent claim 24 teaches a result of the administration of the composition.
Journal of the Chemical Society (1931), pp. 3148-3149, prior art of record, is cited as evidence that LiCl, for instance, 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, again, 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, or the intended results in a particular patient population, etc., 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 previously, 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. This is, logically, precisely why such solubility data has been presented in the prior art in the first place: so that one of ordinary skill may easily prepare, and with a reasonable expectation of success, an aqueous LiCl solution of a desired concentration, within the limits taught by the experimental data presented in the cited art, for any application that may require it such a solution.
Inventor argues, essentially, that because the cited prior art does not explicitly teach each of the limitations of the instant claim set, that the outstanding 103 rejection of is improper. However, this argument conveniently omits that fact that the MPEP directly and explicitly address the instant fact pattern: claims to a composition in which the preamble of the claim merely states the intended use or purpose of the invention rather than any distinct definition of any of the claimed composition’s limitations.
As noted by the MPEP, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention and the preamble of the claim merely states the intended use or purpose of the invention (“…for preventing or inhibiting the formation of…”, “…such that the administration provides…”, “…prevents or inhibits expansion…”, etc.), rather than any distinct definition of any of the claimed composition’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. (Note the discussion at MPEP 2111.02, II.) That being the case, limitations with respect to the intended use or purpose of the instant composition are given no patentable weight.
In sum, again, and as supported by guidance in the MPEP, inventor’s claims simply 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. Each of inventor’s latest amendments to the claim set are all amendments to the preamble portion of the independent claims, and as such are amendments to the portion of the claims which, in any case, have no patentable weight. The cited prior art still reads on the claims as outlined in the previous Office Action and repeated above.
Conclusion
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.
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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 5/3/2026
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