NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/CZ2022/050115, filed Nov. 3, 2022, which claims benefit of priority to Provisional Application 63/279,212, filed Nov. 15, 2021.
Claims 1-18, as amended, are pending.
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 .
Priority
Applicant' s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Jun. 29, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 16-18 are set forth as follows:
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Claims 16-18 do not fall within at least one of the four categories of patent eligible subject matter because they do not recite a machine, composition, or article of manufacture; nor can they be construed as process claims, because they refer to treatment without reciting any active method steps.
For examination purposes, claims 16-18 are construed as product claims which recite an intended use.
Claim Rejections - 35 U.S.C. § 112(b) - Indefiniteness
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.
1. Claims 16-18 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.
As recognized by MPEP § 2173.05(q), attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Here, claims 16-18 recite the use of a combination of compounds for cancer treatment, without setting forth any affirmative steps that delimit how the use is actually practiced. Thus, claims 16-18 recite no clear limitations setting forth a clearly defined process with active method steps. Because applicant's intent is unclear, the scope of the claims cannot be ascertained, rendering the metes and bounds of the claims indefinite.
Further, claims 16-18 merely recite an intended use of the compound, which is given no patentable weight.
As recognized by MPEP § 2111.02 (II), a recitation of the intended use of the claimed product (for cancer treatment) must result in a structural difference between the claimed product and the prior art in order to patentably distinguish the product from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See also MPEP § 2111.04.
For examination purposes, claims 16-18 are construed as directed to the pharmaceutical combination of claim 1.
2. Claims 1-7, 9, 10, 12, 14, and 16-18 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 pre-AIA the applicant regards as the invention.
Claim 1 recites a pharmaceutical combination of active substances comprising four components:
(1) at least one TLR ligand;
(2) at least one compound labelling tumor cells as the target of immune cell attack;
(3) at least one anti-CD40 antibody; and
(4) at least one inhibitor of glutamine metabolism.
However, terms (1), (2), and (4) are indefinite, because the instant specification provides no limiting definition of these terms, which also have no clear-cut, commonly understood definition in the art.
(1) The specification describes "TLR (toll-like receptor) ligands" only in functional terms, with no structural limitations:
TLR ligands are substances responsible for the infiltration of tumors by innate immune cells and for their activation. Furthermore, TLR ligands contribute to the formation of the Th1 anti-tumor environment and promote the formation of co-stimulatory molecules. In this way, TLR ligands promote efficient antigen presentation and the involvement of adaptive immunity (para. [0009]).
The specification provides examples of specific TLR ligands, which are recited in the dependent claims. However, the term is ambiguous because it lacks a clear structural boundary that clearly distinguishes substances included by the term, from substances which are excluded.
(2) Similarly, the "compound labelling tumor cells as the target of immune cell attack" is described only in functional terms, with no structural limitations:
The compounds labelling tumor cells as the target of innate immune cell attack are mainly ligands of cell phagocytic receptors, such as ligands of dectin-1, MR, MBL, CR3, CR4 receptors and scavenger receptors SR-A1, SR-A2 and MARCO. The compound that labels tumor cells as the target of innate immune cell attack is preferably a mannan-biocompatible anchor for membrane (mannan-BAM) conjugate. These compounds bind to tumor cells and label them as targets of innate immune cell attack. Innate immunity cells include neutrophils, monocytes, macrophages, dendritic cells, and NK cells (para. [0010]).
The specification provides examples of specific "compounds labelling tumor cells as the target of immune cell attack," which are recited in the dependent claims. However, the term is ambiguous because it lacks a clear structural boundary that clearly distinguishes substances included by the term, from substances which are excluded.
(3) The term "anti-CD40 antibody" is understood by those of ordinary skill in the art.
(4) Finally, the "inhibitor of glutamine metabolism" is also described only in functional terms, with no structural limitations:
Inhibitors of glutamine metabolism are selected from the group comprising azaserine, 6-diazo-5-oxo-norleucine called DON, 5-diazo-4-oxo-L-norvaline called L-DONV, acivicin, azotomycin, bis-2-(5-phenylacetamido-1,3,4-thiadiazol-2-yl)ethyl sulphide called BPTES, ebselen, chelerythrine, apomorphine, 2-(pyridin-2-yl)-N-(5-(4-(6-(2-(3-(trifluoromethoxy)phenyl)acetamido (pyridazin-3-yl)butyl)-1,3,4-thiadiazol-2-yl)-acetamide called CB-839. These substances may be administered in the form of their prodrugs . . . [which] react to form an active substance in the organism. The prodrugs are also included herein within the term “inhibitor of glutamine metabolism” (para. [0012]).
The specification provides examples of specific inhibitors of glutamine metabolism, which are recited in the dependent claims. However, the term is ambiguous because it lacks a clear structural boundary that clearly distinguishes substances included by the term, from substances which are excluded.
In each case, the exact set of substances encompassed by the functional term, and excluded therefrom, cannot be unambiguously determined by one of ordinary skill in the art. While methods of assaying for the claimed activities are known in the art, the terms include substances with activity levels which are detectable but too low to have any therapeutic utility, as well as substances which have not yet been identified to have the claimed activity.
As recognized by MPEP § 2173.05(g), a claim term is merely functional descriptive language when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure or specific ingredients). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971). Here, substances included by the terms specified above cannot be readily distinguished from substances which are excluded from the claim scope. Therefore, infringing substances cannot be distinguished from non-infringing substances, rendering the metes and bounds of the claims indefinite.
Claim Rejections - 35 USC § 103
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Caisova et al. (International Immunopharmacology 59, 86–96 (2018)) in view of Hanes et al. (WO 2016/007647) (both cited on the IDS dated 6/29/2026).
Caisova et al. disclose the treatment of Panc02 murine model of pancreatic adeno-carcinoma by intratumorally administering a therapeutic combination consisting of mannan anchoring to tumor cell surface by biocompatible anchor for membranes (BAM) (mannan-BAM), and the TLR agonists resiquimod, poly(I:C) (polyinosinic: polycytidylic acid, sodium salt), and lipoteichoic acid (LTA). Additional administration of agonistic anti-CD40 antibody achieved effective therapeutic response (80% recovery) (abstract; p. 88, sec. 2.5; Fig. 12).
Mannan-BAM is the specific "compound labeling tumor cells as the target of immune cell attack" recited by claims 4, 5, 7, 8, 11, 13, and 15.
Resiquimod, poly(I:C) (polyinosinic: polycytidylic acid), and lipoteichoic acid are the specific TLR ligands recited by claims 2, 3, 7, 8, 11, 13, and 15.
The combination includes anti-CD40 antibody, as recited by claims 1, 7, 8, and 10-15.
The tripartite combination of Caisova et al. was administered intratumorally, as recited by claims 9-13 and 15; to treat pancreatic adenocarcinoma, as recited by claims 16-18.
The combination therapy of Caisova et al. differs from the claims in that it does not include an inhibitor of glutamine metabolism.
However, Hanes et al. disclose and claim a nanoencapsulated glutaminase inhibitor, e.g., 6-diazo-5-oxo-L-norleucine (claims 1 and 7), formulated for administration for the treatment of a glutamine addicted cancer, e.g., pancreatic cancer, comprising intratumoral administration of an effective amount of a nanoencapsulated glutaminase inhibitor, concurrently or sequentially with other chemotherapeutics (claims 10-14), i.e., prior to, subsequent to, or simultaneously, as recited by claims 10-15.
6-diazo-5-oxo-L-norleucine is the specific inhibitor of glutamine metabolism recited by claims 6, 8, 11, 13, and 15.
Thus, both Caisova et al. and Hanes et al. disclose methods of intratumorally administering active substances to treat pancreatic adenocarcinoma: Caisova et al. disclose active substances (1), (2), and (3), and Hanes et al. disclose component (4).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the combination administered by Caisova et al. by further co-administering an inhibitor of glutamine metabolism with a reasonable expectation of success, because the active substances of both Caisova et al. and Hanes et al. are disclosed to be useful to treat the same disease (pancreatic adenocarcinoma), and Hanes et al. expressly contemplate the administration of a glutaminase inhibitor in combination with additional chemotherapeutic agents.
As recognized by MPEP §2144.06, “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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