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 1-10 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tian (Macrophage-targeted nanoparticles mediate synergistic photodynamic therapy and immunotherapy of tuberculosis, published 01/2023, PTO-892), as evidenced by Jiang (Vaccination with synthetic long peptide and CpG 2395 in AddaVax induces potent anti-tumor effects, published 2025, PTO-892).
Regarding claims 1-4, Tian teaches PCN-CpG and PCN-CpG@PS (abstract; pg. 1729, Col. 1), wherein the PCN is PCN-224 which is tetrakis(4carboxyphenyl)porphyrin (TCPP) a compound of instant Formula 1, wherein X1 and X3 are NH, X2 and X4 are N, and R1-R9 are H, that is combined with the metal zirconium, Zr4+ (see pgs. 19, 23 of the instant specification that teaches PCN-224 as a compound of instant Formula 1), and wherein the CpG is CpG2395, which is a TLR9 agonist, which is bound to PCN (pg. 1729, Col. 1).
Regarding the term “anticancer” in the preamble of claims 1-6 and 8-9, when reading the preamble in the context of the entire claim, “anticancer” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claims 1 and 6, CpG2395 is an immune modulating agent. As evidenced by Jiang, CpG 2395 is a cancer immunotherapeutic (abstract; pg. 2).
Regarding claim 5, Tian teaches its MOFs as forming coordination bonds between the metal clusters and the organic ligands (pg. 1728, Col. 1).
Regarding claim 8, the recited cancers refer back to the preamble “anticancer” in the phrase “anticancer composition.”
It is further pointed out that the use of the composition to treat cancer in claims 1-6 and 8-9 is an intended use. Applicant is respectfully reminded that if the prior art composition is capable of performing the intended use, then it meets the limitations of the claim; the intended use of the composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Since the product of Tian is capable of performing the instantly claimed intended use, the intended use limitations of the instant claims are met.
Regarding claim 9, while Tian does not explicitly teach PCN-CpG and PCN-CpG@PS as generating singlet oxygen upon light irradiation, it is reasonable to assume PCN-CpG and PCN-CpG@PS would have the same properties since the instant specification teaches PCN-224 as a preferred compound. Thus, while the prior art does not explicitly teach this properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo (Enhancement of antitumor immunotherapy using mitochondria-targeted cancer cell membrane-biomimetic MOF-mediated sonodynamic therapy and checkpoint blockade immunotherapy, published 2022, IDS of 12/05/2024)
Regarding claims 1-8, Luo teaches R837-loaded Zr-TCPP(TPP) nanoparticles, wherein TCPP is a compound of instant Formula 1 when X1 and X3 are NH, X2 and X4 are N, and R1-R9 are H, wherein the metal is Zr4+, and wherein R837 is a TLR7 immunomodulator (pg. 2, 1st full paragraph). Luo teaches its compounds as nano-metal-organic frameworks (nMOFs) formed through the coordination of organic ligands with metal clusters (pg. 2, 2nd full paragraph). As such, the MOFs of Luo meet the limitation of “having a cancer immunotherapeutic agent linked thereto,” recited in claim 1, and “wherein the cancer immunotherapeutic agent coordinates to an unsaturated metal site of the metal cluster” as recited in claim 5, since the immunotherapeutic agent, i.e., R837, is an organic ligand and Luo teaches the organic ligands as coordinated with the nMOFs via the metal clusters.
Luo specifically teaches these complexes for the treatment of breast cancer, hepatocellular carcinoma, and pancreatic cancer (pgs. 3-4) in photodynamic, photothermal, and sonodynamic therapy (SDT) (pg. 6), wherein this treatment augments the production of key immune-related cytokines, enhancing overall immune response induction (pg. 6, Col. 2).
Luo exemplifies a method of treating breast cancer in mice by administering Zr-TCPP(TIPP)/R837 (Figure S5; pg. 6; Fig. 3).
Regarding claim 9, Luo teaches “To evaluate Zr-TCPP(TPP)?R837@M-induced ROS yields, a singlet oxygen sensor green reagent was selected to trap and detect 1O2. With the prolongation of US exposure time, SOSG fluorescent intensity rose substantially” (pg. 6, 1st full paragraph; Figure 2).
Regarding the term “anticancer” in the preamble of claims 1-9, when reading the preamble in the context of the entire claim, “anticancer” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
It is further pointed out that the use of the composition to treat cancer in claims 1-9 is an intended use. Applicant is respectfully reminded that if the prior art composition is capable of performing the intended use, then it meets the limitations of the claim; the intended use of the composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Since the product of Luo is capable of performing the instantly claimed intended use, the intended use limitations of the instant claims are met.
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 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Luo (Enhancement of antitumor immunotherapy using mitochondria-targeted cancer cell membrane-biomimetic MOF-mediated sonodynamic therapy and checkpoint blockade immunotherapy, published 2022, IDS) in view of US 2018/0153796 to Lin (published 2018, PTO-892).
Luo is applied to claims 1-9 as discussed above and incorporated herein.
Regarding claim 10, Lin differs in that it does explicitly teach irradiating the subject with light.
Lin teaches metal-organic frameworks (MOFs) forming a bridge with photosensitizers capable of absorbing X-rays or other ionizing irradiation energy, co-administered with an immunotherapeutic agent (abstract).
Lin teaches the bridging ligand of the MOF as a metal complex of 5, 10, 15, 20-tetra(p-benzoate) porphyrin, which is a compound of instant Formula (1) ([0232]; Fig. 29). Lin further teaches zirconium as a preferred metal in the metal complex of MOFS ([0061], [0083], [0085], [0086], [0262]).
Lin teaches methods of treating cancer by administering to a subject the MOFs for photodynamic therapy and X-Ray Induced Photodynamic Therapy, wherein the subject is irradiated with light ([0245], [0248], [0266], [0273], [0335]-[0337], [0358], [0376]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the sonordynamic therapy of Luo with X-ray induced photodynamic therapy that irradiates the patient with light, as taught by Lin, to arrive at instant claim 10. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Lou teaches that either sonodynamic, photodynamic, or photothermal therapy can be applied to Zr-TCPP(TPP)/R837, a MOF combined with an immunotherapeutic agent, to treat cancer, and
-Lin teaches that it is known in the art to apply X-ray induced photodynamic therapy to subjects administered MOFs combined with immunotherapeutic agents to treat cancer.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at an effective method of treating cancer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
