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 status
In this office action the claims filed on 09 June 2023 is acknowledged and claims 1-6 are pending. Therefore, claims 1-6 are herein under examination.
Priority
This application was filed 09 June 2023 and is a 371 application of PCT/CN2023/ 088119 filed on 04/13/2023, which claims benefit to the foreign application 2022113648 144 filed on 11/02/2022.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in People's Republic of China on 11/02/2022. It is noted, however, that applicant has not filed a certified copy of the 2022113648144 application as required by 37 CFR 1.55.
Thus, the earliest possible priority for the instant application is 04/13/2023.
Examiner’s note: For the compact prosecution MPEP states that “Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application”.
Information Disclosure Statement
The applicant failed their duty to disclose known material information by not submitting an Information Disclosure Statement (IDS). See MPEP §2001.04 and 37 C.F.R. § 1.56. Applicant is respectfully reminded the individuals covered by 37 C.F.R. § 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). See MPEP §2001.06(b).
Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112 (b)
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 2 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.
Regarding claim 2, the limitation “a heating time is 20 s” in 2nd line. There is insufficient antecedent basis for this limitation in the claim. The rejection may be obviated by amending the claim 2 with reciting “the heating time is 20 s.”
Claim Rejections – 35 U.S.C. 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 5-6 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112 (a)
(Written description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Claims 5-6 encompasses a genus of any tumor inhibitor and any therapeutic drug. However, the specification doesn't have adequate support in the disclosure for the tumor-derived microparticle comprising any tumor inhibitor and any therapeutic drug. The specification only discloses the metabolic inhibitor Fluvastatin (Flu) is co incubated with microwave induced tumor cell LLC (see SPEC filed 09 June 2023 [0091] ¶) and the TMPMw containing the chemotherapy drug is explored. Regarding the chemotherapy drug, a traditional platinum-based chemotherapy drug - cisplatin (CDDP) is chosen. A drug encapsulating technology is the same as before. At the cellular level, after 24 h of the stimulation in the LLC, it is found that the TMPMW encapsulating CDDP (TMPMW - CDDP) has a more significant inhibitory effect on the cell proliferation (FIG. 19) (SPEC [0093] ¶). However, specification does not disclose that the tumor-derived microparticle comprising any tumor inhibitor and any therapeutic drug as claimed in instant application. Therefore, the specification fails to identify the any tumor inhibitor and any therapeutic drug.
In the prior art Liu et al. (Small molecule inhibitors targeting the cancers. MedComm, 3(4), p.e181; cited in PTO892; hereinafter “Liu”), teaches to better promote the development of small molecule inhibitors for targeting cancers, and discloses small molecule inhibitors involved in all the approved agents and pivotal drug candidates in clinical trials arranged by the signaling pathways and the classification of small molecule inhibitors. Despite remarkable progress, small molecule inhibitors in cancer treatment date, till now only 88 small molecule inhibitors have been approved by the United States Food and Drug Administration to treat cancers (abstract Fig. 1, and table 1 of Liu). Furthermore, in a separate prior art Ma et al. (Tumor‐derived microparticles in tumor immunology and immunotherapy. European Journal of Immunology, 50(11), pp.1653-1662, 2020; cited in PTO892; hereinafter “Ma”) discloses the release of microparticles by tumor cells (T-MPs) is a very common event in tumor microenvironments. As a result, T-MPs not only influence tumor cell biology but also profoundly forge tumor immunology. Moreover, T-MPs can act as a natural vehicle that delivers therapeutic drugs to tumor cells and immune cells, thus, remodeling tumor microenvironments and resetting antitumor immune responses, thus, conferring T-MPs a potential role in tumor immunotherapies and tumor vaccines (abstract, Fig. 1 p. 1655 of Ma). Ma shows that three patients were treated with intrathoracic injection of cisplatin-packaging MPs, and the other three patients were treated with cisplatin. After a 7-day drug-MP treatment, more than 95% tumor cells in the malignant fluids disappeared, which could be explained by the cytotoxicity of drug MPs to tumor cells. Intriguingly, the fluid in the pleural cavity was reduced quickly (p. 1658 right-col. 3rd ¶ of Ma). Furthermore, T-MPs generated from UV-irradiated tumor cells may contain stimulatory molecules, such as DNA fragments thus, stimulating the production of type I IFNs, IL-12, and IFNγ by DCs. It has been reported that type I interferons play a critical role in CD8+ T-cell priming, and both IL-12 and IFN-γ facilitate antitumor T-cell activation. Thus, although tumor cells contain various immunosuppressive factors, TMPs seem to contain exceeding immune stimulating factors, resulting in generation of innate immune signals in DCs (p. 1657 left-col 1st ¶ of Ma).
Therefore, it is obvious that prior art does not support to identify the tumor-derived microparticle comprising any tumor inhibitor and any therapeutic drug as claimed in instant application.
With these additional evidences, the application method of tumor-derived microparticle comprising any tumor inhibitor and any therapeutic drug is not well established at the time of filling and the ordinary artisan cannot predictably identify any tumor inhibitor and any therapeutic drug in a subject. Therefore, one of skill in the art would neither expect nor predict the appropriate application method of tumor-derived microparticle comprising any tumor inhibitor and any therapeutic drug.
Therefore, it concludes that the claimed genus of any tumor inhibitor and any therapeutic drug to prepare the tumor-derived microparticle doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claims 5-6.
Subject matter free of art.
Current application of claims 1, 3-4 claimed a method for preparing a tumor-derived microparticle by a microwave, comprising step 1, taking Lewis lung carcinoma (LLC) of a lung adenocarcinoma cell line and then culturing the LCC in a culture dish for more than 24 hours (h) to obtain cultured cells; and step 2: performing a microwave heating treatment on the cultured cells obtained in step 1 with a microwave power of 350 - 700 watts (W) and a heating time of 10 - 20 seconds (s) to obtain treated cells and by using a density gradient centrifugation method to obtain a precipitate which is the tumor-derived microparticle TMPMW. In the closest prior art Li et al. (Protocol for generation of lung adenocarcinoma organoids from clinical samples. STAR Protoc. 2, 100239, 2020; cited in PTO892; hereinafter “Li”)) discloses Human cancer tissue-derived organoids maintain the mutational spectrum and histological characteristics of their parental tumors and step-by-step protocol to derive lung adenocarcinoma organoids from primary tumor tissues. Organoid lines can be generated with a success rate of 80% using our protocol. However, Li didn’t perform a microwave heating treatment on the cultured cells to prepare the tumor-derived microparticle. This is contrary from instant method claims, because, current application relates to microwave treatment for obtaining the microparticles of tumor cells and the description of the present application discloses that microparticles of tumor cells obtained after microwave treatment have a higher yield and a more pronounced tumor inhibition effect compared to those obtained by other method (e.g., means of UV irradiation).
Therefore, the method for preparing a tumor-derived microparticle by a microwave, comprising culturing the LCC in a culture dish and performing the microwave heating treatment on the cultured cells obtained to obtain treated cells and using the density gradient centrifugation method to obtain a precipitate of tumor-derived microparticle TMPMW according to instant claims represent a novel, non-obvious product and distinct from the prior art.
Conclusion
Claims 1, 3-4 are allowed. Claims 5-6 are rejected.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684