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
1. Claims 1, 3-8 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Since a certified English translation of has not been provided for JAPAN 2022-025036, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 2/21/2023.
Information Disclosure Statement
3. The information disclosure statements (IDS) were submitted on 8/15/2024; 6/2/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
4. Claim 5 is objected to because of the following informalities: Claim 5 recites “of a viral vectors”. For improved grammar, the claim should recite “viral vector”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 1, 3, 5-8 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.
See claims 1, 3, 5-8 as submitted 8/15/2024.
Claims 1, 5 recite “major”. The term “major” in claims 1, 5 is a relative term which renders the claim indefinite. The term “major” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 3, 6, 7, 8 depend on these claims.
Further as to claim 5, claim 5 recites “is cultured in a medium supplemented with an agent for enhancing production of a viral vectors, said agent comprising, as a major ingredient, a DNA replication inhibitor”. However, claim 4 on which it depends on already recites “cell in which DNA replication is inhibited”. It is not clear if such a recitation of claim 5 is intended to read on such the recitation of claim 4, for example, if that is the same step or not, or if they refer to different steps.
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.
6. Claims 6, 8 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(s) contains subject matter which 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 6, 8 as submitted 8/15/2024
Claims 6, 8 recite carboplatin, oxaliplatin, cisplatin, and nedaplatin and analogs of such compounds. Further, the claims originate from claims 1, 5 reciting “enhancing production of viral vectors” as well as inhibiting DNA replication. Thus, the claim is drawn to a genus of analogs of such drugs.
The following quotation from section 2163 of the Manual of Patent ExaminationProcedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied throughsufficient description of a representative number of species by actual reduction topractice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics,i.e., structure or other physical and/or chemical properties, by functional characteristicscoupled with a known or disclosed correlation between function and structure, or by acombination of such identifying characteristics, sufficient to show the applicant was inpossession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A"representative number of species" means that the species which are adequately describedare representative of the entire genus. Thus, when there is substantial variation within thegenus, one must describe a sufficient variety of species to reflect the variation within thegenus.
Thus, when a claim covers a genus of inventions, the specification must provide writtendescription support for the entire scope of the genus. Support for a genus is generally foundwhere the applicant has provided a number of examples sufficient so that one in the art wouldrecognize from the specification the scope of what is being claimed.
The specification teaches: carboplatin, oxaliplatin, cisplatin, and nedaplatin; including wherein an analog is a compound having a structure derived from the structure indicated above by substitution of a given atom or atoms with another atom or other atoms, which binds covalently to DNA to inhibit synthesis of DNA [0024, 0028, 0032].
However, while the specification as indicated above identifies carboplatin, oxaliplatin, cisplatin, and nedaplatin and atom modification, in view of the breadth of the claims as indicated above, it does not identify a representative sample of such analogs. Thus, the application does not identify a representative sample of analogs as claimed clearly within the breadth of the claimed genus.
There is no apparent common conserved structure to the different analogs that distinguishes those that that are functional as compared to those that are not. There is therefore a high level of uncertainty as to which analogs fall within the scope of the indicated genus.
The specification does not provide a specific structure of any analogs within the genus that correlates with the required function. Because there is no identification of structures common to each analog, nor sufficient representative examples of the analog by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of analogs through identification of a structure and function. While the analogs are required to have a derived structure, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a derived structure does not demonstrate that analog would be able to show function.
For the reasons above, and in view of the uncertainty as to which analogs are encompassed, the application has not provided sufficient written description support for the analogs identified in claims 6, 8.
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.
7. Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106.04 for analysis parameters.
The instant claims are drawn to a DNA replication inhibitor, i.e., composition of matter, which is a statutory category of inventions (Step 1: YES).
Claim 1 recites a DNA replication inhibitor. Such a product reads on a naturally occurring product. For example, Maloney et al. (“(+)-Myristinin A, a Naturally Occurring DNA Polymerase β Inhibitor and Potent DNA-Damaging Agent,” J. Am. Chem. Soc. 127: 4140-4141 (2005))(See PTO-892: Notice of References Cited) teaches: DNA polymerase beta inhibitors capable of blocking the repair of DNA damage; such as myristinin A, a naturally occurring DNA polymerase inhibitor (p. 4140). As such, the instant claim recites a judicial exception (JE) in the form of a law of nature (Step 2A, Prong One: YES).
Claim 1 is only drawn to a DNA replication inhibitor. As such, the claim is limited to only the JE and does not recite any additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO).
As discussed above, the instant claim does not recite any additional elements beyond the JE itself. As such, the instant claim does not recite any additional elements that amount to significantly more than the JE (Step 2B: NO).
Accordingly, the instant claim does not constitute patent eligible subject matter under 35 U.S.C. § 101.
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 (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 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.
8. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maloney et al. (“(+)-Myristinin A, a Naturally Occurring DNA Polymerase β Inhibitor and Potent DNA-Damaging Agent,” J. Am. Chem. Soc. 127: 4140-4141 (2005))(cited above).
See claim 1 as submitted 8/15/2024.
Maloney et al. teaches: DNA polymerase beta inhibitors capable of blocking the repair of DNA damage; such as myristinin A, a naturally occurring DNA polymerase inhibitor (p. 4140). The claim language “for enhancing production of viral vectors” is interpreted as a statement of intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
Thus Maloney et al. anticipates the instant claim.
9. Claims 1, 3, 4, 5, 6, 7, 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adusumilli et al. (“Cisplatin-induced GADD34 upregulation potentiates oncolytic viral therapy in the treatment of malignant pleural mesothelioma,” Cancer Biology & Therapy 5:1: 48-53 (2006))(cited in applicant’s IDS submitted 6/2/2026).
See claims 1, 3, 4, 5, 6, 7, 8 as submitted 8/15/2024.
See also the 35 U.S.C. 112(b) rejection above.
Adusumilli et al. teaches: wherein NV1066 replicates better in the presence of cisplatin (abstract)(as recited in claims 1, 3, 4, 5, 6, 7, 8); MPM cell lines (abstract)(as recited in claims 4, 5).
Thus Adusumilli et al. anticipates the instant claim.
10. Claims 1, 3, 4, 5, 6, 7, 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (“Cisplatin induces autophagy to enhance hepatitis B virus replication via activation of ROS/JNK and inhibition of the Akt/mTOR pathway,” Free Radical Biology and Medicine 131: 225-236 (2019))(cited in applicant’s IDS submitted 6/2/2026).
See claims 1, 3, 4, 5, 6, 7, 8 as submitted 8/15/2024.
See also the 35 U.S.C. 112(b) rejection above.
Chen et al. teaches: cisplatin stimulates HBV replication in vitro and in vivo (abstract)(as recited in claims 1, 3, 6); in HepG2 cells, infected with Ad HBV1.3 and then incubated with cisplatin; wherein cisplatin promotes HBV replication (Section 3.1; Figure 1)(as recited in claims 4, 5, 7, 8).
Thus Adusumilli et al. anticipates the instant claims.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Iinuma et al. (WO2012105476A1)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of WO2012105476A1)(See PTO-892: Notice of References Cited) teaches: oxaliplatin, carboplatin, cisplatin, nedaplatin (p. 4 of translation).
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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