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 1-2 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/22/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a U.S. National phase application under 35 U.S.C 371 of PCT application PCT/JP2022/011959, filed 03/16/2022, which claims benefit under Title 35 U.S.C 119 to Japanese patent application no. JP2021-045942 filed on 03/19/2021. receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 102
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 1-2 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Ghosh (US 2005/0158329)
Instant claims are drawn to a cancer cell growth-inhibiting composition or processed food comprising at least one selected from compounds having structures represented by formulas (1) to (6) ( it is noted that the 6 compounds with chemical formula 100-105 in claim 1 are the same as the compounds of chemical formula 106-111 (rac-PT21 to rac-PT28) of claim 2) and pharmaceutically acceptable salts thereof as an active ingredient:
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Ghosh discloses phytol derived immunoadjuvants and discloses compositions comprising phytol derivatives of formula I or II: (reference claim 6, 32-33)
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Wherein R1 is -NH2-, -NH R2- wherein R2 is hydrocarbyl having 12-10 carbon atoms (is the same as instantly claimed compounds rac-PT21 to rac-PT23) (reference claim 6, 32-33, Fig 1). They disclose their compositions as having use in pharmaceutical or vaccine formulation which can be administered orally ([0022] and [0041]).
It is noted that although Ghosh does not disclose their composition as a cancer cell-inhibiting composition. However, both the cancer cell inhibiting limitation in claim 1 and processed food limitation in claim 2 are the intended use of the compositions. Applicants are reminded that the intended use of a pharmaceutical compound is not given patentable weight, unless the claimed use results in a physical difference between the claimed composition and any prior art compositions. In re Hack, 114 USPQ 161. In the instant case, Claim 1 recites the intended use of the claimed compound as the cancer cell inhibition. There is no physical difference between the claimed composition and the composition disclosed by Ghosh et al. Further, absent evidence to the contrary, the composition of Ghosh which read on the instantly claimed composition are deemed to be capable of performing the recited use of the claim. Furthermore, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
It is a well-settled proposition of patent law that the intended utility of an already well known composition does not render the composition patentable. It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed limitation of the claimed composition to have cancer-inhibiting properties would be present in these same compositions taught by Ghosh. and would therefore elicit these effects whenever it is administered.
Therefore the composition disclosed by Ghosh fully anticipates instant claims 1-2.
Claims 1-2 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Hashizume et al. (US 2022/0135514, referenced in IDS dated 11/22/2023)
Instant claims are as recited above.
Hazhizume et al. discloses cancer cell growth inhibiting composition and a processed food comprising a compound having the following structure which is instantly claimed compound rac-PT21 (reference claims 1, 2, 4, [0053] and abstract).
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Therefore the composition disclosed by Hazhizume et al. fully anticipates instant claims 1-2.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 of U.S. Patent: 12,338,198 (‘198)
Instant claims are drawn to a cancer cell growth-inhibiting composition comprising at least one selected from compounds having structures represented by formulas (1) to (6) and pharmaceutically acceptable salts thereof as an active ingredient:
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‘198 Claim 1 is drawn to a cancer cell growth inhibiting composition comprising at the following compounds or a pharmaceutically acceptable salt thereof as main components, having the following structure amongst 6 others.
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Although the conflicting claims are not identical, they are not patentably distinct from each other because instant claim 1 and 4 of ‘198 specifically recites the instantly claimed compound as an cancer cell growth inhibiting composition. Therefore subject matter disclosed in instant claims 1 of the instant application is fully taught in claim 1 and 4 of patent ‘198 hence anticipates the instant claims.
With regards to instant claim 2, Claims of ‘198 does not specifically teach the processed food comprising the composition of the compound of formula Chemical 105 recited above. However, disclosure of ‘198 discloses that the cancer cell inhibiting composition can also be provided as processed food (col.5, lines 49-62) which includes the compound of formula chemical 105 recited in claim 1 of ‘198. As such it would have been obvious to a person of ordinary skill in the art to utilize the compound of formula 105 in the processed food format.
Conclusion
Claims 1-2 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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