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 .
Claims 1-10 are pending.
Claim Rejections - 35 USC § 112
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 1-10 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.
The claims are drawn broadly to a method of inducing cancer cell death comprising exposing cancer cells to be treated to an effective amount of a nanoparticle composition comprising biocompatible nanoparticles comprising gold, aluminum, carbon, boron, boron nitride, silica, magnesium oxide, titanium, titania, manganese, arsenic, iron-platinum, and/or barium sulfate and having a diameter of longest dimension in the range of 5 nm to 200 nm” Although the scope of the claims are somewhat reined by the chemical composition and size of nanoparticle, the scope of the claim is open in various aspects including without limitation (as to), which cell regulatory mechanisms are altered, which cells are altered (e.g., nanoparticle-laden or non-laden) and the conditions under which alterations are achieved. Furthermore, the scope of the nanoparticle in itself is broadly drawn in terms of its type or shape. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, and any combination thereof.
Here, the specification provides only two embodiments of AuNP nanoparticles and aluminum based nanoparticles. See Examples 1 and 5. Not only are the sizes, 5 nm or 10 nm, insufficient to support the size range claim, but AuNP and aluminum based nanoparticles themselves are insufficient to support the wide range of biocompatible nanoparticles claimed, much less their type and/or shapes. Beyond the examples, the specification reads as a laundry list of materials and features that would make up limitations of the claims. However, the description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). Merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171(Fed. Cir. 2010).
Accordingly, one of ordinary skill in the art would not reasonably recognize that the claim breadth was actually in the applicants’ possession as of the filing date. “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. ‘[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’” Id., at 1173-74, quoting University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 930 (Fed. Cir. 2004). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention” – that is, conceive of the complete and final invention with all its claimed limitations – and disclose the fruits of that effort to the public.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hainfeld et al (U.S. Patent No. 6,955,639).
Hainfeld et al. discloses methods of using metal nanoparticles 0.5-400 nm in diameter to enhance the dose and effectiveness of x-rays or of other kinds of radiation in therapeutic regimes of ablating target tissues, such as tumours (See Abstract). More particularly, the nanoparticles suitable for enhancing radiotherapy include metals such as gold, silver, platinum, palladium, et cetera, and combinations thereof (Column 4, Lines 57-67). The metal core of the nanoparticle should be in the range of 0.8-400 nm, with sizes 0.8-20 nm preferred (Column 5, Lines 1-8) and the metal nanoparticle may be coated with tumour-binding molecules (Column 7, Lines 64-66).
Furthermore, Hainfeld et al. exemplifies the administration of AuNPs into subjects with mammary tumours results in collection in the tumour, and when followed by 26 Gy of ionising radiation, potentiation of the radiation is afforded (See Examples 4 & 5).
While Hainfeld et al. does not explicitly disclose that exposure of AuNPs to cells results in an alteration of one or more cell regulatory mechanisms in nanoparticle-laden cancer cells or other cells, or reducing the expression of thymidylate synthase and/or ribonucleotide reductase (as required by claims 9 and 10), the claimed method is directed to the intended use of a known or obvious composition to induce cancer cell death. Granting a patent on the discovery of an unknown but inherent function (here alteration of one or more cell regulatory mechanisms such as reduction of the expression of thymidylate synthase or the expression of ribonucleotide reductase) would remove from the public that which is in the public domain by virtue of its inclusion in or obviousness from the prior art. Here, Hainfeld et al. already teaches administration of nanoparticle with ionizing radiation, which reads on the only positive, active steps of Applicant's claimed method i.e., exposing cancer cells to a nanoparticle composition and ionizing radiotherapy. Thus, the use of the composition of Hainfeld et al. would naturally alter one or more cell regulatory mechanisms in nanoparticle-laden cancer cells or other cells. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (“when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated.”) Furthermore, the alteration being either the reduced expression of thymidylate synthase or ribonucleotide reductase would be expected because where 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). That being said, “the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
Claim 4, Hainfeld et al. discloses that the particles may be alloyed or layered, and include non-metal elements including silicon and oxygen (Column 9, Line 54 to Column 10, Line 2).
Regarding claim 5, Hainfeld et al. exemplifies the coating of AuNPs with Fab antibody fragments (i.e. an organic coating and the biocompatible nanoparticle comprises carbon; See Example 6).
Claim Rejections - 35 USC § 103
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainfeld et al. (U.S. Patent No. 6,955,639) as applied to claims 1-6 and 8-10 above, and further in view of McGonigle et al. (WO2019/055840A1).
Teachings of Hainfeld et al. are discussed above.
Regarding claim 7, Hainfeld et al. does not teach aluminum.
McGonigle et al. relates to the treatment of cancer. See Abstract. To this end, McGonigle et al. teaches the use of nanoparticles with materials having magnetic resonance activity including metal and their oxides such as aluminum. See para. [0284].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention in view of the combination of Hainfeld et al. and McGonigle et al. to arrive at the claimed. In this regard, it is prima facie obviousness to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Further, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, e.g., In re Linder, 457 F.2d 506, 507 (CCPA 1972); see also In re Dial, 326 F.2d 430,432 (CCPA 1964). It would have been obvious to employ aluminum based nanoparticles so as to incorporate magnetic resonance activity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614
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