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, 4, 5, 7-11, 18-21, and 27 are pending. Claims 11 and 18-21 are withdrawn. No claims have been amended. Claims 1, 4, 5, 7-10 and 27 are under consideration.
Rejections Maintained and New Grounds of Rejections
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4, 5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dai et al. (US 2006/0275371) in view of Chen et al. (US 2018/0177847).
Regarding Claim 1, Dai et al. teach a composition comprising single-walled carbon nanotubes and a therapeutic agent (e.g. paragraphs 0023, 0025, 0028; Claims 1, 15). Dai et al. teach that the therapeutic may be non-covalently bound to the SWNTs (e.g. paragraph 0028, 0083; Claim 24, 41). Dai et al. teach that the therapeutic agent may be a small molecule (e.g. paragraphs 0041, 0058, 0069, and 0088). Dai et al. teach that the active may be delivered to a cancer cell (e.g. claim 23).
Dai et al. do not teach that the small molecule is a therapeutic agent that increases efferocytosis in a diseased tissue marked by the presence of Ly-6Chi monocytes, or is specifically TPI-1 or NSC-87877. This is made up for by the teachings of Chen et al.
Chen et al. teach compositions and methods useful treating cancer in a mammal by blocking the activation of a LILR protein (e.g. abstract). Chen et al. teach that in some embodiments, the compositions are encapsulated in nanomaterials for targeted delivery or formulated in a biodegradable polymer or in nanoparticle (e.g. paragraph 0163). Chen et al. teach that the agent can be an inhibitor of SHP-1, including NSC-87877 or TPI-1 (e.g. paragraph 0146). As evidenced by the instant specification, NSC-87877 and TPI-1 are therapeutic agents that increase efferocytosis in a diseased tissue marked by the presence of Ly-6Chi monocytes, increase efferocytosis of apoptotic cells or cellular degradation products by reversing an anti- phagocytic signal, and increase efferocytosis of cellular degradation products in atherosclerotic plaques. (e.g. paragraphs 0012, 0013; Examples).
Regarding Claims 1, 4, 5, and 7-10, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the small molecules of NSC-87877 or TPI-1 with the single-walled carbon nanotubes of Dai et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Dai et al. teach the inclusion of small molecules, and Chen et al. teach the inclusion of a nanomaterial for targeted delivery, including nanoparticles. One of ordinary skill would have been motivated as both Dai et al. and Chen et al. disclose the treatment of cancer. Regarding the limitations in Claims 4, 5, and 7, these properties are inherent to the therapeutic agents themselves, which are taught by Chen et al. So, while Dai and Chen are silent as to these properties they are necessarily present. “Products of identical chemical composition can not 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.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Dai et al. (US 2006/0275371) in view of Chen et al. (US 2018/0177847) as applied to claims 1, 4, 5, and 7-10 above, and further in view of Lui et al. (Angewandte Chemie International Edition, 2009) and Wu et al. (US 2008/ 0176309).
Regarding Claims 1, 4, 5, and 7-10, the teachings of Dai et al. and Chen et al. are described supra. While Dai et al. teach that the therapeutics are non-covalently bound to the nanotubes, they do not specify π-π stacking interactions. This is made up for by the teachings of Lui et al. and Wu et al.
Lui et al. disclose using supramolecular π-π stacking to load a cancer chemotherapy agent doxorubicin (DOX) onto branched polyethylene glycol(PEG) functionalized SWNTs for in vivo drug delivery applications (e.g. page 7668, column 2). Lui et al. disclose that DOX-loaded SWNTs are stable at neutral pH but released in acidic environments, such as a tumor microenvironment which is slightly acidic, which facilitates the dissociation of DOX from its SWNT carrier. Normal organs and tissues, however, have a neutral pH, at which SWNT–DOX remains stable without releasing free DOX (e.g. page 7670, column 2, last paragraph). Lui et al. teach that their strategy has two critical advantages: 1) DOX is directly loaded on the SWNT surface by simple noncovalent π-π stacking, thus achieving much higher drug loading capacity on nanotubes (up to 4 grams DOX per gram of SWNT), and 2) that the DOX in the SWNT–DOX complex is stacked on the nanotube sidewalls and is thus protected by long branched PEG coating, which allows more stable drug loading and significantly prolonged blood circulation (e.g. page 7670, paragraph bridging columns 1 and 2). Lui et al. further disclose that their strategy can be easily extended to a wide range of lipophilic aromatic drugs (e.g. page 7670, column 1, first paragraph).
Wu et al. disclose the aromatic structure of NSC 87877
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Regarding Claim 27, it would have been obvious to one of ordinary skill in the art at the time of filing to non-covalently bind NSC 87877, as disclosed by Chen and Wu, to the nanotubes by π-π stacking interactions, as disclosed by Dai and Lui. One of ordinary skill in the art would have been motivated to obtain the advantages of localized release in an acidic tumor, higher drug loading, and prolonged blood circulation as taught by Lui et al. One of ordinary skill in the art would have predicted success as NSC 87877 has an aromatic structure capable of π stacking with the nanotubes of Dai et al., and Lui et al. disclose that their strategy can be easily extended to a wide range of lipophilic aromatic drugs.
Response to Arguments
Applicant's arguments filed 10/13/25 have been fully considered but they are not persuasive.
Applicant argues, beginning on page 4, that there is a lack of motivation to combine the references. Neither Dai et al. nor Chen et al. provides any teaching or suggestion that would motivate a person of ordinary skill in the art to combine these disclosures toward targeting the CD47- SIRPa-SHP1 signaling axis for restoring efferocytosis in atherosclerotic disease, as claimed in this application.
This is not found persuasive. As described supra, Dai et al. teach that the therapeutic agent may be a small molecule (e.g. paragraphs 0041, 0058, 0069, and 0088). It would have been obvious to one of ordinary skill in the art at the time of filing to combine Chen’s small molecules of NSC-87877 or TPI-1 with the single-walled carbon nanotubes of Dai et al. One of ordinary skill in the art would have predicted success as Dai et al. teach the inclusion of small molecules, and Chen et al. teach the inclusion of a nanomaterial for targeted delivery, including nanoparticles. One of ordinary skill would have been motivated as both Dai et al. and Chen et al. disclose the treatment of cancer. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Applicant further argues that there is a lack of a reasonable expectation of success, and the claimed invention demonstrates unexpected benefits.
This is not found persuasive. The claims are drawn to a composition and not to a method of delivering drugs to phagocytic cells. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1, for example, requires only a SWNT and a therapeutic agent that increases efferocytosis in a diseased tissue marked by the presence of Ly-6Chi monocytes, wherein the therapeutic agent is bound to the SWNT surface by non-covalent interactions. The property of “increases efferocytosis in a diseased tissue marked by the presence of Ly-6Chi monocytes” is inherent to the drug itself, in this case TPI-1 or NSC-87877. The data presented demonstrate the efficacy of the claimed invention, but do not appear to demonstrate an unexpected result compared to the prior art. SWNTs for drug delivery are known, as shown by Dai et al., and drug delivery of TPI-1 or NSC-87877 is known, as shown by Chen. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the teachings of Chen et al., Dai et al. teach that the therapeutic agent may be a small molecule (e.g. paragraphs 0041, 0058, 0069, and 0088). It would have been obvious to one of ordinary skill in the art at the time of filing to combine the small molecules of NSC-87877 or TPI-1 with the single-walled carbon nanotubes of Dai et al. One of ordinary skill in the art would have predicted success as Dai et al. teach the inclusion of small molecules, and Chen et al. teach the inclusion of a nanomaterial for targeted delivery, including nanoparticles. One of ordinary skill would have been motivated as both Dai et al. and Chen et al. disclose the treatment of cancer. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Regarding the “encapsulation” of the drug in Chen, Chen is not relied upon for the carrier, but for the selection of the small molecules. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Accordingly, the rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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