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 .
Applicant’s preliminary amendment filed 8/1/2024, is acknowledged. Claims 1-12 and 17-24 are pending. Claims 17-24 are new.
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.
Claims 17-21 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claim 17 lacks a specific utility because it merely provides a general statement of diagnostic utility or usefulness in treating of an unspecified disease with regard to the claimed composition. The claimed method also lacks a substantial utility in that it is directed to a method of treating an unspecified disease. Claims 18-21 which depend on claim 17 do not cure the deficiencies of claim 17.
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)(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.
Claim(s) 1-3, 5, 6, 9, 10, 17 and 21-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sartore et al. (WO 2022/009126A1).
Regarding claim 1, Sartore et al. teaches “core-shell bioactive structures.” Page 1, line 5. The shell is made from crosslinked polypeptides (current claim 2). See page 8, lines 28-29. The shell may exhibit characteristics including pores, which reads on “surface indentations” that are “part spherical” (current claim 5). See page 11, lines 6-8.
Regarding claim 3, Sartore et al. teaches that “the polypeptides, can be derived from natural tissue or be synthetic; it is also possible to use a mixture of natural and synthetic polypeptides.” Page 9, lines 2-3. Sartore et al. does not require immunomodulatory polypeptides. Therefore, “one or more non-immunomodulatory polypeptides” is implied.
Regarding claim 6, the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138. In the instant case, the prior art is capable of generating inertial cavitation as Applicant by having a core-shell structure of the same material.
Regarding claim 9, Sartore et al. teaches that “[i]n the core-shell structure of the invention, the weight ratio between core [and shell] can vary within wide limits: each of the two components can constitute from 1 to 99% by weight of the structure.” Page 11, lines 1-3.
Regarding claim 10, Sartore et al. a possible additive includes “drugs or medications useful in the treatment of bone lesions and/or tissue regeneration” (current claims 17, 21 Page 10, lines 23-24.
Regarding claim 22, Sartore et al. teaches that “the polypeptides, can be derived from natural tissue or be synthetic; it is also possible to use a mixture of natural and synthetic polypeptides.” Page 9, lines 2-3. Sartore et al. does not require immunomodulatory polypeptides. Therefore, “at least 95% by weight non-immunomodulatory polypeptides” is implied.
Regarding claim 23, Sartore et al. does not require “a pathogenic antigen protein.” Therefore, the absence of a pathogenic antigen protein is implied.
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.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh (CA 2505520).
Regarding claim 11, Singh relates to protein stabilized liposomes. See Abstract. To this end, “to make the protein stabilized liposomal nanoparticles, substantially water
insoluble pharmaceutical agent, lipid and other agents are dissolved in a suitable solvent (e.g.,
chloroform, methylene chloride, ethyl acetate, ethanol, tetrahydrofuran, dioxane, acetonitrile,
acetone, dimethyl sulfoxide, dimethyl formamide, methyl pyrrolidinone, or the like . . .)” Page 13, lines 2-6. Further, “to generate protein stabilized liposomal nanoparticles, a protein (e.g., human serum albumin) is added (into the aqueous phase) to act as a stabilizing agent or an emulsifier for the formation of stable nanodroplets.” Page 13, lines 12-15. Albumin is known to have cysteine residues. The solvent is preferably evaporated under reduced pressure and dried. See Page 13, lines 26-30.
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) 1, 4, 7, 8, 17-20 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li, et al. (CN106984247) in view of Kwan et al. (WO 2015/075442)
Regarding claim 1, Li discloses a polypeptide particle with a water-immiscible core and a polypeptide shell made of an adjuvant, bovine serum albumin (10016-0017) (current claims 7 and 24). The oil may be soybean oil of sorbitan monoleate (current claim 8). See Embodiment 1.
Li does not teach “wherein the particle has one or more surface indentations.”
Kwan teaches that nanoparticles may have small/shallow imperfections/indentations on their surface having an opening and depth of less than 20 nm (pg. 8, lines 16-24.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the teachings of Li with the teachings of Kwan of allowing small imperfections on the surface. Kwan provides motivation by teaching that small imperfections advantageously do not encapsulate a gas pocket (pg.8, lines 16-24). One of skill in the art would have had reasonable expectation of success at combining Li, and Kwan because they teach methods for the creation of nanoparticles with water immiscible cores and polymer shells.
Regarding claim 4, Li teaches that the polypeptide particles have a diameter (defined as the mean particle size in the specification of the instant claim) of 500nm - 10µm (T).
Regarding claims 17-18, Kwan teaches the particles are used for initiating cavitation. See Abstract.
Regarding claim 19, Kwan teaches the particle can be used where histotripsy or thermal ablation is desired. See page 18, lines 5-6.
Regarding claim 20, Kwan teaches 0.5MHz to 5 MHz and less than 5 MPa. See page 19, lines 13-17.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-12 and 17-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 17-25 of copending Application No. 18/272,113 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a polypeptide particle for inducing cavitation on exposure to ultrasound comprising a core, a polypeptide shell having one or more surface indentions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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