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 .
Acknowledgment is made to Applicant’s response filed 06/11/2026.
Claims 1-14 and 17-22 are pending.
Claims 3, 6, 11-14, 17, and 20-22 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/11/2026.
Claims 1, 2, 4, 5, 7-10, 18, and 19 are currently under consideration to the extent that they read upon Applicant’s elected species.
It is noted that Applicant elected the species of trypsin, wherein in the process of searching the instantly claimed invention, the Examiner came across prior art that reads upon antibodies and cytokines. As such, the species election has been expanded to including antibodies and cytokines.
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.
Claim(s) 1, 4, 5, 7-10, 18, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagstaffe et al (WO 2012/066334)(IDS Reference).
Wagstaffe teaches nanoparticles being coated with plasma proteins (see entire document, for instance, page 18, lines 26-33). Wagstaffe further teaches that the surface of the nanoparticles can have depressions with a width of not more than 50nm, and a depth of 5-50nm (see entire document, for instance, page 6, lines 18-23). The particles are taught as having a diameter of 100-300nm (see entire document, for instance, page 6, lines 4-16). It is noted that plasma proteins comprise antibodies and cytokines. The nanoparticles are taught as carrying drugs, such as anti-cancer agents and small molecule drugs (see entire document, for instance, claim 10 and page 17, lines 22-24).
It is noted that the composition of the prior art is deemed to be structurally the same as instantly claimed invention, and as such, is capable of generating internal cavitation if placed within the same potential environment as is articulated in claim 5.
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 (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 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, 2, 4, 5, 7-10, 18, and 19 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagstaffe et al (WO 2012/066334) and Desai et al (WO 1998/14174)(Both IDS References).
Wagstaffe teaches nanoparticles being coated with plasma proteins (see entire document, for instance, page 18, lines 26-33). Wagstaffe further teaches that the surface of the nanoparticles can have depressions with a width of not more than 50nm, and a depth of 5-50nm (see entire document, for instance, page 6, lines 18-23). The particles are taught as having a diameter of 100-300nm (see entire document, for instance, page 6, lines 4-16). It is noted that plasma proteins comprise antibodies and cytokines. The nanoparticles are taught as carrying drugs, such as anti-cancer agents and small molecule drugs (see entire document, for instance, claim 10 and page 17, lines 22-24). It is noted that the composition of Wagstaffe is deemed to be structurally the same as instantly claimed invention, and as such, is capable of generating internal cavitation if placed within the same potential environment as is articulated in claim 5.
Wagstaffe, while teaching the instantly claimed composition and that plasma protein can coat the outside of the particles, does not expressly teach that a coating can be formed by crosslinked polypeptides as in claim 2.
Desai teaches coatings formed by crosslinked polypeptides, such as polypeptides containing cysteine residues (see entire document, for instance, page 11, lines 8-10 and page 30, lines 21-24). The particles are coated with a stabilizing agent, such as human serum albumin (see entire document, for instance, Abstract and page 10, lines 20-21).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize the crosslinked polypeptide coating of Desai for the nanoparticles of Wagstaffe. One would have been motivated to do so since Desai teaches that the crosslinked coatings of Desai are relatively thin compared to the diameter of coated particles (see entire document, for instance, page 12, lines 2-5).
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.
Claims 1, 2, 4, 5, 7-10, 18, and 19 (all claims currently under consideration) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 17-21 of copending Application No.18/272114 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims teach particles comprising crosslinked polypeptide shells comprising proteins and particles that are the same size as the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 5, 7-10, 18, and 19 (all claims currently under consideration) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 9, 12, 13, 17-22 of copending Application No. 18/272115 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims teach particles comprising crosslinked polypeptide shells comprising proteins and particles that are the same size as the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 5, 7-10, 18, and 19 (all claims currently under consideration) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 17, 19-24 of copending Application No. 18/272110 reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims teach particles comprising crosslinked polypeptide shells comprising proteins and particles that are the same size as the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 5, 7-10, 18, and 19 (all claims currently under consideration) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 and 17-25 of copending Application No. 18/272113 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims teach particles comprising crosslinked polypeptide shells comprising proteins and particles that are the same size as the instantly claimed composition.
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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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