DETAILED ACTION
Notice of Pre-AIA or AIA status
Claims 1-43 are cancelled.
Claims 44-56 are included in the prosecution.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claims 44-56 are rejected under 35 U.S.C. 103 as being unpatentable over Gourapura et al. (US20150265696A1) hereinafter Gourapura in view of Lee et al. ("PEGylation to Improve Protein Stability During Melt Processing", Macromol Biosci. 2015 Oct;15(10):1332-7. doi: 10.1002/mabi.201500143. Epub 2015 Jun 12.) hereinafter Lee and Von Andrian et al. (US20140314865A1) hereinafter Von Andrian.
Regarding claims 44-56, Gourapura discloses a degradable viral nanoparticle construct for delivery of virus or virus-like particles to a cell or tissue of
interest of a subject, the nanoparticle construct comprising: a biodegradable polymer matrix ([0087], [0091]), discloses a plurality of virus or virus-like particles encapsulated within the biodegradable polymer matrix ([0087], [0091]), the nanoparticle construct upon administration to a subject ([0098], [0207]), providing a sustained release of the virus or virus-like particles to the cell or tissue [0146].
Gourapura does not teach a melt processed nanoparticle or upon release from the degradable polymer matrix having the same or substantially similar structural and/or biochemical characteristics as the particles prior to melt processing and does not explicitly disclose a method of treating cancer by administering.
However, Lee is drawn to the effect of PEGylation on protein stability during melt processing using lysozyme and PLGA. The results indicate that PEGylation increases the retained activity of lysozyme, increases dispersion in the melt, and reduces the biphasic release profile in melt processed systems (abstract). Lee discloses a melt processed nanoparticle (abstract) and upon release from the degradable polymer matrix having the same or substantially similar structural and/or biochemical characteristics as the particles prior to melt processing (pg 1335 col 1 2; pg 1336 Fig. 4A).
However, Von Andrian is drawn to methods of designing, manufacturing, and using inventive vaccine nanocarriers and pharmaceutical compositions thereof. The invention provides methods of prophylaxis and/or treatment of diseases, disorders, and conditions comprising administering at least one inventive vaccine nanocarrier to a subject in need thereof (abstract).
Von Andrian discloses the compositions and methods can be used for the prophylaxis and/or treatment of any cancer [0465]. Cancers include but are not limited to biliary tract cancer; brain cancer; breast cancer; cervical cancer; choriocarcinoma; colon cancer; endometrial cancer; esophageal cancer; gastric cancer; intraepithelial neoplasms; lymphomas; liver cancer; lung cancer (e.g., small cell and non-small cell); melanoma; neuroblastomas; oral cancer; ovarian cancer; pancreatic cancer; prostate cancer; rectal cancer; sarcomas; skin cancer; testicular cancer; thyroid cancer; and renal cancer, as well as other carcinomas and sarcomas [0471].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the construct of Gourapura, with melt processed nanoparticle and upon release from the degradable polymer matrix having the same or substantially similar structural and/or biochemical characteristics as the particles prior to melt processing, as taught by Lee, because it would have enabled a melt processed degradable viral nanoparticle construct for delivery of virus or virus-like particles to a site of interest, wherein the composition and methods can be used for the treatment of cancers, thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Lee further discloses that the biodegradable polymer matrix includes a melt processable biodegradable polymer material (abstract; PLGA) that is cytocompatible and, upon degradation, produces substantially non-toxic products (abstract; PLGA to lactic and glycolic acid).
Gourapura further discloses that the virus or virus-like particles having a release profile from the biodegradable polymer material at least partially defined by the degradation of the biodegradable polymer material under physiological conditions ([0146]).
Gourapura further discloses that the virus or virus-like particles are substantially uniformly dispersed in the biodegradable polymer matrix ([0146]).
Gourapura and Lee do not specifically teach that the degradable polymer material has melt temperature below the degradation temperature of the virus or virus-like particles. However, it would have been obvious to one of ordinary skill in the art to have recognized that it is desirable to have used a degradable polymer material having melt temperature below the degradation temperature of the virus or virus-like particles such that the polymer matrix would degrade first to enable the virus or virus-like particle to be released subsequently.
Gourapura. in view of Lee, further discloses that the degradable polymer material comprises poly(lactic-co-glycolic acid) (PLGA) or a copolymer thereof (Gourapura [0087]; Lee abstract; PLGA).
Gourapura further discloses that the cargo molecule comprises at least one of a targeting agent ([0092]; "the presence of the UEA can help direct the composition or vaccine to mucosal specialized follicle or epithelial cells").
Gourapura discloses providing in situ delivery of the virus or virus-like particles upon administration to a subject ([0098]).
Gourapura further discloses being provided in the shape of a plurality of microparticles ([0209]; "Morphology {size and shape} of Nano-PRRSV-VLPs can be determined by coating the freeze-dried vaccine powder with gold-platinum under vacuum with the help of an ion coater and examined using TEM at 10 KV"; [0085]; "In some embodiments, the nanocarrier is a microparticle").
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 44-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of prior U.S. Patent No. 11,654,117 in view of Von Andrian et al. (US20140314865A1) hereinafter Von Andrian.
The instant claims differ from the claims of U.S. Patent No. 11,654,117 because claim 1 of the ‘117 patent does not require the method step of treating cancer by administering. However, Von Andrian is drawn to methods of designing, manufacturing, and using inventive vaccine nanocarriers and pharmaceutical compositions thereof. The invention provides methods of prophylaxis and/or treatment of diseases, disorders, and conditions comprising administering at least one inventive vaccine nanocarrier to a subject in need thereof (abstract). Von Andrian discloses the compositions and methods can be used for the prophylaxis and/or treatment of any cancer [0465]. One of ordinary skill in the art would reasonably expect success in administering the composition of the ‘117 patent to treat cancer as taught by Von Andrian.
This is a nonstatutory double patenting rejection.
Claims 44-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of prior U.S. Patent No. 12156947 in view of Von Andrian et al. (US20140314865A1) hereinafter Von Andrian.
The instant claims differ from the claims of U.S. Patent No. 11,654,117 because claim 1 of the ‘947 patent does not require the method step of treating cancer by administering. However, Von Andrian is drawn to methods of designing, manufacturing, and using inventive vaccine nanocarriers and pharmaceutical compositions thereof. The invention provides methods of prophylaxis and/or treatment of diseases, disorders, and conditions comprising administering at least one inventive vaccine nanocarrier to a subject in need thereof (abstract). Von Andrian discloses the compositions and methods can be used for the prophylaxis and/or treatment of any cancer [0465]. One of ordinary skill in the art would reasonably expect success in administering the composition of the ‘947 patent to treat cancer as taught by Von Andrian.
This is a nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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