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 1-19 are pending.
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) 1-4, 6, 8-10 and 12 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 Weller et al. (US 2004/0228794).
Regarding claims 1 and 6, Weller et al. teaches “therapeutic agent carrier compositions
that include a therapeutic agent carrier comprised of a stimulus sensitive gel or fibrin, or combinations thereof, and a therapeutic agent.” Para. [0016]. To this end, Weller et al. teaches a synthesis of poly(lactic acid-co-glycolic acid) (PEG-g-PLGA) using stannous octoate as a catalyst. See Example 8, para. [0154]. The therapeutic agent may include an aqueous insoluble such as 90-yttrium phosphate (current claim 8-10). See para. [0021]. Further, “the radioactive therapeutic agent includes radioisotope insoluble salt particles that have an average diameter of from about 0.3 to about 3 µm.” Para. [0057]. Weller et al. also teaches that “substantially all particle being substantially spherical in shape.” Para. [0063].
Weller et al. does not expressly teach “wherein the thermogel contains less than 65 ppm stannous octanoate” or “wherein the YPO-4 particle concentration is in the range of 3 mg/ml to 100 mg/ml” (current claim 12). However, where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. Here, in addition to teaching ytrrium phosphate particles of the same size and shape as claimed, Weller et al. also teaches that “the higher the Y3+ concentration the greater the average.” This suggest that concentration is a result effective variable. Accordingly, because the same size and shape are taught by Weller et al., then Weller et al. implicitly teaches the claimed concentration. In any event, “[w]hen the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 2, Weller et al. teaches “21-25% of PEG-g-PLGA aqueous solutions may be particularly useful injectable formulations for drug delivery.” Para. [0146].
Regarding claim 3, Weller et al. teaches pH between about 1 to about 7. See para. [0061].
Regarding claim 4, Weller et al. does not expressly teach “wherein the thermogel is substantially free of water molecules and oxygen molecules” However, where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weller et al. (US 2004/0228794) as applied to claims ) 1-4, 6, 8-10 and 12 is above, and further in view of Delaney Jr. et al. (US 2021/0060183).
Teaching of Weller et al. are discussed above.
Regarding claim 15, Weller et al. does not teach “wherein the functional group is selected from the group consisting of apatite, sodalit, iodide, hydride, and combinations thereof.”
Delaney Jr. et al. relates to bioerodible injectable hydrogels. See para. [0003]. In this regard, Delaney Jr. et al. teaches multi-armed polymer wherein polymer arms comprise a reactive end group and a branched end group comprising covalently attached diagnostic and/or therapeutic groups. See para. [0006]. “In some embodiment, the covalently attached diagnostic and/or therapeutic groups are radiocontrast groups or are radioactive groups.” Para. [0007]. “[T]he radiocontrast groups comprise a monocyclic or multicyclic aromatic structure that comprises a plurality of radiopaque functional groups ( e.g., iodine groups) and a plurality of
hydrophilic functional groups.” Para. [0008]. The radiocontrast agents render the polymer visible under x-ray or suitable for radiation therapy. See para. [0044].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the teachings of Weller et al. and Delaney Jr. et al. and arrive at the claimed invention. 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). 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 incorporate the functional group such as iodine so as either render the polymers visible under x-ray or suitable for radiation therapy as taught by Delaney Jr. et al.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-17 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-17 of prior U.S. Patent No. 12,201,703. This is a statutory double patenting rejection.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,201,703. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to radioactive yttrium phosphate suspensions comprising the same radioactive metal phosphate particles having the same particle size and shape and overlapping concentrations and thermogel.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,491,269. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to radioactive yttrium phosphate suspensions comprising the same radioactive metal phosphate particles having the same particle size and shape and overlapping concentrations.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,521,452 (“the ‘452 patent”) in view of in view of Hunter et al. (US 2003/0144570).
Regarding claims 1-17, although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to radioactive phosphate suspensions comprising the same radioactive metal phosphate particles having the same particle size and shape and overlapping concentrations.
Regarding claim 18, the difference between this claim and claim 1 of the ‘452 patent is that claim 18 specifies a metal phosphate particle as being palladium.
Hunter et al. teaches that implanted radioactive sources having low energy and/or short-half-lives, such as radioactive iodine and palladium (e.g., Pd103) (current claim 19), are used. See para. [0216].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the claimed subject matter of the ‘452 patent with Hunter et al. and arrive at the claimed invention. 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). 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 incorporate radioactive palladium as taught by Hunter et al.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 1618
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