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 .
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.
Claim Objections
Claims 1-2, 4-5, 9, 11, 13, and 16 are objected to because of the following informalities:
Claims 1-2, 4-5, 9, 11, 13, and 16, “Darolutamide” should be lowercase in each instance it appears.
Claim 4, line one, “any one of” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 30 is indefinite because of the term “substantially” in line 3. This term renders the claim indefinite because it is not clear how much coating needs to cover the drug implant to be considered “substantially” covered and the term “substantially” is not explicitly defined in the specification.
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.
Claims 1-2, 4-6, 9, 11, 13-14, 16, 18, 22, 25-26, and 28-30 are rejected under 35 U.S.C. 103 as being as being obvious over Lee et al. (US 2017/0165460 A1) in view of Dervan et al. (US 2018/0064688 A1).
Regarding claim 1, Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). Lee discloses that the drug delivery device is implanted in a patient [0092] and is used to treat diseases such as prostate cancer [0069].
Lee does not disclose that the drug is darolutamide.
Dervan discloses compositions and methods for the treatment of prostate cancer where a prostate drug and polymeric matrix are combined for use as an implant [abstract] [0094] [0100]. Darolutamide is taught as a drug for the treatment of prostate cancer [0009] [0073].
Since Lee generally teaches an implant with a drug to treat prostate cancer, it would have been prima facie obvious to one of ordinary skill in the art to include darolutamide, within the teachings of Lee because Dervan teaches a drug, such as darolutamide, can be combined with a polymer matrix and used in an implant. An ordinarily skilled artisan would be motivated to use darolutamide to treat prostate cancer as taught by Dervan [0009] [0073].
Furthermore, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Lee generally taught drugs to treat prostate cancer, it is prima facie obvious to select darolutamide for incorporation into the implant based on its recognized suitability for the intended use as a drug to treat prostate cancer, as taught by Dervan.
Claim 2 is rendered prima facie obvious because Lee discloses that the drug is present in an amount between 1 and 20 % by weight [0051]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Regarding claims 4-5 and 9 the amount of drug released at the implant site/ in in vitro models would be achieved by one of ordinary skill in the art through routine experimentation. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In the instant case, the general conditions of drug release and ways to modulate the release is taught by Lee. Lee teaches that the delivery device allows for extended, continuous, intermittent, or periodic release of a desired quantity of drug over a desired, predetermined time period, such as 12 hours to 90 days [0094] [0002], that the release of the drug is controlled by diffusion of the drug from the silicone-drug matrix system [0027], the thickness and composition of the outer wall layer is selected to control release of the drug [0039], and the surface area of the matrix system alters the drug release characteristics [0048]. Therefore, an ordinarily skilled artisan would optimize the drug delivery device to achieve the claimed release characteristics following the teachings of Lee.
Claim 6 is rendered prima facie obvious because Lee discloses the polymer matrix is silicone (abstract).
Claim 11 is rendered prima facie obvious because Lee discloses the drug is in solid form [0059] [0086].
Claim 13 is rendered prima facie obvious because Lee discloses the implant has a durometer value from 45 Shore A to 88 Shore A [0035] [0054]. The ordinarily skilled artisan would attain this hardness value for the implant when loaded with 60% w/w of the duroluamide to obtain the durometer value taught by Lee.
Regarding claim 14, Lee discloses the implant is visible by a variety of imaging techniques [0081]. While ultrasound imaging is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches an implant with the same components (silicone), the properties the applicant discloses and/or claims (visible by ultrasound) are necessarily present.
Regarding claim 16, while the drug implant inhibiting modulation of the drug is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches a drug implant with the same components (a drug dispersed in silicone - which spatially separates the drug from surrounding tissue), the properties the applicant discloses and/or claims (inhibiting modulation) are necessarily present.
Claim 18 is rendered prima facie obvious because Lee discloses the implant is elongate and tubular [0032]-[0033].
Claim 22 is rendered prima facie obvious because Lee discloses diameters of the implant such as 0.51 mm and 0.93 mm [0099] [0103]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claims 25-26 and 28, the limitations of the drug implant being “configured to” (directly contact a target tissue, be implanted into a target tissue, or be delivered to a target tissue using a lumen of a needle or catheter) are interpreted as product-by-process limitations. Even though the product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, then the claim is unpatentable even though the prior product was made by a different process.
In the case of claims 25-26, Lee discloses that the drug delivery device is inserted into a tissue site within the patient, to deliver drugs to the prostate [0096], and releases the drug from the device to the tissue site [0009]. The device elastically deforms (i.e., appears to have substantial contact with tissue) [0009]. As such, the Applicant' s limitation regarding the process of configuration to directly contact a target tissue and be implanted into a target tissue is not patentable in view of Lee.
In the case of claim 28, Lee discloses that the device is sized and shaped to fit through a path of a deployment instrument, such as a catheter [0030]-[0031]. As such, the Applicant' s limitation regarding the process of configuration to be delivered to a target tissue using a lumen of a needle or a catheter is not patentable in view of Lee.
Claim 29 is rendered prima facie obvious because Lee does not require the use of a sheath, a scaffold, or a retention member for retaining the drug implant within the target tissue (whole document).
Claim 30 is rendered prima facie obvious because Lee discloses the implant can include a walled structure which is positioned over the matrix system (i.e., a coating) [0048] [0056]. The coating at least partially covers the drug implant.
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, 4-6, 9, 11, 13-14, 16, 18, 22, 25-26, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,666,528 in view of Lee et al. (US 2017/0165460 A1) and Dervan et al. (US 2018/0064688 A1).
Claims 1-2, 4-6, 9, 11, 13-14, 16, 18, 22, 25-26, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,338,119 in view of Lee et al. (US 2017/0165460 A1) and Dervan et al. (US 2018/0064688 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the implant except for darolutamide and the implant being tubular and comprising a coating.
Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). Lee discloses the implant is tubular [0032]-[0033]. Lee discloses the implant can include a walled structure which is positioned over the matrix system (i.e., a coating) [0048] [0056].
Dervan discloses compositions and methods for the treatment of prostate cancer where a prostate drug and polymeric matrix are combined for use as an implant [abstract] [0094] [0100]. Darolutamide is taught as a drug for the treatment of prostate cancer [0009] [0073].
It would have been prima facie obvious to include darolutamide and the implant being tubular and comprising a coating within the claims. The ordinarily skilled artisan would be motivated to configure the implant to be tubular and have a coating as taught by Lee at [0032]-[0033] [0048] [0056]. The ordinarily skilled artisan would be motivated to include darolutamide to treat prostate cancer as taught by Dervan at [0009] [0073].
The weight percentages of each component, and release profile, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
Claims 1-2, 4-6, 9, 11, 13-14, 16, 18, 22, 25-26, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,173,291 in view of Lee et al. (US 2017/0165460 A1) and Dervan et al. (US 2018/0064688 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the implant except for darolutamide and the implant being tubular.
Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). Lee discloses the implant is tubular [0032]-[0033].
Dervan discloses compositions and methods for the treatment of prostate cancer where a prostate drug and polymeric matrix are combined for use as an implant [abstract] [0094] [0100]. Darolutamide is taught as a drug for the treatment of prostate cancer [0009] [0073].
It would have been prima facie obvious to include darolutamide and the implant being tubular within the claims. The ordinarily skilled artisan would be motivated to configure the implant to be tubular as taught by Lee at [0032]-[0033]. The ordinarily skilled artisan would be motivated to include darolutamide to treat prostate cancer as taught by Dervan at [0009] [0073].
The weight percentages of each component, and release profile, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
Claims 1-2, 4-6, 9, 11, 13-14, 16, 18, 22, 25-26, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13-15, and 17-20 of U.S. Patent No. Application No 17/911,775 in view of Lee et al. (US 2017/0165460 A1) and Dervan et al. (US 2018/0064688 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the implant except for darolutamide and the implant being tubular and comprising a coating.
Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). Lee discloses the implant is tubular [0032]-[0033]. Lee discloses the implant can include a walled structure which is positioned over the matrix system (i.e., a coating) [0048] [0056].
Dervan discloses compositions and methods for the treatment of prostate cancer where a prostate drug and polymeric matrix are combined for use as an implant [abstract] [0094] [0100]. Darolutamide is taught as a drug for the treatment of prostate cancer [0009] [0073].
It would have been prima facie obvious to include darolutamide and the implant being tubular and comprising a coating within the copending claims. The ordinarily skilled artisan would be motivated to configure the implant to be tubular and have a coating as taught by Lee at [0032]-[0033] [0048] [0056]. The ordinarily skilled artisan would be motivated to include darolutamide to treat prostate cancer as taught by Dervan at [0009] [0073].
The weight percentages of each component, and release profile, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-6, 9, 11, 13-14, 16, 18, 22, 25-26, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 13-18, and 38-41 of U.S. Patent No. Application No 18/025,611 in view of Lee et al. (US 2017/0165460 A1) and Dervan et al. (US 2018/0064688 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the implant except for darolutamide, the drug being in solid form, the diameter of the implant and the implant being tubular.
Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). Lee discloses the implant is tubular [0032]-[0033]. Lee discloses the drug is in solid form [0059] [0086]. Lee discloses diameters of the implant such as 0.51 mm and 0.93 mm [0099] [0103].
Dervan discloses compositions and methods for the treatment of prostate cancer where a prostate drug and polymeric matrix are combined for use as an implant [abstract] [0094] [0100]. Darolutamide is taught as a drug for the treatment of prostate cancer [0009] [0073].
It would have been prima facie obvious to include darolutamide, the drug being in solid form, the diameter of the implant and the implant being tubular within the copending claims. The ordinarily skilled artisan would be motivated to configure the implant to be tubular, have the claimed diameter, and have the drug be in solid form as taught by Lee at [0032]-[0033] [0059] [0086] [0099] [0103]. The ordinarily skilled artisan would be motivated to include darolutamide to treat prostate cancer as taught by Dervan at [0009] [0073].
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612