DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 06/29/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 64 is objected to because of the following informality:
Claim 64 recites “wherein a diameter of the drug implant is from about 0.1 mm to about 1.5 mm” twice. Appropriate correction is required.
Claim Rejections - 35 USC § 103 (Maintained)
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, 4-5, 9, 11, 13-14, 16, 18, 22, 25, 28-30, 62-63, and 65-66 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). In a preferred embodiment, the silicone is platinum-cured silicone [0053]. Lee discloses that the drug delivery device is implanted in a patient [0092] and is used to treat diseases such as prostate cancer [0069]. 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].
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.
Further regarding claim 1, while Lee does not explicitly disclose that the drug implant is configured to be implanted into prostate tissue, Lee does disclose that the drug delivery device is implanted in a patient [0092] and is used to treat diseases such as prostate cancer [0069]. 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]. The instant specification does not explicitly define what structural limitations the drug implant must have to be configured to be implanted in prostate tissue and it would be reasonably expected from the teachings of Lee that the disclosed implant would be capable of being implanted in prostate tissue.
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 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 reasonably expected to be necessarily present.
Regarding claim 16, while the drug implant inhibiting degradation 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 degradation) are necessarily present.
Claim 18 is rendered prima facie obvious because Lee discloses the implant may be 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 claim 25, 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, it would be reasonably expected from the teachings of Lee that the outer surface of the disclosed implant would have at least 50% contact with the target tissue.
Claim 28 is rendered prima facie obvious because Lee discloses that the device is sized and shaped to fit through a path of a deployment instrument, such as a catheter [0030]-[0031].
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.
Claim 62 is rendered prima facie obvious because Lee discloses a walled structure (i.e., a coating) is optional [0048]. Therefore, a coating is not required for the implant of Lee and Lee discloses drug implants which lack a coating [0048] (Fig 11-13).
Regarding claim 63, Lee does not disclose that the darolutamide is present in the drug implant in an amount of about 1 mg to about 10 mg.
Dervan teaches that a therapeutically effective amount of a prostate drug (such as darolutamide [0009]) typically varies from 0.01 mg/kg to 2000 mg/kg [0060]. The average adult weight is around 62 kg, therefore, Devran teaches around 0.62-124,000 mg as a therapeutically effective amount of the drug.
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 0.62-124,000 mg of darolutamide, within the teachings of Lee because Dervan teaches this amount of a prostate drug, such as darolutamide, is a therapeutically effective amount [0009] [0060]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 65 is rendered prima facie obvious because Lee discloses the implant may be cylindrical (i.e., rod-shaped) [0048] (Fig 5-8).
Regarding claim 66, absent a clear disclosure in the specification regarding what would materially change the composition, "consisting essentially of" is interpreted to be "comprising" language. MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention. Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract) and it would have been obvious to use darolutamide, as taught by Dervan, within the teachings of Lee, as previously discussed.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
Applicant argues at pg. 8 that neither reference teaches nor discloses that the polymer matrix comprises a platinum-cured silicone.
The Examiner disagrees because Lee discloses that in a preferred embodiment the silicone is platinum-cured silicone [0053].
Applicant also argues at pg. 8 that neither references teaches or discloses a drug implant “configured to be implanted into a target tissue of a subject, wherein the target tissue comprises prostate tissue”.
The Examiner disagrees. While Lee does not explicitly disclose that the drug implant is configured to be implanted into prostate tissue, Lee does disclose that the drug delivery device is implanted in a patient [0092] and is used to treat diseases such as prostate cancer [0069]. 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]. The instant specification does not explicitly define what structural limitations the drug implant must have to be configured to be implanted in prostate tissue and it would be reasonably expected from the teachings of Lee that the disclosed implant would be capable of being implanted in prostate tissue.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
Claim 64 is 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) and further in view of Pal et al. (US 2007/0178138 A1).
The 35 U.S.C. 103 rejection over Lee in view of Devran was previously discussed.
Regarding claim 64, Lee discloses diameters of the implant such as 0.51 mm and 0.93 mm [0099] [0103].
Lee does not disclose the claimed length of the drug implant.
Pal teaches polymeric matrix implants to treat an intraperitoneal condition or disease [abstract] [0050] including diseases such as prostate cancer [0050] [0062]. The implants have a length from 0.5 mm to 20 mm [0058]. Pal teaches that the implants provide controlled, precise, steady doses of agents to organs or other body tissues or structures to achieve a desired effect [0018].
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 use a length of 0.5 mm to 20 mm, within the teachings of Lee because Pal teaches an implant to treat diseases such as prostate cancer with this length. The ordinarily skilled artisan would be motivated to use this length of implant because Pal teaches that the implants provide controlled, precise, steady doses of agents to organs or other body tissues or structures to achieve a desired effect [0018]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Response to Arguments
The rejection of claim 64 over Lee, Dervan, and Pal is newly applied and has not been traversed.
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, 9, 11, 13-14, 16, 18, 22, 25, 28-30, and 62-66 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, 4-5, 9, 11, 13-14, 16, 18, 22, 25, 28-30, and 62-66 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).
Claims 1-2, 4-5, 9, 11, 13-14, 16, 18, 22, 25, 28-30, and 62-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No 12,576,063 in view of Lee et al. (US 2017/0165460 A1) and Dervan et al. (US 2018/0064688 A1).
Claims 1-2, 4-5, 9, 11, 13-14, 16, 18, 22, 25, 28-30, and 62-66 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, the implant being rod-shaped, and the silicone being platinum-cured silicone.
Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). In a preferred embodiment, the silicone is platinum-cured silicone [0053]. Lee discloses the implant may be cylindrical (i.e., rod-shaped) [0048] (Fig 5-8).
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 implant being rod-shaped, and platinum-cured silicone within the claims. The ordinarily skilled artisan would be motivated to configure the implant to be rod-shaped and to use platinum-cured silicone as taught by Lee at [0053] [0048] (Fig 5-8). 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, 4-5, 9, 11, 13-14, 16, 18, 22, 25, 28-30, and 62-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 13-14, 18, 38-39, 41, and 61-65 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, and the polymer matrix being platinum-cured silicone.
Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). In a preferred embodiment the silicone is platinum-cured silicone [0053]. Lee discloses the drug is in solid form [0059] [0086].
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, and the polymer matrix being platinum-cured silicone within the copending claims. The ordinarily skilled artisan would be motivated to configure the implant to have the drug be in solid form and for the polymer matrix to be platinum-cured silicone as taught by Lee (abstract) [0053] [0059] [0086]. 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.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims of the conflicting patents/patent application do not include platinum-cured silicone and therefore, the double patenting rejections are moot.
The Examiner disagrees. Lee discloses a drug delivery device formed of a matrix system of a drug dispersed in the biocompatible, non-biodegradable polymer matrix, silicone (abstract). In a preferred embodiment the silicone is platinum-cured silicone [0053]. The ordinarily skilled artisan would be motivated for the polymer matrix to be platinum-cured silicone as taught by Lee (abstract) [0053].
The claims remain rejected over the conflicting claims in view of Lee and Dervan.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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.
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, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights