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 .
Receipt is acknowledged of Applicant’s Request for Continued Examination and Amendment filed on 09/12/2025; and IDS filed on 09/12/2025.
Claims 16, 18, 26, 29 have been amended.
Claim 30 has been added.
Claims 16-21, 23-30 are pending in the instant application.
Claim 30 is withdrawn from further consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/12/2025 has been entered.
Election/Restrictions
Newly submitted claim 30 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 29 is drawn a cylinder member and claims 19 and 20 drawn lengths of the cylinder, wherein newly added claim is drawn to a sphere member.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 3 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 16-18, 21, 23-26, 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JACKSON et al (WO 2018/227293).
JACKSON teaches “plural referents” means “reference ‘a thing’ includes more than one such thing” (see pg. 37, last paragraph), which reads on plurality, of paste compositions (see title), which reads on plurality of discreate depots (see Applicant’s specification at [1303] in reference to the depot can be a “paste”), for controlled release of one or more drugs (see abstract) comprised of polymers (see abstract), such as PLGA/PEG (see pg. 14) and one or more drugs (see abstract), such as 1% docetaxel and 1% bicalutamide (see pg. 14-15), intended use for the prostate (see pg. 5 and 15) to treat prostate cancer (see pg. 35), wherein controlled release for days (see Figures), such as 40 days (see pg. 30 and Figure 3A). Additional disclosures include: a needle or catheter system for injection delivery (see pg. 6 and 28), which reads on tubular delivery device and having a proximal end portion configured to be manipulated by a user and a distal end portion configured to be positioned in a prostate; various paste shapes, such as cylinder, crescent, and hemisphere (see pg. 15 and 32), wherein a cylinder shape would read on “the depot has a first end, a second end, and a length measured between the first and second ends along a longitudinal axis of the at least one depot, and wherein the depot has a substantially constant cross-sectional dimension along its length”.
Note, bicalutamide is an antiandrogen therapeutic agent.
Note, docetaxel is a chemotherapeutic agent.
Note, JACKSON’s paste compositions would be capable of the intended use of “implanted at a different treatment site at a prostate gland of the patient” and “deliverable to the prostate gland through a needle”, because JACKSON’s compositions are the same as claimed by Applicant.
Claim(s) 16-18, 23, 26-27, 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PAL et al (US 2007/0178138).
Regarding claims 16-18, 23, PAL teaches a delivery system for treating prostate cancer (see [0084]) comprised of:
An implant injecting device, wherein the implants are inserted through a trocar and coupled to a syringe-like device or other piston driven apparatus (see [0053]) and Fig. 2 (wherein Fig. 2 is provided below), which is tubular and reads on a tubular delivery device and having a proximal end portion configured to be manipulated by a user and a distal end portion configured to be positioned in a prostate.
PNG
media_image1.png
301
413
media_image1.png
Greyscale
Implants (see [0053]), which reads on a plurality of discrete depots loaded in the delivery device, comprised of: biodegradable polymer, such as such as poly(lactide-co-glycolide) (“PLGA”; see [0008]; [0054] and [0075]) mixed with chemotherapeutic agent (see [0084]), such as docetaxel (see [0030]), is released from the implant for at least about 2 weeks (see Example 3 at [0084]) or months (see [0061]).
Regarding claims 26-27 and 29, PAL teaches the implants can be cylinders (see [0057]), with lengths of 1 mm (see [0058]).
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.
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) 16-21, 23-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over JACKSON et al (WO 2018/227293).
As discussed above, JACKSON teaches “plural referents” means “‘a thing’ includes more than one such thing” (see pg. 37, last paragraph), which reads on plurality, of paste compositions (see title), which reads on plurality of discreate depots (see Applicant’s specification at [1303] in reference to the depot can be a “paste”), for controlled release of one or more drugs (see abstract) comprised of polymers (see abstract), such as PLGA/PEG (see pg. 14) and one or more drugs (see abstract), such as 1% docetaxel and 1% bicalutamide (see pg. 14-15), intended use for the prostate (see pg. 5 and 15) to treat prostate cancer (see pg. 35), wherein controlled release for days (see Figures), such as 40 days (see pg. 30 and Figure 3A). Additional disclosures include: a needle or catheter system for injection delivery (see pg. 6 and 28), which reads on tubular delivery device and having a proximal end portion configured to be manipulated by a user and a distal end portion configured to be positioned in a prostate; various paste shapes, such as cylinder, crescent, and hemisphere (see pg. 15 and 32), wherein a cylinder shape would read on “the depot has a first end, a second end, and a length measured between the first and second ends along a longitudinal axis of the at least one depot, and wherein the depot has a substantially constant cross-sectional dimension along its length”. Note, bicalutamide is an antiandrogen therapeutic agent. Note, docetaxel is a chemotherapeutic agent. Note, JACKSON’s paste compositions would be capable of the intended use of “implanted at a different treatment site at a prostate gland of the patient” and “deliverable to the prostate gland through a needle”, because JACKSON’s paste compositions are the same as claimed by Applicant.
The reference does not specifically teach the dosage or cross-sectional dimensions or having different lengths as claimed by Applicant. The dosage, cross-sectional dimension and length of a cylindrical drug composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal dosage, cross-sectional dimension and length of a cylindrical drug composition in order to best achieve the desired results, such as amounts of drugs and drug release rates for treatment of cancer. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage, cross-sectional dimension and length of a cylindrical drug composition would have been obvious at the time of Applicant's invention. Especially, when JACKSON teaches the effect of paste geometry and drug loading on the release of the drug.
Response to Arguments
Applicant argues that Jackson fails to disclose or suggest, "a delivery device having a proximal end portion configured to be manipulated by a user and a distal end portion configured to be positioned in a prostate; and a plurality of discrete depots loaded in the delivery device," as recited in claim 16.
The Examiner finds this argument unpersuasive, because as discussed in the rejection the prior art teaches using a needle or catheter system for injection delivery (see pg. 6 and 28), which reads on tubular delivery device and having a proximal end portion configured to be manipulated by a user and a distal end portion configured to be positioned in a prostate.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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, Michael Hartley can be reached at (571) 272-0616. 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.
/JAKE M VU/Primary Examiner, Art Unit 1618