DETAILED ACTION
Claims 12, 14-16 and 18-22 are currently pending. Claims 12, 14-15 and 19-20 are currently under examination.
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 .
Election/Restrictions
Applicant affirms the election of Group I with traverse. Applicant traverses the restriction requirement as the Office has not shown why it would be overly burdensome to examine Groups I and II together as they are classified together.
In response, the invention requires a different field of search, thus demonstrating a search burden. The search for continuous delivery device requires different search strings than the method of forming the delivery device. The Restriction is made final.
Withdrawn Rejections
The prior rejection of claim 20 under 112(b) is withdrawn as a result of Applicant providing Despanie reference which demonstrates Elastin-like polypeptide is a term of the art, which is persuasive.
The prior rejection of claim 12 and 14 under 102(a)(1) being anticipated by Lee is withdrawn based on Applicant amending instant claim 12 to contain limitations directed to elastic sealant, which Lee does not teach.
The prior rejection of claim(s) 12, 14-15 and 19 under 35 U.S.C. 103 as being unpatentable over US 2011/0244043 in view of US 2018/0078507 is withdrawn based on Applicant amending instant claim 12 to contain limitations directed to elastic sealant, which the ‘043 publication and the ‘507 publication does not teach.
The prior rejection of claim(s) 12-14 and 20 under 35 U.S.C. 103 as being unpatentable over Lee in view of WO 2006/110487 is withdrawn based on Applicant amending instant claim 12 to contain limitations directed one surface of the disk is exposed to enable uni-direcational release of a substance encapsuled in the substance encapsulated polymeric microsphere, which the combination of Lee and the ‘487 publication do not specifically teach.
Examiner’s Note
Applicant's amendments and arguments filed 07/10/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 07/10/2026, it is noted that claims 12, 14 and 20 have been amended and no new matter or claims have been added.
New Rejection:
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) 12, 14-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0244043 (previously applied) in view of US 5,902,598.
Regarding claims 12, 14-15 and 19, the limitation of a continuous delivery device comprising a plurality of substance-encapsulated polymeric microspheres compressed together is met by the ‘043 publication teaching a controlled releasing composition comprising a plurality of microparticles and a matrix. The microparticles comprise a first material and the matrix comprises a second material (abstract). The first material and/or second material comprises a polymer such as L-lactic acid, dextran and polyethylene glycol [0014]. The controlled release composition may include a pharmaceutical active agent including small molecules ([0081]-[0083]). The particle may comprise an additional agent such as dextran for rate modifying ([0088]-[0089], reading on claim 15). The controlled release compristion may further comprise a coating to modify the desired release properties of the active agent [0101]. The controlled release compristion can be any shape without limitation [0103]. Compression molding to form the controlled release composition is taught ([0118], [0122]). Example 2 teaches the formation of fluorouracil microparticles using fluorouracil, PLLA and dextran, wherein the microparticles are blended with PLGA and PEG and injection molded (Example 2), wherein dextran is taught as a hydrophilic domain (claim 15). The microparticles can be of the size 1 um to 5000 um diameters [0024], overlapping with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The implant is taught to be placed in the pocket of the eye ([0141], [0182]).
The ‘043 publication does not specifically recite a disk (claim 12) and an elastic sealant partially surrounding the disk so that one surface of the disk is exposed to enable unidirectional release of a substance encapsulated in the substance encapsulated polymeric microsphere through the one surface, wherein the elastic sealant consists of a slower degrading polymer than a polymer of the substance-encapsulated polymeric microspheres (claim 12).
The ‘598 patent a device for treating mammalian organism to obtain a desired local or systemic effect comprising administering a sustained release drug delivery system to a mammalian organism in need of such treatment in a controlled manner. The device includes an inner core or reservoir comprising the effective agent and a coating layer which is essentially impermeable to the passage of the effective agent. The second coating layer covers at least a portion of the first coating layer and inner core however at least a small portion of the first coating layer or inner core is not coated with the second coating layer. The second coating layer includes an impermeable film and at least one impermeable disk (abstract). The disk shape with an impermeable exterior and drug core is taught (figure 1, column 4, lines 25-35). The ‘598 patent teaches an inner core or reservoir which contains an agent effective in obtaining a desired effect containing coating layers and a permeable passage that the agent may pass through (column 4, lines 50-67, column 5, lines 3-15). The device is suitable for treating ocular conditions such as glaucoma and implanted in the eye (column 5, lines 65-column 6, line 5). Agents include 5-fluorouracil (column 6, lines 5-15). A large number of polymers may be used to construct the device and the only requirement is they inert and have the required permeability (column 6, lines 60-68). Since the second coating layer is essentially impermeable to the passage of the effective agent, only a portion of the inner core or reservoir and first layer may be coated with the second coating layer, depending on the desired delivery rate of the device, the second coating may only coat a small portion of the surface of the core or may coat a large portion for slower release rates of the effective agent (column 8, lines 5-15). Figure 1 teaches a single diffusion port opening of a drug core with an impermeable film (Figure 1), which would result in a unidirectional release.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the impermeable coating as taught by the ‘598 patent for the coating taught by the ‘043 publication as the ‘043 publication teaches a coating layer over a drug containing core and the ‘598 patent teaches specific impermeable coatings over a drug containing core. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation so success as the ‘043 publication and the ‘598 publication are both directed to ophthalmically implantable devices that contain fluorouracil and have exterior coatings over the drug containing core. One of ordinary skill in the art before the filing date of the claimed invention would have been motivated to use the impermeable containing coatings with an opening because the device containing impermeable coating and an opening is taught to have controlled and sustained release to obtain the desired local effect (column 4, lines 40-50) and the ‘043 publication teaches the desire for controlled release.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0244043 and US 5,902,598 as applied to claims 12, 14-15 and 19 above, and further in view of WO 2006/110487.
As mentioned in the above 103 rejection, all the limitations of claims 12, 14-15 and 19 are taught by the combination of the ‘043 publication and the ‘598 publication.
The ‘487 publication teaches sustained release implants with one or more bioactive agents localized at the desired treatment site which is for treating eyes and wherein the delivery of the bioactive agent may be localized (abstract). In some embodiments the implant comprises a bioactive core having an outer surface that is at least partially covered with a coating layer that comprises a biocompatible polymer matrix and one or more bioactive agents thus allowing for partial coating with at least one surface being exposed. In some embodiments the coating layer covers the entire outer surface of the core (page 9, first paragraph). Polymers useful in the implant include poly(L-lactic acid) (page 9, second paragraph). The coating is taught to modify the release characteristics of the one or more bioactive agents and can include poly(caprolactone) wherein the coating is taught to protect the bioactive agent form environment degradation prior to implantation (page 10, second paragraph, page 23, second paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a PCL coating as taught by the ‘487 publication on the device of the ‘043 publication as the ‘487 publication teaches the PCL coating protects the bioactive agent from the environment before implantation, thus providing a motivation to use a PCL coating on the device of the ‘043 publication which teaches use of a coating. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘487 publication teaches PCL thin coating on a drug delivery implant and the ‘043 publication is directed to a drug delivery device containing a coating. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use PCL on the device of the ‘043 publication and coating the device besides a single opening as the ‘598 patent teaches that it was known to coat devices to provide a single opening for drug release in ophthalmic devices and the ‘043 publication, the ‘598 patent and the ‘487 publication are directed to drug releasing implants with a coat and a coating to deliver active agent to the eye, thus providing an expectation of success of using known coating materials of the ‘487 publication for the specific coating design taught by the ‘598 patent.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘043 publication, the ‘507 publication and the ‘487 publication do not teach unidirectional release. The ‘487 publication discloses the implant comprises a biocompatible core having an outer surface that is at least partially covered with a coating layer that comprises a biocompatible polymer matrix. The ‘487 publication (Varner) includes two coating layers, the first of which include the bioactive agent (not the same as Applicant’s) and the second which is added to modify the rate of release of the bioactive agent form the underlying coating and core. This does not arrive at the unidirectional release.
In response, Applicant is referred to the newly applied rejection above. The ‘598 patent teaches a drug delivery device containing a single opening surrounded by impermeable polymer (abstract, figure 1, column 4, lines 25-35), which would result in unidirectional release as the structure of the device is taught necessarily resulting in unidirectional release.
Applicant argues the ‘487 publication teaches the coating containing one or more bioactive agents, wherein the active agent is removed upon dissolution o the polymer coating and in the core and the uncoated portion of the core is used for handing. There is not teaching or suggestion that the bioactive agent would release unidirectionally through the uncoated portion f the core.
In response, Applicant is referred to the newly applied rejection above. The ‘598 patent teaches a drug delivery device containing a single opening surrounded by impermeable polymer (abstract, figure 1, column 4, lines 25-35), which would result in unidirectional release as the structure of the device is taught necessarily resulting in unidirectional release. One of ordinary skill in the art before the filing date of the claimed invention would have been motivated to use the impermeable containing coatings with an opening because the device containing impermeable coating and an opening is taught to have controlled and sustained release to obtain the desired local effect (column 4, lines 40-50) and the ‘043 publication teaches the desire for controlled release. The instant claims are directed to product claims wherein ‘598 patent teaches the drug containing core being coated expect for an opening and thus would result in release only through said opening resulting in unidirectional release.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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