DETAILED ACTION
Claims 12-22 are currently pending. Claims 12-15 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's election with traverse of Group I in the reply filed on 01/26/2026 is acknowledged. The traversal is on the ground(s) that US restriction practice should have been applied, not Unity of Invention Practice. This is found persuasive. A new Restriction based on US practice is provided below. For compact prosecution Applicant’s election of Group I is acknowledged. Group I is being examined below as the proper claims were placed into Groups I and II, and Applicant has elected Group I with traverse to expedite prosecution.
Claims 16-18 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/26/2026.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 12-15 and 19-20, drawn to a continuous delivery device, classified in 424/426.
II. Claims 16-18 and 21-22, drawn to a method for making a continuous delivery device, classified in 424/426.
The inventions are independent or distinct, each from the other because:
Inventions Group II and Group I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the particles can be formed by spray drying before compression to form the disk.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The instant application is a divisional application of 16/335,947, filed 03/22/2019, which is a national stage entry of PCT/US17/52670, filed 09/21/2017, which claims priority to provisional application 62/399,126, filed 09/23/2016.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 01/23/2023 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 contains the limitation of poly(glycerol sebacate)), wherein the use of double parenthesis is a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 20 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 20 recites “elastin-like polypeptide”. The term "elastin-like" in claim 20 is a term which renders the claim indefinite. The term "elastin-like" is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how structurally different a compound may be and still be considered a “elastin-like”. The instant claims and specification do not provide a clear metes and bounds of the claim and the term “elastin-like” is not defined.
Claim Rejections - 35 USC § 102
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) 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (Lee, Lai Yeng, et al., Chemical Engineering Science, 64 (2009) pgs. 4341-4349).
Regarding claim 12, the limitation of a continuous delivery device, comprising: a disk including a plurality of substance-encapsulated polymeric microspheres compressed together is met by Lee teaching micro-porous polymeric foams for use in tissue engineering and drug delivery comprising spray drying for the encapsulation of paclitaxel in the PLGA polymer matrix which are used to form compressed disks and have constant release rate (abstract, page 4342, second column 2.2).
Regarding claim 14, the limitation of a substance encapsulate din the substance encapsulated polymeric microsphere is selected form a group including a drug and a polymer selected from a group including PLGA is met by Lee teaching micro-porous polymeric foams for use in tissue engineering and drug delivery comprising spray drying for the encapsulation of paclitaxel in the PLGA polymer matrix which are used to form compressed disks and have constant release rate (abstract, page 4342, second column 2.2).
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 in view of US 2018/0078507.
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). 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 ‘043 publication does not specifically recite a disk (claim 12).
The ‘507 publication teaches therapeutic compositions comprising an active agent encapsulated in or incorporated into a biodegradable polymer particle (abstract). The polyesters are taught to include PLA and PLGA [0063]. PLGA particles were taught as compressed into disc [0128]. The ‘507 publication teaches hydrophilic cores of alginate chitosan that is coated with PLGA which is a protein friendly core microenvironment [0008].
Regarding claim 15, the ‘043 publication teaches specifically microparticles formed of drug, dextran and PLGA to be compressed into an implant (Example 2) wherein naturally polymers are taught to include dextran and chitosan [056] and wherein active agents include proteins [0083] and vaccines [0082]. The ‘507 publication teaches the active agent to be vaccines [0011] wherein vaccines and proteins are encapsulated in a hydrophilic alginate chitosan core coated in PLGA to form microspheres. Thus it would be obvious to form hydrophilic domains of natural hydrophilic polymers such as chitosan to provide a microenvironment friendly for proteins when administering the proteins and vaccines taught as active agents in the microspheres by both the ‘043 publication and the ‘507 publication.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to compress the composition as taught by the ‘043 publication into a disc form as the ‘043 publication teaches microparticles which may be compression molded into any shape and the ‘507 publication teaches specifically compression molding of microparticles to form a disk shape. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use a known shape as taught by the ‘507 publication for the composition of the ‘043 publication with an expectation of success as the ‘043 publication teaches any shape may be used and both the ‘043 publication and the ’507 publication are directed to drug releasing device of encapsuled active agents in microparticles which are formed by compression molding.
Claim(s) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0244043 in view of US 2018/0078507 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 of the limitations of claims 12, 14-15 and 19 are taught by the combination of the ‘043 publication and the ‘507 publication.
The combination of references does not specifically teach an elastic sealant partially surrounding the disk so that at least one surface of the disk is exposed (claim 13) wherein the elastic sealant is selected from the group including PCL (claim 20).
The ‘487 publication teaches sustained release implants with one or more bioactive agents localized at the desired treatment site (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 reading on claim 13. 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) (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 polycaprolactone as taught by the ‘487 publication as the coating taught by the ‘043 publication because the ‘043 publication teaches a coating layer to control the release rate of an active agent and the ‘487 publication teaches a specific polymer, PCL, known to coat an implantable device to control the drug release rate. Thus 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 known polymeric compound to achieve the desired controlled release taught by the polymeric coating of the ‘043 publication and optimize the coating surface as the ‘487 publication teaches at least partially coating the core. It is prima facie obvious for a skilled artisan to pursue the known options within his or her own technical grasp to achieve the predictable results of drug releasing device comprising a rate limiting coating.
Claim(s) 12-14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee, Lai Yeng, et al., Chemical Engineering Science, 64 (2009) pgs. 4341-4349) in view of WO 2006/110487.
Regarding claim 12, the limitation of a continuous delivery device, comprising: a disk including a plurality of substance-encapsulated polymeric microspheres compressed together is met by Lee teaching micro-porous polymeric foams for use in tissue engineering and drug delivery comprising spray drying for the encapsulation of paclitaxel in the PLGA polymer matrix which are used to form compressed disks and have constant release rate (abstract, page 4342, second column 2.2).
Regarding claim 14, the limitation of a substance encapsulate din the substance encapsulated polymeric microsphere is selected form a group including a drug and a polymer selected from a group including PLGA is met by Lee teaching micro-porous polymeric foams for use in tissue engineering and drug delivery comprising spray drying for the encapsulation of paclitaxel in the PLGA polymer matrix which are used to form compressed disks and have constant release rate (abstract, page 4342, second column 2.2).
Lee does not specifically teach an elastic sealant partially surrounding the disk so that at least one surface of the disk is exposed (claim 13) wherein the elastic sealant is selected from the group including PCL (claim 20).
The ‘487 publication teaches sustained release implants with one or more bioactive agents localized at the desired treatment site (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 reading on claim 13. 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 Lee 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 Lee. 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 Lee is directed to a drug delivery device. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the surfaces coated as the ‘487 publication teaches at least partial coating, wherein the coating provides protection and alters drug release rate, thus the surfaces coated is an optimizable parameter.
Conclusion
No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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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