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 .
Claim Status
Applicant’s response to the restriction requirement filed on July 7, 2026, has been received and entered. Claims 1-89 have been cancelled. Claims 90-110 are pending in this instant application.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 90-107 drawn to a method of making a medical device in the reply filed on July 7, 2017. However, applicant did not distinctly and specifically point out the supposed errors in the restriction requirement. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 108-110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 90-107 are under consideration.
The election/restriction Requirement is deemed proper and made Final.
Priority
Applicant has filed the in statant Application as a Divisional Application from parent Application 16/074,256 filed on July 31, 2018, which has matured into patent 12/115,289. The designation of Divisional is incorrect as Applicant has elected the same group that has been prosecuted in parent Application 16/074,256, as such the instant Application is a Continuation of Application 16/074,256. Appropriate correction is required.
Acknowledgment is made of applicant's claim for priority to the filing dates of the PCT Patent Application Serial No. US2017/016506 filed on February 3, 2017; and the United States Provisional Patent Application Serial No. 62/291,856 filed on February 5, 2016.
Claim Objections
Claims 90, 91, 95-100, 104-105 are objected to because of the following informalities: Claims 90 and 91 part a. recites “at least one biodegradable moiety” and then “the biodegradable moiety” for consistence the “the biodegradable moiety” should read “the at lease one biodegradable moiety”. Similarly, part b of claim 90 recites “at least one bioactive agent” and “bioactive agent”, for consistence the bioactive agent” should recite “at least one bioactive agent”. For the same reasons “the bioactive agent” of claims 95-97 should read “the at least one bioactive agent”. Claim 90 recites “at least one cross-linkable moiety” claims 98, 99 should recite “the at least one cross-linkable moiety” Claim 100 recites “ “biodegradable moiety” it should recite the biodegradable drug eluting polymer. Claim 104 recites “the initiator” it should recite the at least one initiator. Claim 105 recites “the inhibitor”, it should recite the at least on inhibitor Appropriate correction is required
Claim 98 is objected to because of the following informalities: Claim 98 recites in part “wherein the macromer is comprised of covalently bonded in the following order cross-linkable moiety”. This phrase is confusing and unnecessarily wordy Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 90-107 are 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 90 recites “and at least one initiator or at least one inhibitor without the addition of a solvent”, this is vague and indefinite because it is unclear if the without the addition of a solvent refers to only at least one inhibitor, the at least one initiator or at least one inhibitor, or to the liquid polymerizable mixture. Based on paragraph 10 of the instant specification and in the interest of compact prosecution the claim shall be interpreted as the liquid polymerizable mixture is without the addition of a solvent. Claims 92-107 are included in the rejection as they depend directly or indirectly from claim 90.
Claim 90 recites providing a liquid polymerizable mixture, it is unclear if the liquid polymerizable mixture incudes the at least one initiator or at least one inhibitor as there is a semicolon followed by “and at least one initiator or at least one inhibitor without addition of a solvent”, it is unclear if the portion after the semicolon is part of the polymerizable mixture, especially in light of the claim also reciting “providing a liquid polymerizable mixture comprising at least a macromer that is a liquid at a temperature between about 10°C and about 40°C, wherein the liquid polymerizable mixture is made by covalently linking a connecting moiety to at least one biodegradable moiety and covalently linking at least one cross-linkable moiety to the biodegradable moiety”. The two uses of the term “and” confuses what is the final moiety in the liquid polymerizable liquid. Clarification is required. Part b, in part, recites “mixing with at least one bioactive agent” it is unclear what is being mixed with the at least on bioactive agent. Claims 92-107 are included in the rejection as they depend directly or indirectly from claim 90.
Claim 91 recites “and at least one initiator without the addition of a solvent”, this is vague and indefinite because it is unclear if the without the addition of a solvent refers to only the initiator or to the liquid polymerizable mixture. Based on paragraph 10 of the instant specification and in the interest of compact prosecution the claim shall be interpreted as the liquid polymerizable mixture is without the addition of a solvent.
Because of the placement of the semicolon in part a of claim 91 it is unclear if the liquid polymerizable mixture comprises the at least one initiator or if that is supposed to be a moiety in addition to the liquid polymerizable mixture. Part b of claim 91 in part recites “mixing with vancomycin and rifampin”:, it is unclear what is being mixed with the at least on bioactive agent.
Claim 90 recites in part “providing a liquid polymerizable mixture ….; and at least one initiator or at least one inhibitor”, this is vague and indefinite because as the claims are written they read on the alternative wherein only the macromer is required an inhibitor. One cannot make a polymer without the macromer that polymerizes to make said polymer. Therefore, the liquid polymerizable mixture needs two components the first of which is the macromer and the second of which is either the inhibitor or the initiator. In the interest of compact prosecution, the claim shall be interpreted as requiring the two components including the macromer to be present. Claims 92-107 are included in this rejection as they depend directly or indirectly from claim 90.
Claim 93 recites “wherein the liquid polymerizable mixture comprises at least one initiator and at least one inhibitor, wherein the liquid polymerizable mixture is made by covalently linking a connecting moiety to biodegradable moieties and covalently linking cross-linkable moieties to the biodegradable moieties; and at least one initiator, and wherein the liquid polymerizable mixture is made by covalently linking a polyethylene glycol moiety of a molecular weight below 1000 g/mol to biodegradable lactide moieties and covalently linking cross-linkable acrylate moieties to the lactide moieties; and at least one initiator” the meets and bounds of this claim is unclear as before the “; and” the mixture already comprised an imitator. The serial usage of the term and after each coma makes it unclear where one grouping ends and the next begins.
Claim 98 recites, in part, “cross-linkable moiety 1, biodegradable moiety 1, connecting moiety, biodegradable moiety 2, or cross-linkable moiety 2”, this is vague and indefinite as it is unclear what cross-linkable moiety 1, biodegradable moiety 1, biodegradable moiety 2, or cross-linkable moiety 2 refers to. For example does this refer to biodegradable moiety 1 refer to a first of the at least one biodegradable moiety or does it refer to an order of connection? Do the ones and two refer to different moieties or order of connections?
Claims 97 and 102 are 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. Regarding claim 97 and 102, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention leading to confusion over the intended scope of the claim. See MPEP § 2173.05(d).
Regarding claims 95 and 96, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by " and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). In the interest of compact prosecution, the claim shall be interpreted to man any anesthetic agent.
Claim 107 recites the limitation “the reservoirs" and depends from 102 which depends from claim 90. However, neither claim 102 nor claim 90 include reservoirs. Accordingly, there is insufficient antecedent basis for this limitation in the claim.
Closest Art
The closest prior art is Hubbell et al. (Patent No.: 5, 410,016; Date of Patent April 25, 1995). Hubbell discloses hydrogels of polymerized and crosslinked macromers for controlled drug release (abstract), wherein macromers are biocompatible, biodegradable, polymerizable, an substantially water soluble (column 4 lines 29-30), wherein the macromers of the hydrogels are synthesized by adding biodegradable glycolic acid oligomers to end groups of PEG and end capping with acrylic end groups to produce a water soluble macromers, wherein PEG is dissolved in solvent cooled to room temperature, glycolide was added to the PEG solution to form a PEG-glycolide copolymer, wherein the PEG-glycolide copolymer in solution was refluxed with acryloyl chloride and triethylamine to form the polymer capped by an acrylate at both ends (column 11 line 50 through column 12); wherein instead of glycolide the macromere can comprise lactide moieties (column 11 table 1 and column 28 lines 40-50); wherein the molecular weight of PEG is from 400 and 30,000 Da (column 8 lines 12-15 and column 12 Table 2).
Non-Statutory Obviousness Type 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 90-107 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No.12,115,289. Although the claims at issue are not identical, they are not patentably distinct from each other because each is directed to a method of making a medical device comprising a drug eluting biodegradable polymer a. providing a liquid polymerizable mixture comprising at least a macromer that is a liquid at a temperature between about 10°C and about 40°C, wherein the liquid polymerizable mixture is made by covalently linking a connecting moiety to at least one biodegradable moiety and covalently linking at least one cross-linkable moiety to the biodegradable moiety; and at least one initiator or at least one inhibitor without addition of a solvent;b. mixing with at least one bioactive agent without addition of a solvent, thereby forming a liquid, bioactive agent-containing polymerizable mixture; c. applying the liquid polymerizable mixture onto at least one surface of a medical device; d. initiating polymerization by an external stimulus; and e. polymerizing for a period of time; thereby forming the medical device comprising the drug-eluting polymer. Instant claim 91 is the same method wherein the bioactive agents are vacomycin and rifampin. The difference is that patent ‘289 specifies that the connecting moiety is PEG 200 for claim 1 and the bioactive agent is an anesthetic agent in claim 2. The dependent claims are identical with respect to medical device, bioactive agents, external stimulation, the moieties making up the macromer, the cross linkable moieties, the drug eluting polymer, the connecting moiety, the length of time for polymerization, the initiator, and the formation of reservoirs.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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