DETAILED ACTION
Claims 1-21 are currently pending. Claims 1, 3-7, 10, 13-16 and 21 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 .
Examiner’s Note
Applicant's amendments and arguments filed 10/23/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 10/23/2025, it is noted that claims 1, 4-7, and 21 and no new matter or claims have been added.
New Objection:
Claims 13-16 are objected to because of the following informalities: Claims 13-16 are labeled as (Previously Presented-Withdrawn), however claims 13-16 are not withdrawn. The correct status identifier is (Previously Presented) as claims 13-16 are under examination. Appropriate correction is required.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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.
Claim 5 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 5 contains the limitation of wherein the method is performed until step g for molecules with central moiety of polyethylene with different average molecular weight. It is confusing as to whether each polymerization reaction contains multiple MWs and then the products are mixed, if steps a-g are performed separately with a single MW and then the product is mixed. The claim language is unclear as to what exactly “method is performed” until step g, thus leading to unclear metes and bounds.
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) 1, 3-7, 10, 13-16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/136726 (Applicant provided IDS dated 08/02/2022) in view of Zhang (Applicant provided IDS dated 08/02/2022), Lin-Gibson (Applicant provided IDS dated 08/02/2022) and CN101942079.
Regarding claim 1, the limitation of a method of making a degradable additive-blended polymeric material comprising providing a first polymeric material for a central moiety, contacting the first polymeric material with a monomer B, initiating the reaction at room temperature forming a block copolymer, contacting the block copolymer with a second monomer, initiating a reaction at room temperature between chain ends of the block copolymer and the second monomer forming a macromer is met by the ‘726 publication teaching drug eluting polymers added to the surface of a medical device. The drug eluting polymers are obtained from the polymerization of macromonomers made of a connecting moiety, a biodegradable moiety and a cross-linkable moiety that are liquids at a temperature of 10 to 40 degrees C (abstract, Figure 1). The connecting moiety is taught to be polyethylene glycol (page 5, third paragraph). The biodegradable moiety is taught to be PLA (page 6, second paragraph). The cross-linkable moiety is taught to be methacrylate (page 6, last paragraph to page 7, first paragraph). 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 (sequentially) (page 10, last paragraph, page 4, third paragraph, page 19, first paragraph). Additives is taught to include bioactive agents and/or initiators (page 22, last paragraph). Examples are taught to include DL-lactide and PEG added to the flask at a temperature elevated to 150 degrees C wherein the reaction is allowed to proceed. 21LP2 was dissolved, acryloyl chloride is added and reacted for 24 hours. The macromer was purified by repeated dissolution in dichloromethane and re-precipitation in hexane (page 29-31, Figure 1). The macromonomer or macromer mixture can be liquid, biodegradable and crosslinkable at ambient conditions, at room temperature or at elevated temperatures. Room temperature is meant to be between 0 degrees C and about body temperature or about 40 degree C (page 5, second paragraph), thus reading on the steps of the polymerization and mixing being performed at room temperature.
Regarding the limitation of reacting one or more liquid polymerizable macromers with initiator, blending the liquid mixture with additives and exposing the additive blended liquid polymerizable macromer to an external stimulus to create free radicals for a period of time thereby forming a degradable additive blended gel is met by the ‘726 publication teaching wherein the at least one macromer that is a liquid and at least one initiator, mixing with at least one bioactive agent, forming a liquid bioactive agent-containing polymerizable mixture, initiating polymerization by an external stimulus, polymerizing for a period of time, thereby forming a drug eluting polymer (page 14, third paragraph, page 19, first paragraph, Example 3). The macromonomer or macromer mixture can be liquid, biodegradable and crosslinkable at ambient conditions, at room temperature or at elevated temperatures. Room temperature is meant to be between 0 degrees C and about body temperature or about 40 degree C (page 5, second paragraph), thus reading on the steps of the polymerization and mixing being performed at room temperature.
Regarding claim 3, the limitation of wherein the central moiety is a polyethylene glycol is met by the ‘726 publication teaches polyethylene glycol (Example 1).
Regarding claim 4, the limitation of wherein the central moiety is a polyethylene glycol with an average molecular weight of 200, 400 or 600 is met by the ‘726 publication teaching polyethylene glycol with average molecular weight of 200 g/mol or 400 g/mol (page 5, last paragraph).
Regarding claim 5, the limitation of wherein the reactions are performed until step g for molecules with a central moiety of polyethylene glycol with different average molecular weight, then these liquid polymerizable macromers are mixed together before step h is met by the ‘726 publication teaching such connecting moieties can be mixture of different moieties and can consist of a mixture of different molecular weight distributions, wherein a mixture of PEG with a 200 g/mol and PEG with a weight of 400 g/mol is taught (page 5, last paragraph) wherein reactions can be done sequentially or simultaneously (page 11, first paragraph).
Regarding claims 6-7 and 21 is met by the at least one additive is a therapeutic agent, specifically bupivacaine is met by the ‘726 publication teaching the anesthetic is bupivacaine (claims 41-42).
Regarding claim 10, the limitation of wherein the external stimulus for polymerization is UV irradiation is met by the ‘726 publication teaching polymerization using UV light (page 8, third paragraph, Example 3).
Regarding claims 13-14, the limitation of wherein the additive-blended liquid polymerizable mixture of step (g) is applied to a medical device surface before step (h) is met by the ‘726 publication teaching the macromer is applied to the surface of a medical device and polymerized in situ. The liquid can be a macromer alone or can contain initiators to allow different modes of in situ polymerization (page 4, second paragraph, page 7, first paragraph, page 8, third paragraph). The medical device is taught to contain pores and filling preformed reservoirs (page 27, last paragraph to page 28, first paragraph, Figure 2) which is titanium (page 29, second paragraph, Example 3).
Regarding claims 15-16, the ‘726 publication teaches after the reaction additional purification steps were conducted where the resulting product was dissolve din dichloromethane ad precipitated in hexane, filtered and then dried, wherein after reaction with acryloyl chloride the resulting macromer was purified by repeated dissolution in dichloromethane and reprecipitation in hexane (Example 1).
The ‘726 publication does not specifically teach microwave reaction in steps (c) and (e) (claim 1).
Zhang teaches microwave assisted synthesis of PLLA-PEG-PLLA triblock copolymers (title). The poly(L-lactide)-block-poly(ethylene glycol)-block-poly(L-lactide) triblock copolymers were synthesized effectively by poly(ethylene glycol) initiated ring-opening polymerization of L-lactide under microwave irradiation. The synthesis of triblock copolymers via microwave heating was much faster than via conventional heating (abstract).
Lin-Gibson teaches PEG-dimethacrylates (title) where PEGDMs were also prepared by a microwave-assisted route to achieve fast reaction conversions under solvent free conditions (abstract). PEGDMs were prepared both in solution and under solvent free conditions via microwave-assisted route. (page 1281, first column, first paragraph). Microwave assisted synthesis of PEGDM was formed through PEG and a large excess of MA were mixed in a capped scintillation vial and placed in a commercial domestic microwave for various reaction times ranging from 2 to 10 min (page 1281, second column, first paragraph). The PEGDM is photopolymerized to form a hydrogel (page 1281, second column, 4th paragraph). Microwaves reactions have gained significant interest recently due to their ability to achieve fast reaction rates often without the need for an organic solvent. Microwave energy can be delivered differently to the material through molecular interaction with the electromagnetic field and can increase the local reaction kinetic which leads to significantly reduced reaction time. Microwave reactions are becoming more widely used in convention chemistry and green (solvent free chemistry) and is particularly straightforward in the synthesis of PEGDM (page 1284, first column, second paragraph).
The ’079 publication teaches synthesis of polylactic acid (abstract). The ring opening polymerization reaction is carried out at a constant temperature of 25-280 degrees C from 12-96 hours [0013]. The ring opening polymerization reaction is a microwave irradiation reaction [0016]. Microwave irradiation is used to cause ring-opening polymerization reaction of lactide, it is time saving and energy saving compared to conventional thermal polymerization, microwave heating can significantly reduce energy loss and also has a non-thermal effect on the chemical reaction [0023]. Ring opening polymerization was taught at a constant temperature of 25 degrees C [0064].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use microwave radiation to initiate the reaction between PEG and PLA and additionally use microwave radiation to initiate the reaction between PLA-PEG-PLA and methacrylate as taught by the ‘726 publication because Zhang teaches microwave initiate to react PEG and PLA to form a triblock polymer and Lin-Gibson teaches the reaction of methacrylate using microwave irradiation. It would be obvious and had an expectation of success to one of ordinary skill in the art before the effective filing date to use known methods such as microwave irritation to as a reaction mechanism between PEG, PLA and Methacrylate as was known in the art before the effective filing date of the claimed invention as taught by Zhang and Lin-Gibson to arrive at the claimed macromer which is taught by the ‘726 publication. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to use microwave irradiation as Zhang teaches much faster heating and Lin-Gibson teaches the use of microwave irradiation is straightforward, green and leads to significantly reduced reaction time.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to perform the microwave reaction at about room temperature because the ‘726 publication teaches the reaction temperature to be at room temperature and the ‘079 publication that polymerization through the use of microwaves is known to be used at 25-280 degrees and exemplified at 25 degrees thus teaching that reaction through microwave radiation can be performed at the temperatures taught by the ‘726 publication and given the wide range is an optimizable parameter. As MPEP 2144.05 recites “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 optimization”.
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, 3-7, 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,115,289 in view of WO 2017/136726, Zhang, Lin-Gibson and CN 101942079. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘289 patent are directed to formation of triblock copolymer comprising PEG200, PLA and acrylate polymer forming a macromer which is mixed with an additive and initiator applying to the surface of an implant and initiation polymerization by an external stimulus. The instant application differs in that the ’289 patent does not specifically teach the order of contacting a, b and R before initiating the reactions and does not specifically teach microwave irradiation.
The ‘726 publication teaching drug eluting polymers added to the surface of a medical device. The drug eluting polymers are obtained from the polymerization of macromonomers made of a connecting moiety, a biodegradable moiety and a cross-linkable moiety that are liquids at a temperature of 10 to 40 degrees C (abstract, Figure 1). The connecting moiety is taught to be polyethylene glycol (page 5, third paragraph). The biodegradable moiety is taught to be PLA (page 6, second paragraph). The cross-linkable moiety is taught to be methacrylate (page 6, last paragraph to page 7, first paragraph). 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 (sequentially) (page 10, last paragraph, page 4, third paragraph, page 19, first paragraph). Additives is taught to include bioactive agents and/or initiators (page 22, last paragraph). Examples are taught to include DL-lactide and PEG added to the flask at a temperature elevated to 150 degrees C wherein the reaction is allowed to proceed. 21LP2 was dissolved, acryloyl chloride is added and reacted for 24 hours. The macromer was purified by repeated dissolution in dichloromethane and re-precipitation in hexane (page 29-31, Figure 1).
Zhang teaches microwave assisted synthesis of PLLA-PEG-PLLA triblock copolymers (title). The poly(L-lactide)-block-poly(ethylene glycol)-block-poly(L-lactide) triblock copolymers were synthesized effectively by poly(ethylene glycol) initiated ring-opening polymerization of L-lactide under microwave irradiation. The synthesis of triblock copolymers via microwave heating was much faster than via conventional heating (abstract).
Lin-Gibson teaches PEG-dimethacrylates (title) where PEGDMs were also prepared by a microwave-assisted route to achieve fast reaction conversions under solvent free conditions (abstract). PEGDMs were prepared both in solution and under solvent free conditions via microwave-assisted route. (page 1281, first column, first paragraph). Microwave assisted synthesis of PEGDM was formed through PEG and a large excess of MA were mixed in a capped scintillation vial and placed in a commercial domestic microwave for various reaction times ranging from 2 to 10 min (page 1281, second column, first paragraph). The PEGDM is photopolymerized to form a hydrogel (page 1281, second column, 4th paragraph). Microwaves reactions have gained significant interest recently due to their ability to achieve fast reaction rates often without the need for an organic solvent. Microwave energy can be delivered differently to the material through molecular interaction with the electromagnetic field and can increase the local reaction kinetic which leads to significantly reduced reaction time. Microwave reactions are becoming more widely used in convention chemistry and green (solvent free chemistry) and is particularly straightforward in the synthesis of PEGDM (page 1284, first column, second paragraph).
The ’079 publication teaches synthesis of polylactic acid (abstract). The ring opening polymerization reaction is carried out at a constant temperature of 25-280 degrees C from 12-96 hours [0013]. The ring opening polymerization reaction is a microwave irradiation reaction [0016]. Microwave irradiation is used to cause ring-opening polymerization reaction of lactide, it is time saving and energy saving compared to conventional thermal polymerization, microwave heating can significantly reduce energy loss and also has a non-thermal effect on the chemical reaction [0023]. Ring opening polymerization was taught at a constant temperature of 25 degrees C [0064].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the PEG-PLA triblock copolymer before addition of the methacrylate end capping polymer as the ‘726 publication teaches the formation steps claimed to be used to form macromers comprising PEG-PLA and methacrylate end capping groups. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to use microwave irradiation for the polymerization as Zhang and Lin-Gibson teach the use of microwave irradiation to be faster and considered green thus motivating one of ordinary skill in the art to use microwave irradiation in the macromer formation.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to perform the microwave reaction at about room temperature because the ‘289 patent teaches temperature to be at room temperature for the polymerization mixture and the ‘079 publication that polymerization through the use of microwaves is known to be used at 25-280 degrees and exemplified at 25 degrees thus teaching that reaction through microwave radiation can be performed at the temperatures taught by the ‘289 patent and given the wide range is an optimizable parameter. As MPEP 2144.05 recites “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 optimization”.
Claims 1, 3-7, 13 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 90-110 of copending Application No. 18/818,122 in view of view of WO 2017/136726, Zhang, Lin-Gibson and CN101942079. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘122 application are directed to formation of triblock copolymer comprising PEG200, PLA and acrylate polymer forming a macromer which is mixed with an additive and initiator applying to the surface of an implant and initiation polymerization by an external stimulus. The instant application differs in that the ’122 application does not specifically teach the order of contacting a, b and R before initiating the reactions and does not specifically teach microwave irradiation.
The ‘726 publication teaching drug eluting polymers added to the surface of a medical device. The drug eluting polymers are obtained from the polymerization of macromonomers made of a connecting moiety, a biodegradable moiety and a cross-linkable moiety that are liquids at a temperature of 10 to 40 degrees C (abstract, Figure 1). The connecting moiety is taught to be polyethylene glycol (page 5, third paragraph). The biodegradable moiety is taught to be PLA (page 6, second paragraph). The cross-linkable moiety is taught to be methacrylate (page 6, last paragraph to page 7, first paragraph). 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 (sequentially) (page 10, last paragraph, page 4, third paragraph, page 19, first paragraph). Additives is taught to include bioactive agents and/or initiators (page 22, last paragraph). Examples are taught to include DL-lactide and PEG added to the flask at a temperature elevated to 150 degrees C wherein the reaction is allowed to proceed. 21LP2 was dissolved, acryloyl chloride is added and reacted for 24 hours. The macromer was purified by repeated dissolution in dichloromethane and re-precipitation in hexane (page 29-31, Figure 1).
Zhang teaches microwave assisted synthesis of PLLA-PEG-PLLA triblock copolymers (title). The poly(L-lactide)-block-poly(ethylene glycol)-block-poly(L-lactide) triblock copolymers were synthesized effectively by poly(ethylene glycol) initiated ring-opening polymerization of L-lactide under microwave irradiation. The synthesis of triblock copolymers via microwave heating was much faster than via conventional heating (abstract).
Lin-Gibson teaches PEG-dimethacrylates (title) where PEGDMs were also prepared by a microwave-assisted route to achieve fast reaction conversions under solvent free conditions (abstract). PEGDMs were prepared both in solution and under solvent free conditions via microwave-assisted route. (page 1281, first column, first paragraph). Microwave assisted synthesis of PEGDM was formed through PEG and a large excess of MA were mixed in a capped scintillation vial and placed in a commercial domestic microwave for various reaction times ranging from 2 to 10 min (page 1281, second column, first paragraph). The PEGDM is photopolymerized to form a hydrogel (page 1281, second column, 4th paragraph). Microwaves reactions have gained significant interest recently due to their ability to achieve fast reaction rates often without the need for an organic solvent. Microwave energy can be delivered differently to the material through molecular interaction with the electromagnetic field and can increase the local reaction kinetic which leads to significantly reduced reaction time. Microwave reactions are becoming more widely used in convention chemistry and green (solvent free chemistry) and is particularly straightforward in the synthesis of PEGDM (page 1284, first column, second paragraph).
The ’079 publication teaches synthesis of polylactic acid (abstract). The ring opening polymerization reaction is carried out at a constant temperature of 25-280 degrees C from 12-96 hours [0013]. The ring opening polymerization reaction is a microwave irradiation reaction [0016]. Microwave irradiation is used to cause ring-opening polymerization reaction of lactide, it is time saving and energy saving compared to conventional thermal polymerization, microwave heating can significantly reduce energy loss and also has a non-thermal effect on the chemical reaction [0023]. Ring opening polymerization was taught at a constant temperature of 25 degrees C [0064].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the PEG-PLA triblock copolymer before addition of the methacrylate end capping polymer as taught by the ‘122 application as the ‘726 publication teaches the formation steps claimed to be used to form macromers comprising PEG-PLA and methacrylate end capping groups. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to use microwave irradiation for the polymerization as Zhang and Lin-Gibson teach the use of microwave irradiation to be faster and considered green thus motivating one of ordinary skill in the art to use microwave irradiation in the macromer formation.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to perform the microwave reaction at about room temperature because the ‘122 application teaches temperature to be at room temperature for the polymerization mixture and the ‘079 publication that polymerization through the use of microwaves is known to be used at 25-280 degrees and exemplified at 25 degrees thus teaching that reaction through microwave radiation can be performed at the temperatures taught by the ‘122 application and given the wide range is an optimizable parameter. As MPEP 2144.05 recites “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 optimization”.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Objections/112(b):
Applicant argues the amendments to the instant claims overcome the previously applied objections and 112(b) rejections.
In response the objections and 112(b) rejections are withdrawn as a result of Applicant’s claim amendments. Applicant is referred to modified 112(b) rejection over claim 5 based on Applicant’s claim amendments.
103:
Applicant argues the ‘726 publication does not teach microwave radiation at about room temperature. Applicant also points out that microwave initiating reactions in the claimed methods are achieved at room temperature (starting at room temperature with no additional heating) which is not disclosed in any of the cited art.
In response, Applicant is referred to the modified rejections above. The ‘726 publication teaches the macromonomer or macromer mixture can be liquid, biodegradable and crosslinkable at ambient conditions, at room temperature or at elevated temperatures. Room temperature is meant to be between 0 degrees C and about body temperature or about 40 degree C (page 5, second paragraph), thus reading on the steps of the polymerization and mixing being performed at room temperature. The ’079 publication teaches synthesis of polylactic acid (abstract). The ring opening polymerization reaction is carried out at a constant temperature of 25-280 degrees C from 12-96 hours [0013]. The ring opening polymerization reaction is a microwave irradiation reaction [0016]. Microwave irradiation is used to cause ring-opening polymerization reaction of lactide, it is time saving and energy saving compared to conventional thermal polymerization, microwave heating can significantly reduce energy loss and also has a non-thermal effect on the chemical reaction [0023]. Ring opening polymerization was taught at a constant temperature of 25 degrees C [0064]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to perform the microwave reaction at about room temperature because the ‘726 publication teaches the reaction temperature to be at room temperature and the ‘079 publication that polymerization through the use of microwaves is known to be used at 25-280 degrees and exemplified at 25 degrees thus teaching that reaction through microwave radiation can be performed at the temperatures taught by the ‘726 publication and given the wide range is an optimizable parameter. As MPEP 2144.05 recites “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 optimization”.
Applicant argues keeping the molecular weight of the cumulative copolymers (including methacryaltion) sufficiently low for the polymerization mixture remain liquid at room temperature.
In response, it is noted that Applicant is arguing limitations not present in the instant claims. Claim 4 is directed to a PEG MW for the central moiety, no other molecular weights are claimed, nor are any molecular weights present in the independent claim. The ‘726 publication teaching polyethylene glycol with average molecular weight of 200 g/mol or 400 g/mol (page 5, last paragraph).
Applicant argues Zhang is performed at 100 degrees C, which was necessary as it utilized PEG1000. Therefore, there is not motivation for on skilled in the art to perform the reactions steps at room temperature as required by the claimed invention.
In response, the ‘726 publication teaches the reaction at room temperature (i.e. crosslinkable at room temperature) and additionally teaches the molecular weight of PEG instant claimed. Zhang teaches microwave assisted synthesis using microwave irradiation (abstract). Applicant’s arguments regarding the temperature of the microwave radiation is discussed above as first presented.
Applicant argues Lin-Gibson describes microwave addition of methacrylates to PEG greater than 1000 g/mol.
In response, the ‘726 publication teaches the reaction at room temperature (i.e. crosslinkable at room temperature) and additionally teaches the molecular weight of PEG instant claimed as discussed above.
Double Patenting:
Applicant argues the instant claim are directed to microwave radiation at about room temperature.
In response, Applicant is referred to the modified rejection above. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to perform the microwave reaction at about room temperature because the ‘122 application teaches temperature to be at room temperature for the polymerization mixture and the ‘079 publication that polymerization through the use of microwaves is known to be used at 25-280 degrees and exemplified at 25 degrees thus teaching that reaction through microwave radiation can be performed at the temperatures taught by the ‘122 application and given the wide range is an optimizable parameter. As MPEP 2144.05 recites “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 optimization”.
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.
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, 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.
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.
/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613