DETAILED ACTION
Claims 1-2, 4, 8, 11-12, 16, 18-19, 25, 27-29, 42, 48-49, 53, 58 and 63-64 are currently pending. Claims 1-2, 4, 8, 11-12, 16, 18-19 and 25 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 of Group I in the reply filed on 07/08/2025 is acknowledged. 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 § 818.01(a)).
Claims 27-29, 42, 48-49, 53, 58 and 63-64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2025.
Applicant’s election of Species I, Elastomer, in the reply filed on 07/08/2025 is acknowledged. 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 § 818.01(a)).
Applicant has not provided a specific election for each of Elastomer and Therapeutic Agent. Applicant’s species election is held in abeyance at this time. No claims are withdrawn as a result of the species election.
Priority
The instant application is a national stage entry of PCT/US2021/048203, filed 08/30/2021, which claims priority to provisional application 63/074,714, filed 09/04/2020 and 63/155,393, filed 03/02/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 03/03/2023 and 07/09/2024 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
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 4 and 18 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 4 contains the limitation regarding the outer diameter, inner diameter, height, wherein no conjunction (and, or, and/or) is used between the dimensions. Therefore, the instant claim has unclear metes and bounds as it is unclear if each of the outer, inner and height are required for the band or only one of the limitations. For examination purposes either interpretation will be deemed to meet the instant claims.
Claim 18 contains the limitation of “wherein the shape is a first shape and wherein the medical apparatus is further manufactured by heating the composition to at least a melting temperature of the composite and dye casting the composite into the second shape”. The metes and bounds of the instant claim are unclear, as it is unclear if the claim is directed to the first shape, which is capable of further processing to a second shape, or if the claim is directed to the second shape.
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) 1-2, 12 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (Applicant provided, IDS dated 05/08/2025).
Regarding claims 1-2, the limitation of a drug-eluting elastic medical apparatus comprising a composite of a therapeutic agent and an elastomer, the medical apparatus manufactured by dissolving the elastomer and the therapeutic agent in an organic solvent, and evaporating the organic solvent while the elastomer reforms into the composite having shape is met by Li teaching drug-laden elastomer for surgical treatment of anal fistula (title) wherein elastic silicone bands being fabricated with different concentration of lidocaine are taught (abstract). The method making included silicone elastomer, crosslinker and drug laden rubber bands being made by incorporating the drug into the elastomer by grinding until homogenous and then molded in a groove mold and cured (page 441, last paragraph). MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The process taught by Li would results in the same homogenous elastomeric drug containing medical device, and thus anticipates the instant claim absent factual evidence to the contrary.
Regarding claim 12, the limitation of wherein the therapeutic agent comprises an analgesic, an anti-inflammatory agent, an anti-microbial agent or a sclerotic agent is met by Li teaching lidocaine (abstract).
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) 1-2, 11-12, 16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,545,097.
Regarding claims 1-2, 8, 11 and 18-19, the limitation of a drug-eluting elastic medical apparatus comprising a composite of a therapeutic agent and an elastomer, the medical apparatus manufactured by dissolving the elastomer and the therapeutic agent in an organic solvent, and evaporating the organic solvent while the elastomer reforms into the comprise having a shape is met by the ‘097 patent teaching a composition for delivery of a therapeutic agent comprising a biocompatible block copolymer comprising one or more elastomer blocks and one or more thermoplastic bocks and a therapeutic agent (abstract). The composition is in the form of a medical device (abstract). Thermoplastic blocks are taught to be styrene (column 2, lines 1-4) and polyolefins are taught to be isobutylene (column 4, lines 1-15) specifically triblock copolymers of polystyrene-polyisobutylene-polystyrene (column 5, lines 10-20). The polymer may form the entire device (column 14, lines 5-20). The device may be made by dissolving the polymer in solution wherein the solvent is removed to form the final device forming simple objects (column 14, lines 40-60) where the drug is dissolved in the solvent (column 15, lines 20-26). The ‘097 patent teaches the method of making and the claimed components and therefore would have pores capable of diffusion absent factual evidence to the contrary, further supported by the active agent being taught as released by the ‘097 patent.
Regarding claims 12 and 16, the limitation of wherein the therapeutic agent comprise an analgesic, an anti-inflammatory agent, an anti-microbial agent or a sclerotic agent is met by the ‘097 patent teaching agents include anti-inflammatory agents and combinations of therapeutic agents (column 1, lines 35-55).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (polystyrene-polyisobutylene-styrene block copolymer in overlapping weight% containing anti-inflammatory agent) from within the prior art disclosure of the ‘097 patent, to arrive at the instantly claimed drug eluting elastomeric material “yielding no more than one would have expected from such an arrangement”.
Claim(s) 4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,545,097 as applied to claims 1-2, 11-12, 16 and 18-19 above, and further in view of JP 2003-210502 and Li.
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-2, 8, 11-12, 16 and 18 are taught by the ‘097 patent.
Regarding claim 8, Thermoplastic blocks are taught to be styrene (column 2, lines 1-4) and polyolefins are taught to be isobutylene (column 4, lines 1-15) specifically triblock copolymers of polystyrene-polyisobutylene-polystyrene (column 5, lines 10-20). The polymer may form the entire device (column 14, lines 5-20). The device may be made by dissolving the polymer in solution wherein the solvent is removed to form the final device forming simple objects (column 14, lines 40-60) where the drug is dissolved in the solvent (column 15, lines 20-26). The polyolefin is taught to be 95-45 mol% of the block copolymer, and to 5% to 20 mol% thermoplastic block (column 5, lines 1-5). 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”.
The ‘097 patent does not specifically teach the shape corresponds to a rubber band comprising an outer diameter of 4-6 mm, an inner diameter of 1-2 mm, a height of 1.5 to 2.5 mm (claim 4).
The ‘502 publication teaches elastic band for ligating anal fistula comprising an elastic cord for ligating anal fistula which is inserted into a fistula tract that appears in the anal region [0001]. The diameter is taught to have a range of 1 to 50 mm at the tip the range of 0.05 to 10 mm [0005]. The rubber material is taught to be polyisobutene, isoprene, styrene-butadiene copolymer [0006]. A circular cross section is taught [0007]-[008].
Li teaching drug-laden elastomer for surgical treatment of anal fistula (title) wherein elastic silicone bands being fabricated with different concentration of lidocaine are taught (abstract). The method making included silicone elastomer, crosslinker and drug laden rubber bands being made by incorporating the drug into the elastomer by grinding until homogenous and then molded in a groove mold and cured (page 441, last 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 styrene-isoprene-styrene copolymer as the ‘097 publication teaches styrene-isoprene-styrene copolymer and the ‘502 publication teaches the interchangeability of isoprene and butylene in elastomeric copolymers used in medical device. It would have been prima facie obvious to one of ordinary skill the two monomers could be used interchangeably as the ‘502 publication teaches isobutylene and isoprene to be used in an elastomeric medical device and the ‘097 publication teaches an elastomeric medical device comprising isobutylene monomer.
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 composition of the ‘097 publication to form the medical device of the ‘502 publication because the ‘502 patent teaches the use of the composition to form a medical device comprising styrene-butylene-styrene elastomeric copolymer and the ‘097 publication teaches styrene and isoprene to form elastomeric bands. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Li teaches it is known to use elastomeric polymers and active agents to form band for treat fistula and the ‘097 patent teaches the combination elastomeric polymer and active agent being molded into a medical device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,545,097, JP 2003-210502 and Li as applied to claims 1-2, 4, 8, 11-12, 16 and 18-19 above, and further in view of 2012/0078272.
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-2, 4, 8, 11-12, 16 and 18-19 are taught by the ‘097 patent.
The combination of references does not specifically teach an elastic band applicator, wherein the elastic band applicator is a ligator (claim 25).
The ‘272 publication teaches a device for applying successive resilient ligating bands to tissue. Band-support surfaces located on the arms extend for the from the front end for the accommodating a plurality of ligating bands (abstract). Hemorrhoids are one of the most common surgical diseases around the world. The least expensive and mostly widely used method is rubber band ligation [0002].
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 ligator with the bands taught by the combination of references as Li and the ‘502 publication teach the use of band to treat hemorrhoidal diseases and the ‘272 publication teaches ligator is the least expensive and most widely used method of rubber band ligation, therefore making it obvious to one of ordinary skill in the art before the filing date of the claimed invention to be used with bands used to treat hemorrhoidal diseases.
Conclusion
No claims are allowed.
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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