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 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.
Claims 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Applicant has constructed the claims 19-20 where the block copolymer is capable of forming the layer(s), when the action of layer formation has already occurred, which render the claims confusing. Appropriate clarification or correction to the claim language is required.
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) 1-4, 6, 9, 11-13, 15, 18 and 22 are rejected under 35 U.S.C. 102(a)(1) are anticipated by Oberhoffner et al. US 6,048,947.
Regarding claims 1-4, 6, 15, 18 and 22, Oberhoffner teaches (reference claim 1) surgical suture (corresponding to an implantable device and vessel closure device, as required by instant claims 15 and 18), comprising a triblock copolymer having an ABA structure formed from a biodegradable hard segment A and a biodegradable soft segment B chemically bound to the two hard segments A, wherein the soft segment B is a random terpolymer. The hard segment blocks A contains a glycolide and the soft segment B is formed from trimethylene carbonate, ε-caprolactone and glycolide.
Oberhoffner discloses Example 4 (col 9), with polyglycolide A blocks and intervening B block comprising glycolide (GA), 1,3-dioxan-2-one (which is trimethylene carbonate (TMC)), and ε-caprolactone (CL), where the A blocks together make 60 wt% of the ABA tri-block copolymer and block B makes 40 wt%, and where the weight ratio of monomers in block B (Example 1, col 8) are 30 parts GA, 35 parts TMC and 35 parts CL, which read on the claimed requirements (instant claims 1-4, 6 and 22).
Regarding claim 9, Oberhoffner discloses ABA triblock copolymer Example 4 (col 9, line 32) with melting point of 182.3 oC and melting enthalpy of 15 to 50 J/g (col 3, line 45), meeting the claimed requirements.
Regarding claim 11, Oberhoffner discloses ABA triblock copolymer Example 4, as discussed when addressing claim 1, however Oberhoffner does not provide a percent crystallinity value. Since Oberhoffner’s ABA triblock copolymer reads on the required monomers, their amounts, their configuration as well as meets the required melting point and enthalpy of fusion, the % crystallinity would be inherently present in the disclosed triblock copolymer. Application attention is directed to: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claims 12-13, Oberhoffner discusses (col 8, line 36) the tensile strength and elongation on drawn threads, but does not address the required properties of the as-made triblock copolymers. Since Oberhoffner’s ABA triblock copolymer, as discussed when addressing claim 1, reads on the required monomers, their amounts, and their configuration, the tensile strength and elongation would be inherently present. Application attention is directed to: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
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.
Claims 5, 7-8, 10, 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Oberhoffner et al. US 6,048,947, as applied to claims 1-4, 6, 9, 11-13, 15, 18 and 22, above.
Regarding claim 5, Oberhoffner teaches (col 2, lines 47-49) the triblock copolymer preferably contains 30 to 60 wt. % glycolide (GA), 10 to 40 wt. % trimethylene carbonate (TMC), 10 to 40 wt. % ε-caprolactone (CL), which meet the requirements of TMC and CL, and encompasses the GA limitation, rendering the claimed GA requirement obvious. 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, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 7, Oberhoffner teaches (col 3, lines 34-35) the inherent viscosity of 0.7 to 1.2 dl/g, overlapping the claimed requirement. 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, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 8, Oberhoffner discloses (col 8, line 13) glass transition temperature of the triblock copolymer to be between -10° C and +30° C, overlapping the Tg-1 requirement, which is similar to applicant’s DSC second heat curves in Fig 7A-C where only Tg-1 is observed. Oberhoffner does not disclose a second Tg corresponding to the Tg of the polyglycolide A block. However, the Tg-2 corresponding to the polyglycolide which is 35°C to 40° C, would be reasonably expected to be observed in the first heat cycle of the DSC, similar to applicant’s Fig 6A-C, since Oberhoffner’s ABA triblock copolymer, as discussed when addressing claim 1, reads on the required monomers, their amounts, their configuration as well as meets the required melting point.
Regarding claim 10, Oberhoffner teaches (col 3, lines 44-45) enthalpy of fusion of 15 to 50 J/g, overlapping the claimed requirement. 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, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 14, Oberhoffner discloses elastic modulus of the triblock copolymer to be between 500 and 3000 N/mm2, which is 500 to 3000 MPa, and is close to the required modulus. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 I.
Claims 16-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Oberhoffner et al. US 6,048,947, as applied to claims 1-4, 6, 9, 11-13, 15, 18 and 22, above, and further in view of Ma et al. US 2015/0359648 A1.
Regarding claim 16, Oberhoffner discloses (col 2, lines17-24) the use of triblock copolymers for applications as medical products, but is silent on a stent. Analogous reference Ma (tile) who also teaches polycaprolactone based biodegradable polymers discloses stents of thickness 80 to 100 microns (Ma, claim 1 and para [0039]), meeting the claimed requirement. Advantageously, Ma provides the motivation to create the stent with the desired thickness to offer appropriate radial strength to the scaffold to provide sufficient mechanical support to the blood vessel (para [0040]).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have utilized Oberhoffner triblock copolymer to generate a stent with a thickness of 100 micron as taught by Ma for the same application of creating a scaffold with appropriate radial strength to support the blood vessel.
Regarding claim 17, Ma depicts stent structures with interstices (Ma Fig. 1A, Fig. 3 and Fig 4). Ma further discusses (para [0110]) the polymer thickness of about 50 microns in expanded state when measured by polarized light microscopy.
Regarding claims 19-21, Oberhoffner is silent on a layer, however Ma teaches (paras [0121] and [0123]) coating a layer of polymer and a drug by spraying on to the surface of the scaffold. Ma adds that the polymeric carrier of the drug can be any inventive PLA based polymer or other copolymers which include copolymers of glycolide and caprolactone (Ma para [0048]).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have utilized Oberhoffner triblock copolymer to create a sprayable coating layer as taught by Ma for the same application of creating a scaffold with drug delivery capability.
Applicant is reminded that product-by-process claims are not limited to the manipulations of the recited steps, but only the structure implied by the steps, see MPEP 2113 I. For the instant claims 19 and 20, the formation of the block copolymer layer (on the surface of the scaffold), meets the claimed requirements, independent of how the layer was created.
Applicant’s attention is directed to” "[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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Surbhi M Du whose telephone number is (571)272-9960. The examiner can normally be reached M-F 9:00 am to 5:00pm.
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/S.M.D./
Examiner
Art Unit 1765
/JOHN M COONEY/Primary Examiner, Art Unit 1765
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