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 1-20 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.
In claim 1, the recitation of “at least 30%” raises an issue of indefiniteness because it is not evident of how high can the recovery be for the radial strength or what the upper limit is. Since the limitation of “at least 30%” encompasses percentages of recovery beyond 30 %, one does not know the maximum percent of radial strength recovery possible for the scaffold. It must be noted that MPEP 2173.05(c) states open-ended ranges can raise an issue of indefiniteness by lacking clear boundaries. Dependent claims possess the same ambiguity of the independent claim they depend therefrom. Claims 19,20 recite “one or more of the following conditions: crimping…..no crimping….etc. ....” which is an optional format group of conditions to select from. However, it is not understood how the property of tensile strain at yield would exist under multiple conditions when specifically crimping and NO crimping are totally opposite conditions. Since the features recited do not share a single class or type of property the claim is indefinite for having an improper grouping with dissimilar preparation. For example, “crimping” is not in the same category or force applied on a material as to “NO crimping” such that the parameters of preparation on the material are not functionally equivalents of one another. Thus, Applicant should consider amending the transition clause or remove all the conditions that are dissimilar listed in the grouping that do not fall into the same variables of conditions because it is not evident how one can be provided with the claimed range of 3-4% of tensile strain at yield for a scaffold with both conditions of crimping with the recited conditions and also the no crimping and its recited conditions.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3,18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Scanlon et al. (8585753) or, in the alternative, under 35 U.S.C. 103 as obvious over House et al. (4877661). Scanlon et al. show (Fig. 9) a scaffold 15 (col. 60, lines 28,29). Scanlon et al. disclose there can be a device that is fully capable of being crimped (claim 19 of document) at a first temperature and expanded by being exposed to an elevated second temperature of at least 37°C (when implanted) and less than Tg of a polymer making up the scaffold and within a saline environment, col. 120, lines 31-58 common for self-expanding materials, col. 3, lines 36-40. Scanlon et al. also disclose (col. 10, lines 15-20) there is a first radial strength and a second radial strength. Scanlon et al. further disclose (col. 51, lines 11-16) the scaffold can be considered with the ability to regain at least 30% of the first radial strength of the scaffold. In other words if the structure can maintain its size or shape (one can equate this to at least 30% since one might consider maintain shape and size would need to be 100% to keep a lumen open), it inherently must regain its radial strength and has properties imparted into the structure to provide strength, col. 78, lines 53-58. Scanlon discloses (col. 39, lines 30-40) the material at the same level of scope (claim 1 recites an arbitrary polymer) and states it can be a memory polymer, a thermoplastic polymer, thermoset polymer, thus it inherently has the ability to regain its strength. However, in the alternative Scanlon et al. did not explicitly state the scaffold regains at least 30% of the first radial strength of the scaffold. House et al. teach (col. 4 ) that polymers can be expanded and processed such that the material can regain its first radial strength by at least 30% (see claim 8-col. 10). It would have been obvious to one of ordinary skill in the art to select the appropriate polymer and processing to provide at least 30% recovery of radial strength as taught by House et al. and provide the scaffold of Scanlon et al. with the ability to match the needs of the vessel conditions or environment to maintain structural integrity and restore normal anatomical conditions. Modification of optimal properties only involves routine skill in the art and is a result dependent variable such that one is able to meet the desired need or use. With respect to claim 2, it must be noted it is a product-by-process claim and forming the polymer by dissolving a resin in a solvent to provide a solution to form a first layer for a tube of the polymer and curing the tube and then processing the tube to form the scaffold with the first diameter and then reducing the diameter to a smaller diameter with the scaffold retaining 90% MW of the resin with a portion of the crystallinity is exhibiting ductility upon a load thereon. Thus, Applicant is reminded even 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, 227 USPQ 964,966). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by & different process, the burden shifts to applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, B02, 218 USPO 289, 292 (Fed. Cir, 1953}, MPEP 2113). Scanlon discloses resins can be used and curing of the polymer to form a tube, thus the claimed scaffold is fully capable of being made the same way. However, in the alternative it would have been obvious to one of ordinary skill in the art to use a process to form by dissolving a raw polymeric resin in a solvent to form at least a first polymeric solution, wherein the resin has a relatively high molecular weight; forming at least a first layer of a biocompatible polymer tube comprising a first diameter with the first polymeric solution; curing the tube; processing the tube to form the scaffold comprising the first diameter; and reducing the first diameter of the scaffold to a second smaller diameter, wherein the scaffold retains at least 90% of the molecular weight of the resin and at least a portion a crystallinity of the resin such that the scaffold exhibits ductility upon application of a load such that the scaffold strength is maintained and it matches the desired vessel requirements due to properties of the scaffold material. Regarding claim 3, Scanlon further disclose (COL. 51, lines 11-26) the material can be provided with a strength greater than its second radial strength when over expanded beyond the original intended diameter. With respect to claim 18, Scanlon et al. disclose (col. 99, lines 65-66) the diameter of the device can be within the diameter range of 3.8 mm to 3.94 mm.
Claim(s) 19,20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ramzipoor et al. (2015/0342764).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Ramzipoor et al. disclose a scaffold comprising a tensile strain at yield within a range of 3% to 4% in one or more of the following conditions, see Table 2. With respect to the conditions, Ramzipoor also disclose one can crimp to a diameter, see paragraph 138. Please note all the recited conditions are preparations of the material for the scaffold that results in the recited property, disclosed as shown in the Table. Note claims are to a product and not process of preparing the material, thus the prior art material is capable of being prepared under any of the claimed conditions since it has the same property as claimed.
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.
Claim(s) 1-4,7-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (2016/0213499) in view of House et al. (4877661). Zheng et al. show (Figs. 1,3,4) a scaffold comprising a first radial strength prior to being crimped at a first temperature (paragraph 11) and a second radial strength when expanded and exposed to an elevated second temperature of at least 37°C and less than Tg of a polymer making up the scaffold and within a saline environment (paragraph 46). Zheng et al. disclose (paragraph 481) the scaffold regains at least 20% of the first radial strength of the scaffold, but did not explicitly disclose 30%. House et al. teach (col. 4 ) that polymers can be expanded and processed such that the material can regain its first radial strength by at least 30% (see claim 8-col. 10). It would have been obvious to one of ordinary skill in the art to select the appropriate polymer and processing to provide at least 30% recovery of radial strength as taught by House et al. and provide the scaffold of Zheng et al. with the ability to match the needs of the vessel conditions or environment to maintain structural integrity and restore normal anatomical conditions. Modification of optimal properties only involves routine skill in the art and is a result dependent variable such that one is able to meet the desired need or use. With respect to claim 2, it must be noted it is a product-by-process claim and forming the polymer by dissolving a resin in a solvent to provide a solution to form a first layer for a tube of the polymer and curing the tube and then processing the tube to form the scaffold with the first diameter and then reducing the diameter to a smaller diameter with the scaffold retaining 90% MW of the resin with a portion of the crystallinity is exhibiting ductility upon a load thereon. Thus, Applicant is reminded even 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, 227 USPQ 964,966). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, B02, 218 USPO 289, 292 (Fed. Cir, 1953}, MPEP 2113). Zheng discloses polymers with solvents to be used and form a tube, thus the claimed scaffold is fully capable of being made the same way. However, in the alternative it would have been obvious to one of ordinary skill in the art to use a process to form by dissolving a raw polymeric resin in a solvent to form at least a first polymeric solution, wherein the resin has a relatively high molecular weight; forming at least a first layer of a biocompatible polymer tube comprising a first diameter with the first polymeric solution; curing the tube; processing the tube to form the scaffold comprising the first diameter; and reducing the first diameter of the scaffold to a second smaller diameter, wherein the scaffold retains at least 90% of the molecular weight of the resin and at least a portion a crystallinity of the resin such that the scaffold exhibits ductility upon application of a load such that the scaffold strength is maintained and it matches the desired vessel requirements due to properties of the scaffold material. With respect to claim 3, Zheng discloses (paragraph 771) a scaffold is capable of being over expanded beyond an original intended diameter such that it is configured to be provided with an increase of second radial strength upon that expansion, paragraphs 341,465. Regarding claim 4, Zheng shows (Fig. 1) the scaffold comprises a plurality of circumferential support elements and a plurality of coupling elements, wherein at least one of the coupling elements extends between a first trough of a first circumferential support element and a second trough of a second circumferential support element, wherein the second trough is connected to the at least one of the coupling elements and is defined by a trough undulation. With respect to claim 7, Zheng et al. disclose the surface area of can be in the range of 3 mm2 to 3000 mm2 over an outer surface of the scaffold which contacts a vessel wall, see Tables 11-13. However, Zheng et al. was silent as to the scaffold provided with a total surface area between values of 20 mm2 to 12,000 mm2. Since the surface area over an outer surface of the scaffold which contacts a vessel wall fell within the claimed range of 3 mm2 to 3000 mm2, thus it would have been obvious to provide or optimize the coverage to provide a total surface area of the scaffold between the range 20 mm2 to 12,000 mm2 since one of ordinary skill in the art knowing the surface area for contact is within the range 3 mm2 to 3000 mm2 over an outer surface of the scaffold a total surface area of the scaffold of 20 mm2 to 12,000 mm2 would have been routine skill in the art for a surgeon in modifying the scaffold of Zheng et al. as modified by House et al. such that the appropriate coverage is provided for the patient’s site or treatment location. Finding the optimal dimensions or provisions of properties to support a vessel only involves routine skill in the art. Regarding claims 8,9 Zheng shows (Figs. 1,60) circumferential rings with a sinusoidal pattern thus it can be construed to be configured to control a tensile strain upon expansion such that failure of the scaffold is inhibited since the same structure and material is disclosed by Zheng. Additionally it can be construed the sinusoidal pattern to be configured to capture stress and strain of the scaffold in isolated regions of peaks and troughs of the scaffold since the same structure and material is disclosed by Zheng. With respect to claim 10, it can be understood that the scaffold of Zheng is configured to translate diametric expansion of the scaffold to relative angular changes of the coupling elements due to the uniformity about the circumference and concentric stent pattern, see paragraph 212. Regarding claim 11, Zheng et al. disclose (paragraphs 463) that the property of fatigue life is evaluated and taken into consideration and can be enhanced or the level reduced. Zheng further discloses (paragraphs 464,465,550, 601) the fatigue level of the scaffold is reduced for at least 6 months after expansion. Regarding claim 13, Zheng et al. disclose (paragraphs 143,145) the scaffold has at least one mechanical property be increased for at least 6 months after expansion. Regarding claim 12, Zheng shows a (Table 10) how the strain or expansion can affect the property the scaffold possesses such that it is configured to minimize diametric recoil when an imparted strain remains above a tensile strain at yield and below a strain causing elongation of at least one of the coupling elements. With respect to claim 14, Zheng discloses the radial strength can increase, paragraph 46. Regarding claim 15, Fig. 33 shows how the coupling elements are configured to reorient radially upon expansion such that elongation of the coupling elements is inhibited and the second radial strength is increased. With respect to claim 16, Zheng also discloses (paragraph 25) that the second radial strength does not decrease for at least 6 months after expansion as it would have been obvious to optimize to maintain the strength for the proper amount of time needed for sufficient cellular integration to stabilize the scaffold in the vessel. With respect to claim 17, Zheng et al. disclose (paragraphs 29,247,515) the scaffold is coated with a drug that can be sirolimus, paragraphs 603,612. Regarding claim 18, Zheng et al. further disclose (paragraph 30) the diameter of the scaffold can be within the range of 3.8 mm to 3.94 mm, as finding the optimal diameter only involves routine skill in the art of working set of values.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (2016/0213499) in view of House et al. (4877661) as applied to claims 1, 4 above, and further in view of Ramzipoor et al. (2015/0342764). Zheng et al. in view of House et al. is explained as before. However with respect to claim 5, Zheng et al. as modified by House et al. did not explicitly disclose the distal curved radius along a distal side of the trough undulation, being provided with a distal curved radius between 0.0001 in. to 0.75 in. Ramzipoor et al. teach (paragraph 152) a trough with a distal curved radius along a distal side of the trough undulation having a distal curved radius between 0.0001 in. to 0.75 in. It would have been obvious to one of ordinary skill in the art to utilize a distal curved radius between 0.0001 in. to 0.75 in. for the trough distal side as taught by Ramzipoor et al. in the scaffold of Zheng et al. as modified with House et al. such that they provide appropriate properties to function in the environment handling stresses thereon, see Ramzipoor paragraph 153. Regarding claim 6, Zheng et al. as modified by House et al. did not explicitly disclose the trough forms a radiused extension portion where the at least one of the coupling elements joins a distal side of the first circumferential support element, wherein radiused extension portion has a radius between 0.0001 in. to 0.75 in. Ramzipoor et al. teach (paragraph 151) a radiused extension portion with a radius between 0.0001 in. to 0.75 in. It would have been obvious to one of ordinary skill in the art to utilize a radiused extension portion between 0.0001 in. to 0.75 in. from the trough coupling with the support element as taught by Ramzipoor et al. in the scaffold of Zheng et al. as modified with House et al. such that they provide appropriate properties to function in the environment handling stresses thereon, see Ramzipoor paragraph 153.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799