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 .
Response to Arguments
Applicant's arguments filed 4/22/26 have been fully considered but they are not persuasive. Applicant contends the material or polymer of Scanlon does not have the property or ability to regain 30-60% of it radial strength. First the examiner notes that this a property as mentioned which could be considered inherent to the material of Scanlon’s scaffold because MPEP 2112.01 states when the structure or composition is physically the same, it must have the same properties. Thus, first it is noted claim 1 recites an arbitrary polymer with no specific name or category or type, thus the prior art is said to be considered the same because the term is a vast number of types and Scanlon clearly discloses a polymer at the same level of scope as recited in the claim. Further the recitation of “ability to regain” its radial strength is a property of the material of which clearly Scanlon discusses (col. 10, lines 15-18, col. 47, lines 33-35,59) and mentions in the form of shape or size recovery as it must be noted the claim uses comprising and again fails to specify with any degree of certainty what the exact material is, thus the prior art discloses the material at the same level of scope as Applicant. MPEP states the burden is on Applicant to prove the material is not the same as the Patent office is not a testing facility. Again see MPEP 2112.01 I. "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 the teaching of House, arguments of intended use or process of manufacture do not distinguish prior art product or material compositions in apparatus claims using product-by-process limitations. MPEP 2113 states: the burden is on the applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). House can be said to teach processing a polymer to impart at least 30% of recovery strength and thus is establishing a prima facie case of obviousness with the Scanlon reference for a scaffold.
With respect to claims 19,20 and the rejection over Ramzipoor PGPUB ‘764 it is noted that MPEP 2113 stated: “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 scaffold of Ramzipoor is at the same level of scope as the claim, since neither claim recite any specific structure or material, thus, Ramzipoor discloses the same apparatus.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance House is used solely to suggest modification of a polymer to alter its recovery capability to be at least 30% and thus since as mentioned in the rejections below, overlap of ranges renders a claimed range obvious when there is some portion of overlap, see MPEP 2144.05. The modification was not a substitution of a particular material or some process, just imparting a property. Again claims are to a product or material property, not any method of use or manufacture.
Applicant did not submit any arguments pointing out disagreements with the examiner’s contentions for the teaching of limitations found in Ramzipoor to rejection claims 5,6. Applicant only argued the art applied against the independent claim, of which the examiner was not persuaded the claim(s) distinguish from them. Thus the rejection is maintained.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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. Please note the claim (1) is reciting a property (strength-capable of being regained which can be considered recovery) of the polymer for the scaffold and use of a “product-by-process” recitation with phrases like “crimp at first temperature” and then place in saline environment is intended use. Since Scanlon discloses the polymer is capable of being imparted with shape memory or size recovery (col. 10, lines 15-18) 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%-60 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 impart at least 30% -60% recovery of radial strength per the teaching of 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. MPEP 2144.05 states: 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, 191 USPQ 90 (CCPA 1976), thus House teaches values that overlap with the claimed range. 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 common inventors 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. Please note the recitation of “the scaffold comprises the range of 3% to 4% when the scaffold is exposed to a temperature of at least 37°C in a saline environment” is an intended use and property of the material. Since Ramzipoor discloses the scaffold having the same property, it must have the capability of being produced or used in the same way. Material properties cannot be separated from a composition, since as best interpreted from the claim (noting the claims fail to define any distinguishing feature) the apparatus of Ramzipoor ‘764 inherently possesses the same capability as recited in the claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 values within the range of 30% to 60%. 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. MPEP 2144.05 states: 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, 191 USPQ 90 (CCPA 1976), thus House teaches values that overlap with the claimed range. 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.
Conclusion
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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