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 with respect to claim(s) 1-9 have been considered but are moot because the new ground of rejection over Meyer et al. US 2015/0196305 in view of Ortega et al. US 2017/0252045.
Ortega et al. teaches shape memory polymer foam system for treating aneurysms, the shape memory polymer foam having a first porosity and a second porosity, or first and second densities (paragraph 0013), the first porosity or density being located in the neck of the aneurysm (paragraph 0013) and the second porosity or density being located in the dome of the aneurysm (paragraph 0013) to provide a form porosity, permeability, and shape to stagnate the blood flow and promote thrombus and collagen formation throughout the shape memory foam (paragraph 0013).
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. US 2015/0196305 in view of Ortega et al. US 2017/0252045.
Regarding claim 1, Meyer et al. discloses a left atrial appendage closure (LAAC) device adapted for occluding the left atrial appendage (LAA) (paragraph 0003), the LAAC device comprising a shape memory foam 2 component having a compressed configuration (paragraph 0034, figure 1, first collapsed configuration) in which the shape memory foam component has a first shape that is adapted for delivery (figure 1, paragraph 0034, delivery in collapsed configuration into left atrial appendage 8) and an expanded configuration (paragraph 0035, second expanded configuration) in which the shape memory foam component 2 has a second shape that different from the first shape and is adapted to occlude a left atrial appendage (LAA) (figure 2, occluding left atrial appendage 8), the shape memory foam component formed by crimping a shape memory foam blank into an inverse shape that is an inverse of the second shape; and subsequently cutting the shape memory foam component from the crimped shape memory foam blank, the shape memory foam component having the first shape, but fails to disclose the shape memory foam component including regions having different densities resulting from different amounts of compression imparted to the shape memory foam blank by crimping into the inverse shape, and wherein the regions having different densities are adapted to expand by different amounts when the shape memory foam component changes from the first shape to the second shape.
Ortega et al. teaches shape memory polymer foam system for treating aneurysms, the shape memory polymer foam having a first porosity and a second porosity, or first and second densities (paragraph 0013), the first porosity being located in the neck of the aneurysm (paragraph 0013) and the second porosity being located in the dome of the aneurysm (paragraph 0013) to provide a form porosity, permeability, and shape to stagnate the blood flow and promote thrombus and collagen formation throughout the shape memory foam (paragraph 0013).
Examiner notes Meyer et al. discloses forming the shape memory foam into any suitable shape in the final or expanded configuration (paragraph 0040), and reshaped in a molding element to be of any suitable shape for delivery, the first shape will remain until subjected to a set temperature (paragraph 0040). The claimed phrase “the shape memory foam component formed by crimping a shape memory foam blank into an inverse shape that is an inverse of the second shape; and subsequently cutting the shape memory foam component from the crimped shape memory foam blank, the shape memory foam component having the first shape” and “resulting from different amounts of compression imparted to the shape memory foam blank by crimping into the inverse shape” are being treated as a product by process limitations. Although the combination of references does not disclose “crimping a shape memory foam blank into an inverse shape that is an inverse of the second shape; and subsequently cutting the shape memory foam” and applying “different amounts of compression imparted to the shape memory foam blank by crimping” it is noted that “[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. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. 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). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2. Meyer et al. in combination meets the requirements of the claimed structure of a device having a first and second shape adapted for occluding various portions of the target location, the device clearly meet the requirements of present claims.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Meyer et al. with a shape memory foam component having regions of different porosities or densities to expand the various shapes within different areas of the aneurysm, as taught by Ortega et al. to provide a form porosity, permeability, and shape to stagnate the blood flow and promote thrombus and collagen formation throughout the shape memory foam.
Regarding claim 2, Meyer et al. discloses wherein the second shape comprises a complex shape (figure 2, expanded second shape conforms to the size and shape of the left atrial appendage, paragraph 0028).
Regarding claim 3, Meyer et al. discloses wherein the first shape comprises a cylindrical shape (figure 1, paragraph 0034) and the second shape comprises a non-cylindrical shape (figure 2, expanded shape to conform to the left atrial appendage, paragraph 0028).
Regarding claims 4-8, Meyer et al. discloses wherein the second shape is adapted to occlude an LAA having a profile that resembles a chicken wing, a windsock, a cactus, a cauliflower or a double lobe (paragraph 0028, expanded second shape conforms to the size and shape of the left atrial appendage, Examiner notes the expandable foam will be configured to occlude the left atrial appendage of any shape).
Regarding claim 9, Meyer et al. discloses wherein the shape memory foam component is adapted to change from the first shape to the second shape when exposed to increased temperature and/or increased moisture (paragraph 0008, transition to second shape upon an increase in temperature to occlude the left atrial appendage).
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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