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 .
Election/Restrictions
Applicant’s election without traverse of Species B, Figure 4 in the reply filed on 6/16/26 is acknowledged.
Claims 12 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/16/26.
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 5 and 14 is 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.
Claims 5 discloses “the shape memory polymeric component is disposed on the anchor” on lines 1-2. However, claim 1 discloses the anchor including the shape memory polymeric component. The anchor comprises the shape memory polymeric component, and therefore, the shape memory polymeric component cannot be formed on the anchor.
Claims 14 discloses “the shape memory polymeric component is compressed onto the anchor” on lines 1-2. However, claim 10 discloses the anchor including the shape memory foam component. The anchor comprises the shape memory foam component, and therefore, the shape memory foam component cannot also be compressed on the anchor.
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) 1-7, 9-11 and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer et al. US 2015/0196305.
Regarding claims 1 and 15, Meyer et al. discloses an implantable medical device (for example, figure 6), comprising: a device body 20 (paragraph 0045, a disc shaped member 20 may be additionally added to embodiments with the anchor 2); and an anchor 2 including a shape member polymeric component (paragraph 0036), the anchor secured relative to the device body and configured to secure the device body in a desired location (for example, may be expanded within the LAA, figures 6, 7, paragraph 0052, the anchor may comprises a mesh being coated with a shape memory polymeric shape foam, the coating being formed on the anchor or mesh and providing anchoring assistance, alternatively or additionally, may include hooks 16, figure 5, paragraph 0044); wherein: the shape memory polymeric component has a first configuration for initial implantation (paragraphs 0011, 0027 introducing in a first configuration); and the shape memory polymeric component has a second configuration subsequent to initial implantation (paragraph 0011, transition into a second configuration).
Regarding claims 2 and 3, Meyer et al. discloses wherein the shape memory polymeric component comprises a shape memory foam (paragraph 0036, memory shape foam may be a polymeric material) or a shape memory polymer (paragraph 0036, memory shape foam may be a polymeric material).
Regarding claim 4, Meyer et al. discloses wherein the shape memory polymeric component forms the anchor (anchor portion 2 within the LAA, figure 6).
Regarding claim 5, Meyer et al. discloses wherein the shape memory polymeric component is disposed on the anchor (paragraph 0050, 0052 the anchor may comprise a mesh being coated with a shape memory polymeric shape foam, the coating being formed on the anchor or mesh and providing anchoring assistance).
Regarding claim 6, Meyer et al. discloses wherein the anchor further comprises a removable insertion aid (attachment means 18 for connecting to a delivery device 12, paragraph 0045, shown connected with delivery device wire 12 with similar embodiment in figures 1, 4).
Regarding claim 7, Meyer et al. discloses wherein the shape memory polymeric component changes from the first configuration to the second configuration as a result of a temperature increase of the shape memory polymeric component (paragraph 0008, foam structure transitions from first to second configuration upon an increase of temperature).
Regarding claim 9, Meyer et al. discloses wherein the shape memory polymeric component changes from the first configuration to the second configuration as a result of active actuation (paragraph 0041, a solution heated to a temperature above the transition temperature may be injected during or after insertion of the temperature activated memory shape foam to cause the foam to expand).
Regarding claim 10, Meyer et al. discloses an implantable medical device (for example, figure 6), comprising: a device body 20 (paragraph 0045, a disc shaped member 20 may be additionally added to embodiments with the anchor 2); and an anchor 2 including a shape member polymeric foam component (paragraph 0036, memory shape foam may be a polymeric material), the anchor secured relative to the device body and configured to secure the device body in a desired location (for example, may be expanded within the LAA, figures 6, 7, paragraph 0052, the anchor may comprises a mesh being coated with a shape memory polymeric shape foam, the coating being formed on the anchor or mesh and providing anchoring assistance, alternatively or additionally, may include hooks 16, figure 5); wherein: the shape memory polymeric foam component has a compressed configuration for initial implantation (paragraphs 0011, 0027 introducing in an unexpanded configuration, for example, foam 2 shown compressed or unexpanded in figures 2, 7); and the shape memory polymeric foam component expands into an expanded configuration after implantation (paragraph 0011, 0041, transition into a second configuration when temperature activated).
Regarding claim 11, Meyer et al. discloses wherein the shape memory foam component in its compressed configuration forms the anchor (portion 2 forms the anchor in the expanded and compressed configuration).
Regarding claim 13, Meyer et al. discloses wherein the shape memory foam component 2 is adapted to accommodate an insertion aid therein (attachment means 18 for connecting to a delivery device 12, paragraph 0045, shown connected with delivery device wire 12 with similar embodiment in figures 1, 4), and the anchor is adapted to be inserted into tissue with the insertion aid positioned within the shape memory foam component (figures 1, 4, delivery wire 12 inserted into attachment means 18 on proximal end of shape memory foam component 2 for placement into tissue or LAA, paragraph 0034).
Regarding claim 14, Meyer et al. discloses wherein the shape memory foam component is disposed on the anchor (paragraph 0050, 0052 the anchor may comprise a mesh being coated with a shape memory polymeric shape foam, the coating being formed on the anchor or mesh and providing anchoring assistance). Examiner notes, although the combination of references does not disclose the shape memory foam “being compressed onto the anchor”, 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. 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.
Regarding claim 16, Meyer et al. discloses the first configuration comprises a linear configuration (for example, shape memory anchor 2, figure 1) and the second configuration comprises a curved configuration (for example, shape memory anchor 2 expanded into a curved or bulbous configuration to fill space, figure 6). Regarding claim 17, Meyer et al. discloses wherein the shape memory anchor incudes one or more hooks in the second configuration (shape memory anchor may include hooks 16, figure 5, paragraph 0044).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. US 2015/0196305 in view of Levy US 2009/0054905.
Regarding claim 8, Meyer et al. discloses wherein the shape memory component changes from the first configuration to the second configuration (paragraph 0008), but fails to disclose changing as a result of hydration.
Levy teaches an expandable occlusion anchor comprising a material that changes from a first configuration to a second configuration as a result of hydration (paragraph 0014, 0056, expansion may be provided by hydration, inflation, shape memory, mechanical means, or other means).
Therefore, it would have been obvious to one having ordinary skill in the art to provide expansion as a result of shape memory, hydration, or other means, as taught by Levy and known in the art to provide transformation of the collapsed anchor to an expanded anchor once positioned within the target tissue location.
Conclusion
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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