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, see pages 6-12, filed 06/05/2026 with respect to the rejections of claims 5, 17, and 21 under 35 U.S.C. 103 as being unpatentable over Kaplan et al (US 20170042549 A1), herein referenced to as “Kaplan” in view of Sepetka et al (US 20060116713 A1), herein referenced to as “Sepetka” have been fully considered but they are not persuasive.
The applicant argues that the combination of Kaplan and Sepetka does not explicitly teach: wherein compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 5 mm reduction in the mean diameter. Specifically, they disagrees that the modified device would be capable of the claimed compression behavior due the material properties of the polycarbonate polyurethane-urea foam.
The applicant argues that the Office Action has not pointed to any disclosure indicating that the compression from about 35 mm to about 20 mm along a minor axis causing no more than a 5 mm reduction in mean diameter is an inherent property of foam. The examiner respectfully disagrees.
The examiner explicitly cited to [0085] of the applicant’s patent application publication, reproduced below.
“The compressibility of the body 3002 contributes to the superior sealing capability of the device 3000. The foam may be compressible to provide a larger radial “footprint” and spread out the radial forces from struts on the frame 3040, as further described. The foam body 3002 may have a compressive strength of at least 1 pound per square inch (psi) or within a range of about 1 psi to about 2 psi, or no more than about 2 psi. The “compressive strength” here refers to the pressure to compress the foam to 50% strain. With some foam materials for the body 3002, the pressure may not change from 50% strain through at least 80% strain, and the relation of pressure versus strain may be flat or generally flat. Thus, even with thicker foams for the body 3002, the body 3002 will not exert much more outward force on the tissue due to the increased thickness by itself. In an embodiment, the foam body 3002 is a reticulated, cross linked matrix having at least about 90% void content, an average cell size within the range of from about 250-500 microns, a wall thickness of at least about 2 mm and a compressive strength of at least about 1 psi. In an embodiment, the body 3002 is formed from a foam material having or substantially having the material properties indicated in Table 1. In some embodiments, the body 3002 is formed from materials described in, for example, U.S. Pat. No. 7,803,395, issued Sep. 28, 2010, and titled “Reticulated elastomeric matrices, their manufacture and use in implantable devices,” or U.S. Pat. No. 8,337,487, issued Dec. 25, 2012, and titled “Reticulated elastomeric matrices, their manufacture and use in implantable devices,” the entire disclosures of which are incorporated herein by reference.”
This paragraph explicitly notes that the foam properties are what is conducive to the compressibility of the device, hence the examiner shows that Kaplan as modified by Sepetka to have the foam of Sepetka, which has the same material properties meet the structural limitations of claim 5, and thus is functionally capable of the claimed functional language, as also described by the applicant’s own specification.
The applicant states that it is rather the combination of the “self-expandable support” and the foam that allows for this function and cites [0232] and [0252].
[0232] reproduced below,
“The device 3000 provides superior conformability to a range of different shapes and sizes of LAA's compared with existing solutions to LAA occlusion. This section further details some of the features of the device 3000 that contribute to its conformability, among other advantages. For example, some of the features described herein relate to the shape or contour of the proximal face 3060, the angular transition between the proximal face 3060 and the tubular body 3080, the lengths of the struts 3082, 3086 forming the diamond or square shapes along the tubular body 3080, and the angles of the proximal and distal apexes 3084, 3088 of the diamond or square shapes. For instance, and as further detailed herein, the frame 3040 may have a flat or substantially flat shape or contour of the proximal face 3060, a 90° or approximately 90° angular transition between the proximal face 3060 and the tubular body 3080, relatively short lengths of the struts 3082, 3086 forming the diamond or square shapes along the tubular body 3080, and relatively larger angles of the proximal and distal apexes 3084, 3088 of the diamond or square shapes.”
This paragraph notes that the features of conformability is due the shape or contour of the proximal face, the angular transition between the proximal face and the tubular body, etc. However, none point towards “self-expandable support” which is claimed alone as providing such a function. In fact, more specific structures, which are not found in claims, are described such as “the angular transition between the proximal face and the tubular body”.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
[0252] reproduced below,
“The various structural aspects detailed in this section and elsewhere contributes to the enhanced conformability of the device 3000. For example, the struts 3082, 3086 of the tubular body 3080 may be mechanically independent such that applying a radially inward force on one strut of the struts 3082, 3086, or on one of the quadrilateral shapes defined by four adjacent struts 3082, 3086, does not cause the adjacent struts or quadrilateral shapes to collapse in a similar manner. Such radial force may cause the perimeter of the frame 3040 to instead bulge out. The struts 3082, 3086 may therefore behave independently which contributes to allowing the device 3000 to conform to various and extremely non-circular, for example oval, cross sectional shapes of LAA's, as further described herein, for example with respect to FIGS. 13A-13B and 17A-17B, while still providing a fully sealed and occluded LAA. In some embodiments, the device 3000 may conform to non-uniform (not circular and not oval) shapes to form a seal with non-uniform anatomy.”
This paragraph gives another specific structure, which again, is not claimed within claim 5, of mechanically independent struts allow for the device for the claimed functional language.
Furthermore, Kaplan which is relied upon to disclose the “self-expandable support” in [0013] notes that the struts of support are “independent repositionable anchors”, hence also have mechanically independent struts, further showing that Kaplan as modified with Sepetka would be capable of “wherein compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 5 mm reduction in the mean diameter”.
As such, even with the applicant’s assertion that it is the “self-expandable support” in combination with the “foam” that allows for the claimed functional language, Kaplan as modified by Sepetka meets the structural limitations of the claim, and is capable of wherein compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 5 mm reduction in the mean diameter, as the foam of Kaplan as modified by Sepetka has the same properties that allow for the compressibility of the device, and the self-expandable support is the same as claimed and furthermore has disclosure of having specific structure that is not claimed.
The applicant additionally argues that the Office Action has not identified particular rationale for combining the particular values identified from the extensive number of possible combinations encompassed by the disclosed ranges in Sepetka, and hence this is impermissible hindsight. They explain this as the rationale provided of the foam of Sepetka can “withstand normal manual or mechanical handling during its intended application without tearing, breaking, or crumbling” is a benefit for the particular device of Sepetka and not motivation for combination with the foam of Kaplan.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The examiner respectfully disagrees, as the motivation cited for intended application applies is it an analogous context, and that when one of ordinary skill in the art is using foam in an implant within the left atrial appendage, would desire the foam to not tear, break, crumble, fragment or otherwise disintegrate ([0300] of Sepetka). As such a failure of the foam within the left atrial appendage would prevent occlusion of the left atrial appendage.
The applicant makes similar arguments in regards to claims 17 and 21, and for the same reasons as above the examiner respectfully disagrees.
As such the 103 rejection of the claims will be maintained.
Applicant’s arguments, see page 13, filed 06/05/2026, with respect to the double patenting rejections have been fully considered and are persuasive. The applicant’s timely filing of the terminal disclaimer overcomes the nonstatutory double patenting rejection. The double patenting rejections have been withdrawn.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-11, 13-23, and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al (US 20170042549 A1), herein referenced to as “Kaplan” in view of Sepetka et al (US 20060116713 A1), herein referenced to as “Sepetka”.
Claim 5
Kaplan discloses: A conformable left atrial appendage occlusion device 10 (see Figs. 27A-29B, [0116]), comprising: an expandable tubular foam body 15 (see Figs. 27A-29B, [0117]. See also [0078], polycarbonate-polyurethane urea foam) having a compressible foam sidewall the side wall of 15 between the slots 17 (see Fig. 27F, [0120]), a proximal end proximal end of 15 (see Figs. 27A-29B), a distal end distal end of 15 (see Figs. 27A-29B), and a longitudinal axis the longitudinal axis of 15 from distal to proximal end (see Fig. 27A) defined by the tubular foam body 15, the tubular foam body 15 having a mean diameter the diameter of 15 (see Fig. 27B for a transverse view of the device) in an unconstrained expansion (see Figs. 27A-27C); and a self-expandable support 101 (see Figs. 27A-29B, [0117], when released it deploys into the deployed configuration shown in Fig. 27A) carried within the tubular foam body 15.
Kaplan does not explicitly disclose: wherein compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 5 mm reduction in the mean diameter.
However, Sepetka in a similar field of invention teaches an occlusion device 30 (see Figs. 6-7) with an expandable tubular foam body 32 (see Figs. 6-7) of a polycarbonate polyurethane-urea (see [0057]). Sepetka further teaches: the foam reticulated polymer matrix (see [0331], the polymer matrix makes a “foam implant”, see also [0348]) of the expandable tubular foam body 32 having the following mechanical properties: a permeability of 311 Darcy (see [0307], Darcy from 50 to about 500, 311 within that range), average cell size/pore diameter of 377 µm (see [0298], the largest transverse dimension of the pores is not greater than 700 µm, which 377 is within that range), density of 2.7 lb/ft3 (see [0299], between 0.31 to 9.4 lb/ft3 which 2.7 is between), compressive strength of 1.1 psi (see [0304], 1 to 100 psi, which 1.1 psi is between), tensile strength of 68 psi/32 psi (see [0300], 1 to 125 psi, which 32 and 68 psi is between), and elongation of 219%/243% (see [0300], 50-500% tensile elongation, which 219% and 243% are between).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kaplan to incorporate the teachings of Sepetka and teach a conformable left atrial appendage occlusion device with polycarbonate polyurethane-urea foam with mechanical properties of a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. Motivation for such can be found in Sepetka as this can allow the foam to withstand normal manual or mechanical handing during its intended application without tearing, breaking, crumbling (see [0300]).
The language, "wherein compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 5 mm reduction in the mean diameter," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 5 mm reduction in the mean diameter due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. 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). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I. (As well be applied to other functional language limitations below)
Claim 6
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above.
The language, " wherein compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along the minor axis transverse to the longitudinal axis causes no more than about a 2 mm reduction in the mean diameter," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the compression of the device from a diameter of about 35 mm to a diameter of about 20 mm along a minor axis transverse to the longitudinal axis causes no more than about a 2 mm reduction in the mean diameter due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 7
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above. Kaplan further discloses: wherein the self-expandable support 101 comprises a plurality of distally facing apexes (see annotated Fig. 27A below), and wherein the tubular foam body 15 extends distally beyond the distally facing apexes (see annotated Fig. 27A below) to provide an atraumatic distal bumper(see annotated Fig. 27A below).
PNG
media_image1.png
574
691
media_image1.png
Greyscale
Claim 8
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above. Kaplan further discloses: further comprising at least one anchor 121 (see Figs. 28A-28D, [0131]).
Claim 9
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above. Kaplan further discloses: wherein the tubular foam body 15 (see Fig. 27G) can be compressed within a delivery catheter 1 (see Fig. 27G, [0117]) having an inside diameter of no more than about 20F (see [0097], delivery sheathes within the specification are disclosed to have 20F) and can self-expand to a diameter of at least about 35 mm when released from the delivery catheter (see [0079] and [0123], the foam device expands to between 5-50 mm, which 35 mm is between).
Claim 10
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above.
The language, " wherein application of 0.20 lbs compressive force along the minor axis produces a compression of at least about 0.25 inches along the minor axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the application of 0.20 lbs compressive force along the minor axis produces a compression of at least about 0.25 inches along the minor axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 11
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above.
The language, " wherein application of 0.20 lbs compressive force along the minor axis produces a compression of at least about 0.5 inches along the minor axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the application of 0.20 lbs compressive force along the minor axis produces a compression of at least about 0.5 inches along the minor axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 13
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above. Kaplan and Sepetka does not explicitly teach: wherein the foam sidewall extends in a distal direction beyond a distal end of the support by at least about 2 mm in an unconstrained, expanded state.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kaplan and Sepetka to have wherein the foam sidewall extends in a distal direction beyond a distal end of the support by at least about 2 mm in an unconstrained, expanded state since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kaplan and Sepetka would not operate differently with wherein the foam sidewall extends in a distal direction beyond a distal end of the support by at least about 2 mm in an unconstrained, expanded state. Further, applicant places no criticality on the range claimed, see [0180] of applicant’s patent application publication, which recites from about 1 mm for the bumper which his shorter than “at least about 2 mm” which indicates “at least 2 mm” is not critical as 1 mm is a suitable alternative.
Claim 14
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above. Kaplan further discloses: wherein the foam sidewall 15 comprises a reticulated, cross-linked matrix (see [0078, polycarbonate-polyurethane urea foam) having at least about 90% void content (see [0078], 90% void content), an average pore size within a range of from about 250 - 500 microns (see [0078], 250 microns, which is within 250 – 500).
Sepetka further teaches: wall thickness of at least about 2 mm (see [0170], 2 mm thickness), and wherein a pressure required to compress the foam sidewall to 50% strain is at least about 1 psi (see [0352], 50% compression, compression is a form of strain, 1.53 psi which is at least 1 psi, as it is greater than 1 psi).
Claim 15
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 14, see 103 rejection above. Sepetka further teaches: wherein the pressure required to compress the foam sidewall foam to 50% strain is within a range of from about 1 psi to about 2 psi (see [0352], 50% compression, compression is a form of strain, 1.53 psi which is between 1 and 2 psi).
Claim 16
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 5, see 103 rejection above. Kaplan further discloses: wherein the self-expandable support 101 comprises recapture struts (see annotated Fig. 27A below) configured to extend radially linearly in an unconstrained configuration (see annotated Fig. 27A below).
PNG
media_image2.png
522
633
media_image2.png
Greyscale
Claim 17
Kaplan discloses: A conformable left atrial appendage occlusion device 10 (see Figs. 27A-29B, [0116]), comprising: an expandable tubular foam body 15 (see Figs. 27A-29B, [0117]. See also [0078], polycarbonate-polyurethane urea foam) having a compressible foam sidewall the side wall of 15 between the slots 17 (see Fig. 27F, [0120]), a proximal end proximal end of 15 (see Figs. 27A-29B), a distal end distal end of 15 (see Figs. 27A-29B), and a longitudinal axis the longitudinal axis of 15 from distal to proximal end (see Fig. 27A) defined by the tubular foam body 15, the tubular foam body 15 having a mean diameter the diameter of 15 (see Fig. 27B for a transverse view of the device) in an unconstrained expansion (see Figs. 27A-27C); and a self-expandable support 101 (see Figs. 27A-29B, [0117], when released it deploys into the deployed configuration shown in Fig. 27A) carried within the tubular foam body 15.
Kaplan does not explicitly disclose: wherein compression of the device from a diameter of about 35 mm to a diameter of about 25 mm along a minor axis transverse to the longitudinal axis causes an elongation of at least about 6 mm along a major axis transverse to the minor axis.
However, Sepetka in a similar field of invention teaches an occlusion device 30 (see Figs. 6-7) with an expandable tubular foam body 32 (see Figs. 6-7) of a polycarbonate polyurethane-urea (see [0057]). Sepetka further teaches: the foam reticulated polymer matrix (see [0331], the polymer matrix makes a “foam implant”, see also [0348]) of the expandable tubular foam body 32 having the following mechanical properties: a permeability of 311 Darcy (see [0307], Darcy from 50 to about 500, 311 within that range), average cell size/pore diameter of 377 µm (see [0298], the largest transverse dimension of the pores is not greater than 700 µm, which 377 is within that range), density of 2.7 lb/ft3 (see [0299], between 0.31 to 9.4 lb/ft3 which 2.7 is between), compressive strength of 1.1 psi (see [0304], 1 to 100 psi, which 1.1 psi is between), tensile strength of 68 psi/32 psi (see [0300], 1 to 125 psi, which 32 and 68 psi is between), and elongation of 219%/243% (see [0300], 50-500% tensile elongation, which 219% and 243% are between).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kaplan to incorporate the teachings of Sepetka and teach a conformable left atrial appendage occlusion device with polycarbonate polyurethane-urea foam with mechanical properties of a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. Motivation for such can be found in Sepetka as this can allow the foam to withstand normal manual or mechanical handing during its intended application without tearing, breaking, crumbling (see [0300]).
The language, "wherein compression of the device from a diameter of about 35 mm to a diameter of about 25 mm along a minor axis transverse to the longitudinal axis causes an elongation of at least about 6 mm along a major axis transverse to the minor axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the compression of the device from a diameter of about 35 mm to a diameter of about 25 mm along a minor axis transverse to the longitudinal axis causes an elongation of at least about 6 mm along a major axis transverse to the minor axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 18
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 17, see 103 rejection above.
The language, " wherein compression of the device from a diameter of about 35 mm to a diameter of about 25 mm along the minor axis causes an elongation of at least about 8 mm along the major axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the compression of the device from a diameter of about 35 mm to a diameter of about 25 mm along the minor axis causes an elongation of at least about 8 mm along the major axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 19
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 17, see 103 rejection above. Kaplan further discloses: further comprising at least one anchor 121 (see Figs. 28A-28D, [0131]).
Claim 20
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 17, see 103 rejection above. Kaplan further discloses: wherein the self-expandable support 101 comprises recapture struts (see annotated Fig. 27A below) configured to extend radially linearly in an unconstrained configuration (see annotated Fig. 27A below).
PNG
media_image2.png
522
633
media_image2.png
Greyscale
Claim 21
Kaplan discloses: A conformable left atrial appendage occlusion device 10 (see Figs. 27A-29B, [0116]), comprising: an expandable tubular foam body 15 (see Figs. 27A-29B, [0117]. See also [0078], polycarbonate-polyurethane urea foam) having a compressible foam sidewall the side wall of 15 between the slots 17 (see Fig. 27F, [0120]), a proximal end proximal end of 15 (see Figs. 27A-29B), a distal end distal end of 15 (see Figs. 27A-29B), and a longitudinal axis the longitudinal axis of 15 from distal to proximal end (see Fig. 27A) defined by the tubular foam body 15, the tubular foam body 15 having a mean diameter the diameter of 15 (see Fig. 27B for a transverse view of the device) in an unconstrained expansion (see Figs. 27A-27C); and a self-expandable support 101 (see Figs. 27A-29B, [0117], when released it deploys into the deployed configuration shown in Fig. 27A) carried within the tubular foam body 15.
Kaplan does not explicitly disclose: wherein application of 0.10 lbs compressive force along a minor axis transverse to the longitudinal axis produces a compression of at least about 0.2 inches along the minor axis.
However, Sepetka in a similar field of invention teaches an occlusion device 30 (see Figs. 6-7) with an expandable tubular foam body 32 (see Figs. 6-7) of a polycarbonate polyurethane-urea (see [0057]). Sepetka further teaches: the foam reticulated polymer matrix (see [0331], the polymer matrix makes a “foam implant”, see also [0348]) of the expandable tubular foam body 32 having the following mechanical properties: a permeability of 311 Darcy (see [0307], Darcy from 50 to about 500, 311 within that range), average cell size/pore diameter of 377 µm (see [0298], the largest transverse dimension of the pores is not greater than 700 µm, which 377 is within that range), density of 2.7 lb/ft3 (see [0299], between 0.31 to 9.4 lb/ft3 which 2.7 is between), compressive strength of 1.1 psi (see [0304], 1 to 100 psi, which 1.1 psi is between), tensile strength of 68 psi/32 psi (see [0300], 1 to 125 psi, which 32 and 68 psi is between), and elongation of 219%/243% (see [0300], 50-500% tensile elongation, which 219% and 243% are between).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kaplan to incorporate the teachings of Sepetka and teach a conformable left atrial appendage occlusion device with polycarbonate polyurethane-urea foam with mechanical properties of a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. Motivation for such can be found in Sepetka as this can allow the foam to withstand normal manual or mechanical handing during its intended application without tearing, breaking, crumbling (see [0300]).
The language, " wherein application of 0.10 lbs compressive force along a minor axis transverse to the longitudinal axis produces a compression of at least about 0.2 inches along the minor axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the application of 0.10 lbs compressive force along a minor axis transverse to the longitudinal axis produces a compression of at least about 0.2 inches along the minor axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 22
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 21, see 103 rejection above.
The language, " wherein application of 0.20 lbs compressive force along the minor axis produces a compression of at least about 0.5 inches along the minor axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the application of 0.20 lbs compressive force along the minor axis produces a compression of at least about 0.5 inches along the minor axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 23
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 21, see 103 rejection above.
The language, "wherein application of no more than about 0.30 lbs compressive force along the minor axis produces a compression of at least about 0.6 inches along the minor axis," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Kaplan and Sepetka meets the structural limitations of the claim, and is capable of the application of no more than about 0.30 lbs compressive force along the minor axis produces a compression of at least about 0.6 inches along the minor axis due to the material properties of the polycarbonate polyurethane-urea foam with a permeability of 311 Darcy, average cell size/pore diameter of 377 µm, a density of 2.7 lb/ft3, compressive strength of 1.1 psi, tensile strength of 68 psi/32 psi, and elongation of 219%/243%. This is supported by the applicant’s own patent application publication(see [0085]) which states that the compressibility of the body is due to the foam, and its material properties indicated in Table 1, which is the same as the properties of the foam in Sepetka.
Claim 26
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 21, see 103 rejection above. Kaplan further discloses: wherein the foam sidewall 15 comprises a reticulated, cross-linked matrix (see [0078, polycarbonate-polyurethane urea foam) having at least about 90% void content (see [0078], 90% void content), an average pore size within a range of from about 250 - 500 microns (see [0078], 250 microns, which is within 250 – 500).
Sepetka further teaches: wall thickness of at least about 2 mm (see [0170], 2 mm thickness), and wherein a pressure required to compress the foam sidewall to 50% strain is at least about 1 psi (see [0352], 50% compression, compression is a form of strain, 1.53 psi which is at least 1 psi, as it is greater than 1 psi).
Claim 27
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 26, see 103 rejection above. Sepetka further teaches: wherein the pressure required to compress the foam sidewall foam to 50% strain is within a range of from about 1 psi to about 2 psi (see [0352], 50% compression, compression is a form of strain, 1.53 psi which is between 1 and 2 psi).
Claim(s) 12 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan in view of Sepetka as applied to claims 5 and 21, respectively, above, and further in view of Datta et al (US 7803395 B2), herein referenced to as “Datta”.
Claim 12
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 12, see 103 rejection above. The combination of Kaplan and Sepetka does not explicitly teach: wherein the foam sidewall has an uncompressed thickness of at least about 0.5 mm.
However, Datta in a similar field of invention teaches implantable medical devices (see col. 17, lines 27-39) with a foam sidewall implantable elastomeric matrix forming a sheet, a sidewall of a cylinder is a circumferentially folded sheet (see col. 17, lines 27-39). Datta further teaches: wherein the foam sidewall implantable elastomeric matrix forming a sheet has an uncompressed thickness of at least about 0.5 mm (see col. 17, lines 27-39, thickness about 0.5 mm to about 20 mm, which 0.5 mm is included with the range).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kaplan and Sepetka to incorporate the teachings of Datta and teach a conformable left atrial appendage occlusion device with the foam sidewall has an uncompressed thickness of at least about 0.5 mm. Motivation for such can be found in Datta as this range of thickness is necessary to resist tear of the foam according to testing (see col. 62, lines 16-24).
Claim 24
The combination of Kaplan and Sepetka teaches: The conformable left atrial appendage occlusion device of Claim 21, see 103 rejection above. The combination of Kaplan and Sepetka does not explicitly teach: wherein the foam sidewall has an uncompressed thickness of at least about 0.5 mm.
However, Datta in a similar field of invention teaches implantable medical devices (see col. 17, lines 27-39) with a foam sidewall implantable elastomeric matrix forming a sheet, a sidewall of a cylinder is a circumferentially folded sheet (see col. 17, lines 27-39). Datta further teaches: wherein the foam sidewall implantable elastomeric matrix forming a sheet has an uncompressed thickness of at least about 0.5 mm (see col. 17, lines 27-39, thickness about 0.5 mm to about 20 mm, which 0.5 mm is included with the range).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kaplan and Sepetka to incorporate the teachings of Datta and teach a conformable left atrial appendage occlusion device with the foam sidewall has an uncompressed thickness of at least about 0.5 mm. Motivation for such can be found in Datta as this range of thickness is necessary to resist tear of the foam according to testing (see col. 62, lines 16-24).
Claim 25
The combination of Kaplan, Sepetka, and Datta teaches: The conformable left atrial appendage occlusion device of Claim 24, see 103 rejection above. Datta further teaches: wherein the foam sidewall implantable elastomeric matrix forming a sheet has an uncompressed thickness of at least about 1.5 mm (see col. 17, lines 27-39, thickness about 0.5 mm to about 20 mm, which 1.5 mm is included with the range).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sharma et al (US 20230414840 A1), teaches using foam in hemostatic implants and compression force values of foams
THIS ACTION IS MADE FINAL. 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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights