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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 4-7, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuseth et al. US Patent Application Publication 2017/0196565.
As to claim 1, Tuseth teaches a shunt device 1 comprising:
a cylindrical barrel portion 2 (Figs. 1, 3A, 3B) formed of a plurality of struts arranged in a chevron pattern (Fig. 8; para. 0015);
a plurality of proximal anchor features 4, 4A, 4B emanating from a first axial end of the barrel portion (Figs. 1, 8, 9A, 9B; paras. 0113, 0115); and
a plurality of distal anchor arms 3, 3A, 3B emanating from a second axial end of the barrel portion (Figs. 1, 8, 9A, 9B; paras. 0113, 0115), the plurality of distal anchor arms having a length that is greater than a length of the proximal anchor features (Figs. 3A, 3B, 8, 9a, 9B, 10; paras. 0115-0116).
As to claim 2, each of the plurality of proximal anchor features 4B comprises a primary tissue contact pad (eyelet 6) and a secondary tissue contact pad 6 circumferentially and axially offset from the primary tissue contact pad (Figs. 3A and 3B; para. 0117). Tuseth teaches the eyelets provide an improved grip to the anatomical walls and prevent slipping of the arms on the surface of the anatomical walls (Para. 0024). Thus, the eyelets function as tissue contact pads.
As to claim 4, the barrel portion 2 includes a plurality of wishbone struts (Fig. 8) coupled between secondary tissue contact pads 6, 4A, 4B of the plurality of proximal anchor features 4 (Fig. 8).
As to claim 5, the shunt device 1 is configured to be deployed in a tissue wall such that the shunt device holds the tissue wall between the plurality of proximal anchor features and the plurality of distal anchor arms with the barrel portion disposed at least partially in an opening in the tissue wall (Figs. 1 and 13; paras. 0022, 0113, 0118, 0130).
As to claim 6, the barrel portion 2 has an axis that is angled relative to a plane of the tissue wall when the shunt device is deployed in the tissue wall – where Tuseth teaches the neck 2 (barrel portion) may comprise a tapered portion or be tapered. Tuseth teaches the tapered neck improves safety in that the taper prevents the walls from sliding back over the neck, thereby releasing the anatomical walls from contact, reopening the space therebetween and risking potentially fatal blood leakage (para. 0034). Tuseth teaches the neck 2 (barrel portion) preferably tapers from the atrial side to the aortic side to allow easy insertion as the pump is initially inserted (Fig. 13; para. 0122).
As to claim 7, the plurality of distal anchor arms 3,3B each include an elongated strut 5 terminating in a tissue-contact pad 6 (Figs. 7A, 7B, 8, 10, 12, and 13; para. 0117).
As to claim 11, Tuseth teaches a shunt device 1 comprising:
a cylindrical barrel 2 formed of a plurality of struts arranged in a zigzag pattern (Fig. 8; para, 0123);
a plurality of first tissue contact pads associated with a first axial end of the barrel 2 and configured to deflect radially outward from an axis of the barrel - Tuseth teaches each arm (elements 3, 4) comprises one or more eyelets. The eyelets provide an improved grip to the anatomical walls and prevent slipping of the arms on the surface of the anatomical walls (para. 0024). Thus, the eyelets function as tissue contact pads. Fig. 7B shows the eyelets 6, formed as loops and Fig. 8 shows eyelets or loops on each side of the barrel 2; and
a plurality of second tissue contact pads associated with a second axial end of the barrel and configured to deflect radially outward and toward an axial center of the barrel - where Fig. 8 shows tissue contact pads on each side of the barrel 2;
the plurality of second tissue contact pads 6 being angularly offset from the plurality of first tissue contact pads about the axis of the barrel – where the eyelets at 4B are angularly offset from the eyelets at 4A and/or the eyelets at 3A are angularly offset from the eyelets at 3B (Fig. 8) as broadly as claimed.
As to claim 12, the plurality of first tissue contact pads and one of the plurality of second tissue contact pads are positioned on a first diametrical side of the shunt device, and wherein two of the plurality of second tissue contact pads are positioned on a second diametrical side of the shunt device – where Figs. 5 and 8 show pads 3B and 3A are diametrically opposed and/or pads 4A and 4B are diametrically opposed relative to the barrel 2.
As to claim 13, one of the plurality of second tissue contact pads is angularly positioned between the plurality of first tissue contact pads – where one of the pads 4B is angularly positioned between one of pads 4A as in a line drawn between a pad 4B and a pad 4A, would represent an angle as broadly as claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tuseth et al. US Patent Application Publication 2017/0196565.
As to claim 3, Tuseth teaches the present invention substantially as claimed. Tuseth does not specifically teach the primary tissue contact pad 6 and the secondary tissue contact pad 6 of each of the plurality of proximal anchor features 4 are coupled by a strut 5 that is bowed away from the barrel portion 2. Tuseth does teach examples of arm shapes are illustrated in Figs. 6, 7A, and 7B. Tuseth teaches the shape and dimensions of the arms can be adjusted depending on the requirements. Tuseth further teaches the arms may be partially or completely straight, curved or bent relative to the anatomical wall W (Fig. 6; para. 0121). It would have been an obvious matter of design choice to provide a strut that is bowed away from the barrel portion 2, since such a modification would have involved a mere change in the shape of the component, which Tuseth teaches is acceptable. A change in shape is generally recognized as being within the level of ordinary skill in the art. In Re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tuseth et al. US Patent Application Publication 2017/0196565 in view of Nitzan et al. US Patent Application Publication 2013/0030521.
As to claim 8, Tuseth teaches the present invention substantially as claimed. Tuseth does not teach at least a portion of the elongated strut and tissue-contact pad of each of one or more of the plurality of distal anchor arms is covered with a covering configured to promote tissue-ingrowth. Nitzan, from the same field of endeavor, implantable medical devices, teaches a stent configured to be implanted into a heart having an hourglass-shape covered with a biocompatible material 120. Nitzan teaches the material preferably is generally smooth so as to inhibit thrombus formation, and optionally may be impregnated with carbon so as to promote tissue ingrowth (Nitzan para. 0050). Nitzan teaches a biodegradable material may be disposed in the neck region of the device and configured to biodegrade at a rate similar to a rate at which tissue ingrows into the device. Nitzan teaches a benefit of the cumulative effect of the loss of biodegradable material and ingrowth of tissue may be to maintain the rate of blood flow through the device at or near a desired value (Nitzan para 0018). It would have been obvious to one having ordinary skill in the art to modify Tuseth with a biocompatible, biodegradable material to promote tissue growth for the benefits taught in Nitzan.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tuseth et al. US Patent Application Publication 2017/0196565 in view of Keren US Patent Application Publication 2018/0280667.
As to claim 9, Tuseth teaches the present invention substantially as claimed. Tuseth does not teach the device of claim 1, further comprising a sensor holder emanating from the first axial end of the barrel portion. Keren, from the same field of endeavor, medical shunts, teaches an apparatus 28 that includes a shunt 26 that helps relieve excess intra-atrial pressure, by allowing blood to flow from the higher-pressure atrium to the lower-pressure atrium (Keren para. 0062). Keren teaches in some embodiments, the shunt apparatus 28 comprises one or more pressure sensors, disposed, for example on shunt 26, on any of the longitudinal elements, and/or in sheath 31. Keren teaches such pressure sensors may be used to measure the pressure in the subject’s right atrium and/or left atrium, for the benefit monitoring progression of the treatment, and ascertaining the point in time at which the shunt may be removed form the subject (Keren para. 0062). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the shunt of Tuseth with sensors for the benefits taught in Keren.
As to claim 10, Tuseth/Keren teach the sensor holder comprises a ring configured to deflect outwardly from the barrel portion and have a base of a cylindrical sensor device attached thereto such that the sensor device is positioned on an outside of the barrel portion – where Keren teaches the sensor may be disposed on sheath 31, which is present on a cylindrical sensor device and positioned on an outside of the barrel portion 26 (Keren Fig. 3C; para. 0062).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tuseth et al. US Patent Application Publication 2017/0196565 in view of Brenneman US Patent Application Publication 2012/0101423.
As to claim 14, Tuseth teaches the present invention substantially as claimed. Tuseth does not teach the shunt device comprising a plurality of columns of wishbone struts including a first set of wishbone struts open in a first axial direction and a second set of wishbone struts open in a second axial direction opposite the first axial direction. Tuseth teaches the shunt device can comprise a repeating pattern in various shapes and in one embodiment, comprises columns of wishbone struts (Fig. 8; para. 0123), however, the struts all open in the same axial direction. Brenneman teaches a shunt for implementation in the aorta and inferior vena cava comprising a plurality of loops where the loops turn radially outwardly from the center section, in which case each loop is open toward different axial directions (Brenneman Figs. 3 and 5). Brenneman teaches the construction provides several pairs of longitudinally opposed and aligned distal and proximal petaloids which form a “corolla” flange or rivet clinch which impinges on the vena cava wall and prevents expulsion into the aorta, and the petaloid frames of the proximal section form a corolla flange or rivet clinch which impinges on the aorta wall and prevents the expulsion of the shun into the vena cava .. to keep the fistula open. Brenneman teaches the resilient apposition of the two distal and proximal flanges or corollas will securely hold the shunt rivet in place by resiliently clamping the walls of the aorta and vena cava even over a considerable range of wall thickness or ‘grip range” (Brenneman Figs. 3-5; para. 0030). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Tuseth with the shapes taught in Brenneman for the benefits Brenneman teaches. Additionally, Tuseth teaches various shapes are within the scope of his invention, thus, It would have been an obvious matter of design choice to provide the article of Tuseth with the shape of diametrically opposed open wishbone columns, since such a modification would have involved a mere change in the shape of the component, which Tuseth teaches is acceptable. A change in shape is generally recognized as being within the level of ordinary skill in the art. In Re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)
Tuseth/Brenneman further teach a plurality of proximal anchoring means associated with a first axial end of the barrel and configured to contact a first side of the tissue wall when the barrel is disposed in the opening in the tissue wall (Tuseth Figs. 1 and 13; paras. 0022, 0113, 0118, 0130; Brennerman para. 0030); and
a plurality of distal anchoring means associated with a second axial end of the barrel and configured to contact a second side of the tissue wall opposite the first side when the barrel is disposed in the opening in the tissue wall (Tuseth Figs. 1 and 13; paras. 0022, 0113, 0118, 0130 Brennerman para. 0030).
As to claim 15, at least some of the first set of wishbone struts and the second set of wishbone struts are coupled at apices thereof to respective longitudinal struts of the barrel (Tuseth Fig. 8; Brenneman Figs. 3 and 5).
As to claim 16, Tuseth/Brennerman teach at least some of the first set of wishbone struts and the second set of wishbone struts are not coupled at apices thereof to a longitudinal strut of the barrel – where Tuseth shows in the repeating pattern, portions of the struts are only coupled to an adjacent strut and not to the longitudinal struts forming the arms (Tuseth Fig. 8).
As to claim 17, Tuseth/Brennerman teach the plurality of proximal anchoring means 4 each comprise a primary tissue contact pad 6 coupled to a secondary tissue contact pad 6 (Tuseth Fig. 7A; para. 0117) via a curved connecting strut – where Tuseth teaches the linear portion 5 may be curved (Tuseth Fig. 7A; para. 0121). Note: in Tuseth paragraph 0121, the linear portions are erroneously indicated as element 6 and eyelets as 5. In paragraph 0117, the elements 5 and 6 are correctly identified.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Taft et al. USPN 9789294 and Forcucci et al. US Patent Application Publication 20160022970 are cited to show devices for implanting into a heart wall of a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781