Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
This is in response to the non-provisional application filed 10/25/2024.
Allowable Subject Matter
Claims 15, 16, 19, 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 15 recites wherein the positioner comprises a plurality of elongate arms, wherein deploying the elongate arms comprises moving the elongate arms distally out of openings in the delivery capsule. Claim 19 recites wherein in the delivery state outer surfaces of the elongate arms are flush with an exterior surface of the capsule, and wherein deploying the elongate arms comprises rotating the elongate arms radially outwardly.
The Office agrees the art of record fail to teach or suggest these features.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-6, 8-13 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Publication Number 2010/0191326 (Alkhatib)
Regarding claims 1-6, Alkhatib discloses as shown in Figures 10-14, a delivery system comprising: a catheter body having a distal portion and a proximal portion; a delivery capsule (sleeve 120, is interpreted as a capsule because the plain and ordinary meaning of the term according to Webster’s Dictionary is compact container which is not inconsistent with the specification, see paragraph [0073]) coupled to the distal portion of the catheter body, the delivery capsule capable of housing a prosthetic heart valve therein (note: claim 1 does not recite the prosthetic heart valve, only a capsule capable of holding one); and a positioner (collapsed fingers 110, see paragraph [0073]) having a delivery state configured for delivery and a tissue-contacting state for engaging tissue of a heart, wherein in the tissue-contacting state the positioner is capable of positioning the delivery capsule relative to the heart, wherein the positioner comprises a mechanical positioner assembly, wherein the mechanical positioner assembly comprises a plurality of deployable members, wherein in the delivery state the deployable members are substantially parallel to a central longitudinal axis of the delivery capsule, and wherein in the tissue-contacting state the deployable members extend radially outward from the delivery capsule, wherein the deployable members are flexible elongated arms or tines, wherein the deployable members are pivotably coupled to the delivery capsule, wherein the deployable members are self-deployable to the tissue-contacting state.
Regarding claims 8, 9 Alkhatib et al. discloses wherein a transverse dimension of the mechanical positioner assembly in the tissue-contacting state is such that the deployable members do not pass through a native heart valve of the heart, if deployed in a heart where the transverse dimension of the mechanical positioner assembly in the tissue-contacting state is larger than the native heart valve of the heart, wherein the native heart valve is a native mitral valve, and wherein the deployable members are sized to be cable of contacting opposing sides of a left atrial wall of the heart in the tissue-contacting state. See Figure 2.
Regarding claims 10, 11 Colson et al. discloses as shown in Figure 2 a method comprising: delivering a delivery catheter to a native heart valve of a heart, the delivery catheter including a catheter body, a delivery capsule (sleeve 120, see paragraph [0073]) coupled to a distal portion of the catheter body, a positioner (collapsed fingers 110, see paragraph [0073]) in a delivery state, and a prosthetic heart valve (valve 200, see paragraph [0070]) disposed within the delivery capsule in a low-profile delivery configuration; deploying the positioner to a tissue-contacting state in which the positioner contacts tissue of the heart; deploying the prosthetic heart valve from the delivery capsule; after deploying the prosthetic heart valve, returning the positioner to the delivery state; and removing the delivery catheter, wherein the positioner comprises a plurality of elongate arms, wherein in the delivery state the elongate arms are substantially parallel to a central longitudinal axis of the delivery capsule, and wherein deploying the elongate arms comprises pivoting the elongate arms such that the elongate arms extend radially outward from the delivery capsule. See paragraph [0060].
Regarding claims 12, 13 Colson et al. discloses wherein delivering the delivery catheter comprises delivering the delivery catheter through a guide catheter (shaft 40, see paragraph [0060]) that holds the elongate arms in the delivery state, and wherein deploying the elongate arms comprises removing the elongate arms from the guide catheter, wherein the elongate arms self-deploy to the tissue-contacting state when removed from the guide catheter. See Figures 12-14.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2010/0191326 (Alkhatib et al.) in view of U.S. Patent Publication Number 2002/0058963 (Vale)
Regarding claim 7, Alkhatib fails to disclose wherein the deployable members comprise radiopaque material or comprise one or more radiopaque markers.
Vale, from the same field of endeavor teaches a similar system as shown in Figure 11, where a deployable member used for a similar purpose (centering) comprises radiopaque material for the purpose of tracking it. See paragraph [0073].
It would have been obvious to one of ordinary skill in the art, at the time the invention was made to modify the delivery system disclosed by Colson by substituting some of the material of the projections 132 for the radiopaque material taught by Vale or coating the projections 132 disclosed by Colson with radiopaque material as taught by Vale in order to track the deployable members, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim 14 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2010/0191326 (Alkhatib et al.) in view of U.S. Patent Publication Number 2007/0233222 (Roeder)
Regarding clam 14, Alkhatib et al. fail to disclose wherein the delivery catheter includes a proximal sheath and a distal sheath, wherein the elongate arms are coupled to the proximal sheath, and wherein deploying the prosthetic heart valve comprises distally advancing the distal sheath.
Roeder, from the same field of endeavor teaches a similar method which includes the delivery catheter includes a proximal sheath (proximal sheath 116, see paragraph [0042]) and a distal sheath (proximal sheath 115, see paragraph [0042]), and wherein deploying a prosthetic comprises distally advancing the distal sheath.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Alkhatib et al. by substituting the delivery catheter disclosed by Alkhatib for the one taught by Roeder such that the delivery catheter includes a proximal sheath and a distal sheath, wherein the elongate arms are coupled to the proximal sheath, and wherein deploying the prosthetic heart valve comprises distally advancing the distal sheath. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim 17 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2010/0191326 (Alkhatib et al.) in view of U.S. Patent Publication Number 2011/0137397 (Chau et al.)
Regarding claim 17, Alkhatib et al. fails to disclose wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter from the left atrium and into the mitral valve.
Chau from the same field of endeavor teaches a similar method as shown in Figure 5, wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter from the left atrium and into the mitral valve. See paragraph [0132].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Alkhatib et al. by substituting the steps of advancing the delivery catheter disclosed by Alkhatib et al. for the steps of the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter from the left atrium and into the mitral valve taught by Chau because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim 18 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication Number 2010/0191326 (Alkhatib et al.) in view of U.S. Patent Publication Number 2011/0319989 (Lane et al.)
Regarding claim 18, Lane et al. fails to disclose wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter transapically.
Lane from the same field of endeavor teaches a similar method as shown in Figure 5, wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter transapically. See paragraph [0077].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Alkhatib et al. by substituting the steps of advancing the delivery catheter disclosed by Alkhatib et al. for the steps of the native heart valve is a mitral valve, wherein the native heart valve is a mitral valve, and wherein delivering the delivery catheter to the mitral valve comprises delivering the delivery catheter transapically taught by Lane because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD G LOUIS/Primary Examiner, Art Unit 3771