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 Amendment
The claim amendments filed on 05/21/2025 have been entered. Claims 26-51, and 53-54 remain pending in the application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/21/2025, 06/16/2025, 07/24/2025, 09/03/2025, and 10/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
The Non-Final office action filed on 11/21/2024 indicated claim 52 allowable. Upon further consideration, a new grounds of rejection is filed in view of Buzerak et al (US Patent No. 5,356,424). A second non-Final Office Action is being issued providing the 102 rejection in view of Buzerak ‘424.
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.
Claim 48 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.
Claim 48 states “wherein the distal section has a relatively constant radius of curvature.”, however, claim 44 from which claim 48 depends discloses that the intermediate section of the distal section of the anchor guide transitions in a tapered spiral from a first radius of curvature to a second radius of curvature. It is unclear how the distal section of the anchor guide has a relatively constant radius of curvature, simultaneously while having a first radius of curvature and a second radius of curvature. Therefore, the limitation is rendered indefinite.
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.
Claims 26-30, 32-39, 41-43, and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buzerak et al (US Patent No. 5,356,424).
Regarding claim 26, Buzerak discloses a delivery system for delivering a prosthesis to a diseased valve (the recitation of “delivering a prosthesis to a diseased valve” is intended use, the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114.2), the delivery system comprising:
an outer sheath (Figure 7, item 16);
an inner shaft within the outer sheath (Figure 7, item 12),
the inner shaft translatable (Figure 1 and 7 depicts the inner shaft 12 translating) and rotatable relative to the outer sheath (column 5, lines 53-57 discloses the driver 12 (i.e. inner shaft) rotating relative to the outer sheath 16 by turning handle 14 ); and
an anchor guide (Figure 7, item 46) attached to a distal end of the inner shaft (Figure 7, anchor guide 46 attached to distal end of inner shaft 12 at 54),
the anchor guide comprising a proximal section that defines a central axis and a distal section that curves about the central axis in a tapered spiral and is concentric to the central axis of the proximal section (Figure 7, anchor guide 46 comprises a proximal section defining the central axis, and a distal section that curves about the central axis concentrically in a spiral, the spiraled anchor guide tapers at the end to a point).
Regarding claim 27, Buzerak discloses wherein the tapered spiral of the distal section extends more than 360 degrees (Figure 7, the tapered spiral of the distal section of the anchor guide 46 extends more than 360 degrees around the central axis).
Regarding claim 28, Buzerak discloses further comprising an anchor (Figure 7, anchor 50, wherein the definition of anchor is “something that serves to hold an object firmly” (Merriam-Webster Dictionary) slidably disposed within the anchor guide (column 6, lines 53-56, anchor 50 is slidably disposes within the anchor guide 46).
Regarding claim 29, Buzerak discloses wherein the anchor guide is configured to correctly orient the anchor relative to a longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the anchor guide (Figures 10-12 depicts the anchor guide 46 correctly orienting the anchor 59 relative to the longitudinal axis of the inner shaft 12 to facilitate concentric wrapping of the anchor as it is deployed from the anchor guide).
Regarding claim 30, Buzerak discloses wherein the outer sheath is steerable (column 4, lines 28-40 discloses wherein the outer sheath is steerable).
Regarding claim 32, Buzerak discloses wherein a distal-most portion of the distal section resides in a plane that is orthogonal to the central axis (Figure 7 depicts wherein the distal-most portion of distal section of anchor guide 46 resides in a plane orthogonal to central axis).
Regarding claim 33, Buzerak discloses wherein a curvature of the distal section is configured to match a curvature of an anchor of the prosthesis (Figures 10-12 depicts wherein the curvature of the distal section of anchor guide 46 is configured to match a curvature of the anchor 50).
Regarding claim 34, Buzerak discloses wherein the inner shaft and the anchor guide are of unitary construction (Figure 9, anchor guide 46 and inner shaft are depicted as unitary construction).
Regarding claim 35, Buzerak discloses a delivery system for delivering a prosthesis to a diseased valve (the recitation of “delivering a prosthesis to a diseased valve” is intended use, the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114.2), the delivery system comprising:
an outer sheath (Figure 7, item 16);
an inner shaft within the outer sheath (Figure 7, item 12),
the inner shaft translatable (Figure 1 and 6 depicts the inner shaft 12 translating) and rotatable relative to the outer sheath (column 5, lines 53-57 discloses the driver 12 (i.e. inner shaft) rotating relative to the outer sheath 16 by turning handle 14 ); and
an anchor guide (Figure 7, item 46) attached to a distal end of the inner shaft (Figure 7, anchor guide 46 attached to distal end of inner shaft 12 at 54),
the anchor guide comprising a proximal section that defines a central axis and a distal section that forms a tapered corkscrew and curves concentrically about the central axis of the proximal section, wherein the inner shaft and anchor guide are configured to rotate relative to the outer sheath (Figure 7, anchor guide 46 comprises a proximal section defining the central axis, and a distal section that forms a corkscrew that curves concentrically about the central axis of the proximal section, the corkscrew tapers at the end to a point).
Regarding claim 36, Buzerak discloses wherein the distal section extends more than 360 degrees (Figure 7, the corkscrew of the distal section of the anchor guide 46 extends more than 360 degrees around the central axis).
Regarding claim 37, Buzerak discloses further comprising an anchor slidably disposed within the anchor guide (Figure 7, anchor 50, wherein the definition of anchor is “something that serves to hold an object firmly” (Merriam-Webster Dictionary)) slidably disposed within the anchor guide (column 6, lines 53-56, anchor 50 is slidably disposes within the anchor guide 46).
Regarding claim 38, Buzerak discloses wherein the anchor guide is configured to correctly orient the anchor of the prosthesis relative to the central axis in order to facilitate concentric wrapping of the anchor around the central axis as the anchor is deployed from the anchor guide (Figures 10-12 depicts the anchor guide 46 correctly orienting the anchor 50 relative to the longitudinal axis of the inner shaft 12 to facilitate concentric wrapping of the anchor as it is deployed from the anchor guide). .
Regarding claim 39, Buzerak discloses wherein the outer sheath is steerable (column 4, lines 28-40 discloses wherein the outer sheath is steerable).
Regarding claim 41, Buzerak discloses wherein a distal-most plane of the distal section is orthogonal to the central axis (Figure 7 depicts wherein the distal-most portion of distal section of anchor guide 46 resides in a plane orthogonal to central axis).
Regarding claim 42, Buzerak discloses wherein a curvature of the distal section is configured to match a curvature of an anchor of the prosthesis (Figures 10-12 depicts wherein the curvature of the distal section of anchor guide 46 is configured to match a curvature of the anchor 50).
Regarding claim 43, Buzerak discloses wherein the inner shaft and the anchor guide are of unitary construction (Figure 9, anchor guide 46 and inner shaft are depicted as unitary construction).
Regarding claim 54, Buzerak discloses wherein the distal-most portion of the distal section extends at least 180 degrees (Figure 7, distal section 46 extends at least 180 degrees).
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.
Claims 31 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Buzerak et al (US Patent No. 5,356,424).
Regarding claim 31, the embodiment of Figure 7 of Buzerak discloses the invention substantially as claimed.
However, the embodiment of Figure 7 of Buzerak does not disclose wherein the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end.
The embodiment of Figure 93 discloses an anchor guide (see Buzerak, Figure 19) wherein the distal section transitions continuously from a high pitch, low radius curve (see Buzerak, Figure 19, item 93) at a proximal end to a low pitch, high radius curve at a distal end (see Buzerak, Figure 19, item 94).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the anchor guide of the embodiment of Figure 7 of Buzerak by providing wherein the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end as taught by Buzerak because the results would be predictable. The anchor guide region would still function in the same manner to deliver the anchor except it would be in the shape of the embodiment of Figure 19. Applicant has not demonstrated the criticality of this limitation, or disclosed that this configuration provides an advantage, is used for a particular purpose, or solves a stated problem, therefore, it would be generally recognized as being within the level or ordinary skill in the art to form the anchor guide such that the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end.
Regarding claim 40, the embodiment of Figure 7 of Buzerak discloses the invention substantially as claimed.
However, the embodiment of Figure 7 of Buzerak does not disclose wherein the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end.
The embodiment of Figure 93 discloses an anchor guide (see Buzerak, Figure 19) wherein the distal section transitions continuously from a high pitch, low radius curve (see Buzerak, Figure 19, item 93) at a proximal end to a low pitch, high radius curve at a distal end (see Buzerak, Figure 19, item 94).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the anchor guide of the embodiment of Figure 7 of Buzerak by providing wherein the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end as taught by Buzerak because the results would be predictable. The anchor guide region would still function in the same manner to deliver the anchor except it would be in the shape of the embodiment of Figure 19. Applicant has not demonstrated the criticality of this limitation, or disclosed that this configuration provides an advantage, is used for a particular purpose, or solves a stated problem, therefore, it would be generally recognized as being within the level or ordinary skill in the art to form the anchor guide such that the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end.
Claims 44-51, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Buzerak et al (US Patent No. 5,356,424) in view of Mohamed et al (US Patent No. 8,465,504).
Regarding claim 44, Buzerak discloses delivery system for delivering a prosthesis to a diseased valve (the recitation of “delivering a prosthesis to a diseased valve” is intended use, the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114.2), the delivery system comprising:
an outer sheath (Figure 7, item 16);
an inner shaft within the outer sheath (Figure 7, item 12),
the inner shaft translatable (Figure 1 and 6 depicts the inner shaft 12 translating) and rotatable relative to the outer sheath (column 5, lines 53-57 discloses the driver 12 (i.e. inner shaft) rotating relative to the outer sheath 16 by turning handle 14 ); and
an anchor guide (Figure 7, item 46) attached to a distal end of the inner shaft (Figure 7, anchor guide 46 attached to distal end of inner shaft 12 at 54),
the anchor guide comprising a proximal section that defines a central axis (Figure 7, describes an anchor guide 46 comprising a proximal section that defines a central axis),
a distal section that curves about the central axis (Figure 7, anchor guide 46 depicts a distal section that curves about the central axis), and
an intermediate section between the proximal section and the distal section (Figure 7, anchor guide 46 possesses an intermediate section between the proximal and distal sections),
wherein the distal section is concentric to the central axis of the proximal section (Figure 7, distal section of anchor guide 46 curves around the central axis and is concentric to the proximal section).
Buzerak discloses the invention substantially as claimed.
However, Buzerak does not disclose wherein the intermediate section transitions in a tapered spiral from a first radius of curvature to a second radius of curvature.
Mohamed discloses an anchor guide (see Mohamed, Figure 1) wherein the intermediate section of the helical anchor transitions in a tapered spiral from a first radius of curvature to a second radius of curvature (see Mohamed, Figure 9B “helico-spiral needle”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the anchor guide of Buzerak by providing wherein the intermediate section transitions in a tapered spiral from a first radius of curvature to a second radius of curvature as taught by Mohamed because the results would be predictable. The anchor guide region would still function in the same manner to deliver the anchor except it would be in the shape of Mohamed. Applicant has not demonstrated the criticality of this limitation, or disclosed that this configuration provides an advantage, is used for a particular purpose, or solves a stated problem, therefore, it would be generally recognized as being within the level or ordinary skill in the art to form the anchor guide such that the intermediate section transitions in a tapered spiral from a first radius of curvature to a second radius of curvature.
Regarding claim 45, as set forth supra, the combination discloses wherein the distal section extends more than 360 degrees (see Buzerak, Figure 7, the tapered spiral of the distal section of the anchor guide 46 extends more than 360 degrees around the central axis).
Regarding 46, as set forth supra, the combination discloses wherein the distal section comprises the second radius of curvature (see Mohamed, Figure 9B).
Regarding claim 47, as set forth supra, the combination discloses wherein the distal section resides in a distal-most plane that is orthogonal to the central axis (see Mohamed, Figure 9B).
Regarding claim 48, as set forth supra, the combination discloses wherein the distal section has a relatively constant radius of curvature (see Mohamed, Figure 9B).
Regarding claim 49, as set forth supra, the combination discloses further comprising an anchor (see Buzerak, Figure 7, anchor 50, wherein the definition of anchor is “something that serves to hold an object firmly” (Merriam-Webster Dictionary)) slidably disposed within the anchor guide (column 6, lines 53-56, anchor 50 is slidably disposes within the anchor guide 46).
Regarding claim 50, as set forth supra, the combination discloses wherein a curvature of the distal section is configured to match a curvature of an anchor of the prosthesis (see Buzarek, Figures 10-12 depict the curvature of the anchor 50 matching the curvature of the distal section 46).
Regarding claim 51, as set forth supra, the combination discloses wherein the inner shaft and the anchor guide are of unitary construction (see Buzarek, Figure 9, anchor guide 46 and inner shaft are depicted as unitary construction).
Regarding claim 53, as set forth supra, the combination discloses wherein the second radius of curvature is larger than the first radius of curvature (see Mohamed, Figure 9B, the second radius of curvature is depicted in the tapered spiral larger than the first radius of curvature).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774