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 .
Information Disclosure Statement
The information disclosure statement(s) filed 01/08/2025 has/have been considered by the Examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,191,944 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the cited patent inventions are directed to an apparatus which comprises a left-ventricular assist device comprising a tube, a pump, a frame disposed within at least the distal portion of the tube, and a curved distal-tip element as shown in the table below.
U.S. Application 19/013,744
U.S. Patent 11,191,944 B2
An apparatus, comprising:
a left-ventricular assist device comprising:
a tube configured to be positioned such that a proximal portion of the tube traverses an aortic valve of the subject, and a distal portion of the tube is disposed within a left ventricle of the subject;
a pump
configured to pump blood from the subject's left ventricle to the subject's aorta, via the tube;
and a distal-tip element disposed distally to the pump and configured to define a straight proximal portion that defines a longitudinal axis,
and a curved distal portion that is shaped such as to curve in a first direction with respect to the longitudinal axis of the straight proximal portion before passing through an inflection point and curving in a second direction with respect to the longitudinal axis of the straight proximal portion, such that the curved distal portion defines a bulge on one side of the longitudinal axis of the straight proximal portion.
The apparatus according to claim 1, wherein the left-ventricular assist device further comprises a frame disposed inside the tube and the pump is disposed inside the frame.
The apparatus according to claim 1, wherein the tube defines at least one blood inlet opening that is configured to be disposed within the subject's left ventricle and at least one blood outlet opening that is configured to be disposed within the subject's aorta, and wherein the pump is configured to pump blood through the tube from the subject's left ventricle to the subject's aorta, by pumping the blood into the tube via at least one blood inlet opening and by pumping blood out of the tube via at least one blood outlet opening.
Apparatus comprising:
a left-ventricular assist device configured to assist left-ventricular functioning of a subject, the left-ventricular assist device comprising:
a tube configured such that a proximal portion of the tube traverses an aortic valve of the subject, and a distal portion of the tube is disposed within a left ventricle of the subject;
a frame disposed within at least the distal portion of the tube;
a pump disposed within the frame and
configured to pump blood through the tube from the subject's left ventricle to the subject's aorta, by pumping the blood into the tube via at least one blood inlet opening that is defined by the tube and that is configured to be disposed within the subject's left ventricle, and by pumping blood out of the tube via at least one blood outlet opening that is defined by the tube and that is configured to be disposed within the subject's aorta;
and a distal-tip element configured to define a straight proximal portion that defines a longitudinal axis,
and a curved distal portion that is shaped such as to curve in a first direction with respect to the longitudinal axis of the straight proximal portion before passing through an inflection point and curving in a second direction with respect to the longitudinal axis of the straight proximal portion, such that the curved distal portion defines a bulge on one side of the longitudinal axis of the straight proximal portion.
The apparatus according to claim 1, wherein the tube defines at least one blood inlet opening that is configured to be disposed within the subject's left ventricle, and wherein
the distal-tip element is configured to separate the at least one blood inlet opening from a posterior wall of the subject's left ventricle when the distal-tip element is placed against an apex of the subject's left ventricle.
The apparatus according to claim 1, wherein
the distal-tip element is configured to separate the at least one blood inlet opening from a posterior wall of the subject's left ventricle when the distal-tip element is placed against an apex of the subject's left ventricle.
The apparatus according to claim 1, wherein the distal-tip element has a question-mark shape.
The apparatus according to claim 1, wherein the distal-tip element has a question-mark shape.
The apparatus according to claim 1, wherein the distal-tip element has a tennis-racket shape.
The apparatus according to claim 1, wherein the distal-tip element has a tennis-racket shape.
The apparatus according to claim 1, wherein the curved distal portion of the distal-tip element is shaped such that after passing through the inflection point the curved distal portion continues to curve such that the distal-tip portion crosses back over the longitudinal axis defined by the straight proximal portion
The apparatus according to claim 1, wherein the curved distal portion of the distal-tip element is shaped such that after passing through the inflection point the curved distal portion continues to curve such that the distal-tip portion crosses back over the longitudinal axis defined by the straight proximal portion.
The apparatus according to claim 1, wherein the curved distal portion of the distal-tip element is shaped such that after passing through the inflection point the curved distal portion does not cross back over the longitudinal axis defined by the straight proximal portion.
The apparatus according to claim 1, wherein the curved distal portion of the distal-tip element is shaped such that after passing through the inflection point the curved distal portion does not cross back over the longitudinal axis defined by the straight proximal portion.
The apparatus according to claim 1, wherein the pump comprises an impeller disposed on an axial shaft,
and wherein the distal-tip element comprises an axial-shaft receiving tube configured to receive the axial shaft of the pump, and a distal-tip portion configured to define the curved distal portion of the distal-tip element.
The apparatus according to claim 1, wherein the blood pump comprises an impeller disposed on an axial shaft,
and wherein the distal-tip element comprises an axial-shaft receiving tube configured to receive the axial shaft of the blood pump, and a distal-tip portion configured to define the curved distal portion of the distal-tip element.
The apparatus according to claim 1, wherein the tube defines at least one blood inlet opening that is configured to be disposed within the subject's left ventricle, and
wherein the distal-tip element is configured to separate the at least one blood inlet opening from a septal wall of the subject's left ventricle as the distal-tip element contacts an apex of the subject's left ventricle.
The apparatus according to claim 1,
wherein the distal-tip element is configured to separate the at least one blood inlet opening from a septal wall of the subject's left ventricle as the distal-tip element contacts an apex of the subject's left ventricle
The apparatus according to claim 10, wherein the distal-tip element is configured such that, when distal-tip element is inserted into the left ventricle such that the bulge bulges toward the septal wall, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward a free wall of the subject's left ventricle.
The apparatus according to claim 8, wherein the distal-tip element is configured such that, when distal-tip element is inserted into the left ventricle such that the bulge bulges toward the septal wall, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward a free wall of the subject's left ventricle.
The apparatus according to claim 11, wherein the distal-tip element is configured such that, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward the free wall of the subject's left ventricle by the straight proximal portion of the distal-tip element pivoting about the curved distal portion of the distal-tip element.
The apparatus according to claim 9, wherein the distal-tip element is configured such that, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward the free wall of the subject's left ventricle by the straight proximal portion of the distal-tip element pivoting about the curved distal portion of the distal-tip element.
The apparatus according to claim 1, wherein the distal-tip element is configured such that, upon being deployed within a descending aorta of the subject, the distal-tip element centers itself with respect to an aortic valve of the subject.
The apparatus according to claim 1, wherein the distal-tip element is configured such that, upon being deployed within a descending aorta of the subject, the distal-tip element centers itself with respect to an aortic valve of the subject.
The apparatus according to claim 13, wherein the curved distal portion is shaped that after curving in the first direction the curved distal portion defines an elongated straight portion, before curving the in the second direction, such that the elongated straight portion protrudes at an angle with respect to the longitudinal axis of the proximal straight portion of the distal-tip element.
The apparatus according to claim 11, wherein the curved distal portion is shaped that after curving in the first direction the curved distal portion defines an elongated straight portion, before curving the in the second direction, such that the elongated straight portion protrudes at an angle with respect to the longitudinal axis of the proximal straight portion of the distal-tip element.
The apparatus according to claim 1, wherein a valve is disposed within a distal portion of the distal-tip element.
The apparatus according to claim 15, wherein the valve comprises a duckbill valve.
The apparatus according to claim 1, wherein a duckbill valve is disposed within a distal-most 10 mm of the distal-tip element.
The apparatus according to claim 16, wherein the duckbill valve defines a wide inlet and a narrow tip that defines a slit therethrough, the duckbill valve being proximally facing, such that the wide inlet faces a distal end of the distal-tip element and such that the narrow tip faces away from the distal end of the distal-tip element.
The apparatus according to claim 13, wherein the duckbill valve defines a wide inlet and a narrow tip that defines a slit therethrough, the duckbill valve being proximally facing, such that the wide inlet faces a distal end of the distal-tip element and such that the narrow tip faces away from the distal end of the distal-tip element.
The apparatus according to claim 17, wherein: the left-ventricular assist device is configured for use with a guidewire; the distal-tip element defines a guidewire lumen; and the left-ventricular assist device further comprises a guidewire guide disposed within the guidewire lumen at a location that is proximal to the duckbill valve, the guidewire guide shaped to define a hole therethrough, which narrows in diameter from a proximal end of the guidewire guide to a distal end of the guidewire guide, the shape of the guidewire guide being configured to guide a tip of the guidewire toward the slit at the narrow, proximal end of the duckbill valve, when the guidewire is inserted from a proximal end of the left-ventricular assist device.
The apparatus according to claim 14, wherein: the left-ventricular assist device is configured for use with a guidewire; the distal-tip element defines a guidewire lumen; and the left-ventricular assist device further comprises a guidewire guide disposed within the guidewire lumen at a location that is proximal to the duckbill valve, the guidewire guide shaped to define a hole therethrough, which narrows in diameter from a proximal end of the guidewire guide to a distal end of the guidewire guide, the shape of the guidewire guide being configured to guide a tip of the guidewire toward the slit at the narrow, proximal end of the duckbill valve, when the guidewire is inserted from a proximal end of the left-ventricular assist device.
The apparatus according to claim 18, wherein the duckbill valve is shaped to define a converging guide portion at its proximal end, the converging guide portion converging toward the slit, such that the guide portion is configured to further guide the tip of the guidewire toward the slit.
The apparatus according to claim 15, wherein the duckbill valve is shaped to define a converging guide portion at its proximal end, the converging guide portion converging toward the slit, such that the guide portion is configured to further guide the tip of the guidewire toward the slit.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of 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. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell (US 20120172655 A1 – hereinafter Campbell).
Re. claim 1, Campbell teaches an apparatus, comprising:
a left-ventricular assist device (paragraph 0222 – “In addition to use as an LVAD, the device of the present invention may also be used as a right ventricular assist device in a manner similar to that described above”) comprising:
a tube (figure 22, housing 202) configured to be positioned such that a proximal portion of the tube traverses an aortic valve of the subject, and a distal portion of the tube is disposed within a left ventricle of the subject (paragraph 0168 – “Optionally, the dilating structure 1008, positioned within the left ventricle, can then be urged into contact with the aortic valve, e.g., at the ventricular side of the aortic valve, to separate the aortic valve leaflets from each other…Thereafter, the distal portion 1032 of the housing 1020 is disposed in the left ventricle and a proximal portion of the housing 1020 is located in the ascending aorta, as illustrated in FIG. 34”);
a pump configured to pump blood from the subject's left ventricle to the subject's aorta, via the tube (paragraph 0071 – “The impeller assembly 116 can be arranged to pump blood distally, such as in a right heart assist mode to move blood from the right ventricle to the pulmonary artery. Proximal flow is optimal for left heart support to move blood from the left ventricle to the aorta”);
and a distal-tip element disposed distally to the pump and configured to define a straight proximal portion that defines a longitudinal axis (figure 2 shows the distal tip element 182),
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and a curved distal portion (figure 2, atraumatic tip 182; paragraph 0082 – “The atraumatic tip 182 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto”).
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Campbell does not expressly teach a curved distal portion that is shaped such as to curve in a first direction with respect to the longitudinal axis of the straight proximal portion before passing through an inflection point and curving in a second direction with respect to the longitudinal axis of the straight proximal portion, such that the curved distal portion defines a bulge on one side of the longitudinal axis of the straight proximal portion.
However, Campbell teaches that the distal arcuate atraumatic tip 182 can take any shape (paragraph 0082 – “The atraumatic tip 182 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto. The tip 182 can take any suitable shape, which can vary depending on the degree of curvature of the tip”). Furthermore, it has been held by the courts that the shape of the distal tip is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the tip is significant, as per in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the shape of the distal arcuate, atraumatic tip 182 of Campbell, to try incorporate the curve in a first direction with respect to the longitudinal axis of the straight proximal portion before passing through an inflection point and curving in a second direction with respect to the longitudinal axis of the straight proximal portion, such that the curved distal portion defines a bulge on one side of the longitudinal axis of the straight proximal portion, since such modification would still predictably result in preventing tissue injury and trauma.
Re. claim 3, Campbell further teaches wherein the tube defines at least one blood inlet opening (paragraph 0014 – “The housing includes an inlet, an outlet, and an elongate wall structure disposed circumferentially about the impeller blade”) that is configured to be disposed within the subject's left ventricle (paragraph 0006 – “In a conventional approach, a blood pump having a fixed cross-section is surgically inserted a heart chamber, such as into the left ventricle of the heart and the aortic arch to assist the pumping function of the heart”),
and at least one blood outlet opening (paragraph 0014 – “The housing includes an inlet, an outlet, and an elongate wall structure disposed circumferentially about the impeller blade”) that is configured to be disposed within the subject's aorta (paragraph 0006 – “In a conventional approach, a blood pump having a fixed cross-section is surgically inserted a heart chamber, such as into the left ventricle of the heart and the aortic arch to assist the pumping function of the heart”),
and wherein the pump is configured to pump blood through the tube from the subject's left ventricle to the subject's aorta, by pumping the blood into the tube via at least one blood inlet opening and by pumping blood out of the tube via at least one blood outlet opening (paragraph 0071 – “An impeller assembly 116 disposed at the distal end 108 is configured to pump blood proximally or distally through or along a portion of the heart pump 10 to convey blood from one body cavity to another”).
Re. claim 4, Campbell further teaches wherein the tube defines at least one blood inlet opening that is configured to be disposed within the subject's left ventricle (paragraph 0014 – “The housing includes an inlet, an outlet, and an elongate wall structure disposed circumferentially about the impeller blade”; paragraph 0073 – “For example, the catheter assembly 100 can have a suitable length to reach the left ventricle and sufficient pushability and torquability to traverse the intervening vasculature”),
and wherein the distal-tip element is configured to separate the at least one blood inlet opening from a posterior wall of the subject's left ventricle when the distal-tip element is placed against an apex of the subject's left ventricle (atraumatic tip 182 has the arcuate shape to prevent tissue trauma during contact to, for example, an apex of the subject's left ventricle, paragraph 0082 – “The atraumatic tip 182 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto”).
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Re. claims 5-8, Campbell teaches the distal arcuate atraumatic tip 182 in figure 2 as stated above.
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Campbell does not expressly teach wherein the distal-tip element has a question-mark shape, wherein the distal-tip element has a tennis-racket shape, wherein the curved distal portion of the distal-tip element is shaped such that after passing through the inflection point the curved distal portion continues to curve such that the distal-tip portion crosses back over the longitudinal axis defined by the straight proximal portion, and wherein the curved distal portion of the distal-tip element is shaped such that after passing through the inflection point the curved distal portion does not cross back over the longitudinal axis defined by the straight proximal portion.
However, Campbell teaches that the distal arcuate atraumatic tip 182 can take any shape (paragraph 0082 – “The atraumatic tip 182 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto. The tip 182 can take any suitable shape, which can vary depending on the degree of curvature of the tip”). Furthermore, it has been held by the courts that the shape of the distal tip is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the tip is significant, as per in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the shape of the distal arcuate, atraumatic tip 182 of Campbell, to try the claimed distal-tip configurations as claimed in claims 5-8, since such modification would still predictably result in preventing tissue injury and trauma.
Re. claim 9, Campbell further teaches wherein the pump comprises an impeller disposed on an axial shaft (figure 9 shows an axial shaft connected to the impeller 208),
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and wherein the distal-tip element comprises an axial-shaft receiving tube configured to receive the axial shaft of the pump (figure 13B shows a portion of the distal tip that is receiving the axial shaft),
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and a distal-tip portion configured to define the curved distal portion of the distal-tip element (figure 2 shows the curved distal portion).
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Re. claim 10, Campbell further teaches wherein the tube defines at least one blood inlet opening that is configured to be disposed within the subject's left ventricle (paragraph 0014 – “The housing includes an inlet, an outlet, and an elongate wall structure disposed circumferentially about the impeller blade”; paragraph 0073 – “For example, the catheter assembly 100 can have a suitable length to reach the left ventricle and sufficient pushability and torquability to traverse the intervening vasculature”),
and wherein the distal-tip element is configured to separate the at least one blood inlet opening from a septal wall of the subject's left ventricle as the distal-tip element contacts an apex of the subject's left ventricle (atraumatic tip 182 has the arcuate shape to prevent tissue trauma during contact to, for example, an apex of the subject's left ventricle, paragraph 0082 – “The atraumatic tip 182 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto”).
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Re. claim 11, Campbell teaches the claimed invention of claim 10 as stated above, but does not expressly teach wherein the distal-tip element is configured such that, when distal-tip element is inserted into the left ventricle such that the bulge bulges toward the septal wall, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward a free wall of the subject's left ventricle.
However as per the claim 1 rejection, the obvious arcuate configuration of the atraumatic distal tip 182 as claimed in claim 1 would be configured to perform the intended use as claimed in claim 11. Furthermore, a recitation of 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.
Re. claim 12, Campbell teaches the claimed invention of claim 10 as stated above, but does not expressly teach wherein the distal-tip element is configured such that, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward the free wall of the subject's left ventricle by the straight proximal portion of the distal-tip element pivoting about the curved distal portion of the distal-tip element.
However as per the claim 1 rejection, the obvious arcuate configuration of the atraumatic distal tip 182 as claimed in claim 1 would be configured to perform the intended use as claimed in claim 12. Furthermore, a recitation of 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.
Re. claim 13, Campbell teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the distal-tip element is configured such that, upon being deployed within a descending aorta of the subject, the distal-tip element centers itself with respect to an aortic valve of the subject.
However as per the claim 1 rejection, the obvious arcuate configuration of the atraumatic distal tip 182 as claimed in claim 1 would be configured to perform the intended use as claimed in claim 12. Furthermore, a recitation of 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.
Re. claim 14, Campbell teaches the claimed invention of claim 13 as stated above, but does not expressly teach wherein the curved distal portion is shaped that after curving in the first direction the curved distal portion defines an elongated straight portion, before curving the in the second direction, such that the elongated straight portion protrudes at an angle with respect to the longitudinal axis of the proximal straight portion of the distal-tip element.
However, Campbell teaches that the distal arcuate atraumatic tip 182 can take any shape (paragraph 0082 – “The atraumatic tip 182 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto. The tip 182 can take any suitable shape, which can vary depending on the degree of curvature of the tip”). Furthermore, it has been held by the courts that the shape of the distal tip is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the tip is significant, as per in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the shape of the distal arcuate, atraumatic tip 182 of Campbell, to try the shaped curved distal portion that after curving in the first direction the curved distal portion defines an elongated straight portion, before curving the in the second direction, such that the elongated straight portion protrudes at an angle with respect to the longitudinal axis of the proximal straight portion of the distal-tip element, as claimed in claim 14, since such modification would still predictably result in preventing tissue injury and trauma.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell (US 20120172655 A1 – hereinafter Campbell) in view of Toellner (US 20130085318 A1 – hereinafter Toellner).
Re. claim 2, Campbell teaches the pump as stated above in claim 1, but does not expressly teach wherein the left-ventricular assist device further comprises a frame disposed inside the tube and the pump is disposed inside the frame.
Toellner teaches a similar blood pump (paragraph 0002 - “The application can hence be provided, on the one hand, in the minimally invasive medical field, for example as a blood pump for heart assistance…”). Toellner further teaches that the pump system includes a tube (Toellner figure 4, discharge hose 37) has a proximal and distal end, in which only the distal end is shown to receive a pump housing 33 [frame] within the tube. The pump housing 33 is produced from intersecting nitinol struts (paragraph 0071 - “The distal pump unit comprises a pump housing 33 which is produced from intersecting nitinol struts”), in which the intersecting strut configuration would create a mesh like frame to hold the distal end of the tube 37 to an open state for fluid to pump through. Figure 4 also includes the pump housing 33 which houses the rotor 35 within (paragraph 0071 - “The nitinol housing is provided in parts with a coating 34 which extends distally and proximally to a rotor 35 disposed in the housing 33”).
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Both Campbell and Toellner both teach within the field of blood pumps. Therefore, 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 housing of Campbell, to incorporate the pump housing 39 frame, which lies within the distal end of the tube as taught by Toellner, since such modification would predictably result in facilitating inflow of blood from the intersecting struts of the housing.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell (US 20120172655 A1 – hereinafter Campbell) in view of Jimenez (US 20140039375 A1 – hereinafter Jiminez).
Re. claim 15, Campbell teaches the claimed invention of claim 1, including the distal tip as stated above, but does not expressly teach wherein a valve is disposed within a distal portion of the distal-tip element.
Jiminez teaches an implantable conduit system which teaches a distal tip 1705 which includes a lumen 1500 which acts as a valve (paragraph 0124 – “FIGS. 24A-23B illustrate an example embodiment in which the distal end or tip 1705 of a collapsible inner lumen 1500 is flexible, allowing it to serve as a valve or port”).
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Therefore, 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 distal tip of Campbell, to incorporate the lumen valve within the distal tip as taught by Jiminez, since such modification would predictably result in allowing fluid flow control within the distal tip.
Allowable Subject Matter
Claims 16-19 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:
The prior art of record does not expressly teach, alone or in combination, to a duckbill valve disposed within a distal portion of the distal-tip element. Dependent claims 17-19 are further objected to for their dependencies.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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