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 .
Election/Restrictions
Applicant’s election without traverse of Species A, Claims 1-15, 18-19, and 29 in the reply filed on 7/6/26 is acknowledged. Claims 54 and 70 were withdrawn by Applicant.
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.
Claims 1-15, 18-19 are 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.
1) Claim 1 recites first and second “substantially straight section(s)”. The issue here is that a section can be either straight or not straight. By definition, straight is something is that is “not bend” or “extending continuously in the same direction without curving: a straight line” (The American Heritage Dictionary of the English Language). Thus, it is unclear what “substantially straight”, when something can be either straight (without curving) or not. There are no degrees to the term “straight”, so as to attach the term “substantially” to it. Furthermore, no degree of “substantially straight” has been disclosed by Applicant. Applicant shows a curved section 135 in Fig. 2A/2B, and labels it as “substantially straight”. Again, the disclosed section is curved, not straight or substantially straight. Thus, it is unclear what the scope of “substantially straight” is meant to convey.
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 1-15, 18-19 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0237986 by Tuval.
Regarding Claim 1, Tuval teaches a distal extension for a blood pump (e.g. ¶ 10-11, 210, 276: atraumatic distal extension for a blood pump; Also see ¶¶ 411-413), comprising:
a tubular body extending from a proximal end to a distal end (e.g. ¶ 411 and Fig. 27B: tubular lumen 350/352), the distal end coupled to an intermediate point on the tubular body between the proximal end and the distal end to form a closed loop at a distal end of an atraumatic distal extension (e.g. ¶210-211: the extension loop is atraumatic; Fig. 27A-27C, see annotated Fig. 27B: the distal end and the proximal end can be taken as any of the regions or planes or points where the loop is joined with the stem 350/352), the closed loop defining an aperture extending through the closed loop (e.g. see annotated Fig. 27B: the eye of the loop forms an aperture “through” the closed loop; ¶411: holes 354 also form apertures through the closed loop), the closed loop having a central plane parallel to a central axis of the tubular body at the proximal end (e.g. annotated Fig. 27B: the closed loop is coplanar with the stem 350/352);
wherein the tubular body includes a bend, the bend defining an angle between a central axis of a first substantially straight section of the tubular body proximal to the bend and a central axis of a second substantially straight section of the tubular body distal to the bend [see annotated Fig. 27B: the proximal portion of 350 forms a bend with an angle relative to portion 352. Any two directly adjacent points or cross sectional planes in that proximal section of 350 would form a “substantially” straight section, and this would not be distinguishable from the “substantially straight” sections shown in Fig. 2A and 2B of the instant application, which are curved without explicit disclosure of the degree of the curve that would limit the claims; Furthermore, the material used in the extension is a flexible enough to be straightened (¶380,400,411,413), and the claims do not limit the claims to a particular state of use].
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Figure 1 Annotated Fig. 27B
Regarding Claim 2, Tuval discloses the distal extension of claim 1, wherein a central axis of the aperture extends through the closed loop in a direction perpendicular to the central plane of the closed loop (as can be seen in annotated Fig. 27B, a line perpendicular to the page would coincide with the central axis of the loop, while the page would coincide with the central plane of the loop).
Regarding Claim 3, Tuval discloses the distal extension of claim 2, wherein the aperture is circular (e.g. ¶210: closed circle).
Regarding Claim 4, Tuval discloses the distal extension of claim 2, wherein the aperture is non-circular (e.g. ¶211: closed ellipse).
Regarding Claim 5, Tuval discloses the distal extension of claim 2, wherein a central axis of the aperture is off-center within the closed loop (e.g. ¶¶ 411- 413: the loop is flexible, as it is collapsible and expandable, Figures 27A-27C showing the expanded form. The claim does not require the off-center axis to be in any particular state, and given the flexibility the center axis can be placed in an off-center position).
Regarding Claim 6, Tuval discloses the distal extension of claim 2, wherein a central axis of the aperture is centered within the closed loop (e.g. as can be clearly seen in annotated Fig. 27B).
Regarding Claim 7, Tuval discloses the distal extension of claim 2, wherein a diameter or thickness of the tubular body at the proximal end is different from a diameter or thickness of the tubular body in the closed loop (e.g. as can be seen in annotated Fig. 27B, the loop is thinner than the body 350/352).
Regarding Claim 8, Tuval discloses the distal extension of claim 2, wherein a diameter or thickness of the tubular body at a first point of the closed loop is equal to a diameter or thickness of the tubular body at a second point of the closed loop (e.g. as can be seen in annotated Fig. 27B, the loop has multiple points having the same thickness).
Regarding Claim 9, Tuval discloses the distal extension of claim 2, wherein a diameter or thickness of the tubular body at a first point of the closed loop is different from a diameter or thickness of the tubular body at a second point of the closed loop (e.g. as can be seen in annotated Fig. 27B, the loop has points having different thickness, such as the apertures 354).
Regarding Claim 10, Tuval discloses the distal extension of 2, wherein the tubular body has a constant thickness or diameter along all of the closed loop (e.g. as shown in Fig. 27A).
Regarding Claim 11, Tuval discloses the distal extension of claim 1, wherein a distal end surface of the tubular body is coupled to an outer surface of the tubular body at the intermediate point (as seen in annotated Fig. 27B, the end of the tube is joined with the tube to form the loop).
Regarding Claim 12, Tuval discloses the distal extension of claim 1, wherein the intermediate point is located proximal to the bend (e.g. the same principle as discussed in Claim 1 for the bend and the substantially straight portion, also applies to any two adjacent points that are distal to the intermediate portion. For example, in Fig. 27B the first two points of the loop to the left, define a substantially straight section and are bend relative to the central axis of 352).
Regarding Claim 13, Tuval discloses the distal extension of claim 1, wherein the intermediate point is located distal to the bend (e.g. as seen in annotated Fig. 27B and discussed in Claim 1, the intermediate point is distal to the bend).
Regarding Claim 14, Tuval discloses the distal distal extension of claim 1, wherein the distal extension has a proximal portion that has a stiffness greater than that of a distal portion (e.g. ¶ 276: the proximal portion of the distal extension 120 includes a stiffening part 121 to connect to the rest of the pump).
Regarding Claim 15, Tuval discloses the distal extension of claim 1, wherein the angle defined by the bend is at least 135 degrees and less than 180 degrees (e.g. as discussed in ¶¶ 285, 380, 411-413, the extension is flexible enough to be straightened to fit into the delivery catheter, thus the curve of 350 would be straightened from what is shown in Fig. 27B to 180 degrees).
Regarding Claims 18-19, Tuval discloses the distal extension of claim 1, wherein the closed loop includes a first point, furthest from the intermediate point, that has a radius of curvature that is less than a radius of curvature at a second point closer to the intermediate point than the first point, and wherein a first point, furthest from the proximal end, has a radius of curvature that is less than a radius of curvature at a second point closer to the proximal end than the first point (Again, the claims do not require that this shape is in any particular state, and as discussed in ¶¶ 285, 380, 411-413, the extension is flexible enough to be straightened to fit into the delivery catheter, thus would also be capable of being pinched at a proximal or distal end).
Regarding Claim 29, Tuval distal extension for a blood pump (e.g. ¶ 10-11, 210, 276: atraumatic distal extension for a blood pump), comprising:
a tubular body extending from a proximal end to a distal end (e.g. ¶ 411 and Fig. 27B: tubular lumen 350/352);
the distal end coupled to an intermediate point on the tubular body between the proximal end and the distal end to form a non-circular closed loop at a distal end of an atraumatic distal extension (e.g. ¶210: closed ellipse; ¶210-211: the extension loop is atraumatic; Fig. 27A-27C: the distal end and the proximal end can be taken as any of the regions or planes or points where the loop is joined with the stem 350/352), the non-circular closed loop defining an aperture extending through the non-circular closed loop (e.g. Fig. 27A-27C: the eye of the loop forms an aperture “through” the closed loop; ¶411: holes 354 also form apertures through the closed loop), the non-circular closed loop having a central plane parallel to a central axis of the tubular body at the proximal end (e.g. annotated Fig. 27B: the closed loop is coplanar with the stem 350/352).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER MCDONALD can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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