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 § 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 1-11 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. Claim 1 line 5 recites a first material section, line 7 recites the first material section having a first hardness and line 12 recites the first material section having a second hardness. It is not clear if the first material section is comprised of a single material or more than one material since the first material section has two different hardnesses. For purposes of examination, the first material section is interpreted to include different materials since they have different hardnesses. Claims 2-11 are rejected at least because they depend from claim 1.
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 and 3-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin US 2020/0391009 A1.
Regarding claim 1, Martin discloses a medical tubing (catheter 100 shown in Fig. 2A and described in P0080 with outer layer 103 as shown in Figs. 4A-B and described in P0102) comprising: a tubular body (composite outer layer 103 P0080 as depicted in Figs. 4A-B and described in P0102) having an axis (axis 105, P0081) extending lengthwise, the tubular body having a first region (first region, see annotated Fig. 4B below) and a second region (second region, see annotated Fig. 4B below) both extending along the axis and the first region and the second region having a wall with a plurality of material sections (material sections, see annotated Fig. 4A below wherein Fig. 4A illustrates five material sections, which form a wall as shown in Fig. 4B when the material sections are wound about the inner catheter layers, wherein the top material section illustrated in Fig. 4A is annotated below as a first material section and the middle material section as annotated below is a reinforcement material section) that extend spirally along the axis (method of forming a polymer tube includes wrapping a plurality of polymer strands in a spiral configuration, P0026 and P0092), where the plurality of material sections includes a first material section (first material section, see annotated Figs. 4A and 4B below) and a reinforcement material section (reinforcement material section, see annotated Fig. 4A below, having a higher durometer than adjacent material sections); wherein in the first region, the first material section comprises a first hardness (45D, see annotated Figs. 4A-B below) that is lower than or equal to a respective hardness of each adjacent material section (see annotated Fig. 4B below) and wherein the reinforcement material section comprises a first reinforcement hardness (72D) that is greater than both the first hardness and the respective hardness of each adjacent material section in the first region (see annotated Fig. 4B below); and wherein in the second region, the first material section comprises a second hardness (35D) that is different from the first hardness (45D vs. 35D) and is less than the respective hardness of each adjacent material section in the second region (see annotated Fig. 4B below).
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Regarding claim 3, Martin discloses the medical tubing of claim 1, further comprising an inner liner (inner liner 14, P0082, and shown in Fig. 2A) that is interior to the tubular body (Fig. 2A).
Regarding claim 4, Martin discloses the medical tubing of claim 3, further comprising a reinforcement structure (braid or coil 20, P0082) exterior to the inner liner (Fig. 2A).
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.
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.
Claims 2 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Martin.
Regarding claim 2, Martin discloses the medical tubing of claim 1.
Martin does not teach wherein in the second region, the reinforcement material section comprises a second reinforcement hardness that is lower than the first reinforcement hardness.
However, Martin teaches a variation of polymer strands illustrated by Fig. 3H, for constructing a tubular body from polymer strands P0026, wherein the reinforcement material section (middle strand 130/132 having higher relative durometer to adjacent strands) comprises a first hardness (130 is 72 D as shown in Fig. 3H) and decreases in a distal direction along the tubular body (distal direction, see annotated Fig. 3H below, wherein the hardness of 132 is 63D).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the reinforcement material section to decrease in material hardness distally for the purpose of providing a reinforcement material section that is relatively stiff at a proximal end for stability and torque transmission P0008, and that decreases distally, from 72D to 63D, for the purpose of providing for both stability with the reinforced material but also increasing softness distally for navigating distal curves, P0008 (hardness and flexibility are inversely related, see Applicant’s written description P0143, wherein as durometer decreases distally, flexibility increases distally).
Regarding claim 5, Martin discloses the medical tubing of claim 4, wherein the reinforcement structure is embedded within the wall (reinforcement structure within outer layer, P0039).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Martin by embedding the braid or coil within the outer layer as taught by Martin for the purpose of linking elements that transfer torque, P0082.
Regarding claim 6, Martin discloses the medical tubing of claim 1, wherein the plurality of material sections extends in in a right-hand wind direction in the first region (right-hand wind, P0037).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Martin with a right-hand wind in the first region for the purpose of pre-disposing the catheter to bend or navigate in a particular rotational direction within the anatomy, P0086.
Regarding claim 7, Martin discloses the medical tubing of claim 1, wherein the plurality of material sections extends in in a left-hand wind direction in the first region (left-hand wind, P0037).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Martin with a left-hand wind in the first region for the purpose of pre-disposing the catheter to bend or navigate in a particular rotational direction within the anatomy, P0086.
Regarding claim 8, Martin discloses the medical tubing of claim 1, wherein at least one of the plurality of material sections comprises a non-fusable material (non-fusable material, P0038).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Martin with a non-fusable material as taught by Martin for the purpose of imparting a groove cavity, or other design feature on any surface of the device, P0038.
Regarding claim 9, Martin discloses the medical tubing of claim 1, further comprising a soft distal tip section (distal portion of layer 103 is the softest/least stiff region, P0085).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Martin to comprise a soft distal tip section as taught by Martin for the purpose of bending more easily and gently around the more delicate and tortuous distal curves, P0008.
Regarding claim 10, Martin discloses the medical tubing of claim 9, wherein the soft distal tip section comprises a single material (entirely formed from a single material, claim 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the soft distal section to comprise a single material for the purpose of maximizing softness since the balance described in P0008 between stiffness and softness as it relates to the problem of torque transmission versus navigating tortuous anatomy does not apply at the distal tip section since there is nothing more distal for which torque would need to be transmitted.
Regarding claim 11, Martin discloses the medical tubing of claim 1, wherein the tubular body comprises a proximal region (proximal region, P0033) located proximally to both the first region and the second region, the proximal region comprising a single material (entirely formed from a single material, P0033).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Martin with a proximal region comprising a single material as taught by Martin for the purpose of maximizing stiffness since the balance described in P0008 between stiffness and softness as it relates to torque transmission versus trackability favors torque transmission at the proximal region since the proximal region extends from the patients anatomy during use, not entering the anatomy during use but instead being manipulated by a surgeon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783