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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
Claim 1 line 1, “A catheter comprising a catheter tube” should read “A catheter comprising: a catheter tube”. The suggestion is made to differentiate the preamble of the claim with the rest of the limitations of the claim.
Claim 20 line 2-3, “and a middle tie layer between inner layer and the rolled tube” should read “and a middle tie layer between the inner layer and the rolled tube”.
Appropriate correction is required.
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.
Claim(s) 12, 14, 19-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Speck et al. (US Patent Pub. 20040002728 hereinafter “Speck”).
Regarding Claim 12, Speck teaches (Figs 1 and 3) a catheter (Fig 1, 10) comprising a catheter tube (Fig 1, 12) defining a guidewire lumen (Fig 2, 18; see [0024]), the catheter tube comprising a sheet of polymer material (Fig 3, 41, also see [0026] teaching “the lubricious inner layer 41 is high density polyethylene (HDPE).”) being rolled into a rolled tube (this is considered a product by process limitation, since Speck teaches all the structural elements, it is interpreted that Speck meets the limitations of the claim; the end result is the same catheter with a polymer tube regardless of how the tube is manufactured) having a length (necessarily true, the polymer material would have a length), wherein molecules (Fig 3, the molecular elements forming the polymer sheet 41) of the polymer material (41) extend in a common circumferential direction (See Fig 3, the polymer material 41 extends between the gaps in coil 42, this is circumferentially around the tube, therefore it is interpreted that the molecules within the material 41 also extend in a common circumferential direction; additionally the molecules of the polymer material would extend in both a longitudinal and circumferential direction as the polymer material 41 itself extends in both the longitudinal and circumferential directions) to increase a strength of the catheter tube (this is considered functional language, since Speck teaches the structural elements of a polymer tube, it would necessarily meet the functional od increasing a strength of the catheter).
Regarding Claim 14, Speck teaches the catheter of claim 12, wherein the catheter tube (Fig 1, 12) comprises a proximal portion (See annotated Fig 1), an intermediate portion (see annotated Fig 1) extending distally from the proximal portion, and a distal portion (See annotated Fig 1) extending distally from the intermediate portion, the rolled tube forming at least the distal portion of the catheter tube (see [0025] teaching that Fig 3 is a cross sectional view taken within circle 3 in Fig 1; Fig 3 also includes the molecule/stiffener 42, since the molecule/stiffener is a part of the rolled tube, it is interpreted that the rolled tube is forming the distal portion as shown in annotated Fig 1; additionally as described above, the “rolling” method of making the tube is considered a product by process limitation).
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Annotated Fig 1 (Speck)
Regarding Claim 19, Speck teaches the catheter of claim 12, wherein the catheter tube comprises a three-layer construction (see Speck [0026] "The three polymeric layers 41, 43, 44 are preferably a trilayer extrusion formed by extruding the three layers together."), the rolled tube being an outer layer of the three-layer construction (the rolling of the tube is considered a product by process limitation; as such since the Speck teaches multiple polymeric layers extruded together in [0026] it is interpreted that the outer layer of the tube of Speck meets the structural limitation of the claim, resulting the same catheter with polymeric tube).
Regarding Claim 20, Speck teaches the catheter of claim 19, wherein the three-layer construction comprises an inner layer (41), and a middle tie layer (43) between the inner layer (41) and the rolled tube (44; it is interpreted that layer 44 could be rolled since the method of rolling a tube is a product by process limitation) and configured to bond the rolled tube to the inner layer (See [0026] teaching intermediate layer 43 is an adhesive polymeric between layer 41 and layer 44).
Regarding Claim 21, Speck teaches the catheter of claim 23, wherein the opposite longitudinal edges of the sheet are heat sealed to one another (this is considered a product by process limitation, Speck teaches a catheter comprising a polymer tube, as such the resulting product is the same regardless of the method of making the catheter).
Regarding Claim 22, Speck teaches the catheter of claim 23, wherein the opposite longitudinal edges of the sheet are laminated to one another (this is considered a product by process limitation, Speck teaches a catheter comprising a polymer tube, as such the resulting product is the same regardless of the method of making the catheter).
Regarding Claim 23, Speck teaches the catheter of claim 12, wherein opposite longitudinal edges of the sheet are secured to one another along the length of the rolled tube (this is considered a product by process limitation, Speck teaches a catheter comprising a polymer tube, as such the resulting product is the same regardless of the method of making the catheter).
Claim(s) 1, 14, 19, 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leeflang et al. (US Patent Pub. 20150320971 hereinafter “Leeflang”).
Regarding Claim 1, Leeflang teaches (Fig 1-2d) A catheter comprising: a catheter tube (tube extending from 12 to 14) defining a guidewire lumen (16), the catheter tube comprising a sheet (30) of a polymer material (See [0076] teaching polymer material) being rolled into a rolled tube (See Figs 2a-2d and [0082]) having a length (necessarily true, sheet 30 rolled into a tube as ‘a length’), wherein molecules of the polymer material extend in a common circumferential direction about the rolled tube (Since the polymer material is a sheet, the molecules making up the polymer material will necessarily extend in both a circumferential and longitudinal direction once the polymer sheet is rolled) to increase a strength of the catheter tube (this is considered a functional/intended use recitation, since Leeflang teaches all structural elements of the catheter it is interpreted that the polymer tube of Leeflang would mee the functional recitation of increasing the strength of the catheter).
Regarding Claim 14, Leeflang teaches the catheter of claim 12, wherein the catheter tube comprises a proximal portion (Fig 1A, portion extending between where 12 and 16 are labeled), an intermediate portion (Fig 1A, portion extending between where 16 and 14 are labeled) extending distally from the proximal portion, and a distal portion (Fig 1A, portion extending between where 14 and 15 are labeled) extending distally from the intermediate portion, the rolled tube forming at least the distal portion of the catheter tube (see [0076] teaching that Figs 2a-2d teach how the catheter 10 of Fig 1 is made, therefore it is interpreted that the rolled tube forms at least the distal portion 14 of the catheter 10 of Fig 1A).
Regarding Claim 19, Leeflang teaches the catheter of claim 12, wherein the catheter tube comprises a three-layer construction (See [0072] teaching that the outer layer ay have multiple sublayers and that there is an inner liner, this would lead to at least three layers in the catheter), the rolled tube being an outer layer of the three-layer construction (see [0076] teaching that Figs 2a-2d teach how the catheter 10 of Fig 1 is made, it is interpreted that the outer layer would be rolled in this manner).
Regarding Claim 21, Leeflang teaches the catheter of claim 23, wherein the opposite longitudinal edges (32 and 34) of the sheet (30) are heat sealed to one another (See Fig 2D and [0084] teaching heat bonding; also see [0018] teaching heat sealing).
Regarding Claim 22, Leeflang teaches the catheter of claim 23, wherein the opposite longitudinal edges (32 and 34) of the sheet (30) are laminated to one another (See [0084] teaching how the edges 32 and 34 are attached and how edges could be cut or removed; also see [0018] teaching an alternative to heat sealing edges is laminating the edges).
Regarding Claim 23, Leeflang teaches the catheter of claim 12, wherein opposite longitudinal edges (32 and 34) of the sheet (30) are secured to one another along the length of the rolled tube (See Fig 2D; also see [0084]).
Response to Arguments
Applicant’s arguments, see Pgs. 4-5, filed 2/3/2026, with respect to the rejection(s) of claim(s) 12 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Speck et al. (US Patent Pub. 20040002728 hereinafter “Speck”) and a second rejection is made in view of Leeflang et al. (US Patent Pub. 20150320971 hereinafter “Leeflang”). The applicant has argued that element 42 of Speck would not be considered a molecule of polymer 41. A new interpretation of Speck has been used, along with a different interpretation of Leeflang as 35 USC 102 rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gielenz et al. (US 20100121312) teaches the orientation in which the molecules are extruded could change the strength of the catheter.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783