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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12, 14 and 19-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has not pointed out where the amended claim limitation is supported, nor does there appear to be a written description of the claim limitation ‘wherein substantially all molecules of the extruded sheet of polymer material are aligned and extend along a common circumferential direction orthogonal to the length of the rolled tube’ in the application as filed. Instant paragraph [0032] recites “the molecules 242 may extend generally orthogonal to the longitudinal axis of the sheet 240” but there is no specific support for “substantially all molecules”. Furthermore, see 112b rejection below, as it is unclear the metes and bounds of “substantially all molecules”.
Claims 14 and 19-24 are rejected due to their dependence on claim 12.
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 12, 14 and 19-24 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.
The term “substantially all” in claim 12 is a relative term which renders the claim indefinite. The term “substantially all molecules” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Instant paragraph [0032] recites “the molecules 242 may extend generally orthogonal to the longitudinal axis of the sheet 240” but it is unclear the metes and bounds of “generally” or as the claim language states “substantially all”.
Claims 14 and 19-24 are rejected due to their dependence on claim 12.
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, 19-24 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) having a longitudinal axis (necessarily has a longitudinal axis) defining a guidewire lumen (Fig 2, 18; see [0024]) extending along the longitudinal axis, the catheter tube comprising an extruded sheet of polymer material (Fig 3, 41, also see [0026] teaching “the lubricious inner layer 41 is high density polyethylene (HDPE).”, also see [0026] teaching it the trilayer is formed by extruding three layers) 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) extending along the longitudinal axis of the catheter tube (See Fig 1), wherein substantially all molecules (Fig 3, the molecular elements forming the polymer sheet 41) of the extruded sheet of polymer material (41) are aligned and extend in a common circumferential direction orthogonal to the length of the rolled tube (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; examiner notes the 112b rejection above, it is unclear what the metes and bounds of ‘substantially all molecules’ requires, as such it is interpreted that all the molecules that make up the sheet of polymer are extending in all directions, including a circumferential direction that is orthogonal to the longitudinal axis) to increase a strength of the catheter tube against radial compression (this is considered functional language, since Speck teaches the structural elements of a polymer tube, it would necessarily meet the functional of increasing a strength of the catheter; furthermore see [0013] teaching the tube has strength to avoid radial collapsing pressure).
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).
Regarding claim 24, Speck teaches the catheter of claim 12, further comprising: an inflatable balloon (24) coupled to the catheter tube (12).
Claim(s) 1, 14, 19, 21-24 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) having a longitudinal axis (necessarily true) and defining a guidewire lumen (16) extending along the longitudinal axis, the catheter tube comprising an extruded (see [0089]) 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’) extending along the longitudinal axis of the catheter tube,
wherein substantially all molecules of the extruded sheet of polymer material are aligned and extend along a common circumferential direction orthogonal to the length of 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; also see the 112b rejections above) to increase a strength of the catheter tube against radial compression (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; furthermore see [0074] teaching the tube may be manipulated without risk of buckling/kinking. This is considered strength against radial compression).
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]).
Regarding Claim 24, Leeflang teaches the catheter of claim 12, further comprising an inflatable ballon (see [0067] teaching the distal end 14 could include balloons) coupled to the catheter tube (tube between 12 and 14).
Response to Arguments
Applicant's arguments filed 5/15/2026 have been fully considered but they are not persuasive.
As to the remarks on Pgs. 4-5, the applicant argues that Speck does not teach the amended limitation of “wherein substantially all molecules of the extruded sheet of polymer material are aligned and extend along a common circumferential direction orthogonal to the length of the rolled tube to increase a strength of the catheter tube against radial compression”. The examiner does not find this persuasive. As described above, the language of “substantially all molecules” is unclear. Furthermore, molecules that make up an extruded sheet of polymer inherently are extending in every direction. The applicant argues Speck only teaches the material not the molecules making up the material. However, it is inherent that there are molecules that make up the material and as such those molecules would be extending in all directions of the sheet that is formed by the molecules. For these reasons the rejection is maintained.
As to the remarks on Pg. 6, the applicant argues that Leeflang does not specify that the rolled tube increases a strength of the catheter against radial compression. The examiner does not find this persuasive. This limitation is a functional limitation. Furthermore the ‘rolled tube’ is also a product by process limitation. Therefore the only structural component required is the ‘tube’. Since Leeflang teaches a catheter tube, it would meet the functional limitation of “increases a strength of the catheter against radial compression”. Furthermore, [0074] teaches the tube is able to be manipulated through the patient’s body without substantial risk of buckling/kinking. This is considered “strength of the catheter against radial compression”. For these reasons the rejection is maintained.
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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