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 .
Response to Amendment
The Amendment filed 07/14/2026 has been entered. Claims 1-15 & 17 are pending in the application. Claim 16 is cancelled. Claim 17 is entered as “New”.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because they fail to comply with the following §1.84 sections.
New corrected drawings in compliance with §1.84(m) are required in this application because the shading, in each of the figures, makes it difficult to determine the structure of the claimed invention.
New corrected drawings in compliance with §1.84(l) are required in this application because the line and text quality, in each of the figures, makes it difficult to determine the structure of the claimed invention and prevents satisfactory reproduction characteristics.
It is noted Applicant submitted new figures in an attempt to overcome these objections. However, the drawings were not entered since Figure 2 in the 07/14/2026 drawings contains new matter. Specifically, Figures 2 has different shapes for the tools at the bottom of the catheter, a different shape for the connector connecting the catheter to the tools, and whatever the structure is at the top of the catheter. This is not an exhaustive list.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-15 & 17 are objected to because of the following informalities.
Claim 1 should read --A method of inserting an S-Shape catheter into a pulmonary artery of a person in need, comprising:
introducing the catheter through a femoral vein or an inferior vena cava;
advancing the catheter through a right atrium, a right ventricle, and a right ventricular outflow tract;
advancing the catheter through a pulmonary valve into the pulmonary artery; and
wherein, before introducing the catheter through the femoral vein or the inferior vena cava, the S-Shape catheter is either premanufactured or formed by a practitioner to have an S-Shaped configuration, the S-Shape catheter comprising:
a proximal end and a distal end;
a tube extending from the proximal end to the distal end of the catheter, the tube comprising:
a first curve and a secondary curve disposed between the proximal end and the distal end;
the first curve
the secondary curve
the secondary curve
an intermediate section disposed between the first curve and the secondary curve;
wherein the first curve has a first inner radius, a first arc angle, and a first arc length; and wherein the secondary curve has a second inner radius, a second arc angle, and a second arc length.--; the use of the term “being” is superfluous, since the term “located” and the phrase “configured in a direction” inherently include existence
Appropriate correction is required.
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.
Claims 1-15 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Panetta (U.S. PGPub 2022/0151589), in view of Worley (U.S. PGPub 2013/0338641).
As to Claim 1, Panetta teaches a method (Figures 6A-6D) inserting an S-Shape (as shown in Figures 2A-2C) catheter (100) into (Paragraph 0067) a pulmonary artery (PA) of a person in need (the patient described in Paragraph 0059), comprising:
introducing (as shown in Figure 2A) the catheter (100) through a femoral vein (Paragraph 0059) or an inferior vena cava (the inferior vena cava shown in Figure 2A);
advancing (as shown in Figure 2B) the catheter (100) through (as shown in Figure 2B) a right atrium (RA), a right ventricle (RV), and a right ventricular outflow tract (one of ordinary skill in the art would conclude the right ventricular outflow tract is the portion of the right ventricle shown in Figures 2A-2C below);
advancing (as shown in Figure 2C; Paragraph 0079) the catheter (100) through the pulmonary valve (Paragraph 0067) to the pulmonary artery (PA); and…
the S-Shape (as shown in Figures 2A-2C) catheter (100) comprising:
a proximal end (106) and a distal end (108);
a tube (104) extending from (as shown in Figure 1A) the proximal end (106) to the distal end (108) of the catheter (100), the tube (104) comprising:
a first curve (see Figures 2A-2C below) and a secondary curve (see Figures 2A-2C below) disposed between (as shown in Figure 2B) the proximal end (106) and the distal end (108);
the first curve (see Figures 2A-2C below) being located proximate to (as shown in Figure 2B) the proximal end (106);
the secondary curve (see Figures 2A-2C below) being located distal to (as shown in Figure 2B) the first curve (see Figures 2A-2C below) and disposed proximate to (as shown in Figure 2B) the distal end (108);
the secondary curve (see Figures 2A-2C below) being configured in a direction opposite to (as shown in Figure 2B) the first curve (see Figures 2A-2C below);
an intermediate section (see Figures 2A-2C below) disposed between (as shown in Figure 2B) the first curve (see Figures 2A-2C below) and the secondary curve (see Figures 2A-2C below);
wherein the first curve (see Figures 2A-2C below) has a first inner radius (see R1 in Figure 2B below), a first arc angle (see Θ1 in Figure 2B below), and a first arc length (the length of the first curve between the angle Θ1 arrows shown in Figure 2B below); and
wherein the secondary curve (see Figures 2A-2C below) has a second inner radius (see R2 in Figure 2B below), a second arc angle (see Θ2 in Figure 2B below), and a second arc length (the length of the second curve between the angle Θ2 arrows shown in Figure 2B below).
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Panetta Figures 2A-2C, Modified by Examiner
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Panetta Figure 2B, Modified by Examiner
Panetta is silent on when the catheter is shaped into an S-Shape, so does not explicitly teach before introducing the catheter through the femoral vein or the inferior vena cava, the S-Shape catheter is either premanufactured or formed by a practitioner to have an S-Shaped configuration.
Worley describes a heart catheter (10), and teaches before (Paragraph 0042) introducing (as shown in Figure 2) the catheter (10) through the femoral vein or the inferior vena cava, the S-Shape (where Figure 3 broadly shows a flipped S-Shape catheter) catheter (10) is either premanufactured (Paragraph 0042) or formed by a practitioner to have an S-Shaped configuration (as shown in Figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to premanufacture, as taught by Worley, the S-Shape catheter, as taught by Panetta, to prevent torquing (Paragraph 0053).
Additionally, this limitation is considered a product-by-process, and "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." Since Panetta, as modified, already meets the structural limitations of the claim, the timing of when the catheter was manufactured is not considered patentable. See MPEP 2113.
As to Claim 2, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the first inner radius value, so does not explicitly teach the first inner radius is from about 0.10 cm to about 10.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first inner radius from about 0.10 cm to about 10.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed radius, since one of ordinary skill in the art would understand the first inner radius should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the radius is within the claimed range in certain embodiments –see instant application Paragraphs 0007/0027/0028.
As to Claim 3, Panetta, as modified, teaches all the limitations of Claims 1-2, but is silent on the first inner radius value, so does not explicitly teach the first inner radius is from about 1.0 cm to about 5.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first inner radius from about 1.0 cm to about 5.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed radius, since one of ordinary skill in the art would understand the first inner radius should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the radius is within the claimed range in certain embodiments –see instant application Paragraphs 0007/0028.
As to Claim 4, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the first arc angle value, so does not explicitly teach the first arc angle is from about 10 degrees to about 170 degrees.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first arc angle from about 10 degrees to about 170 degrees, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed angle, since one of ordinary skill in the art would understand the first arc angle should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc angle is within the claimed range in certain embodiments –see instant application Paragraphs 0008/0030.
As to Claim 5, Panetta, as modified, teaches all the limitations of Claims 1 & 4, but is silent on the first arc angle value, so does not explicitly teach the first arc angle is from about 30 degrees to about 150 degrees.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first arc angle from about 30 degrees to about 150 degrees, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc angle, since one of ordinary skill in the art would understand the first arc angle should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc angle is within the claimed range in certain embodiments –see instant application Paragraphs 0008/0031.
As to Claim 6, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the first arc length value, so does not explicitly teach the first arc length is from about 0.10 cm to about 30.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first arc length from about 0.10 cm to about 30.0 cm., since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc length, since one of ordinary skill in the art would understand the first arc length should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc length is within the claimed range in certain embodiments –see instant application Paragraphs 0009/0032.
As to Claim 7, Panetta, as modified, teaches all the limitations of Claims 1 & 6, but is silent on the first arc length value, so does not explicitly teach the first arc length is from about 0.75 cm to about 20.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first arc length from about 0.75 cm to about 20.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc length, since one of ordinary skill in the art would understand the first arc length should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc length is within the claimed range in certain embodiments –see instant application Paragraphs 0009/0033.
As to Claim 8, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the second inner radius value, so does not explicitly teach the second inner radius is from about 0.10 cm to about 10.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the second inner radius from about 0.10 cm to about 10.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed radius, since one of ordinary skill in the art would understand the second inner radius should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the radius is within the claimed range in certain embodiments –see instant application Paragraphs 0010/0027.
As to Claim 9, Panetta, as modified, teaches all the limitations of Claims 1 & 8, but is silent on the second inner radius value, so does not explicitly teach the second inner radius is from about 0.5 cm to about 5.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first inner radius from about 0.5 cm to about 5.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed radius, since one of ordinary skill in the art would understand the second inner radius should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the radius is within the claimed range in certain embodiments –see instant application Paragraphs 0007/0029.
As to Claim 10, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the second arc angle value, so does not explicitly teach the second arc angle is from about 10 degrees to about 170 degrees.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the second arc angle from about 10 degrees to about 170 degrees, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed angle, since one of ordinary skill in the art would understand the second arc angle should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc angle is within the claimed range in certain embodiments –see instant application Paragraphs 0011/0030.
As to Claim 11, Panetta, as modified, teaches all the limitations of Claims 1 & 10, but is silent on the second arc angle value, so does not explicitly teach the second arc angle is from about 30 degrees to about 150 degrees.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the second arc angle from about 30 degrees to about 150 degrees, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc angle, since one of ordinary skill in the art would understand the second arc angle should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc angle is within the claimed range in certain embodiments –see instant application Paragraphs 0011/0031.
As to Claim 12, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the second arc length value, so does not explicitly teach the second arc length is from about 0.10 cm to about 30.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the second arc length from about 0.10 cm to about 30.0 cm., since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc length, since one of ordinary skill in the art would understand the second arc length should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc length is within the claimed range in certain embodiments –see instant application Paragraphs 0012/0032.
As to Claim 13, Panetta, as modified, teaches all the limitations of Claims 1 & 12, but is silent on the second arc length value, so does not explicitly teach the second arc length is from about 0.20 cm to about 20.0 cm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the second arc length from about 0.20 cm to about 20.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc length, since one of ordinary skill in the art would understand the second arc length should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc length is within the claimed range in certain embodiments –see instant application Paragraphs 0009/0034.
As to Claim 14, Panetta, as modified, teaches all the limitations of Claim 1, and continues to teach the distal end (Panetta 108) of the catheter (Panetta 100) is attached with (as shown in Panetta Figure 1A) a functional device (Panetta 110).
As to Claim 15, Panetta, as modified, teaches all the limitations of Claims 1 & 14, and continues to teach the functional device (Panetta 110) comprises a medical balloon (Panetta describes Element 110 as a balloon, and one of ordinary skill in the art would conclude balloon 110 is a medical balloon, since balloon 110 is used as part of a medical device, i.e., Panetta catheter 100), a stent, balloon tip, end-hole catheter, closed-tip catheter, or a combination thereof.
As to Claim 17, Panetta, as modified, teaches all the limitations of Claim 1, but is silent on the values of each of the first inner radius, the first arc angle, the second inner radius, and the second arc angle, so does not explicitly teach the first inner radius is from about 1.0 cm to about 5.0 cm, the first arc angle is from about 30 degrees to about 150 degrees, the second inner radius is from about 0.5 cm to about 5.0 cm, and the second arc angle is from about 30 degrees to about 150 degrees.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first inner radius from about 1.0 cm to about 5.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed radius, since one of ordinary skill in the art would understand the first inner radius should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the radius is within the claimed range in certain embodiments –see instant application Paragraphs 0007/0028.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first arc angle from about 30 degrees to about 150 degrees, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc angle, since one of ordinary skill in the art would understand the first arc angle should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc angle is within the claimed range in certain embodiments –see instant application Paragraphs 0008/0031.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the first inner radius from about 0.5 cm to about 5.0 cm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed radius, since one of ordinary skill in the art would understand the second inner radius should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the radius is within the claimed range in certain embodiments –see instant application Paragraphs 0007/0029.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the second arc angle from about 30 degrees to about 150 degrees, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Panetta, as modified, would not operate differently with the claimed arc angle, since one of ordinary skill in the art would understand the second arc angle should be sized to fit within the claimed veins and heart structures to operate as intended. Further, Applicant has not placed any criticality on the claimed range, only indicating the arc angle is within the claimed range in certain embodiments –see instant application Paragraphs 0011/0031.
Response to Arguments
Applicant's arguments filed 07/14/2026 have been fully considered but they are not persuasive.
Regarding the 103 rejection, Applicant argues Panetta does not teach a pre-formed S-Shape catheter, citing Paragraph 0068, which states a guidewire is used to straighten the “S” curve configuration once inserted. Examiner disagrees with Applicant’s analysis.
One of ordinary skill in the art would conclude based on Panetta Paragraph 0068 the catheter is already in the S shape, since “the guidewire 120 reduces an “S” curve configuration to provide a straighter path”. If the catheter was not already in the S shape, there would be no need to straighten/reduce the S curve configuration.
Applicant continues to argue Examiner’s annotations of Panetta Figures 2A-2C do not align with Panetta Paragraphs 0067-0068, since Panetta does not describe fixed curves, intermediate section, radii, angles, or arc lengths. Examiner disagrees.
Panetta Paragraphs 0067-0068 clearly describe the Panetta catheter, shown in Figures 2A-2E, as having an S shape. Just because the S shape is flexible --via the guidewire-- does not mean the catheter cannot have an S shape prior to insertion. To the contrary, the guidewire provides the ability to change the catheter shape into any desired shape, including an S shape, resulting in the dimensions shown in Figures 2A-2C in the Claim 1 rejection above. It should also be noted, there is no attempt to use the Panetta figures to provide precise dimension, but only to show the dimensions are present.
Lastly, the rejection above does not rely on Panetta alone to teach the catheter is pre-manufactured into the claimed S shape. The rejection relies on Worley, as described above.
Applicant argues Worley cannot be modified into Panetta, since Worley is used for a different method. Examiner disagrees.
The rejection does not rely Worley for how the method is performed with the Worley geometry, but only that a catheter may be pre-manufactured.
Regarding the 103 rejections for Claims 2-13, Applicant argues reliance on Gardener v. TEC Systems, Inc. is misplaced. Applicant believes Panetta does not disclose the same catheter with different dimensions, where changing the dimensions results in Panetta being significantly altered from a flexible catheter to a rigid catheter. Examiner disagrees.
There is nothing in the instant application which mandates the claimed catheter be a rigid catheter. As such, as long as Panetta is capable of having the dimensions with the values as claimed, the Panetta catheter may be changed to and from those dimensional values via the guidewire. This is accomplished using Gardener v. TEC Systems, Inc. to achieve the values for each of the dimensions shown in the annotated Panetta figures in the Claim 1 rejection above. As such, the case law is appropriately applied.
Conclusion
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 DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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