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 .
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.
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.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: the specification is full of improper and confusing grammar. Applicant should amend the specification using proper grammar.
Claim Objections
Claims 1-16 are objected to because of the following informalities.
Claim 1 should read --A method of inserting [[a]]an S-Shape catheter to 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 to a pulmonary artery through a pulmonary valve; and
wherein the S-Shape catheter comprises:
a proximal end and a distal end;
a tube extending from the proximal end to the distal end of the catheter; the tube further comprising:
a first curve and a secondary curve disposed between the proximal end and the distal end;
the first curve located proximate to the proximal end;
the secondary curve located distal to the first curve and disposed proximate to the distal end;
the secondary curve being configured in an opposite direction to the first curve;
an intermediate section disposed between the first curve and the second curve;
wherein the first curve has a first inner radius, a first arc angle, and a first arc length; and
the second curve has a second inner radius, a second arc angle, and a second arc length.--
Claim 16 should read --The method of claim 1, wherein the S-Shape catheter is either pre-manufactured or is formed by a practitioner before the method of inserting the catheter.--
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.
Claims 1 & 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panetta (U.S. PGPub 2022/0151589).
As to Claim 1, Panetta teaches a method (Figures 6A-6D) inserting a S-Shape (as shown in Figures 2A-2C) catheter (100) to (Paragraph 0067) 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 femoral vein (Paragraph 0059) or 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) right atrium (RA), right ventricle (RV), and 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) to the pulmonary artery (PA) through pulmonary valve (Paragraph 0067); and
wherein the S-Shape catheter (100) comprises:
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) further 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) located proximate to (as shown in Figure 2B) the proximal end (106);
the secondary curve (see Figures 2A-2C below) 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 an opposite direction 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 second 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
the second 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
As to Claim 14, Panetta teaches all the limitations of Claim 1, and continues to teach the distal end (108) of the catheter (100) is attached with (as shown in Figure 1A) a functional device (110).
As to Claim 15, Panetta teaches all the limitations of Claims 1 & 14, and continues to teach the functional device (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., catheter 100), a stent, balloon tip, end-hole catheter, closed-tip catheter, or a combination thereof.
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 2-13 are rejected under 35 U.S.C. 103 as being unpatentable over Panetta.
As to Claim 2, Panetta 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Panetta, in view of Worley (U.S. PGPub 2013/0338641).
As to Claim 16, Panetta teaches all the limitations of Claim 1, but is silent on when the catheter is shaped into an S-Shape, so does not explicitly teach the S-Shape catheter is either pre-manufactured or is formed by a practitioner before the operation of inserting the catheter.
Worley describes a heart catheter (10), and teaches the S-Shape catheter (10) is either pre-manufactured (Paragraph 0042) or is formed by a practitioner before the operation of inserting the catheter.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ollivier (2010/0004662) and Voda (7,867,218) teach pre-manufactured heart catheters.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783