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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species IV, Species Component IV(a)(i), Species Component IV(b)(iv), and Species Component IV(c)(v), in the reply filed on 05/19/2026 is acknowledged.
Claims 4, 21-22 & 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Drawings
The drawings are objected to because it appears the heterogeneous material zone 2 lead line is pointing to the incorrect structure in instant application Figure 6.
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
Claim 5 is objected to because of the following informalities.
Claim 5 should read --The catheter of claim 1, wherein at least one end face of the heterogeneous material zone defines a plane which is inclined with respect to the axis of the catheter at an angle
Appropriate correction is required.
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 1-3, 5, 7-8, 10-18 & 20 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 claim(s) are replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. An attempt to point out as much of the indefinite language as possible was attempted and shown below. However, due to the extensive amount of indefinite language, some of the indefinite language may have been missed. Applicant is advised to carefully review the claim language and amend any indefinite language to present a complete operative device.
As to Claim 1, the term “the transition structure”, in Line 2, should read --the at least one transition structure.
The limitation “any continuous closed region of the heterogeneous material zone as a second sub-region”, in Lines 4-5, should read --any continuous closed region of the heterogeneous material zone is referred to as a second sub-region.
The limitation “any section of the transition structure along an axis comprises at least one second sub-region”, in Lines 5-6, is indefinite.
Each of instant application Figures 1-8 --which show embodiments of the transition structure— show possible sections of the transition structure 200 along the axis within the homogeneous material zone. However, by definition, the second sub-regions are within the heterogeneous material zone. As such, the limitation conflicts with the original disclosure, rendering the claim indefinite. For the purpose of examination, the transition structure will be interpreted as a typo, where the heterogeneous material zone should have been typed, so the first part of the limitation reads any section of the heterogeneous material zone along an axis.
The limitation incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which the claimed “axis” belongs to. For the purpose of examination, the axis will be interpreted as the axis of the catheter.
Additionally, it is not clear if the term “at least one second sub-region” includes the second sub-region first defined in Line 5, or if new second sub-regions are being defined. For the purpose of examination, the at least one second sub-region in Line 6 will be interpreted as being comprised of the second sub-region first defined in Line 5.
The limitation “a leading section and/or a trailing section of the transition structure comprise(s) at least one first sub-region and at least one second sub-region”, in Lines 7-8, is indefinite.
The term “the transition structure” should read --the at least one transition structure.
It is not clear if the term “at least one first sub-region” includes the first sub-region first defined in Line 4, or if new first sub-regions are being defined. For the purpose of examination, the at least one first sub-region in Line 8 will be interpreted as being comprised of the first sub-region first defined in Line 4.
It is not clear if the term “at least one second sub-region” includes any of the previously defined second sub-regions, or if new second sub-regions are being defined. For the purpose of examination, the at least one second sub-region in Line 8 will be interpreted as being comprised of the second sub-region first defined in Line 5.
As to Claim 2, the limitation “any axial section of the transition structure comprises at least one first sub-region and at least one second sub-region”, is indefinite. Each of instant application Figures 1-8 --which show embodiments of the transition structure— show possible sections of the transition structure 200 along the axis either only within the homogeneous material zone, or only within the heterogeneous material zone. However, by definition, the first sub-regions are within the homogeneous material zone, and the second sub-regions are within the heterogeneous material zone. As such, the limitation conflicts with the original disclosure, rendering the claim indefinite, since neither of the homogeneous material zone or the heterogeneous material zone may have both of the first sub-region and the second sub-region. The indefiniteness of the claim precludes examination of the merits over the prior art.
As to Claim 3, the limitation “axially from the leading location and/or the trailing location of the transition structure at respective end(s) to an intermediate section of the transition structure, an outer surface area ratio of the homogeneous material zone to the heterogeneous material zone gradually decreases”, is indefinite.
The terms “the leading location” and “the trailing location” lack antecedent basis. For the purpose of examination, the terms will be interpreted as the leading section and the trailing section, respectively.
The limitation incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which the claimed “respective end(s)” belongs to. For the purpose of examination, the respective ends will be interpreted as ends of either the leading or trailing sections.
As to Claim 12, the limitation “at least one end face of the heterogeneous material zone defines a plane which is inclined with respect to an axis of the catheter at an angle” should read --at least one end face of the heterogeneous material zone defines a plane which is inclined with respect to the axis of the catheter at an angle.
The limitation “a greater stiffness difference between the first and second polymeric materials is, a smaller angle is formed” is indefinite. The limitation is grammatically confusing, since the two sections of the limitation have not been grammatically linked to each other. As such, it is not clear how the stiffness difference is related to the smaller angle. Additionally, it is not clear how the stiffness between the first and second polymeric materials may be changed once the catheter has been manufactured. The indefiniteness of the claim precludes examination of the merits over the prior art.
As to Claim 17, the limitation “the inner layer comprises at least one transition structure and/or the outer layer comprises at least one transition structure” is indefinite. It is not clear if either of the “at least one transition structure” mentioned in the limitation are the same at least one transition structure first defined in Claim 1, or if new transition structures are being defined. For the purpose of examination, each instance of the at least one transition structure in Claim 17 will be interpreted as the at least one transition structure first defined in Claim 1.
As to Claim 18, the limitation “the inner layer comprises at least one transition structure” is indefinite. It is not clear if the “at least one transition structure” mentioned in the limitation is the same at least one transition structure first defined in Claims 1 or 17, or if a new transition structure is being defined. For the purpose of examination, the at least one transition structure in Claim 18 will be interpreted as the at least one transition structure first defined in Claim 1.
As to Claim 20, the limitation “the outer layer comprises at least one transition structure” is indefinite. It is not clear if the “at least one transition structure” mentioned in the limitation is the same at least one transition structure first defined in Claims 1 or 17, or if a new transition structure is being defined. For the purpose of examination, the at least one transition structure in Claim 20 will be interpreted as the at least one transition structure first defined in 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, 3, 5, 7-8, 10-11 & 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lunn (U.S. Patent 5,509,910).
As to Claim 1, Lunn teaches a catheter (Figure 6), comprising at least one polymeric layer (3/11/5; Column 7, Lines 6-9; Column 6, Lines 34-39; Column 5, Lines 63-66), wherein the polymeric layer (3/11/5) comprises at least one transition structure (see Figure 6 below) that is a tubular structure (Column 4, Lines 28-37), wherein the transition structure (see Figure 6 below) comprises a homogeneous material zone (see zoomed-in Figure 6 below) and a heterogeneous material zone (see zoomed-in Figure 6 below), wherein: any continuous closed region of the homogeneous material zone is referred to as a first sub-region (this is just a definition; any continuous closed region within either of the Lunn Homogeneous Zones may be interpreted as a first sub-region); any continuous closed region of the heterogeneous material zone as a second sub-region (this is just a definition; any continuous closed region within the Lunn Heterogeneous Zone may be interpreted as a second sub-region); and any section of the heterogeneous material zone (see zoomed-in Figure 6 below; see 112(b) above for interpretation clarification) along an axis (see zoomed-in Figure 6 below) comprises (as shown in Figure 6) at least one second sub-region (one of ordinary skill in the art would conclude any continuous closed region within the Lunn Heterogeneous Zone may be interpreted as a second sub-region, including along the axis), and wherein a leading section (see zoomed-in Figure 6 below) and/or a trailing section (see zoomed-in Figure 6 below) of the transition structure (see Figure 6 below) comprise(s) at least one first sub-region (one of ordinary skill in the art would conclude the leading and trailing sections each include a continuous closed region of the homogeneous material zone) and at least one second sub-region (one of ordinary skill in the art would conclude the leading and trailing sections each include a continuous closed region of the heterogeneous material zone).
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Lunn Figure 6, Modified by Examiner
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Lunn Zoomed-In Figure 6, Modified by Examiner
As to Claim 3, Lunn teaches all the limitations of Claim 1, and continues to teach axially from the leading location (see zoomed-in Figure 6 below in the Claim 1 rejection above) and/or the trailing location (see zoomed-in Figure 6 below in the Claim 1 rejection above) of the transition structure (see Figure 6 below in the Claim 1 rejection above) at respective end(s) (the right end of the leading section or the left end of the trailing section, as shown in zoomed-in Figure 6 below in the Claim 1 rejection above) to an intermediate section (see zoomed-in Figure 6 below in the Claim 1 rejection above) of the transition structure (see Figure 6 below in the Claim 1 rejection above), an outer surface area ratio of the homogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) to the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) gradually decreases. When viewing zoomed-in Figure 6, one of ordinary skill in the art would conclude the homogeneous material zone in a plane perpendicular to the axis decreases, as the heterogeneous material zone in the plane perpendicular to the axis increase, creating the claimed ration decrease.
As to Claim 5, Lunn teaches all the limitations of Claim 1, and continues to teach at least one end face (the left end face of the heterogeneous material zone shown in the zoomed-in Figure 6 in the Claim 1 rejection above) of the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) defines a plane (the plane through the lines defining the left side of section 11 in the zoomed-in Figure 6 in the Claim 1 rejection above) which is inclined (as shown in Figure 6) with respect to (as shown in Figure 6) an axis (the longitudinal axis described in Column 5, Lines 37-56) of the catheter (Figure 6) at an angle (the angles described in Column 5, Lines 37-56), wherein the plane is inclined with respect to the axis of the catheter at an angle ranging from 5° to 60° (the angle is described as approximately 30° in Column 5, Lines 37-56).
As to Claim 7, Lunn teaches all the limitations of Claim 1, and continues to teach at least one edge (the left and right edges –defined by the lines defining section 11 in the zoomed-in Figure 6 in the Claim 1 rejection above—both have a polylineal structure shown as triangular in Figure 6) of the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) has a polylineal structure (as shown in Figure 6).
As to Claim 8, Lunn teaches all the limitations of Claim 1, and continues to teach the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) has a constant axial length (the distal end portion, as described in Column 5, Lines 37-56) in a range of 1-15 mm (Column 5, Lines 37-56, describes a length of approximately 2 mm, which falls within the claimed range) of; or wherein the heterogeneous material zone has a varying axial length with a maximum value of 3-20 mm and a minimum value of 0.5-15 mm.
As to Claim 10, Lunn teaches all the limitations of Claim 1, and continues to teach the homogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) comprises a first polymeric region (see zoomed-in Figure 6 below in the Claim 1 rejection above) and a second polymeric region (see zoomed-in Figure 6 below in the Claim 1 rejection above) situated on opposite sides (as shown in Figure 6) of the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above), wherein the first polymeric region (see zoomed-in Figure 6 below in the Claim 1 rejection above) is made of a first polymeric material (Column 7, Lines 6-9), and the second polymeric region (see zoomed-in Figure 6 below in the Claim 1 rejection above) is made of a second polymeric material (Column 5, Lines 63-66), and wherein a stiffness of the first polymeric material is higher than a stiffness of the second polymeric material. Lunn continues to teach the first polymeric material –comprised of 3/14/15/16—has a Shore of 70D (Column 7, Lines 49-51), the second polymeric material --comprised of section 5—has a Shore of 35 D (Column 7, Lines 47-49), and the intermediate section –comprised of section 11—has a Shore of 55 D (Column 7, Lines 53-65). One of ordinary skill in the art would conclude a higher Shore value results in a higher stiffness, resulting in the first polymeric material having a higher stiffness than the second polymeric material.
As to Claim 11, Lunn teaches all the limitations of Claims 1 & 10, and continues to teach a stiffness (Shore of 55 D; Column 7, Lines 53-65) of the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) is lower than the stiffness (Shore of 70D; Column 7, Lines 49-51) of the first polymeric region (see zoomed-in Figure 6 below in the Claim 1 rejection above) and is higher than the stiffness (Shore of 35 D; Column 7, Lines 47-49) of the second polymeric region (see zoomed-in Figure 6 below in the Claim 1 rejection above). One of ordinary skill in the art would conclude 55 –heterogeneous—is lower than 70 –first polymeric—and higher than 35 –second polymeric.
As to Claim 13, Lunn teaches all the limitations of Claims 1 & 10, and continues to teach the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) is made of (polyamide; Column 7, Lines 48-49) the first (Column 7, Lines 49-51, where outer layer 16 is made of polyamide) and second (polyamide; Column 5, Lines 63-66) polymeric materials, which are blended and fused (Column 7, Lines 40-52, where polyamide is broadly blended together to make the heterogeneous material zone material, then fused to segments 3 & 5, as described in Column 6, Lines 26-45) .
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 Lunn already meets the structural limitations of the claim, the blended and fused limitation is not considered patentable. See MPEP 2113.
As to Claim 14, Lunn teaches all the limitations of Claims 1 & 10, and continues to teach the heterogeneous material zone (see zoomed-in Figure 6 below in the Claim 1 rejection above) is made of (polyamide; Column 7, Lines 48-49) the first (Column 7, Lines 49-51, where outer layer 16 is made of polyamide) and second (polyamide; Column 5, Lines 63-66) polymeric materials, which are piled and joined (Column 7, Lines 40-52, where polyamide is injected into mold 9, creating a pile, then joined via fusion by heating each material, as described in Column 6, Lines 26-45) .
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 Lunn already meets the structural limitations of the claim, the piled and joined limitation is not considered patentable. See MPEP 2113.
As to Claim 15, Lunn teaches all the limitations of Claims 1 & 10, and continues to teach the first polymeric material (Column 7, Lines 6-9) is any one of polytrafluoroethylene, polyolefin, polyurethane, poly(ether-block-amide) and polyamide (Column 7, Lines 49-51, where outer layer 16 is made of polyamide), and wherein the second polymeric material (Column 5, Lines 63-66) is any one of polytrafluoroethylene, polyolefin, polyurethane, poly(ether-block-amide) and polyamide (polyamide; Column 5, Lines 63-66).
As to Claim 16, Lunn teaches all the limitations of Claim 1, and continues to teach a reinforcing layer (15, as shown in Figure 7).
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 17-18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lunn, in view of Macaulay (U.S. Patent 5,234,416).
As to Claim 17, Lunn teaches all the limitations of Claim 1, and continues to teach the catheter (Figure 6) is a triple-layered structure (as shown in Figure 7, where section 3 has three layers –14/15/16) comprising an inner layer (14), an intermediate reinforcing layer (15) and an outer layer (16), wherein the outer layer (16) is a polymeric layer (Column 7, Lines 6-9), and wherein the inner layer (14) comprises (as shown in Figure 7) at least one transition structure (11) and/or the outer layer (16) comprises (as shown in Figure 7) at least one transition structure (11).
Lunn is silent on the material makeup of the inner layer, so does not explicitly teach the inner layer is a polymeric layer.
Macaulay describes a similar multi-layer catheter, and teaches the inner layer (20) is a polymeric layer (Column 5, Lines 64-65).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to make the inner layer, as taught by Lunn, of a polymer, as taught by Macaulay, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
As to Claim 18, Lunn, as modified, teaches all the limitations of Claims 1 & 17, and continues to teach the inner layer (Lunn 14) comprises (as shown in Lunn Figure 7) at least one transition structure (Lunn 11), wherein a distal section (the right side of Lunn 14, as viewed in Lunn Figure 7) of the inner layer (Lunn 14) comprises (as shown in Lunn Figure 7) the at least one transition structure (Lunn 11).
As to Claim 20, Lunn, as modified, teaches all the limitations of Claims 1 & 17, and continues to teach the outer layer (Lunn 16) comprises (as shown in Lunn Figure 7) at least one transition structure (Lunn 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aboytes (2020/0008820), Yourgenlow (2022/0001141), and Salahieh (2017/0080186) each teach a similar transition structure.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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