DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on February 22, 2025. Claims 1-24 are currently pending.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) 1-14 and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (WO 2021/030068, hereinafter Wang).
Concerning claims 1 and 16, the Wang et al. prior art reference teaches a catheter assembly (Figure 8; 100) comprising: a shaft (Figure 8; 102); and a clamping device disposed on the shaft (Figure 8; 300), the clamping device comprising: a first member (Figure 11; 404) comprising a first main body (Figure 17; 442) having a first indicator surface (Figure 11; 418), the first main body defining a first bore having a non-circular cross-sectional profile (Figure 16; 448); a second member (Figure 11; 402) comprising a second main body (Figure 13; 420) having a second indicator surface (Figure 11; 414) and an annular element (Figure 13; 426) extending from a first end portion of the end body, the annular element received within the first inner bore (Figure 18) and comprising an outer surface having a non-circular cross-sectional profile (Figure 13; 434) corresponding to the non-cross-sectional profile of the first inner bore, the second member defining a second inner bore extending through the annular element (Figure 13; 408), the shaft extending through the second inner bore (Figure 10; 102); wherein the clamping device is movable between a first, release state in which the second member is in a first rotational position relative to the first member and the inner bore has a first diameter (Figure 18; D5 | [¶ 0114]), and a second, clamped state in which the second member is in a second rotational position relative to the first member and the second inner bore has a second diameter less than the first diameter (Figure 19 D63 | [¶ 0114]), and wherein when the clamping device is in the clamped state, the first and second indicator surfaces are rotationally aligned with one another (Figure 19), and wherein when the clamping device is in the release state the first and second indicator surfaces are rotationally offset from one another (Figure 18).
Concerning claims 2 and 18, the Wang reference teaches the clamping device of claim 1 and the assembly of claim 16, further comprising a tubular elastomeric member disposed within the annular element (Figure 18; 406) such that the shaft extends through a lumen of the elastomeric member, wherein when the clamping device is in the clamped state an inner surface of the elastomeric member frictionally engages the outer surface of the shaft ([¶ 0091, 0120]).
Concerning claim 3, the Wang reference teaches the clamping device of claim 2, wherein when the clamping device is in the clamped state the clamping device is configured to engage an outer surface of a catheter shaft extending through the inner lumen and the clamping device is restrained from axial movement relative to the catheter shaft, and wherein when the clamping device is in the release state the clamping device can be moved axially along a length of the catheter shaft ([¶ 0120]).
Concerning claim 4, the Wang reference teaches the clamping device of claim 1, wherein the first and second indicator surfaces comprise a respective channel extending at least partially along a length of the indicator surface (Figure 11; 402 and Figure 17; 404 both show the surfaces including a rim with a depression defined therein, which may be interpreted as a channel).
Concerning claim 5, the Wang reference teaches the clamping device of claim 1, wherein the first member comprises a third indicator surface opposite the first indicator surface (Figure 11; 416) and the second member comprises a fourth indicator surface opposite the second indicator surface (Figure 11; 412).
Concerning claim 6, the Wang reference teaches the clamping device of claim 1, wherein the first and second members comprise a plurality of outer surfaces and wherein the outer surfaces are concave (Figures 13-17; curved outer surfaces of 402, 404).
Concerning claim 7, the Wang reference teaches the clamping device of claim 1, further comprising a cap member coupled to the first member (Figure 17; end portion 446 may be interpreted as a cap).
Concerning claims 8 and 9, the Wang reference teaches the clamping device of claim 7, wherein the cap member may be interpreted as being disposed within a first end portion of the first member (Figure 17; the side of the first member in which the cap member 446 is disposed within an area interpreted as a first end portion) or being over a first end portion of the first member (Figure 17; the side of the first member in which the cap member 446 is disposed covers over an area interpreted as a first end portion).
Concerning claim 10, the Wang reference teaches the clamping device of claim 1, wherein when in the clamped state, the first inner bore and the annular element are rotationally offset from one another such that the annular element is compressed by the first inner bore, thereby reducing the diameter of the second inner bore (Figure 19).
Concerning claim 11, the Wang reference teaches the clamping device of claim 1, wherein the annular element comprises one or more engagement members extending longitudinally along the annular element and defining the non-circular outer profile of the annular element (Figure 15; 438).
Concerning claim 12, the Wang reference teaches the clamping device of claim 11, wherein when the first inner bore and the annular element are rotationally offset from one another, the engagement members are deflected inwardly toward the second bore (Figure 19 | [¶ 0095]).
Concerning claim 13, the Wang reference teaches the clamping device of claim 1, wherein the annular element comprises one or more openings extending longitudinally along the annular element and spaced apart about a circumference of the annular element (Figure 15; 438).
Concerning claim 14, the Wang reference teaches the clamping device of claim 13, wherein when the clamping device is in the release state the openings have a first width (Figure 18; W1) and when the clamping device is in the clamped state the openings have a second width narrower than the first width (Figure 19; W2).
Concerning claim 17, the Wang reference teaches the assembly of claim 16, wherein when the second member is in the first rotational position the non-circular cross-section of the annular element is rotationally aligned with the non-circular cross-section of the first inner bore (Figure 18), and wherein when the second member is in the second rotational position the non-circular cross-section of the annular element is rotationally offset from the non-circular cross-section of the first inner bore (Figure 19).
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.
Claim(s) 15 and 19-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2021/030068, hereinafter Wang) in view of Dassa et al. (US 5,3279,597).
Concerning claim 15, the Wang reference teaches the clamping device of claim 1, but does not specifically teach the first member comprising one or more axially-extending protrusions disposed in one or more corresponding recesses of the second member, wherein the recesses each comprise a first stopping surface and a second stopping surface and wherein when the first and second members are rotated relative to one another the one or more protrusions can abut the one or more stopping surfaces to prevent rotation of the first and second members relative to one another past a selected point.
However, the Dassa reference reference teaches a clamping device for a shaft of a catheter similar to that of the Wang reference, wherein the Dassa reference teaches a first member (Figure 1; 14) comprising a first main body (Figure 2; 30), the first main body defining a first inner bore having a non-circular cross-sectional profile (Figure 3b; 30a); a second member (Figure 1; 12) comprising a second main body (Figure 5; 18) and an annular element extending from a first end portion of the main body and defining a second bore (Figure 5; 21) and comprising an outer surface having a non-circular cross-sectional profile (Figure 3a; 26); wherein the clamping device is movable between a first, release state in which the second member is in a first rotational position relative to the first member and the second inner bore has a first diameter (Figure 3a), and a second, clamped state in which the second member is in a second rotational position relative to the first member and the second inner bore has a second diameter less than the first diameter (Figure 3b), wherein the first member comprises one or more axially-extending protrusions (Figure 4; P) disposed in one or more corresponding recesses of the second member (Figure 4; R), wherein the recesses each comprise a first stopping surface and a second stopping surface and wherein when the first and second members are rotated relative to one another the one or more protrusions can abut the one or more stopping surfaces to prevent rotation of the first and second members relative to one another past a selected point (Column 5, Line 67 – Column 6, Line 13).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the Wang reference include the protrusion and recess structures of the Dassa reference to provide a mechanism for limiting the relative rotation of the inner and outer members therein assuring that the catheter shaft will not be deformed when it is held in the clamped position (Column 6, Lines 37-53).
Concerning claim 19, the Wang et al. prior art reference teaches a clamping device (Figure 8; 300) comprising: a first member (Figure 11; 404) comprising a first main body (Figure 17; 442) having a first indicator surface (Figure 11; 416), the first main body defining a first bore extending therethrough (Figure 16; 448); a second member (Figure 11; 402) comprising a second main body (Figure 13; 420) having a second indicator surface (Figure 11; 412) and an annular element (Figure 13; 426) extending from a first end portion of the main body axially away from a second end portion of the main body and into the first inner bore (Figure 18), the annular element defining a second inner bore (Figure 13; 408); wherein the clamping device is movable between a first, release state in which the second member is in a first rotational position relative to the first member and the second inner bore has a first diameter (Figure 18; | [¶ 0114]), and a second, clamped state in which the second member is in a second rotational position relative to the first member and the second inner bore has a second diameter less than the first diameter (Figure 19 | [¶ 0114]), but it does not specifically teach the first member comprising one or more axially-extending protrusions disposed in one or more corresponding recesses of the second member, wherein the recesses each comprise a first stopping surface and a second stopping surface and wherein when the first and second members are rotated relative to one another the one or more protrusions can abut the one or more stopping surfaces to prevent rotation of the first and second members relative to one another past a selected point.
However, the Dassa reference reference teaches a clamping device for a shaft of a catheter similar to that of the Wang reference, wherein the Dassa reference teaches a first member (Figure 1; 14) comprising a first main body (Figure 2; 30), the first main body defining a first inner bore (Figure 3b; 30a); a second member (Figure 1; 12) comprising a second main body (Figure 5; 18) and an annular element extending from a first end portion of the main body and defining a second bore (Figure 5; 21); wherein the clamping device is movable between a first, release state in which the second member is in a first rotational position relative to the first member and the second inner bore has a first diameter (Figure 3a), and a second, clamped state in which the second member is in a second rotational position relative to the first member and the second inner bore has a second diameter less than the first diameter (Figure 3b), wherein the first member comprises one or more axially-extending protrusions (Figure 4; P) disposed in one or more corresponding recesses of the second member (Figure 4; R), wherein the recesses each comprise a first stopping surface and a second stopping surface and wherein when the first and second members are rotated relative to one another the one or more protrusions can abut the one or more stopping surfaces to prevent rotation of the first and second members relative to one another past a selected point (Column 5, Line 67 – Column 6, Line 13).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the Wang reference include the protrusion and recess structures of the Dassa reference to provide a mechanism for limiting the relative rotation of the inner and outer members therein assuring that the catheter shaft will not be deformed when it is held in the clamped position (Column 6, Lines 37-53).
Concerning claim 20, the combination of the Wang and Dassa references teaches the clamping device of claim 19, wherein the Wang reference further teaches the inner bore of the first member having a non-circular cross-sectional profile (Figure 16; 448) and wherein the annular element comprises an outer surface having a corresponding non-circular cross-sectional profile (Figure 13; 434).
Concerning claim 21, the combination of the Wang and Dassa references teaches the clamping device of claim 19, wherein the Wang reference further teaches that when the second member is in a first rotational position relative to the first member the clamping device is in the release state (Figure 18), and wherein when the second member is in a second rotational position relative to the first member the clamping device is in the clamped state (Figure 19).
Concerning claim 22, the combination of the Wang and Dassa references teaches the clamping device of claim 21, wherein the Wang reference further teaches that when the second member is in the first rotational position the non-circular cross-section of the annular element is rotationally aligned with the non-circular cross-section of the first inner bore (Figure 18), and wherein when the second member is in the second rotational position the non-circular cross-section of the annular element is rotationally offset from the non-circular cross-section of the first inner bore (Figure 19).
Concerning claim 23, the combination of the Wang and Dassa references teaches the clamping device of claim 19, wherein the Wang reference further teaches an elastomeric member disposed within the annular element (Figure 18; 406), the elastomeric member defining an inner lumen sized to receive a catheter shaft.
Concerning claim 24, the combination of the Wang and Dassa references teaches the clamping device of claim 19, wherein the Wang reference further teaches that when the clamping device is in the clamped state the clamping device is configured to engage an outer surface of a catheter shaft extending through the inner lumen and the clamping device is restrained from axial movement relative to the catheter shaft, and wherein when the clamping device is in the release state the clamping device can be moved axially along a length of the catheter shaft ([¶ 0120]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Arnim et al. reference (2013/0281979) teaches a clamping device for a shaft of a catheter including a first inner bore having a non-circular cross-sectional profile and an annular element having an outer surface having a non-circular cross-sectional profile; the Parker reference (US 2017/0239444) teaches a clamping device for a catheter including first and second members; the Racz et al. reference (US 2008/0183154) teaches a clamping device for a catheter including first and second members rotatable relative to one another including protrusions and recesses; and the Vitullo et al. reference (US 2006/0217655) teaches a clamp for a catheter that includes protrusions and grooves that indicate to a user when the catheter is locked or unlocked.
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/MARTIN T TON/Examiner, Art Unit 3771 9/18/2026
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