DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 5 is objected to because of the following informalities:
Line 3 recites “the apparatus”. Claim 5 depends on claim 1. Claim 1 recites a catheter apparatus. Examiner suggests replacing “the apparatus” in line 3 of claim 5 with “the catheter apparatus” to put the claim in clearer form.
Claim 9 is objected to because of the following informalities:
Line 2 recites “the friction”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the friction” in line 2 of claim 9 with “friction”.
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 1-20 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.
In regard to claim 1,
Line 17-18 recites “the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body”. It is unclear due to the term “contacts” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Examiner suggests replacing “the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body” in line 17-18 of claim 1 with “the at least one protrusion is configured to contact the compression seal and prevent the catheter from sliding toward the first end of the valve body” or alternatively with “the at least one protrusion is in contact the compression seal and prevents the catheter from sliding toward the first end of the valve body”.
Examiner notes claims 2-18 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 4,
Line 1 recites “wherein the catheter has an outer diameter”. Claim 4 depends on claim 1. Claim 1 states “an outer surface of the catheter having an outer diameter”. It is unclear if the outer diameter of claim 4 is the same as the outer diameter of claim 1 or in addition to the outer diameter of claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “wherein the catheter has an outer diameter of” in line 1 of claim 4 with “wherein the outer diameter of the outer surface of the catheter is”.
In regard to claim 13,
Line 1-4 recites “wherein the at least one protrusion is constructed out of one or more of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth subcarbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel or alloys thereof”. Claim 13 depends on claim 12. Claim 12 recites wherein the at least one protrusion is constructed out of a tungsten-loaded polymer. It is unclear how the at least one protrusion can be constructed out of a tungsten-loaded polymer as claimed in claim 12 but then constructed as claimed in claim 13. Examiner suggests either amending claim 13 to be dependent on claim 1 or amending claim 12 to state that the at least one protrusion can be constructed out of a tungsten-loaded polymer and an additional material and then amending claim 13 to state that the additional material is one or more of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth subcarbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel or alloys thereof.
In regard to claim 14,
Line 1-2 recites “the at least one protrusion has an outer diameter”. Claim 14 depends on claim 1. Claim 1 recites “the at least one protrusion having an outer diameter”. It is unclear if the outer diameter of claim 14 is the same or different to the outer diameter in claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the at least one protrusion has an outer diameter of” in line 1-2 of claim 14 with “the outer diameter of the at least one protrusion is”.
In regard to claim 16,
Line 1-2 recites “the position of the at least one protrusion relative to the first end of the catheter”. There is insufficient antecedent basis for the limitation in this claim. Claim 1 recites “the catheter positioned a distance within the valve lumen”. It is unclear if the position of claim 16 is intended to be the position of the catheter, not the at least one protrusion. For examination purposes Examiner construes the position of claim 16 to be different from claim 1. Examiner suggests replacing “the position of the at least one protrusion relative to the first end of the catheter” in line 1-2 of claim 16 with “a position of the at least one protrusion relative to the first end of the catheter”.
Line 3 recites “the terminal end of the sheath”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the terminal end of the sheath” in line 3 of claim 16 with “a terminal end of the sheath”.
Line 4 recites “said protrusion”. It is unclear if said protrusion refers to a specific protrusion or to the at least one protrusion. For examination purposes Examiner construes “said protrusion” to be “the at least one protrusion”. Examiner suggests replacing “said protrusion” in line 4 of claim 16 with “said at least one protrusion”.
In regard to claim 17,
Line 1-2 recites “further comprising a plurality of spaced apart protrusions”. Claim 17 depends on claim 1. Claim 1 recites at least one protrusion. It is unclear if the plurality of spaced apart protrusions are in addition to the at least one protrusions or if the at least one protrusion comprises the plurality of spaced apart protrusions. For examination purposes Examiner construes the at least one protrusion to comprise a plurality of spaced apart protrusions. Examiner suggests replacing “further comprising a plurality of spaced apart protrusions” in line 1-2 of claim 17 with “wherein the at least one protrusion comprises a plurality of spaced apart protrusions”.
Line 2 recites “the protrusions”. It is unclear if the protrusions refers to the plurality of spaced apart protrusions or to specific protrusions. For examination purposes Examiner construes “the protrusions” to be “the plurality of spaced apart protrusions”. Examiner suggests replacing “the protrusions” in line 2 of claim 17 with “the plurality of spaced apart protrusions”.
Line 4 recites “the terminal end of the sheath”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the terminal end of the sheath” in line 4 of claim 17 with “a terminal end of the sheath”.
Line 5 recites “said protrusion”. It is unclear if said protrusion refers to a specific protrusion or to the at least one protrusion or to the plurality of spaced apart protrusions. For examination purposes Examiner construes “said protrusion” to be “a protrusion of the plurality of spaced apart protrusions”. Examiner suggests replacing “said protrusion” in line 5 of claim 17 with “a protrusion of the plurality of spaced apart protrusions”.
Examiner notes claim 18 is similarly rejected by virtue of its dependency on claim 17.
In regard to claim 18,
Line 1 recites “the protrusions”. It is unclear if the protrusions refers to the plurality of spaced apart protrusions or to specific protrusions. For examination purposes Examiner construes “the protrusions” to be “each of the plurality of spaced apart protrusions”. Examiner suggests replacing “the protrusions” in line 1 of claim 18 with “each of the plurality of spaced apart protrusions”.
In regard to claim 19,
Line 4-5 recites “the proximal end”. There is insufficient antecedent basis for the proximal end. It is unclear if the proximal end is the same as the first end or in addition to the first end. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the proximal end” in line 4-5 of claim 19 with “the first end”.
Line 19 recites “said protrusion”. It is unclear if said protrusion is the same as the at least one protrusion or refers to a specific protrusion of the at least one protrusion. For examination purposes Examiner construes “said protrusion” to be “said at least one protrusion”. Examiner suggests replacing “said protrusion” in line 19 of claim 19 with “said at least one protrusion”.
Line 23-24 recites “the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body”. It is unclear due to the term “contacts” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Examiner suggests replacing “the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body” in line 23-24of claim 19 with “the at least one protrusion is configured to contact the compression seal and prevent the catheter from sliding toward the first end of the valve body” or alternatively with “the at least one protrusion is in contact the compression seal and prevents the catheter from sliding toward the first end of the valve body”.
In regard to claim 20,
Line 10-12 recites “a closed state - wherein the compression seal radially collapses so as to create the reduced inner diameter within the valve lumen”. It is unclear if line 10-12 is claiming the closed state as a state in which the compression seal is radially collapsed so as to create the reduced inner diameter within the valve lumen or if line 10-12 is claiming that while in the closed state the compression seal radially collapses so as to create the reduced inner diameter within the valve lumen. Based on the disclosure it appears the closed state is a state in which the compression seal is radially collapsed so as to create the reduced inner diameter within the valve lumen. Examiner suggests replacing “a closed state - wherein the compression seal radially collapses so as to create the reduced inner diameter within the valve lumen” in line 10-12 of claim 20 with “a closed state - wherein the compression seal is radially collapsed so as to create the reduced inner diameter within the valve lumen”.
Line 12-14 recites “an open state - wherein the compression seal radially moves outwardly so as to no longer create the reduced inner diameter within the valve lumen”. It is unclear if line 12-14 is claiming the opened state as a state in which the compression seal has radially moved outwardly so as to no longer create the reduced inner diameter within the valve lumen or if line 12-14 is claiming that while in the opened state the compression seal radially moves outwardly so as to no longer create the reduced inner diameter within the valve lumen. Based on the disclosure it appears the opened state is a state in which the compression seal has radially moved outwardly so as to no longer create the reduced inner diameter within the valve lumen. Examiner suggests replacing “an open state - wherein the compression seal radially moves outwardly so as to no longer create the reduced inner diameter within the valve lumen” in line 12-14 of claim 20 with “an open state - wherein the compression seal has radially moved outwardly so as to no longer create the reduced inner diameter within the valve lumen”.
Line 25-27 recites “the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body”. It is unclear due to the term “contacts” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Examiner suggests replacing “the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body” in line 25-27 of claim 20 with “the at least one protrusion is configured to contact the compression seal and prevent the catheter from sliding toward the first end of the valve body” or alternatively with “the at least one protrusion is in contact the compression seal and prevents the catheter from sliding toward the first end of the valve body”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 12, line 1 of claim 12 states “The catheter apparatus of claim 12”. Claim 12 cannot be dependent on itself. Examiner suggests amending claim 12 to be dependent on claim 1. For examination purposes Examiner construes claim 12 to be dependent on claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Examiner notes claim 13 is similarly rejected by virtue of its dependency on claim 12.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-8, 11, 14-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bean (U.S. PG publication 20210370022).
In regard to claim 1,
Bean discloses a catheter apparatus (figure 14A, item 340) for use with a hemostasis valve (Examiner notes “for use with a hemostasis valve” is a functional limitation. The hemostasis valve is not positively required by the claim. The catheter apparatus is fully capable of the intended function as supported by paragraph [0058]; see also item 402 and 404 in figure 14a which is construed as an example hemostatic valve and paragraph [0061] which provides other example hemostatic valves the catheter apparatus can be used with), the hemostasis valve providing a valve body having a first end and an opposing second end with a valve lumen extending therebetween (see figure 14a, item 402 and paragraph [0061]; the hemostasis valve providing a valve body having a first end and an opposing second end with a valve lumen extending therebetween is not positively required by the claim. As noted above the hemostasis valve is not required and therefore ALL features of the hemostasis valve are also not required. The catheter apparatus is fully capable of use with a hemostasis valve having the claimed features due to its structure), the hemostasis valve further providing an elongate sheath (figure 14A, item 404) engaged with the second end and in fluid communication with the valve lumen (see figure 14B; the hemostasis valve further providing an elongate sheath engaged with the second end and in fluid communication with the valve lumen is not positively required by the claim. The catheter apparatus is fully capable of use with a hemostasis valve having the claimed features due to its structure), and a compression seal (figure 14A, item 444; paragraph [0061]) positioned substantially proximal to the first end (see figure 14A) and configured for temporarily creating a reduced inner diameter within the valve lumen (paragraph [0061]; a compression seal positioned substantially proximal to the first end and configured for temporarily creating a reduced inner diameter within the valve lumen is not positively required by the claim. The catheter apparatus is fully capable of use with a hemostasis valve having the claimed features due to its structure), the apparatus comprising:
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an elongate catheter (see figure 13A above) having a first end (see figure 13A above) and an opposing second end (see figure 13A above), an outer surface of the catheter having an outer diameter that is less than a neutral inner diameter of the valve lumen (paragraph [0058] and [0062]; Examiner notes the outer surface of the catheter has an outer diameter that is less than a neutral inner diameter of the valve lumen as the valve lumen is not positively required and as supported by paragraph [0058] and [0062], the catheter can be inserted through the valve and therefore would have an outer surface of the catheter having an outer diameter that is less than a neutral inner diameter of the valve lumen), thereby allowing the catheter to be slidably inserted a distance into the valve lumen (paragraph [0062]; see also for example figure 14B); and
an at least one protrusion (figure 13A, item 348) radially extending outwardly from the outer surface of the catheter (see figure 13A), the at least one protrusion having an outer diameter that is less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen (As noted above the valve lumen is not positively required. As supported by paragraph [0062], [0052] and [0058], the at least one protrusion has an outer diameter that is less than the neutral inner diameter of the valve lumen, as the catheter can be inserted through the valve and the at least one protrusion can be moved so that the sealing member/compression seal is within a notch. The outer diameter is greater than the reduced inner diameter of the valve lumen as supported by paragraph [0058] and [0050], as the notches provide a backstop against proximal movement of the catheter when the sealing member/compression seal is within a notch);
whereby, with the catheter positioned a distance within the valve lumen and the compression seal subsequently creating the reduced inner diameter within the valve lumen, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body (paragraph [0058] and [0050]; As noted above the valve lumen and the compression seal is not provided. The catheter is fully capable of use with a valve lumen and the compression seal subsequently creating the reduced inner diameter within the valve lumen such that the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body as supported by paragraph [0058], [0069] and [0050]).
In regard to claim 2,
Bean discloses the catheter apparatus of claim 1, further comprising a hub (figure 13A, item 342) engaged with the first end of the catheter (see figure 13A).
In regard to claim 3,
Bean discloses the catheter apparatus of claim 1, wherein the catheter is constructed out of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polyetheretherketone, polyamide, silicone, polyether block amide and polyethylene (paragraph [0065]).
In regard to claim 4,
Bean discloses the catheter apparatus of claim 1, wherein the catheter has an outer diameter of about 1 French to about 34 French (paragraph [0058]).
In regard to claim 5,
Bean discloses the catheter apparatus of claim 1, wherein the catheter has a length that is greater than a length of the sheath, such that the second end of the catheter may extend a distance beyond a terminal end of the sheath during use of the apparatus (see figure 14B; paragraph [0059]; Examiner notes the sheath is not positively required by the claim. When the catheter is used with a sheath, the catheter has a length that is greater than a length of the sheath, such that the second end of the catheter may extend a distance beyond a terminal end of the sheath during use of the apparatus as supported by paragraph [0059] and figure 14B).
In regard to claim 6,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion extends around an entire circumference of the outer surface of the catheter (see figure 13A and paragraph [0058]).
In regard to claim 7,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion is constructed out of one or more of polyether, polyester, polyimide, nylon, polyurethane, polyetherimide, polycarbonate, polyetheretherketone, polyamide, silicone, polyethylene, acrylic, acrylonitrile butadiene styrene, methylmethacrylate butadiene styrene, polypropylene, polyether block amide ("PEBA"), or any common polymer or combination resulting in a block copolymer (silicone; paragraph [0067]).
In regard to claim 8,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion is constructed out of one or more of stainless steel, nitinol, cobalt chromium, platinum-iridium, or other metals or alloys (other metal; paragraph [0067]).
In regard to claim 11,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion is constructed out of one or more radiopaque materials (metal; paragraph [0067]) to facilitate positioning of the catheter within the valve lumen (paragraph [0065] and [0067]; Examiner notes the valve lumen is not positively required by the claim and “to facilitate positioning of the catheter within the valve lumen” is a functional limitation. Due to the material properties, positioning of the catheter within the valve lumen would be facilitated).
In regard to claim 14,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion has an outer diameter of about 100.1% to about 500% of the outer diameter of the catheter (paragraph [0069]; see figure 13A).
In regard to claim 15,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion has a length of about 0.001 inch to about 20 inches (paragraph [0069]).
In regard to claim 16,
Bean discloses the catheter apparatus of claim 1, wherein the position of the at least one protrusion relative to the first end of the catheter indicates a corresponding distance by which the opposing second end of the catheter extends from the terminal end of the sheath when said protrusion is positioned substantially in line with the compression seal (Examiner notes a sheath and compression seal are not positively required. A sheath of appropriate size with an appropriately placed compression seal is fully capable of use with the catheter apparatus in which the position of the at least one protrusion relative to the first end of the catheter indicates a corresponding distance by which the opposing second end of the catheter extends from the terminal end of the sheath when said protrusion is positioned substantially in line with the compression seal).
In regard to claim 17,
Bean discloses the catheter apparatus of claim 1, further comprising a plurality of spaced apart protrusions along a length of the catheter (see figure 13A wherein multiple ridges 348 are present), each of the protrusions positioned relative to the first end of the catheter so as to indicate a corresponding distance by which the opposing second end of the catheter extends from the terminal end of the sheath when said protrusion is positioned substantially in line with the compression seal (Examiner notes a sheath and compression seal are not positively required. A sheath of appropriate size with an appropriately placed compression seal is fully capable of use with the catheter apparatus in which each of the protrusions positioned relative to the first end of the catheter indicate a corresponding distance by which the opposing second end of the catheter extends from the terminal end of the sheath when said protrusion is positioned substantially in line with the compression seal).
In regard to claim 19,
Bean discloses a catheter apparatus (figure 14A, item 340) for use with a hemostasis valve (Examiner notes “for use with a hemostasis valve” is a functional limitation. The hemostasis valve is not positively required by the claim. The catheter apparatus is fully capable of the intended function as supported by paragraph [0058]; see also item 402 and 404 in figure 14a which is construed as an example hemostatic valve and paragraph [0061] which provides other example hemostatic valves the catheter apparatus can be used with), the hemostasis valve providing a valve body having a first end and an opposing second end with a valve lumen extending therebetween (see figure 14a, item 402 and paragraph [0061]; the hemostasis valve providing a valve body having a first end and an opposing second end with a valve lumen extending therebetween is not positively required by the claim. As noted above the hemostasis valve is not required and therefore ALL features of the hemostasis valve are also not required. The catheter apparatus is fully capable of use with a hemostasis valve having the claimed features due to its structure), the hemostasis valve further providing an elongate sheath (figure 14A, item 404) engaged with the second end (see figure 14B; the hemostasis valve further providing an elongate sheath engaged with the second end is not positively required by the claim. The catheter apparatus is fully capable of use with a hemostasis valve having the claimed features due to its structure), and a compression seal (figure 14A, item 444; paragraph [0061]) positioned substantially proximal to the proximal end (see figure 14A) and configured for temporarily creating a reduced inner diameter within the valve lumen (paragraph [0061]; a compression seal positioned substantially proximal to the proximal end and configured for temporarily creating a reduced inner diameter within the valve lumen is not positively required by the claim. The catheter apparatus is fully capable of use with a hemostasis valve having the claimed features due to its structure), the apparatus comprising:
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an elongate catheter (see figure 13A above) having a first end (see figure 13A above) and an opposing second end (see figure 13A above);
an outer surface of the catheter having an outer diameter that is less than a neutral inner diameter of the valve lumen (paragraph [0058] and [0062]; Examiner notes the outer surface of the catheter has an outer diameter that is less than a neutral inner diameter of the valve lumen as the valve lumen is not positively required and as supported by paragraph [0058] and [0062], the catheter can be inserted through the valve and therefore would have an outer surface of the catheter having an outer diameter that is less than a neutral inner diameter of the valve lumen), thereby allowing the catheter to be slidably inserted a distance into the valve lumen (paragraph [0062]; see also for example figure 14B);
the catheter having a length that is greater than a length of the sheath, such that the second end of the catheter may extend a distance beyond a terminal end of the sheath when the catheter is inserted a distance into the valve lumen (see figure 14B; paragraph [0059]; Examiner notes the sheath is not positively required by the claim. When the catheter is used with a sheath, the catheter has a length that is greater than a length of the sheath, such that the second end of the catheter may extend a distance beyond a terminal end of the sheath during use of the apparatus when the catheter is inserted a distance into the valve lumen as supported by paragraph [0059] and figure 14B); and
an at least one protrusion (figure 13A, item 348) radially extending outwardly from the outer surface of the catheter (see figure 13A) and having an outer diameter that is less than the neutral inner diameter of the valve lumen but greater than the reduced inner diameter of the valve lumen (As noted above the valve lumen is not positively required. As supported by paragraph [0062], [0052] and [0058], the at least one protrusion has an outer diameter that is less than the neutral inner diameter of the valve lumen, as the catheter can be inserted through the valve and the at least one protrusion can be moved so that the sealing member/compression seal is within a notch. The outer diameter is greater than the reduced inner diameter of the valve lumen as supported by paragraph [0058] and [0050], as the notches provide a backstop against proximal movement of the catheter when the sealing member/compression seal is within a notch), the at least one protrusion positioned relative to the first end of the catheter (see figure 13A) so as to indicate a corresponding distance by which the opposing second end of the catheter extends from the terminal end of the sheath when said protrusion is positioned substantially in line with the compression seal (Examiner notes a sheath and compression seal are not positively required. An appropriately sized sheath with an appropriately placed compression seal is fully capable of use with the catheter apparatus in which the at least one protrusion is positioned relative to the first end of the catheter so as to indicate a corresponding distance by which the opposing second end of the catheter extends from the terminal end of the sheath when said protrusion is positioned substantially in line with the compression seal);
whereby, with the catheter positioned a distance within the valve lumen and the compression seal subsequently creating the reduced inner diameter within the valve lumen, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body (paragraph [0058] and [0050]; As noted above the valve lumen and the compression seal is not provided. The catheter is fully capable of use with a valve lumen and the compression seal subsequently creating the reduced inner diameter within the valve lumen such that the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body as supported by paragraph [0058], [0069] and [0050]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bean (U.S. PG publication 20210370022) further in view of Wu (U.S. PG publication 20140194822).
In regard to claim 9,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion is constructed out of a material for engagement between the at least one protrusion and the compression seal when the compression seal creates the reduced inner diameter within the valve lumen (paragraph [0067]; As noted above the compression seal is not positively required by the claim. As supported by paragraph [0058], [0069] and [0050], when the at least one protrusion is engaged with the compression seal, there is engagement between the at least one protrusion and the compression seal when the compression seal creates the reduced inner diameter within the valve lumen).
Bean is silent as to wherein the at least one protrusion is constructed out of a tacky, high-friction material so as to increase the friction between the at least one protrusion and the compression seal when the compression seal creates the reduced inner diameter within the valve lumen.
Wu teaches wherein the catheter apparatus is constructed out of a tacky, high-friction material so as to increase the friction (paragraph [0030]).
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 modify the material of the catheter apparatus of Bean to include wherein the catheter apparatus is constructed out of a tacky, high-friction material so as to increase the friction, as taught by Wu, therefore resulting in wherein the at least one protrusion is constructed out of a tacky, high-friction material so as to increase the friction between the at least one protrusion and the compression seal when the compression seal creates the reduced inner diameter within the valve lumen for the purpose of inducing friction (paragraph [0030] of Wu). Examiner notes Bean further supports various materials including silicone can be used to form the at least one protrusion depending on the desired properties (paragraph [0067] of Bean).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bean (U.S. PG publication 20210370022) further in view of Wang (U.S. PG publication 20210361918).
In regard to claim 10,
Bean discloses the catheter apparatus of claim 1, wherein the at least one protrusion is constructed out of a polymer so as to cooperate with the compression seal to form a seal therebetween when the compression seal creates the reduced inner diameter within the valve lumen (paragraph [0067] and paragraph [0058], [0069] and [0050]. The compression seal and valve lumen are not positively required by the claimed. As supported by [0067], [0058], [0069] and [0050], the at least one protrusion is constructed out of a polymer so as to cooperate with the compression seal to form a seal therebetween when the compression seal creates the reduced inner diameter within the valve lumen).
Bean is silent as to wherein the at least one protrusion is constructed out of a semi-compliant polymer so as to cooperate with the compression seal to form a seal therebetween when the compression seal creates the reduced inner diameter within the valve lumen.
Wang teaches wherein the catheter apparatus is constructed out of a semi-compliant polymer (paragraph [0115]).
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 modify the material of the catheter apparatus of Bean to include wherein the catheter apparatus is constructed out of a semi-compliant polymer, as taught by Wang, therefore resulting in wherein the at least one protrusion is constructed out of a semi-compliant polymer so as to cooperate with the compression seal to form a seal therebetween when the compression seal creates the reduced inner diameter within the valve lumen for the purpose of utilizing a desired material for a desired use (paragraph [0115] of Wang). Examiner notes Bean further supports various materials can be used to form the at least one protrusion depending on the desired properties (paragraph [0067] of Bean).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bean (U.S. PG publication 20210370022) further in view of Kirby (U.S. PG publication 20060264904).
In regard to claim 12,
Bean discloses the catheter apparatus of claim 12 (see 112 rejection above wherein claim 12 is construed to be dependent on claim 1), wherein the at least one protrusion is constructed out of a metal and a polymer (paragraph [0067]).
Bean is silent as to the specific metal and is therefore silent as to wherein the at least one protrusion is constructed out of a tungsten-loaded polymer.
Kirby teaches the catheter apparatus is constructed out of a tungsten-loaded polymer (paragraph [0084]; impregnated polymer with tungsten and nitinol).
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 modify the metal of Bean to be tungsten and nitinol, as taught by Kirby, therefore resulting in wherein the at least one protrusion is constructed out of a tungsten-loaded polymer for the purpose of enabling imaging with an MRI machine (paragraph [0084] of Kirby).
In regard to claim 13,
Bean in view of Kirby teaches the catheter apparatus of claim 12, wherein the at least one protrusion is constructed out of one or more of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth subcarbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel or alloys thereof (see analysis of claim 12 above and paragraph [0084] of Kirby).
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bean (U.S. PG publication 20210370022).
In regard to claim 18,
Bean discloses the catheter apparatus of claim 17.
Bean is silent as to wherein the protrusions are spaced about 0.001 inch to about 20 inches apart from one another.
It would have been an obvious matter of design choice to modify Bean to include wherein the protrusions are spaced about 0.001 inch to about 20 inches apart from one another since the only difference between the prior art and what is claimed is 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. 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). Paragraph [0062], [0069], and [0085] of Bean further supports that the catheter can be modified to be suitable for specific procedures. Additionally, as supported by paragraph [0024] of the instant disclosure, there does not appear to be a criticality to the claimed range as paragraph [0024] states that the distance S between each of the protrusions 44 may also be less than 0.001 inch or more than 20 inches.
In regard to claim 20,
Bean discloses a combination catheter and hemostasis valve system (see all of figure 14a and 14b) comprising:
a hemostasis valve (figure 14A, item 402 and 404; paragraph [0061]. Examiner notes paragraph [0061] includes example hemostatic valves which can be opened and closed such as the valve in Stevens (U.S. patent 5591137) which is cited as being incorporated into Bean by reference) comprising:
a valve body (body formed by item 402) having a first end and an opposing second end (see figure 14A) with a valve lumen extending therebetween (see figure 14A), the valve lumen having a neutral inner diameter (see figure 14A);
an elongate sheath (figure 14B, item 404) engaged with the second end of the valve body and in fluid communication with the valve lumen (see figure 14B); and
a compression seal (figure 14A, item 444) positioned substantially proximal to the first end of the valve body (see figure 14a) and configured for temporarily creating a reduced inner diameter within the valve lumen (paragraph [0061]; reduced inner diameter of closed position; see also figure 5 and 5A of Stevens for example);
the hemostasis valve configured for selectively moving between one of a closed state (paragraph [0061] of Bean; see also figure 5 and 5A of Stevens) - wherein the compression seal radially collapses so as to create the reduced inner diameter within the valve lumen (paragraph [0061] of Bean; see also figure 5 and 5A of Stevens) - and an open state (paragraph [0061] of Bean; see also figure 4 of Stevens) - wherein the compression seal radially moves outwardly so as to no longer create the reduced inner diameter within the valve lumen (paragraph [0061] of Bean; see also figure 4 of Stevens); and
a catheter apparatus (figure 14A, item 406 of Bean) comprising:
an elongate catheter (figure 14A, item 466, 472, and 468 of Bean) having a first end (proximal end of item 466 of Bean) and an opposing second end (figure 14A, item 470 of Bean), an outer surface of the catheter having an outer diameter that is less than the neutral inner diameter of the valve lumen (see figure 14B and paragraph [0059] of Bean wherein the catheter can be inserted and advanced through the valve lumen and therefore has an outer diameter that is less than the neutral inner diameter of the valve lumen), thereby allowing the catheter to be slidably inserted a distance into the valve lumen (see figure 14B and paragraph [0059] of Bean); and
an at least one protrusion (ridge as disclosed in paragraph [0059] of Bean) radially extending outwardly from the outer surface of the catheter (paragraph [0059] of Bean), the at least one protrusion having an outer diameter that is less than the neutral inner diameter of the valve lumen (see figure 14B and paragraph [0059] of Bean wherein the catheter with the at least one protrusion can be inserted and advanced through the valve lumen and therefore has an outer diameter that is less than the neutral inner diameter of the valve lumen)
A first embodiment of Bean is silent as to the at least one protrusion having an outer diameter that is greater than the reduced inner diameter of the valve lumen; whereby, with the catheter positioned a distance within the valve lumen and the hemostasis valve subsequently moved into the closed state, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body.
A second embodiment of Bean teaches the at least one protrusion (figure 13A, item 348) having an outer diameter that is greater than the reduced inner diameter of the valve lumen (paragraph [0069] [0050], and [0058]; Examiner notes the outer diameter is greater than the reduced inner diameter of the valve lumen since the ridges stops movement when engaged with a compressive force of the elastomeric member); whereby, with the catheter positioned a distance within the valve lumen and the hemostasis valve subsequently moved into the closed state, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body (paragraph [0069], [0050], and [0058]).
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 modify the first embodiment of Bean to include the at least one protrusion having an outer diameter that is greater than the reduced inner diameter of the valve lumen; whereby, with the catheter positioned a distance within the valve lumen and the hemostasis valve subsequently moved into the closed state, the at least one protrusion contacts the compression seal and prevents the catheter from sliding toward the first end of the valve body, as taught by the second embodiment of Bean for the purpose of protecting against proximal disengagement of the catheter from a hemostatic valve (paragraph [0050] of Bean).
Conclusion
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783