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 Species III in the reply filed on 04/13/2026 is acknowledged.
Claims 6, 9, 16-18 & 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/13/2026.
Information Disclosure Statement
The Examiner notes that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 800 references for consideration. The Examiner has considered all of the references submitted as part of the Information Disclosure Statements, but has not found any to be of particular relevance. If Applicant is aware of pertinent material in the references, it should be stated in a response to this Office action. Applicant is reminded of MPEP § 2004, paragraph 13:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the initialed references have been considered in a cumulative manner. Examiner further notes that numerous cited references appear to have little or no relevance at all to the disclosed/claimed invention, many of which do not even mention hemostasis valves. Most of the references which do reference hemostasis valves do not have an actuator.
Drawings
The drawings are objected to under 37 CFR 1.83(a) and/or PCT Article 7, Paragraph (1). The drawings must show every feature of the invention specified in the claims, when they are necessary for the understanding of the invention. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
the port configured as an inlet for application of pressure or vacuum to rigidize the rigidizing catheter, as claimed in Claim 15; this feature does not appear to be shown in the elected species; simply labeling this feature in the figures may overcome this objection; however, none of Figures 6A-6C seem to support this feature
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-3, 5, 7-8, 10, 12-15 & 21-24 are objected to because of the following informalities.
Claim 1 should read --A large-bore hemostasis valve, the hemostasis valve comprising:
a housing having a central bore therethrough;
a compression tube movably positioned within the central bore;
an annular elastomeric seal within the central bore rigidly coupled to the compression tube wherein the elastomeric seal has a Shore 00 durometer of between 00-05 and 00-60; and
at least one actuator movably coupled to the housing, the at least one actuator having one or more engagement surfaces engaging with one or more driving surfaces on the compression tube, the at least one actuator configured to move in a first direction and a second direction;
wherein movement of the at least one actuator relative to the housing in the first direction moves the compression tube to compress the annular elastomeric seal to reduce an inner diameter of the annular elastomeric seal, and
wherein movement of the at least one actuator relative to the housing in the second direction is configured to pull the annular elastomeric seal so to move the compression tube to provide for axial expansion of the annular elastomeric seal to increase [[an]]the inner diameter of the annular elastomeric seal.—
Claim 8 should read --The hemostasis valve of claim 1, where the one or more engagement surfaces comprises a cam engaging a driving surface of the one or more driving surfaces on the compression tube.—
Claim 13 should read --The hemostasis valve of claim 1, wherein the at least one actuator is pivotally coupled to the housing with a pivot pin.--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to Claims 19-21, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims surfaces of both ends of the annular elastomeric seal are orthogonal to the central bore. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe any of the surfaces of any part of the elastomeric seal being orthogonal to any part of the central bore. Additionally, one of ordinary skill in the art would not conclude any portion of the seal is inherently orthogonal to any portion of the seal.
Note, this limitation is not an original limitation, and the specification does not explicitly describe this feature in any manner. As such, this limitation is considered new matter.
As to Claim 22, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a side of the annular elastomeric seal rigidly coupled to the compression tube is orthogonal to the central bore. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe any of the surfaces of any part of the elastomeric seal being orthogonal to any part of the central bore. Additionally, one of ordinary skill in the art would not conclude any portion of the seal is inherently orthogonal to any portion of the seal.
Note, this limitation is not an original limitation, and the specification does not explicitly describe this feature in any manner. As such, this limitation is considered new matter.
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 14-15 & 19-22 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.
As to Claim 14, the limitation “comprising a rigidizing catheter coupled to the housing”, in combination with the preamble, is indefinite. The preamble states only a hemostasis valve is being claimed. Claim 14 states the valve is comprised of a rigidizing catheter. Instant application Paragraph 0053 states the “end 107x of the apparatus [the hemostasis valve] may be configured to mate with a catheter, such as a rigidizing catheter”. When reading this, one of ordinary skill in the art would conclude the catheter is not part of the claimed valve. However, the claim positively claims the catheter as part of the valve. As such, the scope of the claim is not clear, rendering the claim indefinite. For the purpose of examination, the claim will be interpreted as the hemostasis valve of claim 1, wherein the housing is configured to be coupled to a rigidizing catheter.
As to Claim 19, the limitation “surfaces of both ends of the annular elastomeric seal are orthogonal to the central bore”, in Lines 7-8, is indefinite. The limitation requires a reference structure of the central bore which is not provided. As such, it is not clear which part of the central bore the surfaces of both ends of the seal are orthogonal to, rendering the claim indefinite.
The term “it”, in Line 19, is indefinite. It is not clear which structure the term is referring to, rendering the claim indefinite. For the purpose of examination, the term will be interpreted as the annular elastomeric seal.
The phrase “an inner diameter”, in Line 20, should read –[[an]]the inner diameter.
As to Claim 20, the limitation “surfaces of both ends of the annular elastomeric seal are orthogonal to the central bore”, in Lines 6-7, is indefinite. The limitation requires a reference structure of the central bore which is not provided. As such, it is not clear which part of the central bore the surfaces of both ends of the seal are orthogonal to, rendering the claim indefinite.
The term “it”, in Line 16, is indefinite. It is not clear which structure the term is referring to, rendering the claim indefinite. For the purpose of examination, the term will be interpreted as the annular elastomeric seal.
The phrase “an inner diameter”, in Line 17, should read –[[an]]the inner diameter.
As to Claim 21, the limitation “surfaces of both ends of the annular elastomeric seal are orthogonal to the central bore”, is indefinite. The limitation requires a reference structure of the central bore which is not provided. As such, it is not clear which part of the central bore the surfaces of both ends of the seal are orthogonal to, rendering the claim indefinite.
As to Claim 22, the limitation “a side of the annular elastomeric seal rigidly coupled to the compression tube is orthogonal to the central bore”, is indefinite. The limitation requires a reference structure of the central bore which is not provided. As such, it is not clear which part of the central bore the side of the seal is orthogonal to, rendering the claim indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5, 7-8, 10, 12-13, 19, 21-22 & 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wollschlager (U.S. Patent 5,941,499), in view of Lampropoulos (U.S. Patent 5,921,968), further in view of Stevens (U.S. Patent 5,591,137), further in view of Pessin (U.S. PGPub 2014/0207083), as evidenced by smooth-on.com (see previously attached Durometer Shore Hardness Scale pdf from smooth- on.com/page/durometer-shore-hardness-scale/).
As to Claim 1, Wollschlager teaches a large-bore hemostasis valve (Figure 12; Note Column 6, Lines 55-67, states Figure 12 is an alternative embodiment of Figure 1, where the spring element biasing actuator 23 is changed), the hemostasis valve (Figure 12) comprising:
a housing (1) having a central bore (5/9) therethrough (as shown in Figure 12);
a compression tube (18) movably positioned within (Column 3, Line 37, to Column 4, Line 19) the central bore (5/9);
an annular (via 17) seal (16) within (as shown in Figure 12) the central bore (5/9) coupled to (as shown in Figure 12) the compression tube (18)…
at least one actuator (23) movably (as shown in Figures 1/2; Column 6, Lines 55-67) coupled to (as shown in Figure 12) the housing (1), the at least one actuator (23) having one or more engagement surfaces (22) engaging with (as shown in Figure 12) one or more driving surfaces (20) on (as shown in Figure 12) the compression tube (18), the at least one actuator (23) configured to move (as shown between Figures 1/2) in a first direction (radially outward) and a second direction (radially inward);
wherein movement (as shown between Figure 2 to Figure 1) of the at least one actuator (23) relative to the housing (1) in the first direction (radially outward) moves (as shown between Figure 2 to Figure 1) the compression tube (18) to compress (as shown between Figure 2 to Figure 1) the annular seal (16) to reduce (as shown in Figure 1) an inner diameter (the diameter of 17) of the annular seal (16), and
wherein movement (as shown between Figure 1 to Figure 2) of the at least one actuator (23) relative to the housing (1) in the second direction (radially inward) is configured to allow the annular seal (16) to move (as shown between Figure 1 to Figure 2) the compression tube (18) to provide for axial expansion (as shown between Figure 1 to Figure 2) the annular seal (16) to increase (as shown between Figure 1 to Figure 2) an inner diameter (the diameter of 17) of the annular seal (16).
Wollschlager is silent on the material of the annular seal, except to say the annular seal is elastic. As such, Wollschlager does not explicitly teach the annular seal is made of an elastomer.
Wollschlager also does not teach the annular seal is rigidly coupled to the compression tube, wherein the elastomeric seal has a Shore 00 durometer of between 00-05 and 00-60, and movement of the at least one actuator relative to the housing in the second direction is configured to pull the annular elastomeric seal.
Lampropoulos describes a similar valve, and teaches the annular seal (24) is elastomeric (silicon; Column 11, Lines 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the annular seal, as taught by Wollschlager, from an elastomeric material –silicon--, as taught by Lampropoulos, “to enable compressible seal to independently conform back to its original configuration when the compressive force is removed (Column 11, Lines 4-6).”
Stevens describes a similar valve, and teaches the annular seal (52) is rigidly coupled to (via 50; Column 10, Line 64, to Column 11, Line 10) the compression tube (136).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to rigidly couple, as taught by Stevens, the elastomeric seal to the compression tube, as taught by Wollschlager, as modified,, "to prevent displacement or misalignment of [the] seal (Column 10, Line 64, to Column 11, Line 10)".
Modifying Stevens into Wollschlager, as modified, results in movement of the at least one actuator (Wollschlager 23) relative to the housing (Wollschlager 1) in the second direction (radially outward, as viewed in Wollschlager Figure 12) is configured to pull (via Stevens 50 being interlocked with Wollschlager 16, as described in Stevens Column 10, Line 64, to Column 11, Line 10) the annular elastomeric seal (Wollschlager 16).
Pessin describes a similar valve and teaches the elastomeric seal (120) has a Shore 00 durometer of between 15 Shore A and 25 Shore A (Paragraph 0093). The website smooth-on.com (see the chart at the bottom of the attached Durometer Shore Hardness Scale pdf) shows 15 Shore A and 25 Shore A is roughly 59 Shore 00 and 68 Shore 00.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to make the elastomeric seal, as taught by Lampropoulos, as modified, from a material with a Shore A between 15 and 25, as taught by Pessin, 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)
It would have been obvious to one of ordinary skill in the art to use the elastomeric seal material to have a Shore 00 durometer of between 00-05 and 00-60, since it has been held "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191
As to Claim 2, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the compression tube (Wollschlager 18) is not biased against the annular elastomeric seal (Wollschlager 16) by a compression spring in-line with the compression tube (Wollschlager 18). One of ordinary skill in the art would conclude a compression spring, as claimed, is not disclosed by Wollschlager, as modified, is not required, and would have no reason to modify Wollschlager, as modified, to have a compression spring in-line with the compression tube.
As to Claim 3, Wollschlager, as modified, teaches all the limitations of Claim 1, but does not teach a lubricous material within a region of the central bore in communication with the annular elastomeric seal, so that the annular elastomeric seal may slide relative to the central bore.
Stevens continues to teach a lubricous material (polytetrafluoroethylene) within a region (the region of the central bore which allows seal 52 to be lubricated; Column 9, Lines 32-47) of the central bore (56/58) in communication with (Column 9, Lines 32-47) the annular elastomeric seal (52), so that the annular elastomeric seal (52) may slide relative to (Column 9, Lines 32-47) the central bore (56/58).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use lubrication, as taught by Stevens, in the central bore, as taught by Wollschlager, as modified,, " to provide a smoother interaction between the components within valve assembly (Column 9, Lines 38-39).”
As to Claim 5, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one actuator (Wollschlager 23) comprises a lever (Wollschlager describes Element 23 as a lever).
As to Claim 7, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the one or more engagement surfaces (Wollschlager 22) comprises one or more of: a cam (Wollschlager 22), a gear, a threaded region, a linkage (Wollschlager 22, with Wollschlager 20).
As to Claim 8, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the one or more engagement surfaces (Wollschlager 22) comprises a cam (Wollschlager 22) engaging a driving surface (Wollschlager 20) on the compression tube (Wollschlager 18).
As to Claim 10, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the annular elastomeric seal (Wollschlager 16) comprises a silicone material (silicon; Lampropoulos Column 11, Lines 7-10).
As to Claim 12, Wollschlager, as modified, teaches all the limitations of Claim 1, but does not teach the annular elastomeric seal has a Shore 00 hardness of between Shore 00-10 and 00-40.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Shore 00 hardness to be between Shore 00-10 and 00-40, since it has been held that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933).
As to Claim 13, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one actuator (Wollschlager 23) is pivotally coupled to (as shown in Wollschlager Figure 12) the housing (Wollschlager 1) with a pivot pin (Wollschlager 29).
As to Claim 19, Wollschlager teaches a large-bore hemostasis valve (Figure 12; Note Column 6, Lines 55-67, states Figure 12 is an alternative embodiment of Figure 1, where the spring element biasing actuator 23 is changed), the hemostasis valve (Figure 12) comprising:
a housing (1) having a central bore (5/9) therethrough (as shown in Figure 12);
a compression tube (18) movably positioned within (Column 3, Line 37, to Column 4, Line 19) the central bore (5/9);
an annular (via 17) seal (16) within (as shown in Figure 12) the central bore (5/9) coupled to (as shown in Figure 12) the compression tube (18)…further wherein surfaces (the surface of 16 facing left, and the surface of 16 facing right, as viewed in Figure 12) of both ends (the left end and the right end of 16, as viewed in Figure 12) of the annular seal (16) are orthogonal to (as shown in Figure 12) the central bore (5/9)…
at least one actuator (23), configured as a lever (Wollschlager describes Element 23 as a lever), movably (as shown in Figures 1/2; Column 6, Lines 55-67) coupled to (as shown in Figure 12) the housing (1), the at least one actuator (23) having one or more engagement surfaces (22) engaging with (as shown in Figure 12) one or more driving surfaces (20) on (as shown in Figure 12) the compression tube (18), the at least one actuator (23) configured to move (as shown between Figures 1/2) in a first direction (radially outward) and a second direction (radially inward);
wherein movement (as shown between Figure 2 to Figure 1) of the at least one actuator (23) relative to the housing (1) in the first direction (radially outward) moves (as shown between Figure 2 to Figure 1) the compression tube (18) to compress (as shown between Figure 2 to Figure 1) the annular seal (16) to reduce (as shown in Figure 1) an inner diameter (the diameter of 17) of the annular seal (16), and
wherein movement (as shown between Figure 1 to Figure 2) of the at least one actuator (23) relative to the housing (1) in the second direction (radially inward) moves (as shown between Figure 1 to Figure 2) the compression tube (18) to allow the annular seal (16) to expand axially (as shown between Figure 1 to Figure 2) to increase (as shown between Figure 1 to Figure 2) an inner diameter (the diameter of 17) of the annular seal (16).
Wollschlager is silent on the material of the annular seal, except to say the annular seal is elastic. As such, Wollschlager does not explicitly teach the annular seal is made of an elastomer.
Wollschlager also does not teach the annular seal is rigidly coupled to the compression tube, wherein the elastomeric seal has a Shore 00 durometer of between 00-05 and 00-60, and movement of the at least one actuator relative to the housing in the second direction is configured to pull the annular elastomeric seal…a lubricous material on the annular elastomeric seal configured to prevent the annular elastomeric seal from sticking.
Lampropoulos describes a similar valve, and teaches the annular seal (24) is elastomeric (silicon; Column 11, Lines 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the annular seal, as taught by Wollschlager, from an elastomeric material –silicon--, as taught by Lampropoulos, “to enable compressible seal to independently conform back to its original configuration when the compressive force is removed (Column 11, Lines 4-6).”
Stevens describes a similar valve, and teaches the annular seal (52) is rigidly coupled to (via 50; Column 10, Line 64, to Column 11, Line 10) the compression tube (136)…a lubricous material (polytetrafluoroethylene) on (Column 9, Lines 32-47) the annular elastomeric seal (52) configured to prevent (Column 9, Lines 32-47) the annular elastomeric seal (52) from sticking (Column 9, Lines 32-47).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to rigidly couple, as taught by Stevens, the elastomeric seal to the compression tube, as taught by Wollschlager, as modified,, "to prevent displacement or misalignment of [the] seal (Column 10, Line 64, to Column 11, Line 10)".
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use lubrication, as taught by Stevens, in the central bore, as taught by Wollschlager, as modified,, " to provide a smoother interaction between the components within valve assembly (Column 9, Lines 38-39).”
Modifying Stevens into Wollschlager, as modified, results in movement of the at least one actuator (Wollschlager 23) relative to the housing (Wollschlager 1) in the second direction (radially outward, as viewed in Wollschlager Figure 12) moves (as shown between Wollschlager Figure 1 to Wollschlager Figure 2) the compression tube (Wollschlager 18) to pull (via Stevens 50 being interlocked with Wollschlager 16, as described in Stevens Column 10, Line 64, to Column 11, Line 10) the annular elastomeric seal (Wollschlager 16).
Pessin describes a similar valve and teaches the elastomeric seal (120) has a Shore 00 durometer of between 15 Shore A and 25 Shore A (Paragraph 0093). The website smooth-on.com (see the chart at the bottom of the attached Durometer Shore Hardness Scale pdf) shows 15 Shore A and 25 Shore A is roughly 59 Shore 00 and 68 Shore 00.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to make the elastomeric seal, as taught by Lampropoulos, as modified, from a material with a Shore A between 15 and 25, as taught by Pessin, 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)
It would have been obvious to one of ordinary skill in the art to use the elastomeric seal material to have a Shore 00 durometer of between 00-05 and 00-60, since it has been held "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191
As to Claim 21, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach surfaces (the surface of Wollschlager 16 facing left, and the surface of Wollschlager 16 facing right, as viewed in Wollschlager Figure 12) of both ends (the left end and the right end of Wollschlager 16, as viewed in Wollschlager Figure 12) of the annular elastomeric seal (Wollschlager 16) are orthogonal to (as shown in Wollschlager Figure 12) the central bore (Wollschlager 5/9).
As to Claim 22, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach a side (the surface of Wollschlager 16 facing right, as viewed in Wollschlager Figure 12) of the annular elastomeric seal (Wollschlager 16) rigidly coupled to (as shown in Wollschlager Figure 12, as modified by Stevens above) the compression tube (Wollschlager 18) is orthogonal to (as shown in Wollschlager Figure 12) the central bore (Wollschlager 5/9).
As to Claim 24, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the central bore (Wollschlager 5/9) is configured to hold a vacuum (see end of paragraph for clarification). Wollschlager Column 4, Line 54, to Column 5, Line 7, describes the valve being capable of sealing off blood pressure in an aorta. As such, one of ordinary skill in the art would conclude the Wollschlager, as modified, valve is capable of holding a vacuum during use. Note, the term “vacuum” is interpreted as a low pressure, not a pump.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wollschlager, in view of Lampropoulos, further in view of Stevens.
As to Claim 20, Wollschlager teaches a large-bore hemostasis valve (Figure 12; Note Column 6, Lines 55-67, states Figure 12 is an alternative embodiment of Figure 1, where the spring element biasing actuator 23 is changed), the hemostasis valve (Figure 12) comprising:
a housing (1) having a central bore (5/9) therethrough (as shown in Figure 12);
a compression tube (18) movably positioned within (Column 3, Line 37, to Column 4, Line 19) the central bore (5/9);
an annular (via 17) seal (16) within (as shown in Figure 12) the central bore (5/9) coupled to (as shown in Figure 12) the compression tube (18), wherein surfaces (the surface of 16 facing left, and the surface of 16 facing right, as viewed in Figure 12) of both ends (the left end and the right end of 16, as viewed in Figure 12) of the annular seal (16) are orthogonal to (as shown in Figure 12) the central bore (5/9);
at least one actuator (23) movably (as shown in Figures 1/2; Column 6, Lines 55-67) coupled to (as shown in Figure 12) the housing (1), the at least one actuator (23) having one or more engagement surfaces (22) engaging with (as shown in Figure 12) one or more driving surfaces (20) on (as shown in Figure 12) the compression tube (18), the at least one actuator (23) configured to move (as shown between Figures 1/2) in a first direction (radially outward) and a second direction (radially inward);
wherein movement (as shown between Figure 2 to Figure 1) of the at least one actuator (23) relative to the housing (1) in the first direction (radially outward) moves (as shown between Figure 2 to Figure 1) the compression tube (18) to compress (as shown between Figure 2 to Figure 1) the annular seal (16) to reduce (as shown in Figure 1) an inner diameter (the diameter of 17) of the annular seal (16), and
wherein movement (as shown between Figure 1 to Figure 2) of the at least one actuator (23) relative to the housing (1) in the second direction (radially inward) moves (as shown between Figure 1 to Figure 2) the compression tube (18) to allow the annular seal (16) to expand axially (as shown between Figure 1 to Figure 2) to increase (as shown between Figure 1 to Figure 2) an inner diameter (the diameter of 17) of the annular seal (16).
Wollschlager is silent on the material of the annular seal, except to say the annular seal is elastic. As such, Wollschlager does not explicitly teach the annular seal is made of an elastomer.
Wollschlager also does not teach the annular seal is rigidly coupled to the compression tube, and movement of the at least one actuator relative to the housing in the second direction is configured to pull the annular elastomeric seal.
Lampropoulos describes a similar valve, and teaches the annular seal (24) is elastomeric (silicon; Column 11, Lines 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the annular seal, as taught by Wollschlager, from an elastomeric material –silicon--, as taught by Lampropoulos, “to enable compressible seal to independently conform back to its original configuration when the compressive force is removed (Column 11, Lines 4-6).”
Stevens describes a similar valve, and teaches the annular seal (52) is rigidly coupled to (via 50; Column 10, Line 64, to Column 11, Line 10) the compression tube (136).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to rigidly couple, as taught by Stevens, the elastomeric seal to the compression tube, as taught by Wollschlager, as modified,, "to prevent displacement or misalignment of [the] seal (Column 10, Line 64, to Column 11, Line 10)".
Modifying Stevens into Wollschlager, as modified, results in movement of the at least one actuator (Wollschlager 23) relative to the housing (Wollschlager 1) in the second direction (radially outward, as viewed in Wollschlager Figure 12) is configured to pull (via Stevens 50 being interlocked with Wollschlager 16, as described in Stevens Column 10, Line 64, to Column 11, Line 10) the annular elastomeric seal (Wollschlager 16).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wollschlager, in view of Lampropoulos, further in view of Stevens, further in view of Pessin, as evidenced by smooth-on.com, further in view of Smith (U.S. PGPub 2007/0270648).
As to Claim 14, Wollschlager, as modified, teaches all the limitations of Claim 1, and continues to teach the housing (Wollschlager 1) is configured to be coupled to (via 11; Column 3, Lines 45-48) a catheter (Wollschlager guiding catheter described in Column 3, Lines 45-48). However, Wollschlager, as modified, is silent on the type of catheter, so does not explicitly teach the catheter is a rigidizing catheter.
Smith describes a catheter, and teaches a rigidizing (Paragraph 0038) catheter (1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the catheter, as taught by Wollschlager, as modified, a rigidizing catheter, as taught by Smith, to prevent catheter twisting (Paragraphs 0006/0007).
As to Claim 15, Wollschlager, as modified, teaches all the limitations of Claims 1 & 14, and continues to teach a port (Wollschlager 14) configured as an inlet for application of pressure or vacuum (Column 3, Lines 51-55; this is also considered intended use; see end of paragraph for clarification) to rigidize the rigidizing catheter (Smith 1).
The intention to use Wollschlager port 14 as a fluid port is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, one of ordinary skill in the art would recognize Wollschlager port 14 may be used as a fluid port.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wollschlager, in view of Lampropoulos, further in view of Stevens, further in view of Pessin, as evidenced by smooth-on.com, further in view of Modlish (U.S. PGPub 2021/0146111).
As to Claim 23, Wollschlager, as modified, teaches all the limitations of Claim 1, but does not teach the central bore is configured to accommodate a medical device having a diameter of 12 mm or more.
Modlish describes a hemostasis valve, and teaches (see Paragraph 0046) the hemostasis valve seal size is a result-effective variable, where the seal size should be of “suitable diameter” to accommodate the device placed through the seal. See MPEP 2144.05(II)(B)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to size the central bore to accommodate a medical device having a diameter of 12 mm or more, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (1955)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. O’Carrol (2018/0001062) and Furnish (2018/0256876) describe similar valves.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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