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 Invention II, claims 13-20 in the reply filed on 05/27/2026 is acknowledged.
Claims 1-12 and 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/27/2026.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (Pub. No.: US 2023/0270988 A1) in view of Schock et al. US Pat. No.: 5,254,097).
Regarding claim 13, Sharma discloses (fig. 3-5) an adaptor (hemostasis valve hub 220) for use in a blood circuit (¶ 0003), the adaptor comprising:
A body defining a main passageway (see first arm 226 and hub base 221) extending therethrough from a first opening at a first end of the body (see distal end 222) to a second opening at a second end of the body (see proximal end 224) (fig. 4);
A side port (second arm 228) extending from the body, a passageway of the side port converging with the main passageway and having a longitudinal axis extending at an acute angel to a longitudinal axis of the body (fig. 4);
Wherein the side port includes a hemostasis valve (proximal end 242 of second arm 228) configured to selectively seal around a medical device inserted through the side port into the main passageway (¶ 0065, ¶ 0074).
While Sharma does not disclose that the adaptor is used in a blood circuit for an extracorporeal life support system, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The adaptor of Sharma is capable of being used in a blood circuit of an extracorporeal life support system since Sharma discloses the adaptor cab be used with medical devices including a blood pump (¶ 0003) and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Sharma fails to disclose an elastomeric valve positioned in the passageway of the side port spaced away from the hemostasis valve, the elastomeric valve located between the hemostasis valve and the main passageway.
Schock teaches (fig. 1-2) an adaptor (Y-shaped cannula body 10) and thus in the same field of endeavor, the adaptor comprising: a side port (leg 16); and an elastomeric valve (slit portion 46, col. 8, ln. 20-24) positioned in the passageway of the side port (fig. 2), the elastomeric valve configured to be self-closing and prevents blood leakage (col. 8, ln. 51-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptor of Sharma such that it comprises an elastomeric valve positioned in the passageway of the side port, as taught by Schock, in order to prevent blood leakage (Schock col. 8, ln. 51-56).
Further such modification such that the adaptor of Sharma includes the elastomeric valve of Schock results in the elastomeric valve being spaced away from the hemostasis valve, the elastomeric valve located between the hemostasis valve and the main passageway.
Regarding claim 14, as discussed above in claim 13, Sharma in view of Schock disclose an elastomeric valve positioned in the passageway. Accordingly, Sharma in view of Schock disclose wherein a volume of the passageway of the side port between the elastomeric valve and the main passageway is 0.02 in3 or less since Schock teaches the elastomeric valve being positioned where the side port converges with the main passageway (primary lumen 40) (Schock fig. 2).
Regarding claim 15, Sharma discloses a vent port (access port 230) extending from the side port (fig. 4, ¶ 0060), wherein the vent port includes a vent passageway converging with the passageway of the side port, wherein the vent port is positioned between the hemostasis valve and the main passageway (fig. 4).
Regarding claim 16, Sharma in view of Schock fail to disclose wherein the hemostasis valve includes a compressible seal having a lumen extending therethrough, and a compression cap configured to exert a compressive force on the compressible seal to reduce a diameter of the lumen through the compressible seal.
However, Sharma discloses the adaptor comprising an additional hemostasis valve (seal 250 and locking nut 244), wherein the hemostasis valve includes a compressible seal (seal 250) having a lumen (seal lumen 251) extending therethrough (¶ 0063), and a compression cap (lock nut 244) configured to exert a compressive force on the compressible seal to reduce a diameter of the lumen through the compressible seal (¶ 0063), such hemostasis valve configured to tighten against a medical device to stabilize the axial positioning of the medical device (¶ 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostasis valve of Sharma in view of Schock such that it includes a compressible seal having a lumen extending therethrough, and a compression cap configured to exert a compressive force on the compressible seal to reduce a diameter of the lumen through the compressible seal, as taught by the additional hemostasis valve of Sharma, in order to configure the hemostasis valve to tighten against a medical device to stabilize the axial positioning of the medical device (Sharma ¶ 0063).
Regarding claim 17, as discussed above in claim 16, Sharma discloses an additional hemostasis valve including a compression cap. Sharma further discloses the compression cap includes a stem (outer portion 248) threadingly engaged to a knob (¶ 0063).
Regarding claim 18, Sharma discloses (fig. 3-5) an adaptor (hemostasis valve hub 220) for use in a blood circuit (¶ 0003), the adaptor comprising:
A body defining a main passageway (see first arm 226 and hub base 221) extending therethrough from a first opening at a first end of the body (see distal end 222) to a second opening at a second end of the body (see proximal end 224) (fig. 4);
A side port (second arm 228) extending from the body, a passageway of the side port converging with the main passageway and having a longitudinal axis extending at an acute angel to a longitudinal axis of the body (fig. 4);
At least one aperture (see access port 230) extending through a thickness of a sidewall of the side port (fig. 4, ¶ 0060);
Wherein the side port includes a hemostasis valve (proximal end 242 of second arm 228) configured to selectively seal around a medical device inserted through the side port into the main passageway (¶ 0065, ¶ 0074).
While Sharma does not disclose that the adaptor is used in a blood circuit for an extracorporeal life support system, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The adaptor of Sharma is capable of being used in a blood circuit of an extracorporeal life support system since Sharma discloses the adaptor cab be used with medical devices including a blood pump (¶ 0003) and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Sharma fails to disclose an elastomeric valve positioned in the passageway of the side port spaced away from the hemostasis valve, the elastomeric valve located between the hemostasis valve and the main passageway.
Schock teaches (fig. 1-2) an adaptor (Y-shaped cannula body 10) and thus in the same field of endeavor, the adaptor comprising: a side port (leg 16); and an elastomeric valve (slit portion 46, col. 8, ln. 20-24) positioned in the passageway of the side port (fig. 2), the elastomeric valve configured to be self-closing and prevents blood leakage (col. 8, ln. 51-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptor of Sharma such that it comprises an elastomeric valve positioned in the passageway of the side port, as taught by Schock, in order to prevent blood leakage (Schock col. 8, ln. 51-56).
Further such modification such that the adaptor of Sharma includes the elastomeric valve of Schock results in the elastomeric valve being spaced away from the hemostasis valve, the elastomeric valve located between the hemostasis valve and the main passageway.
Regarding claim 19, as discussed above in claim 18, Sharma in view of Schock disclose an elastomeric valve. Schock further teaches wherein a surface of the elastomeric valve facing the main passageway (primary lumen 40) is flush with the main passageway of the body (fig. 2).
Regarding claim 20, as discussed above in claim 19, Sharma in view of Schock disclose the surface being flush. Schock further teaches wherein the surface of the elastomeric valve is a concave surface having a same radius of curvature as an interior surface (lumen wall 39) of the body defining the main passageway (fig. 2, col. 5, ln. 54-56, the elastomeric valve is integral with the body and thus has the same radius of curvature).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Argentine (Pub. No.: US 2005/0033239 A1) discloses an adaptor having a hemostasis valve and an elastomeric valve. Kim (Pub. No.: US 2020/0338260 A1) discloses an adaptor having a hemostasis valve and an elastomeric valve.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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