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 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.
Claim 75 is 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.
Regarding claim 75, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 71-72, 74-76, 81, and 83 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Forde (WO 2020156666 A1). For ease of discussion, the examiner will be referencing the foreign document of Forde that the examiner provided.
Regarding claim 71, Forde discloses a gas trap device (900 – Fig.9) for medical supply of liquids to a human or animal body, the device comprising:
a chamber (302 – Fig.9),
an inlet port (204 – Fig.9),
a diffuser in the inlet port (“The fluid arriving at the diffuser from the inlet port” – Para [0237]), the diffuser comprising openings for lateral flow into the chamber of fluid relative to an inlet port axis (“fluid arrives via the inlet port and enters the chamber of the apparatus via the diffuser, through the plurality of holes” – Para [0237]),
an outlet port (206 – Fig.9) spaced apart distally from the inlet port (Fig.11 C) and being linked with a conduit (304 – Fig.11 C) within the chamber and the conduit having an opening (306 – Fig.11 C) within the chamber,
a flow diverter (402 – Fig.10) mounted distally of the inlet port and proximally of the conduit (Fig.9), and
a single-use priming port (212 – Fig.9), configured to allow venting of the chamber during priming and to be permanently sealed upon completion of priming (“trapped air may then be expelled from the system via the venting port” – Para [0217]).
Regarding claim 72, Forde discloses the gas trap device as set forth above, wherein the diverter is configured for flow of inlet fluid to change direction through at least 80° from an inlet port axis and then to flow radially through the diffuser openings and the openings have an area of less than half of an area around the axis (Fig.10).
Regarding claim 74, Forde discloses the gas trap device as set forth above, wherein there are in the range of two to four diffuser openings (“the diffuser comprises at least three holes” – Para [0233]).
Regarding claim 75, Forde discloses the gas trap device as set forth above, wherein the diverter is located within the chamber in a region less than 40% from a proximal end of the chamber, and preferably less than 25% from the proximal end of the chamber (Fig.9).
Regarding claim 76, Forde discloses the gas trap device as set forth above, wherein the diverter forms an end surface of the inlet port (Fig.9, Fig.10), forcing inlet fluid to flow through the diffuser openings (“fluid arrives via the inlet port and enters the chamber of the apparatus via the diffuser, through the plurality of holes” – Para [0237]).
Regarding claim 81, Forde discloses a gas trap device (900 – Fig.9) for medical supply of liquids to a human or animal body, the device comprising:
a spherical-shaped chamber (302 – Fig.11 A) having a proximal inlet side (Shown at 204 – Fig.8) and a distal outlet side (Shown at 206 – Fig.9),
an inlet port (204 – Fig.8),
a diffuser in the inlet port (“The fluid arriving at the diffuser from the inlet port” – Para [0237]), the diffuser comprising openings for lateral flow into the chamber of fluid relative to an inlet port axis (“fluid arrives via the inlet port and enters the chamber of the apparatus via the diffuser, through the plurality of holes” – Para [0237]),
an outlet port (206 – Fig.9) spaced apart distally from the inlet port (Fig.11 C) and being linked with a conduit (304 – Fig.11 C) within the chamber and the conduit having an opening (306 – Fig.11 C) within the chamber,
a flow diverter (402 – Fig.10) mounted distally of the inlet port and proximally of the conduit (Fig.9), and
a single-use priming port (212 – Fig.9), configured to allow venting of the chamber during priming, disposed at the proximal inlet side of the chamber (“trapped air may then be expelled from the system via the venting port” – Para [0217]).
Regarding claim 83, Forde discloses the gas trap device as set forth above, wherein the priming port is proximal to the diffuser (Fig.9).
Claim Rejections - 35 USC § 103
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 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 73 is rejected under 35 U.S.C. 103 as being unpatentable over Forde.
Regarding claim 73, Forde discloses the gas trap device as set forth above, but Forde does not disclose wherein the diffuser openings have an area which is in the range of 20% to 40% of an area around the inlet axis.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify wherein the diffuser openings having an area which is in the range of 20% to 40% of an area around the inlet axis since it has been held that mere changes in size/proportion are obvious, MPEP 2144.04 IV A. the Federal Circuit held that, where the only difference between the prior art and the claims was 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, the claimed device was not patentably distinct from the prior art device. In the instant case, the device of Forde would not operate differently with the claimed size/proportion of the diffuser openings. Further, applicant places no criticality on the size/proportion claimed, indicating simply, “In one example, the openings have an area which is in the range of 20% to 40% of an area around the inlet port axis” (Para [0053]).
Claims 77-80 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Forde in view of Vazales et al. (US Pub No. 20130104884 A1, herein, Vazales).
Regarding claim 77, Forde discloses the gas trap device as set forth above, wherein the priming port comprises a body forming a vent opening (212 – Fig.9), but Forde does not expressly disclose wherein the priming port comprises a cap.
Vazales teaches a priming port (132 – Fig.3B) comprising a cap (135 – Fig.3B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the priming port of Forde to comprise a cap as taught by Vazales since Vazales teaches that a cap provides a safety or backup seal (Vazales, Para [0070]).
Regarding claim 78, Forde discloses the gas trap device as set forth above, but Forde does not expressly disclose wherein the cap and the vent opening have inter-engaging features, which are engageable by pushing the cap into the vent opening.
Vazales teaches a cap (135 – Fig.3B) and a vent opening (132 – Fig.3B) have inter-engaging features, which are engageable by pushing the cap into the vent opening (See annotated Fig.3B below).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the cap and the vent opening of Forde to comprise inter-engaging features as taught by Vazales since Vazales teaches that a vent and a cap having inter-engaging features is a known coupling method to tether a cap to a port (Vazales, Para [0070]).
Regarding claim 79, Forde discloses the gas trap device as set forth above, but Forde does not expressly disclose wherein the cap and the vent opening comprise inter-engaging ridge and groove.
Vazales teaches a cap (135 – Fig.3B) and a vent opening (132 – Fig.3B) comprising an inter-engaging ridge and a groove (See annotated Fig.3B above).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the cap and the vent opening of Forde to comprise an inter-engaging ridge and groove as taught by Vazales since Vazales teaches that a vent and a cap having an inter-engaging ridge and groove is a known coupling method to tether a cap to a port (Vazales, Para [0070]).
Regarding claim 80, Forde discloses the gas trap device as set forth above, but Forde does not disclose wherein the cap has a curved exposed surface.
Vazales teaches a cap (134 – Fig.3B) having a curved exposed surface (Fig.3B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the cap of Forde to have a curved exposed surface as taught by Vazales since Vazales teaches a cap having a curved exposed surface is a known shape for a cap (Vazales, Para [0147]).
Regarding claim 85, Forde discloses the gas trap device as set forth above, wherein the priming port comprises a body forming a vent opening (212 – Fig.9), but Forde does not expressly disclose wherein the priming port comprises a cap.
Vazales teaches a priming port (132 – Fig.3B) comprising a cap (135 – Fig.3B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the priming port of Forde to comprise a cap as taught by Vazales since Vazales teaches that a cap provides a safety or backup seal (Vazales, Para [0070]).
Claims 82 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Forde in view of Block (US Patent No. 5830185 A).
Regarding claim 82, Forde discloses the gas trap device as set forth above, but Forde does not disclose wherein the priming port is disposed adjacent the inlet port.
Block teaches a priming port (66 – Fig.2) disposed adjacent an inlet port (90 – Fig.2).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the priming port of Forde to be adjacent of the inlet port as taught by Block since Block teaches that having a priming port disposed adjacent to the inlet port is a well-known position for a priming port.
Regarding claim 84, Forde discloses the gas trap device as set forth above, comprising a priming port connector (Shown at 212 – Fig.9) but Forde does not disclose wherein the priming port connector extends parallel to the inlet port.
Block teaches a priming port connector(66 – Fig.2) extending parallel to the inlet port (90 – Fig.2).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the priming port connector of Forde to extend parallel to the inlet port as taught by Block since Block teaches that having a priming port connector extending parallel to the inlet port is a well-known position for a priming port connector.
Claims 86-88 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Forde in view of Bormann et al. (US Patent No. 6336916 B1, herein, Bormann).
Regarding claim 86, Forde discloses a method of use of a gas trap device (900 – Fig.9) comprising a chamber (302 – Fig.8), an inlet port (204 – Fig.8), an outlet port (206 – Fig.9) spaced apart distally from the inlet port (Fig.11 C), a flow diverter (402 – Fig.10) within the chamber at a distal end of the inlet port (Fig.9), and a priming port (212 – Fig.9), the method comprising:
allowing flow of a fluid into the chamber to cause the chamber to fill with the priming fluid (“fluid arrives via the inlet port and enters the chamber “ – Para [0237]) and expel gas from the chamber, via the priming port (“trapped air may then be expelled from the system via the venting port” – Para [0217]), and allowing a fluid to flow through the gas trap device (“Fluid, that is now substantially free from bubbles, collects between the diverter and the intake end of the elongated exit tube” – Para [0237]).
However, Forde does not expressly disclose a priming fluid and closing the priming port after expelling the gas.
Bormann teaches a priming fluid (“a first fluid, e.g., a non-biological fluid such as saline” – Col. 3, lines 56-57) and closing the priming port (3 – Fig.1) after expelling the gas (“gas passes along channels 24 and 27 through port 4 to gas passageway 5 to more efficiently vent the device” – Col. 10, lines 32-33, “the vent is sealed” – Col. 10, line 45).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the fluid and the method of Forde to be a prime fluid and to close the priming port after expelling the gas as taught by Bormann since using priming fluid ensures safety to the patient without complications and closing the priming port after expelling gas, prevents gas exterior to the device from entering the device (Bormann, Col. 10, lines 46-47).
Regarding claim 87, Forde, as modified above, discloses wherein the priming fluid is saline (Bormann, “a first fluid, e.g., a non-biological fluid such as saline” – Col. 3, lines 56-57).
Regarding claim 88, Forde, as modified above, does not expressly disclose wherein either the priming port or the outlet port is closed and the priming fluid is allowed to flow through the inlet port until it fills the chamber, upon which the priming port is sealed and flow is prevented through the inlet until the outlet is opened.
Bormann teaches wherein either a priming port or an outlet port (2 – Fig.1) is closed (“fluid flow path downstream of the device remains closed” – Col. 10, lines 22-23) and a priming fluid is allowed to flow through the inlet port (1 – Fig.1) until it fills the chamber (20 – Fig.1)(“second chamber fills with liquid” – Col. 10, lines 23-24), upon which the priming port (3 – Fig.1) is sealed (“the vent is sealed” – Col. 10, line 45) and flow is prevented through the inlet until the outlet is opened.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the method of Forde wherein an outlet port is closed, and a priming fluid fills the chamber, upon which the priming port is sealed as taught by Bormann since using priming fluid ensures safety to the patient without complications and closing the priming port after expelling gas, prevents gas exterior to the device from entering the device (Bormann, Col. 10, lines 46-47).
Regarding claim 90, Forde, as modified above, discloses wherein entrained air from the device attached to an IV line (100 – Fig.1) is expelled during priming (“trapped air may then be expelled from the system via the venting port” – Para [0217]).
Allowable Subject Matter
Claim 89 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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