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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 8, 2025, has been entered.
Acknowledgments
In the reply, filed on December 8, 2025, Applicant amended claims 5 and 18.
Applicant cancelled claim 8.
In the final rejection of September 8, 2025, Examiner objected to claim 18. Applicant amended claim 18. Objection is withdrawn.
Examiner rejected claims 5, 7-8, 10, 13-16, and 18-20 under 35 U.S.C. 112(a). Applicant amended claims 5 and 18. Rejection is withdrawn.
Examiner rejected claims 18-20 under 35 U.S.C. 112(b). Applicant amended claim 18. Rejection is withdrawn.
Currently, claims 5, 7, 10, 13-16, and 18-20 are under examination.
Claim Objections
Claims 5 and 18 are objected to because of the following informalities:
In regards to claim 5, line 5, “the environment” should be changed to “an environment”.
In regards to claim 18, line 5, “the environment” should be changed to “an environment”.
Appropriate correction is required.
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 5, 7, 10, 13-16, and 18-20 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 regards to claim 5, lines 3-5 recite: an air vent between “the chamber volume the environment”. It is unclear what is meant by the term “the chamber volume the environment” as there may be terms missing between “the chamber volume” and “the environment”. Claims 7, 10, and 13-16 are rejected by virtue of being dependent upon claim 5.
In regards to claim 18, lines 4-5 recite: the chamber body comprising “an air vent the environment”. It is unclear what is meant by the term “an air vent the environment” as there may be terms missing between “an air vent” and “the environment”. Claims 19-20 are rejected by virtue of being dependent upon claim 18.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Darling (US 5,730,730).
In regards to claim 18, Darling teaches a method to control fluid flow through a drip chamber (10), the method comprising:
providing a chamber body (30) defining a chamber volume (60), a spike (46), and an inlet tube (138), the chamber body comprising an air vent (90) the environment, and the chamber volume configured to receive the fluid flow from the inlet tube (Figure 3)
providing a valve body (104) coupled to the chamber body via a chamber body coupling of the valve body, wherein the valve body is disposed as a chamber body outlet such that a fluid from the chamber volume can enter a valve inlet (100) of the valve body (Figure 3)
wherein the valve body comprises a frustoconical movable needle valve surface (108) movable between a first position radially closer to a frustoconical fixed needle valve surface (flow path between channels 100 and 102) and decreasing a cross-sectional area of a flow path defined by the frustoconical fixed needle valve surface and the frustoconical movable needle valve surface between the valve inlet and a valve outlet (102) both extending through the frustoconical fixed needle valve surface (Figure 3), and a second position radially spaced apart from the fixed needle valve surface and increasing the cross-sectional area of the flow path between the valve inlet and the valve outlet (column 7, lines 5-10: tapered section 108 is drawn to the right. This action opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the desired or required flow rate), wherein the frustoconical movable needle valve surface is nested within the frustoconical fixed needle valve surface and the fluid flow passes through the valve inlet and the valve outlet both extending through the frustoconical fixed needle valve surface (Figure 3), wherein the frustoconical movable needle valve surface is movable between the first position and the second position to control the fluid flow out of the valve body (Figure 3)(column 7, lines 5-10: tapered section 108 is drawn to the right. This action opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the desired or required flow rate)
In regards to claim 19, Darling teaches rotating a knob (110) to move the movable needle valve surface relative to the fixed needle valve surface (column 7, lines 4-13: An external control knob 110 connected to a proximal end of shaft 106 enables a user to rotate the shaft so that tapered section 108 is drawn to the right… A fluid flow indicating scale 112 may be provided beneath knob 110 to indicate, according to the rotational position of the knob).
In regards to claim 20, Darling teaches axially moving a knob to move the movable needle valve surface relative to the fixed needle valve surface (column 7, lines 4-6: An external control knob 110 connected to a proximal end of shaft 106 enables a user to rotate the shaft so that tapered section 108 is drawn to the right).
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 5, 7, 10, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Darling.
In regards to claim 5, Darling teaches a drip chamber (Figures 1-4) comprising:
a chamber body (30) defining a chamber volume (60), the chamber body comprising a spike (46), an inlet tube (138), and an air vent (90) between the chamber volume the environment
a valve body (104) coupled to the chamber body, the valve body comprising:
a chamber body coupling to receive and couple to the chamber body, wherein the valve body is disposed as a chamber body outlet such that a fluid from the chamber volume can enter the valve body (Figure 3)
a valve inlet (100)
a valve outlet (102)
a needle valve assembly comprising:
a fixed needle valve surface (flow path between channels 100 and 102), wherein the fixed needle valve surface is frustoconical, the valve inlet extends through the frustoconical fixed needle valve surface, and the valve outlet extends through the frustoconical fixed needle valve surface (Figure 3)
a movable needle valve surface (108), wherein the movable needle valve surface is frustoconical, nested within the frustoconical fixed needle valve surface (Figure 3), and the movable needle valve surface is axially movable between a first position radially closer to the fixed needle valve surface and decreasing a cross-sectional area of a flow path defined by the frustoconical fixed needle valve surface and the frustoconical movable needle valve surface between the valve inlet and the valve outlet (Figure 3) and a second position radially spaced apart from the fixed needle valve surface and increasing the cross-sectional area of the flow path between the valve inlet and the valve outlet to control a flow rate between the valve inlet and the valve outlet (column 7, lines 5-10: tapered section 108 is drawn to the right. This action opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the desired or required flow rate)
Darling does not teach the inlet tube extending through the spike, as Darling only teaches the inlet tube extending from the spike (Figure 3). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the inlet tube extending from the spike, of the chamber of Darling, to also extend through the spike, as Applicant has not disclosed that such a configuration of the inlet tube with respect to the spike provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the inlet tube only extending from the spike, as taught by Darling, as either configuration of the inlet tube with respect to the spike will provide for the same end result of communicating liquid from the spike to the chamber body.
In regards to claim 7, in the modified chamber of Darling, Darling teaches wherein the spike defines a spike flow path in fluid communication with the chamber volume (Figure 3).
In regards to claim 10, in the modified chamber of Darling, Darling teaches wherein the valve inlet is in fluid communication with the chamber volume (Figure 3).
In regards to claim 13, in the modified chamber of Darling, Darling teaches a movable knob (110), wherein actuating the knob actuates the movable needle valve surface to control the flow rate between the valve inlet and the valve outlet (column 7, lines 4-10: An external control knob 110 connected to a proximal end of shaft 106 enables a user to rotate the shaft so that tapered section 108 is drawn to the right. This action opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the desired or required flow rate).
In regards to claim 14, in the modified chamber of Darling, Darling teaches wherein the movable knob is in threaded engagement with the valve body (Figure 3) and rotating the knob actuates the movable needle valve surface to control the flow rate between the valve inlet and the valve outlet (column 7, lines 4-14: An external control knob 110 connected to a proximal end of shaft 106 enables a user to rotate the shaft so that tapered section 108 is drawn to the right. This action opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the desired or required flow rate. A fluid flow indicating scale 112 may be provided beneath knob 110 to indicate, according to the rotational position of the knob, the precise fluid flow rate through regulating means 66).
In regards to claim 15, in the modified chamber of Darling, Darling teaches wherein the movable knob is axially movable relative to the valve body and axially moving the knob actuates the movable needle valve surface to control the flow rate between the valve inlet and the valve outlet (column 7, lines 4-10: An external control knob 110 connected to a proximal end of shaft 106 enables a user to rotate the shaft so that tapered section 108 is drawn to the right. This action opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the desired or required flow rate).
In regards to claim 16, in the modified chamber of Darling, Darling teaches wherein the movable knob defines the movable needle valve surface (Figure 3).
Response to Arguments
Applicant’s arguments with respect to claims 5, 7, 10, 13-16, and 18-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783