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 Group I (Claims 1 – 14) in the reply filed on 17 March 2026 is acknowledged.
Claims 15 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 March 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
150 as recited in [0036].
206 as recited in [0041].
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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
206A as shown in Fig. 2.
206B as shown in Fig. 2.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The disclosure is objected to because of the following informalities:
[0036] recites “The patient 100 may move again, such as laying down in bed that induces a pressure drop causing the pressure to fall, which may lower the patient for a second adjusted position150C, which corresponds to a level 152C, which introduces an error 170 representing a hydrostatic pressure error from the level 150.” The Examiner suggests amending this sentence to recite “The patient 100 may move again, such as laying down in bed that induces a pressure drop causing the pressure to fall, which may lower the patient for a second adjusted position150C, which corresponds to a level 152C, which introduces an error 170 representing a hydrostatic pressure error from the level [[150]] 152C” to correct the reference numeral referred to as the level.
Appropriate correction is required.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
Claim 1 recites “a IV fluid output connector.” The Examiner suggests amending this to recite “an IV fluid output connector” to improve the grammar of the claim language.
Claim 1 recites “a IV fluid input connector connected the first chamber.” The Examiner suggests amending this to recite “an IV fluid input connector connected to the first chamber” to improve the clarity of the claim language.
Claim 8 recites “IV fluid input connector connected the first chamber.” The Examiner suggests amending this to recite “IV fluid input connector connected to the first chamber” to improve the clarity of the claim language.
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.
Claim(s) 4 – 6 and 8 – 14 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.
Claim 4 recites “wherein the external membrane is in fluid contact with IV fluid.” It is unclear if this claim language is positively reciting the IV fluid or if this claim language is further limiting the functional claim language of Claim 1 (i.e., every recitation of “IV fluid” in Claim 1 is recited within a “configured for…” clause). Additionally, there is insufficient antecedent basis for the limitation “with IV fluid” in the claim because it cannot be determined if this is a positive recitation of IV fluid or if this is further limiting the functional claim language of Claim 1. Therefore Claim 4 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 5 recites “the IV fluid are the same fluid.” It is unclear if this claim language is positively reciting the IV fluid or if this claim language is further limiting the functional claim language of Claim 1 (i.e., every recitation of “IV fluid” in Claim 1 is recited within a “configured for…” clause). Therefore Claim 5 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 6 recites “the IV fluid are not the same fluid.” It is unclear if this claim language is positively reciting the IV fluid or if this claim language is further limiting the functional claim language of Claim 1 (i.e., every recitation of “IV fluid” in Claim 1 is recited within a “configured for…” clause). Therefore Claim 6 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 8 recites “a hemodynamic monitor electrically connected to a differential pressure sensor of a transducer” and “a differential pressure sensor in the second chamber.” It is unclear if the second recitation of “a differential pressure sensor” is referring to the first recitation of the differential pressure sensor. Therefore Claim 8 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 8 recites “an IV fluid bag connected to an IV fluid input connector of the transducer; a patient IV fluid tube connected to the IV fluid output connector of the transducer…a IV fluid output connector connected to the first chamber; a IV fluid input connector…”. The second recitation of “a IV fluid input connector” creates confusion because it is unclear if this recitation is referring to the first recitation of “an IV fluid input connector” or a separate IV fluid input connector. Additionally, the recitation of “the IV fluid output connector” lacks antecedent basis. The recitation of “a IV fluid output connector” is also unclear because it cannot be determined if this recitation is referring to the previously recited “the IV fluid output connector” or a separate IV fluid output connector. Therefore Claim 8 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 9 – 14 are dependent upon Claim 8 and are therefore rejected for the same reasons as Claim 8 under 35 U.S.C. § 112(b).
Claim 11 recites “wherein the external membrane is in fluid contact with IV fluid.” It is unclear if this claim language is positively reciting the IV fluid or if this claim language is further limiting the functional claim language of Claim 8 (i.e., every recitation of “IV fluid” in Claim 8 is recited within a “configured for…” clause and the recited “IV fluid bag” is not recited to contain an IV fluid). Additionally, there is insufficient antecedent basis for the limitation “with IV fluid” in the claim because it cannot be determined if this is a positive recitation of IV fluid or if this is further limiting the functional claim language of Claim 1. Therefore Claim 11 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 12 recites “the IV fluid are the same fluid.” It is unclear if this claim language is positively reciting the IV fluid or if this claim language is further limiting the functional claim language of Claim 8 (i.e., every recitation of “IV fluid” in Claim 8 is recited within a “configured for…” clause and the recited “IV fluid bag” is not recited to contain an IV fluid). Therefore Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 13 recites “the IV fluid are not the same fluid.” It is unclear if this claim language is positively reciting the IV fluid or if this claim language is further limiting the functional claim language of Claim 8 (i.e., every recitation of “IV fluid” in Claim 8 is recited within a “configured for…” clause and the recited “IV fluid bag” is not recited to contain an IV fluid). Therefore Claim 13 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
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(s) 1, 5, 6, 8, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams (US 5,098,384 A) and Dlugos et al. (US 7,927,270 B2; hereinafter referred to as “Dlugos”).
With regards to claim 1, Abrams discloses (see Fig. 2) a transducer (40) (see Col. 5, lines 30 – 34) comprising:
a first chamber (50) and a second chamber (51) (see Col. 5, lines 35 – 44), wherein the first chamber and the second chamber share a first chamber wall (see at 49 in Fig. 2) that separates the first chamber and the second chamber (see Col. 5, lines 35 – 44 “Pressure sensor 49 separates two chambers 50 and 51.”);
a IV fluid output connector (see Examiner annotated Fig. 2 below; hereinafter referred to as “Fig. A”) connected to the first chamber (see Fig. 2);
a IV fluid input connector (see Fig. A below) connected the first chamber, wherein the first chamber is configured for an IV fluid to flow from the IV fluid input connector to the IV fluid output connector (see Col. 5, lines 30 – 34 and Fig. 2);
a differential pressure sensor (49) (see Col. 5, lines 21 – 44) configured to generate an electrical signal (see Abstract, Col. 4, lines 26 – 47, and Col. 5, lines 21 – 44), wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber (see Fig. 2 and Col. 4, lines 30 – 34), wherein the differential pressure sensor is in fluidic communication with a reference fluid in the second chamber (see Fig. 2 and see Col. 5, lines 35 – 58), and wherein the electrical signal is configured to be generated based at least on a difference in pressure between an IV fluid in the first chamber and the reference fluid in the second chamber (see Abstract, Col. 4, lines 26 – 47, Col. 5, lines 21 – 44, and Claim 2).
a reference tube (53) (see Col. 5, lines 35 – 44) with a first end (see Fig. A below) and a second end (see Fig. A below), wherein the first end of the reference tube is fluidically connected to the second chamber (see Fig. 2), wherein the second end of the reference tube is connected to a membrane (see Col. 6, lines 13 – 27 “the proximal end of the pressure compensating tube (second column) may be attached to the chest wall of a patient, illustratively, by means of a suction cup nipple frequently used for EKG readings and by clamping the proximal end of the tube to the nipple” wherein the suction cup nipple is the membrane) configured to be attached to a patient, and wherein the second chamber and the reference tube are filled with the reference fluid (see Col. 5, lines 35 – 58).
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However Abrams is silent with regards to:
an opening in the shared first chamber wall;
the differential pressure sensor being in the second chamber, and
wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber via the opening in the first chamber wall.
Nonetheless Dlugos, which is within the analogous art of external mechanical pressure sensors (see abstract), teaches (see Fig. 7) an opening (see Examiner annotated Fig. 7 below hereinafter referred to as “Fig. B”) in the shared first chamber wall (see Fig. B below);
a differential pressure sensor (428) in the second chamber (see Fig. B below) configured to generate an electrical signal (see Col. 4, line 37 – Col. 5, line 6 “ pressure readings obtained by pressure sensor 426 along cable 422”), wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber via the opening in the first chamber wall (see Col. 5, lines 7 – 20 and Col. 5, line 62 – Col. 6, line 3).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first chamber, second chamber, and differential pressure sensor of the transducer of Abrams in view of a teaching of Dlugos such that an opening in the shared first chamber wall; the differential pressure sensor being in the second chamber, and wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber via the opening in the first chamber wall. One of ordinary skill in the art would have been motivated to make this modification because Dlugos teaches that this structural relationship of the first chamber, second chamber and differential pressure sensor allows for the pressure sensor to be secured to the second chamber of the transducer while allowing for fluid communication with a fluid through the opening. One of ordinary skill in the art would also be motivated to make this modification because providing a wall upon which the sensor can be secured to provides for more structural support than the wall being the sensor itself. Therefore, when fluid enters either the first or second chamber the sensor is not as easily dislodged because it has a structural wall supporting it.
The transducer of Abrams modified in view of Dlugos will hereinafter be referred to as the transducer of Abrams and Dlugos.
With regards to claim 5, the transducer of Abrams and Dlugos teaches the claimed invention of claim 1, and Abrams further teaches wherein the reference fluid and the IV fluid are the same fluid (see the 35 U.S.C. § 112(b) rejection above) (the language “wherein the reference fluid and the IV fluid are the same fluid” constitutes functional claim language because it further limits the functional claim language of Claim 1. Claimed devices need only to be capable of being used in a manner that meets the functional claim limitation. MPEP 2173.05(g). The claim is also an apparatus claim and is limited by the positively recited structure of the apparatus. MPEP 2114. The Office submits that the transducer of Abrams and Dlugos meets the structural limitations of the claim wherein the reference fluid and IV fluid configured for use inside the transducer can be the same fluid. Abrams describes the reference fluid and IV fluid being the same fluid in Col. 5, lines 21 – 58 because the IV fluid flows from the IV bag through tube 46 into chamber 50 to stopcock valve 60 up to chamber 51 to flush air out.).
With regards to claim 6, the transducer of Abrams and Dlugos teaches the claimed invention of claim 1, and Abrams further teaches wherein the reference fluid and the IV fluid are not the same fluid (see the 35 U.S.C. § 112(b) rejection above) (the language “wherein the reference fluid and the IV fluid are not the same fluid” constitutes functional claim language because it further limits the functional claim language of Claim 1. Claimed devices need only to be capable of being used in a manner that meets the functional claim limitation. MPEP 2173.05(g). The claim is also an apparatus claim and is limited by the positively recited structure of the apparatus. MPEP 2114. The Office submits that the transducer of Abrams and Dlugos meets the structural limitations of the claim wherein the reference fluid and IV fluid configured for use inside the transducer can be different fluids. Abrams describes the reference fluid and IV fluid in Col. 5, lines 21 – 58. Since the reference tube is open to air, a user could adjust the reference fluid such that it is a different fluid by adding a different fluid to the reference tube.)
With regards to claim 8, Abrams discloses (Fig. 2) a system (see Fig. 2) comprising:
a hemodynamic monitor (25) (Col. 5, lines 5 – 20 and Claim 2 “A pressure sensing system…including electronic display means, said sensing device being connected to said display means for providing an indication of the pressure of fluid in said first column”) electrically connected to a differential pressure sensor (49) (see Col. 5, lines 21 – 44) of a transducer (40) (see Col. 5, lines 30 – 34);
an IV fluid bag (41) (see Col. 5, lines 30 – 34) connected to an IV fluid input connector of the transducer (see Fig. A reiterated below);
a patient IV fluid tube (see the tube at the annotated IV fluid output connector in Fig. A reiterated below) connected to the IV fluid output connector of the transducer (see Fig. A reiterated below); and
wherein the transducer comprises:
a first chamber (50) and a second chamber (51) (see Col. 5, lines 35 – 44), wherein the first chamber and the second chamber share a first chamber wall (see at 49 in Fig. 2) that separates the first chamber and the second chamber;
a IV fluid output connector connected to the first chamber (see Fig. A reiterated below);
a IV fluid input connector connected the first chamber (see Fig. A reiterated below), wherein the first chamber is configured for an IV fluid to flow from the IV fluid input connector to the IV fluid output connector (see Col. 5, lines 30 – 34 and Fig. 2);
a differential pressure sensor (49) (see Col. 5, lines 21 – 44) configured to generate an electrical signal (see Abstract, Col. 4, lines 26 – 47, Col. 5, lines 21 – 44 and Claim 2), wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber in the first chamber wall (see Fig. 2 and Col. 4, lines 30 – 34), wherein the differential pressure sensor is in fluidic communication with a reference fluid in the second chamber (see Fig. 2 and see Col. 5, lines 35 – 58), and wherein the electrical signal is configured to be generated based at least on a difference in pressure between an IV fluid in the first chamber and the reference fluid in the second chamber (see Abstract, Col. 4, lines 26 – 47, and Col. 5, lines 21 – 44); and
a reference tube (53) (see Col. 5, lines 35 – 44) with a first end (see Fig. A reiterated below) and a second end (see Fig. A reiterated below), wherein the first end of the reference tube is fluidically connected to the second chamber (see Fig. 2), wherein the second end of the reference tube is connected to a membrane (see Col. 6, lines 13 – 27 “the proximal end of the pressure compensating tube (second column) may be attached to the chest wall of a patient, illustratively, by means of a suction cup nipple frequently used for EKG readings and by clamping the proximal end of the tube to the nipple” wherein the suction cup nipple is the membrane) configured to be attached to a patient, and wherein the second chamber and the reference tube are filled with the reference fluid (see Col. 5, lines 35 – 58).
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However Abrams is silent with regards to:
the transducer comprising:
an opening in the shared first chamber wall;
the differential pressure sensor being in the second chamber; and
wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber via the opening in the first chamber wall.
Nonetheless Dlugos, which is within the analogous art of external mechanical pressure sensors (see abstract), teaches (see Fig. 7) an opening (see Fig. B reiterated below) in the shared first chamber wall (see Fig. B reiterated below);
a differential pressure sensor (428) in the second chamber (see Fig. B reiterated below) configured to generate an electrical signal (see Col. 4, line 37 – Col. 5, line 6 “ pressure readings obtained by pressure sensor 426 along cable 422”), wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber via the opening in the first chamber wall (see Col. 5, lines 7 – 20 and Col. 5, line 62 – Col. 6, line 3).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first chamber, second chamber, and differential pressure sensor of the transducer of the system of Abrams in view of a teaching of Dlugos such that an opening in the shared first chamber wall; the differential pressure sensor being in the second chamber, and wherein the differential pressure sensor is configured to be in fluidic communication with an IV fluid in the first chamber via the opening in the first chamber wall. One of ordinary skill in the art would have been motivated to make this modification because Dlugos teaches that this structural relationship of the first chamber, second chamber and differential pressure sensor allows for the pressure sensor to be secured to the second chamber of the transducer while allowing for fluid communication with a fluid through the opening. One of ordinary skill in the art would also be motivated to make this modification because providing a wall upon which the sensor can be secured to provides for more structural support than the wall being the sensor itself. Therefore, when fluid enters either the first or second chamber the sensor is not as easily dislodged because it has a structural wall supporting it.
The system of Abrams modified in view of a teaching of Dlugos will hereinafter be referred to as the system of Abrams and Dlugos.
With regards to claim 12, the system of Abrams and Dlugos teaches the claimed invention of claim 8, and Abrams further teaches wherein the reference fluid and the IV fluid are the same fluid (see the 35 U.S.C. § 112(b) rejection above) (the language “wherein the reference fluid and the IV fluid are the same fluid” constitutes functional claim language because it further limits the functional claim language of Claim 1. Claimed devices need only to be capable of being used in a manner that meets the functional claim limitation. MPEP 2173.05(g). The claim is also an apparatus claim and is limited by the positively recited structure of the apparatus. MPEP 2114. The Office submits that the transducer of Abrams and Dlugos meets the structural limitations of the claim wherein the reference fluid and IV fluid configured for use inside the transducer can be the same fluid. Abrams describes the reference fluid and IV fluid being the same fluid in Col. 5, lines 21 – 58 because the IV fluid flows from the IV bag through tube 46 into chamber 50 to stopcock valve 60 up to chamber 51 to flush air out.).
With regards to claim 13, the system of Abrams and Dlugos teaches the claimed invention of claim 8, and Abrams further teaches wherein the reference fluid and the IV fluid are not the same fluid (see the 35 U.S.C. § 112(b) rejection above) (the language “wherein the reference fluid and the IV fluid are not the same fluid” constitutes functional claim language because it further limits the functional claim language of Claim 1. Claimed devices need only to be capable of being used in a manner that meets the functional claim limitation. MPEP 2173.05(g). The claim is also an apparatus claim and is limited by the positively recited structure of the apparatus. MPEP 2114. The Office submits that the transducer of Abrams and Dlugos meets the structural limitations of the claim wherein the reference fluid and IV fluid configured for use inside the transducer can be different fluids. Abrams describes the reference fluid and IV fluid in Col. 5, lines 21 – 58. Since the reference tube is open to air, a user could adjust the reference fluid such that it is a different fluid by adding a different fluid to the reference tube.)
Claim(s) 2 – 3 and 9 – 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams and Dlugos as applied to claims 1 and 8 above, and further in view of Lalomia et al. (US 2007/0135779 A1; hereinafter referred to as “Lalomia”).
With regards to claim 2, the transducer of Abrams and Dlugos teaches the claimed invention of claim 1, however, Abrams is silent with regards to wherein the electrical signal is an analog signal.
Nonetheless Lalomia, which is within the analogous art of differential pressure sensors (see [0225]), teaches wherein the electrical signal is an analog signal (see [0225] “The differential pressure sensor may be an analog-type, providing a number representing the differential pressure, or a switch, which provides a digital signal when the differential pressure reaches the predetermined level.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electrical signal of the transducer of Abrams and Dlugos in view of a teaching of Lalomia such that the electrical signal is an analog signal. One of ordinary skill in the art would have been motivated to make this modification because Lalomia teaches that the electrical signal generated by the differential pressure sensor may be a variety of types. Here, the analog signal provides a number representing the differential pressure which is readily understandable by the user.
With regards to claim 3, the transducer of Abrams and Dlugos teaches the claimed invention of claim 1, however, Abrams is silent with regards to wherein the electrical signal is a digital signal.
Nonetheless Lalomia, which is within the analogous art of differential pressure sensors (see [0225]), teaches with regards to wherein the electrical signal is a digital signal (see [0225] “The differential pressure sensor may be an analog-type, providing a number representing the differential pressure, or a switch, which provides a digital signal when the differential pressure reaches the predetermined level.”)..
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electrical signal of the transducer of Abrams and Dlugos in view of a teaching of Lalomia such that the electrical signal is a digital signal. One of ordinary skill in the art would have been motivated to make this modification because Lalomia teaches that the electrical signal generated by the differential pressure sensor may be a variety of types. Here, the digital signal is a switch alerting a user when the differential pressure reaches the predetermined level which is easily understandable.
With regards to claim 9, the system of Abrams and Dlugos teaches the claimed invention of claim 8, however, Abrams is silent with regards to wherein the electrical signal is an analog signal.
Nonetheless Lalomia, which is within the analogous art of differential pressure sensors (see [0225]), teaches wherein the electrical signal is an analog signal (see [0225] “The differential pressure sensor may be an analog-type, providing a number representing the differential pressure, or a switch, which provides a digital signal when the differential pressure reaches the predetermined level.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electrical signal of the transducer of the system of Abrams and Dlugos in view of a teaching of Lalomia such that the electrical signal is an analog signal. One of ordinary skill in the art would have been motivated to make this modification because Lalomia teaches that the electrical signal generated by the differential pressure sensor may be a variety of types. Here, the analog signal provides a number representing the differential pressure which is readily understandable by the user.
With regards to claim 10, the system of Abrams and Dlugos teaches the claimed invention of claim 8, however, Abrams is silent with regards to wherein the electrical signal is a digital signal.
Nonetheless Lalomia, which is within the analogous art of differential pressure sensors (see [0225]), teaches with regards to wherein the electrical signal is a digital signal (see [0225] “The differential pressure sensor may be an analog-type, providing a number representing the differential pressure, or a switch, which provides a digital signal when the differential pressure reaches the predetermined level.”)..
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electrical signal of the transducer of the system of Abrams and Dlugos in view of a teaching of Lalomia such that the electrical signal is a digital signal. One of ordinary skill in the art would have been motivated to make this modification because Lalomia teaches that the electrical signal generated by the differential pressure sensor may be a variety of types. Here, the digital signal is a switch alerting a user when the differential pressure reaches the predetermined level which is easily understandable.
Claim(s) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams and Dlugos as applied to claims 1 and 8 above, and further in view of Riley et al. (US 2013/0255390 A1; hereinafter referred to as “Riley”).
With regards to claim 4, the transducer of Abrams and Dlugos teaches the claimed invention of claim 1, however, Abrams is silent with regards to wherein the differential pressure sensor comprises an external membrane, wherein the external membrane is in fluid contact with IV fluid.
Nonetheless Riley, which is within the analogous art of high pressure sensors for use with a fluid delivery system (see title and abstract), teaches the differential pressure sensor comprises an external membrane, wherein the external membrane is in fluid contact with IV fluid (see [0053] “The pressure sensor 50a may be a disposable, one-time-use device or may be reusable, as discussed above, if contamination between the pressure sensor 50a and patient fluid is sufficiently limited or prevented by some means, such as by use of a protective membrane or similar structure.” Here the protective membrane is the external membrane.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the differential pressure sensor of the transducer of Abrams and Dlugos in view of a teaching of Riley such that the differential pressure sensor comprises an external membrane, wherein the external membrane is in fluid contact with IV fluid. One of ordinary skill in the art would have been motivated to make this modification because Riley teaches that the protective membrane allows for the pressure sensor to be reusable (see [0053] of Riley).
With regards to claim 11, the system of Abrams and Dlugos teaches the claimed invention of claim 8, however, Abrams is silent with regards to wherein the differential pressure sensor comprises an external membrane, wherein the external membrane is in fluid contact with IV fluid.
Nonetheless Riley, which is within the analogous art of high pressure sensors for use with a fluid delivery system (see title and abstract), teaches the differential pressure sensor comprises an external membrane, wherein the external membrane is in fluid contact with IV fluid (see [0053] “The pressure sensor 50a may be a disposable, one-time-use device or may be reusable, as discussed above, if contamination between the pressure sensor 50a and patient fluid is sufficiently limited or prevented by some means, such as by use of a protective membrane or similar structure.” Here the protective membrane is the external membrane.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the differential pressure sensor of the transducer of the system of Abrams and Dlugos in view of a teaching of Riley such that the differential pressure sensor comprises an external membrane, wherein the external membrane is in fluid contact with IV fluid. One of ordinary skill in the art would have been motivated to make this modification because Riley teaches that the protective membrane allows for the pressure sensor to be reusable (see [0053] of Riley).
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams and Dlugos as applied to claims 1 and 8 above, and further in view of Hopping et al. (US 2009/0299272 A1; hereinafter referred to as “Hopping”).
With regards to claim 7, the transducer of Abrams and Dlugos teaches the claimed invention of claim 1, and Abrams teaches wherein the first chamber (50) (see Col. 5, lines 35 – 44) and the second chamber (51) (see Col. 5, lines 35 – 44) are located inside a transducer housing (see at 50, 51 in Fig. 2).
However Abrams is silent with regards to wherein an exterior wall of the transducer housing includes an identifier configured to be optically recognized, and wherein the identifier is associated with the reference fluid.
Nonetheless Hopping, which is within the analogous art of medical connectors (see Fig. 6 and [0049]), teaches an exterior wall of the transducer housing (see at 78 in Fig. 6) includes an identifier (see [0049] and the disclosed bar code) configured to be optically recognized (see [0049] “Connector 78 is fitted with an identification tag, such as a bar code or radio frequency identifier ("RFID") tag.”), and wherein the identifier is associated with the reference fluid (see Fig. 6 which recites “Membrane Port connector with RFID Chip (same as Fresh Solution Bags)” and [0051] which recites “The RFID or other type of identification tag allows for automatic touch-free connection and automatic machine recognition.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the exterior wall of the transducer housing of the transducer of Abrams and Dlugos in view of a teaching of Hopping such that an exterior wall of the transducer housing includes an identifier configured to be optically recognized, and wherein the identifier is associated with the reference fluid. One of ordinary skill in the art would have been motivated to make this modification because Hopping teaches that this identification tag allows for automatic machine recognition to ensure proper connection of the fluid with the other portions of the device (see [0051] of Hopping). Here, the identifier included on the exterior wall of the transducer housing would be associated with the reference fluid when the reference fluid is the same as the IV fluid. This would be the case because Figure 6 and [0051] teaches that the identifier can indicate that the connector is coupled to fresh solution bags.
With regards to claim 14, the transducer of Abrams and Dlugos teaches the claimed invention of claim 8, and Abrams teaches wherein the first chamber (50) (see Col. 5, lines 35 – 44) and the second chamber (51) (see Col. 5, lines 35 – 44) are located inside a transducer housing (see at 50, 51 in Fig. 2).
However Abrams is silent with regards to wherein an exterior wall of the transducer housing includes an identifier configured to be optically recognized, and wherein the identifier is associated with the reference fluid.
Nonetheless Hopping, which is within the analogous art of medical connectors (see Fig. 6 and [0049]), teaches an exterior wall of the transducer housing (see at 78 in Fig. 6) includes an identifier (see [0049] and the disclosed bar code) configured to be optically recognized (see [0049] “Connector 78 is fitted with an identification tag, such as a bar code or radio frequency identifier ("RFID") tag.”), and wherein the identifier is associated with the reference fluid (see Fig. 6 which recites “Membrane Port connector with RFID Chip (same as Fresh Solution Bags)” and [0051] which recites “The RFID or other type of identification tag allows for automatic touch-free connection and automatic machine recognition.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the exterior wall of the transducer housing of the transducer of the system of Abrams and Dlugos in view of a teaching of Hopping such that an exterior wall of the transducer housing includes an identifier configured to be optically recognized, and wherein the identifier is associated with the reference fluid. One of ordinary skill in the art would have been motivated to make this modification because Hopping teaches that this identification tag allows for automatic machine recognition to ensure proper connection of the fluid with the other portions of the device (see [0051] of Hopping). Here, the identifier included on the exterior wall of the transducer housing would be associated with the reference fluid when the reference fluid is the same as the IV fluid. This would be the case because Figure 6 and [0051] teaches that the identifier can indicate that the connector is coupled to fresh solution bags.
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 04/20/2026
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