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 .
Claim Objections
Claims 4, 6-7, 11, and 13-14 are objected to because of the following informalities:
Regarding claims 4 and 11, “the back side” should be corrected to “a back side” for claim language consistency.
Regarding claims 6 and 13, “of mechanical compression” should be corrected to “of the mechanical compression” for claim language consistency.
Regarding claim 7, “a sensor frame” should be corrected to “the sensor frame” and “a pin” should be corrected to “the pin” for claim language consistency.
Regarding claim 14, “a pin” should be corrected to “the pin” for claim language consistency.
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 2-4, 9-11, and 13 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.
Regarding claims 2 and 9, the recitation of “in the same plane” renders the claim unclear. First, there is insufficient antecedent basis for this limitation in the claims. Secondly, the Examiner is unsure if “the same plane” being referenced with respect to the compressed state is the same plane as “the same plane” being referenced with respect to the uncompressed state, or a different plane, as proper antecedent basis is not established for the limitation. For purposes of examination, the Examiner is interpreting “the same plane” in both instances to be any plane that traverses the sensor frame.
Regarding claim 13, the limitation of “the bracket is configured to retain energy from mechanical compression of the fluid bag” renders the claim unclear. Based on the specification and drawings, the springs, or biasing members, of the pressure sensor assembly are configured to retain energy from mechanical compression, not the bracket (see [0041] and [0053] & Fig. 4A-4B). The bracket does not “retain energy from mechanical compression of the fluid bag”. For purposes of examination, the Examiner is interpreting the claim to limit the bracket and biasing members, which are coupled to the bracket, of the pressure assembly to be configured to retain energy from mechanical compression of the fluid bag.
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.
Claim(s) 8-12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohnishi (US 5335551 A).
Regarding claim 8, Ohnishi discloses a back-up infusion pressure sensor module (pillow type pressure detector 23 of Fig. 1-8, col 5 third paragraph) for use in an ophthalmic surgical console (“This invention relates to a pressure detector employed for a medical instrument…it is essential that the use of the medical instrument will not adversely affect the patient's body. For this purpose, it is necessary to control the… pressure into the body in such a manner that such pressures are in predetermined, allowable, ranges.”, col 1 lines 5-23; “The pressure detector 23 may be applied to medical instruments, other than the blood processing apparatus 1, and other fluid pressure detecting instruments”, col 10 lines 28-32; detector 23 would be capable of use in an ophthalmic surgical console), the back-up infusion pressure sensor module comprising:
a squeeze plate configured to engage with a fluid bag (flat plate shaped retaining board 45 configured to engage with bag 24a, which is connected to fluid flow, col 6 lines 42-58 and col 7 first paragraph & Fig. 1-8);
a pressure sensor assembly having a first portion and a second portion (load transmitting board 40, which is being interpreted as a first portion, and base board 28, which is being interpreted as a second portion, col 5 line 35-col 6 line 3 & Fig. 1-4), wherein the first portion pivots relative to a pin coupled to the second portion (board 40 configured to pivot relative to pin 42 coupled to protrusion 41 of board 28, col 6 lines 1-8 & Fig. 4) and the pressure sensor assembly is configured to cause at least one portion of the pressure sensor assembly to contact the fluid bag (board 40 configured to contact bag 24a, col 7 line 67-col 8 line 24 & Fig. 2-3), the pressure sensor assembly comprising: a base mounted to a back side of the pressure sensor assembly (stopper 34 mounted to a back side of base board 28, col 5 lines 55-59 & Fig. 3; alternatively, mounting stand 27, which is mounted to a back side of base board 28, may be interpreted as a base, col 5 lines 29-35 & Fig. 1-5); one or more biasing members (spring 33, col 5 lines 55-56 & Fig. 3); a bracket coupled to the one or more biasing members (retaining member 37 connected, or coupled, to spring 33, col 5 line 55-68 and col 9 lines 5-10 & Fig. 1-8); and a force sensor in contact with the bracket and configured to determine a pressure force from the fluid bag (a load cell type load sensor 25 in contact with retaining member 37, col 5 lines 10-27 and col 9 lines 5-10 & Fig. 1-8; sensor 25 configured to detect pressure force from bag 24a, col 8 lines 24-36 and col 9 lines 33-57 & Fig. 9).
Ohnishi discloses that “The load cell type load sensor 25 is commercially available, and it is designed so that the load cell is distorted by a load applied thereto to change the internal resistance. Therefore, by detecting the variation of the electrical output of the load cell, the value of the load can be detected accurately.” (col 5 lines 22-27).
Regarding claim 9, Ohnishi discloses all the limitations of claim 8. Ohnishi further discloses the back-up infusion pressure sensor module wherein the pressure sensor assembly is configured to have a compressed state and an uncompressed state (a state in which no fluid is supplied to the pressure reaction jig 24 is being interpreted as an uncompressed state, col 8 lines 5-24 & Fig. 9; a state in which fluid is actively flowing through jig 24, compressing board 40, is being interpreted as a compressed state, col 8 lines 24-36 and col 9 lines 33-35 & Fig. 9), wherein:
the pressure sensor assembly is in a compressed state when the first portion of the pressure sensor assembly is positioned in the same plane as the second portion of the pressure sensor assembly (in the state in which fluid is actively flowing through jig 24, compressing board 40, board 40 is positioned in the same plane (“Plane 1” as annotated below in Fig. 3) as base board 28, Fig. 2-3); and the pressure sensor assembly is in an uncompressed state when the first portion of the pressure sensor assembly is biased towards the fluid bag and the first portion is not positioned in the same plane as the second portion (in the state in which no fluid is supplied to the pressure reaction jig 24, board 40 is biased toward bag 24a and board 40 is not positioned in the same plane (“Plane 2” as annotated below in Fig. 3) as base board 28, as board 40 is spaced a predetermined distance from board 28, Fig. 2-3).
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Regarding claim 10, Ohnishi discloses all the limitations of claim 9. Ohnishi further discloses the back-up infusion pressure sensor module wherein the pressure force from the fluid bag acts on the first portion of the pressure sensor assembly and the pressure force is transmitted to the force sensor in both the compressed and uncompressed state (in both states, bag 24a may impart force on board 40, transmitting force to sensor 25, see col 8 lines 12-36 & Fig. 9; depending on the chosen degree of displacement of handle 46, bag 24a may impart force on board 40 and sensor 25 in the uncompressed state).
Regarding claim 11, Ohnishi discloses all the limitations of claim 9. Ohnishi further discloses the back-up infusion pressure sensor module wherein the bracket contacts the back side of the first portion of the pressure sensor assembly when the pressure sensor assembly is in the compressed state (retaining member 37 capable of contacting a back side of board 40 in the compressed state as board 40 may be displaced up to retaining member 37, col 6 lines 1-3 and col 9 lines 33-39 & Fig. 1-8).
Regarding claim 12, Ohnishi discloses all the limitations of claim 8. Ohnishi further discloses the back-up infusion pressure sensor module wherein the module further comprises: an actuator configured to actuate the squeeze plate against the fluid bag, the actuator comprising at least one of: a driver or a leadscrew (operating handle 46, including a threaded shaft configured to actuate board 45 against bag 24a, col 6 lines 21-30 & Fig. 1-8).
Regarding claim 14, Ohnishi discloses all the limitations of claim 8. Ohnishi further discloses the back-up infusion pressure sensor module wherein the first portion of the pressure sensor assembly is coupled to the second portion of the pressure sensor assembly with a pin adapted to pivot the first portion about an axis of the pin (board 40 is coupled to base board 28 with pin 42 adapted to pivot board 40 about an axis of pin 42, col 6 lines 1-8 & Fig. 3-4).
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.
Claim(s) 1-7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohnishi (US 5335551 A), in view of Kitagawa (US 4726435 A).
Regarding claim 1, Ohnishi discloses a back-up infusion pressure sensor module (pillow type pressure detector 23 of Fig. 1-8, col 5 third paragraph) for use in an ophthalmic surgical console (“This invention relates to a pressure detector employed for a medical instrument…it is essential that the use of the medical instrument will not adversely affect the patient's body. For this purpose, it is necessary to control the… pressure into the body in such a manner that such pressures are in predetermined, allowable, ranges.”, col 1 lines 5-23; “The pressure detector 23 may be applied to medical instruments, other than the blood processing apparatus 1, and other fluid pressure detecting instruments”, col 10 lines 28-32; detector 23 would be capable of use in an ophthalmic surgical console), the back-up infusion pressure sensor module comprising:
a squeeze plate configured to engage with a fluid bag (flat plate shaped retaining board 45 configured to engage with bag 24a, which is connected to fluid flow, col 6 lines 42-58 and col 7 first paragraph & Fig. 1-8);
a pressure sensor assembly, having a sensor door and a sensor frame (load transmitting board 40 and base board 28, col 5 line 35-col 6 line 3 & Fig. 1-4), wherein the sensor door pivots relative to a pin coupled to a top portion of the pressure sensor assembly (board 40 configured to pivot relative to pin 42 coupled to protrusion 41 of board 28, col 6 lines 1-8 & Fig. 4), configured to cause the sensor door to be biased towards the fluid bag (“The tip end portion of the load transmitting board 40 is held by a leaf spring 43 so that it is held spaced a predetermined distance from the base board 28.”, col 6 lines 7-10 & Fig. 4; board 40 is held away from board 28, biased toward bag 24a, Fig. 1-4), the pressure sensor assembly comprising:
a base mounted to a back side of the sensor frame of the pressure sensor assembly (stopper 34 mounted to a back side of base board 28, col 5 lines 55-59 & Fig. 3; alternatively, mounting stand 27, which is mounted to a back side of base board 28, may be interpreted as a base, col 5 lines 29-35 & Fig. 1-5); one or more springs (spring 33, col 5 lines 55-56 & Fig. 3, and leaf spring 43, col 6 lines 7-10 & Fig. 4); a bracket coupled to the one or more springs (retaining member 37 connected, or coupled, to spring 33, col 5 line 55-68 and col 9 lines 5-10 & Fig. 1-8); and
a force sensor in contact with a bracket and configured to determine a pressure force from the fluid bag (a load cell type load sensor 25 in contact with retaining member 37, col 5 lines 10-27 and col 9 lines 5-10 & Fig. 1-8; sensor 25 configured to detect pressure from bag 24a, col 8 lines 24-36 and col 9 lines 33-57 & Fig. 9).
Ohnishi discloses that “The load cell type load sensor 25 is commercially available, and it is designed so that the load cell is distorted by a load applied thereto to change the internal resistance. Therefore, by detecting the variation of the electrical output of the load cell, the value of the load can be detected accurately.” (col 5 lines 22-27).
However, Ohnishi fails to explicitly disclose a spring bracket coupled to the one or more springs; and a force sensor in contact with the spring bracket.
However, Kitagawa teaches a load cell weighing apparatus (abstract and Fig. 1-2 and 5) comprising one or more springs (compression coil springs 26, col 3 line 53-col 6 line 2 & Fig. 1-2 and 5); a spring bracket coupled to the one or more springs (plate like receiving member 18 coupled to springs 26, col 3 lines 50-56 & Fig. 1-2 and 5); and a force sensor in contact with the spring bracket (load cell 14 in contact with member 18 through space 16, col 3 lines 40-45 & Fig. 1-2 and 5) and configured to determine a pressure force (col 1 lines 5-20).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Ohnishi with Kitagawa to include a spring bracket coupled to the one or more springs and a force sensor in contact with the spring bracket since such a modification would protect the force sensor against rupture due to excessive deformation and yield the same predictable results pertaining to pressure force measurement (col 1 lines 21-30 and 55-65 and col 4 lines 19-21 of Kitagawa).
As modified, compression springs 26, receiving member 18, and stoppers 22/extending portions 38 of Kitagawa (col 5 lines 3-10 of Kitagawa) would be included to operate alongside load cell sensor 25 of Ohnishi. Compression springs 26 would be coupled to load transmitting board 40, synonymously to how springs 26 are coupled to load supporting member 24 of Kitagawa. Retaining member 37 of Ohnishi would be modified to include through holes for stoppers 22, like casing 30 of Kitagawa (col 3 line 60-col 4 line 2 of Kitagawa).
Regarding claim 2, Ohnishi, as modified, discloses all the limitations of claim 1. Ohnishi further discloses the back-up infusion pressure sensor module wherein the pressure sensor assembly is configured to have a compressed state and an uncompressed state (a state in which no fluid is supplied to the pressure reaction jig 24 is being interpreted as an uncompressed state, col 8 lines 5-24 & Fig. 9; a state in which fluid is actively flowing through jig 24, compressing board 40, is being interpreted as a compressed state, col 8 lines 24-36 and col 9 lines 33-35 & Fig. 9), wherein:
the pressure sensor assembly is in a compressed state when the sensor door is positioned in the same plane as the sensor frame (in the state in which fluid is actively flowing through jig 24, compressing board 40, board 40 is positioned in the same plane (“Plane 1” as annotated above in Fig. 3) as base board 28, Fig. 2-3); and the pressure sensor assembly is in an uncompressed state when the sensor door is biased towards the fluid bag and the sensor door is not positioned in the same plane as the sensor frame (in the state in which no fluid is supplied to the pressure reaction jig 24, board 40 is biased toward bag 24a and board 40 is not positioned in the same plane (“Plane 2” as annotated above in Fig. 3) as base board 28, as board 40 is spaced a predetermined distance from board 28, Fig. 2-3).
Regarding claim 3, Ohnishi, as modified, discloses all the limitations of claim 2. Ohnishi further discloses the back-up infusion pressure sensor module wherein the pressure force from the fluid bag acts on the sensor door of the pressure sensor assembly and the pressure force is transmitted to the force sensor in both the compressed and uncompressed states (in both states, bag 24a may impart force on board 40, transmitting force to sensor 25, see col 8 lines 12-36 & Fig. 9; depending on the chosen degree of displacement of handle 46, bag 24a may impart force on board 40 and sensor 25 in the uncompressed state).
Regarding claim 4, Ohnishi, as modified, discloses all the limitations of claim 2. Ohnishi, as modified, further discloses the back-up infusion pressure sensor module wherein the spring bracket contacts the back side of the sensor door of the pressure sensor assembly when the pressure sensor assembly is in the compressed state (as modified, in the compressed state, receiving member 18 of Kitagawa contacts a back side of board 40, see Fig. 5 of Kitagawa and Fig. 1-3 of Ohnishi; “abutment projections 40 are formed on or secured to portions of casing 30 which face the lower surface of load supporting member 24. Abutment projections 40 serve as stoppers to define the full stroke of load supporting member 24.”, col 5 lines 11-16 of Kitagawa).
Regarding claim 5, Ohnishi, as modified, discloses all the limitations of claim 1. Ohnishi further discloses the back-up infusion pressure sensor module wherein the module further comprises: an actuator configured to actuate the squeeze plate against the fluid bag, the actuator comprising at least one of: a driver or a leadscrew (operating handle 46, including the threaded shaft configured to actuate board 45 against bag 24a, col 6 lines 21-30 & Fig. 1-8).
Regarding claim 6, Ohnishi, as modified, discloses all the limitations of claim 1. Ohnishi further discloses the back-up infusion pressure sensor module wherein the pressure sensor assembly is configured to retain energy from mechanical compression of the fluid bag to provide compression force to the fluid bag in the absence of mechanical compression (as modified, compression springs 26 of Kitagawa would be capable of retaining energy from mechanical compression of bag 24a and provide compression force to bag 24a through board 40 in the absence of mechanical compression from handle 46 and board 45, see col 3 lines 51-65 & Fig. 1-2 of Kitagawa and Fig. 1-8 of Ohnishi).
Regarding claim 7, Ohnishi, as modified, discloses all the limitations of claim 1. Ohnishi further discloses the back-up infusion pressure sensor module wherein the sensor door of the pressure sensor assembly is coupled to a sensor frame of the pressure sensor assembly with a pin adapted to pivot the sensor door of the pressure sensor assembly about an axis of the pin (board 40 is coupled to base board 28 with pin 42 adapted to pivot board 40 about an axis of pin 42, col 6 lines 1-8 & Fig. 3-4).
Regarding claim 13, as best understood in light of the 112(b) rejection set forth above, Ohnishi discloses all the limitations of claim 8. However, Ohnishi fails to explicitly disclose the back-up infusion pressure sensor module wherein the bracket is configured to retain energy from mechanical compression of the fluid bag to provide compression force to the fluid bag in the absence of mechanical compression.
However, Kitagawa teaches a load cell weighing apparatus (abstract and Fig. 1-2 and 5) wherein the bracket is configured to retain energy from mechanical compression (compression coil springs 26 and receiving member 18 capable of retaining energy from mechanical compression, col 3 line 39-col 6 line 7 & Fig. 1-2 and 5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Ohnishi with Kitagawa to include the bracket being configured to retain energy from mechanical compression since such a modification would protect the force sensor against rupture due to excessive deformation and yield the same predictable results pertaining to pressure force measurement (col 1 lines 21-30 and 55-65 and col 4 lines 19-21 of Kitagawa).
As modified, compression springs 26, receiving member 18, and stoppers 22/extending portions 38 of Kitagawa (col 5 lines 3-10 of Kitagawa) would be included to operate alongside load cell sensor 25 of Ohnishi. Compression springs 26 would be coupled to load transmitting board 40, synonymously to how springs 26 are coupled to load supporting member 24 of Kitagawa. Retaining member 37 of Ohnishi would be modified to include through holes for stoppers 22, like casing 30 of Kitagawa (col 3 line 60-col 4 line 2 of Kitagawa). As combined, compression springs 26 of Kitagawa would be capable of retaining energy from mechanical compression of bag 24a and provide compression force to bag 24a through board 40 in the absence of mechanical compression from handle 46 and board 45.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohnishi (US 5335551 A) as applied to claim 8 above, and further in view of Rake (US 20050211725 A1).
Regarding claim 15, Ohnishi discloses all the limitations of claim 8. Ohnishi further discloses the back-up infusion pressure sensor module wherein the bracket is made of stainless steel (col 5 lines 65-69). However, Ohnishi fails to explicitly disclose wherein the squeeze plate, the first portion of the pressure sensor assembly, and the second portion of the pressure sensor assembly are formed of a stainless steel or aluminum.
However, Rake teaches a pressure infusion pump (abstract) wherein the squeeze plate, the first portion of the pressure sensor assembly, and the second portion of the pressure sensor assembly are formed of a stainless steel (anchor 247, [0172] & Fig. 24, platen 244, which may be integrally molded or formed with spacer 246, [0170] and [0172] & Fig. 24, and the housing of infusion pump 238 may be made of stainless steel, [0162]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Ohnishi with Rake to include the squeeze plate, the first portion of the pressure sensor assembly, and the second portion of the pressure sensor assembly formed of stainless steel since Rake teaches stainless steel to be an art effective material for a pressure delivering module and would minimize the occurrence of stress fatigue following repeated usage of the device ([0172] of Rake).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kling (US 9586728 B2), see Fig. 6.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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