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 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 and 10 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 5 recites the limitation "the first side cover" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
Claim 10 recites the limitation "the first side cover" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
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 1-2 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simpson (US 20080200791 A1).
With respect to claim 1, Simpson discloses a blood physiological parameter sensing device (see paragraph 0357 and Fig. 1A-1E: system #10 that includes an analyte sensor #14), comprising:
a housing (see paragraph 0357-0359 and see Fig. 1A-1E; housing is interpreted to be central structure seen in Fig. 1A and 1B);
a channel structure, disposed inside the housing and having a channel for a liquid to be measured to pass through (see paragraph 0359 and Fig. 1A-1E: fluid coupler #20 which has a channel for liquid to pass through);
a control unit, disposed inside the housing (see paragraph 0362: sensor electronics such as a potentiostat is disposed on the fluid coupler which is inside the housing); and
a sensing unit, disposed inside the housing, electrically connected to the control unit (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f with sensor electronics such as a potentiostat is disposed on the fluid coupler which is inside the housing where the sensor and sensor electronics is connected wired or wirelessly), and having a sensing end, the sensing end passing through the channel structure, disposed inside the channel (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f), and having an electrochemical sensing material (see paragraph 0358: sensor #14 is configured to measure concentration of an analyte and can be made of an electrode which is electrochemical sensing), the electrochemical sensing material being for exchanging electrons with the blood physiological parameters in the liquid to be measured to produce a redox reaction to generate a current or voltage change parameter (see paragraph 0358: sensor #14 can include a combination of working electrodes, reference electrodes and counter electrodes which produces a redox reaction to generate current and voltage; and see paragraph 0305 and 0362: potentiostat works to keep potential constant by noticing changes in the resistance of the system a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat), and the sensing unit transmitting the current or voltage change parameter to the control unit to obtain a blood physiological parameter concentration value according to the current or voltage change parameter (see paragraph 0558-0559: sensed signal of voltage or current change is sent to sensor electronics to associate the signal with a glucose concentration).
With respect to claim 2, all limitations of claim 1 apply in which Simpson further discloses wherein the channel structure comprises a body, a first connector and a second connector (see paragraph 0382 and Fig. 1A-1E: fluid coupler #20 includes first side #20a and second side #20b); the first connector and the second connector are respectively disposed at two ends of the body, the body, the first connector and the second connector jointly form the channel, and the sensing end passes through the body (see paragraph 0382 and Fig. 1A-1E: fluid coupler #20 includes first side #20a and second side #20b where the sensor #14 passes through).
With respect to claim 6, Simpson discloses a blood physiological parameter sensing system (see paragraph 0357 and Fig. 1A-1E: system #10 that includes an analyte sensor #14), comprising:
an extracorporeal circulation device, further comprising a host, an input tube, and an output tube, the input tube being connected to the host, and the output tube being connected to the host (see paragraph 0109 and 0379: extracorporeal circuitry device with a host and input and output tubes);
a display device (see paragraph 0651: display); and
a blood physiological parameter sensing device (see paragraph 0357 and Fig. 1A-1E: system #10 that includes an analyte sensor #14), further comprising a housing (see paragraph 0357-0359 and see Fig. 1A-1E; housing is interpreted to be central structure seen in Fig. 1A and 1B), a channel structure (see paragraph 0359 and Fig. 1A-1E: fluid coupler #20 which has a channel for liquid to pass through), a control unit (see paragraph 0362: sensor electronics such as a potentiostat is disposed on the fluid coupler which is inside the housing), and a sensing unit (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f with sensor electronics such as a potentiostat is disposed on the fluid coupler which is inside the housing where the sensor and sensor electronics is connected wired or wirelessly), the channel structure being disposed inside the housing and comprising a channel (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f), two ends of the channel structure being respectively connected to the input tube and the output tube (see paragraph 0362 and see Fig. 1A-1E: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f) ; the control unit being disposed inside the housing and is electrically connected to the display device or connected with the display device (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f with sensor electronics such as a potentiostat is disposed on the fluid coupler which is inside the housing where the sensor and sensor electronics is connected wired or wirelessly; and see paragraph 0651: a display can be provided proximal to device), the sensing unit being disposed inside the housing and electrically connected to the control unit, and having a sensing end (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f with sensor electronics such as a potentiostat is disposed on the fluid coupler which is inside the housing where the sensor and sensor electronics is connected wired or wirelessly), the sensing end passing through the channel structure (see paragraph 0362: sensor #14 passes through the fluid coupler #20 via fluid coupler lumen #20f), being disposed inside the channel, and having an electrochemical sensing material (see paragraph 0358: sensor #14 is configured to measure concentration of an analyte and can be made of an electrode which is electrochemical sensing);
wherein when the host provides a liquid to be measured, the liquid to be measured sequentially passes through the input tube, the channel and the output tube and returns to the inside of the host to form a circulation loop, and the electrochemical sensing material and the blood physiological parameters in the liquid to be measured produce electron exchange in the redox reaction to generate a current or voltage change parameter (see paragraph 0358: sensor #14 can include a combination of working electrodes, reference electrodes and counter electrodes which produces a redox reaction to generate current and voltage; and see paragraph 0305 and 0362: potentiostat works to keep potential constant by noticing changes in the resistance of the system a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat where when blood passes through the channel the sensor analyzes the glucose concentration); the sensing unit transmits the current or voltage change parameter to the control unit, the control unit obtains a blood physiological parameter concentration value according to the current or voltage change parameter, and the blood physiological parameter concentration value is sent to the display device, and the display device displays the blood physiological parameter concentration value (see paragraph 0558-0559: sensed signal of voltage or current change is sent to sensor electronics to associate the signal with a glucose concentration; and see paragraph 0651-0652: display results).
With respect to claim 7, all limitations of claim 6 apply in which Simpson further discloses wherein the channel structure comprises a body, a first connector and a second connector (see paragraph 0382 and Fig. 1A-1E: fluid coupler #20 includes first side #20a and second side #20b); the first connector and the second connector are respectively disposed at two ends of the body, the body, the first connector and the second connector jointly form the channel, and the sensing end passes through the body (see paragraph 0382 and Fig. 1A-1E: fluid coupler #20 includes first side #20a and second side #20b where the sensor #14 passes through); the input tube is connected to the first connector, and the output tube is connected to the second connector (see paragraph 0382 and Fig. 1A-1E).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Hiss (US 20040149028 A1).
With respect to claim 3, all limitations of claim 2 apply in which Simpson further discloses wherein the housing comprises a bottom, a first side cover, a second side cover, a base, an upper cover, and a battery, the first side cover and the second side cover are disposed on the base and form a cavity (see paragraph 0357-0359, 0642 and Figs. 1A-1E: housing has a bottom, a cover, two sides and a battery where a cavity is formed in the middle for sensor #14 to flow through).
Simpson does not specifically disclose the control unit is disposed on the bottom, and the base is disposed above the control unit, the body is disposed on the base, the upper cover is disposed on the body, the battery is disposed on the control unit and is electrically connected to the control unit, the first connector passes through the first side cover, and the second connector passes through the second side cover.
Hiss teaches a housing that comprises a bottom (see paragraph 0015-0018 and Fig. 1: lower shell #5), a first side cover (see paragraph 0015-0018 and Fig. 1: #22 outer part on left), a second side cover (see paragraph 0015-0018 and Fig. 1, #22 outer part on the right), a base (see paragraph 0015-0018, 0024 and Fig. 1: outer part #24), an upper cover (see paragraph 0015-0018 and Fig. 1: upper shell #25); a control unit is disposed on the bottom (see paragraph 0023 and Fig. 2: printed circuit board #20), and the base is disposed above the control unit (see Fig. 1-2), a body is disposed on the base (see Fig. 1-2, tube #2 is disposed above #24), the upper cover is disposed on the body (see Fig. 1-2: upper shell #25 is disposed on tube #1), battery is disposed on control unit and is electrically connected to control unit (see Fig. 1-2 and paragraph 0023: electronic components #21 are fitted to printed circuit board #20), a first connector passed through the first side cover (see Fig. 1-2: central piece #6 goes through #22 on the left side), and a second connector passes through the second side cover (see Fig. 1-2: central piece #6 goes through #22 on the right side).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson with the teachings of Hiss to have added multi piece enclosure to a housing because it would have resulted in the predictable result of protecting and supporting a flow sensor body and electronics (Hiss: see [0007]).
With respect to claim 4, all limitations of claim 3 apply in which Hiss further teaches wherein a groove is opened on the top of the body (see paragraph 0015-0018 and Fig. 1: circumferential groove is made in wall of tube #2)), and the blood physiological parameter sensing device further includes two waterproof gaskets (see paragraph 0015-0018 and Fig. 1: there are two O-ring #3 sealings on either side of tube #3)), and the waterproof gaskets are disposed in the groove and clamp the sensing end (see paragraph 0015-0018 and Fig. 1: O-rings are disposed in groove and they seal the flow sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson with the teachings of Hiss to have included a groove and two waterproof gaskets because it would have resulted in the predictable result of mounting a tube using seals to ensure that the bending of a housing is not transmitted to the tube (Hiss: see [0016]).
With respect to claim 8, all limitations of claim 7 apply in which Simpson further discloses wherein the housing comprises a bottom, a first side cover, a second side cover, a base, an upper cover, and a battery, the first side cover and the second side cover are disposed on the base and form a cavity (see paragraph 0357-0359, 0642 and Figs. 1A-1E: housing has a bottom, a cover, two sides and a battery where a cavity is formed in the middle for sensor #14 to flow through); the body, the control unit, the base, the upper cover, the battery are disposed in the cavity (see paragraph 0357-0359, 0642 and Figs. 1A-1E).
Simpson does not specifically disclose the control unit is disposed on the bottom, and the base is disposed above the control unit, the body is disposed on the base, the upper cover is disposed on the body, the battery is disposed on the control unit and is electrically connected to the control unit, the first connector passes through the first side cover, and the second connector passes through the second side cover.
Hiss teaches a housing that comprises a bottom (see paragraph 0015-0018 and Fig. 1: lower shell #5), a first side cover (see paragraph 0015-0018 and Fig. 1: #22 outer part on left), a second side cover (see paragraph 0015-0018 and Fig. 1, #22 outer part on the right), a base (see paragraph 0015-0018, 0024 and Fig. 1: outer part #24), an upper cover (see paragraph 0015-0018 and Fig. 1: upper shell #25); a control unit is disposed on the bottom (see paragraph 0023 and Fig. 2: printed circuit board #20), and the base is disposed above the control unit (see Fig. 1-2), a body is disposed on the base (see Fig. 1-2, tube #2 is disposed above #24), the upper cover is disposed on the body (see Fig. 1-2: upper shell #25 is disposed on tube #1), battery is disposed on control unit and is electrically connected to control unit (see Fig. 1-2 and paragraph 0023: electronic components #21 are fitted to printed circuit board #20), a first connector passed through the first side cover (see Fig. 1-2: central piece #6 goes through #22 on the left side), and a second connector passes through the second side cover (see Fig. 1-2: central piece #6 goes through #22 on the right side).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson with the teachings of Hiss to have added multi piece enclosure to a housing because it would have resulted in the predictable result of protecting and supporting a flow sensor body and electronics (Hiss: see [0007]).
With respect to claim 9, all limitations of claim 8 apply in which Hiss further teaches wherein a groove is opened on the top of the body (see paragraph 0015-0018 and Fig. 1: circumferential groove is made in wall of tube #2)), and the blood physiological parameter sensing device further includes two waterproof gaskets (see paragraph 0015-0018 and Fig. 1: there are two O-ring #3 sealings on either side of tube #3)), and the waterproof gaskets are disposed in the groove and clamp the sensing end (see paragraph 0015-0018 and Fig. 1: O-rings are disposed in groove and they seal the flow sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson with the teachings of Hiss to have included a groove and two waterproof gaskets because it would have resulted in the predictable result of mounting a tube using seals to ensure that the bending of a housing is not transmitted to the tube (Hiss: see [0016]).
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of Lipman (US 20140376762 A1).
With respect to claim 5, all limitations of claim 2 apply in which Simpson further discloses a switch and a USB slot, and the switch and the USB slot are electrically connected to the control unit (see paragraph 0779: operable connections between the local and remote analyzers #608,610 and the analyte sensor #14 can be accomplished by a hardwire such as a USB).
Simpson does not specifically teach that the first side cover has a USB slot.
Lipman teaches a first side cover that has a USB slot (see paragraph 0079 and Fig. 7C: device comprises a USB port #720 on side cover).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson with the teachings of Lipman to have added a USB slot to a side cover because it would have resulted in the predictable result of transferring collected data via a physical connection to a device (Lipman: see [0027], [0066]).
With respect to claim 10, all limitations of claim 7 apply in which Simpson further a switch and a USB slot, and the switch and the USB slot are electrically connected to the control unit (see paragraph 0779: operable connections between the local and remote analyzers #608,610 and the analyte sensor #14 can be accomplished by a hardwire such as a USB).
Simpson does not specifically teach that the first side cover has a USB slot.
Lipman teaches a first side cover that has a USB slot (see paragraph 0079 and Fig. 7C: device comprises a USB port #720 on side cover).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Simpson with the teachings of Lipman to have added a USB slot to a side cover because it would have resulted in the predictable result of transferring collected data via a physical connection to a device (Lipman: see [0027], [0066]).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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