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 .
Information Disclosure Statement
The information disclosure statement filed 7/19/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, copies of the listed foreign patent document and the four listed non-patent literature documents have not been provided. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] claims priority to U.S. Patent Application No. 17/993,302; since this application was issued as U.S. Patent No. 12,042,589 on 7/23/2024, paragraph [0001] should be updated to indicate this.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: Line 2 should be amended to recite “in a wired manner or wirelessly” in order to be grammatically correct (since data cannot be sent “wired”). Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Commas should be placed around the phrase “or clinician” on lines 1-2 and line 4 since, without commas, it could appear that the claim requires “at least one doctor” (i.e. a person) or “clinician computer” (i.e. a computer). The term “a” should be inserted before the term “caregiver” on line 3 in order to be grammatically correct. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: The term “an” should be inserted before the phrase “insulin injection” on line 2 in order to be grammatically correct. 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 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites a method step (“wherein the peritonitis determination is provided in combination with insulin injection made using feedback from a patient effluent glucose biosensor”), rendering the claim indefinite since the claim is written as a device claim (“The PD system of Claim 1”). As per MPEP 2173.05(p)(II), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method claims. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed; specifically, claim 17 is interpreted as reciting “The PD system of Claim 1, wherein the peritonitis determination is configured to be provided in combination with [an] insulin injection made using feedback from a patient effluent glucose biosensor”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites that “either the control unit of the cycler or the water purifier control unit is configured to analyze the sensed temperature” (lines 1-2), but claim 5 (upon which claim 6 depends) requires the water purifier control unit to be “configured to analyze the sensed temperature” (line 4). Therefore, claim 6 does not include all the limitations of claim 5. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-4 and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank (PG PUB 2014/0018727) in view of Gerber (PG PUB 2018/0043080).
Re claim 1, Burbank discloses a peritoneal dialysis system 900+901 (Fig 8A,9; Para 102 sets forth that the PD system 900 and the water purification system 901 “operate together as a complete system”; it is noted that all reference characters cited below refer to Fig 8A and/or Fig 9 unless otherwise noted) comprising: a cycler 900 (Para 102) including a pump actuator 943 (Para 107) and a control unit 907 (Para 103) in operable communication with the pump actuator (Para 103); a disposable set 911+914+915+916+917+919+920+944+945 (comparable to disposable set 700 of Fig7A; Para 107) including a disposable cassette 911 (Para 107) having a pump chamber 944 (Para 107), the disposable cassette sized and arranged to be held by the cycler such that the pump chamber is in operable communication with the pump actuator (Para 107), the disposable set including a patient line 945 (Para 107) and a drain line 920 (Para 111) extending from the disposable cassette (as seen in Fig 8A); and a temperature sensor 985 (Para 115) operably coupled to one of the patient line, the drain line, or the disposable cassette to sense a temperature of effluent PD fluid removed from a patient (Para 115). Burbank does not discloses that the control unit is configured to use the sensed temperature to form a patient peritonitis determination and communicate the peritonitis determination.
Gerber, however, teaches a PD system (Para 2) that comprises a temperature sensor (Para 169 – represented by step 104d in Fig 1; Para 174 – represented by step 206d in Fig 2) operably coupled to a drain line (Para 169 – “a temperature sensor along the effluent line”; Para 174 – “temperature sensors in the effluent line”) to sense a temperature of effluent PD fluid removed from a patient (Para 169 – “a temperature of effluent removed during the current PD session can be measured”; Para 174 – “a temperature of the peritoneal dialysis filtrate can be determined”), wherein a control unit is configured to use the sensed temperature to form a patient peritonitis determination and communicate the peritonitis determination (Para 171 – represented by step 106d in Fig 1; Para 177 – represented by step 210 in Fig 2) for the purpose of determining if possible medical intervention is needed (Para 2). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank to include the control unit so that it is configured to use the sensed temperature to form a patient peritonitis determination and communicate that determination, as taught by Gerber, for the purpose of determining if possible medical intervention is needed (Para 2).
Re claim 2, Burbank discloses that the sensed temperature is sent to the control unit from the temperature sensor (Para 106), and wherein the control unit is configured to analyze the sensed temperature (Para 106).
Re claim 3, Burbank discloses that the sensed temperature is sent to the control unit wired or wirelessly (Para 106,109).
Re claim 4, Burbank as modified by Gerber in the rejection of claim 1 above (to use the sensed temperature to form a peritonitis determination) discloses a network (indicated by the dotted line extending from module 956 in Fig 8A) and at least one doctor or clinician computer 956 (Para 111) in communication with the control unit via the network (Para 111), the control unit configured to communicate the peritonitis determination to at least one of a patient or caregiver via a user interface 906 (Para 115) of the cycler or the at least one doctor or clinician computer via the network (Para 111).
Re claim 12, Burbank as modified by Gerber in the rejection of claim 1 above discloses all the claimed features with Gerber teaching that the control unit is configured to analyze the sensed temperature of the effluent PD fluid removed from the patient by comparing the sensed temperature to a temperature of fresh PD fluid delivered to the patient and sensed by the temperature sensor (Para 174). The motivation cited in claim 1 also applies to this claim.
Re claim 13, Burbank as modified by Gerber in the rejection of claim 1 above discloses all the claimed features with Gerber teaching that the control unit is configured to analyze the sensed temperature of the effluent PD fluid removed from the patient by determining an increase in temperature due to peritonitis or the onset thereof (Para 171). The motivation cited in claim 1 also applies to this claim.
Re claim 14, Burbank as modified by Gerber in the rejection of claim 1 above discloses all the claimed features with Gerber teaching that the increase in temperature due to peritonitis or the onset thereof is detectable regardless of whether the sensed temperature is offset due to sensing through the patient line, the drain line, or the disposable cassette (Para 171). The motivation cited in claim 1 also applies to this claim.
Re claim 15, Burbank as modified by Gerber in the rejection of claim 1 above discloses all the claimed features with Gerber teaching that the peritonitis determination is a first peritonitis indicator, and which includes at least one different peritonitis indicator useable in combination with the first peritonitis indicator to form an overall peritonitis determination (Para 23, 171). The motivation cited in claim 1 also applies to this claim.
Re claim 16, Burbank as modified by Gerber in the rejection of claim 1 above discloses all the claimed features with Gerbe teaching that the at least one different peritonitis indicator useable in combination with the first peritonitis indicator is obtained from at least one of a white blood cell biosensor or a white blood cell impedance sensor (Para 23, 171). The motivation cited in claim 1 also applies to this claim.
Re claim 17, Burbank as modified by Gerber in the rejection of claim 1 above discloses all the claimed features with Gerber teaching that the peritonitis determination is configured to be provided in combination with insulin injection made using feedback from a patient effluent glucose biosensor (Para 171). The motivation cited in claim 1 also applies to this claim.
Re claim 18, Burbank as modified by Gerber in the rejection of claim 1 above (to use the sensed temperature to form a peritonitis determination) discloses a user interface 906D (Para 103) configured to: receive the peritonitis determination from the control unit; and display information indicative of the peritonitis determination (Para 115).
Re claim 19, Burbank discloses that the control unit and the user interface are included within the cycler (as seen in Fig 8A).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank (PG PUB 2014/0018727)/Gerber (PG PUB 2018/0043080) in view of Fitzgerald et al. (PG PUB 2017/0319770).
Re claim 5, Burbank discloses a water purifier 901 configured to supply purified water to the disposable set (Para 111), the water purifier including a water purifier control unit 959 (Para 111), and wherein the cycler control unit and the water purifier control unit are in communication (Para 111). Burbank/Gerber does not disclose that the sensed temperature is sent to the water purifier control unit, wherein the water purifier control unit is configured to analyze the sensed temperature, and wherein the communication between the cycler control unit and the water purifier control unit allows the control unit of the cycler to communicate the peritonitis determination. Fitzgerald, however, teaches sending sensed information to a control unit of a water purifier so that the control unit of the water purifier can analyze the sensed information and communicate with a control unit of a cycler to communicate the determination made by the control unit of the water purifier (Para 38). This action would achieve the same result as sending the information to and analyzing the information at the cycler control unit; thus, this arrangement and that of Burbank were art-recognized equivalents at the time the invention was made. Therefore, it would have been obvious to one of ordinary skill in the art to modify Burbank/Gerber to include the system so that the sensed temperature is sent to and analyzed by the water purifier control unit so that the determination can be communicated to the cycler control unit, as taught by Fitzgerald, since it has been held that modifying an invention with art-recognized equivalents involves only routine skill in the art.
Re claim 6, Burbank as modified by Gerber in the rejection of claim 1 above discloses that the control unit of the cycler is configured to analyze the sensed temperature (Para 106).
Claims 7-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank (PG PUB 2014/0018727)/Gerber (PG PUB 2018/0043080) in view of Elbadry et al. (PG PUB 2019/0358387).
Re claim 7, Burbank as modified by Gerber in the rejection of claim 1 above disclose all the claimed features except explicitly disclosing that the temperature sensor is configured to be placed in a connector. Elbadry, however, teaches a system comprising a temperature sensor 3 (Fig 2; Para 180) wherein the temperature sensor is configured to be placed in a connector 26 (Fig 2; Para 180) configured to couple to a drain line (via connectors 13,14 – Para 180) for the purpose of providing the sensor as a durable component that can be used with multiple disposable drain lines (Para 125). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank to include the temperature sensor in a connector configured to couple to the patient line or the drain line, as taught by Gerber, for the purpose of providing the sensor as a durable component that can be used with multiple disposable drain lines (Para 125).
Re claim 8, Burbank/Gerber as modified by Elbadry in the rejection of claim 7 above discloses all the claimed features with Elbadry teaching that the connector is configured to be spliced between two sections (connected to connectors 13 and 14 in Fig 2) of the patient line or the drain line (Para 181). The motivation cited in claim 7 above also applies to this claim.
Re claim 9, Burbank/Gerber as modified by Elbadry in the rejection of claim 7 above discloses all the claimed features with Elbadry teaching that the connector includes electrodes (“leads” – Para 348) positioned and arranged to contact (a) effluent fluid flowing through the patient line or the drain line, or (b) the patient line or the drain line directly (Para 241). The motivation cited in claim 7 above also applies to this claim.
Re claim 10, Burbank/Gerber as modified by Elbadry in the rejection of claim 7 above disclose that a thermally conductive segment 15 (Fig 2) is spliced between sections of the patient line or the drain line (via connectors 13 and 14, Para 181), and wherein the connector is connected directly to the thermally conductive segment (as seen in Fig 2). The motivation cited in claim 7 above also applies to this claim.
Re claim11, Burbank/Gerber as modified by Elbadry in the rejection of claim 7 above discloses that the connector includes leads (shown in Fig 33 extending from sensor 75) extending from the electrodes to (i) the control unit (Para 241). The motivation cited in claim 7 above also applies to this claim.
Re claim 20, Burbank/Gerber disclose all the claimed features but do not explicitly disclose that the temperature sensor includes at least one of a thermocouple or a thermistor. Elbadry, however, teaches using a thermistor (Para 240) to sense the temperature in an effluent line (Para 240) for the purpose of achieving optimal heat-transfer (Para 241). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Burbank/Gerber to include the temperature sensor as a thermistor, as taught by Elbadry, for the purpose of achieving optimal heat-transfer (Para 241).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2006/0161107 to Mantle, PG PUB 2017/0281064 to Bayon, and PG PUB 2019/0290496 to Brownhill et al. each pertain to temperature sensing in a way similar to that which is claimed. PG PUB 2019/0381231 to Tsoory et al. teaches a correlation between peritonitis, blood glucose control and fluid temperature. PG PUB 2005/0171503 to Van Den Berghe et al. teaches a correlation between peritonitis and blood glucose control.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
