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 .
Response to Amendment
Applicant’s amendments filed on 02/11/2026 has been fully considered. Claims 1, 3, and 6-11 are pending. Claims 1, 3, 6, and 8-11 are amended. Claims 2, 4-5, 7, and 12 are cancelled.
Response to Arguments
Amendment of claim 3 overcomes the claim objection of record. The claim objection of claim 3 is now withdrawn.
Applicant’s arguments with respect to amended independent claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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 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 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Abel et al. (Publication No. US 2020/0338253 A1).
Regarding claim 1, Abel teaches an extracorporeal circuit for decapneization of an organic fluid (treatment system D100 for reducing carbon dioxide from blood; Figure 22; Paragraph 0540), the extracorporeal circuit comprising: a drainage line for draining from a patient the organic fluid to be decapneized (B_in; Figure 22; Paragraph 0547); a re-infusion line for re-infusing the patient with the organic fluid after decapneization (B_out; Figure 22; Paragraph 0547); at least one organic fluid pump group arranged at least on said drainage line (fluid pump D2; Paragraph 0540; Figure 22); at least one decapneizer into which the drainage line enters and from which the re-infusion line exits (gas exchanger 10 where Bin enters and Bout exits; Figure 22; Paragraph 0541 and 0547); a first sensor mounted on the drainage line upstream from the at least one decapneizer between the at least one organic fluid pump group and the at least one decapneizer for detecting at least one input parameter of the organic fluid (pH and CO2 partial pressure sensor can be placed upstream between the pump D2 and gas exchanger 10 at D16; Figure 22; Paragraph 0552); and a second sensor mounted on the re-infusion line at downstream from the at least one decapneizer for detecting at least one output parameter of the organic fluid (pH and CO2 partial pressure sensor can be placed downstream from gas exchanger 10 at D17 for detection; Figure 22; Paragraph 0552). Abel does not expressly teach a first distance, a second distance, wherein the second distance is greater than or equal to the first distance and both the first distance and the second distance are greater than 1 cm, whereby the at least one input parameter and the at least one output parameter are not influenced by gas diffusion inside the at least one decapneizer or a flow within the drainage line.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a first and second distance be greater than 1 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04)(IV)(A). In the instant case, the first and second sensors of Abel would not operate differently with the claimed first and second distances since it has the same function of measuring the input fluid and the output fluid with respect to the decapneizer/gas exchanger. Further, applicant places no criticality on the range claimed, indicating simply that the distance “can vary” and “about” within the claimed ranges (claim 1; page 6, lines 1-20 of the instant application’s specification). In the specification of the instant application at page 6, lines 1-20, the application discusses the first and second distance ranges and stating that “possible falsification of the parameters detected” may occur, however, does not clearly discuss any possibility of unexpected results when providing the first and second distances at the claimed ranges, for example, evidence of precision of CO2 partial pressure measurements when the first and second sensors are at a distance of greater than 1 cm versus at a distance less than 1 cm. The burden shifts to the applicant to provide evidence of unexpected results with the claimed first and second distances (MPEP 716.02).
The modified Abel teaches a first distance, a second distance, wherein the second distance is greater than or equal to the first distance and both the first distance and the second distance are greater than 1 cm, whereby the at least one input parameter and the at least one output parameter are not influenced by gas diffusion inside the at least one decapneizer or a flow within the drainage line (see combination above – obvious that the first and second distance of the first and second sensor away from the gas exchanger will allow for the input and output parameter to be uninfluenced by gas diffusion).
Regarding claim 6, Abel teaches the extracorporeal circuit of claim 1. Abel does not expressly teach wherein the first distance varies in a range between 1 to 2 cm, and the second distance varies in a range between 1 to 10 cm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first distance at a range between 1 to 2 cm and the second distance at a range between 1 to 10 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04)(IV)(A). In the instant case, the first and second sensors of Abel would not operate differently with the claimed first and second distances since it has the same function of measuring the input fluid and the output fluid with respect to the decapneizer/gas exchanger. Further, applicant places no criticality on the range claimed, indicating simply that the distance “can vary” and “about” within the claimed ranges (claim 1; page 6, lines 1-20 of the instant application’s specification). In the specification of the instant application at page 6, lines 1-20, the application discusses the first and second distance ranges and stating that “possible falsification of the parameters detected” may occur, however, does not clearly discuss any possibility of unexpected results when providing the first and second distances at the claimed ranges, for example, evidence of precision of sensor measurements when the first and second sensors are at a distance of greater than 1 cm, such as a first distance between 1 to 2 cm and a second distance between 1 to 10 cm, versus at a distance less than 1 cm. The burden shifts to the applicant to provide evidence of unexpected results with the claimed first and second distances (MPEP 716.02).
Regarding claim 7, Abel teaches the extracorporeal circuit of claim 1. Abel further teaches wherein said first sensor is selected from CO2 pressure sensors, pH sensors, and HCO3 bicarbonate sensors (pH and CO2 partial pressure sensor can be placed upstream between the pump D2 and gas exchanger 10 at D16; Figure 22; Paragraph 0552).
Regarding claim 8, Abel teaches the extracorporeal circuit of claim 1. Abel further teaches wherein said second sensor is selected from CO2 pressure sensors, pH sensors, and HCO3 bicarbonate sensors (pH and CO2 partial pressure sensor can be placed downstream from gas exchanger 10 at D17 for detection; Figure 22; Paragraph 0552).
Regarding claim 9, Abel teaches the extracorporeal circuit of claim 1. Abel further teaches wherein said first sensor and second sensor are the same or different from each other (pH sensors at lines D16 and D17 or CO2 sensors at lines D16 and D17 are the same to measure the difference in pH or CO2 partial pressures before and after the gas exchanger 10; Figure 22; Paragraph 0552).
Regarding claim 10, Abel teaches the extracorporeal circuit of claim 1. Abel further teaches wherein said at least one input parameter and said at least one output parameter are chosen from the group consisting of: CO2 partial pressure (PiCO2), CO2 concentration (TiCO2), pH value, and bicarbonate (HCO3) concentration (pH value or CO2 partial pressure values measured from pH sensors or CO2 sensors at lines D16 and D17; Figure 22; Paragraph 0552).
Regarding claim 11, Abel teaches a decapneizer (gas exchanger 10; Figure 22; Paragraph 0054 and 0540-0541) comprising: a containing body in which a flow of oxygen is intended to flow (body of gas exchanger 10 where oxygen flows; Paragraph 0054 and 0540; Figure 22); a first inlet of oxygen (buffer solution entered from inlet port 7 and can contain oxygen for blood enrichment; Paragraph 0054 and 0069; Figure 22) and a first outlet of carbon dioxide (buffer solution with collected carbon dioxide exits at outlet port 8; Paragraph 0069; Figure 22); a second inlet of a line for draining from a patient a fluid to be decapneized (inlet port 4 for the line B_in for a fluid to be decapeneized; Paragraph 0069 and 0547; Figure 22); a second outlet of a line for re-infusing the patient with decapneized fluid (outlet port 5 for the line B_out for re-infusing the patient with decapneized fluid; Paragraph 0069 and 0547; Figure 22); and a first sensor associated with said containing body at from said second inlet (pH and CO2 partial pressure sensor at D16 is associated with body of gas exchanger 10 at inlet port 4; Figure 22; Paragraph 0069 and 0552), said first sensor detecting at least one input parameter of the fluid to be decapneized (pH and CO2 partial pressure sensor can be placed upstream between the pump D2 and gas exchanger 10 at D16; Figure 22; Paragraph 0552); and a second sensor associated with the containing body from said second outlet (pH and CO2 partial pressure sensor at D17 is associated with body of gas exchanger 10 from outlet port 5; Figure 22; Paragraph 0552), said second sensor detecting at least one output parameter of the fluid (pH and CO2 partial pressure sensor can be placed downstream from gas exchanger 10 at D17 for detection; Figure 22; Paragraph 0069 and 0552). Abel does not teach a first distance, a second distance, wherein the second distance is greater than or equal to the first distance and both the first distance and the second distance are greater than 1 cm, whereby the at least one input parameter and the at least one output parameter are not influenced by gas diffusion inside the decapneizer or a flow within the line for draining from the patient the fluid to be decapneized.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a first and second distance be greater than 1 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04)(IV)(A). In the instant case, the first and second sensors of Abel would not operate differently with the claimed first and second distances since it has the same function of measuring the input fluid and the output fluid with respect to the decapneizer/gas exchanger. Further, applicant places no criticality on the range claimed, indicating simply that the distance “can vary” and “about” within the claimed ranges (claim 1; page 6, lines 1-20 of the instant application’s specification). In the specification of the instant application at page 6, lines 1-20, the application discusses the first and second distance ranges and stating that “possible falsification of the parameters detected” may occur, however, does not clearly discuss any possibility of unexpected results when providing the first and second distances at the claimed ranges, for example, evidence of precision of CO2 partial pressure measurements when the first and second sensors are at a distance of greater than 1 cm versus at a distance less than 1 cm. The burden shifts to the applicant to provide evidence of unexpected results with the claimed first and second distances (MPEP 716.02).
The modified Abel teaches a first distance, a second distance, wherein the second distance is greater than or equal to the first distance and both the first distance and the second distance are greater than 1 cm, whereby the at least one input parameter and the at least one output parameter are not influenced by gas diffusion inside the decapneizer or a flow within the line for draining from the patient the fluid to be decapneized (see combination above – obvious that the first and second distance of the first and second sensor away from the gas exchanger will allow for the input and output parameter to be uninfluenced by gas diffusion).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Abel et al. (Publication No. US 2020/0338253 A1) in view of Brieske et al. (Publication No. US 2008/0171960 A1).
Regarding claim 3, Abel teaches the extracorporeal circuit of claim 1. Abel does not teach further comprising a haemofilter.
However, Brieske teaches further comprising a haemofilter (arterial filter 44; Figure 1; Paragraph 0023).
Abel and Brieske are both considered to be analogous to the claimed invention because they are in the same field of extracorporeal circuits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abel to incorporate the teachings of Brieske to have the arterial haemofilter of Brieske downstream of the first and second sensor of Abel in the extracorporeal circuit of Abel. This would allow for the enriched blood to be filtered through the filter before returning into the bloodstream of the patient (Brieske; Paragraph 0023; Figure 1).
The combination of Abel in view of Brieske further teaches wherein the first sensor and the second sensor are arranged upstream of the haemofilter (see combination above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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