DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 02/27/2026.
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 .
Status of Claims
Claim(s) 1-22 is/are pending in the application.
Claim(s) 8-22 is/are withdrawn from further consideration
Claim(s) 1-7 is/are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 04/04/2023, 01/21/2026, and 04/14/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments filed on 02/27/2026 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to the drawing objection(s), Applicant’s amendment(s) to the claim(s) has/have overcome the objection(s).
With respect to the claim rejection(s) under 35 U.S.C. § 112(b), applicant's amendment(s) to the claim(s) has/have overcome the claim rejection(s).
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
In claim 1, “the arrangement of the measuring electrode and the at least one counter electrode is configured to allow for an evaluation of a current or voltage between the electrodes to infer the presence or absence of a fluid in the surrounding empty space” should read -- the arrangement of the measuring electrode and the at least one counter electrode is configured to allow for an evaluation of a current or voltage between the electrodes to infer the presence or absence of a fluid in [[the]] a surrounding of the empty space --.
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) 1-7 is/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 1 recites the limitation “the arrangement of the measuring electrode and the at least one counter electrode is configured to allow for an evaluation of a current or voltage between the electrodes to infer the presence or absence of a fluid in a surrounding of the empty space” which is indefinite. It is unclear if the claimed “fluid” same or different from the “disinfectant fluid” in the empty space introduced in line 4 of claim 1. The limitation has been examined below as if it read -- the arrangement of the measuring electrode and the at least one counter electrode is configured to allow for an evaluation of a current or voltage between the electrodes to infer the presence or absence of [[the disinfectant fluid in a surrounding of the empty space --.
Claim(s) 2-7 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof.
Claim 4 recites the limitation “at least on part of the outer wall of the inner pipe portion is provided with a coating made of a conductive material” which is indefinite. There is not sufficient antecedent basis for “outer wall of the inner pipe” in the claim. The limitation has been examined below as if it read -- at least on part of [[
Claim 6 recites the limitation “at least on part of the inner wall of the outer pipe portion is provided with a coating made of a conductive material” which is indefinite. There is not sufficient antecedent basis for “outer wall of the inner pipe” in the claim. The limitation has been examined below as if it read -- at least on part of [[
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 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 7 is/are rejected under 35 U.S.C 103 as being unpatentable over Hougaard (US PGPUB 20210008362) in view of Rush (US PGPUB 20050249606).
Regarding claim 1, Hougaard discloses an access system for a medical device (a medical tube coupling system (4+6) that can provide fluid communication between one or two sources of liquid: ¶0002, 0064; Figs. 1 and 4-6), which system has a housing body (a housing body of (4+6): Figs. 5-6) in which an inner pipe portion for transporting a medical fluid is formed (a first interior pipe 13 that is capable of transporting a medical fluid: ¶0066 and Figs. 5-6), which portion is enclosed by an outer pipe portion (a first exterior pipe 14: ¶0066 and Figs. 5-6) so as to form an empty space surrounding the inner pipe portion (a gap 45 between the first interior pipe 13 and first exterior pipe 14: ¶0080 and Fig. 6), the empty space being for receiving a disinfectant fluid (the empty space 45 is capable of receiving a disinfectant fluid: ¶0010-0011 and 0080), the housing body having an opening (an opening of the housing body, wherein the opening is connected to a proximal end 5 of a tube 3: Figs. 1 and 3).
Hougaard does not disclose a measuring electrode and at least one counter electrode are arranged in the housing body such that the measuring electrode interacts with the at least one counter electrode via the empty space, and the arrangement of the measuring electrode and the at least one counter electrode is configured to allow for an evaluation of a current or voltage between the electrodes to infer the presence or absence of the disinfectant fluid in a surrounding of the empty space.
In an analogous art for being directed to solve the same problem, assessing a flow condition of a fluid, Rush discloses a device for use in assessing a flow condition of a fluid or a fluid in a flow path (Abstract). Rush further discloses the device comprising a sensor 800 having a pair of electrodes in a flow path 200 (¶0071 and Fig. 6A), wherein the pairs of electrodes comprising a counter electrode and a working/measuring electrode (¶0029 and 0032) for the benefit(s) of detecting a current/voltage between electrodes and indicating the absence or presence of a fluid at the electrodes (¶0071).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the access system of Hougaard in view of Rush by incorporating a pair of electrodes in the housing body comprising a measuring electrode and a counter electrode such that the measuring electrode interacts with the counter electrode via the empty space, in order to detect a current/voltage between electrodes and indicate the absence or presence of a fluid at the electrodes, as suggested in ¶0071 of Rush. Thus, the arrangement of the measuring electrode and the one counter electrode of Hougaard in view of Rush is capable of allowing for an evaluation of a current or voltage between the electrodes to infer the presence or absence of the disinfectant fluid in a surrounding of the empty space.
Regarding claim 7, Hougaard further discloses the access system comprises a connector (a double lumen tube 3: ¶0064 and Figs. 1-2) which is capable of being inserted into the opening (Fig. 1) and which has a pipe portion that extends into the empty space (Fig. 1) and is capable of being connected to the inner pipe portion of the housing body in a fluid-tight manner (¶0019-0021 and Fig. 1: providing fluid communication), a connection point between the inner pipe portion of the housing body and the pipe portion of the connector being located in the empty space (Fig. 1).
Claim(s) 2 is/are rejected under 35 U.S.C 103 as being unpatentable over Hougaard (US PGPUB 20210008362) in view of Rush (US PGPUB 20050249606), as applied to claim 1 above, and further in view of Pudil (US PGPUB 20140217028) and Mathiesen (US PGPUB 20040059285).
Regarding claim 2, Hougaard/Rush does not disclose the measuring electrode is a pin which is electrically insulated from the housing body and extends into the empty space.
In an analogous art for being directed to solve the same problem, having electrodes to contact any fluid to measure the conductivity of fluid, Pudil discloses hemodialysis, hemofiltration, hemodiafiltration, and peritoneal dialysis systems having a dialysate regeneration system based on regenerative substances such as sorbent materials (Abstract and ¶0004). Pudil further discloses there are various electrode head geometries and all electrodes are used to contact any fluid to measure the conductivity of the fluid and pin electrode refers to a rod electrode with small diameter (¶0160).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Hougaard/Rush in view of Pudil by changing the shape of the measuring electrode to a pin electrode, in order to provide a contact to fluid to measure the conductivity of the fluid, as suggested in ¶0160 of Pudil and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). The prior art electrode would not perform differently than claimed measuring electrode having the pin-shape. Thus, the claimed measuring electrode is not patentably distinct from the prior art electrode. In addition, Examiner notes that Applicant places no criticality on the electrode shape claimed (the shape of the electrode is not disclosed in Applicant’s published application as having any unique advantages). Since the measuring electrode of Hougaard/Rush/Pudil is a pin, the pin electrode is capable of extending into the empty space.
Hougaard/Rush/Pudil does not disclose the measuring electrode is electrically insulated from the housing body.
In an analogous art for being directed to solve the same problem, providing an insulating sheath for electrode, Mathiesen discloses an apparatus is provided for injecting a fluid into body tissue (Abstract). Mathiesen further discloses to have an insulating sheath surrounded an electrode rod for the benefit of avoiding the production of edge effects by the electric field in use (¶0057).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the access system of Hougaard/Rush/Pudil in view of Mathiesen by incorporating an insulating sheath surrounded the pin electrode, in order to avoid the production of edge effects by the electric field in use, as suggested in ¶0057 of Mathiesen.
Claim(s) 3-6 is/are rejected under 35 U.S.C 103 as being unpatentable over Hougaard (US PGPUB 20210008362) in view of Rush (US PGPUB 20050249606), as applied to claim 1 above, and further in view of Roger (US PGPUB 20080065006).
Regarding claim 3, Hougaard/Rush does not disclose the at least one counter electrode is formed by at least one part of the inner pipe portion.
In the same field of endeavor, access system for a medical device, Roger discloses an access device (an electrical contact coupling device 80: ¶0072 and 0111) comprising an outer pipe portion (a probe member 82: ¶0111 and Figs. 2A-B) and an inner pipe portion (a channel 85: ¶0111 and Figs. 2A-B). Roger further discloses an electrode formed by at least one part of the inner pipe portion (an electrode 86 inserted into at least one part of the inner pipe portion 85: ¶0111 and Figs. 2A-B) for the benefit of providing an electrical connection and fluid contact with fluid flowing through a fluid circuit (¶0075).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the access system of Hougaard/Rush in view of Roger by having the at least one counter electrode formed by at least one part of the inner pipe portion, in order to provide an electrical connection and fluid contact with fluid flowing through a fluid circuit, as suggested in ¶0075 of Roger.
Regarding claim 4, Hougaard/Rush does not disclose at least one part of the inner pipe portion consists of a conductive material or at least one part of an outer wall of the inner pipe portion is provided with a coating made of a conductive material.
Roger further discloses the access device can be made of any suitable material such as stainless steel (¶0072; A person having ordinary skill in the art would have understood that stainless steel is a conductive material). From the teaching of Roger, a person having ordinary skill in the art would have recognized/deduced that making at least one part of the inner pipe portion with a conductive material yields the predictable result of enabling efficient transfer of electrical energy and signals across the access system.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the access system of Hougaard/Rush/Roger in view of Roger by making at least one part of the inner pipe portion with a conductive material, motivated by the desires to enable efficient transfer of electrical energy and signals across the access system, as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding claim 5, Hougaard/Rush does not disclose the at least one counter electrode is formed by at least one part of the outer pipe portion.
Roger further discloses an electrode formed by at least one part of the outer pipe portion (an electrode 86 inserted into at least one part of the outer pipe portion 82: ¶0111 and Figs. 2A-B) for the benefit of providing an electrical connection and fluid contact with fluid flowing through a fluid circuit (¶0075).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the access system of Hougaard/Rush in view of Roger by having the at least one counter electrode formed by at least one part of the outer pipe portion, in order to provide an electrical connection and fluid contact with fluid flowing through a fluid circuit, as suggested in ¶0075 of Roger.
Regarding claim 6, Hougaard/Rush does not disclose at least one part of the outer pipe portion consists of a conductive material or at least one part of an inner wall of the outer pipe portion is provided with a coating made of a conductive material.
Roger further discloses the access device can be made of any suitable material such as stainless steel (¶0072; A person having ordinary skill in the art would have understood that stainless steel is a conductive material). From the teaching of Roger, a person having ordinary skill in the art would have recognized/deduced that making at least one part of the outer pipe portion with a conductive material yields the predictable result of enabling efficient transfer of electrical energy and signals across the access system.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the access system of Hougaard/Rush/Roger in view of Roger by making at least one part of the outer pipe portion with a conductive material, motivated by the desires to enable efficient transfer of electrical energy and signals across the access system, as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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