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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/15/2025 has been entered.
Status of the Claims
The amendment filed 10/15/2025 has been entered. Claim 1 has been amended and claim 2 has been cancelled. Claims 1 and 3-20 are currently pending, and claims 1 and 3-15 are examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome the 35 U.S.C. § 112(a) rejection previously set forth in the Final Rejection filed 9/26/2025.
All 35 U.S.C. § 103 rejections from the previous office action are maintained and modified only in response to the amendments to the claims.
New grounds of rejection under 35 U.S.C. § 102 are outlined below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1, “a pressure activation mechanism fluidically coupled to the reference chamber, the pressure activation mechanism having an at-rest configuration wherein there is no differential pressure to drive reference fluid through the reference junction, and an engaged configuration wherein the pressure activation mechanism generates continuous pressure within the reference chamber” is being interpreted under 35 U.S.C. 112(f). Prong 1: a pressure activation mechanism (uses the generic placeholder “mechanism”), prong 2: wherein there is no differential pressure to drive reference fluid through the reference junction […] wherein the pressure activation mechanism generates continuous pressure within the reference chamber (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the corresponding structure for performing the functions is described in the specification (paras. [0019, 0026], claim 3, and Fig. 3A-3B) such as pistons 206 and 266.
Claim 6, “a mechanical latching mechanism to lock the second movable piston in a pressurized position” is being interpreted under 35 U.S.C. 112(f). Prong 1: a mechanical latching mechanism (uses the generic placeholder “mechanism”), prong 2: to lock the second movable piston in a pressurized position (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 6 invokes 112(f). However, the corresponding structure for performing the functions is described in the specification (paras. [0012-0013] and Figs. 1A-1B) such as locking member 110.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, and 12-13 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Neukum (US 5139641 A).
Regarding claim 1, Neukum teaches a single-use electrochemical analytical sensor (the pH measuring chain in Fig. 1 for measuring liquid substances [col. 4, lines 14-26; col. 5, lines 33-39]) comprising:
a sensing electrode configured to contact process fluid (pH measuring electrode 11 in Fig. 1 contacts the substance to be measured [col. 4, lines 14-26]);
a reference chamber containing an electrolyte (electrolyte vessel 23 in Fig. 1 [col. 5, lines 1-14]);
a reference electrode disposed in the electrolyte (electrode insert 27 is immersed in the electrolyte in Fig. 1 [col. 5, lines 1-14]);
a reference junction configured to contact the process fluid (diaphragm 30 in Fig. 1 contacts the medium to the examined [col. 5, lines 26-32 and lines 40-55]), the reference junction being further configured to generate a flow of electrolyte into the process fluid (electrolyte fluid escapes from the electrolyte chamber through diaphragm 30 [col. 2, lines 35-49]);
a pressure activation mechanism fluidically coupled to the reference chamber (piston 22 in Fig. 1 [col. 4, lines 59-68]), the pressure activation mechanism having an at-rest configuration, and an engaged configuration (pressure is introduced in the reference chamber by the piston only when the pH measuring chain is in operation [col. 4, lines 5-13 and 53-58]).
The limitation “wherein there is no differential pressure to drive reference fluid through the reference junction” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Neukum teaches a pressure activation mechanism with an at-rest configuration that is configured to perform the functional limitations above (pressure is introduced in the reference chamber by the piston only when the pH measuring chain is in operation [col. 4, lines 5-13 and 53-58]).
The limitation “wherein the pressure activation mechanism generates continuous pressure within the reference chamber” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Neukum teaches a pressure activation mechanism with an engaged configuration that is configured to perform the functional limitations above (pressure is introduced in the reference chamber by the piston only when the pH measuring chain is in operation [col. 4, lines 5-13 and 53-58]).
The limitation “wherein the pressure activation mechanism is user-actuatable to transition from the at-rest configuration to the engaged configuration” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Neukum teaches a pressure activation mechanism that is configured to perform the functional limitations above (pressure is introduced in the reference chamber by the piston only when a user operates the pH measuring chain [col. 4, lines 5-13 and 53-58]).
Regarding claim 3, Neukum teaches the single-use electrochemical analytical sensor of claim 1, and further teaches wherein the pressure activation mechanism includes: a first movable piston (piston 22 in Fig. 1) disposed to generate pressure within the reference chamber with movement of the first movable piston (piston 22 generates pressure in the electrolyte vessel 25 [col. 5, lines 56-60]).
Regarding claim 12, Neukum teaches the single-use electrochemical analytical sensor of claim 1, and further teaches wherein the reference junction is a porous disc (diaphragm 30 has a porous structure [col. 5, lines 59-60]).
Regarding claim 13, Neukum teaches the single-use electrochemical analytical sensor of claim 12, and further teaches wherein the disc is constructed of a material selected from the group consisting of ceramic and polymer (diaphragm 30 is formed from ceramic material [col. 5, lines 26-32]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 20190264161 A1) in view of Fletcher et al. (US 20020189943 A1).
Regarding claim 1, Hu teaches a single-use electrochemical analytical sensor (pH sensor 100 in Fig. 5A) comprising:
a sensing electrode configured to contact process fluid (pH glass electrode 142 in Fig. 5A is exposed to the process [0030]);
a reference chamber containing an electrolyte (reference fill cavity 154 in Fig. 5A is filled with a suitable liquid or gelled electrolyte [0031]);
a reference electrode (reference electrode 152 in Fig. 5A) disposed in the electrolyte (reference electrode is disposed within a reference electrolyte in claim 9);
a reference junction (reference junction 150 in Fig. 5A) configured to contact the process fluid (reference junction is exposed to the process [0030]), the reference junction being further configured to generate a flow of electrolyte into the process fluid (reference junction has sufficient porosity to support the flow of ions from reference fill cavity into the process [0031]).
Hu is silent to the limitation wherein the sensor further comprises a pressure activation mechanism fluidically coupled to the reference chamber, the pressure activation mechanism having an at-rest configuration wherein there is no differential pressure to drive reference fluid through the reference junction, and an engaged configuration wherein the pressure activation mechanism generates continuous pressure within the reference chamber; and wherein the pressure activation mechanism is user-actuatable to transition from the at-rest configuration to the engaged configuration.
Fletcher teaches an electrochemical analytical sensor (pH sensor 10 in Fig. 1A [0011, 0021]) with a pressurized reference chamber (pressurized reservoir 20 and the reservoir in lower housing 14 in Fig. 1A [0021]) containing an electrolyte (electrolyte 22 in Fig. 1A [0021]), wherein a reference electrode is disposed in the electrolyte (reference electrode 34 is in contact with the electrolyte in Fig. 1A [0008, 0021]), and a reference junction (external junction 26 in Fig. 1A [0021]), wherein a pressure activation mechanism is fluidically coupled to the reference chamber (spring 16 and piston 18 are affixed to the top of reservoir 20 to pressurize the electrolyte 22 in reservoir 20 to flow into the reservoir in lower housing 14 in Fig. 1A [0021, 0024]). Fletcher further teaches that this pressure activation mechanism pressurizes the internal electrolyte such that the process fluid does not flow back into the reference chamber via the reference junction [0031, 0034].
Hu and Fletcher are both considered analogous to the claimed invention because they are in the same field of pH sensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference chamber in Hu by fluidically coupling a pressure activation mechanism to the reference chamber (i.e., by affixing a spring and piston to the top of the reference chamber), as taught in Fletcher, since this would prevent process fluid from flowing back into the reference chamber via the reference junction [0031, 0034 in Fletcher]. With this modification, the spring and piston are affixed to the top of reference fill cavity 154 in Fig. 6A of Hu, such that the spring and piston are coupled to the movement of the plunger (plunger 134 in Fig. 3A of Hu). Therefore, the pressure activation mechanism has an at-rest configuration wherein there is no differential pressure to drive reference fluid through the reference junction to allow the user to fill the chamber with electrolyte (the configuration associated with Fig. 6A [0035 in Hu]) and an engaged configuration wherein the reference chamber is sealed (the configuration associated with Fig. 6B [0035 in Hu]). Furthermore, Fletcher teaches the claimed improvement as a known technique that is applicable to the base device in Hu. One skilled in the art could have applied the pressure activation mechanism fluidically coupled to the reference chamber in Fletcher in the same way to the base device in Hu, yielding predictable results (MPEP 2143(I)(D)).
The limitation “wherein the pressure activation mechanism does not generate pressure within the reference chamber” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Hu teaches a pressure activation mechanism with an at-rest configuration that is configured to perform the functional limitations above (as stated in the modification above, the pressure activation mechanism has an at-rest configuration associated with Fig. 6A in Hu wherein there is no differential pressure to drive reference fluid through the reference junction to allow the user to fill the chamber with electrolyte [0035 in Hu]).
The limitation “wherein the pressure activation mechanism generates continuous pressure within the reference chamber” is a functional recitation. In the instant case, modified Hu teaches a pressure activation mechanism with an engaged configuration that is configured to perform the functional limitations above (as stated in the modification above, the pressure activation mechanism has an engaged configuration associated with Fig. 6B in Hu wherein the reference chamber is sealed [0035 in Hu], and the spring and piston, upon sealing, continuously pressurize the electrolyte the reference chamber by the initial actuation of the piston [0021, 0024 in Fletcher]).
The limitation “wherein the pressure activation mechanism is user-actuatable to transition from the at-rest configuration to the engaged configuration” is a functional limitation. In the instant case, modified Hu teaches a pressure activation mechanism that is configured to perform the functional limitations above (the plunger is user-actuatable [0024 in Hu], such that the pressure activation mechanism switches from the at-rest configuration to the engaged configuration in response to user input).
Regarding claim 3, modified Hu teaches the single-use electrochemical analytical sensor of claim 1, and further teaches wherein the pressure activation mechanism includes: a first movable piston (piston 18 in Fig. 1A [0021 in Fletcher]) disposed to generate pressure within the reference chamber with movement of the first movable piston (spring 16 and piston 18 pressurize the electrolyte 22 in reservoir 20 to flow into the reservoir in lower housing 14 in Fig. 1A by actuating the piston [0021, 0024 in Fletcher]).
Regarding claim 4, modified Hu teaches the single-use electrochemical analytical sensor of claim 3, but is silent to the limitation wherein an O-ring seal is disposed about the first movable piston.
Hu teaches an O-ring seal disposed about a movable piston (sealing element 158 disposed about plunger 134 in Fig. 6B is an O-ring [0031]), wherein using an O-ring seal disposed about a piston is a common method for achieving a proper seal between the piston and surrounding wall [0031, 0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first movable piston in modified Hu by disposing an O-ring seal about the first movable piston, as taught in Hu, since this would achieve a proper seal between the piston and surrounding wall [0031, 0036 in Hu]. Furthermore, Hu teaches the claimed improvement as a known technique that is applicable to the base device in modified Hu. One skilled in the art could have applied the O-ring seal disposed about the piston in Hu in the same way to the base device in modified Hu, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 5, modified Hu teaches the single-use electrochemical analytical sensor of claim 3, but is silent to the sensor further comprising a second movable piston, the second movable piston being spaced from the first movable piston by a spring.
However, to incorporate a piston on both ends of the spring (spring 16 in Fig. 1A in Fletcher) instead of only the end of the spring facing the electrolyte, such that a second movable piston is spaced from the first movable piston by a spring would constitute a mere duplication of parts that would yield a predictable result. It has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B).
Regarding claim 6, modified Hu teaches the single-use electrochemical analytical sensor of claim 5, but is silent to the sensor further comprising a mechanical latching mechanism to lock the second movable piston in a pressurized position.
Hu teaches a mechanical latching mechanism (slide lock 120 in Fig. 2) used to lock the movement of the sensor plunger during operation [0027]. This ensures that the internal pressure of the process being measured does not push the plunger back [0020].
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to modify the second movable piston in modified Hu by adding a slide lock, as taught in Hu, since this would ensure that the internal pressure of the process being measured would not push the piston back [0020 in Hu]. Furthermore, the claimed limitation of a mechanical latching mechanism to lock the second movable piston in a pressurized position is obvious because Hu teaches the claimed improvement as a known technique that is applicable to the base device in modified Hu. One skilled in the art could have applied the slide lock in Hu in the same way to the base device in modified Hu, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 7, modified Hu teaches the single-use electrochemical analytical sensor of claim 5.
The limitation “wherein the spring is configured to move the first movable piston away from the second movable piston as the electrolyte flows into the process fluid to maintain pressure in the electrolyte” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Hu teaches a single-use electrochemical analytical sensor that is configured to perform the functional limitations above (the compression axis of the spring is aligned parallel to the longitudinal axis of the reference chamber [spring 16 in Fig. 1A in Fletcher]. Therefore, in the configuration taught in the rejection of claim 5, the compressed spring would automatically move the first movable piston away from the second movable piston as the electrolyte flows into the process fluid. This would inherently maintain pressure in the electrolyte).
Regarding claim 8, modified Hu teaches the single-use electrochemical analytical sensor of claim 7, and further teaches a sidewall of the sensor (the sidewall of plunger 134 in Fig. 3A in Hu) containing the first movable piston (as detailed in the rejection of claim 1, the first piston is positioned within the reference chamber of the plunger).
Modified Hu is silent to the limitation wherein a sidewall of the sensor containing the first movable piston is constructed from a material that allows a position of the first movable piston to be viewed through the sidewall.
Hu teaches that a sidewall of a sleeve containing a movable piston (plunger sleeve 114 containing plunger 134 in Fig. 3A) is transparent, such that a user can observe operations inside the sleeve [0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sidewall of the sensor containing the first movable piston in modified Hu by making the sidewall out of a transparent material, as taught in Hu, since this would allow a user to observe operations inside the sleeve [0035 in Hu]. Furthermore, Hu teaches the claimed improvement as a known technique that is applicable to the base device in modified Hu. One skilled in the art could have applied the transparent sidewall material in Hu in the same way to the base device in modified Hu, yielding predictable results (MPEP 2143(I)(D)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Regarding claim 9, modified Hu teaches the single-use electrochemical analytical sensor of claim 1, and Hu further teaches wherein the electrolyte is a gel (reference fill cavity is filled with a suitable gelled electrolyte [0031 in Hu]).
Regarding claim 10, modified Hu teaches the single-use electrochemical analytical sensor of claim 1, but is silent to the limitation wherein the reference chamber comprises a primary reference chamber coupled to the reference junction and a secondary reference chamber coupled to the pressure activation mechanism, wherein the primary reference chamber and secondary reference chamber are fluidically coupled.
Fletcher further teaches that the reference chamber (pressurized reservoir 20 and the reservoir in lower housing 14 in Fig. 1A [0021]) comprises a primary reference chamber coupled to the reference junction (the reservoir in lower housing 14 is coupled to external junction 26 in Fig. 1A [0021]) and a secondary reference chamber coupled to the pressure activation mechanism (pressurized reservoir 20 is coupled to piston 18 in Fig. 1A [0021]), wherein the primary reference chamber and secondary reference chambers are fluidically coupled (fluid electrolyte 22 flows from reservoir 20 to the reservoir in lower housing 14 through porous member 24 in Fig. 1A [0021]). Fletcher further teaches that having these two chambers separated by a porous member enables control of the electrolyte flow rate [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference chamber in modified Hu by dividing the reference chamber into primary and secondary reference chambers separated by a porous member, such that the primary reference chamber is coupled to the reference junction and the secondary reference chamber is coupled to the pressure activation mechanism, as taught in Fletcher, since this would enable control of the electrolyte flow rate [0030 in Fletcher]. Furthermore, Fletcher teaches the claimed improvement as a known technique that is applicable to the base device in modified Hu. One skilled in the art could have applied the two-part reference chamber in Fletcher in the same way to the base device in modified Hu, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 11, modified Hu teaches the single-use electrochemical analytical sensor of claim 10, and further teaches wherein the secondary reference chamber includes the electrolyte (fluid electrolyte 22 flows from reservoir 20 to the reservoir in lower housing 14 through porous member 24 in Fig. 1A, such that both reservoirs contain electrolyte [0021 in Fletcher]).
Regarding claim 12, modified Hu teaches the single-use electrochemical analytical sensor of claim 1, and Hu further teaches wherein the reference junction is a porous disc (circular reference junction 150 in Fig. 5A is porous [0031 in Hu]).
Regarding claim 13, modified Hu teaches the single-use electrochemical analytical sensor of claim 12, and Hu further teaches wherein the disc is constructed of a material selected from the group consisting of ceramic and polymer (reference junction is formed from ceramic [0031 in Hu]).
Regarding claim 14, modified Hu teaches the single-use electrochemical analytical sensor of claim 1, and Hu further teaches the sensor comprising a downstream flowthrough process coupling operably coupled to the sensor (pH sensor is operably coupled to a bioreactor bag flange 102 in Fig. 1A [0023 in Hu]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Fletcher, as applied to claim 14, and further in view of Fadell et. al (US 9562819 B2).
Regarding claim 15, modified Hu teaches the single-use electrochemical analytical sensor of claim 14, but is silent to the limitation wherein at least one of the sensor and the process coupling are sterilized.
Fadell teaches a polymeric seal system for coupling a single-use bioreactor to a sensing instrument [col. 2, lines 39-42]. The process- and instrument-side couplings are formed of radiation sterilizable polymer [col. 2, lines 50-57], so the bioreactor/coupler system can be pre-sterilized using radiation prior to use, minimizing the number of steps required for an end user setting up the system [col. 6, lines 32-36].
Modified Hu and Fadell are both considered analogous to the claimed invention because they are in the same field of sensors for single-use bioreactors. It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to modify the bioreactor bag flange in modified Hu by constructing the flange with a radiation sterilizable polymer, as taught in Fadell, since this would allow the bioreactor/coupler system to be pre-sterilized prior to use and minimize the number of steps required for an end user setting up the system ([col. 6, lines 32-36] in Fadell).
The limitation “wherein at least one of the sensor and the process coupling are sterilized” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Hu modified by Fadell teaches the electrochemical sensor that is configured to perform the functional limitations above, as the process coupling (bioreactor bag flange) is radiation sterilizable ([col. 2, lines 50-57] in Fadell).
Response to Arguments
Applicant's arguments, see Remarks pgs. 5-7, filed 10/15/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered and are not persuasive.
Applicant’s Argument #1:
Applicant argues on pgs. 5-7 that neither Hu nor Fletcher teach all of the claimed limitations of amended claim 1, particularly “the pressure activation mechanism having an at-rest configuration wherein there is no differential pressure to drive reference fluid through the reference junction, and an engaged configuration wherein the pressure activation mechanism generates continuous pressure within the reference chamber.”
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. Hu or Fletcher individually do not teach a pressure activation mechanism with at-rest and engaged configurations. However, the combination of the teachings of Hu and Fletcher results in the amended limitations, including the pressure activation mechanism from Fletcher resulting in at-rest and engaged configurations based on the user-actuation of the piston in Hu (see the 103 rejection of claim 1 above).
Applicant’s Argument #2:
Applicant argues on pg. 7 that because claims 3-15 depend on independent claim 1, if independent claim 1 is allowable, dependent claims 3-15 are likewise allowable.
Examiner’s Response #2:
Based on the above response #1, applicant’s arguments regarding the amended claim 1 are not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
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