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 .
Status of the Claims
The Amendment filed February 5, 2026 has been entered. Claims 1, 4, and 6-7 have been amended; claims 21-25 are new; and claims 2-3, 5, and 16-20 have been cancelled. Claims 1, 4, 6-15 and 21-25 are currently pending and are examined herein.
Status of the Rejection
New grounds of claim objection are necessitated by the amendment as outlined below.
The claim interpretation under 35 U.S.C. § 112(f) is modified in response to the amendment.
New grounds of claim rejection under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendment as outlined below.
All 35 U.S.C. § 102 and 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2025 and 6/1/2026 has been considered by the examiner.
Claim Objection
Claims 24-25 are objected to because of the following informalities:
Claims 24-25: please amend “manual input” to – the manual input--.
Appropriate correction is required.
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.
Claim 1, “a user actuatable member coupled to the second movable piston, wherein the user actuatable member is configured to receive manual input to cause relative movement between the first and second pistons”, is being interpreted under 35 U.S.C. 112(f) . Prong 1: a user actuatable member (uses the generic placeholder), prong 2: configured to receive manual input to cause relative movement between the first and second pistons (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). The corresponding structure for performing the functions is NOT described in the specification. The instant specification discloses: Instead, a user-actuatable mechanism 204 is used to generate the desired pressure in reference chamber 202. In one example, a piston 206 is depressed, or otherwise actuated, in cylinder 208 that is part of, or fluidically coupled to, reference chamber 202 to generate the desired pressure at the time of process start up [para. 0020 in PG-Pub]; Such pressurization is preferably done via a manual operation of a knob or user-actuatable pressure activation mechanism, such as mechanism 204 (shown in FIG. 3B) [para. 0027 in PG-Pub]; The sensor could include a spring member that is preloaded at the factory and that is released on-site to apply pressure to reference chamber. In another example, an unloaded spring member could be compressed via pushing on-site. In yet another example, an unloaded spring member could be compressed via pulling on-site. In still another example, an unloaded spring member could be compressed via a screw member on-site [para. 0032 in PG-Pub]; and an unloaded spring member could be compressed via pushing and twisting on-site. In another example, an unloaded spring member could be compressed via pulling and twisting on-site” [para. 0033 in PG-Pub]. Note that Figs. 3A-3B show the pressure activation mechanism 204 is coupled to the second movable piston 266. The specification does not disclose the structure of the user actuatable member which is a component of the pressure activation mechanism 204 coupled to the second movable piston, wherein the user actuatable member is configured to receive manual input to cause relative movement between the first and second pistons. Note that a manual operation of a knob is alternative to the user-actuatable pressure activation mechanism 204 as disclosed in [para. 0027], thus a knob is not a component of the user-actuatable pressure activation mechanism 204.
Claim 6, “a mechanical latching mechanism to lock position of the second movable piston”, is being interpreted under 35 U.S.C. 112(f) . Prong 1: a mechanical latching mechanism (uses the generic placeholder), prong 2: lock position of the second movable piston (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 6 invokes 112(f). The corresponding structure for performing the functions is described in the specification (paragraph [0030]) such as the installer pushes or pulls the piston cap while features on the cylinder body retain the cap as the user turns it 90 degrees. Alternatively, the cap could be retained by snap features without rotation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 6-15 and 21-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “the pressure activation mechanism having … a user actuatable member coupled to the second movable piston, wherein the user actuatable member is configured to receive manual input to cause relative movement between the first and second pistons”, and the specification/drawings do not support that the pressure activation mechanism having a user actuatable member, which is coupled to the second movable piston, wherein the user actuatable member is configured to receive manual input to cause relative movement between the first and second pistons. Figs. 3A-3B shows the pressure activation mechanism 204 is coupled to the second movable piston 266, and the specification does not disclose that the pressure activation mechanism has a component of a user actuatable member coupled to the second movable piston, wherein the user actuatable member is configured to receive manual input to cause relative movement between the first and second pistons. Claims 4, 6-15 and 21-25 depend on the independent claim 1, therefore, claims 1, 4, 6-15 and 21-25 are new matters.
Claims 23-25 recite “wherein the manual input includes rotation of a knob” (claim 23), “wherein the manual input includes pushing the second movable piston” (claim 24), and “wherein the manual input includes pulling the second movable piston” (claim 25). The specification does not support the user actuatable member is configured to receive manual input which includes rotation of a knob (claim 23), pushing the second movable piston (claim 24), and pulling the second movable piston (claim 25). Note that [para. 0027 in PG-Pub] discloses: Such pressurization is preferably done via a manual operation of a knob or user-actuatable pressure activation mechanism, such as mechanism 204 (shown in FIG. 3B). Thus, a manual operation of a knob is alternative to the user-actuatable pressure activation mechanism 204. Furthermore, the manual operation of a knob is different from the claimed rotation of a knob. Therefore, claims 23-25 are new matters.
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 1, 4, 6-15 and 21-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 1, claim 1 recites “a user actuatable member coupled to the second movable piston, wherein the user actuatable member is configured to receive manual input to cause relative movement between the first and second pistons”, which invokes 112(f) and the specification does not provide the corresponding structure for performing the functions above. Furthermore, claim 1 recites “the movement compresses the compression spring”, and is unclear if the movement refers to the movement of the first movable piston or the relative movement between the first and second pistons. Therefore, the scope of claim 1 is indefinite. Claims 4, 6-15 and 21-25 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding claim 7, claim 7 recites “The single-use electrochemical analytical sensor of claim 5”, and claim 5 is cancelled. It is unclear which claim does claim 7 depend upon. Therefore, the scope of claim 7 is indefinite. Claim 8 is further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of indefinite claim 7.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-8, filed 2/5/2026, with respect to the 35 U.S.C. § 102 and 35 U.S.C. § 103 rejections have been fully considered, and all 102 and 103 rejections have been withdrawn.
Applicant’s Argument #1:
Regarding claim 1, Applicant argues at pages 6-7 that the amended claim 1 includes the subject matter previously set forth in dependent claim 5 in addition to that of dependent claim 3. The dependent claim 5 was not rejected based on Neukum. The provision of a second movable piston is not mere duplication of parts. Instead, the movable second piston enables user actuation of the pressure activation mechanism.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but all prior art rejections have been withdrawn.
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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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