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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on October 10th, 2025. Claims 1-17 are pending. Claims 11-17 are newly added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 10th, 2025 has been entered.
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.
Claims 7 and 13 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.
The metes and bounds of claim 7 are indefinitely defined as claim 7 recites “…wherein the at least one filament is a singular filament, and the method further comprises: securing the at least one filament…” that presents a contradiction to the established structure of a filament (i.e. singular filament).
This is likewise seen in claim 13.
Claim 11 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.
Similar to claim 7 discussed above, the metes and bounds of claim 11 are indefinitely defined as claim 7 recites “…wherein the at least one filament is a plurality of filaments, and the method further comprises: securing the at least one filament…” that presents a contradiction to the established structure of a plurality of filaments. Clarification is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-7, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla et al. (US 2021/0109079), hereafter Pierskalla, in view of Rybak (USPN 3,791,376) and Kane (US 2013/0323845).
With regard to claim 1, Pierskalla discloses a physiological sensor for measurement of carbon dioxide comprising a closed chamber (see outer housing enclosing the elements of the sensor as in fig. 2, for example) containing a sensor liquid 20, at least partially bounded by a carbon dioxide permeable membrane 18, at least two electrodes 16 provided within the chamber in contact with the sensor fluid, and a support structure 14 for supporting the membrane, and at least one filament 22 (and particularly as a singular filament) wound around the support structure and on top of the membrane for securing the gas-permeable membrane to the support structure (pars.[0028-0033], figs. 1&2, for example). With regard to claims 3 and 7, Pierskalla discloses a singular filament as the winding filament 22 and the winding of the filament disclosed in Pierskalla provides for securing by an adhesive, bonding, and crimping as fixation media (par.[0030,0033]). With regard to claim 4, Pierskalla discloses that the winding filament (i.e. singular, long filament) itself is wound around a proximal side of the of the closed chamber and a distal side of the closed chamber, wherein Examiner notes that such sides are broadly established herein and does not preclude the present arrangement in Pierskalla wherein the upper portion of the filament wind is given as a proximal side of the chamber and the lower portion of the filament wind is given as a side relatively distal to said proximal side (i.e. see fig. 1 in the cross-section, wherein the wind portion at the upper part is the proximal side of the chamber, and the wind portion opposite and spaced therefrom, being adjacent the numerical identifier ‘22’ is at the relatively distal portion of the chamber). This is similarly seen in the likewise application step as recited in claim 8. With regard to claim 5, and including the above relevant discussion, Pierskalla discloses applying the carbon dioxide permeable membrane over a support structure so as to define a closed chamber of the physiological sensor, and winding the filament around the support structure on top of the membrane so as to secure the membrane to the support structure (pars.[0011,0028-0033], figs 1-4, for example). With regard to claims 12 and 13, Pierskalla discloses a singular filament that is secured to one or more of the support structure or the carbon dioxide permeable membrane by a fixation medium (i.e. adhesive; par.[0033]).
With regards to claims 1 and 5, Pierskalla does not specifically disclose at least one filament wound at least twice as claimed.
However, it would have been obvious to one of ordinary skill in the art to modify Pierskalla to provide at least one filament wound at least twice as claimed through routine engineering and optimization in order to more securely retain the membrane to the support structure as likewise desired in Pierskalla, and wherein such a modification is seen as an obvious engineering design choice and/or optimization as the number of windings of the filament is a result effective variable to the amount of force applied for such securement of the membrane to the support and absent a showing of a criticality or unexpected results arising otherwise such a combination is seen as obvious for the reasons discussed above. See also MPEP 2144 VI, B.
Further, with regard to claims 1 and 5, Pierskalla does not specifically disclose that the at least one filament is formed from one of the materials as recited therein.
With regards to claims 2 and 6, Pierskalla does not specifically disclose that the material is low-density polyethylene.
With regards to claims 3 and 7, Pierskalla discloses a singular filament as winding filament 22 and securing the filament to the sensor body by a fixation medium, such as in an adhesive, but does not explicitly disclose securing the filament to itself using a fixation medium.
However, such a modification would have been obvious to one of ordinary skill in the art as a routine engineering design choice as an obvious alternative securement location that remains to provide the winding filament wrapped/surrounding the membrane body to secure it to the sensor body as likewise desired in Pierskalla. As discussed above, this is an obvious engineering design choice for the reasons discussed therein and absent a showing of a criticality or unexpected results arising otherwise.
Kane discloses a carbon dioxide sensor (abstract). Kane discloses a layer of low-density polyethylene formed by an annular heat seal around a disk of the sensor component (membrane) (pars.[0039,0040], for example).
Rybak discloses a microsonde for catheter use and for the continuous measurement of partial oxygen pressure wherein a gas permeable membrane 10 is secured by wrapped nylon thread 12 for proper functioning (lines 51-66, col. 2).
It would have been obvious to one of ordinary skill in the art to modify Pierskalla to utilize low-density polyethylene for the winding filament such as suggested by the analogous art of Rybak and Kane in a physiological sensor in which Rybak provides nylon, a thermoplastic and biocompatible, as a wrapped filament material for securing a membrane, and Kane provides another thermoplastic in LDPE and in application to surround the membrane sensor, which provides a suitable alternative thermoplastic material of construction that would have a reasonable expectation of success in securing a gas permeable membrane for proper functioning as likewise desired by Pierskalla.
Claim(s) 4, 8, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla in view of Rybak and Kane as applied to claims 1-3, 5-7, 12, and 13 above.
As discussed above, Pierskalla[Rybak/Kane] provides for winding a singular filament on a proximal side of the closed chamber and a distal side of the closed chamber, but Pierskalla[Rybak/Kane] does not specifically disclose utilizing first and second filaments for said proximal and distal sides respectively as in cls. 4 and 8, and similarly does not disclose a plurality of filaments as in cls. 10 and 11.
However, it would have been obvious to one of ordinary skill in the art through a routine engineering design choice to utilize a first and second filament in lieu of a singular filament for the proximal and distal sides, and likewise as in cls. 10&11 wherein Pierskalla already provides for securement of the filament to the support structure/carbon dioxide permeable membrane and accomplishing such with a plurality of filaments in lieu of one filament represents an obvious duplication of the parts for accomplishing a likewise desired effect (i.e. by multiple divided lengths as opposed to a singular, longer length filament), and wherein it would be readily apparent to one of ordinary skill in the art that additional filaments for winding would provide even greater securing of the membrane to the support structure as likewise desired in Pierskalla. Such a modification is seen as an obvious engineering design choice for the reasons discussed above and absent a showing of a criticality or unexpected results arising otherwise. See also MPEP 2144 VI, A-C.
Further, as previously discussed above, Examiner notes that such sides are broadly established herein and does not preclude the present arrangement in Pierskalla wherein the upper portion of the filament wind is given as a proximal side of the chamber and the lower portion of the filament wind is given as a distal side as it is distal relative to said proximal side (i.e. see fig. 1 in the cross-section, wherein the wind portion at the upper part is the proximal side of the chamber, and the wind portion opposite and spaced therefrom, being adjacent the numerical identifier ‘22’ is at the relatively distal portion of the chamber).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla in view of Rybak and Kane, as applied to claims 1-3, 5-7, 12, and 13 above, and in further view of Omtveit (US 2008/0319278).
Pierskalla/Rybak/Kane does not specifically disclose wherein the winding is performed whilst the support structure is submerged in a sensor fluid.
Omtveit discloses a physiological sensing device for measuring carbon dioxide (abstract, pars.[0001-0003,0103,0104]). Omtveit further discloses that during manufacturing the membrane is fixed onto the support while immersed in the de-ionised water and propylene glycol solution so that the chamber bounded by the membrane, electrodes, and ribs is completely filled with the liquid, and thus this chamber forms a partial pressure carbon dioxide sensor (par.[0108], fig. 2).
It would have been obvious to one of ordinary skill in the art to modify Pierskalla/Rybak/Kane to provide the winding of the filament is performed whilst the support structure is submerged in a sensor fluid such as taught by the analogous physiological sensor for carbon dioxide of Omtveit in order to provide a manufactured sensor that is completely filled with the liquid and thus the chamber forms a suitable and effective partial pressure carbon dioxide sensor.
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla in view of Rybak and Kane as applied to claims 1-3, 5-7, 12, and 13 above, and further in view of Sengun (US 2016/0175088).
Pierskall/Rybak/Kane does not specifically disclose that the at least one filament is formed from high-density polyethylene or ultra-high-molecular-weight polyethylene.
Sengun discloses reinforcement material in a ribbon portion attached or integrally formed with at least one suture tail (abstract). Sengun discloses that the reinforcement material can be formed from ultra-high-molecular-weight polyethylene or high-molecular-weight polyethylene (par.[0062], figs. 3,4, for example).
It would have been obvious to one of ordinary skill in the art to modify Pierskalla/Rybak/Kane to utilize the at least one filament formed from high-density polyethylene or ultra-high-molecular-weight polyethylene such as suggested by the analogous art of Sengun to reinforcement filament/ribbon structures in biological application for holding and securing and with biocompatible material in which the choosing of high-density polyethylene or ultra-high-molecular-weight polyethylene represents an obvious alternative choice of material of construction to likewise thermoplastics as in Rybak and Kane, and would have a reasonable expectation of success in Pierskalla/Rybak/Kane for the likewise desired purpose of retaining and securing the membrane to the sensor body.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection provided in view of the amendments to the claims.
Further, with regard to Rybak previously applied, Applicant asserts that the combination was improper as the combination operate in different dimensional and physiological domains.
Examiner asserts that the set forth teachings of Rybak utilized to inform Pierskalla are without any particular reliance on dimension and physiological domain. The disclosure of Rybak provides analogous subject matter in that a nylon filament is utilized in a physiological sensor as a securing means for the membrane and such a biocompatible material represents a material of construction that would have a reasonable expectation of success in securing a gas permeable membrane for proper functioning as likewise desired by Pierskalla.
Herein, with respect to the claims as amended, Examiner directs Applicant to the above-discussed new grounds of rejection.
At the base level, claims 1-3, 5-7, 12, and 13 are rejected under 35 USC 103 as being unpatentable over Pierskalla in view of Rybak and Kane (newly-applied).
The remaining dependent claims are rejected over the cited prior art and for the reasons discussed above in the body of the action.
Examiner further asserts that claims 7, 11, and 13, as amended, are rejected under 35 USC 112 b/2nd paragraph for the reasons discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden can be reached at 571 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEIL N TURK/Primary Examiner, Art Unit 1798