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 April 27th, 2026. Claims 1-25 are canceled. Claims 26-50 are newly added.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of filaments of UHMWPE as a bundle of filaments with adhesive disposed between individual fibers must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 35 is 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.
The recitation of claim 35 is drawn to new matter in the disclosure, wherein the specification does not provide adequate support for the recitation therein to an UHMWPE bundle of filaments wherein adhesive is disposed between individual filaments of the bundle.
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 26-50 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.
Independent claims 26 and 42 recites the limitation "the filament". There is insufficient antecedent basis for this limitation in the claim.
It appears Applicant intends to recite “the at least one filament.”
Claims 28, 31-34, 36, 39, 40, 44, and 47-49 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.
Claims 28, 31-34, 36, 39, 40, 44, and 47-49 recite the limitation "the filament". There is insufficient antecedent basis for this limitation in the claim.
It appears Applicant intends to recite a combination of “the single, continuous filament” and “the at least one filament” as pertinently seen through each claim’s dependency (i.e. those claims going directly back to independent cl. 26/52 appear intended as “the at least one filament” and those claims going back to recitation of “single, continuous filament” appear intended as “the single, continuous filament”).
Claim 30 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.
The metes and bounds of the sensor of claim 30 are indefinitely defined herein. The claim sets forth a grouping to “…secured to one or more of…by welding, adhesive bonding…” in which the choices of “by welding” and “adhesive bonding” are incompatible with the set forth “secured to one or more of” as they are not places of securement, but are acts thereof.
These choices should be removed from the listing.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 35 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 35 provides particular discussion to UHMWPE filaments, whereas a plurality of UHMWPE filaments is not necessitated by the claim dependency. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
It appears that Applicant intends to recite something on the order of “…sensor of claim 29, wherein the plurality of filaments are formed from…”
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) 26-28, 31, 36, 38, 39, 41-44, 47 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, continuous filament as in cls. 27, 43; and secured to itself by adhesive as in cls. 28,44; pars.[0028-0033]) wound around the support structure and on top of the membrane for securing the gas-permeable membrane to the support structure (further noting that the act of winding is provided as implicitly seen through the disclosure of the winding filament, however, in terms of the device claim (and likewise throughout the dependent claims, the active step is not necessitated, and wherein Pierskalla provides such a wound disposition for the functionality of securing the membrane to the support structure) (pars.[0028-0033], figs. 1&2, for example). With regard to claims 27, 36, 43, 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]), and with respect to cl. 36 the recitation is drawn to a process recitation not afforded patentable weight (to the particular sequence of steps in welding after winding). With regard to claims 29, 30, 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). With regard to claim 41, Pierskalla discloses the carbon dioxide permeable membrane 18 has a thickness between 1 and 100 micrometers (par.[0037], fig. 8, for example) . With regard to claim 42, 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 27, 28, 43, and 44, Pierskalla discloses a singular filament that is secured to itself by an adhesive bonding (par.[0033]). With regard to claim 38, Pierskalla provides that the sensor body support structure 14 is cylindrical (par.[0029], cl. 1, fig. 2, for example). Further, with regard to claim 39, the recitation is not attributed patentable weight as it is drawn to process recitations within a device claim.
With regards to claims 26 and 42, 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 26 and 42, 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 31 and 47, Pierskalla does not specifically disclose that the material is low-density polyethylene.
With regards to claims 27 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) 38 and 39 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).
Pierskalla has been discussed above.
As discussed above, it is set forth that Pierskalla discloses a support structure that is cylindrical as in cl. 38 (see par.[0028], cl. 1, fig. 2) (and wherein the recitation of claim 39 is not attributed patentable weight as it is drawn to process recitations).
However, if it is taken that the support structure 14 of Pierskalla is not cylindrical, than such a modification would have been obvious to one of ordinary skill in the art.
Pierskalla discloses a cylindrical membrane 18 and a sensor cover 12 that covers and houses the support structure 14 and membrane 18 wherein such sensor cover may be C-shaped as well as other shapes.
By this, it would have been obvious to one of ordinary skill in the art through a routine engineering design choice to modify the shape of the support structure of Pierskalla to be cylindrical in providing a likewise shape to that of membrane that affords a suitable shape for their complementary engagement as likewise desired. Further, such 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.
Claim(s) 29, 30, 37, 45, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla in view of Rybak and Kane as applied to claims 26-28, 31, 36, 38, 39, 41-44, 47 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 a plurality of filaments wound around the support structure as in cl. 29/45 and secured to one or more of as those choices in cl. 30/46.
However, it would have been obvious to one of ordinary skill in the art through a routine engineering design choice to utilize a plurality of filaments, such as in a first and second filament in lieu of a singular filament for the proximal and distal sides 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).
With regard to claim 37, the recitation is drawn to a process recitation not afforded patentable weight in a device claim (to the particular sequence of steps in welding after winding).
Claim(s) 32-34, 40, 48, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla in view of Rybak and Kane as applied to claims 26-28, 31, 36, 38, 39, 41-44, 47 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.
Further, with regard to cls. 33, 40, the recitations are drawn to conditional process recitations not necessitated by the claim and not afforded patentable weight in a device claim, and wherein, as discussed above, the combined prior art provides to disclose the material of construction of the UHMWPE that is thus fully capable thereof in as much as recited and required herein.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierskalla in view of Rybak and Kane, as applied to claims 26-28, 31, 36, 38, 39, 41-44, 47 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.
Response to Arguments
Applicant's arguments filed April 27th, 2026 and January 20th, 2026 have been fully considered but they are not persuasive.
Initially, Examiner asserts that among the responses of April 27th, 2026 and January 20th, 2026, only the response of January 20th, 2026 provides substantive arguments to of the claims against the cited prior art.
However, the arguments presented within the response of January 20th, 2026 are drawn to a different claim set than presented herein.
Examiner will respond to those arguments as presented and as best construed with the newly-presented claims 26-50.
Applicant provides an argument to the whole of prior claims 1-17 (presented in non-compliant fashion in the response of January 20th, 2026) and asserts that the claims explicitly require filaments that are “wound” around the support structure “by the winding tension of the wound filament.”
Applicant asserts that this is fundamentally different from the attachment methods in the prior art wherein Kane discloses heat sealing/shrinking of an LDPE film layer to create a “mushroom” structure; Sengun discloses sutures for ligament repair, and Rybak discloses nylon thread but provides no teaching about maintaining a winding tension over time.
Applicant further asserts that Examiner’s interpretation that treats “wound around” as merely “physically disposed around” ignores the critical functional requirement of maintaining tension to secure the membrane.
With respect to claims 26-41 to the device, such interpretation is maintained and consistent with the claims wherein the claims are drawn to a device and no such process steps of winding and details thereto are necessitated or attributed patentable weight. Further, as will be discussed below, the prior art provides a commensurate “wound around” disposition and that also functionally provides for the recited securement.
With respect to the method of claims 42-50, the process steps to the winding and details thereof are positively provided and necessitated, and it will be shown that the prior art provides for such recited steps.
Initially, Examiner asserts that Applicant has pointed the prior art of Kane, Sengun, and Rybak with respect to purported deficiencies in the winding and securing, however, these references have not been relied upon for these features as seen through the Office Action of October 20th, 2025.
As presented in the Office Action of October 20th, 2025, it is seen that the primary reference of Pierskalla is not deficient in providing such winding of filament to secure the membrane to the support structure.
This is seen as in pars.[0028-0033] with respect to the winding filament 22, membrane 18, and sensor body 14, wherein it is provided the winding filament is provided around and over the carbon dioxide permeable membrane so as to secure the membrane to the support structure as claimed.
Pierskalla’s deficiency comes in that of lacking an explicit discussion at least two winds of the filament about the support structure and over the membrane (both in a physical disposition as in the device claim 26, and in the active step of “winding at least twice…” as in the method claim 42).
To this end, Examiner asserts that 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.
This is likewise applied, as seen in the prior Office Action of October 20th, 2025 with respect to that of the method (therein as cl. 5), and in which the disclosure of Pierskalla (i.e. pars.[0028-0033]) clearly provides that the winding filament is clearly, actively provided in a step of winding in order to secure the membrane to the support structure as likewise claimed.
Applicant further asserts that the Specification establishes that the claimed materials – particularly UHMWPE – provide unexpected results specifically for wound filament applications.
Applicant cites claims 18 and 24 as UHMWPE filaments achieve diameters of 25 microns and become even thinner when wound (specification page 11). Applicant asserts that this creates exceptionally flat winding profiles less than 30 microns thick and this ultra-thin capability is critical for minimizing sensor size in physiological applications.
Initially, Examiner asserts that claim 18 is drawn to UHMWPE having a diameter of 50microns or less when wound around the support structure, and claim 24 is drawn to UHMWPE providing a flat winding profile with a thickness of less than 30 microns when wound under tension, which does not coincide with cited achieving diameters of 25 microns and becoming even thinner when wound as purported.
Additionally, the specification at page 11 does not support this nor the particular dimensions cited.
Further, and with respect to the present claim listing, which does not include claims 18 and 24, a best correspondence is seen with respect to claims 34 and 40.
Furthermore, to the above, and likewise to the recitations presented in now-canceled claims 18 and 24, the recitations of claims 34 and 40 are predicated on conditional process recitations not actively necessitated or provided particular weight in a device claim (herein by way of “has a diameter of 50micrometers or less…when wound around…” and “provides a…having a thickness of less than 30 micrometers when wound under tension.”)
Lastly, Applicant’s general testaments to “provide unexpected results” and “ultra-thin capability is critical for…” are not persuasive as they are both not commensurate in scope with the claims and are not provided with substantive evidence thereto.
A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997). See also MPEP 2145.
As previously discussed in the prior Office Action, Sengun is provided as a secondary prior art that is analogous to the primary reference of Pierskalla in that Sengun is drawn to reinforcement filament/ribbon structures in biological application for holding and securing with a biocompatible material, and wherein 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.
Further, Applicant’s arguments toward purported long-term membrane sealing integrity and allowing epoxy infiltration are not substantive and wherein the claims do not necessitate or require any such timeframe of longevity.
Further, as discussed above, the analogous art of Sengun provides for the choosing of UHMWPE that also implicitly has such purported capabilities as cited by Applicant.
Applicant further asserts that the “reasonable expectation of success” with the alternative materials of construction to the filament(s) is improper.
Applicant asserts that a person of ordinary skill in the art would not expect a heat-shrinkable film to function as a winding filament.
Examiner asserts that the prior art of Kane, which is analogous art to that of a carbon dioxide sensor and provides a layer of low-density polyethylene formed by an annular heat seal around a disk of the sensor membrane, wherein an annular seal and a winding filament both share the property of being annular and capable of being conformed to a curved surface.
Further, as discussed above in the body of the action, 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.
It is thereby maintained that one of ordinary skill in the art would appreciate utilizing LDPE to the winding filament of Pierskalla.
Applicant further discussion to Kane’s purported “one-time seal” while the claimed filaments must maintain elastic tension indefinitely, and Sangun’s sutures experience cyclic loading in tissue, are not persuasive as they are not commensurate in scope with the claims.
Applicant further asserts that the claims require particular tension control, such as in prior claim 23.
Examiner asserts that the recitation of claim 23 is predicated on a conditional process recitation (its manufacture, sterilization, storage, and use) not afforded patentable weight in a device claim that is both not necessitated, as it is conditional, and further, not attributed patentable weight as it is drawn to process recitations within a device claim.
As discussed above, newly-added claims 26-34, and 36-50 are rejected over the cited prior art for at least these reasons as best-gleaned with respect to herein-canceled claims, and for those reasons provided in the body of the action.
Further, claims 26-50 are rejected under 35 USC 112 b/2nd paragraph for the reasons discussed above.
Claim 35 is rejected under 35 USC 112a/1st paragraph.
Claim 35 is rejected under 35 USC 112 d/4th paragraph.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tilson et al. (US 2020/0178763) discloses a device that can dynamically transition from a configuration of high flexibility to a configuration of high rigidity to help guide a medical device (par.[0004]). Tilson discloses that the rigidizing overtube has a tensile member as in a UHMWPE fiber bundle (implicitly providing adhesive between individual filaments of the bundle given that it is a fiber bundle), wherein the tensile member can be wrapped to provide capstan drag and boost the clamping force (pars.[0101,0110], for example).
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 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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798
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