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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/24/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 10/24/2024. As directed by the amendment, claims 1 and 4 have been amended, claims 5-8 have been cancelled, and claims 9-14 have been added. As such, claims 1-4 and 9-14 are pending in the instant application.
Applicant has amended claim 4 to address minor informalities; the previous objections to the claims are withdrawn.
Applicant has cancelled claim 5, rendering the previous rejections thereof under 35 USC 112 moot.
Applicant has amended claims 1-3 such that a person is no longer positively recited, and Applicant has cancelled claims 6-8; as such, the previous rejections under 35 USC 101 are withdrawn.
Application 16/894,703 has been abandoned/is no longer co-pending, and the claims of 17/140,040 were amended such that they no longer anticipate or render obvious the instant amended claims; as such, the double patenting rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 10/24/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive. [Note: Applicant’s arguments reference Bayron US 5,746,199, applied in the rejection of parent application 16/894,703, now abandoned, which are relevant because the instant claims have been amended include limitations from the claims of the parent application, such that Bayron is applicable as discussed in the updated rejections below.]
On page 6 of Remarks, regarding the limitations added to claim 1 and the Examiner’s rationale for why integrally connecting one end of a deployable tape to prevent detachment thereof when deploying would have been obvious to an artisan, Applicant argues “any invention can be rejected by stating a rationale for including an inventive feature” but then confusingly asserts that “[n]o rationale has been presented in the rejection that would lead one…to modify the teachings of all the relied upon references…hypothetical combination might combine a bladder cushion of Henry [note: Henry was not applied in the Final Rejection mailed 10/24/2024; it is presumed Applicant meant “Kumar”] with the sleeve wall in Walters and utilizing the tape (Bayron), but nothing would lead one…to utilize tape opposite the first end integrally connected to the sleeve in combination with the remaining claim features.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner maintains that it would have been obvious to an artisan for the tape (adhesive tag 519) of Walters Figs. 8A-B, when modified to be wrapped around and peelable off the end of the upper end of the sleeve as taught by Bayron (as applied in the rejections of the parent application and in the updated rejections below), to be integrally connected to the sleeve on one end of the tape in order to predictably prevent detachment of the tape from the sleeve e.g. when deploying the other end of the tape, because this arrangement was general knowledge to an artisan before the effective filing date of the claimed invention, as any person who has seen/used e.g. a tape diaper or similar tape deployment arrangements would know, and it would provide the predictable result of ensuring that the tape is maintained in place and does not become detached e.g. during deployment or transport. An artisan is not an automaton, see MPEP 2141.II.C, and they are allowed to use common sense when making rejections, particularly when the limitation in question is “unusually simple and particularly straightforward,” as noted by Applicant on page 7 of Remarks, and ensuring that one end of a deployable tape stays connected to the supporting substrate is extremely simply and very straightforward. However, in the interest of compact prosecution, the Examiner has included Hirsch in the rejections below, to provide an explicit teaching of this well-known and obvious tape configuration to solve the “problem” of providing a securely attached peelable tape fastener near the opening of a bag/sleeve for detachable yet retained deployment of the tape. As such, the amended claims remain rejected in view of prior art as discussed in the updated rejections below.
Applicant acknowledges on page 6 of Remarks that “hypothetical combination might combine a bladder cushion of [Kumar] with the sleeve wall in Walters and utilizing tape (Bayron)” but then asserts that “nothing would lead one…to utilize tape opposite the first end integrally connection to the sleeve in combination with the remaining claim features…such a rejection is a product of impermissible hindsight.”
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant does not dispute the modification of Walters to include a bladder cushion or wrapped tape; they seem to be asserting that since Walters and Bayron do not explicitly state that the second end of the tape is “integrally connected to the sleeve,” that such a common and well-known configuration would not have been obvious/would require improper hindsight to incorporate into modified Walters. The Examiner disagrees, as this configuration was general knowledge of artisans and produces predictable results without any need to consult the instant disclosure, as discussed above, and Hirsch has been provided in the rejection below as an explicit teaching of this well-known and obvious tape configuration.
On page 6 of Remarks, Applicant argues that there is “no motivation to combine…Bayron relates to a catheter and [Kumar] a bladder cushion…no suggestion in these references of the desirability to combine these references with one another…the rejection has not identified such a suggestion.”
The Examiner respectfully notes that the rejection is not based on a combination of Bayron and Kumar. Rather, the rejection is based on a modification of/combination with the base reference of Walters, which discloses a face-contacting surface and upper sleeve tape, to include a bladder cushion on the face-contacting surface as taught by Kumar and, separately, a wrapped/peelable tape configuration as taught by Bayron. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine flows from the teachings of the prior art regarding the same elements/constructions as instantly claimed, in order to provide the obvious benefits that flow from their inclusion into Walters, as discussed in the updated rejections below.
Applicant argues on page 8 of Remarks that the rejection in the parent application “lack[s] evidentiary foundation” and is “set forth based upon “common sense”,” asserting that “the structure and content of the argument is lacking evidentiary basis…[t]o the extent that the rejection [in the parent application] relies on official notice, Applicant does not acquiesce and requests documentary evidence.”
Hirsch has been provided as the requested “documentary evidence” in the rejection below to support the Examiner’s position that integrally connecting one end of the wrapped, peelable tape taught by Bayron to the sleeve of modified Walters would have been obvious to an artisan before the effective filing date of the claimed invention, in order to provide the predictable result of ensuring that the tape is maintained in place and does not become detached e.g. during deployment or transport. Additional “documentary evidence” regarding this well-known tape configuration can be found in the Conclusion section below.
Claim Interpretation
“A bottom” and “a top” of the mask per claims 1 and 9 is understood to correspond to the patient-contacting/rear side of the mask and the outward-facing/front side of the mask, respectively, when the mask is placed on the face of a patient, i.e. the “bottom” and “top” are assigned when the mask is oriented/positioned as shown in instant Fig. 2.
In light of the bottom of instant para [47], “integrally connected” is understood to mean “attached in a way that is not intended to be separated”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 9 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 9 positively recites the person’s face. To address this rejection, Applicant could amend the claim to read “the mask configured to form.
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 4 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the air cushion" in line 10. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “an air cushion”.
Regarding claim 12, it is unclear in the claim whether “an air cushion” refers to that of claim 4 or a different air cushion. As best understood, for purposes of examination, they are the same air cushion, such that Applicant could address this rejection by amending claim 12 to read “the air cushion”.
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, 2, 4, 9, 11, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Walters (US 2014/0041673 A1; hereinafter “Walters”) in view of Kumar et al. (US 2003/0047189 A1; hereinafter “Kumar”), Bayron et al. (US 5,746,199; hereinafter “Bayron”) and Hirsch (US 4,008,851; hereinafter “Hirsch”).
Regarding claim 1, Walters discloses an apparatus (bodily fluids guard, e.g. BFG 500) (e.g. Figs. 8A-B), comprising:
a mask (annulus 518) (where the annulus comprehends a mask because it covers at least part of a person’s face in use) configured to fit over a person's face configured for covering the person’s mouth (518…pushed against the patient’s face, para [0085]; i.e. similar to Fig. 2A or 11E);
an expandable hollow sleeve (flexible sleeve wall 516) (during extubation, the sleeve wall 516 will automatically be caused to unfold and extend around the tube 106 upon extubation, para [0085]; see the described expansion from Fig. 8A to 8B) connected to the mask (Figs. 8A-B; para [0085]); and
tape (adhesive tag 519) at an end of an expandable portion (upper portion in Fig. 8B) of the sleeve wherein one end of the tape (the free upper end) is configured to be off the sleeve and a second end of the tape (lower end) opposite the first end is connected to the sleeve (Fig. 8B).
While Walters acknowledges that breathing tubes can be inserted through the mouth or the nose (para [0076]), Walters is silent regarding the mask configured for covering the person’s mouth and nose. However, Kumar demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to provide a mask (mask 20) (Figs. 1-3) covering the person’s mouth and nose, to enable both oral and nasal access (e.g. paras [0013-14]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Walters such that the mask is configured for covering the person’s mouth and nose as taught by Kumar, in order to provide the predictable result of a single annulus/mask configured to allow for sanitary removal of both oral and/or nasal tubes for versatility and/or ease of ordering/inventory.
Walters further suggests that the sleeve is connected to a top of the mask (Fig. 8B; para [0085]), and the top would have been an obvious choice to an artisan before the effective filing date of the claimed invention to try out of the finite locations on annulus 518 in order to provide the functionality of Walters, particularly since this location would minimize external areas that could retain debris (e.g. by avoiding the channel that would form if the sleeve were connected lower inside the interior of the annulus than the top thereof).
Walter is silent regarding wherein the tape is wrapped around the sleeve, wherein the free end of the tape is configured to be peeled off the sleeve, and wherein the second end of the tape is integrally connected to the sleeve. However, Bayron teaches/suggests that it was known in the respiratory therapy art before the effective filing date of the claimed invention to utilize tape (seal forming adhesive tape 72) (Figs. 5-6) wrapped around an upper longitudinal end of an expandable hollow sleeve (bag-like attachment 60) for attaching the sleeve to a tubular medical component (fixture 70) (para [0067]), wherein one end of the tape is configured to be peeled off the sleeve (see the free end of 72 in Fig. 5), because it would have been obvious to an artisan before the effective filing date of the claimed invention for said free end to have been peeled off the sleeve, so as to have delivered the sleeve/tape in an initial, wrapped storage position around the sleeve, and wherein Bayron further suggests that the second end of the tape (see the attached end of 72 in Bayron Fig. 5) is integrally connected to the sleeve, because it would have been obvious to an artisan before the effective filing date of the claimed invention for said opposing end to be integrally connected to the sleeve in order to maintain it in position/prevent detachment/loss of the tape, because this was a well-established configuration for peelable, deployable tape before the effective filing date of the claimed invention, as demonstrated by Hirsch (Figs. 1-6; adhesive tape is relatively permanently attached at one end to a bag near the open end thereof and is strippably attached to the bag in the remaining portions, abstract; closure tap 16 is relatively permanently attached at one end 18 to bag 10, col. 2, lines 16-20). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Walters such that the tape at the end of the expandable portion of the sleeve is wrapped around the sleeve in said location, wherein one end of the tape is configured to be peeled off the sleeve and wherein the second/other end of the tape is integrally connected to the sleeve as taught/suggested by Bayron and reinforced by Hirsch, in order to provide the predictable results of an easily deployed, pre-stored tape means for allowing the mask/sleeve of Walters to be used in a sterile fashion (Bayron col. 7, lines 25-63), with one end integrally connected to the sleeve so as to predictably maintain the tape in position/prevent detachment/loss of the tape during transport and/or tape deployment.
Regarding claim 2, Walters in view of Kumar, Bayron and Hirsch teaches the apparatus as recited in claim 1, wherein Walter further discloses wherein the expandable hollow sleeve is folded up into a compressed state (Fig. 8A) and configured to unfold into an expanded state (Fig. 8B) (para [0085]).
Regarding claims 4 and 12, Walters discloses a method, comprising:
placing an endotracheal tube (breathing tube 106) in a mouth belonging to a patient (breathing tube 106, such as of a ETT or an LM device, para [0084]; intubation, para [0085], i.e. similar to Fig. 2A or 11E);
placing a sanitary extubation cover over the endotracheal tube (Fig. 8B; see also para [0085], i.e. similar to Fig. 11E), the sanitary extubation cover (bodily fluids guard, e.g. BFG 500) (e.g. Figs. 8A-B) comprising a mask (annulus 518) (where the annulus comprehends a mask because it covers at least part of a person’s face in use, i.e. similar to Fig. 2A or 11E) and an expandable hollow sleeve (flexible sleeve wall 516) (during extubation, the sleeve wall 516 will automatically be caused to unfold and extend around the tube 106 upon extubation, para [0085]; see expansion from Fig. 8A to 8B) connected to the mask (Figs. 8A-B; para [0085]), and tape (adhesive tag 519) at an end of an expandable portion (upper portion in Fig. 8B) of the sleeve wherein one end of the tape (the free upper end) is configured to be off the sleeve and a second end of the tape (lower end) opposite the first end is connected to the sleeve (Fig. 8B), the hollow sleeve configured to expand when pulled thereby providing an extended cover for contents therein (Fig. 8B; para [0085]);
placing the mask against a face belonging to the patient covering the patient’s mouth (518…pushed against the patient’s face, para [0085], i.e. similar to Fig. 11E);
removing the endotracheal tube from the mouth while the mask remains on the face, wherein, as the endotracheal tube is removed, the hollow sleeve expands and covers the endotracheal tube (during extubation, the sleeve wall 516 will automatically be caused to unfold and extend around the tube 106 upon extubation, para [0085]; see expansion from Fig. 8A to 8B in view of e.g. Fig. 11F);
removing the mask from the face (Fig. 8B; bodily fluids guard of Fig. 8A with an extubated breathing tube retracted and sealed therein for disposal, para [0044], where the BFG must be removed from the face in order to be thrown away as inferred by Walters); and
disposing of the sanitary extubation cover (bodily fluids guard of Fig. 8A with an extubated breathing tube retracted and sealed therein for disposal, para [0044]).
While Walters acknowledges that breathing tubes can be inserted through the mouth or the nose (para [0076]), Walters is silent regarding wherein the mask is connected to an air cushion and covering the mouth and nose, forming an airtight seal between the person’s face and the mask. However, Kumar demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention to provide a mask (mask 20) (Figs. 1-3) covering the person’s mouth and nose and an air cushion (soft seal 32) connected to the mask, forming an airtight seal between the person’s face and the mask (Figs. 2 and 4; abstract, para [0027]), to enable both oral and nasal access (e.g. paras [0013-14]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the method of Walters to include an air cushion connected to the mask and covering the person’s mouth and nose, forming an airtight seal between the person’s face and the mask as taught by Kumar, in order to provide the predictable result of a single annulus/mask configured to allow for sanitary removal of both oral and/or nasal tubes (for versatility and/or ease of ordering/inventory) and a comfortable patient-interfacing/sealing side for said annulus/mask that provides for sterile extubation using standard components.
Walter is silent regarding wherein the tape is wrapped around the sleeve, wherein the free end of the tape is configured to be peeled off the sleeve, and wherein the second end of the tape is integrally connected to the sleeve. However, Bayron teaches/suggests that it was known in the respiratory therapy art before the effective filing date of the claimed invention to utilize tape (seal forming adhesive tape 72) (Figs. 5-6) wrapped around an upper longitudinal end of an expandable hollow sleeve (bag-like attachment 60) for attaching the sleeve to a tubular medical component (fixture 70) (para [0067]), wherein one end of the tape is configured to be peeled off the sleeve (see the free end of 72 in Fig. 5), because it would have been obvious to an artisan before the effective filing date of the claimed invention for said free end to have been peeled off the sleeve, so as to have delivered the sleeve/tape in an initial, wrapped storage position around the sleeve, and wherein Bayron further suggests that the second end of the tape (see the attached end of 72 in Bayron Fig. 5) is integrally connected to the sleeve, because it would have been obvious to an artisan before the effective filing date of the claimed invention for said opposing end to be integrally connected to the sleeve in order to maintain it in position/prevent detachment/loss of the tape, because this was a well-established configuration for peelable, deployable tape before the effective filing date of the claimed invention, as demonstrated by Hirsch (Figs. 1-6; adhesive tape is relatively permanently attached at one end to a bag near the open end thereof and is strippably attached to the bag in the remaining portions, abstract; closure tap 16 is relatively permanently attached at one end 18 to bag 10, col. 2, lines 16-20). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Walters such that the tape at the end of the expandable portion of the sleeve is wrapped around the sleeve in said location, wherein one end of the tape is configured to be peeled off the sleeve and wherein the second/other end of the tape is integrally connected to the sleeve as taught/suggested by Bayron and reinforced by Hirsch, in order to provide the predictable results of an easily deployed, pre-stored tape means for allowing the mask/sleeve of Walters to be used in a sterile fashion (Bayron col. 7, lines 25-63), with one end integrally connected to the sleeve so as to predictably maintain the tape in position/prevent detachment/loss of the tape during transport and/or tape deployment.
Regarding claim 9, Walters in view of Kumar, Bayron and Hirsch teaches the apparatus as recited in claim 1, wherein Kumar further educates modified Walters to include an air cushion (soft seal 32) connected to the mask at a bottom of the mask forming an airtight seal between the person’s face and the mask (Kumar Figs. 2 and 4; abstract, para [0027]), in order to provide the predictable result of a comfortable patient-interfacing/sealing side for said annulus/mask that provides for sterile extubation using standard components.
Regarding claims 11 and 14, Walters in view of Kumar, Bayron and Hirsch teaches the apparatus and method as recited in claims 1 and 4, wherein Kumar further educates modified Walters to include wherein the mask further comprises a/at least one porthole (inflation valve, para [0027] and/or aperture 34) (Figs. 2-3; para [0028]), in order to provide the predictable result(s) of a standard means for providing for adjustable inflation of a/the air cushion and/or to allow discharge of exhaled gases, gas sampling and/or gas or oxygen delivery (Kumar para [0028]) during the extubation process disclosed by Walters.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Kumar, Bayron and Hirsch as applied to claim 1 above, and further in view of Erlich (US 4,772,275; hereinafter “Erlich”).
Regarding claim 3, Walters in view of Kumar, Bayron and Hirsch teaches the apparatus as recited in claim 1, but modified Walters is silent regarding wherein the expandable hollow sleeve is made out of a stretchable material. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Erlich teaches that it was known in the medical tube disposal cover art before the effective filing date of the claimed invention for an expandable hollow sleeve (sheath 22) (Fig. 2) for covering a medical tube (catheter 12) for disposal thereof (abstract) to be made out of a stretchable material (silicone elastomers, col. 4, lines 8). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the sleeve of modified Walters to be made out of a stretchable material as taught by Erlich, in order to provide the predictable result of a sleeve that is able to stretch, if necessary, to cover a large range of endotracheal tube lengths for aiding in sanitary extubation thereof.
Claim(s) 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Kumar, Bayron and Hirsch as applied to claims 1 and 4 above, and further in view of Jacobelli (US 5,660,174; hereinafter “Jacobelli”).
Regarding claims 10 and 13, Walters in view of Kumar, Bayron and Hirsch teaches the apparatus and method as recited in claims 9 and 12, but modified Walters is silent regarding wherein the air cushion is made/comprised of silicone. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Jacobelli demonstrates that it was standard before the effective filing date of the claimed invention for an air cushion (inflated cushion 8) (Fig. 5) to be made/comprised of silicone (col. 2, lines 53-64). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the air cushion of modified Walters to be made/comprised of silicone as taught by Jacobelli, in order to provide the predictable result of a soft/pliable, hypoallergenic patient-interfacing/sealing cushion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding wrapped, peelable tapes with one end integrally connected to the supporting substrate: Andersson et al. (US 2003/0014030 A1); Hong et al. (TW 202000256 A); Kido et al. (US 6,544,242 B1); Rutledge (WO 95/19259); Sanchez et al. (GB 2173770 A). Additional reference regarding an extendable sleeve for a face mask: O’Dea (WO 2021/191884 A1; e.g. Figs. 54-55 and 64-65).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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, Brandy Lee can be reached at 571-270-7410. 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.
/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785