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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 03/28/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 1/09/2025. As directed by the preliminary amendments, claims 1-51 have been cancelled and claims 52-71 have been added. As such, claims 52-71 are being examined in this application.
Drawings
The drawings are objected to because the first side, second side, third side and fourth side of the fixation element, central column of successive arcuate cuts and pair of side columns of successive arcuate cuts of claim 1 and first face of the first interface body and second face of the second interface body of claim 69 does not have a reference number. 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 Objections
Claim(s) 69 is/are objected to because of the following informalities:
Claim 69, lines 1-3, recites “…wherein the first attachment structure is on a first face of the first interface body and the second attachment structure is on a second face of the first interface body…” but should recite “…wherein the first attachment structure is on a first face of the first interface body and the second attachment structure is on a second face of the second interface body…” as seen in Fig. 3 of applicant’s drawings.
Appropriate correction 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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claim(s) 52-55 and 57-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20140000626 A1) in view of Kooij (US 20100000534 A1).
Regarding claim 52, O’Connor teaches a fixation structure (dermal patch 550, and first part 553, see Figs. 15-17) configured to cooperate with a patient interface to secure the patient interface on a face of a patient (see Figs. 15-17 and [0584] and [0591]), the fixation structure comprising:
a body (dermal patch 550 comprises a body as seen in Fig. 17) comprising:
a first edge (first edge, see O’Connor Annotated Fig. 17);
a second edge (second edge, see O’Connor Annotated Fig. 17) opposite the first edge (see O’Connor Annotated Fig. 17), the second edge being rounded (see O’Connor Annotated Fig. 17), the second edge being wider than the first edge (the second edge is wider than the first edge as seen in O’Connor Annotated Fig. 17);
a third edge (third edge, see O’Connor Annotated Fig. 17) extending between the first edge and the second edge (see O’Connor Annotated Fig. 17);
a fourth edge (fourth edge, see O’Connor Annotated Fig. 17) opposite the third edge, the fourth edge extending between the first edge and the second edge (see O’Connor Annotated Fig. 17);
a patient-facing region configured to adhere to skin of the patient (dermal patch 550 has a patient-facing region that is adhered to the patient’s skin as seen in Figs. 15-17 and [0598]); and
an interface-facing region opposite the patient-facing region (dermal patch 550 has an interface-facing region, which faces the user interface, opposite the patient facing region as seen in Figs. 15-17 and [0598]), the interface- facing region comprising a fixation element (first part 553, see Fig. 17), the fixation element comprising:
a hooked fastener attachable to a complementary looped attachment structure on a patient-facing surface of the patient interface (O’Connor teaches the two-part releasable attachment or connection arrangement 551, which comprises of first part 553 and user interface patch 552, may comprise a hook and loop material as a fastener as seen in Figs. 15-17 [0601] and [0602]);
a first side (first side, see O’Connor Annotated Fig. 17);
a second side (second side, see O’Connor Annotated Fig. 17) opposite the first side, wherein the first side of the fixation element is closer to the first edge of the body than the second side of the fixation element is to the second edge of the body (see Figs. 15-17 where the first side of the first part 553 is closer to the first edge of dermal patch 550 than the second side of the first part 553 is to the second edge of dermal patch 550 as there is a bigger gap between the first side and the first edge than the second side and the second edge. This is especially since the first side and first edge holds the nasal prong to the user’s nose as seen in Figs. 15-16);
a third side (third side, see O’Connor Annotated Fig. 17) extending between the first side and the second side (see O’Connor Annotated Fig. 17);
a fourth side (fourth side, see O’Connor Annotated Fig. 17) opposite the third side, the fourth side extending between the first side and the second side (see O’Connor Annotated Fig. 17); and
a plurality of cuts extending through the fixation element (O’Connor teaches the first part 553 is divided by at least one slit or slot into regions as seen in Fig. 36l and [0608]-[0609] and [0635]-[0636])
wherein the plurality of cuts are arranged in a pattern of:
a central column of successive arcuate cuts that extend between the first side and the second side, the central column of successive arcuate cuts oriented in a first direction (see Fig. 36l wherein slits 3351 is a central column of successive arcuate cuts that extend between the first side and the second side and is oriented in a first direction), and
a pair of side columns of successive arcuate cuts arranged on either side of the central column of successive arcuate cuts, the pair of side columns of successive arcuate cuts oriented in a second direction generally opposite the first direction, wherein the pair of side columns of successive arcuate cuts extend inwardly from the third side and the fourth side respectively and are offset with respect to the central column of successive arcuate cuts (see Fig. 36l wherein slits 3350 is a pair of side columns of successive arcuate cuts arranged on a side of slits 3351 that is oriented in a second direction opposite the first direction. Furthermore, slits 3350 extend inwardly from the third and fourth side respectively and is offset with respect to slits 3351 as seen in Fig. 36l).
But does not teach the first edge being rounded;
the third edge and the fourth edge being concave with respect to a central longitudinal axis of the body
O’Connor Annotated Fig. 17
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However, Kooij teaches the first edge being rounded (see Kooij’s Annotated Fig. 2);
the third edge and the fourth edge being concave with respect to a central longitudinal axis of the body (see Kooij’s Annotated Fig. 2).
Kooij’s Annotated Fig. 2
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Kooij teaches a patient adhesive strip 2010 (taken as fixation structure) as seen in Fig. 2 and [0125] and O’Connor teaches the dermal patch can take other shapes as seen in [0604]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fixation structure taught by O’Connor to use the shape of the fixation structure as taught by Kooij as it will allow more degrees of freedom in placing the structure on the patient’s face by being contoured so as to avoid the eye area. Furthermore, the further wider area near the second edge would aid in securing device and the narrower portion near the first edge would allow the structure to fit better in the center of the first where there is less area to adhere to.
Regarding claim 53, O’Connor in view of Kooij teaches the structure of claim 52, and O’Connor further teaches wherein the patient-facing region comprises an adhesive (O’Connor teaches the dermal patch to have a dermatologically sensitive adhesive (such as a hydrocolloid for example) that attaches or adheres the dermal patch to a user's skin as seen in [0148]).
Regarding claim 54, O’Connor in view of Kooij teaches the structure of claim 53, but does not teach wherein the adhesive is silicone-based.
However, Kooij further teaches the adhesive can be silicone gel or hydrocolloid as seen in [0273] and [0283].
Kooij teaches a patient adhesive strip 2010 (taken as fixation structure) as seen in Fig. 2 and [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fixation structure taught by O’Connor in view of Kooij to use a silicone gel adhesive instead of hydrocolloid as taught by Kooij as a known adhesive within the art that can also promote skin healing (see [0283]).
Regarding claim 55, O’Connor in view of Kooij teaches the structure of claim 53, and O’Connor further teaches wherein the adhesive is hydrocolloid- based (O’Connor teaches the dermal patch to have a dermatologically sensitive adhesive (such as a hydrocolloid for example) that attaches or adheres the dermal patch to a user's skin as seen in [0148]).
Regarding claim 57, O’Connor in view of Kooij teaches the structure of claim 52, and Kooij further teaches wherein the third edge and the fourth edge are symmetrical relative to the central longitudinal axis of the body (see Kooij’s Annotated Fig. 2).
Regarding claim 58, O’Connor in view of Kooij teaches the structure of claim 52, and O’Connor further teaches wherein the body has a thickness that allows the body to flex in response to movement of the face of the patient (O’Connor teaches the pad to be relatively thin and able to stretch and conform to the patient’s face as seen in [0604] and [0607]).
Regarding claim 59, O’Connor in view of Kooij teaches the structure of claim 58, and O’Connor further teaches wherein the thickness of the body is substantially uniform (see Fig. 17).
Regarding claim 60, O’Connor in view of Kooij teaches the structure of claim 52, and Kooij further teaches wherein the first edge and the second edge are convex (see Kooij’s Annotated Fig. 2).
Regarding claim 61, O’Connor in view of Kooij teaches the structure of claim 52, and O’Connor further teaches wherein the third side and the fourth side are longer than the first side and the second side (see O’Connor Annotated Fig. 17).
Regarding claim 62, O’Connor in view of Kooij teaches the structure of claim 52, and O’Connor further teaches wherein the third side of the fixation element is adjacent the third edge of the body and the fourth side of the fixation element is adjacent the fourth edge of the body (see Figs. 15-17 and O’Connor Annotated Fig. 17).
Regarding claim 63, O’Connor in view of Kooij teaches the structure of claim 52, and O’Connor further teaches wherein the fixation element has a first length that is less than a second length of the body (see Figs. 15-17, first part 553 has a length that is less than a length of dermal patch 550 since it cannot be seen when in use on patient’s face).
Regarding claim 64, O’Connor in view of Kooij teaches the structure of claim 63, and O’Connor further teaches wherein a ratio of the first length to the second length is between 0.3 and 0.8 (the first part 553 can occupy up to 75% of the interface side surface area of the dermal patch as seen in [0603]).
Regarding claim 65, O’Connor in view of Kooij teaches a system (securement system 500, see Figs. 15-17 and [0591] of O’Connor) comprising:
a first fixation structure defined by Claim 52; and
a second fixation structure defined by Claim 52 (see Figs. 15-17 of O’Connor, where there are two dermal patches 550 to be placed on each cheek of the user).
Regarding claim 66, O’Connor in view of Kooij teaches the system of claim 65, and O’Connor further teaches further comprising:
the patient interface comprising a first attachment structure and a second attachment structure (O’Connor teaches two user interface patches 552 as seen in Figs. 15-17 and [0599], wherein the left user interface patch 552 is taken as the first attachment structure and the right user interface patch 552 is taken as the right attachment structure), the first attachment structure and the second attachment structure facing towards the face of the patient in use (the user interface patch 552 faces first patch 553 to be affixed and therefore faces the face of the patient in use as seen in Figs. 15-17 and [0598]-[0599]).
Regarding claim 67, O’Connor in view of Kooij teaches the structure of claim 66, and O’Connor further teaches wherein the patient interface further comprises:
a first interface body (first interface body, see O’Connor’s Annotated Fig. 17) comprising a first internal gases delivery lumen (see Figs. 15-17 and [0543]-[0544]) ;
a second interface body (second interface body, see O’Connor’s Annotated Fig. 17) comprising a second internal gases delivery lumen (see Figs. 15-17);
a first nasal delivery element extending from the first interface body (see O’Connor’s Annotated Fig. 17); and
a second nasal delivery element extending from the second interface body. (see O’Connor’s Annotated Fig. 17)
Regarding claim 68, O’Connor in view of Kooij teaches the structure of claim 67, and O’Connor further teaches wherein the patient interface further comprises a bridge connecting the first interface body to the second interface body (there is a bridge pointed by reference numeral 503 as shown in Figs. 15 and 17).
Regarding claim 69, O’Connor in view of Kooij teaches the structure of claim 67, and O’Connor further teaches wherein the first attachment structure is on a first face of the first interface body and the second attachment structure is on a second face of the first interface body (see claim objection above; see O’Connor’s Annotated Fig. 17), the first face and the second face facing towards the face of the patient in use (the first face and the second face of the first interface body and the second interface body face towards the face of the patient in use as they are attaching to the user interface patches 552 as seen in Figs. 15-17).
Regarding claim 70, O’Connor in view of Kooij teaches the structure of claim 69, and O’Connor further teaches wherein the first attachment structure is configured to engage the first fixation structure and the second attachment structure is configured to engage the second attachment structure (see Figs. 15-17 and [0597]-[0599]).
Regarding claim 71, O’Connor in view of Kooij teaches the structure of claim 65, and O’Connor further teaches wherein the patient interface comprises a nasal cannula, a nasal mask, an oral mask, an oro-nasal mask, a full face mask, an unsealed oro-nasal mask, a nasal pillows mask, or an endotracheal tube (Figs. 15-17 and see [0396] and [0591], the patient interface is a nasal cannula).
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 20140000626 A1) in view of Kooij (US 20100000534 A1) and, as applied to claim 52 above and further in view of Gulliver (US 20150090255 A1).
Regarding claim 56, O’Connor in view of Kooij teaches the structure of claim 52, and but does not teach wherein adhesion of the patient-facing region to the skin of the patient is greater than adhesion of the fixation element to the patient interface.
However, Gulliver teaches a securement system 5 as shown in Fig. 1 comprising a dermal patch 10 as seen in [0270]-[0271]. The dermal patch 10 is provided with a first part 14 of the two-part releasable attachment, wherein the second component is tube patch or pad 20. The tube 2 with pad 20 can be released from the patient without removal of dermal patch 10 as seen in [0272]. As such, the adhesion of dermal patch 10 to a user’s skin is greater than the adhesion of first part 14 (taken as fixation element) to tube 2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fixation structure taught O’Connor in view of Kooij to replace the fixation element and attachment structure with the fixation element and attachment structure as taught by Gulliver as an alternative design two-part releasable attachment which performs similar functions and allows a tube to be attached to a user’s face without any patient interface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gallant (US 20090217492 A1) teaches a releasable fastener arrangement.
Bunyan (US 2877765 A) teaches slits within bandages.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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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.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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