Prosecution Insights
Last updated: October 25, 2026
Application No. 18/799,883

NASAL RESPIRATORY INTERFACE AND ADJUSTABLE HEADGEAR

Non-Final OA §103§DP
Filed
Aug 09, 2024
Priority
Mar 02, 2016 — provisional 62/302,453 +4 more
Examiner
KHONG, BRIAN THAI-BINH
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Fisher & Paykel Healthcare Limited
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
10m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
202 granted / 303 resolved
-3.3% vs TC avg
Strong +37% interview lift
Without
With
+37.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
37 currently pending
Career history
335
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
42.2%
+2.2% vs TC avg
§102
17.8%
-22.2% vs TC avg
§112
28.6%
-11.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 303 resolved cases

Office Action

§103 §DP
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 . Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: A first releasable connector in Claims 1 and 15. The corresponding structure is an adhesive member 337 (hook and loop fastener) on first tab 332 which locks on to second strap 304 (Fig 14; paragraph 0175). The tab is shown to be rotated on an axis 341. It is noted that the first tab 332 is described to have similar construction to second tab 334. A second releasable connector in Claim 1. The corresponding structure is an adhesive member 337 (hook and loop fastener) on second tab 334 which locks on to first strap 302 (Fig 14; paragraph 0175). The tab is shown to be rotated on an axis 341. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. Claims 2-19 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al. (US 2013/0220327A1) in view of Ng et al. (US 2010/0319700 A1). Regarding Claim 2, Barlow discloses an adjustable headgear (apparatus of Figs 19-20; rear headgear strap, paragraph 0144), comprising: a first strap (380, Figs 19-20); a second strap (381, Figs 19-20); a first tab (388 of 380, Figs 19-20) coupled to the first strap (388 is connected to 380, Figs 19-20), the first tab comprising a cuff (382, Figs 19-20) configured to releasably connect the first tab to the second strap (382 shown to releasably connect and surround 381, Figs 19-20); and a second tab (388 of 381, Figs 19-20) coupled to the second strap (388 is connected to 381, Figs 19-20), the second tab comprising a cuff (384, Figs 19-20) configured to releasably connect the second tab to the first strap (384 shown to releasably connect and surround 380, Figs 19-20); wherein the first strap and the second strap are adjustable relative to one another and are secured in an adjustment position (straps 380 and 381 shown to extend and contract along the length of the overall strap 379, Fig 20; headgear cuffs 382 and 384 are adapted to releasably connect the headgear straps 380 and 381 to each other, in a length-adjustable manner, wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; wing portions of the cuffs secure the straps into place through the hook and loop material). Barlow fails to explicitly disclose the first tab configured to rotate relative to the first strap about a first axis; the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; the second tab configured to rotate relative to the second strap about a second axis; the second tab comprising a second releasable connector configured to releasably connect the second tab to the first strap; the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap and/or releasable connection of the second tab to the first strap. However, Barlow further teaches the tab portions 388 and cuffs 382 and 384 are capable of being bent onto the straps 380 and 381 via arrows (Fig 19) and the tab portions 388 may hang loosely (paragraph 0144). Additionally, Barlow teaches that the headgear is made of materials that enable headgear to stay in place on the hair mechanically, whilst also not being too sticky or pulling on the hair (paragraph 0134) and can be made of a piled textile and fabric (paragraph 0135). Furthermore, Barlow teaches the headgear is formed from a breathable, stretchable, formable and durable fabric (paragraph 0168). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tabs to be made of this stretchable and formable fabric to allow them to rotate relative to the straps by bending the tabs, as taught by Barlow, since this would be a known capability of the tabs due to the material used for the headgear. One of ordinary skill in the art would obviously recognize that these tabs are capable of being bent due to being part of and being made of the material of the straps. Because of this, a patient would obviously be capable of rotating or bending the tabs relative to the straps at an axis that connects the tabs to the rest of the straps by pinching the tabs with their fingers from above and below the tabs. It is noted that Applicant has not further claimed the structure or mechanism involved that allows the tabs to rotate. Barlow teaches wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps) (paragraph 0144). Barlow fails to teach the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; the second tab comprising a second releasable connector configured to releasably connect the second tab to the first strap; the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap and/or releasable connection of the second tab to the first strap. However, Ng, of the same field of endeavor, teaches a shroud for a mask system (Abstract) including a tab (295, Fig 35-2) comprising a releasable connector (hook and loop tab 295, paragraph 0133; the connector is the hook and loop on the tab 295) configured to releasably connect the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, paragraph 0133), the strap is secured in an adjustment position at least in part by the releasable connection of the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, hook and loop attachment also facilitates adjustment of the length of the straps, paragraph 0133) to engage the remainder of the strap to removably secure the strap in place (paragraph 0133). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional hook portions to the tabs and allow the tabs to removably secure onto the straps, as taught by Ng, to engage the remainder of the strap to removably secure the strap in place (Ng: paragraph 0133). This improvement would ensure the tabs are removably secured onto the straps so that they are locked into place and do not stick out from the straps when in use, particularly when the patient is no longer adjusting the length of the straps. This would make the straps flush and further strengthen the secured position of the cuffs on the straps. Regarding Claim 3, Barlow-Ng combination teaches the first strap further comprises a first endcap (Barlow: 382, Figs 19-20) and the second strap further comprises a second endcap (Barlow: 384, Figs 19-20), wherein the first tab is carried by the first endcap and the second tab is carried by the second endcap (Barlow: 388 is carried on both 382 and 384, Figs 19-20). Regarding Claim 4, Barlow-Ng combination teaches the endcaps are disposed at the ends of the straps (Barlow: paragraph 0144). The current embodiment of Barlow-Ng combination fails to teach the first endcap and the first strap are coupled by an overmolded connection and the second endcap and the second strap are coupled by an overmolded connection. However, an alternative embodiment of Barlow teaches the first endcap and the first strap are coupled by an overmolded connection and the second endcap and the second strap are coupled by an overmolded connection (casing cuffs may be overmoulded onto the straps, paragraph 0150) since it is a known way to attach the cuffs to the straps (paragraph 0150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endcaps or cuffs to be overmolded onto the straps, as taught by Barlow, since it is a known way to attach the cuffs to the straps (Barlow: paragraph 0150). Overmolding is a simple and known manufacturing technique that would not change the operation of the device. Regarding Claim 5, the current embodiment of Barlow-Ng combination fails to teach the first strap and the second strap each comprise a plastic core and a textile covering. However, Barlow further teaches a strap (390, Fig 21) that comprises a plastic core (394, Fig 21) and a textile covering (392, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170) since this is a known form of the headgear material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps to have a polymer/plastic core with a textile/fabric covering, as taught by Barlow, since this is a known form of the headgear material. Regarding Claim 6, Barlow-Ng combination teaches the textile covering is or comprises a loop portion of a hook-and-loop fastener (Barlow: loop material on the straps, paragraph 0144; the fabric covering of the straps of the headgear would have the loops) and each of the first releasable connector and the second releasable connector is or comprises a hook portion of the hook-and-loop fastener (Barlow: hook material of the wing portions, paragraph 0144; Ng: hook and loop tab 295, paragraph 0133; the tabs 388 of Barlow would have the hooks). Regarding Claim 7, Barlow-Ng combination teaches the textile covering covers an inner surface and an outer surface of each of the first strap and the second strap (Barlow: 392 shown to cover both the top and bottom surfaces of 390, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170; 392 would obviously be covering the inner surface facing towards the user in use and the outer surface facing away from the user in use). It is noted that Applicant has not claimed what the “inner” and “outer” phrases are in relation to. Regarding Claim 8, Barlow-Ng combination teaches the textile covering comprises a first layer and a second layer (Barlow: 392 shown to have a first top layer and a second bottom layer above and below 394, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170). Regarding Claim 9, Barlow-Ng combination teaches the textile covering comprises a tube (Barlow: the top and bottom layers of 392 form a tube around 394, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170). Regarding Claim 10, Barlow-Ng combination teaches the first strap and the second strap are in frictional contact with one another to provide a resistance to relative movement of the first strap and the second strap (Barlow: wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; the straps 380 and 381 would obviously have frictional contact with each other due to the frictional interaction of surfaces between the first and second straps and the involvement of the hook and loop materials). Regarding Claim 11, Barlow-Ng combination teaches the first strap and the second strap are positioned one on top of the other when overlapped (Barlow: 380 and 381 are shown to be on top of each other and overlapping each other, Figs 19-20). Regarding Claim 12, Barlow-Ng combination teaches the first axis is aligned with a width direction of the first strap and the second axis is aligned with a width direction of the second strap (Barlow: headgear is formed from a breathable, stretchable, formable and durable fabric, paragraph 0168; 388 can be bent at the axes that attaches 388 to 384 and 382, Fig 20; see annotated Fig 20 below). PNG media_image1.png 444 632 media_image1.png Greyscale Regarding Claim 13, Barlow-Ng combination teaches the first strap and the second strap are located in one of a rear strap of the adjustable headgear (Barlow: a strap 379, e.g., rear headgear strap, paragraph 0144). Regarding Claim 14, Barlow-Ng combination teaches the first strap and the second strap are in frictional contact with one another to provide a resistance to relative movement of the first strap and the second strap (Barlow: wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; the straps 380 and 381 would obviously have frictional contact with each other due to the frictional interaction of surfaces between the first and second straps and the involvement of the hook and loop materials). Regarding Claim 15, Barlow discloses an adjustable headgear (apparatus of Figs 19-20; rear headgear strap, paragraph 0144), comprising: a first strap (380, Figs 19-20) having an endcap (382, Figs 19-20); a second strap (381, Figs 19-20); and a first tab (388 of 380, Figs 19-20) carried by the endcap (388 shown to be on 382, Figs 19-20); wherein the first strap and the second strap are adjustable relative to one another and are secured in an adjustment position (straps 380 and 381 shown to extend and contract along the length of the overall strap 379, Fig 20; headgear cuffs 382 and 384 are adapted to releasably connect the headgear straps 380 and 381 to each other, in a length-adjustable manner, wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; wing portions of the cuffs secure the straps into place through the hook and loop material). Barlow fails to explicitly disclose the first tab configured to rotate relative to the first strap about a first axis that is aligned with a width direction of the first strap; the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; wherein the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap. However, Barlow further teaches the tab portions 388 and cuffs 382 and 384 are capable of being bent onto the straps 380 and 381 via arrows (Fig 19) and the tab portions 388 may hang loosely (paragraph 0144). Additionally, Barlow teaches that the headgear is made of materials that enable headgear to stay in place on the hair mechanically, whilst also not being too sticky or pulling on the hair (paragraph 0134) and can be made of a piled textile and fabric (paragraph 0135). Furthermore, Barlow teaches the headgear is formed from a breathable, stretchable, formable and durable fabric (paragraph 0168). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tabs to be made of this stretchable and formable fabric to allow them to rotate relative to the cuffs/endcaps by bending the tabs, as taught by Barlow, since this would be a known capability of the tabs due to the material used for the headgear. One of ordinary skill in the art would obviously recognize that these tabs are capable of being bent due to being part of and being made of the material of the straps. Because of this, a patient would obviously be capable of rotating or bending the tabs relative to the straps at an axis that connects the tabs to the rest of the straps or endcaps/cuffs by pinching the tabs with their fingers from above and below the tabs (see axes where 388 is bent in annotated Fig 20 below). It is noted that Applicant has not further claimed the structure or mechanism involved that allows the tabs to rotate. PNG media_image1.png 444 632 media_image1.png Greyscale Barlow teaches wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps) (paragraph 0144). Barlow fails to teach the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; wherein the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap. However, Ng, of the same field of endeavor, teaches a shroud for a mask system (Abstract) including a tab (295, Fig 35-2) comprising a releasable connector (hook and loop tab 295, paragraph 0133; the connector is the hook and loop on the tab 295) configured to releasably connect the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, paragraph 0133), the strap is secured in an adjustment position at least in part by the releasable connection of the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, hook and loop attachment also facilitates adjustment of the length of the straps, paragraph 0133) to engage the remainder of the strap to removably secure the strap in place (paragraph 0133). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional hook portions to the tabs and allow the tabs to removably secure onto the straps, as taught by Ng, to engage the remainder of the strap to removably secure the strap in place (Ng: paragraph 0133). This improvement would ensure the tabs are removably secured onto the straps so that they are locked into place and do not stick out from the straps when in use, particularly when the patient is no longer adjusting the length of the straps. This would make the straps flush and further strengthen the secured position of the cuffs on the straps. Regarding Claim 16, Barlow-Ng combination teaches the first strap and the second strap are positioned one on top of the other when overlapped (Barlow: 380 and 381 are shown to be on top of each other and overlapping each other, Figs 19-20). Regarding Claim 17, Barlow-Ng combination teaches the first strap and the second strap are in frictional contact with one another to provide a resistance to relative movement of the first strap and the second strap (Barlow: wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; the straps 380 and 381 would obviously have frictional contact with each other due to the frictional interaction of surfaces between the first and second straps and the involvement of the hook and loop materials). Regarding Claim 18, Barlow-Ng combination teaches the endcaps are disposed at the ends of the straps (Barlow: paragraph 0144). The current embodiment of Barlow-Ng combination fails to teach the endcap and the first strap are coupled by an overmolded connection. However, an alternative embodiment of Barlow teaches the endcap and the first strap are coupled by an overmolded connection (casing cuffs may be overmoulded onto the straps, paragraph 0150) since it is a known way to attach the cuffs to the straps (paragraph 0150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endcaps or cuffs to be overmolded onto the straps, as taught by Barlow, since it is a known way to attach the cuffs to the straps (Barlow: paragraph 0150). Overmolding is a simple and known manufacturing technique that would not change the operation of the device. Regarding Claim 19, the current embodiment of Barlow-Ng combination fails to teach one or both of the first strap and the second strap comprise a plastic core and a textile covering. However, Barlow further teaches a strap (390, Fig 21) that comprises a plastic core (394, Fig 21) and a textile covering (392, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170) since this is a known form of the headgear material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps to have a polymer/plastic core with a textile/fabric covering, as taught by Barlow, since this is a known form of the headgear material. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 2-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 7 of U.S. Patent No. 12,083,277, hereafter ‘277, in view of Barlow et al. (US 2013/0220327A1) and Ng et al. (US 2010/0319700 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art. Regarding Claim 2, ‘277 discloses most of the claimed invention (Claims 6 and 7; the headgear is described to be adjustable) except for: a first tab configured to rotate relative to the first strap about a first axis, the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; and a second tab configured to rotate relative to the second strap about a second axis, the second tab comprising a second releasable connector configured to releasably connect the second tab to the first strap; wherein the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap and/or releasable connection of the second tab to the first strap. However, Barlow, of the same field of endeavor, teaches a patient interface (Abstract) including the tab portions 388 and cuffs 382 and 384 are capable of being bent onto the straps 380 and 381 via arrows (Fig 19) and the tab portions 388 may hang loosely (paragraph 0144). Additionally, Barlow teaches that the headgear is made of materials that enable headgear to stay in place on the hair mechanically, whilst also not being too sticky or pulling on the hair (paragraph 0134) and can be made of a piled textile and fabric (paragraph 0135). Furthermore, Barlow teaches the headgear is formed from a breathable, stretchable, formable and durable fabric (paragraph 0168). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tabs to be made of this stretchable and formable fabric to allow them to rotate relative to the straps by bending the tabs, as taught by Barlow, since this would be a known capability of the tabs due to the material used for the headgear. One of ordinary skill in the art would obviously recognize that these tabs are capable of being bent due to being part of and being made of the material of the straps. Because of this, a patient would obviously be capable of rotating or bending the tabs relative to the straps at an axis that connects the tabs to the rest of the straps by pinching the tabs with their fingers from above and below the tabs. It is noted that Applicant has not further claimed the structure or mechanism involved that allows the tabs to rotate. ‘277-Barlow combination teaches wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps) (Barlow: paragraph 0144). ‘277-Barlow combination fails to teach the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; the second tab comprising a second releasable connector configured to releasably connect the second tab to the first strap; the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap and/or releasable connection of the second tab to the first strap. However, Ng, of the same field of endeavor, teaches a shroud for a mask system (Abstract) including a tab (295, Fig 35-2) comprising a releasable connector (hook and loop tab 295, paragraph 0133; the connector is the hook and loop on the tab 295) configured to releasably connect the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, paragraph 0133), the strap is secured in an adjustment position at least in part by the releasable connection of the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, hook and loop attachment also facilitates adjustment of the length of the straps, paragraph 0133) to engage the remainder of the strap to removably secure the strap in place (paragraph 0133). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional hook portions to the tabs and allow the tabs to removably secure onto the straps modified with loop portions, as taught by Ng, to engage the remainder of the strap to removably secure the strap in place (Ng: paragraph 0133). This improvement would ensure the tabs are removably secured onto the straps so that they are locked into place and do not stick out from the straps when in use, particularly when the patient is no longer adjusting the length of the straps. This would make the straps flush and further strengthen the secured position of the endcaps on the straps. Regarding Claim 3, ‘277-Barlow-Ng combination teaches all of the claimed invention (‘277: Claims 6 and 7). Regarding Claim 4, the current embodiment of ‘277-Barlow-Ng combination fails to teach the first endcap and the first strap are coupled by an overmolded connection and the second endcap and the second strap are coupled by an overmolded connection. However, an alternative embodiment of Barlow teaches the first endcap and the first strap are coupled by an overmolded connection and the second endcap and the second strap are coupled by an overmolded connection (casing cuffs may be overmoulded onto the straps, paragraph 0150) since it is a known way to attach the cuffs to the straps (paragraph 0150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endcaps or cuffs to be overmolded onto the straps, as taught by Barlow, since it is a known way to attach the cuffs to the straps (Barlow: paragraph 0150). Overmolding is a simple and known manufacturing technique that would not change the operation of the device. Regarding Claim 5, the current embodiment of ‘277-Barlow-Ng combination fails to teach the first strap and the second strap each comprise a plastic core and a textile covering. However, Barlow further teaches a strap (390, Fig 21) that comprises a plastic core (394, Fig 21) and a textile covering (392, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170) since this is a known form of the headgear material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps to have a polymer/plastic core with a textile/fabric covering, as taught by Barlow, since this is a known form of the headgear material. Regarding Claim 6, ‘277-Barlow-Ng combination teaches the textile covering is or comprises a loop portion of a hook-and-loop fastener (Barlow: loop material on the straps, paragraph 0144; the fabric covering of the straps of the headgear would have the loops due to the tabs having hooks) and each of the first releasable connector and the second releasable connector is or comprises a hook portion of the hook-and-loop fastener (Barlow: hook material of the wing portions, paragraph 0144; Ng: hook and loop tab 295, paragraph 0133; the tabs of ‘277 would have the hooks). Regarding Claim 7, ‘277-Barlow-Ng combination teaches the textile covering covers an inner surface and an outer surface of each of the first strap and the second strap (Barlow: 392 shown to cover both the top and bottom surfaces of 390, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170; 392 would obviously be covering the inner surface facing towards the user in use and the outer surface facing away from the user in use). It is noted that Applicant has not claimed what the “inner” and “outer” phrases are in relation to. Regarding Claim 8, ‘277-Barlow-Ng combination teaches the textile covering comprises a first layer and a second layer (Barlow: 392 shown to have a first top layer and a second bottom layer above and below 394, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170). Regarding Claim 9, ‘277-Barlow-Ng combination teaches the textile covering comprises a tube (Barlow: the top and bottom layers of 392 form a tube around 394, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170). Regarding Claim 10, ‘277-Barlow-Ng combination teaches the first strap and the second strap are in frictional contact with one another to provide a resistance to relative movement of the first strap and the second strap (Barlow: wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; the straps of ‘277 would obviously have frictional contact with each other due to the frictional interaction of surfaces between the first and second straps and the involvement of the hook and loop materials). Regarding Claim 11, ‘277-Barlow-Ng combination teaches all of the claimed invention (‘277: Claims 6 and 7; straps would obviously be on top of each other due to the straps going to the holes of each endcap). Regarding Claim 12, ‘277-Barlow-Ng combination teaches the first axis is aligned with a width direction of the first strap and the second axis is aligned with a width direction of the second strap (Barlow: headgear is formed from a breathable, stretchable, formable and durable fabric, paragraph 0168; 388 can be bent at the axes that attaches 388 to 384 and 382, Fig 20; see annotated Fig 20 below). PNG media_image1.png 444 632 media_image1.png Greyscale Regarding Claim 13, the current ‘277-Barlow-Ng combination fails to teach the first strap and the second strap are located in one or both of a top strap and a rear strap of the adjustable headgear. However, Barlow further teaches the first strap and the second strap are located in one of a rear strap of the adjustable headgear (a strap 379, e.g., rear headgear strap, paragraph 0144) since this is a known location of where this type of strap would be placed on a headgear. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the straps on a rear strap of the headgear, as taught by Barlow, since this is a known location of where this type of strap would be placed on a headgear. Regarding Claim 14, ‘277-Barlow-Ng combination teaches the first strap and the second strap are in frictional contact with one another to provide a resistance to relative movement of the first strap and the second strap (Barlow: wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; the straps of ‘277 would obviously have frictional contact with each other due to the frictional interaction of surfaces between the first and second straps and the involvement of the hook and loop materials). Regarding Claim 15, ‘277 discloses most of the claimed invention (Claims 6 and 7; the headgear is described to be adjustable ) except for: the first tab configured to rotate relative to the first strap about a first axis that is aligned with a width direction of the first strap; the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; wherein the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap. However, Barlow further teaches the tab portions 388 and cuffs 382 and 384 are capable of being bent onto the straps 380 and 381 via arrows (Fig 19) and the tab portions 388 may hang loosely (paragraph 0144). Additionally, Barlow teaches that the headgear is made of materials that enable headgear to stay in place on the hair mechanically, whilst also not being too sticky or pulling on the hair (paragraph 0134) and can be made of a piled textile and fabric (paragraph 0135). Furthermore, Barlow teaches the headgear is formed from a breathable, stretchable, formable and durable fabric (paragraph 0168). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tabs to be made of this stretchable and formable fabric to allow them to rotate relative to the cuffs/endcaps by bending the tabs, as taught by Barlow, since this would be a known capability of the tabs due to the material used for the headgear. One of ordinary skill in the art would obviously recognize that these tabs are capable of being bent due to being part of and being made of the material of the straps. Because of this, a patient would obviously be capable of rotating or bending the tabs relative to the straps at an axis that connects the tabs to the rest of the straps or endcaps/cuffs by pinching the tabs with their fingers from above and below the tabs (see axes where 388 is bent in annotated Fig 20 below). It is noted that Applicant has not further claimed the structure or mechanism involved that allows the tabs to rotate. PNG media_image1.png 444 632 media_image1.png Greyscale Barlow teaches wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps) (paragraph 0144). Barlow fails to teach the first tab comprising a first releasable connector configured to releasably connect the first tab to the second strap; wherein the first strap and the second strap are secured in an adjustment position at least in part by releasable connection of the first tab to the second strap. However, Ng, of the same field of endeavor, teaches a shroud for a mask system (Abstract) including a tab (295, Fig 35-2) comprising a releasable connector (hook and loop tab 295, paragraph 0133; the connector is the hook and loop on the tab 295) configured to releasably connect the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, paragraph 0133), the strap is secured in an adjustment position at least in part by the releasable connection of the tab to the strap (each strap may include a hook and loop tab 295 structured to engage the remainder of the strap to removably secure the strap in place, hook and loop attachment also facilitates adjustment of the length of the straps, paragraph 0133) to engage the remainder of the strap to removably secure the strap in place (paragraph 0133). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional hook portions to the tabs and allow the tabs to removably secure onto the straps modified with loop portions, as taught by Ng, to engage the remainder of the strap to removably secure the strap in place (Ng: paragraph 0133). This improvement would ensure the tabs are removably secured onto the straps so that they are locked into place and do not stick out from the straps when in use, particularly when the patient is no longer adjusting the length of the straps. This would make the straps flush and further strengthen the secured position of the cuffs/endcaps on the straps. Regarding Claim 16, ‘277-Barlow-Ng combination teaches all of the claimed invention (‘277: Claims 6 and 7; straps would obviously be on top of each other due to the straps going to the holes of each endcap). Regarding Claim 17, ‘277-Barlow-Ng combination teaches the first strap and the second strap are in frictional contact with one another to provide a resistance to relative movement of the first strap and the second strap (Barlow: wing portions 386 may connect to the headgear straps through the use of hook and loop material, (e.g., hook material of the wing portions and loop material on the straps), paragraph 0144; the straps of ‘277 would obviously have frictional contact with each other due to the frictional interaction of surfaces between the first and second straps and the involvement of the hook and loop materials). Regarding Claim 18, the current embodiment of ‘277-Barlow-Ng combination fails to teach the endcap and the first strap are coupled by an overmolded connection. However, an alternative embodiment of Barlow teaches the endcap and the first strap are coupled by an overmolded connection (casing cuffs may be overmoulded onto the straps, paragraph 0150) since it is a known way to attach the cuffs to the straps (paragraph 0150). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endcaps or cuffs to be overmolded onto the straps, as taught by Barlow, since it is a known way to attach the cuffs to the straps (Barlow: paragraph 0150). Overmolding is a simple and known manufacturing technique that would not change the operation of the device. Regarding Claim 19, the current embodiment of ‘277-Barlow-Ng combination fails to teach one or both of the first strap and the second strap comprise a plastic core and a textile covering. However, Barlow further teaches a strap (390, Fig 21) that comprises a plastic core (394, Fig 21) and a textile covering (392, Fig 21; headgear material 390 may be formed by extruding a layer of polymer 394, such as a thermoplastic elastomer, and as the polymer 394 is being extruded, fabric 392 is laminated onto the polymer 394, paragraph 0170) since this is a known form of the headgear material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps to have a polymer/plastic core with a textile/fabric covering, as taught by Barlow, since this is a known form of the headgear material. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including: US 20120132209 A1 shows a strap with end caps (Fig 20a). Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN THAI-BINH KHONG whose telephone number is (571)272-1857. The examiner can normally be reached Monday to Thursday 9:00 am-6:00 pm. 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, Kendra Carter can be reached at (571) 272-9034. 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. /BRIAN T KHONG/ Examiner, Art Unit 3785
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Prosecution Timeline

Aug 09, 2024
Application Filed
Sep 28, 2026
Non-Final Rejection mailed — §103, §DP (current)

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