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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/6/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 8/6/2025. As directed by the amendment, claim 1 has been amended, claims 20 and 39 have been cancelled, and claims 42-46 have been added. As such, claims 1-3, 5-19, 21-25, 36, 38 and 40-46 are pending in the instant application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Although it is noted that a main body/arms could be arbitrarily delineated in previously-applied Rose to meet the newly-added limitations of claim 1, since newly-applied Liu below teaches a rear panel with a single pair of arms according to new claim 44, the rejection in view of Rose is not updated below to avoid duplicate rejections of claim 1 for purposes of compact prosecution.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “35A” has been used to designate “end margin” (e.g. Fig. 7), “lower margin” (e.g. Fig. 16) and “tips” (e.g. Fig. 20), and reference character “35B” has been used to designate “end margin” (e.g. Fig. 16) and “stem portion” (e.g. Fig. 24). 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. 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
Claims 1, 7-11, 16, 18, 25, 36 and 43 are objected to because of the following informalities:
Claim 1, line 5 should read “the first end” because it is clearly referring to that of lines 4-5
Claim 1, in combination with the previous amendment to include where “[each] lower corner area includes a portion of the respective [laterally extending] arm,” i.e. reflecting the delineations of e.g. instant Fig. 7, line 18 would be more clearly supported by the specification if it read “each laterally extending arm including a portion that is inclined upwardly” since the arm portions along the sides and in the lower corner areas of the rear panel run along the main body/are not upwardly inclined away from the main body
Claim 1, lines 27-28 would be clearer if it read “joined to a respective lower corner…each of the lower corner areas…the respective laterally extending arm”
Claims 7-11 would have clearer antecedent basis if they read “the central longitudinal axis”
Claim 16, line 2 should have a colon after ‘formula’, not a semi-colon
Claim 16, line 4 would have clearer antecedent basis if it read “the central longitudinal axis” and “the opposed top and base margins”
Regarding claim 18, in lines 1-3, “the main body…base margins” is unnecessarily redundant in view of claim 1, lines 14-16, and claim 18, lines 6-7 are unnecessarily redundant in view of claim 3, from which claim 18 depends
Claim 18, line 9 should read “and extends”
Regarding claim 18, lines 9-11, “at an angle between 0˚ and 90˚” is confusing and unnecessarily redundant in view of “extend[s] away from both the central horizontal and vertical planes” because horizontal and vertical define 0˚ and 90˚, respectively, so something inclined upwardly and extending away from both must necessarily be at an angle greater than 0˚ and less than 90˚
Claim 25, line 2 should read “main body
Claim 36, line 2 should read “joined to a respective laterally extending arm
Claim 43, line 1 would be clearer if it read “each lower corner area”
Appropriate correction is required.
Applicant is advised that should claim 5 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-19, 21-25, 36, 38 and 40-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 44 (and thus their dependent claims), the specification as originally filed does not support “each upper side strap having first and second opposed ends” in combination with “the second end of each upper side strap being entirely joined to (the distal arm end of) a respective laterally extending arm of the rear panel at a join (located in an upper corner region of the rear panel),” because the elements joined at a join at the distal arm end/located in an upper corner region of the rear panel (at 30 in e.g. instant Fig. 4) are legs 27B, which are parts of the crown strap 5DA per instant Fig. 4 and para [0050], whereas “upper sides straps” 5A are joined to legs 27A (at joins 29, see e.g. instant Fig. 4), i.e. the upper sides straps 5A are not “entirely joined to…the rear panel.” Moreover, even if 5A+5DA combined were considered to correspond to an “upper side strap,” this structure does not have “first and second opposed ends” as claimed; it has three radially-spaced ends, only one of which (at 30 in Fig. 4) is understood to be “entirely joined to…the rear panel.” For purposes of examination, upper straps with any number of ends, one of each of which is attached to a rear panel, will read on the claimed upper straps.
Regarding claims 5 and 23, the previous amendment of claim 1 to include where “[each] lower corner area includes a portion of the respective [laterally extending] arm,” means that the claims reflect the delineations of e.g. instant Fig. 7, where the laterally extending arms include portions that run along the sides and to the lower corner areas of the rear panel. As such, there is no support for the combination of limitations of amended claim 1 with those of claim 5/23, because the width of the portions of the arms that extend to the lower corner areas are much wider than the width of the portions that are inclined upwardly away from the main body, i.e. the width is not substantially uniform/constant along the length (see modified Fig. 7 below). Applicant could address this rejection by amending claims 5/23 to read “wherein each distal arm end”.
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Regarding claim 36, there is no mention in the specification as originally filed of “a butt joint,” much less one at the second ends of each side strap that meets the limitations of claim 1.
Regarding claim 41, the specification as originally filed does not support the second ends of the lower side straps being specifically “joined to the base margin…using an overlap weld,” because, while instant para [0050] supports welded joins and Fig. 4 supports the second ends of the side straps overlapping the base margin, no particular area/extent for the joins within the overlapped areas is specified, e.g. it is not stated that the joins occupy the entire overlapped regions/that the joins specifically include the base margin. To address this rejection, Applicant could amend the claim to read “is joined to
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 1-3, 5-19, 21-25, 36, 38 and 40-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 44 (and thus their dependent claims) recites the limitation "the sides of the user’s head" in line 6 and line 22, respectively. There is insufficient antecedent basis for this limitation in the claim. Which sides of the head are being referenced: front, back, left, right, and/or top? As best understood, it is left and right sides, but this should be made clear in the claims.
Regarding claims 1, 38 and 44, the preambles of claims 1 and 44 present a patient interface as intended use of the claimed headgear, but then the bodies of claims 1, 38 and 44 recite “strap[s] being/is secured to[,] or [being] configured to be secured to, the patient interface” (emphasis added) wherein the first part of the ‘or’ statement is a positive recitation of the patient interface, rendering it unclear whether the headgear does or does not comprise the patient interface. As best understood, for purposes of examination, the claims are intended to be directed only to the headgear, as an apparatus separate from a patient interface, such that Applicant could address this rejection by amending claims 1, 38 and 44 to read “strap[s]
Regarding claims 1 and 44 (and thus their dependent claims), the intended scope of “formed from a single piece of material” is unclear, because it reads as a product-by-process limitation, and it is unclear if the final product is intended to be a single component (see e.g. instant para [0070]), or just that the main body and rear panel are e.g. cut out from a single piece of material (e.g. instant para [0034], which describes how multiple separate elements can be “formed from a single piece of material”). As best understood, for purposes of examination, it is the former, such that Applicant could address this rejection by amending the claims to read “are] comprised by a single piece of material”.
Regarding claim 6, line 1 refers to the “the distal arm end” (emphasis added) but two distal arm ends are recited in claim 1, such that it is unclear to which claim 6 is referring. As best understood, for purposes of examination, claim 6 is intended to further limit both of the distal arm ends, such that the claim could be amended to read “each distal arm end” to confirm this interpretation, where, in combination with the understanding of claim 6 above, claims 7-9 should be concurrently amended to read “each end margin”.
Claims 10, 11 and 46 recite the limitation "the side margins of the rear panel" in lines 1-2 of each claim. There is insufficient antecedent basis for this limitation in the claims, because while the independent claims recite side margins of the main body, they do not stipulate that these are necessarily the same as the rear panel. To address this rejection, Applicant could amend the claims to read either "the side margins of the main body of the rear panel" or "
Claim 12 recites the limitation "the longitudinal axis of each arm" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, and it is unclear what is to be considered the longitudinal axis of the side arms when they are delineated as shown in e.g. instant Fig. 7 as required by claim 1 as discussed above. To address this rejection, Applicant could amend the claim to read "the longitudinal axis of each distal arm end".
Further regarding claim 12, it is unclear how an arm can be upwardly inclined per claim 1, but inclined at an angle of 90˚, i.e. extending horizontally, per claim 12. To address this rejection, Applicant could amend claim 12 to read e.g. “greater than 40˚ and less than 90˚”.
Regarding claims 14 and 15, it is unclear whether the phrase “can be” indicates a positive limitation or not. As best understood, for purposes of examination, it is intended to convey a required limitation(s), such that Applicant could amend the claims to read “is” to address this rejection.
Claim 14 recites the limitation "the main portion" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Applicant could address this rejection by amending lines 3-4, 6-7 and 11-12 to read “the main body” (three instances).
Claim 14 recites the limitation "the two most upper points" in line 17. There is insufficient antecedent basis for this limitation in the claim. Applicant could address this rejection by amending the claim to read "
Claim 15 recites the limitation "the main portion…the main panel" in line 6. There is insufficient antecedent basis for these limitations in the claim, and it is unclear how the main [area] could be any ratio to itself other than 1. Applicant could address this rejection by amending the claim to read “the main body…the rear panel”.
Claim 16, line 3 recites “the laterally extending arm”, wherein it is unclear to which of the pair in claim 1 this is referring. As best understood, for purposes of examination, the claim will be considered to read “each laterally extending arm”.
Claim 16 recites the limitation "the main portion" in line 5. There is insufficient antecedent basis for this limitation in the claim. Applicant could address this rejection by amending the claim to read “the main body”.
Claim 25 recites the limitation "the width of each laterally extending arm" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, and the laterally extending arms in accordance with claim 1 do not have a single width, see modified Fig. 7 above, such that it is unclear to which width claim 25 is referring. As best understood, for purposes of examination, the claim will be considered to read “the width of each distal arm end”.
Regarding claim 43, line 3 recites “the lower corner area”, wherein it is unclear to which of the two in claim 1 this is referring. As best understood, for purposes of examination, the claim will be considered to read “each lower corner area”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As best understood (see 112b discussion above), claim 25 recites that the width of each distal arm end is 40-80% the width/distance between the top and base margins of the main body, which conflicts with the claim 1 range of 30-60%. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
The claimed “main body” is understood to be a notational delineation of an area within the rear panel, see e.g. instant Fig. 7 versus instant Fig. 17, which have the same overall rear panel shape but with differently-shaped main bodies 33 sketched therein, i.e. Fig. 7 depicts a rectangular main body whereas Fig. 17 shows a generally trapezoidal main body. The main body of claim 1 is only required to have top, base and side margins (but no particular shape, and none of margins have to be shared with the rear panel), allowing it to look like e.g. any of the modifications A-D below (or even a slightly narrower version of E), whereas the main body of claim 44 has additional specifications that limit it to something like modification E below.
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.
Claim(s) 1-3, 5, 6, 8, 10, 11, 17, 18, 21-25, 38 and 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2015/043119 A1; hereinafter “Liu”; wherein the page citations below refer to the translation provided with this office action) in view of Bearne et al. (WO 2016/075658 A1; hereinafter “Bearne”).
Regarding claims 1 and 25, Liu discloses headgear (Fig. 17a) configured to be secured to a patient interface of a respiratory therapy system, to mount the patient interface on a user's head (page 1), the headgear comprising:
a pair of upper side straps, each upper side strap having first (distal free ends to the right and left, respectively) and second (at upper joints 1160) opposed ends, [the] first end of each upper side strap being secured to, or being configured to be secured to, the patient interface and to extend along the sides of the user's head (the upper pair of side straps extending from upper joints 1160 in Fig. 17a; page 1, second and third paras on page 12);
a rear panel (neck connector 1140) configured to engage the rear of the user's head, the second end (at joint 1160) of each upper side strap being joined to the rear panel such that the pair of upper side straps extend from the rear panel (Fig. 17a; page 1, second and third paras on page 12); wherein:
the rear panel comprises a main body and a pair of laterally extending arms formed from a single piece of material (Fig. 17a, see e.g. modified A below; page 1, ninth full para on page 3, e.g. page 9, second and third paras on page 12), the second end of each upper side strap being entirely joined to a respective laterally extending arm of the rear panel at a join (upper joint 1160) located in an upper corner region of the rear panel (Fig. 17a; second and third paras on page 12);
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the main body comprising:
opposed top and base margins which are spaced apart by a distance (distance between top and bottom edges, see e.g. Fig. 17a modified A, above),
opposed side margins extending between the top and base margins (right and left edges, see e.g. Fig. 17a modified A, above), and
a central longitudinal axis bisecting the top and base margins (vertical line through the middle of the rectangle of Fig. 17a modified A, above);
each laterally extending arm being inclined upwardly away from the main body and away from the central longitudinal axis, extending away from a respective side margin of the main body and comprising a distal arm end (upper portions of the arms, comprising upper joints 1160) (Fig. 17a, see modified A above),
each distal arm end having a width measured in a direction substantially parallel with the central longitudinal axis (Fig. 17a, see modified A above);
wherein the width of each distal arm end is between 30% to 60% of the distance between the opposed top and base margins of the main body/as best understood, the ratio of the width of each [distal arm end] to the width of the main body portion is between 0.4 and 0.[6]:1 (Fig. 17a, where an arbitrarily-drawn main body can be delineated such that the claimed relative dimensions are met, see e.g. Liu Fig. 17a modified A above, which suggests the lower end of the claimed range and where the top of the rectangle delineating the main body can be shifted lower to arrive the upper end of the claimed range);
a pair of lower side straps (lower straps 1150) each formed separately from the rear panel, each lower side strap having first (distal free end, to the right and left in Fig. 17a, respectively) and second opposed ends (at lower joints 1160), wherein the second end of each of the lower side straps is joined to a lower corner area of the rear panel at a join (lower joint 1160), the lower corner area including at least a portion of the respective arm and the main body of the rear panel (Fig. 17a, see modified A above; second full para on page 11; second and third paras on page 12).
While Liu further teaches that the angles of the joints and straps can be adjusted (Figs. 6a-b and 22a-b; second full para on page 11: “the joint angle, the overlap area and the angle of the joint portion can be adjusted; bottom of page 8-top of page 9; the bottom of the third para on page 12: “connection joints…1160 can be adjusted according to the splicing or overlapping area, angle and direction of the connecting members”), Liu is silent regarding wherein the first ends of each upper side strap and the first ends of each lower side strap are inclined towards one another on each respective side of the headgear. However, Bearne teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention in for the first ends (end 1534B) of each upper side strap (comprising lower strap 1530B) and the first ends (end 1536B) of each lower side strap (comprising upper strap 1532B) to be inclined towards one another on each respective side of the headgear (Figs. 22-23; paras [0260-261]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Liu to include wherein the first ends of each upper side strap and the first ends of each lower side strap are inclined towards one another on each respective side of the headgear as taught by Bearne, in order to provide the predictable results of orienting both the upper and lower straps to apply both a horizontal force vector and a vertical force vector to retain the patient interface against the face and create a better seal and lessen the need for large adjustments along the crown strap (Bearne para [0260]).
Regarding claim 2, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu further discloses wherein the side margins of the main body of the rear panel are substantially parallel and substantially equal length such that the main body is substantially rectangular (Fig. 17a, see modified A above).
Regarding claim 3, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu further discloses wherein the side margins of the main body of the rear panel are substantially equal length and are inclined relative to the base margin such that the main body is substantially trapezoidal, because the main body of Liu is fully capable of being delineated as claimed while still meeting the limitations of claim 1, see Liu Fig. 17a, modified B below.
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Regarding claim 5, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu further discloses wherein each laterally extending arm is of substantially uniform width along its length, because the main body/arms of Liu are fully capable of being delineated as claimed while still meeting the limitations of claim 1, see Liu Fig. 17a, modified C below.
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Regarding claim 6, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein the distal arm end comprises a substantially straight end margin (Fig. 17a, where the margins at upper joints 1160 are straight, and see also the lower left image in Fig. 6b, as well as Fig. 4 and the last full para of page 7).
Regarding claim 8, Liu in view of Bearne teaches the headgear or claim 6, wherein Liu discloses wherein the end margin is inclined relative to the longitudinal axis (Fig. 17a, where the margins at upper joints 1160 are angled downwardly, and see also the lower left image in Fig. 6b, as well as Fig. 4 and the last full para of page 7).
Regarding claim 10, Liu in view of Bearne teaches the headgear of claim 3, wherein Liu discloses wherein, as best understood, the side margins [of the main body] of the rear panel are inclined relative to the longitudinal axis at a different angle to the angle of inclination of the laterally extending arms relative to the longitudinal axis (Fig. 17a, see e.g. modified B above, where the side margins are angled inwardly whereas the arms are inclined outwardly, or modified D below, where the side margins have a steeper angle than the arms).
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Regarding claim 11, Liu in view of Bearne teaches the headgear of claim 3, wherein Liu discloses wherein, as best understood, the side margins [of the main body] of the rear panel are inclined at an angle between 0° and 40° relative to the longitudinal axis of the rear panel, because the sides of the main body of Liu are fully capable of being delineated as claimed while still meeting the limitations of claim 1, see e.g. Liu Fig. 17a, modified A-D above.
Regarding claim 17, Liu in view of Bearne teaches the headgear of claim 3, wherein Liu discloses wherein each laterally extending arm extends from a respective side margin and the top margin of the main body (Fig. 17a, see e.g. modified A-B above).
Regarding claim 18, Liu in view of Bearne teaches the headgear of claim 3, wherein Liu discloses wherein the main body of the rear panel comprises opposing top and base margins, opposing side margins connecting the opposing top and base margins, a central vertical plane connecting the mid points of the opposing top and base margins, and a central horizontal plane connecting the mid points of the opposing side margins (Fig. 17a, see modified B above),
wherein the opposing side margins are inclined relative to the opposing top and base margin, and are of equal length, such that the main body is substantially trapezoidal (Fig. 17a, see modified B above);
wherein each laterally extending arm extends from one of the pair of side margins and the top margin of the trapezoidal shaped main body above the central horizontal plane and extend away from both the central horizontal and vertical planes, and at an angle between 0˚ and 90˚ from the horizontal plane (Fig. 17a, see modified B above).
Regarding claim 21, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein each laterally extending arm tapers along its length (Fig. 17a, see e.g. modified D above, where the arms taper outwardly along their length).
Regarding claim 22, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein each laterally extending arm flares along its length (Fig. 17a, see e.g. modified D above, where the arms flare inwardly along their length).
Regarding claim 23, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein each laterally extending arm is of substantially constant width along its length (Fig. 17a, see modified C above).
Regarding claim 24, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein the distal arm end of each laterally extending arm is stepped or tapered or waisted, so that the distal arm end is of narrower width than the remainder of the laterally extending arm (Fig. 17a, see modified D above).
Regarding claim 38, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein the first end of each of the lower side straps is secured to or configured to be secured to, the patient interface and to extend along the sides of the user's head (Fig. 17a, page 1).
Regarding claim 40, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein the second end of each lower side strap is joined to the main body of the rear panel such that the pair of the lower side straps extend from the rear panel (Fig. 17a).
Regarding claim 41, Liu in view of Bearne teaches the headgear of claim 40, wherein Liu discloses wherein the second end of each lower side strap is joined to the base margin of the main body of the rear panel using an overlap weld (Fig. 17a; second full para on page 11: “lower straps are joined and/or overlapped by…welding…to form the joint portion”; second and third paras on page 12).
Regarding claim 42, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses/teaches/suggests wherein each of the joins is formed by a stitched, glued, or welded joint (Fig. 17a; second full para on page 11: “straps are joined and/or overlapped by…welding…to form the joint portion”; bottom of page 8: “method of connection includes, but is not limited to, sewing, welding…adhesive tape”; second and third paras on page 12).
Regarding claim 43, Liu in view of Bearne teaches the headgear of claim 1, wherein Liu discloses wherein the lower corner area is located closer to the central longitudinal axis than the upper corner region on a same side of the headgear (Fig. 17a).
Claim(s) 7, 9, 12-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bearne as applied to claims 1-3, 6 and 8 above, and further in view of Amarasinghe et al. (US 2016/0045700 A1; hereinafter “Amarasinghe”).
Regarding claim 7, Liu in view of Bearne teaches the headgear of claim 6, but modified Liu is silent regarding wherein the end margin is parallel with the longitudinal axis. However, Liu further teaches that the angles of the joints and straps can be adjusted (Figs. 6a-b and 22a-b; second full para on page 11: “the joint angle, the overlap area and the angle of the joint portion can be adjusted; bottom of page 8-top of page 9; the bottom of the third para on page 12: “connection joints…1160 can be adjusted according to the splicing or overlapping area, angle and direction of the connecting members”; see also Fig. 4 and the last full para of page 7), a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to optimize the angles (α/β) at which rear panel arm end margins (connection edge portions 4’/2’) extend to include wherein the end margin is parallel with the longitudinal axis (Fig. 6; paras [0174] and [0179] in view of para [0177]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include wherein the end margin is parallel with the longitudinal axis as taught by Amarasignhe, in order to provide a joint/end margin that is angled vertically as known in the art, to predictably create a desired distribution of the mask holding forces and/or degree of patient comfort (Amarasignhe paras [0045] and [0178]), particularly one that directs the forces more around the occipital bone rather than over it and that can be stamped out of a standard rectangular sheet of material with minimal cuts, e.g. two side cuts and a top cut, by providing a Y-shape as taught by Liu Fig. 17a but with more outwardly/horizontally-angled arms, e.g. similar to the lower arms taught by Amarasignhe (Fig. 6; para [0177]), see e.g. Liu+Ho as depicted on page 37 below.
Regarding claim 9, Liu in view of Bearne teaches the headgear of claim 8, but modified Liu is silent regarding wherein the end margin is inclined relative to the longitudinal axis at an angle between 0.1 and 20˚. However, Liu further teaches that the angles of the joints and straps can be adjusted (Figs. 6a-b and 22a-b; second full para on page 11: “the joint angle, the overlap area and the angle of the joint portion can be adjusted; bottom of page 8-top of page 9; the bottom of the third para on page 12: “connection joints…1160 can be adjusted according to the splicing or overlapping area, angle and direction of the connecting members”; see also Fig. 4 and the last full para of page 7), a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to optimize the angles (α/β) at which rear panel arm end margins (connection edge portions 4’/2’) extend to include wherein the end margin is inclined relative to the longitudinal axis at an angle between 0.1 and 20˚ (Fig. 6; paras [0174] and [0179] in view of para [0177]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include wherein the end margin is inclined relative to the longitudinal axis at an angle between 0.1 and 20˚ as taught by Amarasignhe, in order to provide a joint/end margin that is angled closer to vertical as known in the art, i.e. within a range as claimed to accommodate to provide manufacturing tolerances, to predictably create a desired distribution of the mask holding forces and/or degree of patient comfort (Amarasignhe paras [0045] and [0178]), particularly one that directs the forces more around the occipital bone rather than over it by providing a Y-shape as taught by Liu Fig. 17a but with more outwardly/horizontally-angled arms as discussed above regarding claim 7, and that maintains a substantial overlap of the arms with the straps by having them oriented at matching angles.
Regarding claim 12, Liu in view of Bearne teaches the headgear of claim 1, but modified Liu is silent regarding wherein the longitudinal axis of each arm is inclined at an angle between 40˚ and [<]90° relative to the longitudinal axis of the rear panel. However, Liu further teaches that the angles of the joints and straps can be adjusted (Figs. 6a-b and 22a-b; second full para on page 11: “the joint angle, the overlap area and the angle of the joint portion can be adjusted; bottom of page 8-top of page 9; the bottom of the third para on page 12: “connection joints…1160 can be adjusted according to the splicing or overlapping area, angle and direction of the connecting members”), a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention wherein the longitudinal axis of each arm is inclined at an angle between 40˚ and [<]90° relative to the longitudinal axis of the rear panel (Fig. 6; angle A1 in the range of about 30-40˚, para [0177], where 40˚ is within and thus anticipates the instant range). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include wherein the longitudinal axis of each arm is inclined at an angle between 40˚ and [<]90° relative to the longitudinal axis of the rear panel as taught by Amarasignhe, in order to provide arms that aligned with upper straps that are angled as known in the art, to predictably create a desired distribution of the mask holding forces and/or degree of patient comfort (Amarasignhe paras [0045] and [0178]), particularly one that directs the forces more around the occipital bone rather than over it by providing a Y-shape as taught by Liu Fig. 17a but with more outwardly/horizontally-angled arms as discussed above regarding claim 7 and that maintains a substantial overlap of the arms with the straps by having them oriented at matching angles.
Regarding claim 13, Liu in view of Bearne teaches the headgear of claim 1, but modified Liu is silent regarding wherein the entire rear panel is constrained within a notional rectangle of 100-300mm wide by 50-120mm tall, or 180-200mm wide by 75-95mm tall. However, a change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention wherein the entire rear panel is constrained within a notional rectangle of 82-90mm wide (L2) about by 42-[4]6mm tall (w2) (Fig. 6; para [0177]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include wherein the entire rear panel is constrained within a notional rectangle of 100-300mm wide by 50-120mm tall, or 180-200mm wide by 75-95mm tall through routine experimentation and as suggested by Amarasinghe, in order to appropriately size the rear panel for a given size of patient head and so that the rear panel does not cause excessive discomfort during use (Amarasinghe para [0178]), where dimensions as claimed, i.e. slightly larger than those explicitly disclosed by Amarasinghe, would have predictably provided a slightly larger rear panel for individuals with larger heads.
Regarding claim 14, Liu in view of Bearne teaches the headgear of claim 2, wherein Liu discloses or suggests wherein the rear panel can be defined by any one or more of the following ratios:
a. the ratio of the length of a laterally extending arm to the length of the main portion is between 0.65 and 0.8, length being measured in a direction perpendicular to the longitudinal axis;
b. the ratio of the height of a laterally extending arm to the height of the main portion, height being measured in a direction parallel to the longitudinal axis, is between 1.1 and 1.6;
c. the ratio of the length of the entire rear panel to the length of the main portion is between 2.0 and 3.0;
d. the ratio of the area of a laterally extending arm to the area of the main portion is between 0.3 and 0.5;
e. the ratio of the area of both laterally extending arms to the area of the entire rear panel is between 0.3 and 0.7;
f. the ratio of a cut out or recess formed adjacent the upper margin of the rear panel as defined by the area between the upper margin of the rear panel and a notional horizontal line extending between and connecting the two most upper points of the laterally extending arms, to the area of the entire rear panel is between 0.3 and 0.5; or
g. the rear panel comprises between 30 and 70% of a notional rectangular area that surrounds and contacts all extreme points of the rear panel, because Liu Fig. 17a suggests these ratios and/or a main body/arms can be delineated in the rear panel of Liu Fig. 17a such that the instant ratios are met, a change in size and/or shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A&B, and/or optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, where Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to appropriately size a rear panel/its associated main body and arms (Fig. 6; para [0176-178]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include the claimed ratio(s) through routine experimentation and as taught by Amarasinghe, in order to appropriately size the rear panel/its associated main body and arms for a given size of patient head and so that the rear panel does not cause excessive discomfort during use (Amarasinghe para [0178]).
Regarding claim 15, Liu in view of Bearne teaches the headgear of claim 3, wherein Liu discloses or suggests wherein the rear panel can be defined by any one or more of the following ratios:
a. the total area of the rear panel is between 8000 and 13000mm2;
b. the ratio of the area of both laterally extending arms to the area of the main portion of the rear panel is between 0.1 and 0.3; or
c. the ratio of the area of the main portion to the entire area of the main panel is between 0.75 and 1.0, because Liu Fig. 17a suggests these ratios and/or a main body/arms can be delineated in the rear panel of Liu Fig. 17a such that the instant ratios are met, a change in size and/or shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A&B, and/or optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, where Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to appropriately size a rear panel/its associated main body and arms (Fig. 6; para [0176-178]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include the claimed ratio(s) through routine experimentation and as taught by Amarasinghe, in order to appropriately size the rear panel/its associated main body and arms for a given size of patient head and so that the rear panel does not cause excessive discomfort during use (Amarasinghe para [0178]).
Regarding claim 19, Liu in view of Bearne teaches the headgear of claim 3, wherein Liu discloses or suggests wherein each laterally extending arm extends away from one of the pair of side margins and the top margin of the trapezoidal shaped main body, and the area of each laterally extending arm is less than 15% of the area of the main body because Liu Fig. 17a suggests these ratios and/or a main body/arms can be delineated in the rear panel of Liu Fig. 17a such that the instant ratios are met, a change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A, and/or optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, where Amarasinghe teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to appropriately size a rear panel/its associated main body and arms (Fig. 6; para [0176-178]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include the claimed ratio through routine experimentation and as taught by Amarasinghe, in order to appropriately size the rear panel/its associated main body and arms for a given size of patient head and so that the rear panel does not cause excessive discomfort during use (Amarasinghe para [0178]), and where smaller arms would predictably result in less material costs for the rear panel and/or less likelihood of undesired movement of the arms during manufacture as compared to bigger/longer arms, when maintaining the same sized main body.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bearne as applied to claims 1, and further in view of Ho (WO 2018/002169 A1; hereinafter “Ho”).
Regarding claim 12, Liu in view of Bearne teaches the headgear of claim 1, but modified Liu is silent regarding wherein the longitudinal axis of each arm is inclined at an angle between 40˚ and [<]90° relative to the longitudinal axis of the rear panel. However, Liu further teaches that the angles of the joints and straps can be adjusted (Figs. 6a-b and 22a-b; second full para on page 11: “the joint angle, the overlap area and the angle of the joint portion can be adjusted; bottom of page 8-top of page 9; the bottom of the third para on page 12: “connection joints…1160 can be adjusted according to the splicing or overlapping area, angle and direction of the connecting members”), a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Ho teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention wherein the longitudinal axis of each arm is inclined at an angle between 40˚ and [<]90° relative to the longitudinal axis of the rear panel (Figs. 5-7; A2 = 155˚ in Fig. 6 and 110.8˚ in Fig. 7, which thus teaches wherein the longitudinal axis of each arm is inclined at an angle an angle of 77.5˚ or 55.4˚, respectively). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include wherein the longitudinal axis of each arm is inclined at an angle between 40˚ and <90° relative to the longitudinal axis of the rear panel as taught by Ho, in order to provide arms that are aligned with upper straps that are angled as known in the art, to predictably create a desired distribution of the mask holding forces for fit and comfort (Ho paras [05] and [45]), particularly one that directs the forces more around the occipital bone rather than over it by providing a Y-shape as taught by Liu Fig. 17a but with more outwardly-angled arms as taught by Ho (Fig. 7), see combination of Liu+Ho on page 37 below, and that maintains a substantial overlap of the arms with the straps by having them oriented at matching angles.
Claim(s) 16 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over as applied to claim 1, and further in view of Dunn et al. (US 2014/0190486 A1; hereinafter “Dunn”).
Regarding claim 16, Liu in view of Bearne teaches the headgear of claim 1, but modified Liu is silent regarding where the rear panel is defined by the following formula; w2=1/2 dl - 1/2 c;
where w2=the width of the laterally extending arm as measured in a direction substantially parallel with the longitudinal axis, dl= the distance between opposed top and base margins of the main portion, and c = the clearance between adjacent rear panels required during manufacture of multiple rear panels on a sheet of material to ensure a satisfactory quality of cut. This claim is being treated as a product-by-process claim and is limited only by the structure implied by the formula. The formula implies that the product, the rear panel, is of a shape and size such that multiple rear panels can fit on one sheet and not overlap, and a change in shape and/or shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.A&B. The concept of nesting headgear elements to minimize waste when stamping out the components was already known in the art before the effective filing date of the claimed invention, see e.g. where Dunn teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to include wherein multiple headgear components are manufactured adjacent to one another with a desired clearance between elements (e.g. D3-D4 in Fig. 3-8) (see Figs. 3-6 to 3-9). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention for the rear panel of modified Liu to be of a shape/size such that multiple rear panels can fit on one sheet and not overlap, i.e. as defined by the instant formula, as taught by Dunn, for the purpose of allowing bulk manufacture with minimal waste/high yield (Dunn paras [0068], [0083] and [0089-92]).
Regarding claim 36, Liu in view of Bearne teaches the headgear of claim 1, but modified Liu is silent regarding wherein the second end of each side strap is joined to each laterally extending arm, respectively, of the rear panel via a butt joint. However, Dunn teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention to utilize butt joints, including ones where the materials are initially overlapped (Fig. 4-2; paras [0076-77]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to wherein the second end of each side strap is joined to each laterally extending arm, respectively, of the rear panel via a butt joint as taught by Dunn, in order to provide the predictable result of flush joint that is less likely to cause irritation, chaffing and/or marking and/or is visually appealing (Dunn para [0077]).
Claim(s) 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Ho.
Regarding claim 44, Liu discloses headgear (Fig. 17a) configured to be secured to a patient interface of a respiratory therapy system, to mount the patient interface on a user's head (page 1), the headgear comprising:
a rear panel (neck connector 1140) configured to engage the rear of the user's head (Fig. 17a; page 1), the rear panel comprising:
a main body comprising an inverted trapezoidal shape having opposed top and base margins which are spaced apart by a distance and wherein the base margin is shorter than the top margin, a central longitudinal axis bisecting the top and base margins, opposed side margins each inclined towards the central longitudinal axis in a direction from the top margin to the base margin, the main body defining lower corners of the rear panel at an intersection of the base margin and each of the side margins (see Fig. 17a modified E, below); and
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a single pair of arms, each arm extending from the top margin, each arm being inclined upwardly away from the main body and away from the central longitudinal axis, and comprising a distal arm end defining an upper corner of the rear panel (see Fig. 17a modified E, above);
wherein the main body and the single pair of arms are formed from a single piece of material (Fig. 17a, see e.g. modified E above; page 1, ninth full para on page 3, e.g. page 9, second and third paras on page 12);
a pair of upper side straps each formed separately from the rear panel (the upper pair of side straps extending from upper joints 1160 in Fig. 17a; page 1, second and third paras on page 12), each upper side strap having first (distal free ends to the right and left, respectively) and second (at upper joints 1160) opposed ends, a first end of each upper side strap being secured to, or being configured to be secured to, the patient interface and to extend along the sides of the user's head (page 1), the second end of each upper side strap being entirely joined to the distal arm end of a respective arm of the rear panel at a join (upper joint 1160) (Fig. 17a); and
a pair of lower side straps (lower straps 1150) each formed separately from the rear panel, each lower side strap having first (distal free end, to the right and left in Fig. 17a, respectively) and second (at lower joints 1160) opposed ends, a first end of each lower side strap being secured to, or being configured to be secured to, the patient interface and to extend along the sides of the user's head (page 1), wherein the second end of each of the lower side straps is joined to the lower corner of the main body of the rear panel at a join (lower joints 1160) (Fig. 17a, see modified E above; second full para on page 11; second and third paras on page 12).
Liu is silent regarding wherein the arms are laterally extending arms extending from an intersection of the top margin and a respective side margin of the main body. However, Liu further teaches that the angles of the joints and straps can be adjusted (Figs. 6a-b and 22a-b; second full para on page 11: “the joint angle, the overlap area and the angle of the joint portion can be adjusted; bottom of page 8-top of page 9; the bottom of the third para on page 12: “connection joints…1160 can be adjusted according to the splicing or overlapping area, angle and direction of the connecting members”), a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and Ho teaches that it was known in the respiratory mask headgear art before the effective filing date of the claimed invention for a rear panel with an inverted trapezoidal shaped main body to include wherein the upper arms are laterally extending arms extending from an intersection of the top margin and a respective side margin of the main body (see Ho Fig. modified below).
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Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Liu to include wherein the arms are laterally extending arms extending from an intersection of the top margin and a respective side margin of the main body as taught by Ho (see combination Liu Fig. 17a and Ho Fig. 7 below), in order to provide arms that are aligned with upper straps that are angled as known in the art, to predictably create a desired distribution of the mask holding forces for fit and comfort (Ho paras [05] and [45]), particularly one that directs the forces more around the occipital bone rather than over it by providing a Y-shape as taught by Liu Fig. 17a but with more outwardly-angled arms as taught by Ho (Fig. 7 modified, above), and that maintains a substantial overlap of the arms with the straps by having them oriented at matching angles, see e.g. the combination below, where the upper portion of Ho has been overlapped onto the lower portion of Liu,.
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Regarding claim 45, Liu in view of Ho teaches the headgear of claim 44, wherein Liu discloses/teaches/suggests wherein each of the joins is formed by a stitched, glued, or welded joint (Fig. 17a; second full para on page 11: “straps are joined and/or overlapped by…welding…to form the joint portion”; bottom of page 8: “method of connection includes, but is not limited to, sewing, welding…adhesive tape”; second and third paras on page 12).
Regarding claim 46, Liu in view of Ho teaches the headgear of claim 44, wherein modified Liu teaches wherein the side margins [of the main body] of the rear panel are inclined relative to the central longitudinal axis at a different angle to an angle of inclination of the laterally extending arms relative to the central longitudinal axis, because the combination of the Y-shape as taught by Liu Fig. 17a with more outwardly-angled arms as taught by Ho (Fig. 7 modified, above) teaches the construction discussed in claim 44 above, where the arms extend at an angle much closer to horizontal than the sides of the inverted trapezoid.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional reference teaching a rear panel with a single pair of upper lateral arms for respiratory mask headgear: Eschen et al. (DE 102007050369 A1; Fig. 10e). Additional reference teaching strap angles as known structural considerations when designing respiratory mask headgear: previously-cited Formica (US 2011/0197341 A1; Fig. 22); Ho (US 2011/0072553 A1; Fig.12). Additional reference regarding shapes for main bodies of rear panels: Olsen et al. (US 2014/0096774 A1; Figs. 58A-D). Additional reference teaching known means for attaching respiratory mask headgear straps to a rear panel: Harwood et al. (US 2016/0325067 A1; Figs. 17 and 20). Additional reference regarding nesting of respiratory mask headgear components, including rear panels, to reduce waste during manufacture: Carroll et al. (US 2009/0211583 A1; Fig. 10).
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.
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785