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 .
Response to Amendment
This office action is in response to preliminary amendment filed on 12/08/2025. As directed by the amendment, no claims were canceled, claims 1-20 were amended, and no claims were newly added. Thus, claims 1-20 are presently pending in this application.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see specification paragraph [0112]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. The amended specification [0112] still contains “browser-executable code” as described above. See MPEP § 608.01.
Claim Objections
Claim 1 and 18 are objected to because of the following informalities:
Regarding claim 1 line 1, the term “A attachment supporting apparatus” should read --An attachment supporting apparatus-- for grammatical correctness.
Regarding claim 18 line 12, the term “bottome” should read --bottom-- for spelling correctness.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 19 line 5, the term “a head profile” is unclear as to if the term is the same or different than “a scanned head profile” of line 3.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 10, 13, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thompson et al. (US 2019/0134436; hereinafter “Thompson”).
Regarding claim 1, Thompson discloses a attachment supporting apparatus for a respiratory-protective-device (headnet 20 supports respiratory mask 40) comprising:
a support member (head covering 22) having a contour defining a planar surface having a central hub region ([0029] head covering 22 perimeter is a contour; central hub would be above the opening 36, all of which contacts the parietal region) to contact and maintain engagement against a parietal region of a head of a person (Fig. 4 headnet 20 connects to back of the head, in parietal region), wherein the support member is connected to the respiratory protective device to maintain a pre-defined position of the respiratory protective device over a facial region of the person (Fig. 4, [0033] headnet 20 uses plurality of straps 24, 28, 30, and 32 to couple to the respiratory mask 40); and
a plurality of anchorable structures formed in the support member (channels 34a, 34b on edge portion 26 of head covering 22, for sliding in straps 24, 28, etc) to define a plurality of holes along a circumferential edge of the support member (openings on ends of channels 34a, 34b) wherein the plurality of holes are defined to extend through the support member (openings on end of channels 34a, 34b begin the extension into the head covering 22) from a top side to a bottom side in a direction perpendicular to the contour of the support member (channels 34a, 34b and their respective openings extend from 34a at the top to 34b on the bottom along the head covering 22; openings on channels extend perpendicular to perimeter).
along a portion of the contour, including at the parietal region (channels 34a, 34b on edge portion 26 of head covering 22, for sliding in straps 24, 28, etc).
Regarding claim 2, Thompson discloses the respiratory protective device is a facial covering (personal protective equipment respiratory mask 40 covers the facial area, Fig. 4).
Regarding claim 3, Thompson discloses the plurality of anchorable structures includes two or more anchorable structures extending outwardly from the circumferential edge of the support member (two channels 34a, 34b have end openings extending from the perimeter of covering 22).
Regarding claim 4, Thompson discloses the support member defines a plurality of gaps or is formed of a mesh material to provide a lightweight, breathable surface ([0029] “head covering 22 may include any appropriate elastic or non-elastic material”, and “the head covering 22 includes a lattice pattern of interweaving strands of material forming a support structure with open weave or net construction”).
Regarding claim 5, Thompson discloses a plurality of struts of the support member define the plurality of gaps (connective material between the gaps in open weave/net appear to function as struts within the head covering 22 to prevent certain motion when elastic material is pulled on by straps), which have a set of pre-defined shapes (Fig. 2 head covering mesh material is made of small holes in the open weave/net construction; appear to be small rhombus shapes)
Regarding claim 6, Thompson discloses the set of pre-defined shapes of the plurality of struts and the plurality of gaps defined thereby form a tessellating pattern (see rejection to claim 5; small rhombus shape open weave/net construction is a repeating pattern of gaps, which appear to be geometric shapes as well).
Regarding claim 7, Thompson discloses the plurality of gaps are offset from the circumferential edge by a margin (Fig. 2 boundaries of channels 34a,b offset the pattern in the open weave/net, and edge portion 26 seemingly defines the end of head covering 22, thus the end of the pattern in the open weave/net).
Regarding claim 10, Thompson discloses the contour is over, or in proximity to, at least one of: a vertex region of the head; an occiput region of the head; an inion region of the head; or any region therebetween (Fig. 4 appears to have headnet 20 cover vertex and inion region of the head, and may touch the occiput region. Exact placement on the head would also depend on how tight/loose the straps are pulled against the head).
Regarding claim 13, Thompson discloses the support member comprises ethyl-vinyl acetate, silicones, neoprene ([0029] head covering 22 made of material that may be silicone or rubber).
Regarding claim 17, Thompson discloses the plurality of anchorable structures are integral to the support member (channels 34a, 34b receive straps 24, 28 via sliding into the outer hole of the channels) such that the plurality of holes are defined through the support member from the top side to the bottom side (Fig. 2 channels 34a, 34b have entry openings; and channel 34a on top, channel 34b on bottom).
Regarding claim 18, Thompson discloses a system comprising: an attachment supporting apparatus for a respiratory protective device (headnet 20) comprising:
a support member (head covering 22) having a contour defining a planar surface having a central hub region ([0029] head covering 22 perimeter is a contour; central hub would be above the opening 36, all of which contacts the parietal region) to contact and maintain engagement against a parietal region of a head of a person (Fig. 4 headnet 20 connects to back of the head, in parietal region), wherein the support member is connected to the respiratory protective device to maintain a pre-defined position of the respiratory protective device over a facial region of the person (Fig. 4, [0033] headnet 20 uses plurality of straps 24, 28, 30, and 32 to couple to the respiratory mask 40); and
a plurality of anchorable structures formed in the support member (channels 34a, 34b on edge portion 26 of head covering 22, for sliding in straps 24, 28, etc) to define a plurality of holes along a circumferential edge of the support member (openings on ends of channels 34a, 34b), wherein the plurality of holes are defined to extend through the support member (openings on end of channels 34a, 34b begin the extension into the head covering 22) from a top side to a bottome side in a direction perpendicular to the contour of the support member (channels 34a, 34b and their respective openings extend from 34a at the top to 34b on the bottom along the head covering 22; openings on channels extend perpendicular to perimeter); and
the respiratory protective device having a plurality of corresponding anchorable structures (Fig. 4 straps 24a, 28a are anchored to the mask 40 with the circular pins and are at least anchored in some way; [0037] “the first 24a, 24b and second 28a, 28b pairs of straps are couplable to a personal protective equipment mask facepiece 44”); and
two or more straps to connect the respiratory protective device to the attachment supporting apparatus (straps 24, 28), wherein each of the two or more straps is configurable between at least a first length and a second length ([0031] “the straps 24, 28 may be slidable within the channels 34a, 34 b to allow for a greater degree of adjustment of the personal protective equipment on the user's head”; the adjustment would be to at least a first and second length).
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grashow (US 2016/0354571).
Regarding claim 19, Grashow discloses a method of fabricating an attachment supporting apparatus for a respiratory-protective-device (see Grashow headgear component 22 connecting to patient interface device 8), the method comprising:
acquiring (i) a set of images or scans of a person or (ii) a scanned head profile of a head of the person (see Grashow electronic apparatus 3 including adjustment determination unit 30 using headgear force sensors 34; [0033] “The 3-D model of the patient's head and neck can be useful in determining optimal adjustments for adjustable features such as straps 20, and adjustment determination unit may also use the 3-D model of the patient's head and neck to calculate the adjustment information”);
generating, by a processor, a model that defines a head profile of the person based on (i) the set of images or scans of the person or (ii) the scanned head profile of the person (see Grashow [0032] “ adjustment determination unit 30 may be any type of processing apparatus such as a microprocessor”);
determining, by the processor, a plurality of anthropometric landmarks, or landmarks derived therefrom, wherein the plurality of anthropometric landmarks, or landmarks derived therefrom, include at least one of a vertex region of the head, an occiput region of the head, an inion region of the head, any region therebetween, or any region proximal thereto (see Grashow [0033] “adjustment determination unit 30 is structured to receive a 3-D model of the patient's face”, and scans of the head and neck [0033]; which would include all the claimed regions of the head); and
determining, by the processor, using the determined plurality of anthropometric landmarks, or landmarks derived therefrom, at least one of a support member or a contour (see Grashow fabric of headgear component 22 in Fig. 1 or 3 contacting back of head) thereof that can be placed on the person, wherein the support member or the contour thereof extends over at least one of the vertex region of the head, the occiput region of the head, the inion region of the head, any region therebetween, or any region proximal thereto (see Grashow headgear component modified using information from adjustment determination unit 30 to cover back of head);
wherein at least one of the support member or the contour thereof is employed in one or more manufacturing operations to manufacture or fabricate the attachment supporting apparatus (see Grashow [0041] adjustment determination unit 30 outputs adjustment information to manufacturer; “ the adjustment information is provided to a manufacturer that manufactures custom sized adjustable features for patient interface device 8 or adjusts the patient interface prior to shipping to the patient or clinician based on the adjustment information”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-9, 11, 15-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson as applied to claim 1 above, and further in view of Grashow.
Regarding claim 8, Thompson discloses straps (see Thompson straps 24, 28), but is silent as to wherein the straps comprise a marking or calibration scale for customizing and controlling the pressure exerted by the respiratory protective device on the facial region of the person. However, Grashow teaches the straps comprise a marking or calibration scale for customizing and controlling the pressure exerted by the respiratory protective device on the facial region of the person (see Grashow [0026] straps on headgear component 22 include indicia 23… could be notches, numbers, etc.). 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 of Thompson with the addition of a marking or calibration scale as taught by Grashow so as to communicate adjustment information to a clinician or patient (Grashow [0026]) and consistently mark an accurate patient head size.
Regarding claim 9, modified Thompson discloses the straps extend from, or are coupled to two or more anchorable structures of the plurality of anchorable structures (see Thompson straps 24, 28 fed into channels 34a,b),
wherein the two or more anchorable structures are selected for customizing and controlling the pressure exerted by the respiratory protective device on the facial region of the person (Channels 34a, 34b determine placement of straps and how tight/loose the straps are pulled against the head with head covering 22).
Regarding claim 11, Thompson is silent as to the support member and the contour associated with the support member are customized to a scanned head profile of a back of the head of the person. However, Grashow teaches the support member and the contour associated with the support member are customized to a scanned head profile of a back of the head of the person (see Grashow electronic apparatus 3 including adjustment determination unit 30 using headgear force sensors 34; [0033] “The 3-D model of the patient's head and neck can be useful in determining optimal adjustments for adjustable features such as straps 20, and adjustment determination unit may also use the 3-D model of the patient's head and neck to calculate the adjustment information”). 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 apparatus of Thompson with the addition of an electronic apparatus able to scan the head profile of a person as taught by Grashow so as to be able to determine personal fit characteristics and optimal adjustment for features such as the contour of the apparatus.
Regarding claim 15, Thompson is silent as to the support member includes recess to house electronic components. However, Grashow teaches the support member includes recess to house electronic components (see Grashow Fig. 3 headgear force sensors 34, and connection to electronic apparatus 3). 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 support member of Thompson with the recess to house electronic components such as sensors as taught by Grashow so as to be able to connect electronic improvements to the apparatus, such as for scanning a head profile to make customized fit apparatuses.
Regarding claim 16, Thompson is silent as to an electronics module and an active device each coupled to the support member. However, Grashow teaches an electronics module and an active device each coupled to the support member (see Grashow headgear force sensors 34 and electronics apparatus 3 both physically and operatively connected to headgear component 22). 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 support member of Thompson with the addition of an electronics module and active device to the support member as taught by Grashow so as to be able to connect electronic improvements to the apparatus, such as for scanning a head profile to make customized fit apparatuses.
Regarding claim 20, Thompson discloses a method comprising:
providing an attachment supporting apparatus for a respiratory protective device (see Thompson headnet 20 supports respiratory mask 40) comprising:
a support member (see Thompson head covering 22) having a contour defining a planar surface having a central hub region (see Thompson [0029] head covering 22 perimeter is a contour; central hub would be above the opening 36, all of which contacts the parietal region), wherein the support member is connected to the respiratory protective device to maintain a pre-defined position of the respiratory protective device over a facial region of a user (see Thompson Fig. 4, [0033] headnet 20 uses plurality of straps 24, 28, 30, and 32 to couple to the respiratory mask 40); and
a plurality of anchorable structures formed in the support member (channels 34a, 34b on edge portion 26 of head covering 22, for sliding in straps 24, 28, etc) to define a plurality of holes along a circumferential edge of the support member (openings on ends of channels 34a, 34b), wherein the plurality of holes are defined to extend through the support member (openings on end of channels 34a, 34b begin the extension into the head covering 22) from a top side to a bottome side in a direction perpendicular to the contour of the support member (channels 34a, 34b and their respective openings extend from 34a at the top to 34b on the bottom along the head covering 22; openings on channels extend perpendicular to perimeter).
Thompson is silent as to measuring a head region of the user to obtain a plurality of anatomical facial landmarks; and
fitting the attachment supporting apparatus or the contour to the head region of the user such that the central hub region contacts and maintains engagement against a parietal region of the user.
However, Grashow teaches measuring a head region of the user to obtain a plurality of anatomical facial landmarks (see Grashow electronic apparatus 3 including adjustment determination unit 30 using headgear force sensors 34; [0033] “The 3-D model of the patient's head and neck can be useful in determining optimal adjustments for adjustable features such as straps 20, and adjustment determination unit may also use the 3-D model of the patient's head and neck to calculate the adjustment information”). 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 apparatus of Thompson with the addition of an electronic apparatus able to scan the head profile of a person as taught by Grashow so as to be able to determine personal fit characteristics and optimal adjustment for features such as the contour of the apparatus.
Thus, modified Thompson discloses fitting the attachment supporting apparatus or the contour to the head region of the user such that the central hub region contacts and maintains engagement against a parietal region of the user (see modification to include measurement and calibration system of Grashow, which would be used to create customized headnet 20 of Thompson. Fig. 4 of Thompson shows headnet 20 making contact with parietal region of head).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Thompson as applied to claim 1 above, and further in view of Waterford et al. (US 11,484,734; hereinafter “Waterford”).
Regarding claim 12, Thompson discloses the support member is constructed using elastomeric materials (see Thompson [0029] head covering 22 made of elastic materials, silicone, rubber). Thompson is silent as to the construction of the support member via additive manufacturing or injection molding. However, Waterford teaches the support member is constructed via additive manufacturing or injection molding using elastomeric materials (see Waterford Col. 3 lines 38-40, 51-54 “Many existing elastomeric facemasks, such as half-face respirator masks, are created through injection molding using machined molds”; and additive manufacturing is a suitable alternative for creating both the face mask and strap system). 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 construction method of the support member of Thompson with the additive manufacturing or injection molding construction method as taught by Waterford as this would have been an obvious substitution for one known type of construction method for another and would yield predictable results, i.e. constructing the support member using elastomeric materials.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Thompson as applied to claim 1 above, and further in view of Qu et al. (US 11,969,035; hereinafter “Qu”).
Regarding claim 14, Thompson discloses the support member comprises a material (see Thompson [0029] head covering 22 made of appropriate elastic material such as silicone or rubber), but is silent as to the material is compatible with a decontaminating operation comprising UV radiation or cleaning solvents. However, Qu teaches the material is compatible with a decontaminating operation comprising cleaning solvents (see Qu Col. 11 lines 52-54 “In the case of long-term wear of the ear straps (or when the user determines the ear straps need to be replaced or washed)”, such as ear strap as connector element 230 in Fig. 2A, part of the 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 modify the treatment of the material of Thompson with the cleanable quality of the material as taught by Qu as this would have been an obvious substitution for one known type of material of the support member for another and would yield predictable results, i.e. function as a support member, but provide the function of being washed for cleanliness.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
Applicant argues, on page 10 of the remarks, that the objection to the hyperlinks in the specification should be withdrawn due to the amended specification. However, Examiner disagrees because the amended specification [0112] still contains “browser-executable code” as described in the objection above. Therefore, the objection still stands.
Applicant argues, on pages 11-12 of the remarks, that “Thompson fails to teach each and every feature of claim 1”. However, Examiner notes that Thompson’s headnet 20 is used to ensure a proper fit of the facepiece to the user as well (see Thompson [0003]). Additionally, the language of claim 1 reads on “a plurality of anchorable structure formed in the support member”, which reads on the channels 34a, 34b of Thompson, see rejection to claim 1 above. The channel 34a and respective opening is on the top side of head covering 22, while channel 34b and respective opening is on the bottom side. The channel openings appear to extend through the covering 22 perpendicular to the outer perimeter of the covering 22. Thompson opening 36 is not relied on in any part of the rejection. Therefore, the rejection still stands.
Applicant argues, on pages 13-14 of the remarks, that “For example, the scanning process of Grashow does not "obtain a plurality of anatomical facial landmarks," as claimed. Additionally, the 3D scanned data in Grashow does not inform the shape and/or contour of the attachment supporting apparatus. The method of claim 19 incorporates a customized attachment supporting apparatus with a customized contour configured to cover a user's head, including the parietal region, for consistent engagement”. However, Examiner fails to see where the exact quoted language that is said to be claimed. Regardless, Grashow does disclose a 3-D model of the patient’s head, which encompasses the entirety of the head and anthropometric landmarks/features of the face. Additionally, the adjustment determination unit 30 of Grashow does inform the way in which the headgear 22 is placed on the head, see rejection above ([0035] and [0042]). Therefore, the rejection still stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785