DETAILED ACTION
This office action is in response to the amendment filed 2/22/2024. As directed by the amendment, claims 2-5, 7-8, 10-13, 16, and 18-20 have been amended, claims 14-15, 17, 22, and 25-49 have been cancelled, and no claims have been newly added. Thus, claims 1-13, 16, 18-21, and 23-24 are presenting pending in this application.
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.
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 connection portion” and “a second connection portion” in claims 1 and 24.
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 § 102
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.
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 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.
Claim(s) 1-3 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al (2011/0253143).
Regarding claim 1, Ho in fig 2 discloses a headgear for use with a respiratory patient interface, the headgear comprising: a backstrap portion (116) (lower side portion); at least one top strap portion (112) (portion of headgear member (112) adapted to fit over a crown of a patient’s head) (para [0026]); a first adjustable ear loop (left ear loop comprising upper retention member (120), lower retention member (130), and lower portion of headgear member (112)) (para [0027]) comprising a first connection portion (121) (upper end of upper retention member) configured to be removably attachable to a first attachment zone (114) (upper side portion) of the headgear such that the first adjustable ear loop defines a first ear opening (para [0027]), wherein the first attachment zone (114) is configured to be attachable to different portions along the first connection portion (121) to adjust a size of the first ear opening (para [0027]); and a second adjustable ear loop (right ear loop comprising upper retention member (120), lower retention member (130), and lower portion of headgear member (112)) (para [0027]) comprising a second connection portion (121) (upper end of upper retention member) configured to be removably attachable to a second attachment zone (114) (upper side portion) of the headgear such that the second adjustable ear loop defines a second ear opening (para [0027]), wherein the second attachment zone (114) is configured to be attachable to different portions along the second connection portion (121) to adjust a size of the second ear opening (para [0027]).
Regarding claim 2, Ho in fig 2 shows the first ear opening and the second ear opening comprise a rounded triangular shape (as shown in fig 2, ear openings are shown to be a rounded triangular shape with a base along upper retention member (120) and a rounded vertex extending from the base).
Regarding claim 3, Ho discloses in fig 2 the first ear opening and the second ear opening are shaped and configured such that the first adjustable ear loop and the second adjustable ear loop avoid the ears of a user (as shown in fig 2, first and second ear openings are shown to avoid the ears of a user).
Regarding claim 16, Ho discloses the first adjustable ear loop and the second adjustable ear loop are symmetrical about the backstrap portion (because the first and second ear loops are formed from a pair of upper retention members (120) and lower retention members (130), it is considered that the adjustable ear loops are the same size and therefore are symmetrical about the backstrap portion) (para [0027]).
Claim(s) 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landis (2004/0065330).
Regarding claim 23, Landis discloses a headgear for use with a respiratory patient interface, the headgear comprising: a backstrap portion (172) (body section); a first top strap portion (first (right) upper strap (174)); a second top strap portion (second (left) upper strap (175)) (para [0073]), and a forehead securement member (122) (tabs (122) of CPAP device (100)) (para [0053]) configured to be removably attachable to first and second attachment zones (124b) (hook and loop portion) (para [0075]) of the headgear to provide horizontal stability to the headgear in use (forehead securement member (122) is used to secure CPAP system (100) to a patient and therefore would allow the CPAP system to be horizontally stabilized on a patient’s head in use) (para [0075]).
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 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.
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 1-7, 12-13, 16, 20-21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulliver et al (2015/0075534) in view of Ho et al (2008/0121234).
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Regarding claim 1, Gulliver in figs 1-6 discloses a headgear (1) for use with a respiratory patient interface (4) (user interface) (para [0160]), and as shown in fig 4, the headgear (1) comprising: a backstrap portion (5) (portion extending about rear region); at least one top strap portion (12) (strap (12) extending about upper region (6)) (para [0186]); a first adjustable ear loop (7) (portion of strap extending about left ear forms an ear loop (para [0164]), and the loop about an, or each ear of the user, may be adjustable, such as adjustable by the size of the loop provided for encircling partially or wholly the ear or ears of a user (para [0039])), and a second adjustable ear loop (7) (portion of strap extending about right ear forms an ear loop (para [0164]), and the loop about an, or each ear of the user, may be adjustable, such as adjustable by the size of the loop provided for encircling partially or wholly the ear or ears of a user (para [0039])
Gulliver does not disclose the first adjustable ear loop is comprises a first connection portion configured to be removably attachable to a first attachment zone of the headgear such that the first adjustable ear loop defines a first ear opening, wherein the first attachment zone is configured to be attachable to different portions along the first connection portion to adjust a size of the first ear opening; and the second ear adjustable loop comprises a second connection portion configured to be removably attachable to a second attachment zone of the headgear such that the second adjustable ear loop defines a second ear opening, wherein the second attachment zone is configured to be attachable to different portions along the second connection portion to adjust a size of the second ear opening.
However, Ho in fig 15 teaches a respiratory interface including a first ear loop formed by an upper strap (26a’) and a lower strap (26b’), wherein the first ear loop (26a’, 26b’) includes a first connection portion configured to be removably attachable to a first attachment zone of the headgear ) such that the first adjustable ear loop defines a first ear opening (includes a hook and loop fastener configured to attach to a headgear (24) to form an ear loop) (para [0054]) wherein the first attachment zone is configured to be attachable to different portions along the first connection portion to adjust a size of the first ear opening (as shown in fig 15, ear loop straps (26a’, 26b’) can be moved about the top of a patient’s head, which would adjust a size of an ear loop) (para [0054]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the first and second adjustable ear loops of Gulliver by providing the ends of the ear loops with a first connection portion configured to be removably attachable to a first attachment zone of the headgear such that the first adjustable ear loop defines a first ear opening, wherein the first attachment zone is configured to be attachable to different portions along the first connection portion to adjust a size of the first ear opening as taught by Ho in order to provide a known mechanism for adjusting the size of an ear loop (Gulliver, para [0039]), and would allow the pressure distribution about the contact footprint produced by the respiratory patient interface to be influenced (Ho, para [0054]).
Regarding claim 2, Gulliver in fig 4 shows the first ear opening and the second ear opening (7) to have a rounded triangular shape.
Regarding claim 3, Gulliver in fig 4 shows the first ear opening and the second ear opening (7) are shaped and configured such that the first adjustable ear loop and the second adjustable ear loop (7) avoid the ears of a user.
Regarding claim 4, the modified Gulliver’s reference disclose the first attachment zone and the second attachment zone comprise one of a hook material or a loop material, wherein the first connection portion and the second connection portion comprise the other of the hook material or the loop material (connection between the attachment zone and the connection portion is a hook-and-loop fastener) (para [0054]).
Regarding claim 5, Gulliver in figs 4-5 discloses the at least one top strap portion (12) comprises a first top strap portion and a second top strap portion that is selectively connectable to the first top strap portion (as shown in figs 4-5 top strap portion (12) can be configured to be a two-part releasable connection system and shown to have a first top strap portion extending from a left ear loop and a second top strap portion extending from a right ear loop and connected by a buckle) (para [0186]).
Regarding claim 6, Gulliver in the annotated fig 4 above discloses the first top strap portion extends from a first end of the backstrap portion and the second top strap portion extends from a second end of the backstrap portion.
Regarding claim 7, Gulliver discloses the upper portion of the ear loop is attached to the top strap portion (see annotated fig 4, above), and modified Gulliver’s reference discloses the upper portion of the ear loop (26a’ of Ho) includes an attachment zone comprising a hook and loop material (Ho, para [0054]), and therefore the first attachment zone is located on the first top strap portion, and the second attachment zone is located on the second top strap portion.
Regarding claim 12, Gulliver discloses the first top strap portion and the second top strap portion are configured to be adjustable to conform to a size of a head of the user (first top strap and second strap form adjustment strap (12) with a two-part releasable connection system (para [0186]).
Regarding claim 13, Gulliver discloses the first top strap portion comprises a slot configured to receive the second top strap portion (as shown in fig 6a, adjustment strap (12) includes a buckle (13) including a first (right) top strap part comprising a slot configured to receive a receiving hook of a second (left) top strap part) (fig 6a, para [0123]).
Regarding claim 16, Gulliver discloses the first adjustable ear loop and the second adjustable ear loop are symmetrical about the backstrap portion (para [0199]).
Regarding claim 20, Gulliver disclose the first adjustable ear loop (7) and the second adjustable ear loop (7) comprise respective attachment zones (15) (releasable connectable part) (para [0223]).
Regarding claim 21, Gulliver discloses the respective attachment zones (15) are configured to be removably attachable to the respiratory patient interface (4) (para [0223]).
Regarding claim 24, Gulliver in figs 1-6 discloses a patient interface assembly for delivering respiratory support to a user, the patient interface assembly comprising a headgear (1) shown in fig 4, above, for use with a respiratory patient interface (4) (user interface) (para [0160]), and as shown in fig 4, the headgear (1) comprising: a backstrap portion (5) (portion extending about rear region); at least one top strap portion (12) (strap (12) extending about upper region (6)) (para [0186]); a first adjustable ear loop (7) (portion of strap extending about left ear forms an ear loop (para [0164]), and the loop about an, or each ear of the user, may be adjustable, such as adjustable by the size of the loop provided for encircling partially or wholly the ear or ears of a user (para [0039])), and a second adjustable ear loop (7) (portion of strap extending about right ear forms an ear loop (para [0164]), and the loop about an, or each ear of the user, may be adjustable, such as adjustable by the size of the loop provided for encircling partially or wholly the ear or ears of a user (para [0039]); and a respiratory patient interface (4) (user interface) (para [0113]) configured to deliver respiratory support to the patient, wherein the respiratory patient interface (4) is removably attachable to the headgear (1) (para [0154]).
Gulliver does not disclose the first adjustable ear loop comprises a first connection portion configured to be removably attachable to a first attachment zone of the headgear such that the first adjustable ear loop defines a first ear opening, wherein the first attachment zone is configured to be attachable to different portions along the first connection portion to adjust a size of the first ear opening; and the second ear adjustable loop comprises a second connection portion configured to be removably attachable to a second attachment zone of the headgear such that the second adjustable ear loop defines a second ear opening, wherein the second attachment zone is configured to be attachable to different portions along the second connection portion to adjust a size of the second ear opening.
However, Ho in fig 15 teaches a respiratory interface including a first ear loop formed by an upper strap (26a’) and a lower strap (26b’), wherein the first ear loop (26a’, 26b’) includes a first connection portion configured to be removably attachable to a first attachment zone of the headgear ) such that the first adjustable ear loop defines a first ear opening (includes a hook and loop fastener configured to attach to a headgear (24) to form an ear loop) (para [0054]) wherein the first attachment zone is configured to be attachable to different portions along the first connection portion to adjust a size of the first ear opening (as shown in fig 15, ear loop straps (26a’, 26b’) can be moved about the top of a patient’s head, which would adjust a size of an ear loop) (para [0054]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the first and second adjustable ear loops of Gulliver by providing the ends of the ear loops with a first connection portion configured to be removably attachable to a first attachment zone of the headgear such that the first adjustable ear loop defines a first ear opening, wherein the first attachment zone is configured to be attachable to different portions along the first connection portion to adjust a size of the first ear opening as taught by Ho in order to provide a known mechanism for adjusting the size of an ear loop (Gulliver, para [0039]), and would allow the pressure distribution about the contact footprint produced by the respiratory patient interface to be influenced (Ho, para [0054]).
Claims 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulliver et al and Ho et al as applied to claim 5 above, and further in view of Landis (2004/0065330).
Regarding claim 8, modified Gulliver discloses a first top strap portion and a second top portion.
Modified Gulliver does not disclose the first top strap portion comprises a first protruding portion and the second top strap portion comprises a second protruding portion.
However, Landis discloses a respiratory interface including a continuous positive airway pressure system (CPAP) (100) having a bladder-like interface (102) (para [0049]) including a forehead securement member (122) (tabs) including attachment zones (124a, b) (hook and loops portions) (para [0053]), and a headgear including a top first top strap portion (174) and a second top strap portion (175) (upper straps) formed as a portion protruding from a rear of the headgear (para [0073]), wherein the first and second top strap portions (174, 175) are provided with a respective attachment zone (para [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Gulliver by providing a CPAP interface having a bladder-like interface and including a forehead securement member including attachment zones, and providing the top strap portion with a first protruding portion and an attachment zone and the second top strap portion with a second protruding portion and an attachment zone as taught by Landis in order to allow the headgear to support an elastic CPAP system to allow the respiratory interface to be capable of off axis movement and/or pivoting (Landis, abstract).
Regarding claim 9, the modified Gulliver’s reference discloses the first protruding portion (174 of Landis) comprises a third attachment zone and the second protruding portion (175 of Landis) comprises a fourth attachment zone (distal portions (174a, 175a of Landis) of each protruding portion (174, 175 of Landis) each include the other of hook or loop portion (124b of Landis) for releasably engaging the hook or loop portion (124a of Landis) of each tab (122 of Landis) of continuous positive airway pressure system (100 of Landis) (Landis, par [0075]).
Regarding claim 10, the modified Gulliver’s reference discloses a forehead securement member (122 of Landis) (tabs (122 of Landis) attached to CPAP system (100 of Landis) configured to be removably attachable to the third attachment zone and the fourth attachment zone (Landis, para [0075]).
Regarding claim 11, the modified Gulliver’s reference discloses the forehead securement member (122 of Landis) comprises one of a hook material or a loop material (124a of Landis) (Landis, para [0053]) and wherein the third attachment zone and the fourth attachment zone (124b of Landis) comprise the other one of the hook material and the loop material (Landis, para [0075]).
Claims 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulliver et al and Ho et al as applied to claim 1 above, and further in view of Jestrabek-Hart (6,470,886).
Regarding claim 18, modified Gulliver discloses a first attachment zone and a second attachment zone comprise a hook and loop material to connect to a headgear (Ho, para [0054]).
Modified Gulliver does not disclose the first attachment zone and the second attachment zone comprise a hook material and a remainder of the headgear comprises a loop material.
However, Jestrabek-Hart teaches a respiratory interface including a plurality of elastic straps (13) to secure a respiratory mask to a headgear, and including an attachment zone (4) comprising a hook material (col 6, ln 15-32), and a headgear (head cover) comprising an outer surface comprising a loop material that the hook side of a hook and loop fastener will receive and attach (col 4, ln 62-col 5, ln 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Gulliver so that a remainder of the headgear comprises a loop material as taught by Jestrabek-Hart in order to allow for the hook side of a hook and loop type fastener to attach anywhere on the outside of the headgear which allows a multitude of adjustment possibilities (Jestrabek-Hart, col 3, ln 7-10).
Claims 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulliver et al and Ho et al as applied to claim 5 above, and further in view of Grashow (2016/0354571).
Regarding claim 19, modified Gulliver discloses a first adjustable ear loop and the second adjustable ear loop.
Modified Gulliver does not disclose the first adjustable ear loop and the second adjustable ear loop comprise respective ear loop size indicators, the respective ear loop size indicators correspond to a respective size of the first ear opening and the second ear opening.
However, Grashow in fig 1 teaches a respiratory interface including a strap portion (20) shown in fig 1 to form a loop around a user’s ears, wherein the strap portion (20) comprises an ear loop size indicator (23) (indicia) configured to indicate different adjustment of the straps (para [0026]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the first adjustable ear loop and the second adjustable ear loop by providing respective ear loop size indicators, the respective ear loop size indicators correspond to a respective size of the first ear opening and the second ear opening as taught by Grashow in order to indicate different adjustment of the first and second ear loops and be useful in communicating adjustment information to a clinician or patient (Grashow, para [0026]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bearne et al (2016/0067441), McLauren et al (2020/0338294), Grashow et al (10,589,048), and Kooij et al (2022/0249792) disclose patient interfaces with ear loops and a respiratory interface; Kastros (2021/0244573) and Cumming et al (2012/0296252) discloses a cap with adjustable ear loops
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785