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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the terms “comprising” in line 1, “comprises” in line 8, and “comprises” in line 9 are considered claim terminology that should be avoided. Correction is required. See MPEP § 608.01(b).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 11-13, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wade et al. (US 2018/0008452).
As to claim 1, Wade discloses a patient interface (CPAP nasal mask and headgear, Figs. 7A-7B) comprising a plenum chamber 158 pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure (paragraph [0071]), the plenum chamber including:
at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (shown in Fig. 7A-7B on CPAP nasal mask 158);
a seal-forming structure that is constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, wherein the seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (seal shown on nasal mask 158 where the mask meets the facial skin around the nose, see Fig. 7A-7B, paragraph [0071]),
the patient interface further comprising a positioning and stabilising structure (see annotated Fig. 7B below) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (paragraph [0071]),
the patient interface further comprising a hoop structure (see annotated Fig. 7B below) comprising:
a top portion configured to extend over a top of the patient's head (see annotated Fig. 7B);
a chin portion (jaw stop pocket 114) configured to extend below the patient's chin or lower jaw (see annotated Fig. 7B below, paragraph [0071]); and
an inflatable body (jaw stop 112, labeled in Fig. 6B, see annotated Fig. 7B below) positioned, in use, between a portion of the hoop structure and the patient's head (see Fig. 7B, paragraph [0064]).
PNG
media_image1.png
659
820
media_image1.png
Greyscale
As to claim 2, Wade discloses the patient interface of claim 1, wherein the hoop structure is formed separately from the positioning and stabilising structure (paragraph [0065] – the device can be retrofitted to an existing CPAP mask and headgear).
As to claim 3, Wade discloses the patient interface of claim 1, wherein the hoop structure is formed as part of the positioning and stabilising structure (paragraph [0065] – alternatively, the device can be integrated with a CPAP mask and headgear during manufacture of the CPAP equipment.
As to claim 6, Wade discloses the patient interface of claim 1, wherein the inflatable body 112 is positioned in use between the patient's chin and/or lower jaw and the chin portion 114 (see Fig. 7A, Fig. 7B).
As to claim 11, Wade discloses the patient interface of claim 1, wherein an interior of the inflatable body 112 is not in fluid communication with an interior of the plenum chamber (see Figs. 7A-7B).
As to claim 12, Wade discloses the patient interface of claim 1, wherein the inflatable portion 112 is detachable from the hoop structure (jaw stop device 112 is simply placed in pocket 114 and therefore, is capable of being detached from the pocket 114, see Figs. 7A-7B, Figs. 5A-5B, paragraph [0068]).
As to claim 13, Wade discloses a patient interface (CPAP nasal mask and headgear, Figs. 7A-7B) comprising a plenum chamber 158 pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure (paragraph [0071]), the plenum chamber including:
at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (shown in Fig. 7A-7B on CPAP nasal mask 158);
a seal-forming structure that is constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, wherein the seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (seal shown on nasal mask 158 where the mask meets the facial skin around the nose, see Fig. 7A-7B, paragraph [0071]),
the patient interface further comprising a positioning and stabilising structure (see annotated Fig. 7B below) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (paragraph [0071]),
the patient interface further comprising a chin portion 114 configured to extend below the patient's chin or lower jaw (jaw stop pocket 114) configured to extend below the patient's chin or lower jaw (see annotated Fig. 7B below, paragraph [0071]), the chin portion connected to the positioning and stabilising structure, the plenum chamber, or a frame of the patient interface (at regions 136, see Fig. 7B, paragraph [0071]), and
an inflatable body 112 (jaw stop 112, labeled in Fig. 6B, see annotated Fig. 7B below) positioned, in use, between the chin portion 114 and the patient's chin or lower jaw (see Fig. 7B, paragraph [0064]).
PNG
media_image2.png
659
820
media_image2.png
Greyscale
As to claim 18, Wade discloses the patient interface of claim 13, wherein an interior of the inflatable body 116 is not in fluid communication with an interior of the plenum chamber 158 (see Figs. 7A-7B).
As to claim 19, Wade discloses a hoop structure (see Fig. 6A) for reducing or eliminating mouth drop in a patient during respiratory pressure therapy, the hoop structure comprising: a top portion 146 configured to extend over a top of the patient's head; a chin portion 114 configured to extend below the patient's chin or lower jaw; and an inflatable body 112 positioned, in use, between a portion 114 of the hoop structure and the patient's head (see Fig. 6A, paragraph [0070]).
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 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.
Claims 4, 5, 10, 14, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wade et al. (US 2018/0008452), in view of Berthon-Jones et al. (US 2010/0000543).
As to claim 4, Wade discloses the patient interface of claim 1, but does not disclose that the inflatable body comprises one or more folds and/or thinned regions. However, Berthon-Jones teaches an inflatable body (bladder/raviolis 145, Fig. 2) for a patient interface headgear, the inflatable body 145 comprising one or more folds (see pleated shape, Fig. 6-9, paragraphs [0084], [0090]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the inflatable body of Wade to have the pleated shape as taught by Berthon-Jones to provide an alternative known shape for the inflatable body that can adjust to different sizes.
As to claim 5, modified Wade discloses the patient interface of claim 4, comprising a bellows portion (see pleated shape, Fig. 6-9, paragraphs [0084], [0090]).
As to claim 10, Wade discloses the patient interface of claim 1, but does not disclose that an interior of the inflatable body is in fluid communication with an interior of the plenum chamber. However, Berthon-Jones teaches an inflatable body in fluid communication with the plenum chamber of a patient interface (Figs. 1-2, paragraph [0084]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the inflatable body of Wade to allow the inflatable body to adjust with the change in pressure (paragraph [0084]).
As to claim 14, Wade discloses the patient interface of claim 1, but does not disclose that the inflatable body comprises one or more folds and/or thinned regions. However, Berthon-Jones teaches an inflatable body (bladder/raviolis 145, Fig. 2) for a patient interface headgear, the inflatable body 145 comprising one or more folds (see pleated shape, Fig. 6-9, paragraphs [0084], [0090]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the inflatable body of Wade to have the pleated shape as taught by Berthon-Jones to provide an alternative known shape for the inflatable body that can adjust to different sizes.
As to claim 15, modified Wade discloses the patient interface of claim 14, comprising a bellows portion (see pleated shape, Fig. 6-9, paragraphs [0084], [0090]).
As to claim 17, Wade discloses the patient interface of claim 1, but does not disclose that an interior of the inflatable body is in fluid communication with an interior of the plenum chamber. However, Berthon-Jones teaches an inflatable body (bladder/raviolis 145, Fig. 2) for a patient interface headgear, the inflatable body 145 comprising one or more folds (see pleated shape, Fig. 6-9, paragraphs [0084], [0090]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the inflatable body of Wade to have the pleated shape as taught by Berthon-Jones to provide an alternative known shape for the inflatable body that can adjust to different sizes.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wade et al. (US 2018/0008452), in view of Kooij et al (US 2019/0022343).
As to claim 7, Wade discloses the patient interface of claim 1, but does not disclose that the inflatable body is positioned in use between the top of the patient's head and the top portion. However, Kooij teaches a patient interface having a hoop structure (3350, Fig. 16) including an inflatable body (inflatable loop insert member 3420 in the form of a U-shaped bladder, see Fig. 16) positioned in use between the top of the patient’s head and a top portion 3350, 3600 of the hoop structure (paragraphs [0279]-[0280]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Wade to include an inflatable body between the top of the patient’s head and a top portion of the patient’s head, as taught by Kooij, in order to allow the patient to alter the size and fit of the patient interface as desired (paragraph [0280]).
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wade et al. (US 2018/0008452), in view of Kahlert et al (US 2023/0218427).
As to claim 8, Wade discloses the patient interface of claim 1, wherein the inflatable body creates in use a force which acts on the patient's chin and/or lower jaw region (paragraph [0051]), but does not disclose that the inflatable body further comprises one or more sensors configured to measure the magnitude of the force. However, Kahlert teaches an inflatable body for a patient interface (expandable member 306, Fig. 3, paragraph [0070]), which includes a sensor (pressure sensor) for measuring the magnitude of force applied to the patient by the inflatable body (paragraph [0070]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Wade so that the inflatable body includes a sensor for measuring the magnitude of force applied to the patient, as taught by Kahlert, in order to provide a feedback loop for controlling the level of inflation to a achieve a desired level of force on the patient’s head.
As to claim 16, Wade discloses the patient interface of claim 13, wherein the inflatable body creates in use a force which acts on the patient's chin and/or lower jaw region (paragraph [0051]), but does not disclose that the inflatable body further comprises one or more sensors configured to measure the magnitude of the force. However, Kahlert teaches an inflatable body for a patient interface (expandable member 306, Fig. 3, paragraph [0070]), which includes a sensor (pressure sensor) for measuring the magnitude of force applied to the patient by the inflatable body (paragraph [0070]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Wade so that the inflatable body includes a sensor for measuring the magnitude of force applied to the patient, as taught by Kahlert, in order to provide a feedback loop for controlling the level of inflation to a achieve a desired level of force on the patient’s head.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wade et al. (US 2018/0008452), in view of Veliss et al. (US 2008/0060649).
As to claim 9, Wade discloses the patient interface of claim 1, but does not disclose that the top portion is connected to the chin portion by the plenum chamber and/or a frame of the patient interface. However, Veliss teaches a patient interface 1600 having a hoop structure in which the top portion 1605 is connected to a chin portion 1606by a frame of the patient interface (see paragraph [0371], Fig. 27-1, 27-2). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Wade to have the alternative strap arrangement, as taught by Veliss, in order to provide an equally suitable alternative strap arrangement for a CPAP headgear which performs equally well to secure the patient interface while retaining the mouth in a closed position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Quinn (US 2016/0089261) discloses a cervical collar for a patient interface which includes a chin supporting member.
Rafiqpoor (US 2024/0058559) discloses a head harness with a pusher 41 for urging the jaw closed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785