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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 08/21/2024 has been received and fully considered.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 line 2 “1.2 time” should be corrected to “1.2 times” for the sake of clarity.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Examiner notes in claim 9 the limitation “connection means” is being interpreted under 35 U.S.C. 112(f) as the limitation does not recite sufficient structure. Examiner is interpreting the limitation to mean any sort of stitching, seam, coupler, etc. which can connect two pieces of textile fabric.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 5, 10, and 11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 5 positively recites “between the patient’s zygomatic bones”. Claim 10 positively recites “a temporal bone of the patient’s head”. Claim 11 positively recites “helix of an ear of the patient”. Examiner notes both of these rejections may be obviated by using functional language such as “configured to” in the above mentioned claims.
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 1-8, 15, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2022005400A1 to Valiyambath et al. (hereinafter “Vali”).
Regarding claim 1, Vali discloses a positioning and stabilising structure for a patient interface (Fig. 9A positioning and stabilizing structure 11300), comprising:
a first textile portion comprising a front section and a rear section, the front section and rear section forming a continuous loop of material (Fig. 9B second posterior portion 11308, first lower textile portion 11320);
wherein the front section comprises at least one opening and is configured to house a plenum chamber adjacent to the at least one opening (Fig. 9B plenum chamber 11200 and connection port 11600 are in the front section of first lower textile portion 11320);
wherein when in use, the first textile portion is movable between a first resting position and a second breathing position, the front section configured to overlay a patient's frontal bone and the first textile portion configured to at least circumferentially and resiliently fit to the patient's head in the first position (Fig. 9A shows the first resting position on the patient’s frontal bone; Fig. 9B shows the second breathing position; Examiner notes the front section of the lower textile portion is capable of overlaying a patient’s frontal bone and capable of circumferentially and resiliently fitting the patient’s head), and
the front section configured to overlay the patient's zygomatic bone and the first textile portion configured to provide a force to hold the plenum chamber in a therapeutically effective position on the patient’s head in the second position (Fig. 9B shows the front section is able to be overlaid on the patient’s zygomatic bone and the plenum chamber 11200 is held in a therapeutically effective position (delivering air to the patient’s nares); Paragraph 0260 discloses the positioning and stabilizing structure holds the seal forming structure in a therapeutically effective position on the patient’s head).
Regarding claim 2, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses wherein the rear section is configured to overlay the patient's occipital bone or parietal bone (Figs. 9A and 9B show the rear section is capable of overlaying the patient’s occipital bone or parietal bone).
Regarding claim 3, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses wherein the at least one opening comprises at least one mating means for connecting to an air circuit (Fig. 9A shows magnetic elements 11610).
Regarding claim 4, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses wherein the at least one opening comprises at least one magnetic ring (Examiner notes the magnetic elements are embedded in a ring, and thus the ring structure is magnetic).
Regarding claim 5, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses wherein the front section forms a bifurcated section between the patient's zygomatic bones when in use (Fig. 9B shows bifurcation point 11312 which is between the patient’s zygomatic bones when in use).
Regarding claim 6, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses a second textile portion movably connected to the first textile portion and configured to at least circumferentially and resiliently fit to a patient's head in the first resting position and second breathing position (Fig. 9A upper textile portion 11310 is connected to lower textile portion 11320 and circumferentially and resiliently fits on the patient’s head in both positions as shown in Figs. 9A and 9B).
Regarding claim 7, Vali discloses the positioning and stabilizing structure according to claim 6, and Vali further discloses wherein the second textile portion is configured to overlay the patient's occipital bone and frontal bone (Fig. 9A shows the upper textile portion 11310 is configured to overlay the patient’s occipital bone and frontal bone).
Regarding claim 8, Vali discloses the positioning and stabilizing structure of claim 6, and Vali further discloses wherein the second textile portion is integral with the rear section of the first textile portion (Fig. 9B shows the upper textile portion 11310 and the lower textile portion 11320 are integral with one another at the bifurcation point 11312 on a rear section of the lower textile portion 11310; See Annotated Fig. 9B for designation of the rear section of the first textile portion).
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Regarding claim 15, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses wherein the front section forms a bifurcated section comprising a first part and a second part between the patient's temporal bones when in use (Fig. 9B bifurcation points 11312, 11314; See Annotated Fig. 8B for designation of the bifurcated section, first part, and second part);
wherein the second part comprises the at least one opening (Fig. 9A shows the opening in the designated second part);
wherein when in use, the first part and the rear section is configured to at least circumferentially and resiliently fit to the patient's head in the first and second position (Figs. 9A-B shows the second part circumferentially and resiliently fits the patient’s head in the first and second positions), and
the second part is movable between the first position and the second position, the second part configured to overlay the patient's frontal bone in the first position, and the second part configured to overlay the patient's zygomatic bone in the second position (Figs. 9A-B show the designated second part is movable between the first and second position, where the second part is capable of overlaying the patient’s frontal bone in the first position, and the second part capable of overlaying the patient’s zygomatic bone in the second position).
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Regarding claim 19, Vali discloses the positioning and stabilizing structure according to claim 1, and Vali further discloses wherein the front section comprises a rigidiser (Paragraphs 0234-0235 discloses the lower textile portion may be rigidized at certain parts).
Regarding claim 20, Vali discloses a patient interface (Figs. 9A-B generally), comprising:
a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (Fig. 9B plenum chamber 11200; Paragraph 0085 discloses the plenum chamber is pressurizable to a therapeutic pressure of at least 6 cmH2O), said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Fig. 9A shows the inlet port in the connection port 11600 and the plenum chamber has hole in it to allow for therapeutic airflow),
a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways (Fig. 9B seal-forming structure 11100), said 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, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use (Fig. 9B shows therapeutic airflow is delivered to the patient’s nares; Paragraphs 0257 & 0259 disclose the seal forming structure contains the plenum chamber which is in communication with an air circuit); and
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head (Fig. 9B positioning and stabilizing structure 11300; Paragraph 0260 discloses the positioning and stabilizing structure holds the seal forming structure in a therapeutically effective position on the patient’s head);
wherein the positioning and stabilising structure comprises:
a first textile portion comprising a front section and a rear section, the front section and rear section forming a continuous loop of material (Fig. 9B second posterior portion 11308, first lower textile portion 11320);
wherein the front section comprises at least one opening and is configured to house a plenum chamber adjacent to the at least one opening (Fig. 9B plenum chamber 11200 and connection port 11600 are in the front section of first lower textile portion 11320);
wherein when in use, the first textile portion is movable between a first resting position and a second breathing position, the front section configured to overlay a patient's frontal bone and the first textile portion configured to at least circumferentially and resiliently fit to the patient's head in the first resting position (Fig. 9A shows the first resting position on the patient’s frontal bone; Fig. 9B shows the second breathing position), and
the front section configured to overlay the patient's zygomatic bone and the first textile portion configured to provide a force to hold the plenum chamber in a therapeutically effective position on the patient’s head in the second breathing position (Fig. 9B shows the front section is able to be overlaid on the patient’s zygomatic bone and the plenum chamber 11200 is held in a therapeutically effective position (delivering air to the patient’s nares); Paragraph 0260 discloses the positioning and stabilizing structure holds the seal forming structure in a therapeutically effective position on the patient’s head).
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, 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 9-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vali in view of US20220096770A1 to Grashow et al. (hereinafter “Grashow”).
Regarding claim 9, Vali discloses the positioning and stabilizing structure of claim 6, but does not disclose wherein the second textile portion is movably connected to the first textile portion via connection means. However, Grashow teaches a headgear for use with a patient interface which has a textile portion movably connected to another textile portion via connection means (Fig. 4B seam 304, wrapping panels 303, horizontal panel 302, overlap region 309; Paragraph 0048 discloses the seam allows the panels to be joined together; Examiner notes the seam is the connection means and the straps are able to move relative to one another).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the headgear of Vali to have a textile portion movably connected to the first textile portion via connection means, as taught by Grashow, in order to provide an alternative means of connection between the textile portions. Examiner notes the modification would allow for the textile portions to be independently movable to allow for easier configurations of the straps relative to one another.
Regarding claim 10, Vali in view of Grashow discloses the positioning and stabilizing structure according to claim 9, and Vali as modified by Grashow further discloses wherein the connection means overlays a temporal bone of the patient's head when in use (Examiner notes Vali as modified by Grashow would have the seam at the bifurcation points of Vali and thus would overlay a temporal bone of the patient when in use).
Regarding claim 11, Vali in view of Grashow discloses the positioning and stabilizing structure according to claim 9, and Vali as modified by Grashow further discloses wherein the connection means is adjacent to a helix of an ear of the patient (Examiner notes Vali as modified by Grashow would have the seam at the bifurcation points of Vali and thus would be adjacent to a helix of an ear of the patient).
Regarding claim 12, Vali in view of Grashow discloses the positioning and stabilizing structure of claim 9, and Vali in view of Grashow further discloses wherein the connection means is detachable (Examiner notes the seam of Grashow is capable of being detached from the headgear).
Regarding claim 18, Vali discloses the positioning and stabilizing structure according to claim 1, but does not disclose wherein the rear section of the first textile portion comprises a cut and detachable mating means. However, Grashow teaches a headgear for use with a patient interface which has a cut textile portion movably connected to another textile portion via detachable connection means (Fig. 4B seam 304, wrapping panels 303, horizontal panel 302, overlap region 309; Paragraph 0048 discloses the seam allows the panels to be joined together; Examiner notes the seam is the connection means and the straps are able to move relative to one another; Examiner further notes the seam of Grashow is capable of being detached from the headgear).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the headgear of Vali to have a rear section of the first textile portion comprises a cut and detachable mating means, as taught by Grashow, in order to provide an alternative means of connection between the textile portions. Examiner notes the modification would allow for the textile portions to be independently movable to allow for easier configurations of the straps relative to one another.
Claims 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Vali.
Regarding claim 13, Vali discloses the positioning and stabilizing structure according to claim 6, and Vali further discloses wherein the first textile portion is more stretchable relative to the second textile portion (Paragraph 0088 discloses the seal retention band is more stretchable than the upper textile portion). Vali does not disclose wherein the first textile portion is at least 1.2 times more stretchable relative to the second textile portion. However, Vali describes the headgear may have a seal retention strap which is more stretchable than the upper textile portion (Paragraph 0227). Vali discloses this configuration results in the lower textile portion to be stretched more easily downward.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize Vali within Applicant’s claimed range of at least 1.2 times more stretchable for the benefit of providing extra stretch and length relative to the upper textile portion. It has been held that discovering an optimum value of a result effective variable involves only skill routine skill in the art.
Regarding claim 14, Vali discloses the positioning or stabilizing structure according to claim 6, and Vali further discloses wherein the second textile portion is wider relative to the first textile portion (Paragraph 0230 discloses the upper textile portion may be wider than the lower textile portion). Vali does not disclose wherein the second textile portion is at least 1.2 times wider relative to the first textile portion. However, Vali describes the upper textile portion may be wider than the lower textile portion (Paragraph 0230). Vali discloses this configuration results in the ability to accommodate sensors and circuitry (Paragraph 0230; See Fig. 9B).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize Vali within Applicant’s claimed range of at least 1.2 times wider for the benefit of accommodating sensors and circuitry in the second textile portion. It has been held that discovering an optimum value of a result effective variable involves only skill routine skill in the art.
Regarding claim 16, Vali discloses the positioning and stabilizing structure according to claim 15, and Vali further discloses wherein the second part is more stretchable relative to the first part (Paragraph 0088 discloses the seal retention band is more stretchable than the upper textile portion). Vali does not disclose wherein the second part is at least 1.2 times more stretchable relative to the first part. However, Vali describes the headgear may have a seal retention strap which is more stretchable than the upper textile portion (Paragraph 0227). Vali discloses this configuration results in the lower textile portion to be stretched more easily downward.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize Vali within Applicant’s claimed range of at least 1.2 times more stretchable for the benefit of providing extra stretch and length relative to the first part. It has been held that discovering an optimum value of a result effective variable involves only skill routine skill in the art.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vali in view of US20180214655A1 to Kooij et al. (hereinafter “Kooij”).
Regarding claim 17, Vali discloses the positioning and stabilizing structure according to claim 15, but Vali does not disclose wherein the front section further comprises a lateral projection. However, Kooij teaches headgear for a patient interface which has a front section that has a lateral projection (Fig. 4D strap 6002a, second flexible material 6008; Paragraph 0150 discloses the flexible material is wrapped around the strap; Paragraph 0149 discloses strap 6002a may have the same structure as strap 6002).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the top strap of Vali’s headgear to have a lateral projection, as taught by Kooij, in order to avoid any irritation of the skin of the user (Paragraph 0184).
Vali as modified by Kooij further discloses a lateral projection for screening the second part (Examiner notes a user is capable of moving the bottom strap to place it on top of the lateral projection of Kooij).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20210338961-A1 to Godwin; US-20210213229-A1 to Wood; US-20200368478-A1 to Baluchagi; US-20200246572-A1 to Scheiner; US-20200230343-A1 to Sims; US-20200197649-A1 to Haibach; US-20200061398-A1 to Rummery; US-20190290875-A1 to Amarasinghe; US-20190217040-A1 to Amarasinghe; US-20170119988-A1 to Allan; US-20160256655-A1 to Mah; US-20110114099-A1 to Goldstein; US-20090107508-A1 to Brambilla; US-20060218702-A1 to Santos; US-20050150499-A1 to Bordewick; US-20040025885-A1 to Payne; US-20040025884-A1 to McKown; US-20020117177-A1 to Kwok; US-10912910-B1 to Yezerski; US-10722673-B2 to Kooij; US-10688266-B2 to Cullen; US-10569044-B2 to Dunn; US-10561812-B2 to Skipper; US-10449317-B2 to Barlow; and US-10369319-B2 to Formica.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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