DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/9/2026 has been entered.
Claims 1-3, 9-10, 12-19 are currently pending and are being examined.
Response to Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive. With respect to the 112 rejection of claim 9, Applicant traverses and points to Figures 13c and 13d and paragraphs [0095] and [0096] for support. It is agreed that those figures and paragraphs show the resilient member within the channel aperture. However, there is no support in the original specification or drawings that the resilient member is within the channel aperture (as recited in claim 9) and also the respiratory hose extending from the first end to the second end along the channel aperture (as recited in claim 1 from which claim 9 depends) and also that the respiratory hose extends through the resilient member along the entire length of the resilient member. While Figure 13a-d does show a resilient member 1306 that can be in the channel, the resilient member 1306 is a gas conduit, and the hose 104 is coupled to the resilient member 1306, and the resilient member 1306 connects to extension hose ([0095]). Therefore, there is not support for both the resilient member and the respiratory hose extending through the first aperture, second aperture and channel aperture.
The remaining rejections under 112 are moot in view of applicant’s amendment. However, new antecedent basis issues are now addressed below.
With respect to Wood, applicant argues that the reference does not show the resilient insert 12 does not extend to a heigh greater than the width of the head of a user when the user’s head is positioned on the first surface. However, it is noted that the claim does not specify what “the width” of the head is. Thus, it is being interpreted as the width of the face mask 26 shown below. It is also noted that this is being interpreted as an intended use limitation and that it is capable of use with patients of various size heads, therefore if used with a user with a very small head such as a premature infant it is thus capable of use such that the height of the resilient member is greater than a width of the head.
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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 1, 3, 9-10, 12-19 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 1 recites “the resilient member… extending… to a height greater than the width of the head of a user when the user’s head is positioned on the first surface of the support device” which positively recites the human body. It is suggested that applicant use “configured to” or similar language to obviate the rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 has been amended to recite “the resilient member is positioned within the first aperture and is positioned at least partially within the channel aperture and wherein the respiratory hose extends through the second aperture defined by the resilient member along the entire length of the resilient member. ” There is no support in the original specification or drawings that the resilient member is within the channel aperture (as recited in claim 9) and also the respiratory hose extending rom the first end to the second end along the channel aperture (as recited in claim 1 from which claim 9 depends). While Figure 13a-d does show a resilient member 1306 that can be in the channel, the resilient member 1306 is a gas conduit, and the hose 104 is coupled to the resilient member 1306 and the resilient member 1306 connects to extension hose ([0095]).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 9-10, 12-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the width" and “the head” in line 10. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected due to their dependency.
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, 3, 10, 12-14, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood (US 9,089,463 B1).
Regarding claim 1, Wood discloses an apparatus (Figures 1-2; Abstract), comprising: a support device (11), wherein the support device defines a first surface (top surface of 11) and an opposite second surface (bottom surface of 11), a first end (end closest in Figure 1) and an opposite second end (end further away in Figure 1), the support device comprising: a first aperture (formed by concavity 20 and passage 23) proximate the first surface extending from the first surface to the second surface (Figure 2); and a channel aperture (19) extending from the first end toward the second end (19 extends from closest end in Figure 1 inwardly toward the opposite end), wherein the channel aperture at least partially defines the second surface (Figures 1-2); a resilient member (12; Col. 3, lines 62-67), the resilient member defining a second aperture (formed by passageway 22 and depression 21; Figure 2), the resilient member extending at least partially into the first aperture (insofar as it extends into concavity 20) of the support device and extending a first length above the first surface of the support device to a height greater than the width of the head of a user when the user’s head is positioned on the first surface of the support device (see annotated Figure 2 below; since the claim does not specify what “the width” of the head is it is being interpreted as the width of the face mask shown below; it is also noted that this is being interpreted as an intended use limitation and that it is capable of use with patients of various size heads, therefore if used with a user with a very small head such as a premature infant it is thus capable of use such that the height of the resilient member is greater than a width of the head); and a respiratory hose (25) for transport of respiratory gas, the respiratory hose extending from the first end of the support device toward the second end of the support device along the channel aperture (Figure 2), extending from the channel aperture through the aperture, extending through the second aperture defined by the resilient member and extending a second length above the first surface of the support device (Figure 2), wherein the first length of the resilient member is less than the second length of the respiratory hose such that the resilient member provides support and stability to the respiratory hose adjacent the first aperture of the support device so that the respiratory hose is positional vertically above the support device (Figure 2).
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Regarding claim 3, Wood discloses wherein the respiratory hose (25) has a first section and a second section, wherein the first and the second sections have different flexibility (section of 25 within resilient member 12 will have less flexibility than the section of 25 that is not inside 12).
Regarding claim 10, Wood further discloses wherein the resilient member (12) is releasably coupled to the flexible hose (hose 25 is capable of being removed; Figure 2).
Regarding claim 12, Wood discloses wherein the resilient member comprises a substantially-circular cross-section and continuous surface area (at 22; Figures 1-2).
Regarding claim 13, Wood discloses wherein the resilient member comprises a length of continuous sleeve defined by a non-continuous substantially-circular cross-section (as best can be understood, portion 22 is a continuous sleeve of circular cross section and is non-continuous at concavity 21).
Regarding claim 14, Wood discloses wherein at least a portion of the resilient member comprises a broken surface area (at portion 21).
Regarding claim 19, Wood discloses wherein the resilient member is formed of a polymer (Col. 3, lines 62-68).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 9,089,463 B1) in view of Hoffman (US 2007/0163600 A1).
Regarding claims 15-17, Wood discloses that as applied above wherein the resilient member is connected to a mask of a user by a hose (25) and port (24) but does not disclose the resilient member comprises a spiral, helical, or helix configuration. Hoffman teaches a CPAP device having a support (vest 28) is coupled to a mask (142) of a user by a broken surface of spiral, helical or helix configuration (68; Figures 1A, 2A). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the resilient device of Wood having a spiral, helical, or helix configuration as taught by Hoffman connecting the mask to provide a greater degree of flexibility and ability to tailor the overall length of the hose ([0094]-[0095], [0112]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 9,089,463 B1) in view of Goldstein (US 6,230,350 B1).
Regarding claim 18, Wood discloses that as applied above wherein the resilient material is a polymer. Wood does not disclose wherein the resilient material is metal. Goldstein teaches a head support with air access wherein a resilient member comprises metal as an alternative to polymer (Col. 5, lines 1-10). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Wood made of metal as taught by Goldstein as being a suitable alternative to polymer for supporting the tube. Furthermore, it has been held that the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art. In re Leshin, 227 F.2d 197,125 USPQ 416 (CCPA 1960).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786