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 .
Claim Objections
Claim(s) 11 is/are objected to because of the following informalities:
Claim 11, Ln. 3 recites “the upper lip region” which should read “an upper lip region” as it is a first introduction
Appropriate correction is required.
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(s) 16-17 is/are 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. Each of claims 16 and 17 uses the language “any one or more of” before presenting a list of six individual options. While the individual options recited by each claim are clearly described in the specification, the breadth of each claim’s recitation of “any one or more of” implies combinations of the six recited options, such as all six included simultaneously in one embodiment, are covered by the scope of the claims. By example, there is not found to be reasonable disclosure in the application as originally filed for the tether in claim 16 comprising all of a filament, a wire, a fibre, a ribbon, a string, and a braided element simultaneously. Thus, the particular wording of claims 16 and 17 (i.e. “any one or more of”) defines potential embodiments beyond the reasonably understood disclosure of the originally filed application. The claims thus lack sufficient written description support for the overall breadth recited by the claims.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 101 because in general, if a claimed element of the device is positively recited so that the human body, or a part thereof, is also positively recited, then the claim is deemed to be directed towards or encompassing a human organism. In this case, the claim recites the limitation “the tether … being spaced from the face of the patient.” Therefore, claim 1 contains subject matter that is unpatentable because it appears to positively recite the patient’s face for the spacing evaluation. It is suggested that the claim be amended to read “the tether … being spaced from the face of the patient when worn” or “the tether … is configured to be spaced from the face of the patient.”
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 1-10, 12-15, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephens et al. (U.S. Pub. 2017/0368288).
Regarding claim 1, Stephens discloses a patient interface (Fig. 1) for use with a respiratory support apparatus for delivering breathable gases to a patient, the patient interface comprising, a cushion (Fig. 2 #30; ¶0038) at least partially defining an internal cavity (Fig. 2 internal space within #30), the cushion comprising a pair of opposing cushion side walls (Fig. 2 left and right portions of #32) and a sealing flange (Fig. 3 #36; ¶0042) arranged to seal against the a face of the patient; a gases inlet (Fig. 1 #14; ¶0038) in fluid communication with the internal cavity; and a tether (Figs. 2 & 4A #84, 184, 194; ¶0051 – joined elongated bodies 194 form a single “tether”); wherein the tether extends substantially laterally across the cushion inside the internal cavity between the pair of opposing cushion side walls (Figs. 2 & 4A), the tether being mounted to the pair of opposing cushion side walls (Figs. 2 & 4A; ¶¶0051-0052). It is noted that while the claim uses the terminology “a pair of opposing cushion side walls” the disclosed opposing cushion side walls are part of a continuous wall structure (e.g. Fig. 3 #102a, 102b). Thus, the limitation is understood to imply opposing side wall portions of the cushion.
Stephens is silent as to whether the tether is spaced from the face of the patient.
While Stephens does not expressly discuss the tension member 84, 184 as spaced from the face of the patient, Stephens also does not discuss the tension member 84, 184 as contacting any portion of the patient’s face. One of ordinary skill in the art would thus be left to question what can be reasonably inferred from the overall disclosure of Stephens about the relationship between the tension member 184 and the patient’s face. The context of the cushion 30 in Figs. 1-5 is as a cushion to be disposed over both a patient’s nose and mouth (¶¶0037-0038). The positioning of tension member 84 shown in Fig. 5 would thus be understood as generally corresponding to a mid-vertical portion of the patient’s nose. Notably in Fig. 2 tension member 84 is positioned a meaningful vertical distance upward from cushion body engagement portion 36. Thus, the patient’s nose will only be expected to contact the tension member 84 if the patient’s nose projects a particular distance into the cushion at the exact height location of tension member 84. Additionally, the intended operation of tension member 84 in Stephens is to allow vertical adjustment of its positioning by way of a turning of adjustment assembly 82 (e.g. ¶0054-0055). This leads to two key factors of consideration. First, adjustment assembly 82 allows tension member 84 to be retracted away from the patient’s face, which will increase the distance the patient’s nose would be required to project into the cushion 30 in order to contact tension member 84. Second, some patients will have a flatter nasal profile which will project a shorter distance into the cushion 30 than many other patients. Taking those two considerations into account one of ordinary skill in the art would have considered it prima facie obvious that for some patients having a flatter nose profile selective retraction of tension member 84 via adjustment assembly 82 would obviously result in at least a temporary configuration where the patient’s face, and specially the patient’s nose, was not in contact with tension member 84.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stephens the tether is spaced from the face of the patient in light of the overall disclosure of Stephens and specifically at least in consideration of the fact that for some patients having a flatter nose profile selective retraction of tension member 84 via adjustment assembly 82 would obviously result in at least a temporary configuration where the patient’s face, and specially the patient’s nose, was not in contact with tension member 84.
Regarding claim 2, Stephens further teaches the tether is integral with the cushion (Fig. 2; ¶¶0051-0052).
Regarding claim 3, Stephens further teaches the tether and the cushion are separate components (Fig. 2 #194 is not the same structure as #32).
Regarding claim 4, Stephens further teaches a pair of laterally spaced mounts (Fig. 2 at #199; ¶¶0052-0053) on the cushion, the tether being secured to the cushion by the pair of laterally spaced apart mounts.
Regarding claim 5, Stephens further teaches the pair of opposing cushion side walls are laterally spaced by a predetermined distance (e.g. Fig. 2), the tether being configured to substantially maintain the predetermined distance (Fig. 2; ¶¶0051-0055).
Regarding claim 6, Stephens further teaches the tether is configured to resist laterally outward movement of the pair of opposing cushion side walls (Fig. 2; ¶¶0050-0052).
Regarding claim 7, Stephens further teaches the tether is configured to allow laterally inward movement of the pair of opposing cushion side walls (Fig. 2; ¶¶0050-0052).
Regarding claim 8, Stephens further suggests as obvious the tether is inextensible under tensile forces (Fig. 2). The clear function of tension member 184 is to resist outward movement (e.g. Fig. 2).
Regarding claim 9, Stephens further teaches the tether is collapsible under compressive forces (¶¶0054-0055).
Regarding claim 10, Stephens further suggests as obvious the tether is inelastic (Fig. 2; ¶¶0054-0055). The clear function of tension member 184 is to maintain its set orientation and not be elastically stretchable (e.g. Fig. 2).
Regarding claim 12, Stephens further teaches the cushion comprises a nasal bridge region (Fig. 5 top of #36) and the tether is positioned below the nasal bridge region (Fig. 5).
Regarding claim 13, Stephens further teaches the cushion comprises a pair of side of nose portions (Fig. 5 right and left sides at top of #36) and the tether is positioned below the side of nose portions (Fig. 5). The claim does not specify any boundaries for the side of nose portions. Thus, their boundaries can be arbitrarily drawn, such as exclusively above tension member 84 in Fig. 5.
Regarding claim 14, Stephens further teaches the side of nose portions are provided on, or comprise part of, the pair of opposing cushion side walls (Fig. 5).
Regarding claim 15, Stephens further suggests as obvious the tether is rigid, or at least comprises a rigid portion (Fig. 2; ¶¶0054-0055). The instant application indicates “rigid” can be understood as not bending if only held at one end (¶00143). The clear function of tension member 184 is to maintain its set orientation and not be elastically stretchable, which would have obviously suggested a structure not easily bent (e.g. Fig. 2).
Regarding claim 17, Stephens further suggests as obvious the tether is formed from any one or more of: plastic (¶0041); metal; silicone; a woven material; a knitted material; and a braided material. While Stephens is silent on the specific material of tension member 84 it is noted that tension member 84 is directly connected to cushion body 32 which is discussed as made from amongst a series of common materials (¶0041). One of ordinary skill in the art would thus have considered it prima facie obvious to have selected a similar material for tension member 84.
Regarding claim 19, Stephens further teaches the tether comprises a non-circular transverse cross section (Fig. 2).
Claim(s) 1-5, 7 and 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al. (U.S. Pub. 2019/0298958).
Regarding claim 1, O’Connor discloses a patient interface (Figs. 7-8; ¶¶0077-0079) for use with a respiratory support apparatus for delivering breathable gases to a patient, the patient interface comprising, a cushion (Figs. 7-8 #1000; ¶0057) at least partially defining an internal cavity (Figs. 7-8 interior of #1000), the cushion comprising a pair of opposing cushion side walls (Fig. 8 opposite lateral walls of #1000) and a sealing flange (Fig. 7 left flap of #1000; ¶0057) arranged to seal against the a face of the patient; a gases inlet (Fig. 7 #210; ¶0069) in fluid communication with the internal cavity; and a tether (Figs. 7-8 individual #252a; ¶¶0077-0079 – when support members 252 not interconnected); wherein the tether extends substantially laterally across the cushion inside the internal cavity between the pair of opposing cushion side walls (Figs. 7-8 individual #252a extending horizontally across). It is noted that while the claim uses the terminology “a pair of opposing cushion side walls” the disclosed opposing cushion side walls are part of a continuous wall structure (e.g. Fig. 3 #102a, 102b). Thus, the limitation is understood to imply opposing side wall portions of the cushion.
In the cited embodiment O’Connor is silent as to whether the tether being mounted to the pair of opposing cushion side walls, and being spaced from the face of the patient.
However, support members 252 in O’Connor are discussed as forming a skeleton type of structure (¶¶0077, 0080) and in a related embodiment support members 252 are discussed as being located interiorly of the mask housing and integrally formed with that mask housing (¶0080). Further, one of ordinary skill in the art viewing Fig. 7 would have obviously expected the individual support members 252 to not be intended to contact the user’s face based upon how they are illustrated as following the contour of mask housing 200.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in O’Connor the tether being mounted to the pair of opposing cushion side walls, and being spaced from the face of the patient based upon the teaching in a related embodiment of O’Connor that support members 252 are discussed as being both located interiorly of the mask housing and integrally formed with that mask housing and then with the path of support members 252 along the mask housing in Fig. 7 clearly suggested as away from where the patient’s face would be expected to contact.
Regarding claim 2, O’Connor further teaches the tether is integral with the cushion (Fig. 7; ¶0080).
Regarding claim 3, O’Connor further teaches the tether and the cushion are separate components (Figs. 7-8 #252a is not the same structure as #200; ¶¶0077-0080).
Regarding claim 4, O’Connor further suggests as obvious a pair of laterally spaced mounts (Fig. 8 horizontal #252a will connect to mask body 200 at opposite ends) on the cushion, the tether being secured to the cushion by the pair of laterally spaced apart mounts. The claim does not preclude the tether from being connected to the cushion at locations other than the pair of laterally spaced apart mounts.
Regarding claim 5, O’Connor further teaches the pair of opposing cushion side walls are laterally spaced by a predetermined distance (e.g. Fig. 7), the tether being configured to substantially maintain the predetermined distance (¶0079 – resilient).
Regarding claim 7, O’Connor further teaches the tether is configured to allow laterally inward movement of the pair of opposing cushion side walls (¶0079 – resilient).
Regarding claim 9, O’Connor further teaches the tether is collapsible under compressive forces (¶0079 – resilient).
Regarding claim 10, O’Connor further teaches the tether is inelastic (¶0079 – metal wire).
Regarding claim 11, O’Connor further suggests as obvious the tether and the pair of opposing cushion side walls are configured such that the tether extends across, but is spaced from, the upper lip region of the patient (e.g. lower horizontal #252a in Fig. 7). O’Connor teaches that support members 252 can be located in various positions and orientations. The lower horizontal support member 252a illustrated in Fig. 7 would be obviously expected by one of ordinary skill in the art to extend across the patient’s upper lip region when recognizing that the mask interface of O’Connor can be specifically a nasal mask (¶0057).
Regarding claim 12, O’Connor further teaches the cushion comprises a nasal bridge region (Fig. 8 top of #1000) and the tether is positioned below the nasal bridge region (Figs. 7-8).
Regarding claim 13, O’Connor further teaches the cushion comprises a pair of side of nose portions (Fig. 8 right and left sides at top of #1000) and the tether is positioned below the side of nose portions (Figs. 7-8). The claim does not specify any boundaries for the side of nose portions. Thus, their boundaries can be arbitrarily drawn, such as exclusively above support member 252a in Figs. 7-8.
Regarding claim 14, O’Connor further teaches the side of nose portions are provided on, or comprise part of, the pair of opposing cushion side walls (Figs. 7-8).
Regarding claim 15, O’Connor further teaches the tether is rigid, or at least comprises a rigid portion (¶0079 – metal wire). The instant application indicates “rigid” can be understood as not bending if only held at one end (¶00143).
Regarding claim 16, O’Connor further teaches the tether comprises any one or more of: a filament (¶0079); a wire (¶0079); one or more fibres; a ribbon; string; and a braided element.
Regarding claim 17, O’Connor further teaches the tether is formed from any one or more of: plastic (¶0079); metal (¶0079); silicone; a woven material; a knitted material; and a braided material.
Regarding claim 18, O’Connor further suggests as obvious the tether comprises a circular or elliptical transverse cross section (¶0079). One of ordinary skill in the art would obviously expect the terms “filament” and “wire” in O’Connor to connote a circular cross section.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 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 at (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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785