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) 12 is/are objected to because of the following informalities:
Claim 12, Ln. 3 recites “the nose the user’s face” which should read “the nose of the user’s face”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim(s) 6-9 is/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 pre-AIA the applicant regards as the invention.
Claim 6 recites the limitation “a plurality of abrasive elements formed on an inner surface of the access portion” in Ln. 1-2 which deems the claim indefinite. The abrasive elements 404 are shown in Fig. 4. Notably, the abrasive elements 404 in Fig. 4 are not accurately located on what would be considered an interior of access portion 403, i.e. the space where intruding member 420 is received. Instead, the abrasive elements 404 in Fig. 4 are located on what would be an inner surface of the respiratory interface when worn. The present claim language does not clearly capture that distinction. For the purposes of examination the limitation will be interpreted as reading “a plurality of abrasive elements formed on a surface of the access portion configured to be directed toward the user’s face when the respiratory interface is worn”.
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.
Claim(s) 1-9, 11-12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lehman (U.S. Pub. 2013/0172768).
Regarding claim 1, Lehman discloses a respiratory interface (Fig. 1; ¶0031), comprising: a mask shell (Fig. 1 #19; ¶0031) configured to cover a portion of a user’s face (Figs. 4-5); and an access portion (Fig. 1 one of #15, 20; ¶0031) configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (¶0045; e.g. Figs. 4-5 – access through diaphragms 15, 20).
Regarding claim 2, Lehman discloses the access portion comprises a compliant material (¶0041).
Regarding claim 3, Lehman discloses the compliant material comprises an elastic material (¶0041 – degree of elasticity).
Regarding claim 4, Lehman discloses the access portion comprises a substantially finger-shaped surface curvature (¶0041 – membranes 25, 30 will deform to match the shape of a finger if a finger were to be inserted through either of membranes 25, 30). It is noted that the language “finger-shaped surface curvature” is not understood to require a closed end for the access portion. Instead, the finger-shaped surface curvature could be generally cylindrical in the manner of a finger.
Regarding claim 5, Lehman discloses the mask shell comprises a first material (¶0032) having a first rigidity; the access portion comprises a second material (¶0041) having a second rigidity; and the first rigidity is higher than the second rigidity (the only consideration of elasticity, i.e. an opposite of rigidity, is discussed of membranes 25, 30).
Regarding claim 6, Lehman discloses the access portion comprises a plurality of abrasive elements (¶0044 – texture 44 on both membrane surfaces) formed on a surface of the access portion configured to be directed toward the user’s face when the respiratory interface is worn.
Regarding claim 7, Lehman discloses the plurality of abrasive elements comprises a roughened surface pattern (¶0044 – e.g. rough textured surface).
Regarding claim 8, Lehman discloses the plurality of abrasive elements are formed from a same material as a membrane of the access portion (¶0044).
Regarding claim 9, Lehman discloses the plurality of abrasive elements are formed from a material attached to or embedded within a membrane (Fig. 1 #25, 30; ¶¶0041,0044) of the access portion (¶0044).
Regarding claim 11, Lehman discloses a second access portion (Fig. 1 other of #15, 20; ¶0031), wherein the first access portion is located on a first side face of the mask shell, and the second access portion is located on a second side face of the mask shell opposite the first side face (Fig. 1 – up vs. down).
Regarding claim 12, Lehman discloses the covered portion of the user’s face comprises the nose of the user’s face (Fig. 5); and the access portion is configured to allow the user to access the nose of the user’s face by an intruding member (Fig. 5 upper #36; ¶0049).
Regarding claim 15, Lehman discloses a method of manufacturing a respiratory interface (the mask of Fig. 1 must be manufactured), comprising: forming a mask shell (Fig. 1 #19; ¶0031), the mask shell being configured to cover a portion of a user’s face (Figs. 4-5); and forming an access portion (Fig. 1 one of #15, 20; ¶0031), the access portion configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (¶0045; e.g. Figs. 4-5 – access through diaphragms 15, 20).
Claim(s) 1-3, 5, 10-12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rollins (U.S. Patent 4328797).
Regarding claim 1, Rollins discloses a respiratory interface (Fig. 1; Col. 4-5), comprising: a mask shell (Fig. 1 #13; Col. 4) configured to cover a portion of a user’s face (Fig. 1); and an access portion (Fig. 1 #35; Col. 4, Ln. 62 – Col. 5, Ln. 7) configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (Fig. 1 access for #33).
Regarding claim 2, Rollins discloses the access portion comprises a compliant material (Fig. 1 #37; Col. 4, Ln. 62 – Col. 5, Ln. 7).
Regarding claim 3, Rollins discloses the compliant material comprises an elastic material (Col. 4, Ln. 62-66 – foam rubber).
Regarding claim 5, Rollins discloses the mask shell comprises a first material (Col. 4, Ln. 14-29) having a first rigidity; the access portion comprises a second material (Col. 4, Ln. 62-66) having a second rigidity; and the first rigidity is higher than the second rigidity (the only consideration of flexing during use is at key hole 35).
Regarding claim 10, Rollins the mask shell comprises a raised portion (Fig. 1 #31 is raised and supports the material in #35) supporting the access portion.
Regarding claim 11, Rollins discloses a second access portion (Fig. 2 other #35 on right side of mask), wherein the first access portion is located on a first side face of the mask shell, and the second access portion is located on a second side face of the mask shell opposite the first side face (Fig. 2 – left vs. right).
Regarding claim 12, Rollins discloses the covered portion of the user’s face comprises the nose of the user’s face (Fig. 1); and the access portion is configured to allow the user to access the nose of the user’s face by an intruding member (Fig. 1 #33; Col. 4, Ln. 50-52 – nasogastric tube).
Regarding claim 15, Rollins discloses a method of manufacturing a respiratory interface (the mask of Fig. 1 must be manufactured), comprising: forming a mask shell (Fig. 1 #13; Col. 4), the mask shell being configured to cover a portion of a user’s face (Fig. 1; Col. 4); and forming an access portion (Fig. 1 #35; Col. 4, Ln. 62 – Col. 5, Ln. 7), the access portion configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (Fig. 1 access for #33).
Claim(s) 1-3, 10 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Groll et al. (U.S. Patent 9981104).
Regarding claim 1, Groll discloses a respiratory interface (Fig. 5; Col. 5-6), comprising: a mask shell (Fig. 5 #20; Col. 5, Ln. 24-31) configured to cover a portion of a user’s face (Fig. 6); and an access portion (Fig. 5 #310; Col. 5, Ln. 24-31) configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (Col. 6, Ln. 15-38 – material of nasal interface 310 is “elastic and stretchy” which would allow a person to manually deform that part of the mask 20 to contact a portion of the user’s face inside of mask 20).
Regarding claim 2, Groll discloses the access portion comprises a compliant material (Col. 6, Ln. 15-38 – elastic and stretchy).
Regarding claim 3, Groll discloses the compliant material comprises an elastic material (Col. 6, Ln. 15-38 – elastic and stretchy).
Regarding claim 10, Groll the mask shell comprises a raised portion (Fig. 5 #400) supporting the access portion.
Regarding claim 12, Groll discloses the covered portion of the user’s face comprises the nose of the user’s face (Fig. 6); and the access portion is configured to allow the user to access the nose of the user’s face by an intruding member (Fig. 5). A finger, serving as the intruding member, can be used to manually deform nasal interface 310 such that contact is made with a portion of the user’s face inside of mask 20.
Regarding claim 13, Groll discloses a ventilation device (Figs. 4-5), comprising: a gas supply configured to supply pressurized gas (Col. 6, Ln. 39-48 – CPAP machine); and the respiratory interface of claim 1 (see above).
Regarding claim 14, Groll discloses the ventilation device is one of a continuous positive pressure airway device (Col. 6, Ln. 39-48 – CPAP machine)
Regarding claim 15, Groll discloses a method of manufacturing a respiratory interface (the mask of Fig. 5 must be manufactured), comprising: forming a mask shell (Fig. 5 #20; Col. 5, Ln. 24-31), the mask shell being configured to cover a portion of a user’s face (Fig. 6); and forming an access portion (Fig. 5 #310; Col. 5, Ln. 24-31), the access portion configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (Col. 6, Ln. 15-38 – material of nasal interface 310 is “elastic and stretchy” which would allow a person to manually deform that part of the mask 20 to contact a portion of the user’s face inside of mask 20).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lehman (U.S. Pub. 2013/0172768) in view of Lehman (U.S. Patent 11020557).
Regarding claim 16, Lehman discloses a method comprising: forming a mask shell (Fig. 1 #19; ¶0031), the mask shell being configured to cover a portion of a user’s face (Figs. 4-5); and forming an access portion (Fig. 1 one of #15, 20; ¶0031), the access portion configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (¶0045; e.g. Figs. 4-5 – access through diaphragms 15, 20).
Lehman fails to disclose a non-transitory computer-readable medium that stores a set of instructions that is executable by at least one processor of an apparatus to cause the apparatus to perform the method.
Lehman ‘557 teaches a medical face mask including membranes 114, 122 (Fig. 1) and teaches the membranes 114, 122 as manufactured with their surrounding apertures 112, 120 (Col. 5, Ln. 36-48). Thus, one of ordinary skill in the art would have obviously expected the membranes 114, 122 and their surrounding apertures 112, 120 to have been formed by a same control apparatus performing the manufacturing since they are taught as manufactured together. One of ordinary skill in the art would have obviously expected a stored set of instructions to be used when performing manufacturing of an item.
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 incorporated in Lehman a non-transitory computer-readable medium that stores a set of instructions that is executable by at least one processor of an apparatus to cause the apparatus to perform the method based upon the teaching in Lehman ‘557 that it is desirable to form membranes and their surrounding apertures together during manufacturing.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollins (U.S. Patent 4328797) in view of Mohanraj et al. (U.S. Pub. 2022/0241622).
Regarding claim 16, Rollins discloses a method comprising: forming a mask shell (Fig. 1 #13; Col. 4), the mask shell being configured to cover a portion of a user’s face (Fig. 1; Col. 4); and forming an access portion (Fig. 1 #35; Col. 4, Ln. 62 – Col. 5, Ln. 7), the access portion configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (Fig. 1 access for #33).
Rollins fails to disclose a non-transitory computer-readable medium that stores a set of instructions that is executable by at least one processor of an apparatus to cause the apparatus to perform the method.
Mohanraj teaches a medical face mask (Fig. 1) and teaches the various portions of the mask are formed by any of injection molding, cast molding, and 3D printing (¶0138). One of ordinary skill in the art would have obviously expected a stored set of instructions to be used when performing manufacturing based on injection molding, cast molding or 3D printing.
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 incorporated in Rollins a non-transitory computer-readable medium that stores a set of instructions that is executable by at least one processor of an apparatus to cause the apparatus to perform the method based upon an obvious expectation in the art to form mask portions by any of injection molding, cast molding, or 3D printing, with those manufacturing techniques obviously being implemented by way of a stored set of instructions.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groll et al. (U.S. Patent 9981104).
Regarding claim 16, Groll discloses a method comprising: forming a mask shell (Fig. 5 #20; Col. 5, Ln. 24-31), the mask shell being configured to cover a portion of a user’s face (Fig. 6); and forming an access portion (Fig. 5 #310; Col. 5, Ln. 24-31), the access portion configured to allow the user to access the portion of the user’s face covered by the mask shell without removing the respiratory interface from the user’s face (Col. 6, Ln. 15-38 – material of nasal interface 310 is “elastic and stretchy” which would allow a person to manually deform that part of the mask 20 to contact a portion of the user’s face inside of mask 20).
Groll fails to disclose a non-transitory computer-readable medium that stores a set of instructions that is executable by at least one processor of an apparatus to cause the apparatus to perform the method.
However, Groll teaches the cited mask shell and access portion as being pieces of fabric sewn together (Col. 5, Ln. 24-31). One of ordinary skill in the art would have considered it prima facie obvious that the mask pieces of Groll would be provided in standard sizes which would be cut by machine in order to save time over having to be cut by hand. It is noted that the claimed steps are only two separate forming actions and that the claim does not require the apparatus to connect the mask shell to the access portion.
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 incorporated in Groll a non-transitory computer-readable medium that stores a set of instructions that is executable by at least one processor of an apparatus to cause the apparatus to perform the method in order to provide the benefit of using a machine to cut the fabric for the mask shell and the access portion in order to save time over having those pieces be cut by hand. It is again noted that the claim does not recite any step of connecting the mask shell to the access portion.
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. Particularly note is made of the finger access allowed by Shiue (U.S. Pub. 2019/0359303; Fig. 4) and King (U.S. Pub. 2021/0274862; Fig. 2). Applicant may wish to consider specifying the access portion as an enclosed cavity configured to be directed toward the user’s face which is configured to not be passed through by an inserted intruding member (or some similar language). Note is additionally made as to how the type of condom facial device taught in Vaughn (U.S. Pub. 2007/0193586; Figs. 10 & 14) can be read on the claims.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785