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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on December 2, 2025 has been entered.
Response to Arguments
This Office Action is in response to the amendment filed on December 2, 2025. As directed by the amendment, Claims 1 and 14 have been amended. Claims 17 and 18 are new claims. Claims 1-18 are pending in the instant application.
Regarding the Office Action mailed February 5, 2024:
Applicant has not resolved all the rejections under Double Patenting. Therefore, the rejections are maintained.
Applicant’s arguments regarding the 35 USC 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference and/or interpretation applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant has amended the claims and added new claims to further narrow the scope of the claim. Therefore, Examiner applies a new interpretation of the 35 USC 103 rejections. Please see below for more details. It is suggested that Applicant further defines the structure of the mounting device and its structural connection with the adapter and harness clip.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
The phrase “an upper portion” should be changed to –the upper portion—for consistency (Claim 1, Line 4, Line 6, and Line 12).
The phrase “a lower portion” should be changed to –the lower portion—for consistency (Claim 1, Line 5, Line 7, and Lines 12-13).
The phrase “a lower portion” should be changed to –the lower portion—for consistency (Claim 13, Lines 1-2).
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.
Claims 3, 4, 10, 15, and 16 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 3 states “said harness clip is pre-fitted on lower harness tabs” (Lines 1-2). This statement is indefinite because it is unclear how a single harness clip is pre-fitted on multiple lower harness tabs. It appears the applicant was trying to say there are multiple harness clips and each harness clip is pre-fitted on each lower harness tab. However, the claim limitation creates confusion since the claim only requires one harness clip to fit both lower harness tabs. Therefore, the number of harness clips cannot be determined. For examination purposes, the claim limitation will be interpreted as there are multiple harness clips and each one is pre-fitted on each lower harness tab. Similar rejections are applied to Claim 4 (Lines 1-2).
Claim 4 states “following pre-fitting of the harness clip, can be inserted” (Lines 3). This statement is indefinite because it is unclear what is being inserted into the orifice. It appears the applicant was trying to say the end stoppers are inserted into the orifice. However, it is also possible by the wording of the claim that the harness clip or the lower harness tabs are inserted into the orifice. Therefore, the component inserted into the orifice cannot be determined. For examination purposes, the claim limitation will be interpreted as the end stoppers are inserted into the orifice.
Claim 4 states “can be inserted” (Line 3). This statement is indefinite because it is unclear if the end stoppers are inserted into the orifice. It appears the applicant was trying to say the end stoppers are inserted into the orifice. However, the use of “can be inserted” does not positively state that the end stoppers are inserted into the orifice. It is possible that the end stoppers are not inserted into the orifice but are merely capable of being inserted. Therefore, whether or not the end stoppers are inserted into the orifice cannot be determined. For examination purposes, the claim limitation will be interpreted as the end stoppers are inserted into the orifice.
Claim 4 states “end stoppers which” and “inserted into an orifice in a harness end” (Lines 2-3). This statement is indefinite because it is unclear how many orifices and harness ends are there. It appears the applicant was trying to say there are multiple orifices and harness ends. However, the claim limitation discusses more than one end stopper being inserted into a single orifice in a harness end. Therefore, the number of orifices and harness ends cannot be determined. For examination purposes, the claim limitation will be interpreted as there are multiple orifices and harness ends and each end stopper is inserted into each orifice of each harness end.
Claim 10 states “a further color marking” (Line 1). This statement is indefinite because it is unclear if an additional color marking was previously mentioned. It appears the applicant was trying to say the color markings mentioned in Claim 6. However, since Claim 10 is dependent on Claim 1, there is no mention of a color marking in Claim 1. Therefore, the number of color markings involved cannot be determined. For examination purposes, the claim limitation will be interpreted as “a color marking”.
Claim 15 states “a harness tab” (Line 2). This statement is indefinite because it is unclear if the harness tab is the same as the lower harness tabs mentioned in Claim 4. It appears the applicant was trying to say they’re the same. However, it is possible there are multiple different harness tabs involved. Therefore, the number of harness tabs cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claim 16 is rejected for being dependent on rejected Claim 4.
Claim Rejections - 35 USC § 101
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 4, 15, and 16 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 4 states “harness clip is pre-fitted on lower harness tabs in a cheek region” (Lines 1-2). This statement is directed to or encompasses a human organism as the claim limitation requires the harness clip to be pre-fitted on lower harness tabs in a cheek region of a human. Without the cheek region of the human, there would be no location or place where the harness clip is pre-fitted to the lower harness tabs. For examination purposes, the claim limitation will be interpreted as the lower harness tabs are configured to be at a cheek region of the wearer.
Claims 15 and 16 are rejected for being dependent on rejected Claim 4.
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 1-3, 5-10, 13, 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lubke et al. (US 2006/0283461 A1) in view of Rummery et al. (US 2010/0307502 A1) and Gunaratnam et al. (US 6,374,826 B1).
Regarding Claim 1, Lubke discloses a set of holding arrangements for a head harness (apparatus of Fig 152; 1050 and 1060 attach to patient interface 1010, Figs 152 and 155; apparatus of Figs 9-11; 264 attaches to 250 and 260, Figs 9-11; Figs 19-23 shows alternative arrangement with lower arrangement being 364 attaching to 371), wherein the set of holding arrangements comprises at least a first holding arrangement (1050 attaching to upper part of 1010, Figs 152 and 155; upper 264 attaches to 250, Figs 9-11) for an upper portion of a patient interface and a second holding arrangement (1060 attaching to lower part of 1010, Figs 152 and 155; lower 264 attaches to 260, Figs 9-11; 364 attaching to 371, Figs 19-23) for a lower portion of the patient interface, the first holding arrangement for an upper portion of the patient interface and the second holding arrangement for a lower portion of the patient interface comprising an identification mechanism (shape of 1050 and 1060, Figs 152 and 155; shape of upper and lower 264 with 250 and 260, Figs 9-11; shape of 364 and 371, Figs 19-23) in a region of the patient interface which render the first holding arrangement for an upper portion of the patient interface distinguishable from the second holding arrangement for a lower portion of the patient interface (the shape of 1050 is different and distinguishable from the shape of 1060, Figs 152 and 155; shape of upper and lower 264 are different, Figs 9-11; shape of 364 is different from upper 264, Figs 9-11 and 19-23), wherein said first and second holding arrangements are configured differently for the upper and lower portions of the patient interface (1050 connects to upper part of 1010 and 1060 connects to lower part of 1010, Figs 152 and 155; upper 264 attaches to 250 while lower 264 attaches to 260, Fig 9-11; 364 connects to 371 while upper 264 attaches to 250, Figs 9-11 and Figs 19-23), wherein the set further comprises a plurality of holding elements (1050 and 1060, Figs 152-155; upper and lower 264, Figs 9-11; 364, Figs 19-23) which serve to connect the head harness to the patient interface at at least four contact points (1050, 1060, upper and lower 264, and 364 are all shown to connect to at least four contact points on the patient interfaces, Figs 9-11, 19-23, 152, and 155), wherein components of the second holding arrangement for a lower portion of the patient interface comprise at least a harness clip (1064, Figs 167-170; 364, Figs 19-23) and an adapter (1071, Figs 167-170; 371, Figs 19-23).
Lubke fails to explicitly disclose about the holding arrangements comprising identification markings; the adapter located in a mounting device, the mounting device in its entirety being attached to a surface of the patient interface or integrated therein.
However, Rummery, of the same field of endeavor, teaches a patient interface system (Abstract) including the holding arrangements comprising identification markings (340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246) to ensure correct alignment and to indicate which is left side and right side (paragraph 0246).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add identification markings on the holding arrangements, as taught by Rummery, to ensure correct alignment and to indicate which is left side and right side (Rummery: paragraph 0246). This would ensure proper alignment and assembly of parts.
Lubke-Rummery combination fails to teach the adapter located in a mounting device, the mounting device in its entirety being attached to a surface of the patient interface or integrated therein.
However, Gunaratnam, of the same field of endeavor, teaches a connector arrangement (Abstract) including the adapter (210, Fig 2a) located in a mounting device (200, Fig 2a; 210 is attached to 200 by 230, Fig 2a), the mounting device in its entirety being attached to a surface of the patient interface (the entirety of 200 is attached to the surface of the patient interface on the right side of 200, Fig 2a) since this is a known headgear connection (Column 1, Lines 48-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a strap or mounting device between the adapter and the patient interface, as taught by Gunaratnam, since this is a known headgear connection (Gunaratnam: Column 1, Lines 48-50). This addition would also provide more adjustability by adding an additional short strap between the adapter and patient interface. It is noted that Applicant has not further defined the structure of the mounting device and any further details regarding its connection to the adapter. It is also noted that the claim limitation does not specify what surface of the patient interface the mounting device is attached to or the surface of the mounting device abutting or being directly attached to the surface of the patient interface.
Regarding Claim 2, the current Lubke-Rummery-Gunaratnam combination does not explicitly teach the first and second holding arrangements are configured differently for right and left portions of the patient interface.
However, Rummery further teaches the first and second holding arrangements are configured differently for right and left portions of the patient interface (322l, 322r, 84l, and 84r are configured differently from each other, Figs 18k-18l) to allow for a more intuitive assembly for the user (paragraph 0245) and to ensure correct alignment of the patient interface structure (paragraph 0246).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shapes of the holding arrangements to be configured differently for right and left portions, as taught by Rummery, to allow for a more intuitive assembly for the user (Rummery: paragraph 0245) and to ensure correct alignment of the patient interface structure (Rummery: paragraph 0246). By modifying the shape for the left and right portions, the holding arrangements are easier to assemble with the patient interface.
Regarding Claim 3, Lubke-Rummery-Gunaratnam combination teaches said harness clip is pre-fitted on lower harness tabs of the head harness (Lubke: 364 shown to be connected or pre-fitted to the lower harness tab, see annotated Fig 23 below) and is connected inseparably to textile material (Lubke: lower harness tab made of textile material, see annotated Fig 23 below; material backing 246, Fig 12; 244 attached to 246 via stitching, paragraph 0166) by end stoppers (Lubke: 244, Fig 23) which fit over ends of the lower harness tabs (Lubke: 244 goes over the end of the harness tab, see annotated Fig 23 below) and is at least one of sewn, adhesively bonded or welded there (Lubke: via stitching, welding, gluing, paragraph 0166). It is noted that the “pre-fitted” limitation is interpreted as a Product-by-Process claim limitation. The patentability of a product does not depend on its method of production. See MPEP 2113.
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Regarding Claim 5, Lubke-Rummery-Gunaratnam combination teaches said harness clip is pre-fitted on a harness tab (Lubke: 1064 shown to be pre-fitted to 1065, Figs 159-166), and latches in the adapter (Lubke: 1064 latches into 1071, Figs 167-170) which is located in the mounting device (Gunaratnam: 210 is attached to 200 by 230, Fig 2a). It is noted that the “pre-fitted” limitation is interpreted as a Product-by-Process claim limitation. The patentability of a product does not depend on its method of production. See MPEP 2113.
Regarding Claim 6, Lubke-Rummery-Gunaratnam combination teaches the identification markings further comprise color markings on said harness clip and said adapter for the harness clip (Rummery: 340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246; the indicia would inherently have a color). It is noted that Applicant has not specified the types of color involved.
Regarding Claim 7, Lubke-Rummery-Gunaratnam combination teaches the identification markings further comprise raised or depressed identification markings on said harness clip and said adapter for the harness clip (Rummery: 340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246; the indicia are shown to be raised or depressed due to the physical presence of 322l, 322r, 74l, 74r, 342, and 344, Figs 18h-18j).
Regarding Claim 8, Lubke-Rummery-Gunaratnam combination teaches the identification markings further comprise at least one of letters (Rummery: 340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246; letters are shown).
Regarding Claim 9, Lubke-Rummery-Gunaratnam combination teaches the identification markings further comprise symbols (Rummery: 340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246; letters are symbols).
Regarding Claim 10, Lubke-Rummery-Gunaratnam combination teaches a touch and close fastener (Lubke: 228, 238, Fig 9) and a corresponding harness mount (Lubke: 254, Fig 9). The current Lubke-Rummery-Gunaratnam combination does not explicitly teach a further color marking is present in the form of a colored touch-and-close fastener and/or a colored harness end and/or colored seams in a same color as a corresponding harness mount.
However, Rummery further teaches color markings (340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246; the indicia would inherently have a color) to allow for a more intuitive assembly for the user (paragraph 0245) and to ensure correct alignment of the patient interface structure (paragraph 0246).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the touch and close fastener and corresponding harness mount to have indicia that inherently have a color, as taught by Rummery, to allow for a more intuitive assembly for the user (Rummery: paragraph 0245) and to ensure correct alignment of the patient interface structure (Rummery: paragraph 0246). Having indicia for the fasteners and harness mount would obviously allow for easier assembly of the device and ensure correct alignment. It is noted that Applicant has not specified the types of color involved.
Regarding Claim 13, Lubke-Rummery-Gunaratnam combination teaches at least the second holding arrangement for a lower portion of the patient interface comprises the harness clip (Lubke: 1064, Figs 167-170; 364, Figs 19-23) and the adapter (Lubke: 1071, Figs 167-170; 371, Figs 19-23).
Regarding Claim 14, Lubke-Rummery-Gunaratnam combination teaches the adapter is pivotable relative to the mounting device (Gunaratnam: 210 shown to be pivotable relative to 200 due to 230, Fig 2a; connector is free to move relative to mask frame, Column 1, Lines 52-55).
Regarding Claim 17, Lubke-Rummery-Gunaratnam combination teaches the identification markings of the harness clip and the adapter comprising mechanical coding (Rummery: 340, 342, 344, Figs 18h-18j; connectors may include indicia 340, paragraph 0246).
Regarding Claim 18, Lubke-Rummery-Gunaratnam combination teaches the adapter is separate from the mounting device (Gunaratnam: 210 is shown to be a separate component from 200, Fig 2a).
The current Lubke-Rummery-Gunaratnam combination fails to explicitly teach that the adapter is removable therefrom.
However, Gunaratnam teaches an alternate embodiment including an adapter (140, Fig 1; 140 is an adapter to allow the connection 110 to 120 and 130, Fig 1) being removable from the mounting device (110, Fig 1; straps include hook and loop material, Column 1, Lines 30-43) to allow for adjustment of the length of material for a good fit of the mask (Column 1, Lines 30-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter to be removeable from the mounting device or strap 200 of Gunaratnam by making strap 200 separable with hook and loop material, as taught by Gunaratnam, to allow for adjustment of the length of material for a good fit of the mask (Gunaratnam: Column 1, Lines 30-43). This improvement would also allow strap 200 to be removeable for replacement.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lubke et al. (US 2006/0283461 A1), Rummery et al. (US 2010/0307502 A1), and Gunaratnam et al. (US 6,374,826 B1) as applied to Claim 1, and in further view of Keller et al. (US 6,003,213 A).
Regarding Claim 11, Lubke-Rummery-Gunaratnam combination teaches the claimed invention of Claim 1. Lubke-Rummery-Gunaratnam combination fails to teach the first and/or the second holding arrangement further comprises an actuating element in the form of a sliding sleeve which can be pushed over the harness clip.
However, Keller, reasonably pertinent to the problem of preventing unintentional release of a buckle, teaches a buckle (Abstract) including an actuating element in the form of a sliding sleeve which can be pushed over the harness clip (150 shown to be pushed over 110, Fig 3; 250 shown to be pushed over 210, Fig 5; 150 positioned to prevent expansion of 132 to securely retain 120 in 140, Column 2, Lines 45-52; 250 positioned to prevent expansion of 232 to retain 220 in 240, Column 6, Lines 30-40) to prevent inadvertent or accidental separation (Column 1, Lines 28-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a sliding sleeve, as taught by Keller, to prevent inadvertent or accidental separation (Keller: Column 1, Lines 28-30).
Regarding Claim 12, Lubke-Rummery-Gunaratnam-Keller combination teaches the sliding sleeve is capable of releasing a snap connection between the harness clip and the adapter (Keller: 150 shown to release snap connection between 110 and 130, Fig 2; 250 shown to release snap connection between 210 and 230, Fig 6).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lubke et al. (US 2006/0283461 A1), Rummery et al. (US 2010/0307502 A1), and Gunaratnam et al. (US 6,374,826 B1) as applied to Claim 1, and in further view of Berthon-Jones (US 2008/0099023 A1), hereafter Berthon.
Regarding Claim 4, Lubke-Rummery-Gunaratnam combination teaches the claimed invention of Claim 1. Lubke-Rummery-Gunaratnam combination fails to teach said harness clip is pre-fitted on lower harness tabs in a cheek region and is connected to textile material by end stoppers which, following pre-fitting of the harness clip, can be inserted into an orifice in a harness end.
However, Berthon, of the same field of endeavor, teaches a mask assembly (Abstract) including a connection mechanism (D-ring with hook, Fig 1) is pre-fitted on lower harness tabs (tabs or ends of 35, Fig 1) in a cheek region (35 would be configured to be at a cheek region of the user, Fig 1) and is connected to textile material (35 are straps made of textile material, Fig 1) by end stoppers (press stud, Fig 1; positions of ends of straps marked by marking pen, belt rivet hole punch used to put hole near end of each strap, press stud may be inserted into hole, paragraph 0039) which, following pre-fitting of the connection mechanism, can be inserted into an orifice in a harness end (hole near end of each strap, paragraph 0039) to have a correct fitting strap length (paragraph 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lower straps to have press studs that hold the ends of the lower straps, as taught by Berthon, to have a correct fitting strap length (Berthon: paragraph 0032). This modification would allow for head harness to be correctly fitted for the patient so that the strap length at the ends of the straps do not need to be readjusted each time. This is also a known way to assemble the straps in which the straps are cut to fit the patient wearing the head harness. This way to assemble the straps would make it easier to modify the head harness as it would not require creating a completely different, separate head harness for each unique patient. It is noted that the “pre-fitted” limitation is interpreted as a Product-by-Process claim limitation. Additionally, the use of “following pre-fitting” is also interpreted as a Product-by-Process claim limitation. The patentability of a product does not depend on its method of production. See MPEP 2113.
Regarding Claim 15, Lubke-Rummery-Gunaratnam-Berthon combination teaches the orifice can be one of many pre-punched holes on the strap (Berthon: paragraph 0032).
The current Lubke-Rummery-Gunaratnam-Berthon combination fails to explicitly teach the orifice is located 14±2 mm from an end of a harness tab.
However, one of ordinary skill in the art before the effective filing date of the claimed invention would be capable of locating the orifice at 14±2 mm from an end of a harness tab since the claimed relative dimensions would not perform different than the prior art device. See MPEP 2144.04, Section IV, Sub-section A. Additionally, one of ordinary skill in the art would be capable of discovering these ranges though routine experimentation. See MPEP 2144.05, Section II, Sub-section A. In the instant specification, Applicant discusses the orifice at 14±2 mm but does not further elaborate why specifically these measurements are utilized (Page 10, Lines 7-9). Applicant has not detailed anything regarding the criticality of this claimed range and does not mention anything about this range producing unexpected results. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orifice to be at 14±2 mm from an end of a harness tab since the claimed relative dimensions would not perform different than the prior art device and since one of ordinary skill in the art would be capable of finding these claimed ranges through routine experimentation and optimization. Furthermore, one of ordinary skill in the art would be motivated to find the claimed ranges since the device would have to be adjusted or sized to optimally fit the faces of different patients.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lubke et al. (US 2006/0283461 A1), Rummery et al. (US 2010/0307502 A1), Gunaratnam et al. (US 6,374,826 B1), and Berthon-Jones (US 2008/0099023 A1), hereafter Berthon, as applied to Claim 4, and in further view of Stitches Sew me your stuff (2012), hereafter Stitches.
Regarding Claim 16, Lubke-Rummery-Gunaratnam-Berthon combination teaches the claimed invention of Claim 4. Lubke-Rummery-Gunaratnam-Berthon combination fails to teach the orifice is reinforced by a zigzag hole seam.
However, Stitches, reasonably pertinent to the problem of reinforcing orifices, teaches a method of sewing a buttonhole (Page 1) including the orifice is reinforced by a zigzag hole seam (See image below; Page 4) since it is known to reinforce buttonholes or orifices on fabric with a zig zag seam.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a zigzag hole seam around the orifice, as taught by Stitches, since it is known to reinforce buttonholes or orifices on fabric with a zig zag seam. This addition would ensure the orifice is maintained and would not fall apart when the end stoppers are placed in the orifice.
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,511,068, hereafter ‘068. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 1, ‘068 discloses all of the claimed invention (Claim 1; mounting device is on the patient interface and thus must obviously have some kind of attachment that would be on a surface of the patient interface). It is noted that Applicant has not specified what surface the mounting device is attached to.
Regarding Claim 2, ‘068 discloses all of the claimed invention (Claim 2).
Regarding Claim 3, ‘068 discloses all of the claimed invention (Claim 3).
Regarding Claim 5, ‘068 discloses all of the claimed invention (Claim 4).
Regarding Claim 6, ‘068 discloses all of the claimed invention (Claim 5).
Regarding Claim 7, ‘068 discloses all of the claimed invention (Claim 6).
Regarding Claim 8, ‘068 discloses all of the claimed invention (Claim 7).
Regarding Claim 9, ‘068 discloses all of the claimed invention (Claim 8).
Regarding Claim 10, ‘068 discloses all of the claimed invention (Claim 9).
Regarding Claim 11, ‘068 discloses all of the claimed invention (Claim 1).
Regarding Claim 12, ‘068 discloses all of the claimed invention (Claim 1).
Regarding Claim 13, ‘068 discloses all of the claimed invention (Claim 1).
Regarding Claim 14, ‘068 discloses all of the claimed invention (Claim 10).
Regarding Claim 17, ‘068 discloses all of the claimed invention (Claims 8 and/or 9; identification markings with letters, numbers, or symbols would be a form of mechanical coding).
Claims 4 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,511,068, hereafter ‘068, in view of Berthon-Jones (US 2008/0099023 A1), hereafter Berthon. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 4, ‘068 discloses the claimed invention of Claim 1. ‘068 also discloses said harness clip is pre-fitted on lower harness tabs in a cheek region and is connected to textile material by end stoppers (Claim 3).
‘068 fails to disclose the end stoppers can be inserted into an orifice on a harness end.
However, Berthon, of the same field of endeavor, teaches a mask assembly (Abstract) including end stoppers (press stud, Fig 1; positions of ends of straps marked by marking pen, belt rivet hole punch used to put hole near end of each strap, press stud may be inserted into hole, paragraph 0039) which, following pre-fitting of the connection mechanism (D-ring with hook, Fig 1; tabs or ends of 35, Fig 1), can be inserted into an orifice in a harness end (hole near end of each strap, paragraph 0039) to have a correct fitting strap length (paragraph 0032).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lower straps to have press studs that hold the ends of the lower straps, as taught by Berthon, to have a correct fitting strap length (Berthon: paragraph 0032). This modification would allow for head harness to be correctly fitted for the patient so that the strap length at the ends of the straps do not need to be readjusted each time. This is also a known way to assemble the straps in which the straps are cut to fit the patient wearing the head harness. This way to assemble the straps would make it easier to modify the head harness as it would not require creating a completely different, separate head harness for each unique patient. It is noted that the “pre-fitted” limitation is interpreted as a Product-by-Process claim limitation. Additionally, the use of “following pre-fitting” is also interpreted as a Product-by-Process claim limitation. The patentability of a product does not depend on its method of production. See MPEP 2113.
Regarding Claim 15, ‘068-Berthon combination teaches the orifice can be one of many pre-punched holes on the strap (Berthon: paragraph 0032).
The current ‘068-Berthon combination fails to explicitly teach the orifice is located 14±2 mm from an end of a harness tab.
However, one of ordinary skill in the art before the effective filing date of the claimed invention would be capable of locating the orifice at 14±2 mm from an end of a harness tab since the claimed relative dimensions would not perform different than the prior art device. See MPEP 2144.04, Section IV, Sub-section A. Additionally, one of ordinary skill in the art would be capable of discovering these ranges though routine experimentation. See MPEP 2144.05, Section II, Sub-section A. In the instant specification, Applicant discusses the orifice at 14±2 mm but does not further elaborate why specifically these measurements are utilized (Page 10, Lines 7-9). Applicant has not detailed anything regarding the criticality of this claimed range and does not mention anything about this range producing unexpected results. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orifice to be at 14±2 mm from an end of a harness tab since the claimed relative dimensions would not perform different than the prior art device and since one of ordinary skill in the art would be capable of finding these claimed ranges through routine experimentation and optimization. Furthermore, one of ordinary skill in the art would be motivated to find the claimed ranges since the device would have to be adjusted or sized to optimally fit the faces of different patients.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,511,068, hereafter ‘068, and Berthon-Jones (US 2008/0099023 A1), hereafter Berthon, as applied to Claim 4, and in further view of Stitches Sew me your stuff (2012), hereafter Stitches. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 16, ‘068-Berthon combination teaches the claimed invention of Claim 4. ‘068-Berthon combination fails to teach the orifice is reinforced by a zigzag hole seam.
However, Stitches, reasonably pertinent to the problem of reinforcing orifices, teaches a method of sewing a buttonhole (Page 1) including the orifice is reinforced by a zigzag hole seam (See image below; Page 4) since it is known to reinforce buttonholes or orifices on fabric with a zig zag seam.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a zigzag hole seam around the orifice, as taught by Stitches, since it is known to reinforce buttonholes or orifices on fabric with a zig zag seam. This addition would ensure the orifice is maintained and would not fall apart when the end stoppers are placed in the orifice.
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Claims 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,511,068, hereafter ‘068, in view of Gunaratnam et al. (US 6,374,826 B1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 18, ‘068 discloses the claimed invention of Claim 1. ‘068 fails to disclose the adapter is separate from the mounting device and removable therefrom.
However, Gunaratnam, of the same field of endeavor, teaches a connector arrangement (Abstract) including the adapter is separate from the mounting device (210 is shown to be a separate component from 200, Fig 2a) since this is a known headgear connection (Column 1, Lines 48-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the adapter be separate from the mounting device and have the mounting device be a strap, as taught by Gunaratnam, since this is a known headgear connection (Gunaratnam: Column 1, Lines 48-50). This addition would also provide more adjustability by adding an additional short strap between the adapter and patient interface. Since the adapter and mounting device (strap) are materially different, the two components would obviously have to be separate. It is noted that Applicant has not further defined the structure of the mounting device and any further details regarding its connection to the adapter.
The current ‘068-Gunaratnam combination fails to teach the adapter being removable from the mounting device.
However, Gunaratnam teaches an alternate embodiment including an adapter (140, Fig 1; 140 is an adapter to allow the connection 110 to 120 and 130, Fig 1) being removable from the mounting device (110, Fig 1; straps include hook and loop material, Column 1, Lines 30-43) to allow for adjustment of the length of material for a good fit of the mask (Column 1, Lines 30-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter to be removeable from the mounting device or strap 200 of Gunaratnam by making strap 200 separable with hook and loop material, as taught by Gunaratnam, to allow for adjustment of the length of material for a good fit of the mask (Gunaratnam: Column 1, Lines 30-43). This improvement would also allow strap 200 to be removeable for replacement.
Conclusion
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/BRIAN T KHONG/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785