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 .
Specification
The amendment filed 15 Mar 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the international patent application PCT/SG2022/050668 and of the foreign patent application SG 10202110296S is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 1 6 Sep 2022, see MPEP 1893.03(b). Therefore the specification amendment of 15 Mar 2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim(s) 18, 20, 27-28 and 30 is/are objected to because of the following informalities:
Claim 18, Ln. 4 recites “the joint” which should read “the stitchless joint” for consistency with claim 1
Claim 20, Ln. 4 recites “the joint” which should read “the stitchless joint” for consistency with claim 1
Claim 27, Ln. 11 recites “an otobasion superior” which should read “the otobasion superior” following after Ln. 6 of the claim
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) 24-25, 27-28 and 30 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 24 recites the limitation “the headgear” in Ln. 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “the headgear portion,” following after claim 1.
Claim 25 recites the limitation “the headgear” in Ln. 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “the headgear portion,” following after claim 1.
Claim 27 recites the limitation “a connection port” in Ln. 8 which deems the claim indefinite. It is unclear whether reference is intended to the same connection port as Ln. 3 of the claim or to an alternate connection port. The former interpretation appears most accurate. For the purposes of examination the limitation will be interpreted as reading “the connection port”.
Claim 27 recites several new elements but makes no mention of the headgear portion of claim 1. It appears the headgear portion of claim 1 must be part of at least one of the new elements recited by the instant claim. The claim is thus indefinite as it appears to be defining a set of new elements fully in addition to the headgear portion of claim 1 while the disclosure of the instant application appears to require the headgear portion of claim 1 to be part of at least one of the new elements. Applicant is encouraged to somehow relate the new elements of the instant claim to the headgear portion of claim 1.
Claim 28 recites the limitation “a stitchless joint comprising at least one polymer layer” in Ln. 1-2 which deems the claim indefinite. It is unclear whether reference is intended to prior stitchless joint and at least one polymer layer of claim 1 3 or whether a further stitchless joint and at least one polymer layer are being presently claimed. The former interpretation appears most accurate. For the purposes of examination the limitation will be interpreted as reading “the stitchless joint comprising the at least one polymer layer,” following after claim 1.
Claim 28 recites the limitation “the headgear conduit” in Ln. 2 which deems the claim indefinite. Claim 27 has recited a pair of headgear conduits. The present limitation is thus indefinite as it only recites a single headgear conduit, but without relating it to the prior headgear conduits of claim 27. For the purposes of examination the limitation will be interpreted as reading “one of the pair of headgear conduits”.
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) 1-7, 11-12 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chodkowski et al. (U.S. Pub. 2014/0305439).
Regarding claim 1, Chodkowski discloses a positioning and stabilising structure (Figs. 3-7 using the design of Fig. 2; ¶0044-0046) to provide a force to hold a seal-forming structure of a patient interface (Fig. 3 #36; ¶0048) in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure to at least the patient's nares throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising: a headgear portion (e.g. Fig. 3 #30 represented as Fig. 2 #20; ¶¶0044-0046, 0048), the headgear portion comprising a first headgear portion (Fig. 2 “D”; ¶¶0044-0045) and a second headgear portion (Fig. 2 one of “E” or “F”; ¶¶0044-0045), wherein the first headgear portion and the second headgear portion are joined by a stitchless joint (Fig. 2 not stitched; ¶¶0044-0045) comprising at least one polymer layer (Fig. 2 #22, 22; ¶¶0044-0045) spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion (Fig. 2; ¶¶0044-0045).
Regarding claim 2, Chodkowski discloses adjacent edges of the first headgear portion and the second headgear portion joined by the stitchless joint are non-overlapping (Fig. 2 “D”, “E”, and “F” do not overlap).
Regarding claim 3, Chodkowski discloses the adjacent edges of the first headgear portion and the second headgear portion joined by the stitchless joint are abutting when the positioning and stabilising structure is unloaded (Fig. 2 “D” & “E” abut).
Regarding claim 4, Chodkowski discloses the adjacent edges of the first headgear portion and the second headgear portion are directly joined together in addition to the at least one polymer layer (Fig. 2 “D” & “E” are directly joined).
Regarding claim 5, Chodkowski discloses the adjacent edges of the first headgear portion and the second headgear portion are welded together (¶0011).
Regarding claim 6, Chodkowski discloses the adjacent edges of the first headgear portion and the second headgear portion are not directly joined (Fig. 2 “D” & “F” are not directly joined).
Regarding claim 7, Chodkowski discloses the first headgear portion and the second headgear portion are strap portions (Figs. 2-3).
Regarding claim 11, Chodkowski discloses the at least one polymer layer surrounds the first headgear portion and the second headgear portion at the stitchless joint (Fig. 2 #22, 22 on top and bottom).
Regarding claim 12, Chodkowski discloses the at least one polymer layer comprises a first polymer layer (Fig. 2 top #22; ¶¶0044-0045) applied to a first side of the first headgear portion and the second headgear portion, and a second polymer layer (Fig. 2 bottom #22; ¶¶0044-0045) applied to a second side of the first headgear portion and the second headgear portion.
Regarding claim 34, Chodkowski discloses a patent interface (e.g. Fig. 3), comprising: a seal-forming structure (Fig. 3 #36; ¶0048) constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure to at least the patient's nares throughout the patient's respiratory cycle in use; and a positioning and stabilising structure (Figs. 3-7 using the design of Fig. 2; ¶0044-0046) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising: a headgear portion (e.g. Fig. 3 #30 represented as Fig. 2 #20; ¶¶0044-0046, 0048), the headgear portion comprising a first headgear portion (Fig. 2 “D”; ¶¶0044-0045) and a second headgear portion (Fig. 2 one of “E” or “F”; ¶¶0044-0045), wherein the first headgear portion and the second headgear portion are joined by a stitchless joint (Fig. 2 not stitched; ¶¶0044-0045) comprising at least one polymer layer (Fig. 2 #22, 22; ¶¶0044-0045) spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion (Fig. 2; ¶¶0044-0045).
Claim(s) 1, 8, 11, 27, 30 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (U.S. Pub. 2012/0325219).
Regarding claim 1, Smith, in a first reading, discloses a positioning and stabilising structure (Fig. 2 #14, 16; ¶0019) to provide a force to hold a seal-forming structure of a patient interface (Fig. 2 #12; ¶0019) in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure to at least the patient's nares throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising: a headgear portion (Fig. 2 #14, 16; ¶0019), the headgear portion comprising a first headgear portion (Figs. 3 & 5 #18; ¶0021) and a second headgear portion (Figs. 3 & 6 #20; ¶0021), wherein the first headgear portion and the second headgear portion are joined by a stitchless joint (Fig. 3; ¶0021 – friction fit) comprising at least one polymer layer (Fig. 2 #16; ¶0029 – e.g. molded silicone) spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion (Fig. 2 #16 full spans between #18 and #20). The phrasing “applied to” in plain language only requires a contacting and does not require a permanent attachment. The at least one polymer layer is not limited to only being located at the stitchless joint and can thus extend well beyond the stitchless joint while reading on the claim.
Regarding claim 8, Smith, in the first reading, discloses the first headgear portion and the second headgear portion are headgear conduit portions (Fig. 3).
Regarding claim 11, Smith, in the first reading, discloses the at least one polymer layer surrounds the first headgear portion and the second headgear portion at the stitchless joint (Fig. 3).
Regarding claim 27, Smith, in the first reading, discloses the positioning and stabilising structure comprises: at least one gas delivery tube (Fig. 4 #13A, 13B; ¶0020) to receive the flow of air from a connection port (Fig. 4 #8; ¶0020) on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (Figs. 1 & 3), wherein the at least one gas delivery tube comprises a pair of headgear conduits (Fig. 4 #13A, 13B; ¶0020) to receive the flow of air from the connection port on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, each headgear conduit constructed and arranged to contact, in use, at least a region of the patient's head superior to the otobasion superior of the patient's head on a respective side of the patient's head (Figs. 1 & 3); and a headgear strap (Fig. 1 #48; ¶0028).
Regarding claim 30, Smith, in the first reading, discloses a flexible cover (Fig. 2 #16; ¶0029) provided to at least a portion of each headgear conduit.
Regarding claim 34, Smith, in a first reading, discloses a patent interface (Fig. 2; ¶0019), comprising: a seal-forming structure (Fig. 2 #12; ¶0019) constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure to at least the patient's nares throughout the patient's respiratory cycle in use; and a positioning and stabilising structure (Fig. 2 #14, 16; ¶0019) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising: a headgear portion (Fig. 2 #14, 16; ¶0019), the headgear portion comprising a first headgear portion (Figs. 3 & 5 #18; ¶0021) and a second headgear portion (Figs. 3 & 6 #20; ¶0021), wherein the first headgear portion and the second headgear portion are joined by a stitchless joint (Fig. 3; ¶0021 – friction fit) comprising at least one polymer layer (Fig. 2 #16; ¶0029 – e.g. molded silicone) spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion (Fig. 2 #16 full spans between #18 and #20). The phrasing “applied to” in plain language only requires a contacting and does not require a permanent attachment. The at least one polymer layer is not limited to only being located at the stitchless joint and can thus extend well beyond the stitchless joint while reading on the claim.
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) 1-2, 6-7, 9-11, 18, 20, 24-25, 27-28, 30 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Pub. 2012/0325219) in view of Sims (U.S. Pub. 2020/0230343).
Regarding claim 1, Smith, in a second reading, discloses a positioning and stabilising structure (Figs. 1-2 #14, 16, 48; ¶¶0019, 0028) to provide a force to hold a seal-forming structure of a patient interface (Fig. 2 #12; ¶0019) in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure to at least the patient's nares throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising: a headgear portion (Fig. 1 #16, 48; ¶0028), the headgear portion comprising a first headgear portion (Fig. 1 #16; ¶0028) and a second headgear portion (Fig. 1 #48; ¶0028).
Smith fails to disclose the first headgear portion and the second headgear portion are joined by a stitchless joint comprising at least one polymer layer spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion.
Sims teaches a respiratory mask (Fig. 1) wherein a rear strap (Fig. # 206; ¶0203) and a forward strap (Fig. 6 #208; ¶0203) are joined by a stitchless joint (Fig. 6 at #207; ¶¶0208-0209) comprising at least one layer (Fig. 7 #207; ¶¶0208-0209) spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion (Figs. 6-15; ¶¶0206-0209). One of ordinary skill in the art would obviously recognize overmolding as using polymer materials. Sims teaches a stitchless joint between forward and rear straps as providing the benefit of permanently connecting the straps in a secure manner where their material is joined (¶¶0208-0209).
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 Smith the first headgear portion and the second headgear portion are joined by a stitchless joint comprising at least one polymer layer spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion in order to provide the benefit of permanently connecting headgear component 16 and rear strap 48 in a secure manner where their material is joined in view of Sims.
Regarding claim 2, Smith, in the second reading, teaches the invention as modified above and together with Sims further teaches adjacent edges of the first headgear portion and the second headgear portion joined by the stitchless joint are non-overlapping (Sims – Fig. 14 not overlapping).
Regarding claim 6, Smith, in the second reading, teaches the invention as modified above and together with Sims further teaches the adjacent edges of the first headgear portion and the second headgear portion are not directly joined (Sims – Fig. 14 not directly joined).
Regarding claim 7, Smith, in the second reading, teaches the invention as modified above and further teaches the first headgear portion and the second headgear portion are strap portions (Fig. 1). Headgear component 16 is readable as a strap portion based on how it wraps around tubing assembly 14 and is thus a strap encompassing tubing assembly 14.
Regarding claim 9, Smith, in the second reading, teaches the invention as modified above and together with Sims further teaches one of the first headgear portion and the second headgear portion is a strap portion (Smith – Fig. 1 #48), and the other one of the first headgear portion and the second headgear portion is a headgear conduit portion (Smith – Fig. 1 #16). Headgear component 16 is readable as a headgear conduit portion based on how it wraps around tubing assembly 14 indicating it is part of an overall headgear conduit passage.
Regarding claim 10, Smith, in the second reading, teaches the invention as modified above and together with Sims further teaches one of the first headgear portion and the second headgear portion is a strap connection tab portion (Smith – Fig. 1 #48; Sims – Figs. 11-14 #212; ¶0205), and the other one of the first headgear portion and the second headgear portion is a headgear conduit portion (Smith – Fig. 1 #16). Headgear component 16 is readable as a headgear conduit portion based on how it wraps around tubing assembly 14 indicating it is part of an overall headgear conduit passage.
Regarding claim 11, Smith, in the second reading, teaches the invention as modified above and together with Sims further teaches the at least one polymer layer surrounds the first headgear portion and the second headgear portion at the stitchless joint (Sims – Figs. 14-15).
Regarding claim 18, Smith, in the second reading, teaches the invention as modified above but is silent as to whether the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 20 N across the stitchless joint.
It is noted that the claim does not specifically identify how much of the tension resistance must be provided by the at least one polymer layer. The joint 207 of Sims is formed of an overmolded material (¶¶0208-0209) and will be obviously expected by one of ordinary skill in the art to provide a strong tension resistance. One of ordinary skill in the art would have considered a resistance at joint 207 of Sims of at least 20 N to have been an obvious parameter of use given the particular configuration at joint 207.
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 the modified Smith the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 20 N across the stitchless joint based upon an expected strength provided by joint 207 of Sims.
Regarding claim 20, Smith, in the second reading, teaches the invention as modified above but is silent as to whether the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 40 N across the stitchless joint.
It is noted that the claim does not specifically identify how much of the tension resistance must be provided by the at least one polymer layer. The joint 207 of Sims is formed of an overmolded material (¶¶0208-0209) and will be obviously expected by one of ordinary skill in the art to provide a strong tension resistance. One of ordinary skill in the art would have considered a resistance at joint 207 of Sims of at least 40 N to have been an obvious parameter of use given the particular configuration at joint 207.
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 the modified Smith the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 40 N across the stitchless joint based upon an expected strength provided by joint 207 of Sims.
Regarding claim 24, Smith, in the second reading, teaches the invention as modified above but is silent as to whether the at least one polymer layer imparts shape holding properties of the headgear portion.
However, the joint 207 of Sims is formed of an overmolded material (¶¶0208-0209) which one of ordinary skill in the art would have obviously expected to impart some degree of shape holding.
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 the modified Smith the at least one polymer layer imparts shape holding properties of the headgear portion based upon the obvious expectation that the overmolding material at joint 207 of Sims would impart some degree of shape holding.
Regarding claim 25, Smith, in the second reading, teaches the invention as modified above but is silent as to whether the at least one polymer layer imparts increased rigidity to at least a portion of the headgear portion.
However, the joint 207 of Sims is formed of an overmolded material (¶¶0208-0209) which one of ordinary skill in the art would have obviously expected to impart some degree of rigidity.
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 the modified Smith the at least one polymer layer imparts shape holding properties of the headgear portion based upon the obvious expectation that the overmolding material at joint 207 of Sims would impart some degree of rigidity.
Regarding claim 27, Smith, in the second reading, teaches the invention as modified above and further teaches the positioning and stabilising structure comprises: at least one gas delivery tube (Fig. 4 #13A, 13B; ¶0020) to receive the flow of air from a connection port (Fig. 4 #8; ¶0020) on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (Figs. 1 & 3), wherein the at least one gas delivery tube comprises a pair of headgear conduits (Fig. 4 #13A, 13B; ¶0020) to receive the flow of air from the connection port on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, each headgear conduit constructed and arranged to contact, in use, at least a region of the patient's head superior to the otobasion superior of the patient's head on a respective side of the patient's head (Figs. 1 & 3); and a headgear strap (Fig. 1 #48; ¶0028).
Regarding claim 28, Smith, in the second reading, teaches the invention as modified above and together with Sims further teaches the stitchless joint (see Sims incorporation in claim 1 above) comprising the at least one polymer layer is provided between a portion of the headgear conduit (Smith – Fig. 1 #14) and a portion of the headgear strap (Smith – Fig. 1 #48; Sims – Figs. 6-7).
Regarding claim 30, Smith, in the second reading, teaches the invention as modified above and further teaches a flexible cover (Fig. 2 #16; ¶0029) provided to at least a portion of each headgear conduit.
Regarding claim 34, Smith, in a second reading, discloses a patent interface (Fig. 2; ¶0019), comprising: a seal-forming structure (Fig. 2 #12; ¶0019) constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure to at least the patient's nares throughout the patient's respiratory cycle in use; and a positioning and stabilising structure (Figs. 1-2 #14, 16, 48; ¶¶0019, 0028) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising: a headgear portion (Fig. 1 #16, 48; ¶0028), the headgear portion comprising a first headgear portion (Fig. 1 #16; ¶0028) and a second headgear portion (Fig. 1 #48; ¶0028).
Smith fails to disclose the first headgear portion and the second headgear portion are joined by a stitchless joint comprising at least one polymer layer spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion.
Sims teaches a respiratory mask (Fig. 1) wherein a rear strap (Fig. # 206; ¶0203) and a forward strap (Fig. 6 #208; ¶0203) are joined by a stitchless joint (Fig. 6 at #207; ¶¶0208-0209) comprising at least one layer (Fig. 7 #207; ¶¶0208-0209) spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion (Figs. 6-15; ¶¶0206-0209). One of ordinary skill in the art would obviously recognize overmolding as using polymer materials. Sims teaches a stitchless joint between forward and rear straps as providing the benefit of permanently connecting the straps in a secure manner where their material is joined (¶¶0208-0209).
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 Smith the first headgear portion and the second headgear portion are joined by a stitchless joint comprising at least one polymer layer spanning between the first headgear portion and the second headgear portion and applied to the first headgear portion and the second headgear portion in order to provide the benefit of permanently connecting headgear component 16 and rear strap 48 in a secure manner where their material is joined in view of Sims.
Claim(s) 18, 20 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chodkowski et al. (U.S. Pub. 2014/0305439).
Regarding claim 18, Chodkowski is silent as to whether the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 20 N across the stitchless joint.
It is noted that the claim does not specifically identify how much of the tension resistance must be provided by the at least one polymer layer. Chodkowski teaches layer 22 as able to be made from silicone (¶0044). Further, Chodkowski teaches the headgear as selected for desired physical properties such as stiffness (¶0045). One of ordinary skill in the art would have considered a resistance at the joint between sub-portions D, E and F to have obviously provided a resistance of at least 20 N in order to form a secure and comfortable headgear shaping.
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 Chodkowski the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 20 N across the stitchless joint based upon an obvious expectation that the physical properties of the headgear in Chodkowski would have been obviously selected to provide the claimed tension resistance to form a secure and comfortable headgear shaping in light of the overall disclosure of Chodkowski.
Regarding claim 20, Chodkowski is silent as to whether the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 40 N across the stitchless joint.
It is noted that the claim does not specifically identify how much of the tension resistance must be provided by the at least one polymer layer. Chodkowski teaches layer 22 as able to be made from silicone (¶0044). Further, Chodkowski teaches the headgear as selected for desired physical properties such as stiffness (¶0045). One of ordinary skill in the art would have considered a resistance at the joint between sub-portions D, E and F to have obviously provided a resistance of at least 40 N in order to form a secure and comfortable headgear shaping.
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 Chodkowski the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 40 N across the stitchless joint based upon an obvious expectation that the physical properties of the headgear in Chodkowski would have been obviously selected to provide the claimed tension resistance to form a secure and comfortable headgear shaping in light of the overall disclosure of Chodkowski.
Regarding claim 24, Chodkowski is silent as to whether the at least one polymer layer imparts shape holding properties of the headgear portion.
However, Chodkowski teaches layer 22 as able to be made from silicone (¶0044). One of ordinary skill in the art would have obviously expected silicone to impart some degree of shape holding. Further, Chodkowski teaches the headgear as selected for desired physical properties such as stiffness (¶0045).
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 Chodkowski the at least one polymer layer imparts shape holding properties of the headgear portion based upon an obvious expectation that the physical properties of the headgear in Chodkowski would have been obviously expected to impart some degree of shape holding in light of the overall disclosure of Chodkowski.
Regarding claim 25, Chodkowski is silent as to whether the at least one polymer layer imparts increased rigidity to at least a portion of the headgear portion.
However, Chodkowski teaches layer 22 as able to be made from silicone (¶0044). One of ordinary skill in the art would have obviously expected silicone to impart some degree of rigidity. Further, Chodkowski teaches the headgear as selected for desired physical properties such as stiffness (¶0045).
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 Chodkowski the at least one polymer layer imparts increased rigidity to at least a portion of the headgear portion based upon an obvious expectation that the physical properties of the headgear in Chodkowski would have been obviously expected to impart some degree of rigidity in light of the overall disclosure of Chodkowski.
Claim(s) 18, 20 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. Pub. 2012/0325219).
Regarding claim 18, Smith, in the first reading, is silent as to whether the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 20 N across the stitchless joint.
It is noted that the claim does not specifically identify how much of the tension resistance must be provided by the at least one polymer layer. The friction fit in Smith between bellows segment 18 and straight segment 20 (Figs. 5-6) will be obviously expected by one of ordinary skill in the art to provide a strong tension resistance. One of ordinary skill in the art would have considered a resistance at the joint between bellows segment 18 and straight segment 20 of at least 20 N to have been an obvious parameter of use given the particular configuration at that joint.
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 Smith the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 20 N across the stitchless joint as the friction fit between bellows segment 18 and straight segment 20 would have been obviously expected to provide a tension resistance at least 20 N in light of the overall disclosure of Smith.
Regarding claim 20, Smith, in the first reading, is silent as to whether the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 40 N across the stitchless joint.
It is noted that the claim does not specifically identify how much of the tension resistance must be provided by the at least one polymer layer. The friction fit in Smith between bellows segment 18 and straight segment 20 (Figs. 5-6) will be obviously expected by one of ordinary skill in the art to provide a strong tension resistance. One of ordinary skill in the art would have considered a resistance at the joint between bellows segment 18 and straight segment 20 of at least 40 N to have been an obvious parameter of use given the particular configuration at that joint.
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 Smith the at least one polymer layer overlaps each of the first headgear portion and the second headgear portion by a minimum distance to resist a tension force of at least 40 N across the stitchless joint as the friction fit between bellows segment 18 and straight segment 20 would have been obviously expected to provide a tension resistance at least 40 N in light of the overall disclosure of Smith.
Regarding claim 24, Smith, in the first reading, is silent as to whether the at least one polymer layer imparts shape holding properties of the headgear portion.
However, Smith teaches headgear component 16 as able to be made from such materials as molded silicone (¶0029). One of ordinary skill in the art would have obviously expected molded silicone to impart some degree of shape holding.
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 Smith the at least one polymer layer imparts shape holding properties of the headgear portion as the use of molded silicone, as taught by Smith, would have been obviously expected to impart some degree of shape holding in light of the overall disclosure of Smith.
Regarding claim 25, Smith, in the first reading, is silent as to whether the at least one polymer layer imparts increased rigidity to at least a portion of the headgear portion.
However, Smith teaches headgear component 16 as able to be made from such materials as molded silicone (¶0029). One of ordinary skill in the art would have obviously expected molded silicone to impart some degree of rigidity.
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 Smith the at least one polymer layer imparts increased rigidity to at least a portion of the headgear portion as the use of molded silicone, as taught by Smith, would have been obviously expected to impart some degree of rigidity in light of the overall disclosure of Smith.
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. Note is made of additional prior art readable on the independent claims: Dunn et al. (U.S. Pub. 2014/0190486; Figs. 4-7 to 4-8), Freestone et al. (U.S. Pub. 2018/0207385; Figs. 39-40), Barlow et al. (WO Pub. 2020/000033 A1; Figs. 5G-5H and separately Fig. 9E), Pereria et al. (U.S. Pub. 2020/0282169; Figs. 54A-57), Freestone et al. (U.S. Pub. 2021/0170134; each of Figs. 3, 14 & 67) and Hammer (U.S. Pub. 2023/0181859; each of Figs. 6B, 7B, 8, 9B, 10 & 14B).
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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