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 .
Response to Amendment
The Amendment filed 07 Aug 2026 has been entered. Claims 1-4, 6-7 and 10-14 are pending in the application with claims 5 and 8 canceled. Claims 1, 3-4, 6-7 and 10-14 are currently amended. Applicant’s amendment to the Drawings, Specification, and Claims have overcome some, but not every, objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 11 May 2026. The remaining issues are discussed below. Further, the amendment to the Drawings and Specification have introduced significant amounts of new matter, as discussed below.
The prior 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections are withdrawn as requested (Pg. 29-37) based on the amendment to the claims.
Response to Arguments
Applicant's arguments filed 07 Aug 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 112(a) rejection of claim 6 applicant argues that Figs. 1-5 provide the required written description support for the requirements of the claim (Pg. 23-24). It is initially noted that in original Figs. 2-3 the full structure is termed as adhesive element 4. By contrast claim 6 appears to be attempting to claim from the same Figs. 2-3 an adhesive element as a component of the structure of Figs. 2-3 and specifically on “the non-adhesive side” of that component. The originally filed application has no consideration of placing “an adhesive element” on “the non-adhesive side.” Further, that language is clearly contradictory since the language “the non-adhesive side” implies a side without adhesive and not a side with an adhesive element. It is additionally noted that applicant’s citation of ¶0014 of the specification on Pg. 23 of the Remarks is not fully accurate as the originally filed specification never uses the term “ferromagnetic”.
Additionally, applicant cites to ¶¶0014, 0017 of the specification as allegedly supporting the combination of features in claim 6, which asserting the claimed combination does not mix and match embodiments. Examiner respectfully disagrees with that assertion. Specifically, only the embodiment of Figs. 1-5 is described as using interlocking element 3, as shown in Figs. 1 & 3-5, but is not described as using a “harness”. The use of a “harness” is only described in relation to Figs. 7-11. The embodiment of Figs. 7-11 instead of using an interlocking element is described as using the type of magnetic coupling element shown in Fig. 8 which is then in use connected to the type of anchoring element shown in Fig. 10 in order to arrive at the in-use configuration of Fig. 11. Thus, the use of an “interlocking element” and a “harness” are only found in separately disclosed embodiments not disclosed as usable together. Applicant’s citation to ¶¶0014, 0017 is only generic in the “Summary of the Invention” section. Those paragraphs use language such as “in some embodiments” and “in another aspect” which cannot be read as clearly linking use of their structures together, especially when the later Detailed Description fails to describe any consideration of their use together.
Thus, the 35 U.S.C. 112(a) rejection of claim 6 is maintained.
Regarding the 35 U.S.C. 112(b) rejection of claim 10 applicant asserts that ¶0038 identifies the claimed band structures and the claim is thus definite as amended (Pg. 27). While the preceding Office action has indicated that appeared to be a correct interpretation upon review that is not found accurate. Specifically, claim 10 recites “each band structure including a rigid portion and a flexible portion”. The only passage in the specification which relates to the band design is found in ¶0010. Notably, that paragraph discusses “the body may be one or more bands instead of a mesh”. Thus, the discussion in ¶0010 of the bands including rigid portions and flexible portions to allow bending can only reasonably be understood as being drawn to the body of the harness, when the harness body takes a different form than the mesh shown in Fig. 7. Thus, amended claim 10 is now rejected under 35 U.S.C. 112(a). Upon review the claim should be amended back to the prior language of claim 10 with the band structures recited as defining the body of the harness.
Applicant’s arguments, see Pg. 29-32, filed 07 Aug 2026, with respect to amended claim 4 and the 35 U.S.C. 102(a)(1) rejection based on Kooij et al. (U.S. Pub. 2010/0000534) have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) rejection has been withdrawn.
Regarding the 35 U.S.C. 102(a)(1) rejection based on Kooij et al. (U.S. Pub. 2010/0000534) applicant asserts that Kooij fails to teach or suggest the overall requirements of the claim, to include the separately identifiable structures of the harness recited by claim 4 (Pg. 29-32).
Examiner concurs with this argument at least in regard to the claimed language that the harness terminates with a magnetic coupling element. While Kooij teaches that magnets can be used in place of hook and loop fastener (¶0194) it is acknowledged that there is no clear expectation that the use of magnets in Kooij would specifically result in a magnetic coupling element at a terminal end of the harness. Instead, the expectation of one of ordinary skill in the art would be that following from the teaching of Kooij that the magnets may be provided to the adhesive strip and/or the frame or support and/or the connector strips 2144 would have expected the magnets to be placed inward from a terminal end of the connector strip. Only by attaching a magnet to the connector strip with a larger structure than just the magnet itself would there be any possibility that what holds the magnet to the connector strip would reach the terminal end of the connector strip, while being distinct from the connector strip. Such a modified configuration would not have been prima facie obvious based upon Kooij.
Applicant’s arguments, see Pg. 33-37, filed 07 Aug 2026, with respect to amended claim 1 and the 35 U.S.C. 103 rejection based on Kooij et al. (U.S. Pub. 2010/0000534) in view of Barlow (U.S. Pub. 2012/0138060) have been fully considered and are persuasive. The 35 U.S.C. 103 rejection has been withdrawn.
Regarding the 35 U.S.C. 103 rejection applicant asserts that Kooij and Barlow fail to teach or suggest the overall requirements of the claim, to include the separately identifiable structures of the harness recited by claim 1 (Pg. 33-37). Examiner concurs with this argument in a similar manner to what is discussed above.
Drawings
The drawings were received on 07 Aug 2026. These drawings are not acceptable. Figs. 1-6F & 8 are found to introduce new matter and cannot be entered. Specifically:
Amended Fig. 1 bears relation to original Fig. 1 but changes the labeling of the figure such that the previously identified structures in the original specification of claim 1 (i.e. magnetically mounted strapless facial mask 1, interfacing cushion 2, interlocking element 3 and adhesive element 4) are no longer represented and there elements and fully differently termed in the amended specification. As a specific example, interfacing cushion 2 has been changed to instead be harness 2. This is clearly new matter.
Amended Fig. 2 bears relation to original Fig. 2 but changes the labeling so that instead of the full structure of Fig. 2 being labeled as adhesive element 4 only a portion of the structure of Fig. 2 is now labeled as adhesive element 621. This is clearly new matter.
Amended Fig. 3 bears relation to original Fig. 3 but attempts to add labeling not supported by the originally filed application. By example, amended Fig. 3 attempts to define adhesive element 621 on non-adhesive side 62. This is clearly new matter.
Amended Fig. 4 bears relation to original Fig. 4 but instead of labeling the full upper structure as interlocking element 3 amended Fig. 4 instead attempts to only label a lower portion of the upper structure as interlocking element 52. The amended Fig. 4 also shows adhesive side 61 and non-adhesive side 62 as being on a same surface. Additionally, amended Fig. 4 attempts to define adhesive element 621 on non-adhesive side 62. This is clearly new matter.
Amended Fig. 5 bears relation to original Fig. 5 but instead of labeling the full upper structure as interlocking element 3 amended Fig. 5 instead attempts to only label a lower portion of the upper structure as interlocking element 52. Additionally, amended Fig. 5 attempts to define adhesive element 621 on non-adhesive side 62. This is clearly new matter.
Amended Figs. 6A-6B illustrate a configuration not shown in any of the originally filed drawings. Thus, attempting to define mesh structure 31 in Figs. 6A-6B as the mesh discussed in the originally filed specification amounts to new matter. This is clearly new matter.
Amended Figs. 6C-6D illustrate a configuration not shown in any of the originally filed drawings. Thus, attempting to the harness body as having the particular shape in Figs. 6C-6D amounts to new matter. This is clearly new matter.
Amended Figs. 6E-6F bear relation to the two lower photographs of original Fig. 7. However, Fig. 6E shows a different pattern of holes from the lower right photograph of original Fig. 7 and Fig. 6F does not show its harness body as fitting onto the respiratory mask in the same manner of placement as the lower left photograph of original Fig. 7. This is clearly new matter.
Amended Fig. 8 bears relation to original Fig. 8. While original Fig. 8 only shows a partial structure amended Fig. 8 attempts to show a full structure. There is insufficient description of Fig. 8 in the originally filed application to support the range of details attempted to be illustrated in amended Fig. 8. This is clearly new matter.
Specification
The amendment filed 07 Aug 2026 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 specification has been amended to include details related to the amended drawings which are not supported by the originally filed application. Note is made of the above discussion of the new matter found in relation to Figs. 1-6F & 8. Correspondingly, amended paragraphs 0034-0038 & 0040 are all found to include new matter based upon their adding of new details not discussed in the originally filed application and/or meaningfully changing of the description of elements in the drawings.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 6 and 10-11 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 recites “an adhesive element disposed on the non-adhesive side and having magnetic or ferromagnetic properties”. There is no discussion in the application as originally filed of the magnetically attractable anchoring element having a “non-adhesive side” with an adhesive element. Additionally, the originally filed specification never uses the term “ferromagnetic”. This is thus a first element of new matter in claim 6.
Secondly, claim 4 has recited a harness 4 which claim 6 then recites as including “an interlocking element having a magnetic portion, the interlocking element being configured to operatively engage with the adhesive element by mechanical fit and to magnetically couple with the non-adhesive side and the adhesive element to secure the anchoring element and the harness together.” The use of a “harness” is only described in relation to Figs. 7-11. Instead, only the embodiment of Figs. 1-5 is described as using interlocking element 3, as shown in Figs. 1 & 3-5, but is not described as using a “harness”. The embodiment of Figs. 7-11 instead of using an interlocking element is described as using the type of magnetic coupling element shown in Fig. 8 which is then in use connected to the type of anchoring element shown in Fig. 10 in order to arrive at the in-use configuration of Fig. 11. Thus, the use of an “interlocking element” and a “harness” are only found in separately disclosed embodiments not disclosed as usable together. The limitations recited by the instant claim appear only drawn to the fully distinct embodiments. The claim thus appears to be improperly attempting to mix and match limitations from different embodiments not suitably discussed as compatible together in the originally filed application. It is thus found that the requirements of claim 6 lack sufficient written description support in the application as originally filed.
Claim 10 recites the limitation “the one or more connecting elements comprise one or more band structures, each band structure including a rigid portion and a flexible portion”. The only passage in the specification which relates to this specific rigid and flexible band design is found in ¶0010. Notably, that paragraph discusses “the body may be one or more bands instead of a mesh”. Thus, the discussion in ¶0010 of the bands including rigid portions and flexible portions to allow bending can only reasonably be understood as being drawn to the body of the harness, when the harness body takes a different form than the mesh shown in Fig. 7. There is thus lack of sufficient written description in the application as originally filed for the present claiming of this particular band structure are part of the one or more connecting elements (as opposed to defining the body of the harness). Upon review the claim it is suggested to amend back to the prior language of claim 10 with the band structures recited as defining the body of the harness.
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 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 “an adhesive element disposed on the non-adhesive side” in Ln. 4 which deems the claim indefinite. It is confusing to initially expressly recite “a non-adhesive side” and then to later claim that non-adhesive side as comprising “an adhesive element”. That language is clearly contradictory since the language “the non-adhesive side” implies a side without adhesive and not a side with an adhesive element. The claiming of a non-adhesive side including an adhesive element feels deceptive and thus deems the claim indefinite since something cannot be both non-adhesive and adhesive at the same time.
Allowable Subject Matter
Claim(s) 1-4, 7 and 12-14 is/are allowed.
Claim(s) 6 would be allowable if rewritten to overcome the rejection(s) under both 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 10-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the previously cited Kooij remains the closest prior art. Examiner concurs with applicant’s arguments that Kooij fails to render the instant claim as prima facie obvious. While Kooij teaches that magnets can be used in place of hook and loop fastener (¶0194) it is acknowledged that there is no clear expectation that the use of magnets in Kooij would specifically result in a magnetic coupling element at a terminal end of the harness. Instead, the expectation of one of ordinary skill in the art would be that following from the teaching of Kooij that the magnets may be provided to the adhesive strip and/or the frame or support and/or the connector strips 2144 would have expected the magnets to be placed inward from a terminal end of the connector strip. Only by attaching a magnet to the connector strip with a larger structure than just the magnet itself would there be any possibility that what holds the magnet to the connector strip would reach the terminal end of the connector strip, while being distinct from the connector strip. Such a modified configuration would not have been prima facie obvious based upon Kooij.
It is additionally noted that the claim has been amended to specify the “elastic body configured to be fitted onto and conform to the respiratory mask” and “the harness is structurally separate from the respiratory mask” which focuses and limits what may be considered as a “harness” in reviewing the prior art.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 4, the previously cited Kooij remains the closest prior art. Examiner concurs with applicant’s arguments that Kooij fails to render the instant claim as prima facie obvious. While Kooij teaches that magnets can be used in place of hook and loop fastener (¶0194) it is acknowledged that there is no clear expectation that the use of magnets in Kooij would specifically result in a magnetic coupling element at a terminal end of the harness. Instead, the expectation of one of ordinary skill in the art would be that following from the teaching of Kooij that the magnets may be provided to the adhesive strip and/or the frame or support and/or the connector strips 2144 would have expected the magnets to be placed inward from a terminal end of the connector strip. Only by attaching a magnet to the connector strip with a larger structure than just the magnet itself would there be any possibility that what holds the magnet to the connector strip would reach the terminal end of the connector strip, while being distinct from the connector strip. Such a modified configuration would not have been prima facie obvious based upon Kooij.
It is additionally noted that the claim has been amended to specify “the harness is structurally separate from and configured to be fitted onto a respiratory mask” which focuses and limits what may be considered as a “harness” in reviewing the prior art.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 7, the claim is found allowable for the same reasons discussed above in regard to claim 4.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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