DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 26, 27, 30, 32, 35, 36, 39 are objected to because of the following informalities:
Claim 26 refers to “the flow of breath”, “a breathflow”, and “the breath flow rate” – if all referring to the same breathflow/breath flow parameter, they should be referred to using the same terminology throughout the claims.
Claim 30 refers to “a user”; it is unclear if this is the same user as that of claim 26 or an additional user.
Claims 27, 35, 36, 39 define additional components which are also included in the device in addition to those which have already been defined; they should be recited as the device further comprising these elements.
Claim 32 still recites “IR sensors” without providing the terms “IR” stands for.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: elements 505a, 505b, 506, 506a, 506b in figure 5; elements 602, 603 in figures 6a and 6b. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the single valve located in two nasal conduits must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 26, 27, 30-42 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 26 now recites that “the electronically operated valve is located in each of the two nasal conduits”; there is no disclosure of a single valve located in two nasal conduits. Figure 4 sets forth two nasal conduits, each with a valve 404a and 404b; figure 5 sets forth a single valve 508 that is not located in either of the nasal conduits 503. No part of the disclosure describes a single valve located in two conduits. As such, the disclosure does not reasonably convey possession of a device with “an electronically operated valve” where “the electronically operated valve is located in each of the two nasal conduits” at the time the invention was filed.
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 26, 27, 30-42 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 26 now recites “storing data comprising defining a breathing exercise”. In addition to being grammatically incorrect, it is unclear what the intent is – to store data which defines an exercise to be performed? Or to store data which comprises data of an exercise which has already been performed? Clarification is required.
Further, the claim recites “to compare data representing the breathing exercise”; it is entirely unclear if this is additional data related to the breathing exercise, or if this is the same data as in the previous clause, where this sets forth a third term of comprising/defining/representing some breathing exercise.
Still further, it is unclear how data somehow related to a “breathing exercise” can be compared with a measured breath flow rate – does the breathing exercise define an ideal breath flow rate? If not, what is within the breathing exercise data that would allow comparison? Is the breathing exercise actually performed by the user at some point? Clarification is required.
Claim 26 in line 12 recites “control the valves”; there is no antecedent basis for this limitation in the claim as line 3 only defines a valve in the singular.
Claim 26 now recites that “the electronically operated valve is located in each of the two nasal conduits”; it is entirely unclear how a single valve can be in two places at the same time. It is unclear if the intent is to define a single valve which is located separately from the conduits, or a single valve in addition to two more valves, one in each conduit, or to define a single valve in each conduit. Clarification is required.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06. Claim 26 cannot be further treated on the merits.
Claims 30, 32, 33, and 34 all depend from cancelled claim 29; for the purposes of examination all will be treated as though depending from claim 26 but correction is required.
Claim 31 defines the device as “including a nasal piece comprising two nasal conduits for engagement with a user’s nostrils and wherein the electronically operated valve is located in each of the two nasal conduits for regulating the flow of breath through the airway”; it is unclear if these nasal conduits for use with “a user’s nostrils” are in addition to the nasal conduits already defined in claim 26 such that the device operates on two users at the same time, or if this is a redundant recitation of this limitation. Further, the claim again calls for a single valve to be located “in each of the two nasal conduits”, but then refers to “close one of the valves” where there is no antecedent basis for more than one valve to be present. Clarification is required.
Claim 30 calls for comparing “the user’s breath flow rate” against “a preset breath rate”; it is entirely unclear if a breath rate is also now involved in the invention in addition to a flow rate, or if this should refer to a preset breath flow rate. The same issue is found in claims 31, 38, and 40. Clarification is required.
Claim 30 calls for operation of the valve when the flow rate is “detected as being higher than a preset breath rate”; claim 26 calls for operation of the valve[s] “in dependence on the result of the comparison” between breathing exercise data and measured breath flow rate – it is unclear if the claim 30 is further defining this comparison of claim 26, or if this is an additional comparison to be performed that provides an alternative route for controlling operation of the valve[s]. The same is found in claim 31. Clarification is required.
Claim limitation “vibrational indicator”, first recited in claim 39, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No structure or details of any element performing vibration is defined at any point in the specification, particularly not any structure or details for any “vibrational indicator”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Response to Arguments
Applicant's arguments filed 30 March 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant generally asserts that the disclosure sets forth sufficient description of a vibrational indicator by virtue of describing “examples of the vibrational indicator in use”; this is entirely unpersuasive, as none of the cited portions set forth any corresponding structural description of a vibrational indicator and do not even refer to a “vibrational indicator” as the component performing any sort of vibration in those passages. Merely describing the function of the “vibrational indicator” does not meet the requirement of describing the corresponding structure, material, or acts for performing the entire claimed function.
Applicant’s remarks do not address any other previously applied 112 rejections; the Examiner notes that the amendment to the claims have resulted in significantly more serious 112 rejections, as set forth above.
Regarding the art rejections, Applicant argues that “none of the prior art documents recite all of” the features including “an electronically operated valve in each of the two nasal conduits”. As this has not been claimed, Applicants further remarks regarding how the previously applied references might relate to this are moot.
Conclusion
No art has been applied against the claims at this time; however, as all the claims are rejected under at least 112a and 112b they are not presently allowable and the question of prior art will be revisited if applicable upon resolution of the above issues.
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.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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