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
This office action is in response to preliminary amendment filed on 11/18/2024. As directed by the amendment, claims 1-34 were canceled, no claims were amended, and claims 35-54 were newly added. Thus, claims 35-54 are presently pending in this application.
Drawings
Figures 1A-1B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claims 35-54 are objected to because of the following informalities:
Regarding claim 35 line 7, line 12, line 14, line 18, the term “the device” should read --the inhalation and/or exhalation device-- to remain consistent with line 1.
Regarding claim 35 line 11, line 13, line 16, line 17, line 19, and line 20, the term “said mouthpiece” should read --said non-protruding mouthpiece-- to remain consistent with line 3.
Regarding claim 36-48 line 1, the term “The device” should read --The inhalation and/or exhalation device-- to remain consistent with claim 35 line 1.
Regarding claim 42 lines 1 and 2, the term “the device” should read --the inhalation and/or exhalation device-- to remain consistent with line 1.
Regarding claim 49 line 6, line 8, line 12, line 14, and line 18, the term “the device” should read --the inhalation and/or exhalation device-- the remain consistent with line 1.
Regarding claims 50-54 line 1, the term “The device” should read --The inhalation and/or exhalation device-- to remain consistent with claim 49 line 1.
Regarding claim 52 line 1, the term “said device” should read --said inhalation and/or exhalation device-- to remain consistent with claim 49 line 1.
Regarding claim 53 line 1 and line 2, the term “the device” should read --the inhalation and/or exhalation device-- to remain consistent with claim 49 line 1.
Regarding claim 53 line 4, the term “said conduit” should read --said gas conduit-- to remain consistent with claim 49 line 4.
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 35-54 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.
Regarding claim 35 line 3, the term “a non-protruding mouthpiece” is unclear as to how the language of “non-protruding” is met by the mouthpiece 50 such as in Fig. 2A-B. The mouthpiece appears to protrude at least some amount relative to various structures in the drawing. In line 9, the term “the mouth-hole” is indefinite because it lacks proper antecedent basis, and is unclear as to if the term is the same or different than “a person whose mouth sealingly contacts” of line 7. In line 12, the term “an inhalation device” is unclear as to if the term is the same or different than line 1. In line 13, the term “a gas” is unclear as to if the term is the same or different than line 10. In line 14, the term “an exhalation device” is unclear as to if the term is the same or different than line 1. In line 17, the term “a gas” is unclear as to if the term is the same or different than line 10. In line 18, the term “an inhalation/exhalation device” is unclear as to what the slash between inhalation and exhalation entails regarding the claim language. Is the slash an “or”, “and”, or other type of statement? In addition, the term is unclear as to if the term is the same or different than line 1.
Regarding claim 36 line 4, the term “a user” is unclear as to if the term is the same or different than claim 35 line 7 “a person”. In line 4-5, the term “said bottom of the device” is indefinite because it lacks proper antecedent basis. In line 5, the term “said front of the device” is indefinite because it lacks proper antecedent basis.
Regarding claim 37 line 2, the term “said top” is indefinite because it lacks proper antecedent basis.
Regarding claim 45 line 1, the term “the height” is indefinite because it lacks proper antecedent basis.
Regarding claim 49 line 12, the term “an inhalation device” is unclear as to if the term is the same or different than line 1. In line 13, the term “a gas” is unclear as to if the term is the same or different than line 10. In line 14, the term “an exhalation device” is unclear as to if the term is the same or different than line 1. In line 17, the term “a gas” is unclear as to if the term is the same or different than line 10. In line 18, the term “an inhalation/exhalation device” is unclear as to what the slash between inhalation and exhalation entails regarding the claim language. Is the slash an “or”, “and”, or other type of statement? In addition, the term is unclear as to if the term is the same or different than line 1.
Regarding claim 50 line 1-2, the term “a non-protruding mouthpiece” is unclear as to how the language of “non-protruding” is met by the mouthpiece 50 such as in Fig. 2A-B. The mouthpiece appears to protrude at least some amount relative to various structures in the drawing.
Regarding claim 52 line 1, the term “an exhalation device” is unclear as to if the term is the same or different than claim 49 line 1. In line 1-2, the term “an inhalation/exhalation device” is unclear as to if the term is the same or different than claim 49 line 1. Additionally, the term is unclear as to what the slash between inhalation and exhalation entails regarding the claim language. Is the slash an “or”, “and”, or other type of statement? In addition, the term is unclear as to if the term is the same or different than line 1. In line 2-3, the term “a person” is unclear as to if the term is the same or different than claim 49 line 8. In line 3¸ the term “a gas” is unclear as to if the term is the same or different than claim 49 line 10.
Regarding claim 53 line 1, the term “an inhalation device” is unclear as to if the term is the same or different than claim 49 line 1. In line 1-2, the term “an inhalation/exhalation device” is unclear as to if the term is the same or different than claim 49 line 1. Additionally, the term is unclear as to what the slash between inhalation and exhalation entails regarding the claim language. Is the slash an “or”, “and”, or other type of statement? In addition, the term is unclear as to if the term is the same or different than line 1. In line 3, the term “a person” is unclear as to if the term is the same or different than claim 49 line 8. In line 3, the term “a gas” is unclear as to if the term is the same or different than claim 49 line 10.
Regarding claim 54 line 2, the term “a gas” is unclear as to if the term is the same or different than claim 49 line 10.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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 (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 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.
Claims 35-42, 44-45, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallach (US 2018/0008189).
Regarding claim 35, Wallach discloses an inhalation and/or exhalation device (Figs. 8A-8C device 112) comprising:
a body comprising an external surface (housing 12 of device 112);
a non-protruding mouthpiece comprising a mouthpiece bore having an opening at said external surface (exhalation inlet 14 at proximal end 102 is open); and
a gas conduit having a proximal end in fluid communication with said mouthpiece bore and a distal end (exhalation conduit 18; [0243] conduit 18 between proximal end 102 and distal end 116 of the device),
the device thereby configured to allow a person whose mouth sealingly contacts a portion of said external surface of said body that surrounds said opening to provide fluid communication between the mouth-hole of the person and said opening ([0247] a user holds device 112 with exhalation inlet 14 in proximity of the mouth) to:
inhale a gas into the mouth ([0247] can inhale a released inhalable substance from an inhalable substance dispenser 46), the gas first passing through said gas conduit (dispenser 46 is on the distal end 116 and passes through conduit 18 to the mouth at exhalation inlet 14), said mouthpiece bore (inhale through opening of inlet 14), and then out through said opening of said mouthpiece into the mouth to be inhaled so that the device is an inhalation device ([0247] can inhale released inhalable substance);
exhale a gas from the mouth into said opening of said mouthpiece ([0247] as the user exhales into exhalation inlet 14), through said mouthpiece bore into said gas conduit so that the device is an exhalation device ([0247] exhalation into conduit 18 leads to exhalation determiner 60); or
inhale a gas into the mouth, the gas first passing through said gas conduit, said mouthpiece bore, and then out through said opening of said mouthpiece into the mouth to be inhaled ([0247] regarding the user is able to inhale the released inhalable substance) and exhale a gas from the mouth into said opening of said mouthpiece, through said mouthpiece bore into said gas conduit so that the device is an inhalation/exhalation device ([0247] user can also exhale into the device at inlet 14 towards exhalation determiner 60),
wherein said mouthpiece comprises a front (Fig. 8A portion of proximal end most distal at the end of inlet 14), a bottom (Fig. 8A where proximal end 102 meets the distal end of housing portion 12c), a left (Fig. 8A left side of proximal end 102) and a right side (Fig. 8A right side of proximal end 102) wherein said opening of said mouthpiece is on said front of said mouthpiece (Fig. 8A inlet 14 is on the front of the proximal end 102).
Regarding claim 36, Wallach discloses said body has a bottom (Fig. 8A bottom end of middle section 12c of housing contacting the top end of proximal end 102), a front (Fig. 8A front face of housing 12 where ball 72 is disposed), a left side (Fig. 8A left side of housing 12) and a right side (Fig. 8A right side of housing 12); and
said mouthpiece is located near a bottom-front of the device (proximal end 102 with inlet 14 is at the bottom end of housing 12) so that during use when the mouth of a user sealingly encircles said opening ([0247] a user holds device 112 with exhalation inlet 14 in proximity of the mouth), the user's lower lip contacts said bottom of the device (inlet 14 is at the bottom of housing 12) and the user's upper lip contacts said front of the device so that said opening of said mouthpiece is in fluid communication with the mouth of the user (proximal end 102 comprising inlet 14 shares a face with front of housing 12, wherein when the user puts their mouth around inlet 14 the mouth would contact front of the device).
Regarding claim 37, Wallach discloses said gas conduit extends from proximate to said bottom of said body upwards towards said top of said body ([0243] “a proximal end 102 including an exhalation inlet 14, a distal end 116 with an exhalation outlet 20 and an exhalation conduit 18 therebetween”).
Regarding claim 38, Wallach discloses said front of said body is outwardly curved (Fig. 8C front of housing 12 appears to be curved based on the cross-section shown at the top of middle section 12c being curved at the top).
Regarding claim 39, Wallach discloses said front of said body is flat (Fig. 8C front of housing 12 in section 12b is flat at least along the center line and is not ribbed).
Regarding claim 40, Wallach discloses said bottom of said body is outwardly curved (Fig. 8C bottom of proximal section 12a of housing 12 is outwardly curved to receive the curve of proximal end 102).
Regarding claim 41, Wallach discloses said bottom of said body is flat (Fig. 8C bottom of proximal section 12a of housing 12 is not ribbed).
Regarding claim 42, Wallach discloses the device is configured so that during use, a vertical axis of the device is at an angle relative to the vertical axis of the user's head, said angle being between 20° and 70° (Fig. 8C articulated middle section 12c bends the vertical axis of the device mouthpiece relative to the vertical axis of the user’s head. Fig. 8C depicts an angle between 20-70° because the device is not fully straight nor fully at a right angle).
Regarding claim 44, Wallach discloses said opening is flush with said front of said mouthpiece (Fig. 8A portion of proximal end most distal at the end of inlet 14 is the front of the mouthpiece, which comprises the opening).
Regarding claim 45, Wallach discloses at the height of said opening, said front of said mouthpiece is convexly curved (Fig. 8A the opening of inlet 14 is convexly curved).
Regarding claim 47, Wallach discloses an angle between said front and said bottom of said mouthpiece is greater than 70° (Fig. 8C angle between the front and bottom of proximal end 102 with inlet 14 is a right angle, 90°).
Claims 49-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reshef et al. (US 2020/0121868; hereinafter “Reshef”).
Regarding claim 49, Reshef discloses an inhalation and/or exhalation device (Figs. 3A-C of inhaler device with replaceable flow tract), comprising:
two reversibly-mateable assemblies having a mated state (Fig. 3C mated inhaler) and a separated state (Fig. 3A where tract 300 and inhaler housing 308),
a body assembly (inhaler housing 308); and
a conduit assembly comprising a mouthpiece and a gas conduit (replaceable flow tract 300 comprising mouthpiece 302 and conduit 314),
said mouthpiece comprising a mouthpiece bore having an opening (mouthpiece 302 has hole in the top);
in said mated state, said opening at an external surface of the device (Fig. 3C hole at top of mouthpiece 302 is on the external side of inhaler 308) and said gas conduit having a proximal end in fluid communication with said mouthpiece bore and a distal end (mouthpiece 302 is connected to conduit 314 in overall structure of flow tract 300),
the device thereby configured to allow a person whose mouth sealingly encircles said opening to:
inhale a gas into the mouth (user inhales in inhaler 308 at mouthpiece 302), the gas first passing through said gas conduit (Fig. 2 method of using inhaler 308, including sealing flow path 203 between the inhaler housing 308 internal components when connected to conduit 314), said mouthpiece bore, and then out through said opening of said mouthpiece into the mouth to be inhaled so that the device is an inhalation device (Fig. 2 step 204 of using the inhaler device, when user is at mouthpiece 302);
exhale a gas from the mouth into said opening of said mouthpiece, through said mouthpiece bore into said gas conduit so that the device is an exhalation device ([0177-0178] flow tract 300, analogous to tract 400, the conduit 420/314 exhales into the conduit with the air pushing out of valve 431); or
inhale a gas into the mouth (user inhales in inhaler 308 at mouthpiece 302), the gas first passing through said gas conduit (Fig. 2 method of using inhaler 308, including sealing flow path 203 between the inhaler housing 308 internal components when connected to conduit 314), said mouthpiece bore, and then out through said opening of said mouthpiece into the mouth to be inhaled (Fig. 2 step 204 of using the inhaler device, when user is at mouthpiece 302) and exhale a gas from the mouth into said opening of said mouthpiece, through said mouthpiece bore into said gas conduit so that the device is an inhalation/exhalation device ([0177-0178] flow tract 300, analogous to tract 400, the conduit 420/314 exhales into the conduit with the air pushing out of valve 431).
Regarding claim 50, Reshef discloses said mouthpiece is a non-protruding mouthpiece (Fig. 3C mouthpiece 302 follows the same rounded shape as the body of inhaler 308).
Regarding claim 51, Reshef discloses said conduit assembly is configured to slidingly move into a conduit-assembly passage of said body assembly from said separated state to said mated state and slidingly moved out of said conduit-assembly passage from said mated state to said separated state (replaceable flow tract 300 is inserted in the passage opening 306 within inhaler housing 308. The flow tract conduit 314 is slid into opening 306 and through the subsequent passage).
Regarding claim 52, Reshef discloses said device is an exhalation device or an inhalation/exhalation device and said mouthpiece is an exhalation inlet configured to allow a person whose mouth sealingly encircles said opening (user encircles opening of mouthpiece 302 to use the device) to exhale a gas from the mouth, through said mouthpiece into said gas conduit ([0177-0178] flow tract 300, analogous to tract 400, the conduit 420/314 exhales into the conduit with the air pushing out of valve 431).
Regarding claim 53, Reshef discloses the device is an inhalation device or an inhalation/exhalation device and said mouthpiece is an inhalation inlet of the device configured to allow a person whose mouth sealingly encircles said opening (user encircles opening of mouthpiece 302 to use the device) to inhale a gas, the gas first passing through said conduit and then out through said mouthpiece into the mouth to be inhaled (Fig. 2 step 204 use inhaler device).
Regarding claim 54, Reshef discloses deliver a substance to the person whose mouth encircles said opening (user encircles opening of mouthpiece 302 to use the device ) and inhales a gas into the mouth, the substance carried by the inhaled gas (Abstract “a replaceable flow tract for use with an inhaler device which delivers at least one substance to a user”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 43, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Wallach as applied to claim 42 above, and further in view of Wallach.
Regarding claim 43, Wallach discloses a width of said front and of said bottom of said mouthpiece (see Wallach [0243] housing 12 width “a” is 50mm), but is silent as to the width is about 15 mm and about 35 mm. However, the exhalation inlet 14 of Wallach is narrower than the width of the overall housing, meaning the width of the mouthpiece is less than 50mm. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make a width of said front and bottom of said mouthpiece between 15-35 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 46, Wallach discloses a thickness of said device (see Wallach [0243] housing 12 thickness if 10mm), but is silent as to a convex curvature of said front of said mouthpiece is such that, in side view, a depth of said opening is between about 2 mm and about 6 mm. However, the opening of exhalation inlet 14 is thinner than the thickness of the device since there are walls surrounding the inlet 14, providing a smaller thickness than 10mm. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make a depth of said opening is between about 2 mm and about 6 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 48, Wallach discloses a height of said device (see Wallach [0243] housing 12 “c” is 80mm), but is silent as to a distance of a center of said opening from said bottom of said mouthpiece is between about 5 mm and about 10 mm. However, the center of the opening of exhalation inlet 14 of Wallach to the bottom of said mouthpiece (see Wallach proximal end 102 meets the distal end of housing portion 12c) in Fig. 8A appears to be about 1/8th of the size of the entirety of height “c”, thus being approximately 10mm. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make a distance of a center of said opening from said bottom of said mouthpiece is between about 5 mm and about 10 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Guo et al. (US 2020/0337375), Legendy et al. (US 2020/0315253), and Capone (US 2024/0373940) are cited to show an electronic cigarette with attachable mouthpiece.
Petrikova (US 2022/0257880) and van der Linden et al. (US 5,950,619) are cited to show an inhaler.
Scatterday (US 11,297,879) is cited to show an inhaler with removable cap.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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