CTNF 18/566,007 CTNF 98552 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-36 AIA 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 “an inhalation detection sensor” of claim 5 line 1-2 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. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 07-30-06 This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a crushing unit” of claim 11 line 3 Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 5, 7-9, and 11-12 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 5 line 3-4 , the term “the inhalation detection sensor is configured to open and close the first valve by detecting an inhaling action of a user” is unclear as to how the sensor is able to detect the user’s inhalation. The specification states “the controller 17 may include an inhalation detection sensor” ( spec page 6 line 18) , but the controller 17 in Figs. 1-2 appears to be positioned over the carrier chamber 12. How can the controller 17, if it comprises the inhalation detection sensor, sense inhalation at the mouthpiece 12 from the positioning at the chamber 12? Additionally, how does the sensor then communicate with the first valve in order to open or close the valve? Regarding claim 7 line 3 and claim 11 line 2 , the term “powder” is unclear as to if the term is the same or different than in claim 1 line 8. Regarding claim 11 line 3-4 , the term “the powder supply further comprises a crushing unit configured to crush the powder capsules supplied by the powder cartridge” is unclear as to how the powder capsules are both crushed by the crushing unit, and supplied by the powder cartridge. What triggers the powder cartridge to supply the powder capsules? Are the powder capsules crushed upon impact with the crushing unit? Regarding claim 12 line 1 , the term “one of the claims 1 to 11” is unclear as to why the term does not match the claims filed 11/30/2023 saying “of claim 1,”. To avoid an incompliant amendment, the claims must be updated to the same language as was already previously amended. Any remaining claims are rejected as being dependent upon a rejected base claim. Claim limitation “a crushing unit” of claim 11 line 3 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. 07-34-23 Regarding the “a crushing unit” of claim 11 line 3, the specification states “the crushing unit 156 may crush the powder capsules MC discharged from the powder cartridge 152” (spec page 8 line 9-10). However, it is not clear what structure is able to perform the crushing of powder capsules as disclosed. 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. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 1, 4-5, 7-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hochrainer et al. (US 2005/0263151; hereinafter “Hochrainer”) in view of Tucker (US 2014/0261488) . Regarding claim 1 , Hochrainer discloses a powder inhalation device with a propellant ( see Hochrainer powder inhaler 1) , the powder inhalation device comprising: a housing pipe ( see Hochrainer housing of powder inhaler 1; Fig. 1 center of inhaler comprising device for supply powder 6) . Hochrainer discloses a carrier chamber disposed at one end portion of the housing pipe ( see Hochrainer pressure medium system 3; [0058] the pressure medium system may be a cartridge filled with gas other than air) , but is silent as to the carrier chamber is filled with the propellant. However, Tucker teaches a carrier chamber is filled with the propellant ( see Tucker electronic smoking article 60; where first cartridge 70 comprising liquid supply reservoir 14a. Liquid supply reservoir 14a includes pressurization arrangement 50a, and [0040] the liquid material may include ethanol, and including an aerosol former to form the gas.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the carrier chamber pressurized gas contents of Hochrainer with the propellant, in the form of ethanol and aerosol, filled chamber of pressurized gas contents as taught by Tucker as this would have been an obvious substitution for one known type of pressurized gas other than air for another and would yield predictable results, i.e. provide pressurized gas to hold and then push out of the carrier chamber. Modified Hochrainer discloses a mouthpiece portion disposed at the other end portion of the housing pipe ( see Hochrainer mouthpiece 2) ; a first valve disposed between the carrier chamber and the housing pipe ( see Hochrainer valve 5) ; and a powder supply configured to supply powder into the housing pipe ( see Hochrainer powder formulation 7 in device for supplying powder 6) . Regarding claim 4 , modified Hochrainer discloses wherein pressure inside the carrier chamber is higher than atmospheric pressure ( see Hochrainer pressurized gas stream 8 would be higher than regular atmospheric pressure in order to qualify as “pressurized”). Regarding claim 5 , modified Hochrainer discloses an inhalation detection sensor ( see Hochrainer through-flow sensor 19 on mouthpiece 2) , wherein the inhalation detection sensor is configured to open and close the first valve by detecting an inhaling action of a user ( see Hochrainer [0077] the through-flow sensor 19 measures as the patient breathes in [the inhalation] and generates an input signal that acts on actuator valve 5 to open) . Regarding claim 7 , modified Hochrainer discloses the powder supply comprises: a powder cartridge configured to accommodate powder ( see Hochrainer powder formulation 7 in capsule 15) ; and a powder spray ( see Hochrainer powder through nozzle 10) . Regarding claim 8 , modified Hochrainer discloses the powder spray is disposed inclined toward the mouthpiece portion ( see Hochrainer exit of nozzle 10 such as in Figs. 2a,b has two inclined channels 11, 12 that point towards the mouthpiece 2). Regarding claim 9 , modified Hochrainer discloses the powder spray comprises a streamlined structure ( see Hochrainer nozzle 10 sprays powder towards the mouthpiece 2 in a straight line). Regarding claim 11 , modified Hochrainer discloses the powder cartridge comprises a plurality of powder capsules comprising powder ( see Hochrainer [0057] plurality of capsules within inhaler 1; “Alternatively, the reservoir may be a collection of capsules that are filled with the powder formulation and introduced mechanically or manually into the nebulizing chamber”) , and the powder supply further comprises a crushing unit configured to crush the powder capsules supplied by the powder cartridge ( see Hochrainer [0018] “the capsule or one of the multi dose containers is pierced and the powder is emptied out and nebulized using the air breathed in by the patient”) . 07-22-aia AIA Claim s 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hochrainer in view of Tucker as applied to claim 1 above, and further in view of Mecikalski (US 5,568,807) . Regarding claim 2 , modified Hochrainer is silent as to a second valve disposed between the mouthpiece portion and the housing pipe. However, Mecikalski teaches a second valve disposed between the mouthpiece portion and the housing pipe ( see Mecikalski second valve section 14 in between mouthpiece 17 and chamber section 13. Second valve section 14 comprising second valve 32a,b in Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the mouthpiece and housing pipe of modified Hochrainer with the addition of a second valve as taught by Mecikalski so as to prevent backflow through the inhaler device. Regarding claim 6 , modified Hochrainer discloses the powder supply is disposed between the first valve and the second valve ( see Hochrainer powder device 6 between valve 5 and modified in valve 32a,b of Mecikalski from claim 2) . 07-22-aia AIA Claim s 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hochrainer in view of Tucker as applied to claim 1 above, and further in view of Yamada et al. (US 2013/0019862; hereinafter “Yamada”) . Regarding claim 3 , modified Hochrainer discloses a carrier cartridge disposed at an opposite end portion to one end portion of the carrier chamber facing the housing pipe. However, Yamada teaches a carrier cartridge disposed at an opposite end portion to one end portion of the carrier chamber facing the housing pipe ( see Yamada air intake opening 12, on the distal ends of the aerosol inhalator. Liquid tank 14 is attached to the housing via supply pipe 48 with supply port 49. The inner reservoir 14 comprises flavor solution L [0047], and propylene glycol [0077]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve for supplying gas for the carrier chamber of modified Hochrainer with the liquid tank with supply pipe and port as taught by Yamada so as to provide the user with an option to flavor the inhalant. Regarding claim 10 , modified Hochrainer discloses the carrier chamber and the carrier cartridge further comprise an excipient, and the excipient comprises a flavoring agent ( see Yamada propylene glycol and flavoring comprised in liquid reservoir 14. Reservoir 14 comprises a propellant and excipient, as would be needed to fill pressure medium system 3) . 07-22-aia AIA Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hochrainer in view of Tucker as applied to claim 1 above, and further in view of Cocker et al. (US 12,343,470; hereinafter “Cocker”) . Regarding claim 12 , modified Hochrainer discloses an active substance powder ( see Hochrainer [0006-7] “medicament formulation” refers to a powdered formulation with active ingredient, known as a drug or active substance) , but is silent as to the powder comprises nicotine. However, Cocker teaches the powder comprises nicotine ( see Cocker Dry Powder inhaler with Co. 4 lines 7-12, where the dry powder cartridge 200 may comprise nicotine powder ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the active substance powder of modified Hochrainer with the nicotine powder as taught by Cocker as this would have been an obvious substitution for one known type of active substance or drug powder for another and would yield predictable results, i.e. function as the active powder in a dry powder inhalation device. Conclusion 07-96 The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure. Dunne et al. (US 2007/0272763) is cited to show a dispensing device for dispensing powder, with a valve between the powder and mouthpiece and a pressurized chamber. Sexton et al. (US 2005/0166912) is cited to show an inhaler with medicament comprising a propellant in a pressurized aerosol container. Cohen et al. (US 2011/0036346) is cited to show a personal inhalation device with medium comprising a nicotine powder or propylene glycol solute. Slutsky et al. (US 6,102,036) is cited to show a breath actuated inhaler for nicotine powder with a valve between the powder and mouthpiece. Cheatham, III et al. (US 10,820,855) is cited to show an inhaler with nicotine powder and ethanol. Dillmann et al. (US 2018/0255834) is cited to show an e-cigarette with a liquid reservoir and separate composition reservoir. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GWYNNETH L HOWELL/Examiner, Art Unit 3785 /RACHEL T SIPPEL/Primary Examiner, Art Unit 3785 Application/Control Number: 18/566,007 Page 2 Art Unit: 3785 Application/Control Number: 18/566,007 Page 3 Art Unit: 3785 Application/Control Number: 18/566,007 Page 4 Art Unit: 3785 Application/Control Number: 18/566,007 Page 5 Art Unit: 3785 Application/Control Number: 18/566,007 Page 6 Art Unit: 3785 Application/Control Number: 18/566,007 Page 7 Art Unit: 3785 Application/Control Number: 18/566,007 Page 8 Art Unit: 3785 Application/Control Number: 18/566,007 Page 9 Art Unit: 3785 Application/Control Number: 18/566,007 Page 10 Art Unit: 3785 Application/Control Number: 18/566,007 Page 11 Art Unit: 3785 Application/Control Number: 18/566,007 Page 13 Art Unit: 3785 Application/Control Number: 18/566,007 Page 14 Art Unit: 3785 Application/Control Number: 18/566,007 Page 15 Art Unit: 3785
Prosecution Insights