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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 Dec 2025 has been entered.
Claims 1-29 are pending in the application. Claim 1 is currently amended.
Response to Arguments
Applicant's arguments filed 22 Dec 2025 have been fully considered and are persuasive. Examiner concurs with applicant’s assertion that Fink (WO Pub. 2009/111612 A1) fails to teach or suggest the amended portion of claim 1 (Pg. 6-7). The prior 35 U.S.C. 102(a)(1) rejection is thus withdrawn.
Note is made that the below cited Robertson et al. (U.S. Patent 5487378) was brought to applicant’s attention in the Conclusion section of each of the two preceding Office actions. Applicant is encouraged to further review the additional prior art which have additionally been repeatedly noted and which may also be read on claim 1: Loeffler et al. (U.S. Pub. 2002/0134372; Figs. 2 & 6), Sugita et al. (U.S. Pub. 2010/0024814; Fig. 1), Mullinger et al. (U.S. Pub. 2014/0116426; Fig. 1), and Gallem et al. (U.S. Pub. 2017/0232211; Fig. 9a).
Terminal Disclaimer
The terminal disclaimer filed on 22 Dec 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patents 9,962,507; 9,956,360; 10,449,314; 10,525,220; 10,898,666; 11,285,285; 11,738,158; 11,771,852 and U.S. Applications 18/219,329 and 17/609,610 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-29 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25-26 of copending Application No. 19/052,152 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all requirements of instant claim 1 are reasonably found within the overall scope of reference claim 25 (e.g. the module insertion guide of reference claim 25 will obviously be received at a receiving region of the housing), the instant claim merely being broader in scope. A further mapping of dependent claims is as follows:
Instant claim 2 vs. reference claim 26
Instant claims 3-4 as obvious in view of reference claim 25 – the reference claim’s combination module can be disposed of if desired
Instant claims 5-12 as obvious in view of reference claim 25 – the reference claim’s reservoir must be either non-collapsible or collapsible as the instant claims indicate the difference between the two options to be merely an obvious matter of design choice alternative
Instant claims 13-24 vs. limitations in reference claim 25
Instant claims 25-29 vs. limitations in reference claim 25
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1-29 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 19/052,182 in view of Smith Robertson et al. (U.S. Patent 5487378). Reference claim 2 includes all limitations of instant claim 1 with the exception of the specificity that the housing defining a receiving region into which the combined module is received.
Robertson teaches an inhaler (Figs. 15-19; Col. 15-17) including a fluid reservoir (Fig. 16 #606; Col. 16, Ln. 2-9) and an electronically actuated ejector mechanism (Fig. 16 #608; Col. 16), wherein the ejector mechanism is coupled to the reservoir as a combined module (Fig. 16; Col. 15, Ln. 58-67) removable from a housing of the inhaler (Fig. 16; Col. 15, Ln. 58-67), the housing defining a receiving region into which the combined module is received (Figs. 15a-16 – combined reservoir 606 and aerosol generator 608 received in lower portion of the inhaler’s housing). Robertson a receiving region of the housing as providing the benefit of allowing the inhaler housing to be reusable while the cartridge it receives (i.e. the cited combined module) is replaceable (Col. 15, Ln. 58-60).
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 reference claim 2 the housing defining a receiving region into which the combined module is received in order to provide the benefit of presenting a portion of the housing which can receive the combined module in a replaceable manner in view of Robertson. A further mapping of dependent claims is as follows:
Instant claim 2 vs. limitations in reference claim 1
Instant claims 3-4 as obvious in view of reference claim 1 – the reference claim’s combination module can be disposed of if desired
Instant claims 5-12 as obvious in view of reference claim 1 – the reference claim’s reservoir must be either non-collapsible or collapsible as the instant claims indicate the difference between the two options to be merely an obvious matter of design choice alternative
Instant claims 13-24 vs. limitations in reference claim 1 (nicotine)
Instant claims 25-29 vs. limitations in reference claim 1
This is a provisional nonstatutory double patenting rejection.
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) 1-12 and 26-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robertson et al. (U.S. Patent 5487378).
Regarding claim 1, Robertson discloses an electronically actuated droplet delivery device (Figs. 15-19; Col. 15-17) comprising: a housing (#618 in text, #619 in figures) including a mouthpiece (Fig. 15b #602) located at an airflow exit side of the housing; a fluid reservoir (Fig. 16 #606; Col. 16, Ln. 2-9) disposed within or in fluid communication with the housing (Fig. 16); an electronically actuated ejector mechanism (Fig. 16 #608; Col. 16) including an aperture plate (Fig. 16 #622; Col. 16, Col. 3, Ln. 39-45) having a plurality of openings (Fig. 18; Col. 3, Ln. 39-45) formed through its thickness configured to generate an ejected stream of droplets, wherein the ejector mechanism is coupled to the reservoir as a combined module (Fig. 16; Col. 15, Ln. 58-67) removable from the housing (Fig. 16; Col. 15, Ln. 58-67), the housing defining a receiving region into which the combined module is received (Figs. 15a-16 – combined reservoir 606 and aerosol generator 608 received in lower portion of the inhaler’s housing); and an electronic actuator (Fig. 17 #624; Col. 16) operably coupled to oscillate the aperture plate at a frequency that generates the ejected stream of droplets.
Regarding claim 2, Robertson discloses at least about 50% of the droplets in the ejected stream of droplets have an average ejected droplet diameter of less than about 5 microns (Col. 3, Ln. 17-23 – maximum opening below 5 microns to produce droplets within that range).
Regarding claim 3, Robertson discloses the combined module is disposable (Col. 15, Ln. 58-60 – replaceable cartridge).
Regarding claim 4, Robertson discloses the combined module is disposable (Col. 15, Ln. 58-60 – replaceable cartridge).
Regarding claim 5, Robertson discloses the reservoir is non-collapsible (Fig. 2 #12 around #10 is a “solid vessel”; Col. 9, Ln. 31-58). The claim does not require the entire reservoir to be non-collapsible. Reservoir 606 will include the same solid outer vessel as Fig. 2. The reservoir is able to be read as a combination of the solid vessel 12 and the collapsible bag/sachet 10. Thus, a portion of the cited reservoir is non-collapsible.
Regarding claim 6, Robertson discloses the reservoir is non-collapsible (Fig. 2 #12 around #10 is a “solid vessel”; Col. 9, Ln. 31-58). The claim does not require the entire reservoir to be non-collapsible. Reservoir 606 will include the same solid outer vessel as Fig. 2. The reservoir is able to be read as a combination of the solid vessel 12 and the collapsible bag/sachet 10. Thus, a portion of the cited reservoir is non-collapsible.
Regarding claim 7, Robertson discloses the reservoir is non-collapsible (Fig. 2 #12 around #10 is a “solid vessel”; Col. 9, Ln. 31-58). The claim does not require the entire reservoir to be non-collapsible. Reservoir 606 will include the same solid outer vessel as Fig. 2. The reservoir is able to be read as a combination of the solid vessel 12 and the collapsible bag/sachet 10. Thus, a portion of the cited reservoir is non-collapsible.
Regarding claim 8, Robertson discloses the reservoir is non-collapsible (Fig. 2 #12 around #10 is a “solid vessel”; Col. 9, Ln. 31-58). The claim does not require the entire reservoir to be non-collapsible. Reservoir 606 will include the same solid outer vessel as Fig. 2. The reservoir is able to be read as a combination of the solid vessel 12 and the collapsible bag/sachet 10. Thus, a portion of the cited reservoir is non-collapsible.
Regarding claim 9, Robertson discloses the reservoir is collapsible (Col. 5, Ln. 30-33 & Col. 16, Ln. 36-39 – collapsible sachet).
Regarding claim 10, Robertson discloses the reservoir is collapsible (Col. 5, Ln. 30-33 & Col. 16, Ln. 36-39 – collapsible sachet).
Regarding claim 11, Robertson discloses the reservoir is collapsible (Col. 5, Ln. 30-33 & Col. 16, Ln. 36-39 – collapsible sachet).
Regarding claim 12, Robertson discloses the reservoir is collapsible (Col. 5, Ln. 30-33 & Col. 16, Ln. 36-39 – collapsible sachet).
Regarding claim 26, Robertson discloses the electronic actuator is a piezoelectric actuator (Col. 16, Ln. 14-18).
Regarding claim 27, Robertson discloses the electronic actuator is a piezoelectric actuator (Col. 16, Ln. 14-18).
Regarding claim 28, Robertson discloses the electronic actuator is a piezoelectric actuator (Col. 16, Ln. 14-18).
Regarding claim 29, Robertson discloses the electronic actuator is a piezoelectric actuator (Col. 16, Ln. 14-18).
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) 13-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robertson et al. (U.S. Patent 5487378) in view of Smith et al. (U.S. Pub. 2003/0140921).
Regarding claim 13, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 14, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 15, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 16, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 17, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 18, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 19, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 20, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 21, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 22, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 23, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 24, Robertson fails to disclose the reservoir includes nicotine or a chemical that is in marijuana.
Smith teaches an aerosol generating system (Fig. 1) and teaches nicotine as one
particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device (¶0061).
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 Robertson the fluid reservoir includes nicotine based upon an obvious design choice to select nicotine as one particular fluid suitable for use as a pharmaceutical in an aerosol generating inhalation device in view of Smith.
Regarding claim 25, Robertson teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (Col. 16, Ln. 14-18).
Conclusion
Regarding claim 1 further attention is drawn to the following references with teaching of a combined module in accordance with claim 1: Loeffler et al. (U.S. Pub. 2002/0134372; Figs. 2 & 6), Sugita et al. (U.S. Pub. 2010/0024814; Fig. 1), Mullinger et al. (U.S. Pub. 2014/0116426; Fig. 1), and Gallem et al. (U.S. Pub. 2017/0232211; Fig. 9a).
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