DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 Jun 2026 has been entered.
Claims 1-30 are pending in the application. Claim 1 is currently amended. Applicant’s amendment to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 03 Dec 2025.
The prior 35 U.S.C. 102(a)(1) rejection is withdrawn as requested (Pg. 6-8) based on the amendment to the claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner concurs with applicant’s assertion that amended claim 1 patentably distinguishes over Fukumoto et al. (U.S. Pub. 2010/0083956). The prior 35 U.S.C. 102(a)(1) rejection is thus withdrawn.
It is noted that the below cited Dunfield et al. (U.S. Pub. 2005/0150489) had already been brought to applicant’s attention in each of the preceding Office actions.
Claim Objections
Claim(s) 1-30 is/are objected to because of the following informalities:
Claim 1, Ln. 14 recites “ejects droplets” which should read “ejects the ejected stream of droplets” for consistency with the earlier recitation in the claim
Appropriate correction is required.
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, 4-5 and 8 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 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 found within the overall scope of reference claim 6, the instant claim merely being broader. The surface tension plate of reference claim 1 is readable on the “intervening region” of instant claim 1. It is noted that the instant application has defined at least some of the particular materials recited in reference claim 6 as being of high modulus (e.g. instant claim 8). A further mapping of dependent claims is as follows:
Instant claim 4 as obvious in view of reference claim 6. The instant claim is recited using product-by-process language and is treated accordingly (MPEP 2113). The claimed pre-processing does not require any particular technique during manufacturing nor any imply any particular structural variation to distinguish from a similar structure which would not be pre-processed.
Instant claims 5 and 8 vs. reference claim 6
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 2-3, 6-7 and 9-30 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 19/052,152 in view of Dunfield et al. (U.S. Pub. 2005/0150489). Reference claim 6 is silent as to particular droplet size, is silent as to what fluid is being used and is silent as to whether the electronic actuator is a piezoelectric actuator.
Dunfield teaches an inhaler (Fig. 1; ¶0019) including an aperture plate (Figs. 4-5 #114; ¶0049) having a plurality of openings (Fig. 4 #108; ¶0045) and a piezoelectric actuator (¶0049) to vibrate the aperture plate. Dunfield teaches a piezo element as a particularly desirable form of mechanical actuator for ejecting droplets (¶0049). Dunfield further teaches it is an obvious design choice to tailor the droplet size based upon which area of a user’s respiratory tract is intended to receive the droplets, with sizes of 2 microns or less being useful for alveolar delivery (¶0057). And Dunfield teaches nicotine as a useful fluid to delivery as droplets when supplying an addiction treatment plan for a user (¶0063).
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 6 1) the droplet sizes of instant claim 2 based upon an obvious design choice of droplet size when desiring to provide treatment to a user’s alveoli, 2) to have specified the fluid as nicotine in order to provide the benefit of supplying an addiction treatment plan for a user, and 3) to have specified the electronic actuator as a piezoelectric actuator in order to provide the benefit of selecting a particularly desirable form of mechanical actuator for ejecting droplets all in view of Dunfield.
This is a provisional nonstatutory double patenting rejection.
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) 1-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunfield et al. (U.S. Pub. 2005/0150489) in view of Fukumoto et al. (U.S. Pub. 2010/0083956).
Regarding claim 1, Dunfield discloses an electronically actuated droplet delivery device (Fig. 1; ¶0019) comprising: a housing (Fig. 1 outer shell) including a mouthpiece (Fig. 1 #42; ¶0022) located at an airflow exit side of the housing; a fluid reservoir (Fig. 5 #138; ¶0048) disposed within or in fluid communication with the housing; an electronically actuated aperture plate (Figs. 4-5 #114; ¶0049) having a plurality of openings (Fig. 4 #108; ¶0045) formed through its thickness configured to generate an ejected stream of droplets (Fig. 5 #120; ¶0046), wherein the aperture plate is structurally distinct from the fluid reservoir (Fig. 5 space between #138 and #114); an intervening region (Fig. 5 #124; ¶0047) defined between the fluid reservoir and the aperture plate providing fluid communication between the fluid reservoir and the plurality of openings (Fig. 5); wherein the aperture plate comprises a fluid-contact surface (Fig. 5 top of #114) facing the intervening region and an opposite droplet-ejection surface (Fig. 5 bottom of #114) facing the airflow exit side of the housing, and wherein fluid from the fluid reservoir is supplied through the intervening region to the fluid-contact surface prior to droplet formation (Fig. 5), such that oscillation of the aperture plate ejects the ejected stream of droplets through the plurality of openings from the droplet-ejection surface (Fig. 5; ¶0049); and an electronic actuator (¶0049 – piezo element) directly or indirectly coupled to the aperture plate and configured to drive oscillation of the aperture plate at a frequency that generates the ejected stream of droplets (¶0049 –creates vibrations in orifice plate 114 at a desired frequency).
Dunfield is silent as to whether the aperture plate formed from a high modulus polymeric material. Dunfield does not discuss a particular material for the aperture plate. The language “high modulus polymeric material” is interpreted in light of the list of exemplary materials discussed in ¶00134 of the instant specification, which also directly corresponds to the list of polymers in instant claims 5-8.
Fukumoto teaches an inhaler (Fig. 4; ¶0057) comprising an aperture plate (Figs. 1-4 #3 or #6; ¶0035) which can be formed from various polymeric organic resins, to include polyimide (¶¶0049-0050). Fukumoto teaches polyimide as one particularly “suitable” material for use as an orifice plate in an inhaler (¶¶0049-0050).
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 Dunfield the aperture plate formed from polyimide, which is a high modulus polymeric material, in order to provide the benefit of selecting polyimide as a particular material recognized in the art as “suitable” for use as an orifice plate in an inhaler in view of Fukumoto.
Regarding claim 2, Dunfield teaches the invention as modified above and further teaches at least about 50% of the droplets have an average ejected droplet diameter of less than about 5 microns (¶0057 – alveolar delivery).
Regarding claim 3, Dunfield teaches the invention as modified above and further suggests as obvious the aperture plate is pre-processed to reduce residual stresses that may accumulate in its morphology and thickness (e.g. Dunfield – ¶0049; Fukumoto – ¶¶0039, 0085). The instant claim is recited using product-by-process language and is treated accordingly (MPEP 2113). The claimed pre-processing does not require any particular technique during manufacturing nor imply any particular structural variation to distinguish from a similar structure which would not be pre-processed. The formation of the orifice plate 14 with the materials discussed in ¶¶0049-0050 of Fukumoto will obviously be intended to be optimal for its use in an inhaler.
Regarding claim 4, Dunfield teaches the invention as modified above and further suggests as obvious the aperture plate is pre-processed to reduce residual stresses that may accumulate in its morphology and thickness (e.g. Dunfield – ¶0049; Fukumoto – ¶¶0039, 0085). The instant claim is recited using product-by-process language and is treated accordingly (MPEP 2113). The claimed pre-processing does not require any particular technique during manufacturing nor imply any particular structural variation to distinguish from a similar structure which would not be pre-processed. The formation of the orifice plate 14 with the materials discussed in ¶¶0049-0050 of Fukumoto will obviously be intended to be optimal for its use in an inhaler.
Regarding claim 5, Dunfield teaches the invention as modified above and Fukumoto as incorporated therein further teaches the high modulus polymeric material includes a polymer selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), and ultra-high molecular weight polyethylene (UHMWPE) (¶0050 – polyimide).
Regarding claim 6, Dunfield teaches the invention as modified above and Fukumoto as incorporated therein further teaches the high modulus polymeric material includes a polymer selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), and ultra-high molecular weight polyethylene (UHMWPE) (¶0050 – polyimide).
Regarding claim 7, Dunfield teaches the invention as modified above and Fukumoto as incorporated therein further teaches the high modulus polymeric material includes a polymer selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), and ultra-high molecular weight polyethylene (UHMWPE) (¶0050 – polyimide).
Regarding claim 8, Dunfield teaches the invention as modified above and Fukumoto as incorporated therein further teaches the high modulus polymeric material includes a polymer selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), and ultra-high molecular weight polyethylene (UHMWPE) (¶0050 – polyimide).
Regarding claim 9, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 10, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 11, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 12, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 13, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 14, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 15, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 16, Dunfield teaches the invention as modified above and further teaches the fluid reservoir includes a fluid with nicotine (¶0063)
Regarding claim 17, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 18, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 19, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 20, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 21, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 22, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 23, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 24, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 25, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 26, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 27, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 28, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 29, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Regarding claim 30, Dunfield teaches the invention as modified above and further teaches the invention as modified above and further teaches the electronic actuator is a piezoelectric actuator (¶0049).
Conclusion
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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights