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 .
This office action is in response to the amendment filed 8/18/25. As directed by the amendment, claim 1 has been cancelled and claims 2-22 have been added. As such, claims 2-22 are pending in the instant application.
Claim Interpretation
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.
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.
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: acceleration system … configured to accelerate” in claim 20.
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
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 6, 8, 12, and 15 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.
The term “about 10” in claim 6 (emphasis added) is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what qualifies, or does not qualify, as being ‘about 10’.
The term “about 1 cm” in claim 8 (emphasis added) is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what qualifies, or does not qualify, as being ‘about 1 cm’.
The term “substantially parallel” in claim 12 (emphasis added) is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what qualifies, or does not qualify, as being ‘substantially parallel’.
Claim 15 recites the limitation "the dosage instruction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the cartridge" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 2-3, 5-7, 9, 11, 13, 16, and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burt et al. (2013/0079733) in view of Ganan-Calvo (6,405,936).
Regarding claim 2, Burt discloses a fluid delivery device (see abstract, Fig. 36-37, para. 0005, 0165 for example) which includes a housing (see Fig. 36-37, housing 170, para. 0164); a fluid vaporizer disposed within the housing and configured to receive fluid and produce an aerosol mist of liquid particles from the fluid (see Fig. 36-37, fluid vaporizer 20, para. 0165, 0113, 0005), and a pump configured to accelerate the aerosol mist produced by the vaporizer and eject the vaporized fluid (see Fig. 36-37, pump labeled below in annotated Fig. 37, which receives the fluid from vaporizer 20 and accelerates it to be ejected from the device as shown). Burt is silent as to the ejected vaporized fluid having a Weber number that is equal to or greater than 1; however, Ganan-Calvo discloses an aerosol delivery device which ejects aerosol having a Weber number that is equal to or greater than 1 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34). Thus 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 Burt device to eject vaporized liquid with a Weber number that is equal to or greater than 1, as taught by Ganan-Calvo, in order to provide a stable microjet of flow with desired monodisperse aerosol with high degree of uniformity in particle size (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34).
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Regarding claim 3, the modified Burt device’s fluid vaporizer includes a piezoelectric transducer (see Burt para. 0020 for example).
Regarding claim 5, the modified Burt device’s pump is configured to reduce a size of the liquid particles produced by the fluid vaporizer (the modified Burt device includes each structural and functional limitation that it would also reduce the size of the liquid particles).
Regarding claim 6, the modified Burt device’s pump is configured to reduce a size on average of the liquid particles produced by the vaporizer by a factor of about 10 (the modified Burt device includes each structural and functional limitation that it would also reduce the size of the liquid particles by a factor of about 10).
Regarding claim 7, the modified Burt device’s housing has a fluid-retaining reservoir and the vaporizer is configured to receive fluid from the reservoir (see Burt Fig. 37, reservoir 80, see para. 0165).
Regarding claim 9, the modified Burt device’s housing has an outlet formed therein and positioned such that the vaporizer can eject the mist from the housing through the outlet (see Burt Fig. 37 housing 170 having an outlet which allows fluid to be ejected via 162).
Regarding claim 11, the modified Burt device’s pump includes a fluid inlet port and fluid outlet port being positioned adjacent to the outlet in the housing (see Burt Fig. 37 and annotated Fig. 37 above showing pump inlet labeled and pump outlet at 162).
Regarding claim 13, the modified Burt device further includes a cartridge removably matable to the housing and configured to deliver fluid to the housing (see Burt Fig. 37, removable cartridge 80, see para. 0028-0031).
Regarding claim 16, the modified Burt device further includes a controller disposed on the housing and configured to alter a frequency of the vaporizer and at least one of pump speed or duration (see Burt para. 0024-0025, 0164-0165).
Regarding claim 18, the modified Burt device is configured to eject a vaporized fluid having a Weber number that is in a range of 1 to 100 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34).
Regarding claim 19, the modified Burt device is configured to eject a vaporized fluid having a Weber number that is in a range of 10 to 50 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34).
Regarding claim 20, Burt discloses a fluid delivery device (see abstract, Fig. 36-37, para. 0005, 0165 for example) which includes a housing (see Fig. 36-37, housing 170, para. 0164); a fluid vaporizer disposed within the housing and configured to receive fluid and produce an aerosol mist of liquid particles from the fluid (see Fig. 36-37, fluid vaporizer 20, para. 0165, 0113, 0005), and an acceleration system configured to accelerate the aerosol mist produced by the vaporizer and eject the vaporized fluid (see Fig. 36-37, pump labeled above in annotated Fig. 37, which receives the fluid from vaporizer 20 and accelerates it to be ejected from the device as shown). Burt is silent as to the ejected vaporized fluid having a Weber number that is equal to or greater than 1; however, Ganan-Calvo discloses an aerosol delivery device which ejects aerosol having a Weber number that is equal to or greater than 1 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34). Thus 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 Burt device to eject vaporized liquid with a Weber number that is equal to or greater than 1, as taught by Ganan-Calvo, in order to provide a stable microjet of flow with desired monodisperse aerosol with high degree of uniformity in particle size (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34). The modified Burt device includes the same structural and functional limitations (vaporizer ejecting mist of droplets with Weber number equal to or greater than 1) such that it produces a mist of individual non-coalescing droplets by creating an inertia-dominated fluid regime.
Regarding claim 21, the modified Burt device is configured to eject a vaporized fluid having a Weber number that is in a range of 1 to 100 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34).
Regarding claim 22, the modified Burt device is configured to eject a vaporized fluid having a Weber number that is in a range of 10 to 50 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burt and Ganan-Calvo as applied to claim 2 above, and further in view of Srinivasan et al. (2004/0260234).
Regarding claim 8, the modified Burt device is silent as to the vaporizer and pump being configured to generate mist that can pass into up to 1 cm of tissue when an outlet of the housing through which the aerosol passes is positioned about 1 cm away from the tissue; however, Srinivasan discloses a similar device which teaches this limitation (see Srinivasan para. 0005 and 0109). Thus 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 modified Burt device to generate mist to pass into up to 1 cm of tissue when positioned about 1 cm away, as taught by Srinivasan, in order to provide transdermal delivery of drugs to the patient (see Srinivasan para. 0005 and 0109).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burt and Ganan-Calvo as applied to claims 13 and 2 above, and further in view of Smith et al. (2003/0140921).
Regarding claim 14, the modified Burt device is silent as to the cartridge including dosage or timing instructions to the device including pump speed and frequence of vibration of the vaporizer (see Burt para. 0024-0025, 0164-0165 which discloses control of operating parameters); however, Smith discloses a similar vaporizer device which includes a cartridge including dosage/timing instructions (see Smith Fig. 1 and 11, para. 0050, 0076-0078). Thus 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 modified Burt device’s cartridge to provide dosing/timing instructions, as taught by Smith, to provide proper control for delivery of the fluid held within the cartridge (Smith abstract, para. 0050, 0076-0078).
Regarding claim 15, the modified Burt device discloses an activation switch electronically coupled to the vaporizer and pump to activate these elements (see Burt Fig. 36-37, control buttons/switches 163,163A, see para. 0164). Burt is silent as to the activation being according to dosage instructions of the cartridge (Burt para. 0024-0025, 0164-0165 which discloses control of operating parameters); however, Smith discloses a similar vaporizer device which includes a cartridge including dosage/timing instructions (see Smith Fig. 1 and 11, para. 0050, 0076-0078). Thus 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 modified Burt device’s cartridge to provide dosing/timing instructions, as taught by Smith, to provide proper control for delivery of the fluid held within the cartridge (Smith abstract, para. 0050, 0076-0078).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burt and Ganan-Calvo as applied to claim 2 above, and further in view of Riebman et al. (2016/0114112).
Regarding claim 17, the modified Burt device is silent as to including a sensor disposed on the housing configured to determine a distance from the device to a skin of a patient (Burt para. 0028 disclosing various sensors such as proximity sensor); however, Riebman discloses a similar vaporizer device which includes a sensor configured to determine a distance of the device to skin of the patient (see Riebman para. 0089). Thus 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 modified Burt device to include a sensor to determine distance from the skin of the patient, as taught by Riebman, in order to ensure proper positioning of the device in relation to the patient.
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.
Claims 2, 4-6, 9-12, and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-23 of U.S. Patent No. 11,273,267.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims include each structural and functional limitations as claimed (see claim 19 which discloses housing, fluid vaporizer, and pump as claimed, claim 21 disclosing the claimed Weber number and thus resultant fluid flow properties, individual non-coalescing droplets via inertia-dominated fluid regime) but also includes additional elements, such as the inlet and outlet configured to disrupt flow path of the aerosol mist, such that the patent claims are narrower versions of the instant claims.
Instant claims 2, 4-6, 9-12, and 20 correspond to patent claim 21. Instant claims 18 and 21 correspond to patent claim 22. Instant claims 19 and 22 correspond to patent claim 23.
Claims 3, 7, 13, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 11,273,267 in view of Burt.
Regarding instant claim 3, the patent claim 21 is silent as to the vaporizer including a piezoelectric transducer; however, Burt teaches this limitation (see Burt para. 0020 for example). Thus 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 patent claim 21 device’s vaporizer to be a piezoelectric transducer, as taught by Burt, as this would have been obvious substitution of one known element for another and one would expect the modified patent claim 21 device to perform equally as well.
Regarding instant claim 7, the patent claim 21 is silent as to the housing has a fluid-retaining reservoir and the vaporizer is configured to receive fluid from the reservoir; however, Burt teaches this limitation (see Burt Fig. 37, reservoir 80, see para. 0165). Thus 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 patent claim 21 device to include a fluid-retaining reservoir, as taught by Burt, in order to provide the necessary structural elements to hold/contain a fluid to be vaporized and delivered to the patient.
Regarding claim 13, the patent claim 21 is silent as to including a cartridge removably matable to the housing and configured to deliver fluid to the housing; however, Burt teaches this limitation (see Burt Fig. 37, removable cartridge 80, see para. 0028-0031). Thus 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 patent claim 21 device to include a removable cartridge, as taught by Burt, in order to provide the necessary structural elements to hold/contain a fluid to be vaporized and delivered to the patient.
Regarding instant claim 16, the patent claim 21 is silent as to including a controller disposed on the housing and configured to alter a frequency of the vaporizer and at least one of pump speed or duration; however, Burt teaches this limitation (see Burt para. 0024-0025, 0164-0165). Thus 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 patent claim 21 device to include a controller, as taught by Burt, in order to provide necessary elements to provide controlled delivery of the vaporized mist.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 11,273,267 in view of Srinivasan.
Regarding instant claim 8, the modified patent claim 21 device is silent as to the vaporizer and pump being configured to generate mist that can pass into up to 1 cm of tissue when an outlet of the housing through which the aerosol passes is positioned about 1 cm away from the tissue; however, Srinivasan discloses a similar device which teaches this limitation (see Srinivasan para. 0005 and 0109). Thus 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 patent claim 21 device to generate mist to pass into up to 1 cm of tissue when positioned about 1 cm away, as taught by Srinivasan, in order to provide transdermal delivery of drugs to the patient (see Srinivasan para. 0005 and 0109).
Claims 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 11,273,267 in view of Burt and Smith.
Regarding instant claim 14, the modified patent claim 21 device is silent as to the cartridge including dosage or timing instructions to the device including pump speed and frequence of vibration of the vaporizer (see Burt para. 0024-0025, 0164-0165 which discloses control of operating parameters); however, Smith discloses a similar vaporizer device which includes a cartridge including dosage/timing instructions (see Smith Fig. 1 and 11, para. 0050, 0076-0078). Thus 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 modified patent claim 21 device’s cartridge to provide dosing/timing instructions, as taught by Smith, to provide proper control for delivery of the fluid held within the cartridge (Smith abstract, para. 0050, 0076-0078).
Regarding instant claim 15, the patent claim 21 device is silent as to an activation switch electronically coupled to the vaporizer and pump to activate these elements (see Burt Fig. 36-37, control buttons/switches 163,163A, see para. 0164) and is silent as to the activation being according to dosage instructions of the cartridge (Burt para. 0024-0025, 0164-0165 which discloses control of operating parameters); however, Smith discloses a similar vaporizer device which includes a cartridge including dosage/timing instructions (see Smith Fig. 1 and 11, para. 0050, 0076-0078). Thus 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 modified patent claim 21 device’s cartridge to provide dosing/timing instructions for activation via a switch, as taught by Smith and Burt, to provide proper control for delivery of the fluid held within the cartridge (Smith abstract, para. 0050, 0076-0078).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 11,273,267 in view of Riebman.
Regarding instant claim 17, the patent claim 21 device is silent as to including a sensor disposed on the housing configured to determine a distance from the device to a skin of a patient; however, Riebman discloses a similar vaporizer device which includes a sensor configured to determine a distance of the device to skin of the patient (see Riebman para. 0089). Thus 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 patent claim 21 device to include a sensor to determine distance from the skin of the patient, as taught by Riebman, in order to ensure proper positioning of the device in relation to the patient.
Claims 2-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, and 16-21 of U.S. Patent No. 9,700,686 in view of Ganan-Calvo.
Regarding instant claim 2, the patent claims include each structural and functional limitations as claimed (see claim 1 which discloses housing, fluid vaporizer, and pump as claimed, but is silent as to the ejected vaporized fluid having a Weber number that is equal to or greater than 1; however, Ganan-Calvo discloses an aerosol delivery device which ejects aerosol having a Weber number that is equal to or greater than 1 (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34). Thus 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 patent claimed device to eject vaporized liquid with a Weber number that is equal to or greater than 1, as taught by Ganan-Calvo, in order to provide a stable microjet of flow with desired monodisperse aerosol with high degree of uniformity in particle size (see Ganan-Calvo col. 2 ln. 35-46 and col. 13 ln. 25-34).
Instant claims 2, 4, and 18-22 correspond to patent claim 1. Instant claim 3 corresponds to patent claim 2. Instant claims 5-8 corresponds to patent claims 3-6, respectively. Instant claims 9-12 corresponds to patent claims 8-11, respectively. Instant claims 13-14 correspond to patent claims 16-17, respectively. Instant claims 15-17 corresponds to patent claims 19-21, respectively.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on the same reference/combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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/COLIN W STUART/Primary Examiner, Art Unit 3785