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 .
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 and 6 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of:
claims 7 of copending Application No. 18/285523 (reference application R1)
claim 7 of copending Application No. 18/282926 (reference application R2)
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 of copending Application Nos. 18/285523 (reference application R1), 18/282926 (reference application R2), and 18/282648 (reference application R3). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of reference applications R1-3 anticipate the claims of the instant application (by teaching at least the limitations of the instant application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-11 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1, “a cartridge accommodation portion configured to accommodate a cartridge comprising a film containing the emulsion therein” is unclear as to which element contains the emulsion, i.e. the cartridge accommodation portion, the cartridge, or the film. The clause is interpreted to recite them in the alternative.
Dependent Claims 2-11 are also rejected for relying on at least one rejected claim above.
Claim Rejections - 35 USC § 102
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, 3-7, and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kosel 20220134072.
Regarding Claim 1, Kosel teaches an electronic device (100) for releasing emulsion (150) through a microneedle (112), the electronic device comprising:
a cartridge accommodation portion (portion of 110 surrounding 152) configured to accommodate a cartridge (152) comprising a film (106A) containing the emulsion therein (Fig 2);
a crushing circuit (incl. 102, 106 excl. 106A, 142, 140) comprising:
a substrate (102),
a crushing element (incl. 142) formed on a side (Figs 1-2) of the substrate and configured to crush at least a portion of the film of the cartridge disposed in the cartridge accommodation portion (Fig 3; 142 crushes all of 152 incl. 106A), and
an elastic element (106 excl. 106A) disposed between the side of the substrate and the cartridge (Figs 1-3), the elastic element being configured to generate a force that moves the emulsion in a predetermined direction in response to the film being crushed (106 directs, by its walls exerting force, the crushing and movement in the direction away from the substrate to push the emulsion out of microneedle(s) 112);
the microneedle (112) configured to release the emulsion to an outside of the electronic device (Fig 3), wherein the emulsion is exposed as at least the portion of the cartridge is crushed and is moved in the predetermined direction based on the force generated by the elastic element (Figs 2-3);
a processor (404 and/or 120 replaced by a processor and battery per [0060]) configured to generate a crushing signal (processor controlling activation of 100 including electrical circuits); and
a transmission circuit (incl. 122, 120, and conductors between 120 and 104) configured to transmit the crushing signal to the crushing circuit ([0034-35, 60]).
Regarding claim 3, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches the crushing element comprises a material that generates heat by the crushing signal (electrolysis suing electrodes generates waste heat), and at least the portion of the cartridge is crushed by heat generated by the crushing element (any heat generated, contributes to crushing by increasing expansion of the fluid 140).
Regarding claim 4, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches the material of the crushing element is a metal having a specific resistance (the crushing element may include 104, which are Ti/Pt electrodes per [0053]).
Regarding claim 5, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches at least the portion of the cartridge crushed by the heat is a thin-film cell (152 is at least partially formed by 106A, which may be formed of Parylene C, a thin-film cell).
Regarding claim 6, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches the crushing circuit further comprises an emulsion release element (portion of 110, e.g. 110A) attached to the elastic element (Fig 2, e.g. via 110, 102), and the elastic element and the emulsion release element are configured to move the emulsion in a direction of the microneedle when at least the portion of the cartridge is crushed by the crushing element (Figs 2-4A).
Regarding claim 7, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches an indicator indicating an amount of emulsion to be released (the geometry and expansion of the bellows 106 indicates the amount of emulsion delivered; [0058]).
Regarding claim 9, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches the processor is configured to, when the cartridge comprises a plurality of blocks, each containing the emulsion, generate the crushing signal to crush one or more blocks of the plurality of blocks ([0036], Fig 4B).
Regarding claim 10, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches the crushing circuit comprises a plurality of crushing elements, and the plurality of crushing elements respectively corresponds to the plurality of blocks in position (each block formed of a complete unit 100; Fig 4B).
Claim Rejections - 35 USC § 103
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.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kosel in view of Angel 20030083645.
Regarding Claim 8, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel does not teach a button configured to receive, from a user, an amount of emulsion to be released.
However, Angel teaches using a button for a user to press in order to release an amount of emulsion through a microneedle device ([0021]; Figs 1A-2D), thereby providing on-demand delivery of precise drug quantities ([0021]).
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 device of Kosel to further include a user operated button as taught by Angel in order to provide on-demand delivery of precise amounts of drug through the microneedles ([0021]).
.
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kosel in view of Wikipedia, Parylene, April 2021, retrieved from Wayback Machine, https://web.archive.org/web/20210419050159/https://en.wikipedia.org/wiki/Parylene; and Emilija Ilic et al., Silicon Corrosion in Neutral Media: The Influence of Confined Geometries and Crevice Corrosion in Simulated Physiological Solutions, 20 March 2019, Journal of the Electrochemical Society, 166(6)C125-C133).
Regarding claim 11, Kosel teaches all the limitations of the claimed invention as discussed above. Kosel further teaches the materials in contact with the emulsion being Parylene C (of 106/106a) and polished silicon (of 110).
Kosel does not specifically teach acidity of the emulsion is between 7-8 pH.
However, Parylene C is operable in a wide range of pH (evidentiary reference: bottom of p.9 of Wikipedia, Parylene, April 2021, retrieved from Wayback Machine).
And, silicon stability is highest in neutral pH environments (pH 7-8, incl. 7.4; evidentiary reference: p.2 last two lines of col.1 and first paragraph of col.2 of Emilija Ilic et al., Silicon Corrosion in Neutral Media: The Influence of Confined Geometries and Crevice Corrosion in Simulated Physiological Solutions, 20 March 2019, Journal of the Electrochemical Society, 166(6)C125-C133).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an emulsion of pH 7-8 with the apparatus of Kosel because the silicon substrate containing the emulsion of Kosel is most stable in environments of pH 7-8; and because this limitation is drawn to the material (emulsion) worked upon by the claimed apparatus (electronic device for emulsion expulsion) and MPEP2115 provides that inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.
Response to Arguments
Applicant's arguments filed 14 May 2026 have been fully considered but they are not persuasive.
Applicant argues that the cartridge of Kosel does not have any film containing the emulsion therein.
However, the full recitation of the relevant clause in claim 1 is: “a cartridge accommodation portion configured to accommodate a cartridge comprising a film containing the emulsion therein”, which is not clear as to which component must contain the emulsion therein, i.e. the cartridge accommodation portion, the cartridge, or the film. Kosel teaches at least the emulsion being contained within the cartridge and the cartridge comprising a film.
Applicant’s second argument depends on the first argument which is already fully addressed above.
Applicant asserts that Kosel teaches “the force generated by the bellows membrane 106 is what would actually cause the film to be crushed. Thus, the bellows membrane would not “generate a force that moves the emulsion in a predetermined direction in response to the film being crushed”
It appears that Applicant is arguing that the claim requires a complete separation in time between the crushing and the directing. However, the claim recitation itself does not require such separation in time. The actions of directing emulsion and crushing film/cartridge can occur at least partially simultaneously (overlapping) while still satisfying the requirement for the directing action to be “in response” to the crushing action. In this case, the crushing of the film causes emulsion to flow and the force of the bellows directs direction of flow even as the crushing continues to occur.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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, Devon Kramer can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741
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