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 light of the amendments to the claims filed 09/22/2023 in which claims 2, 8, 10-11, 13, 16-18, 21, 25, 27, 29, 36, and 77 are amended and claims 3-7, 9, 12, 19-20, 22, 24, 37-38, 42-76, and 78-82 are amended, claims 1-2, 8, 10-11, 13-18, 21, 23, 25-36, 39-41, and 77 are pending in the instant application.
Priority
The instant application claims priority to U.S. Provisional App. no. 63/367,755 filed on 07/06/2022.
Claims 1-2, 8, 10-11, 13-18, 21, 23, 25-36, 39-41, and 77 receive priority to the prior-filed application, filed on 07/06/2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 8, 10-11, 13-18, 21, 23, 25-36, and 39-41), Species IIA (Fig. 2), Species IIB (Fig. 4D), Species IC (Fig. 1-3), and Species ID (Fig. 7) in the reply filed on 01/30/2026 is acknowledged.
Upon reconsideration of the species elections, the examiner withdraws the requirement for election of Species B and D as the species of these groups have little/unobvious difference such that they would be found in the same search areas with little increased search burden. Further, the species election of Species IIA as being directed to Fig. 2 may also comprise Species IA and IIIA as these species have little/unobvious difference in structure from Species IIA such that they would be found in the same search areas with little increased search burden.
In view of the reconsideration of the species elections, the elected species may be considered Group I, Species IA-IIIA, and Species IC.
Applicant’s species election is allegedly drawn to claims 1-2, 8, 10-11, 13-18, 21, 23, 25-36, and 39-41. The examiner additionally notes that claims 28-34 and 41 (Species IVA: Fig. 5) are directed to non-elected species and are therefore withdrawn.
Claims 28-34, 41, and 77 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected election/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/30/2026.
Accordingly, claims 1-2, 8, 10-11, 13-18, 21, 23, 25-36, 39-41, and 77 are pending in the instant application and claims 1-2, 8, 10-11, 13-18, 21, 23, 25-27, 35-36, and 39-40 are examined on the merits herein.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the auger (Claim 23) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The term ampoule is spelled as both “ampule” and “ampoule”.
The outer annulus is referred to by an incorrect reference number (para. 0086).
The bottom of the outer annular is referred to by an incorrect reference number (para. 0087).
Appropriate correction is required.
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.
Claims 1, 13-17, 21, 25-27, 36, 39-40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent 12,110,223 B2 to Smith.
Regarding claim 1, Smith discloses an applicator for topically applying a therapeutic agent (col. 6 ln. 1-19, substance 20 can be a medicament, biological sample; Fig. 12-13, 24A-B), the applicator comprising:
a container configured to store the therapeutic agent (Fig. 12-13, opening structure/container 1 to store ampoule 19 comprising substance 20);
an actuator configured to release the therapeutic agent from the container (col. 4 ln. 50-67 and col. 5 ln. 1-26; Fig. 12-13, push button 2 and associated structure act as an actuator configured to break ampoule 19); and
a tip configured to absorb the therapeutic agent released from the container (col. 4 ln. 34-49, tip 3 is a sponge; Fig. 12-13, tip 3 absorbing liquid from broken ampoule 19), the tip further configured to release the therapeutic agent to a treatment area in response to contact between the tip and the treatment area (col. 4 ln. 34-49, tip 3 is a sponge which would be considered to release liquid upon pressure).
Regarding claim 13, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the therapeutic agent comprises at least one of a liquid, a gel, or a patch (col. 6 ln. 1-19, substance 20 can be a medicament, biological sample; Fig. 12-13, 17-18; Fig. 24A showing liquid in top ampoule).
Regarding claim 14, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the tip comprises a porous, absorbent, and/or an adsorbent material (col. 4 ln. 34-49, tip 3 is a sponge, sponge is inherently porous; Fig. 12-13, tip 3 absorbing liquid from broken ampoule 19).
Regarding claim 15, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the tip comprises pores (col. 4 ln. 34-49, tip 3 is a sponge, sponge is inherently porous; Fig. 12-13, tip 3 absorbing liquid from broken ampoule 19).
Regarding claim 16, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the tip comprises at least one of a hygroscopic, hydrophilic, absorbent, or an adsorbent material (col. 4 ln. 34-49, tip 3 is a sponge, sponge is inherently porous; Fig. 12-13, tip 3 absorbing liquid from broken ampoule 19), the tip configured to retain the therapeutic agent when the tip is not in contact with the treatment area (col. 4 ln. 34-49; tip 3 is a sponge which would be considered to release liquid upon pressure; Fig. 12-13, tip 3 absorbing liquid from broken ampoule 19).
Regarding claim 17, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the tip comprises at least one of a dome-shaped, conical, cylindrical, chiseled, multiply curved, or polygonal shape (Fig. 12-13, tip 3 is polygonal).
Regarding claim 21, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the container comprises a capsule, the capsule comprising a frangible or puncturable material, the capsule configured to fracture or puncture in response to at least one of an applied circumferential pressure or an applied radial pressure (col. 6 ln. 1-19, ampoule 19 fractures upon radial application of free rolling ball 16C; Fig. 12-13, opening structure/container 1 to store ampoule 19 comprising substance 20).
Regarding claim 25, the cited prior art discloses the invention of claim 21. Smith further discloses comprising a puncture cap configured to puncture an end of the capsule (col. 7 ln. 24-31; Fig. 11A, push button 2 comprising puncture ball to enhance breakage of ampoule 19).
Regarding claim 26, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the container further comprises a tube configured to transport the therapeutic agent to the tip (Fig. 12-13, tube connecting opening structure/container 1 to tip 3).
Regarding claim 27, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the actuator comprises at least one of a twist end, a push end, a clicker, or a plunge end actuation mechanism (col. 4 ln. 50-67 and col. 5 ln. 1-26; Fig. 12-13, push button 2 and associated structure act as an actuator configured to break ampoule 19).
Regarding claim 36, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the container comprises a plurality of capsules configured to store the therapeutic agent (Fig. 24A-B, 19A and 19X ampoules), the actuator configured to release the therapeutic agent from each of the plurality of capsules independently and separately, the actuator configured to release the therapeutic agent to the treatment area from each of the plurality of capsules independently and separately (col. 7 ln. 15-31, depression of push button 2 can allow for staggered release of substances from ampoules, partial depression to break only a single ampoule can allow for independent and separate release from the ampoules and to the treatment area).
Regarding claim 39, Smith discloses a method for topically applying a therapeutic agent to a treatment area (col. 6 ln. 1-19, substance 20 can be a medicament, biological sample; Fig. 12-13, 24A-B), the method comprising:
storing, in a container, a therapeutic agent (Fig. 12-13, opening structure/container 1 to store ampoule 19 comprising substance 20);
releasing, by an actuator, the therapeutic agent from the container (col. 4 ln. 50-67 and col. 5 ln. 1-26; Fig. 12-13, push button 2 and associated structure act as an actuator configured to break ampoule 19);
absorbing, by a tip, the therapeutic agent released from the container (col. 4 ln. 34-49, tip 3 is a sponge; Fig. 12-13, tip 3 absorbing liquid from broken ampoule 19); and
releasing, by the tip, the therapeutic agent to a treatment area in response to contact between the tip and the treatment area (col. 4 ln. 34-49, tip 3 is a sponge which would be considered to release liquid upon pressure).
Regarding claim 40, the cited prior art discloses the method of claim 40. Smith further discloses comprising absorbing at least some therapeutic agent from the treatment area (col. 4 ln. 34-49, tip 3 is a sponge which would be considered to absorb liquid upon release of pressure).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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.
Claims 2 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied above, and further in view of U.S. Patent no. 11,542,136 B1 to May.
Regarding claim 2, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the therapeutic agent comprises at least one of a chemexfoliant, a soothing agent, or an organic agent.
May discloses an applicator for topical application comprising a therapeutic agent comprising at least one of a chemexfoliant, a soothing agent, or an organic agent to increase the use cases of the applicator (col. 34 ln. 34-60; Fig. 1).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the invention of Smith to comprise a therapeutic agent as taught by May, because May discloses a similar applicator to that of Smith comprising an absorbent tip and a body for breaking an ampoule (Fig. 1) and Smith discloses that their system may be used for medicaments (col. 6 ln. 1-19). Therefore, it would be considered obvious to one of ordinary skill looking at the disclosure of May to utilize the applicator of Smith with the claimed medicaments with a reasonable expectation of success.
Regarding claim 35, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the tip comprises a roller configured to control a release of fluid material.
May teaches an applicator comprising a roller configured to control a release of fluid material such that it assists in dispensing the flowable material from the dispenser to a receiving surface (col. 11 ln. 4-25).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tip of Smith to comprise a roller as taught by May, because May teaches that a roller assists in dispensing a flowable material from a dispenser (col. 11 ln. 4-25).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied above, and further in view of WO/2003/075979 A2 to Simon.
Regarding claim 8, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a light source, the light source integrated within or attached to a body of the applicator.
Simon discloses a syringe comprising a light source integrated within or attached to a body of the syringe to illuminate the area of the body that is receiving treatment to ensure proper positioning (para. 0022-0024; para. 0028; para. 0139-0140; Fig. 17, chemiluminescent light source 1740 on syringe 1710).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the applicator of Smith to comprise a light source as taught by Simon, because Simon teaches that the light source of their invention provides illumination that is lightweight and independent of an external power supply to ensure proper positioning of a medicament applicator in low light situations (para. 0022-0024).
Regarding claim 10, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a chemiluminescent light source.
Simon discloses a syringe comprising a chemiluminescent light source to illuminate the area of the body that is receiving treatment to ensure proper positioning ( (para. 0022-0024; para. 0028; para. 0139-0140; Fig. 17, chemiluminescent light source 1740 on syringe 1710).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the applicator of Smith to comprise a light source as taught by Simon, because Simon teaches that the light source of their invention provides illumination that is lightweight and independent of an external power supply to ensure proper positioning of a medicament applicator in low light situations (para. 0022-0024).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied above, and further in view of WO/2012/139155 A1 to Penrose.
Regarding claim 11, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a light source, the light source comprising a plurality of selectable spectral ranges, wherein the spectral ranges are configured to illuminate stained tissue for selective identification of tissue.
Penrose discloses a syringe comprising a light source, the light source comprising a plurality of selectable spectral ranges, wherein the spectral ranges are configured to illuminate stained tissue for selective identification of tissue to minimize positional error of the syringe (pg. 4 ln. 11-33 and pg. 5 ln. 1-2; pg. 10 ln. 4-11; Fig. 1, light source 104 comprising light emitter 106).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the applicator of Smith to comprise the light source of Penrose, because Penrose teaches that their device minimizes positional error (pg. 4 ln. 11-33 and pg. 5 ln. 1-2). Further, the ability to select a spectral range provides individual choice for a user of the system to more easily visualize the light from the light source.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied above.
Regarding claim 18, the cited prior art discloses the invention of claim 1. Smith further discloses wherein the tip corresponds to a contour of a treatment area (Fig. 12-13, tip 3 is generally flat and would be considered to correspond to a contour of some parts of a body); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the tip comprises a projection, the projection comprising a nipple or an extension, wherein a shape of the projection corresponds to a contour of the treatment area.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the tip such that the tip comprises a projection, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Further, Smith contemplates multiple tips that could be used with the container of their invention (Fig. 25B).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied above, and further in view of US/2009/0143765 A1 to Slocum.
Regarding claim 23, the cited prior art discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose an auger configured to control an amount of a linear pressure.
Slocum teaches a syringe comprising an auger configured to control an amount of linear pressure to allow for mixing of materials and to maximize the amount of injected fluids (para. 0041; Fig. 2, compressible auger 14 within syringe 10).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the dual-ampoule applicator of Smith to comprise the auger of Slocum, because Slocum teaches that an auger connected to the push mechanism allows for mixing of materials and maximizes an amount of injected fluids (para. 0041).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent no. 4,784,506 A to Koreska discloses an applicator comprising an absorbent tip and an ampoule. US/2003/0080151 A1 to D’Alessio discloses an applicator comprising an ampoule and a protective barrier tip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
18 February 2026