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 .
Response to Amendment
Claims 47-54 and 57-68 are currently pending. Claims 1-46 and 55-56 and 69-75 were canceled prior to examination.
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 47-48, 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6 of U.S. Patent No. 12201795. Although the claims at issue are not identical, they are not patentably distinct from each other because 12201795 anticipates the claims of the instant Application, as "species anticipate genus”. See mapping below parts in bold are narrower:
US 12201795
Instant application 19033009
1. A method of preparing a topical applicator, including: introducing topical formulation constituents into an empty topical applicator container with a movable elevator and a rotatable knob to move the elevator; attaching the topical applicator to a mixing apparatus; mixing the topical formulation constituents into a topical formulation by the mixing apparatus; removing the topical applicator container and movable elevator with the topical formulation constituents mixed from the mixing apparatus; applying a dispense cap having a skin engagement surface with at least one dispense aperture to the topical applicator container to thereby enclose the topical formulation; and manually pushing the elevator toward the applicator cap, without rotating the knob, to purge air from the topical applicator.
47. A method of preparing a topical applicator, including: introducing topical formulation constituents into an empty topical applicator container with a movable elevator, and a knob to move the elevator; attaching the topical applicator to a mixing apparatus; mixing the topical formulation constituents into a topical formulation by the mixing apparatus; removing the topical applicator container and movable elevator with the topical formulation constituents mixed; and applying a dispense cap having a skin engagement surface with a plurality of dispense apertures to the topical applicator to thereby enclose the topical formulation.
48. (Original) The method of claim 47 further comprising manually pushing the elevator toward the applicator cap without rotating a nut to purge air from the topical applicator container.
62. (Original) A method of preparing and using a topical applicator, including: introducing topical formulation constituents into an empty topical applicator, attaching the topical applicator to a mixing apparatus, mixing the topical formulation constituents into a topical formulation, removing the topical applicator from the mixing apparatus, applying an applicator cap to the topical applicator to capture the topical formulation, the applicator cap having a plurality of apertures and a dome shaped or a flat skin engaging surface.
63. The method of claim 62 further comprising purging air from topical applicator.
5. The method of claim 1 further comprising applying a cover over the dispense cap.
52. The method of claim 47 further comprising applying a cover to the dispense cap.
6. A method of preparing a topical applicator, the method comprising: receiving at a facility a plurality of dispense containers, each container having a reservoir and an elevator movable by a rotatable knob; receiving at the facility medicaments for adding to the dispense containers; adding at least one medicament to a reservoir of one of the plurality of dispense containers at the facility; adding a dispense cap to the dispense container, the dispense cap having a dome shaped or flat dispense skin engaging surface with at least one aperture; adding a cover to the dispense cap; providing the dispense container with the at least one medicament, the dispense cap, and the cover to an end user; and purging the reservoir of the dispense container of air by pushing the elevator toward the dispense cap without rotating the knob.
53. The method of claim 47 further comprising purging air in a reservoir containing the topical formulation.
57. A method of distributing pharmaceutical formulations in a dispense container, the method comprising: receiving at a compounding facility a plurality of dispense containers having elevators movable by rotatable knobs; receiving at the compounding facility medicaments for adding to the dispense containers; adding at least one medicament to a reservoir of one of the dispense container at the compounding facility; mixing at the compounding facility the at least one medicament in the reservoir of the dispense container by a mixer with a motor powered paddle; adding a dispense cap to the dispense container, the dispense cap having a dome shaped or flat dispense skin engaging surface with a plurality of apertures; adding a cover to the dispense cap; providing the dispense container with the mixed at least one medicament, the dispense cap, and the cover to an end user.
7. The method of claim 6, further comprising receiving at the facility the plurality of dispense containers with the containers already filled with a base material.
58. The method of claim 57, further comprising receiving at the compounder the plurality of dispense containers with the containers already filled with a base material.
9. The method of any of claim 6, further comprising adding a prescription label to an exterior of the dispense container and packaging the dispense container in an envelope.
61. The method of claim 57, further comprising adding a prescription label to an exterior of the dispense container and packaging the dispense container in an envelope.
11. The method of claim 10 further comprising adding a cover over the applicator cap.
64. The method of claim 62 further comprising adding a cover over the applicator cap.
17. The method of claim 12 further comprising attaching a threaded lid with a shaft and paddle attached thereto to the topical applicator and then attaching the topical applicator to a mixing apparatus.
18. The method of claim 17 further including attaching the shaft to the mixing apparatus.
19. The method of claim 12 further comprising adding a cover to the applicator cap.
20. The method of claim 19 further comprising putting a prescription label on the topical applicator.
65. The method of claim 62 further comprising attaching a threaded lid with a shaft and paddle attached thereto to the topical applicator before attaching the topical applicator to the mixing apparatus.
66. The method of claim 65 further including attaching the shaft to the mixing machine.
67. The method of any claim 62, further comprising adding a cover to the applicator cap.
68. The method of claim 67 further comprising putting a prescription label on the topical applicator.
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.
Claim(s) 47, 52, 57-60, 62, 64-67 are rejected under 35 U.S.C. 103 as being unpatentable over Konietzko US 5397178 in view of Thulin US 2013/0170886 A1.
Regarding claim 47 and 62, Konietzko discloses a method of preparing a topical applicator (abstract), including: introducing topical formulation constituents into an empty topical applicator container with a movable elevator (Col 3 lines 10-25 which disclose a container with a movable bottom or elevator, Col 4 line 10-15 disclose the materials are mixed in the container and therefore much be added to the container); attaching the topical applicator to a mixing apparatus (fig 7 and Col 4 lines 46-54); mixing the topical formulation constituents into a topical formulation by the mixing apparatus (fig 7 and Col 4 lines 46-68); removing the topical applicator container and movable elevator with the topical formulation constituents mixed (Col 4 lines 65-68); and applying a dispense cap (Col 5 lines 5-15).
Konietzko fails to disclose a knob to move the elevator and a dispense cap having a skin engagement surface with a plurality of dispense apertures to the topical applicator to thereby enclose the topical formulation.
Thulin discloses a dispenser with a movable elevator (abstract) there by being in a related field of endeavor. Thullin also teaches a knob (32, fig 1) for moving the elevator up in order to dispense the product [0049] and that the dispenser cap (52, fig 1) as a skin engagement surface with a plurality of dispense apertures to the topical applicator to thereby enclose the topical formulation [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used a knob to move the elevator of Konietzko as it is a known means for moving a movable base up to dispense a product. Additionally, the addition of a cap with holes for product dispensing is also well known and as taught by Thulin aid in application of the product [0048].
Regarding claim 52, 64, and 67, Konietzko in view of Thulin, Thulin further discloses the dispenser has a cover (28, fig 1) [0056].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have added a cover as taught by Thulin to underlying composition free from dust, contamination, and accidental spillage.
Regarding claim 57, Konietzko discloses a method of distributing pharmaceutical formulations in a dispense container (abstract), the method comprising:
receiving at a composing facility a plurality of dispense containers having elevators (Col 3 lines 10-25 which disclose a container with a movable bottom or elevator, and Col 1 lines 38-45 which disclose dispensing mixed compounds in small containers to avoid decanting off large containers, this implies the multiple different compounds can be mixed and put into containers for later distribution);
receiving at the compounding facility medicaments for adding to the dispense containers (implied because materials need to be present in order to be mixed);
adding at least one medicament to a reservoir of one of the dispense container at the compounding facility (implied because materials need to be present in order to be mixed and Col 1 line 55-62 discloses pharmaceutical compounds);
mixing at the compounding facility the at least one medicament in the reservoir of the dispense container by a mixer with a motor-powered paddle (Col 4 lines 60-65, which notes a power motor);
adding a dispense cap to the dispense container (Col 4 line 65- Col 5 line 15 which notes sealing the mixing “port” after mixing with a cap).
Konietzko fails to disclose a knob to move the elevator and a dispense cap having a skin engagement surface with a plurality of dispense apertures to the topical applicator to thereby enclose the topical formulation and a cover.
Thulin discloses a dispenser with a movable elevator (abstract) there by being in a related field of endeavor. Thulin also teaches a knob (32, fig 1) for moving the elevator up in order to dispense the product [0049] and that the dispenser cap (52, fig 1) as a skin engagement surface with a plurality of dispense apertures to the topical applicator to thereby enclose the topical formulation [0048]). Thulin further discloses the dispenser has a cover (28, fig 1) [0056].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used a knob to move the elevator of Konietzko as it is a known means for moving a movable base up to dispense a product. Additionally, the addition of a cap with holes for product dispensing is also well known and as taught by Thulin aid in application of the product [0048]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have added a cover as taught by Thulin to underlying composition free from dust, contamination, and accidental spillage.
Regarding claim 58, Konietzko discloses further comprising receiving at the compounder the plurality of dispense containers with the containers already filled with a base material the containers (Col 1 lines 10-25 which disclose the compounds require a base material, sometimes multiple, to be added prior to mixing).
Regarding claim 59, Konietzko discloses further comprising adding a base material to the reservoir of the one of the dispense container (Col 1 lines 10-25 which disclose the compounds require a base material, sometimes multiple, to be added prior to mixing).
Regarding claim 60, Konietzko discloses further comprising adding a plurality of medicaments to the reservoir before the mixing (Col 1 lines 10-25 which disclose the compounds require a base material or medicament, sometimes multiple, to be added prior to mixing).
Regarding claim 65, Konietzko discloses further comprising attaching a threaded lid with a shaft and paddle attached thereto to the topical applicator before attaching the topical applicator to the mixing apparatus (Col 4, lines 45-55).
Regarding claim 66, Konietzko discloses further including attaching the shaft to the mixing machine (fig 7, shows a shaft, 54, attached to the machine, Col 4, lines 45-55).
Claim(s) 49-51, 61, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Konietzko US 5397178 in view of Thulin and in further view of Konietzko US 2017/0050157 A1 (hereafter referred to as Konietzko-2017).
Regarding claim 49 and 68, Konietzko in view of Thulin fail to disclose further comprising applying a prescription label to the applicator.
Regarding claim 50, Konietzko in view of Thulin fail to disclose further comprising packaging the applicator in a sealed prescription envelope with instructions for use.
Regarding claim 51, Konietzko in view of Thulin fail to disclose further comprising packaging the applicator in a sealed prescription envelope with instructions for use.
Regarding claim 61, Konietzko in view of Thulin fail to disclose further comprising applying a prescription label to the applicator and packaging the dispense container in an envelope.
Regarding claims 49-51, 61 and 68 Konietzko-2017 teaches a compound formulating method/ machine (abstract). Konietzko-2017 teaches applying a label along with pertinent patient information [0087]. Additionally, Konietzko-2017 teaches the process is performed in a pharmacy thereby being at a single location [0009].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a label and performed the mixing application in one setting as the mixed compound would need to be labeled so the contents was known. Different mediations require different strengths and or mixing prior to dispensing to allow for the product to be self-stable until needed.
While Konietzko-2017 fails to teach packing the medication in an envelope. It would have been obvious to one of ordinary skill in the art to have packed the labeled medication container into the envelop to product the patient’s privacy after purchase.
Allowed Claims
Claim 48, 53-54, and 63 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: US 5397178, US 2017/00501574, and US 10315832.
US 5397178 and US 2017/00501574 teaches mixing a pharmaceutical compound by adding a compound to a container, mixing the compound and sealing the container. There is no mention of applying a dispensing cap or purging the reservoir of the dispense container of air by pushing the elevator toward the dispense cap without rotating a knob opposite the dispense cap.
US 10315832 teaches a dispenser with an elevator and knob and dispensing cap, and filling the dispenser from a top-down or bottom-up approach; however, US 10315832 fail to teach attaching and removing the applicator/ dispenser to a mixing apparatus, mixing the contents within the applicator/ dispenser, and purging the reservoir of the dispense container of air by pushing the elevator toward the dispense cap without rotating a knob opposite the dispense cap.
All of the reference alone or in combination fail to teach or suggest purging the reservoir of the dispense container of air by pushing the elevator toward the dispense cap without rotating a knob opposite the dispense cap.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
