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 .
This office action is in response to applicant’s communication of 08/07/2025. Currently claims 1-2, 4, 7-11, 18-20, 25, 27, 30, 35, 37-39, 43-44, and 48-51 are rejected below.
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(s) 1-2, 4, 7-11, 18-20, 25, 27, 30, 35, 37-39, 43-44, and 48-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer (US 6,537,242 B1) in view of Glines (US 6,716,190 B1).
Palmer discloses a device (as in figures 1-10) for controlled application of a therapeutic solution to a tissue of a subject in need thereof, comprising: an applicator (10 or 36) that further comprises at least one micropore (40), wherein the at least one micropore comprises an opening that is substantially flush with a bottom surface of the applicator (see figure 4 and 3 for example); and a means (28/32) for reversibly attaching the applicator to a dispensing device.
Palmer discloses the claimed invention except for the smooth bottom surface (devoid of needles) and tapering openings. Gilnes teaches that it is known to use an applicator with a smooth bottom surface (devoid of needles) and tapering openings as set forth in the device shown in figures 2a-10 and particularly as in figure 2a-2b discussed in paragraphs at columns 13-15 to provide a known alternative means to dispense a fluid from a syringe or tube to treat a patient for a medical procedure. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Palmer with a smooth bottom surface (devoid of needles) and tapering openings as taught by Glines, since such a modification would provide the system with an applicator with a smooth bottom surface (devoid of needles) and tapering openings for providing a known alternative means to dispense a fluid from a syringe or tube to treat a patient for a medical procedure.
Concerning claim 2 and a plurality of micropores, wherein each of the micropores is substantially identical in size (note 40 and 43 multiples).
Concerning claim 4 and the device is configured for use with a cosmetic procedure, a medical procedure, or a combination thereof (see abstract).
Concerning claim 7 and the dispensing device comprises a syringe, container or tube (see 30).
Concerning claim 8 and the means for attaching the applicator to the dispensing device, syringe comprises a Luer fitting (see 28 and 34).
Concerning claim 9 and the dispensing device comprises a container of commercially available topical therapeutic agent, and the therapeutic solution comprises the contents of the container of commercially available topical therapeutic agent (note disclosure of the substance in container 30).
Concerning claim 10 and the means for reversibly attaching the applicator to the container of commercially available topical therapeutic agent comprises a first threaded surface disposed on a neck of the applicator, wherein the first threaded surface comprises threads that are complementary to a second threaded surface that is disposed near an opening of the container of commercially available topical therapeutic agent (see luer attaching structures on 28 and 34).
Concerning claim 11 and the therapeutic solution comprises a therapeutic agent (see paragraph at column 2 lines 39-44).
Concerning claim 18 and the diameter of the micropore is at least the size of the inner diameter of a 33-gauge needle; Palmer in view of Glines discloses the claimed invention except for the explicit disclosure of the micropore is at least the size of the inner diameter of a 33-gauge needle. It would have been obvious to one having ordinary skill in the art at the time the invention was made to the micropore is at least the size of the inner diameter of a 33-gauge needle, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). 33 Gauge needles are well known sizes to size medical dispensing and delivery devices in order to effectively transfer fluids in a controlled manner.
Concerning claim 19 and a sufficient diameter to permit the therapeutic solution to flow therethrough (see paragraph at column 2 lines 39-44).
Concerning claim 20 and the micropore comprises a diameter that is as large as an inner diameter of a 15-qauge needle.
Palmer in view of Glines discloses the claimed invention except for a diameter that is as large as an inner diameter of a 15-qauge needleless than about 0.5 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a diameter that is as large as an inner diameter of a 15-qauge needle since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Crafting micropores comprising a diameter that is as large as an inner diameter of a 15-qauge needle are well known sizes to size medical dispensing and delivery devices in order to effectively transfer fluids in a controlled manner.
Concerning claim 25 and the bottom surface of the applicator is substantially circular, substantially oval, or substantially polygonal in shape (see figure 4).
Concerning claim 27 and the applicator comprises a medical-grade material (note disclosure of material of 10 suitable for medical procedure).
Concerning claim 30 and the tissue comprises skin, muscle, connective tissue, or a combination thereof (note intended use of device 10 disclosure).
Concerning claim 35 and a device (note disclosure discussion in rejections above) for controlled application of a product during a cosmetic resurfacing procedure, the device comprising: a disc-shaped applicator Palmer 10 further comprising at least 12 micropores (40/43), wherein each of the micropores comprise a diameter of 1 mm or less; each of the micropores comprises an opening that is substantially flush with a bottom surface of the applicator (see figure 4 and 3 for example); and a Luer fitting (28/34). Also note Glines teachings tapering openings as set forth in the device shown in figures 2a-10 and particularly as in figure 2a-2b discussed in paragraphs at columns 13-15 to provide a known alternative means to dispense a fluid from a syringe or tube to treat a patient for a medical procedure.
Concerning claim 37 and a method of administering one or more therapeutic products to a tissue of a subject in need thereof, the method comprising: obtaining a volume of the therapeutic product; and expressing the volume of the therapeutic product through the device of claim1 and onto the tissue of the subject (note description of the Palmer device of claim 1 in the rejection above and see paragraph at column 2 lines 39-44).
Concerning claim 38 obtaining the volume of the therapeutic product comprises drawing the biological fluid into a syringe (see Palmer paragraph column 5 lines 28-44).
Concerning claim 39 and further comprising attaching an applicator to the syringe (see Palmer paragraph column 5 lines 45-62).
Concerning claim 43 and a method of reducing contamination during application of a topical solution to a subject in need thereof, the method comprising: obtaining a volume of topical solution; and expressing the volume of topical solution through the device of claim 1 and onto the tissue of the subject (see previous disclosure of claim 1 above and Palmer paragraph column 5 lines 28-44).
Concerning claim 44 and a kit for applying a therapeutic solution comprising the device of claim1 and a dispensing device (see previous disclosure of claim 1 above and dispensing device 30).
Concerning claims 48-51 see discussion above and rejections as made in claim 1 and Palmer in view of Glines teachings of an applicator with a smooth bottom surface (devoid of needles) and tapering openings as set forth in the device shown in figures 2a-10 and particularly as in figure 2a-2b discussed in paragraphs at columns 13-15 to provide a known alternative means to dispense a fluid from a syringe or tube to treat a patient for a medical procedure.
Response to Arguments
Applicant's arguments filed 8/7/2025 have been fully considered but they are not persuasive. As discussed in the rejection above examiner is of the position that Palmer in view of the teachings of Glines teaches the newly amended claims as pending.
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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783