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 .
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) 1 – 3, 5 – 7, 12 – 14, and 16 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak et al. (USPN 4,927,408 – in IDS) in view of Manzo (US PGPUB 2016/0213514 – in IDS).
Regarding claims 1, 12, 19, and 20, Haak discloses a hydrogelionic circuit based electrical biofilm treatment system and method (e.g. ABSTRACT, col 2, lines 15 – 24, col 7, lines 18 – 28), comprising: a first chamber containing a salt solution (e.g. electrolyte reservoir 28, FIG. 1, col 4, lines 51 – 55; The electrolyte reservoir 28 ... may contain any one or more of the following: NaCl, electrochemically inert salts and buffers", col 9, lines 58 – 63); a second chamber containing a therapeutic solution (e.g. agent reservoir 26, FIG. 1, col 4, lines 51 – 55; expressions “agent” and "drug" are used interchangeable ... as any therapeutically active substance, col 3, line 68 – col 4, line 5), the second chamber being configured to interface with a portion of a surface overlaying a target region (e.g. The system adheres to the skin 22, FIG. 1, col 4, lines 48 – 55); a hydrogel membrane separating the first chamber from the second chamber (separated by a selectively permeable membrane 30, FIG. 1, col 4, lines 51 – 55; The selectively permeable membrane 30 may also be a hydrogel, col 6, lines 23 – 25); and an electrode (donor electrode 10, FIG. 1, col 4, lines 40 – 41) configured to apply an electrical current to the first chamber to induce an ion current in the salt solution, wherein the ion current acts on the second chamber to iontophoretically transport molecules from the therapeutic solution across the surface to the target region (electrical current to facilitate agent delivery, ABSTRACT; first electrode pad positioned in current conducting relationship to said body surface, col 3, lines 10 – 35; Transport of species during the passage of electrical current is accomplished via ... electromigration, col 7, lines 17 – 51). But Haak fails to teach a third and fourth chamber and a counter electrode coupled to the third chamber and forming a complete circuit with the electrode.
Manzo teaches it is known to use a counter electrode, wherein the electrode and the counter electrode are configured to form a complete circuit in which the ion current flows across the surface overlaying the target region through the first chamber, the second chamber, the third chamber, and the fourth chamber in between the electrode and the counter electrode (e.g. ¶ 10, 25 and Figs. 1A-1C).
It would have been obivous to one having ordinary skill in the art to modify the invention as taught by Haak with the counter electrode, third chamber and fourth chamber as taught by Manzo, since such a modification would provide the predictable results of better allowing ion current flow across the target region.
Regarding claim 2 and 13, Haak discloses the hydrogel membrane is ionically conductive configured to transmit the ion current to the second chamber (e.g. allowing passage of the counter ions, col 6, lines 24 – 45; col 7, lines 17 – 51).
Regarding claims 3 and 14, Haak discloses the hydrogel membrane as claimed above, but doesn’t specifically recite a polyethylene glycol (PEG) hydrogel matrix or the other solutions. Haak does discloses using various materials and that “the hydrogel can be any state of the art material” (e.g. col 8, lines 10 – 20). Using a PEG hydrogel matrix was well known to provide transport. It would have been obvious to one having ordinary skill in the art to modify the hydrogel membrane as taught by Haak with the well known PEG hydrogel matrix, since such a modification would provide the predictable results of providing effective transport.
Regarding claims 5 and 16, Haak discloses the salt solution comprises at least one of: a phosphate salt solution, a sulfate salt solution, citrate salt solution, carbonate salt solution, or polyacrylate salt solution (electrolyte reservoir 26 would be ... sodium phosphate buffer, col 13, lines 10 – 14).
Regarding claims 6 and 17, Haak discloses the salt solution as previously described, but fails to describe wherein the salt solution contains an amount of salt required to maintain a pH in the range of 6.5 to 8.5 at the surface overlaying the target region. Haak does disclose that pH could damage the skin (e.g. col 2, lines 45 – 49) as well as disclosing the use of buffers to control pH (e.g.col 9, lines 58 – 63) as well as disclosing pH is a variable in the transport equation (e.g. col 8, lines 10 – 20, col 8, lines 60 – 66). It would have been obvious to one having ordinary skill in the art at the time the invention was made to select the appropriate pH based on the electrolyte being used, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Regarding claim 7, Haak discloses the salt solution is configured to absorb heat generated by electrode overpotential to maintain a temperature below 43°C at the surface overlaying the target region (e.g. the device is capable of based on the current supplied, col 4, line 51 – 55, col 9, lines 58 – 63, it is noted that it is an inherent capability of contents of reservoir to absorb, at least some, heat).
Regarding claim 18, the device as taught by Haak in view of Manzo would have been capable of overlaying a cutaneous wound.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak et al. as applied to claims 1 and 20 above, and further in view of Keating et al. (US PGPUB 2004/0052857 – in IDS).
Regarding claim 4 and 15, Haak in view of Manzo discloses the hydrogel membrane as described above, but fails to describe wherein the hydrogel membrane is configured to configured to contain salt ions stably within the first chamber due to aqueous two-phase separation (ATPS). Haak describes various materials for the hydrogels, including cellulose, PVA, polyacylmide and others (col 6, lines 23 – 39) used to separate the salt reservoir. Keating discloses such materials (e.g. ¶ 59) used with salts in ATPS (e.g. ABSTRACT and ¶ 53). Accordingly, it would have been obvious to one having ordinary skill in the art to modify the materials used by Haak in view of Manzo with the claimed combination of materials and salts as disclosed by Keating, since such a modification would provide the predictable results of reducing passive diffusion.
Claim(s) 8 – 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak et al. in view of Manzo as applied to claim 1 above, and further in view of EyeGate Pharmaceuticals (WO 2010/009087 A1 – in IDS).
Regarding claims 8 – 11, Haak discloses the chambers as previously described, but fails to explicitly recite the chambers are embedded within an ocular lens. EyeGate describes an ocular lens within a layered iontophoresis device (e.g. FIGS. 23 – 25, page 24, line 28 – page 27, line 20), as well as other ocular iontophoresis delivery device with an electrode (3), a layer of hydrogel containing salt (4) and a therapeutic reservoir (5), (e.g. FIG. 20, page 11, lines 1 – 9; page 34, lines 6 – 11). It would have been obvious to one having ordinary skill in the art to incorporate the therapeutic device of Haak in view of Manzo in any physical form, such as the ocular lens of EyeGate, so as to facilitate ocular drug delivery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796