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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) for the following reasons:
a) The figures appear to be pixelated and blurry. All lines should be solid, dark, and continuous.
b) Some figures seen to be photographs
The figures fail to show details (especially microstructures, bulb shapes, and labels in figs. 1-3, etc.) as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Claim Objections
Applicant is advised that should claim 7 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 is a duplication of claim 7. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3-6, 8, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (KR Publication No. 2021-0012215), hereinafter, Choi, in view of Lonky (US Patent No 8,915,894), hereinafter, Lonky, further in view of Angel (US Patent No. 7,066,922), hereinafter, Angel, and further in view of Stanley (US Patent No. 5,122,127). Hereinafter, Stanley.
Regarding claim 1, Choi discloses a mucosal suction patch (Choi: suction portion 330 has a shape like a sucker of an octopus, a crater shape in fig. 3a; pp. 5, paragraphs 10-13) comprising at least one bulb having an elasticity such that, the at least one bulb being in an expanded state, upon applying mechanical pressure on the pressure applying surface, the at least one bulb is deformed, and when the mechanical pressure is released while the mucosa sealing surface is on a subject mucosa, the at least one bulb at least partially regains its expanded state, temporarily creating negative pressure inside the at least one cavity, which deforms the mucosa, which reversibly fills up at least part of the at least one bulb cavity (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6).
Choi fails, however, to disclose that the mucosal suction patch has an external volume of between 50 µL and 5000 µL and that the mucosal patch comprises:
at least one bulb forming at least one cavity, each of the at least one cavity being in fluid communication with at least one opening, and one or more of the at least one cavity enclosing a drug;
a mucosa sealing surface delimiting the at least one opening;
a pressure applying surface opposite to the mucosa sealing surface;
and causes the drug to migrate in the mucosa.
Angel teaches a mucosal suction patch having an external volume of between 50 µL and 5000 µL (Angel: transdermal transport device 10 has volume capacity in the range of 100 µL to 5 mL, or 100 µL to 5000 µL in figs. 2A and 2B; col. 8, lines 51-56)
Lonky teaches a patch comprising at least one bulb forming at least one cavity (Lonky: vacuum cup 110 includes a top 220 and base 240 with connecting side walls 230 that define a hollow interior cavity 290 in figs. 1-4; col. 7, lines 62-64), each of the at least one cavity being in fluid communication with at least one opening (Lonky: hollow cavity 290 comprises surfaces that are in direct contact with the skin including surfaces 250 and 312 and, therefore, constitute an opening in fluid communication with the skin; col. 7, line 64 – col. 8, line 6), and one or more of the at least one cavity enclosing a drug (Lonky: cavities located in the interior of vacuum cup 110 may contain a liquid agent for use as a drug delivery device; col. 15, lines 16-30);
a mucosa sealing surface delimiting the at least one opening (Lonky: the primary contact surface 555 of the cup base 240 can be covered with a sealing material 413, as shown in figs. 4-5; col. 9, lines 51-59); and
a pressure applying surface opposite to the mucosa sealing surface (Lonky: axial pressure 677 applied to surface opposite mucosa sealing surface at base 240 with sealing material 413 in fig. 6; col. 10, lines 27-33);
Stanley teaches causing the drug to migrate in the mucosa (Stanley: mucosal dome 10 including housing 12 for transmucosal delivery of a medication in a dose-to-effect manner in figs. 1-3; col. 10, lines 48-54).
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 oral mucosal suction patch of Choi, which included microstructures with sucker-like adsorption units that create suction upon mechanical pressing to the oral mucosa, to incorporate the compressible vacuum cup structure with a defined hollow interior cavity capable of enclosing a drug/agent, a sealing material on the contact surface, and a pressure applying surface opposite the sealing surface, as taught by Lonky, in order to provide a more robust, self-contained bulb-like cavity for controlled drug enclosure and reliable vacuum-assisted delivery while maintaining direct mucosal contact.
It would have further been obvious to select the external volume of the patch/cavity to be between 50 µL and 5000 µL, as taught by Angel, in order to provide an appropriate dose volume for localized transmucosal delivery.
It would have further been obvious to utilize the resulting suction patch such that the drug migrates in the mucosa, as taught by Stanley, in order to achieve efficient systemic delivery of the active agent through direct mucosal contact.
Regarding claim 3, modified Choi discloses the mucosal suction patch of claim 1, but fails to disclose that the drug is in a formulation further comprising at least one excipient.
Stanley teaches that the drug is in a formulation further comprising at least one excipient (Stanley: permeation enhancer used for altering drug’s permeability across mucosal membrane; col. 8; lines 39-42).
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 mucosal suction patch of the modified Choi device to include at least one excipient in the drug formulation, as taught by Stanley, in order to alter the drug’s permeability across the mucosal membrane and thereby improve transmucosal delivery and absorption of the active agent.
Regarding claim 4, modified Choi discloses the mucosal suction patch of claim 3, wherein the at least one excipient comprises a permeation enhancer (Stanley: permeation enhancer used for altering drug’s permeability across mucosal membrane; col. 8; lines 39-42).
Regarding claim 5, modified Choi discloses the mucosal suction patch of claim 1, comprising a single bulb (Lonky: vacuum cup 110 includes a top 220 and base 240 with connecting side walls 230 that define a hollow interior cavity 290 in figs. 1-4; col. 7, lines 62-64).
Regarding claim 6, modified Choi discloses the mucosal suction patch of claim 1, further comprising a sealer (Lonky: the primary contact surface 555 of the cup base 240 can be covered with a sealing material 413, as shown in figs. 4-5; col. 9, lines 51-59).
Regarding claim 8, modified Choi discloses the mucosal suction patch defined in claim1, for transmucosal administration of the drug to a subject (Stanley: mucosal dome 10 including housing 12 for transmucosal delivery of a medication in a dose-to-effect manner in figs. 1-3; col. 10, lines 48-54).
Regarding claim 15, modified Choi discloses the mucosal suction patch of claim 1, wherein the mucosa is oral or vaginal mucosa (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6).
Regarding claim 16, modified Choi discloses the mucosal suction patch claim 1, wherein the mucosa is oral mucosa (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Lonky, Angel, and Stanley, as applied to claim 1, and further in view of (Baik, S., Kim, D. W., Park, Y., Lee, T. J., Ho Bhang, S., & Pang, C. (2017). A wet-tolerant adhesive patch inspired by protuberances in suction cups of octopi. Nature, 546(7658), 396-400), hereinafter, Baik et al.
Regarding claim 2, modified Choi discloses the mucosal suction patch of claim 1, but fails to expressly disclose that the at least one bulb's elasticity is of about 0.01 MPa to about 1000 MPa.
Baik et al. teaches that the at least one bulb's elasticity is of about 0.01 MPa to about 1000 MPa (Baik et al., pp. 400, paragraph 1, “E is the elastic modulus of the polymeric materials (for s-PUA, this is about 1.5 MPa; for polydimethylsiloxane (PDMS), another polymer that we used to create OIAs so as to analyse their adhesion mechanism, E is about 0.1 MPa)”).
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 mucosal suction patch of the modified Choi device to be formed of a material having an elasticity (Young’s modulus) of about 0.01 MPa to about 1000 MPa, as taught by Baik et al., in order to allow the bulb (or suction microstructures) to deform under applied mechanical pressure on the pressure applying surface and at least partially regain its expanded state upon release while sealed to the mucosa, thereby creating the claimed temporary negative pressure inside the cavity.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Lonky, Angel, and Stanley, as applied to claim 1 above, and further in view of (Taverner, A., MacKay, J., Laurent, F., Hunter, T., Liu, K., Mangat, K., ... & Mrsny, R. J. (2020). Cholix protein domain I functions as a carrier element for efficient apical to basal epithelial transcytosis. Tissue Barriers, 8(1), 1710429), hereinafter, Taverner et al.
Regarding claim 7, modified Choi discloses the mucosal suction patch of claim 1, but fails to disclose that the drug has a molecular weight of about 1 kDa to about 50 kDa.
Taverner teaches that the drug has a molecular weight of about 1 kDa to about 50 kDa (Taverner et al., pp. 6, col. 1, paragraph 1; “RFP alone, having a molecular weight of 25.9 kDa was used as a transcytosis control”; pp. 17, col. 2, paragraph 1; further exemplified with human growth hormone fusions, ~22 kDa, in the context of efficient epithelial transcytosis across mucosal barriers).
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 mucosal suction patch of the modified Choi device to enclose a drug in the cavity for transmucosal deliver, such that the drug has a molecular weight of about 1 kDa to about 50 kDa, as taught be Taverner et al., in order to enable effective delivery of therapeutically relevant macromolecular drugs that are otherwise difficult to administer transmucosally.
Claim 17 is rejected for the same reasons set forth above with respect to claim 7.
Claims 9, 12-14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Stanley.
Regarding claim 9, Choi discloses a method of using a mucosal suction patch (Choi: suction portion 330 has a shape like a sucker of an octopus, a crater shape in fig. 3a; pp. 5, paragraphs 10-13) comprising:
applying mechanical pressure on the mucosal suction patch containing the drug prior to or while placing a mucosal sealing surface of the mucosal suction patch on a mucosa of the subject; and releasing the mechanical pressure on the mucosal suction patch to create a suction and deformation of the mucosa (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6),
whereby the drug migrates through the mucosal epithelium and enters systemic circulation of the subject (Stanley: mucosal dome 10 including housing 12 for transmucosal delivery of a medication in a dose-to-effect manner in figs. 1-3; col. 10, lines 48-54).
Choi fails, however, to explicitly disclose the transmucosal delivery of a drug in a subject, whereby the drug migrates through the mucosal epithelium and enters systemic circulation of the subject.
Stanley teaches for the transmucosal delivery of a drug in a subject (Stanley: mucosal dome 10 including housing 12 for transmucosal delivery of a medication in a dose-to-effect manner in figs. 1-3; col. 10, lines 48-54) whereby the drug migrates through the mucosal epithelium and enters systemic circulation of the subject (Stanley: mucosal dome 10 including housing 12 for transmucosal delivery of a medication in a dose-to-effect manner in figs. 1-3; col. 10, lines 48-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the mucosal suction patch of Choi as a method of using a mucosal suction patch for the transmucosal delivery of a drug in a subject comprising applying mechanical pressure on the mucosal suction patch containing the drug prior to or while placing a mucosal sealing surface of the mucosal suction patch on a mucosa of the subject, and releasing the mechanical pressure on the mucosal suction patch to create a suction and deformation of the mucosa, whereby the drug migrates through the mucosal epithelium and enters systemic circulation of the subject, as taught by Stanley, in order to achieve effective non-invasive systemic delivery of the drug through direct mucosal contact and suction-enhanced adhesion.
Regarding claim 12, modified Choi discloses the method of claim 9, wherein the mucosal suction patch is applied on the mucosa for about 1 minute to 10 hours, preferably 5 minutes to 30 minutes (Choi: the biodegradable adhesive used for body part 100 is completely dissolved 6 to 10 hours after being attached so that the user can separate it after being attached to the oral mucosa; pp. 4, paragraph 8).
Regarding claim 13, modified Choi discloses the method of claim 9, but fails to disclose that the drug is in a formulation further comprising at least one excipient.
Stanley teaches that the drug is in a formulation further comprising at least one excipient (Stanley: permeation enhancer used for altering drug’s permeability across mucosal membrane; col. 8; lines 39-42).
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 mucosal suction patch of the modified Choi device to include at least one excipient in the drug formulation, as taught by Stanley, in order to alter the drug’s permeability across the mucosal membrane and thereby improve transmucosal delivery and absorption of the active agent.
Regarding claim 14, modified Choi discloses the method of claim 13, wherein the at least one excipient comprises a permeation enhancer (Stanley: permeation enhancer used for altering drug’s permeability across mucosal membrane; col. 8; lines 39-42).
Regarding claim 18, modified Choi discloses the method of claim 9, wherein the mucosa is oral or vaginal mucosa (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6).
Regarding claim 19, modified Choi discloses the method of claim 9, wherein the mucosa is oral mucosa (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Stanley, as applied to claim 9 above, and further in view of Baik et al.
Regarding claim 10, modified Choi discloses the method of claim 9, but fails to explicitly disclose that the mucosal suction patch adheres to the mucosa with a strength of about 0.5 kPa to about 200 kPa.
Baik et al. teaches that the mucosal suction patch adheres to the mucosa with a strength of about 0.5 kPa to about 200 kPa (Baik et al., pp. 397, fig. 2, “the normal adhesion forces of the 50-μ m OIA sample increased noticeably when exposed to wet or oily conditions (with adhesion forces of around 37 kPa in moist conditions, 41 kPa under water, and 154 kPa under silicone oil)”).
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 method of using the mucosal suction patch of modified Choi, wherein the mucosal suction patch is pressed onto the mucosa to create suction and deformation, such that the mucosal suction patch adheres to the mucosa with a strength of about 0.5 kPa to about 200 kPa, as taught by Baik et al., in order to provide sufficient and reliable adhesion strength for maintaining the patch in place on the mucosa during the desired delivery period while still allowing easy removal.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Stanley, as applied to claim 9 above, and further in view of Lonky.
Regarding claim 11, modified Choi discloses the method of claim 9 comprising at least one bulb, whereby the at least one bulb having an elasticity such that, the at least one bulb being in an expanded state, upon applying the mechanical pressure on the pressure applying surface, the at least one bulb is deformed, and when the mechanical pressure is released, the at least one bulb at least partially regains its expanded state (Choi: when various sucker shapes of microstructure 300 of oral patch 100 are pressed toward oral mucosa10, adsorption of the microstructure is applied due to negative pressure; once applied, non-adhesive portion is dissolved so that effective material 110 can be released into the oral cavity through the release surface in figs. 8-9; pp. 7, paragraphs 4 and 6).
Modified Choi fails, however, to disclose the at least one bulb forming at least one cavity, each of the at least one cavity being in fluid communication with at least one opening, and one or more of the at least one cavity enclosing the drug;
the mucosa sealing surface delimiting the at least one opening; and
a pressure applying surface opposite to the mucosa sealing surface.
Lonky teaches the at least one bulb forming at least one cavity (Lonky: vacuum cup 110 includes a top 220 and base 240 with connecting side walls 230 that define a hollow interior cavity 290 in figs. 1-4; col. 7, lines 62-64), each of the at least one cavity being in fluid communication with at least one opening (Lonky: hollow cavity 290 comprises surfaces that are in direct contact with the skin including surfaces 250 and 312 and, therefore, constitute an opening in fluid communication with the skin; col. 7, line 64 – col. 8, line 6), and one or more of the at least one cavity enclosing the drug (Lonky: cavities located in the interior of vacuum cup 110 may contain a liquid agent for use as a drug delivery device; col. 15, lines 16-30);
the mucosa sealing surface delimiting the at least one opening (Lonky: the primary contact surface 555 of the cup base 240 can be covered with a sealing material 413, as shown in figs. 4-5; col. 9, lines 51-59); and
a pressure applying surface opposite to the mucosa sealing surface (Lonky: axial pressure 677 applied to surface opposite mucosa sealing surface at base 240 with sealing material 413 in fig. 6; col. 10, lines 27-33);
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 method of using the mucosal suction patch of modified Choi such that the patch comprises at least one bulb forming at least one cavity, each of the at least one cavity being in fluid communication with at least one opening and one or more of the at least one cavity enclosing the drug, a mucosa sealing surface delimiting the at least one opening, and a pressure applying surface opposite to the mucosa sealing surface, whereby the at least one bulb has an elasticity such that upon applying mechanical pressure the bulb is deformed and upon release it at least partially regains its expanded state to create suction and deformation of the mucosa, as taught by Lonky, in order to provide the patch with a functional compressible bulb/cavity structure that enables reliable manual pressure-activated suction, sealing to the mucosa, drug enclosure, and enhanced transmucosal delivery.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Stanley, as applied to claim 9 above, and further in view of Taverner.
Regarding claim 20, modified Choi discloses the method of claim 9, but fails to disclose that the drug has a molecular weight of about 1 kDa to about 50 kDa.
Taverner teaches that the drug has a molecular weight of about 1 kDa to about 50 kDa (Taverner et al., pp. 6, col. 1, paragraph 1; “RFP alone, having a molecular weight of 25.9 kDa was used as a transcytosis control”; pp. 17, col. 2, paragraph 1; further exemplified with human growth hormone fusions, ~22 kDa, in the context of efficient epithelial transcytosis across mucosal barriers).
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 mucosal suction patch of the modified Choi device to enclose a drug in the cavity for transmucosal delivery, such that the drug has a molecular weight of about 1 kDa to about 50 kDa, as taught be Taverner et al., in order to enable effective delivery of therapeutically relevant macromolecular drugs that are otherwise difficult to administer transmucosally.
Conclusion
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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