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
This office action is responsive to the amendment filed on 02/20/2026. As directed by the amendment: claims 1-43 have been cancelled. Claims 44, 49, 55 and 60 have been added.
Thus, claims 44-65 are still pending in this application.
Applicant’s amendments to the specification, and abstract have overcome each and every objection previously set forth in the Non-final Office Action mailed on 10/21/2025.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the Non-final Office Action mailed on 10/21/2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 108 in figures 1B and 1C is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 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 44-65 are rejected under 35 U.S.C. 103 as being unpatentable over Unger et al (WO 2017173478 A1) in view of Fohrman et al (US 20150182703 A1).
Regarding claim 44, Unger et al disclose a device (see fig 1, device 10), comprising: an agent carrier for contacting an external surface of tissue of an eye of a subject (abstract, para 0032, 0241, claim 1), wherein the agent carrier comprises a solid agent carrier body (para 0061) and a plurality of channels extending partially or wholly through the agent carrier body to terminate at an agent transfer surface and configured to retain an agent and transport the agent to the tissue (para 0045-46 and 0106), and wherein the agent carrier comprises or is acoustically coupled to a piezoelectric substrate (piezoelectric substrate 14, para 0032 and claim 1); an electrode (electrode 12) electrically coupled to the piezoelectric substrate (para 0032, 0190 and claim 1); and a controller electrically coupled to the electrode and configured to apply an electrical signal to the electrode to propagate an acoustic wave on and/or in the piezoelectric substrate to noninvasively deliver the agent from the agent carrier into the tissue (para 0032, 0064 and claim 1).
Unger et al fail to teach said plurality of channels are a nanoscale plurality of channels but teach said agent carrier of the device may comprise any one or more of: an absorbent material, an adsorbent material, a micro channel, a reservoir, or a combination thereof (para 0045) and further teach the agent of the device may comprise an antibody, a drug, a nanoparticle, and any combination thereof (para 0061).
However, Fohrman et al disclose a device (see figs 6A-C) comprising an agent carrier (45) with a nanoscale plurality of channels (20 and para 0132 and 0134).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plurality of channels of Unger et al and incorporate the teachings of Fohrman et al to have said agent carrier comprises a nanoscale plurality of channels. This would provide the benefit of delivering said agent without alteration of the agents from their current or previous forms, thereby ensuring preservation of molecular and/or agent function, minimizing toxicity while yielding optimal bioavailability for the patient as well as providing for positive patient outcomes (para 0005).
Regarding claim 45, Unger et al in view of Fohrman et al disclose the limitations of claim 44 but fail to teach said device wherein at least 70% of the plurality of nanoscale channels have a maximum width exceeding the maximum width of the agent by no more than ten- fold (x10).
However, Fohrman et al disclose the plurality of nanoscale channels have an interior diameter of at least 4 times greater than the width of the largest protein macromolecules (para 0023).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Unger et al in view of Fohrman et al to wherein at least 70% of the plurality of nanoscale channels have a maximum width exceeding the maximum width of the agent by no more than ten- fold (x10) since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Unger et al in view of Fohrman et al would not operate differently with the claimed width and since the plurality of nanoscale channels of Fohrman et al have a maximum width exceeding the maximum width of the agent, then the device would function appropriately having the claimed width. Further, applicant places no criticality on the width claimed, indicating simply that at least 70% of the plurality of nanoscale channels have a maximum width exceeding the maximum width of the agent by no more than ten- fold (x10) (specification pp. [0117]).
Regarding claim 46, Unger et al in view of Fohrman et al disclose the limitations of claim 44 and further teach wherein the plurality of channels terminate at the agent transfer surface as pores (para 0048 and 0108) but fail to teach said pores having a maximum width between 1 nm and 500nm.
However, Fohrman et al disclose nanoscale channels with an outer diameter of approximately 900 to 90,000 nanometers each (para 0023).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Unger et al in view of Fohrman et al by making the pores having a maximum width between 1 nm and 500nm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 47, Unger et al in view of Fohrman et al disclose the device of Claim 46, wherein the pores have randomized geometric shapes (para 0197, A wide variety of shapes and sizes of pores may be utilized).
Regarding claim 48, Unger et al in view of Fohrman et al disclose the limitations of claim 44 but fail to teach wherein at least 70% of the plurality of nanoscale channels have a maximum width of below 500 nm.
However, Fohrman et al disclose Fohrman et al disclose nanoscale channels with an outer diameter of approximately 900 to 90,000 nanometers (para 0023).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Unger et al in view of Fohrman et al to wherein at least 70% of the plurality of nanoscale channels have a maximum width exceeding the maximum width of below 500 nm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Unger et al in view of Fohrman et al would not operate differently with the claimed width and since the plurality of nanoscale channels of Fohrman et al have at least approximately 900 to 90,000 nanometers in size, then the device would function appropriately having at least 70% of the plurality of nanoscale channels have a maximum width of below 500 nm. Further, applicant places no criticality on the width claimed, indicating simply that at least 70% of the plurality of nanoscale channels have a maximum width of below 500 nm (specification pp. [0124]).
Regarding claim 49, Unger et al in view of Fohrman et al disclose the limitations of claim 44 but fail to teach wherein a porosity of the plurality of nanoscale channels accounts for up to 70% of a total volume of the agent carrier.
However, Unger et al discloses the agent carrier comprise any one or more of: a porous absorbent material, a porous adsorbent material (para 0045 and 0230).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Unger et al in view of Fohrman et al to have t a porosity of the plurality of nanoscale channels accounts for up to 70% of a total volume of the agent carrier since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Unger et al in view of Fohrman et al would not operate differently with the claimed porosity and since the plurality of nanoscale channels comprise any one or more of: a porous absorbent material, a porous adsorbent material, then the device would function appropriately having a porosity of the plurality of nanoscale channels accounts for up to 70% of a total volume of the agent carrier. Further, applicant places no criticality on the porosity claimed, indicating simply that a porosity of the plurality of nanoscale channels accounts for up to 70% of a total volume of the agent carrier (specification pp. [0072]).
Regarding claim 50, Unger et al in view of Fohrman et al disclose the limitations of claim 44 but fail to teach wherein the plurality of nanoscale channels are provided in an amount of at least 15000 channels/cm2 of the agent carrier body.
However, Fohrman et al disclose an agent carrier body with the plurality of nanoscale channels (see figs 6A-C).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Unger et al in view of Fohrman et al to have the plurality of nanoscale channels are provided in an amount of at least 15000 channels/cm2 of the agent carrier body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Unger et al in view of Fohrman et al would not operate differently having the plurality of nanoscale channels provided in an amount of at least 15000 channels/cm2 of the agent carrier body. Further, applicant places no criticality on the amount claimed, indicating simply that the plurality of nanoscale channels are provided in an amount of at least 15000 channels/cm2 of the agent carrier body (specification pp. [0019])
Regarding claim 51, Unger et al in view of Fohrman et al disclose the device of Claim 44, wherein the agent carrier is formed from silicon, porated silicon, germanium, graphene, synthetic polymer, or a combination thereof (para 0060).
Regarding claim 52, Unger et al in view of Fohrman et al disclose the device of Claim 44, wherein the device: does not comprise an electrode for contacting the tissue surface (see fig 1, electrode 12 does not contact tissue), and/or is not configured to utilize repulsive electromotive force to transport a charged agent into and/or through the tissue in contact with the agent transfer surface (para 0038, 0040 and para 0170).
Regarding claim 53, Unger et al in view of Fohrman et al disclose the device of Claim 44, wherein the agent transfer surface does not comprise microneedles (para 0050 and 0109).
Regarding claim 54, Unger et al in view of Fohrman et al disclose the device of Claim 44, wherein the device comprises an internal reservoir in fluid communication with the nanoscale channels and comprising some or all of the agent (para 0192, 0196).
Regarding claim 55, Unger et al disclose a method for delivering an agent to a target tissue of an eye of a subject (see fig 1, para 0062, 0160 and claim 1), the method comprising: providing a device (device 10) comprising: an agent carrier (abstract, para 0032, 0241, claim 1) comprising a solid agent carrier body (para 0061) having a plurality of channels that extend partially or wholly through the agent carrier body to terminate at an agent transfer surface (para 0045-46 and 0106), wherein the agent is held in the channels (para 0046), and wherein the agent carrier comprises or is acoustically coupled to a piezoelectric substrate (piezoelectric substrate 14, para 0032 and claim 1); an electrode (electrode 12) electrically coupled to the piezoelectric substrate (para 0032, 0190 and claim 1); and a controller electrically coupled to the electrode (para 0032, 0064 and claim 1); contacting an external surface of the target tissue of the eye with the agent transfer surface of the agent carrier (para 0062), and applying an electrical signal to the electrode of the device to propagate acoustic waves on and/or in the piezoelectric substrate of the device, and thereby deliver the agent from the agent carrier to the target tissue, wherein the target tissue remains intact during delivery (para 0062, 0064 and claim 1).
Unger et al fail to teach said plurality of channels are a nanoscale plurality of channels but teach said agent carrier of the device may comprise any one or more of: an absorbent material, an adsorbent material, a micro channel, a reservoir, or a combination thereof (para 0045) and further teach the agent of the device may comprise an antibody, a drug, a nanoparticle, and any combination thereof (para 0061).
However, Fohrman et al disclose a device (see figs 6A-C) comprising an agent carrier (45) with a nanoscale plurality of channels (20 and para 0132 and 0134).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plurality of channels of Unger et al and incorporate the teachings of Fohrman et al to have said agent carrier comprises a nanoscale plurality of channels. This would provide the benefit of delivering said agent without alteration of the agents from their current or previous forms, thereby ensuring preservation of molecular and/or agent function, minimizing toxicity while yielding optimal bioavailability for the patient as well as providing for positive patient outcomes (para 0005).
Regarding claim 56, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein the method comprises delivering the agent into or through any one or more of: epithelium, sub-epithelium, mucosa, sub-mucosa, mucous membrane vasculature, cornea, corneal epithelium, Bowman's membrane, corneal stroma, corneal endothelium, conjunctiva, Tenon's fascia, episclera, sclera, choroid, choriocapillaris, Bruch's membrane, retinal pigment epithelium, neural retina, retinal blood vessels, internal limiting membrane, and vitreous humour (para 0067).
Regarding claim 57, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein the agent transfer surface does not penetrate the target tissue (para 0128 and 0132, claim 14).
Regarding claim 58, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein the delivery of the agent to the target tissue induces at least a mucosal immune response in the subject (para 0073, 0077 and 0223).
Regarding claim 59, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein the delivery of the agent to the target tissue induces a systemic immune response in the subject (para 0073, 0154 and 0222).
Regarding claim 60, Unger et al in view of Fohrman et al disclose the limitations of claim 55, but fail to teach wherein propagating the acoustic waves comprises generating ultrasonic power in a range of 0.05 to 5.25 Wcm2.
However, Unger et al discloses propagating the acoustic waves comprises generating ultrasonic power (para 0024).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Unger et al in view of Fohrman et al to have propagating the acoustic waves comprises generating ultrasonic power in a range of 0.05 to 5.25 Wcm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Unger et al in view of Fohrman et al would not operate differently having propagating the acoustic waves comprises generating ultrasonic power in a range of 0.05 to 5.25 Wcm2. Further, applicant places no criticality on the range claimed, indicating simply that the propagating the acoustic waves comprises generating ultrasonic power in a range of 0.05 to 5.25 Wcm2 (specification pp. [0020]).
Regarding claim 61, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein delivering the agent comprises transportation of the agent through the nanoscale channels by the acoustic waves to the agent transfer surface (para 0062, 0187 and 0225).
Regarding claim 62, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein the target tissue is a corneal epithelial tissue of the eye (para 0067).
Regarding claim 63, Unger et al in view of Fohrman et al disclose the method of Claim 62, wherein the method comprises contacting the agent transfer surface with the corneal epithelial tissue of the eye and delivering a target amount of the agent into the cornea of the eye (para 0160).
Regarding claim 64, Unger et al in view of Fohrman et al disclose the method of Claim 55, wherein the target tissue is a conjunctival tissue of the eye (para 0067).
Regarding claim 65, Unger et al in view of Fohrman et al disclose the method of Claim 64, wherein the method comprises contacting the agent transfer surface with the conjunctival tissue of the eye and delivering a target amount of the agent into the conjunctiva of the eye (para 0241 and claim 19).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 02/20/2026, with respect to the rejection(s) of claim(s) 44-65 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Unger et al (WO 2017173478 A1) in view of Fohrman et al (US 20150182703 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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