Prosecution Insights
Last updated: August 14, 2026
Application No. 18/622,067

METHODS FOR BETTER DELIVERY OF ACTIVE AGENTS TO TUMORS

Non-Final OA §103§112
Filed
Mar 29, 2024
Priority
Jul 24, 2015 — provisional 62/196,578 +4 more
Examiner
VU, QUYNH-NHU HOANG
Art Unit
Tech Center
Assignee
Vivasor Inc.
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
1y 1m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allowance Rate
677 granted / 991 resolved
+8.3% vs TC avg
Strong +28% interview lift
Without
With
+27.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
39 currently pending
Career history
1044
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
44.2%
+4.2% vs TC avg
§102
19.4%
-20.6% vs TC avg
§112
27.3%
-12.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 991 resolved cases

Office Action

§103 §112
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). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “... the delivery device contacts one or more layers of epidermis with one or more reversible permeability enhancers...” of claim 1; the limitation “the one or more bioactive agents moves or diffuses deeper through the epidermis through a basal layer of the epidermis and into at least a portion of underlying viable dermis to achieve an uptake of a portion of the one or more bioactive agents by one or more susceptible blood capillary plexus or lymphatic capillary plexus” of the claim 1; the limitation “wherein after administration and uptake, the one or more bioactive agents circulates through the blood vasculature or lymphatic vasculature to one or more tumors” of the claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Note: applicant is requested to show a that the delivery device, i.e., needle contacts or inserts into an epidermis layer, and the bioactive agents moves/diffuses through the epidermis through a basal layer of the epidermis and into at least portion of underlying viable dermis. The Figs. 1-2B shows the structure of the skin layers but does not show that the needle being inserted into the epidermis layer, and the bioactive agent moves/diffuses through the epidermis through at least portion of underlying viable dermis. In addition, the Figs. 9A-9B are blurry. Examiner makes a guessing that the Figs. 9A-9B show as a cancer tumor, but they do not show the claimed subject matter, as required in the claimed invention. 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 Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 3-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 3-4 recite that “wherein the total liquid dosage of the one or more bioactive agents is administered to a plurality of depths within the epidermis consisting only of one or more viable epidermal layers and not a non-viable epidermal layer; “wherein the plurality of depths within the viable epidermis is from about 1µm to about 250 µm beyond the deepest non-viable epidermal layer but still within the viable epidermis” are vague. According to the original specification, US-PG Pub. 2004/0238570 states in para [0153] that: ... wherein the sub doses are administered to the skin (e.g., non-viable epidermis and/or viable epidermis and/or viable dermis) at a depth of about 10 μm to about 4,500 μm or about 1 μm to about 4,000 μm beyond a most superficial layer of the epidermis, but still within the viable skin above the subcutaneous tissue. Based on the statement in the para [0153] of the PGPub’570 above, it is confusing to Examiner that what is depth of the skin that not in a non-viable epidermal layer? The claim 4 states that the depths are within the viable epidermis is from 1-250 μm beyond the deepest non-viable epidermal layer. Based on the claim 5, it is contradicted with the statement in the para [0153] in PGPub’570 above. In other words, the range of 1µm to about 250 µm could be in non-viable epidermis and/or viable epidermis and/or viable dermis. 112 6th Acknowledgement With regard to Applicant’s “means for controlling the administration flow rate including at least one component” and the limitation “means for penetrating at least a most superficial layer of the epidermis” of claim 8, the language appears to be an attempt to invoke 35 USC 112, 6th paragraph interpretation of the claims. A claim limitation will be interpreted to invoke 35 U.S.C. 112, sixth paragraph, if it meets the following 3-prong analysis: (A) the claim limitations must use the phrase “means for ” or “step for; ” (B) the “means for ” or “step for ” must be modified by functional language; and (C) the phrase “means for ” or “step for ” must not be modified by sufficient structure, material or acts for achieving the specified function. In the instant case, applicant appears to have met the limitations set forth in MPEP § 2181, and examiner has turned to the specification for clarification. In the specification, applicant defines the “means for controlling the administration flow rate including at least one component” is equivalent to a pump, a fluid delivery rate controller, a syringe, a pen, an elastomer membrane.... Applicant defines the “means for penetrating at least a most superficial layer of the epidermis” as a needle. Accordingly, the examiner is interpreting the “means for controlling the administration flow rate including at least one component” is equivalent to a pump, a fluid delivery rate controller, a syringe, a pen, an elastomer membrane.... And the limitation “means for penetrating at least a most superficial layer of the epidermis” is interpreted to encompass a needle and its equivalents. Equivalent structures may include those that perform the function specified in the claim, structures that are not excluded by any specific definition provided in the specification for an equivalent, or is a structural equivalent of the corresponding element disclosed in the specification. See MPEP 2183. 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 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 1-11, 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Pettis et al. (US 2005/0180952) in view of Weadock et al. (US 10,376,674). Regarding claims 1 & 13, as best as understood, Pettis discloses a method of treating a subject with a disease comprising one or more tumors by administering one or more bioactive agents to the one or more cancers, i.e., tumors, lymph nodes, para [0017, 0035-0037] comprising: (a) applying one or more delivery devices having between 2 and 50,000 delivery structures, i.e., multiple needle arrays, para [0080], to one or more sites of a skin of a subject comprising blood vasculature and lymphatic vasculature, see abstract and para [0002, 0031], wherein the delivery device contacts one or more layers of epidermis (at least tips of the microneedles contact layer(s) of epidermis during an insertion; para [0082] states that: skin is penetrated to a depth of 0.5-2mm = 500-2000 µm (which is in the required ranges of the claimed invention); the formulations are delivered at a targeted depth just under the stratum corneum and encompassing the epidermis and upper dermis, e.g., about 0.025-2.5 mm = 25-2500 µm... For example: to target the Langerhan’s cells in the dermal space of human skin, delivery would need to encompass, at least, in part, the epidermal tissue depth typically ranging from 0.025-0.2 mm = 25-2500 µm in humans, para [0082]. Therefore, the delivery device, i.e., microneedles must be contacted at least one of the epidermis layers) with one or more reversible permeability enhancers comprising a chemical, physical permeability enhancer (e.g., cytotoxic drugs, or a chemical targeting of the tumor , e.g., tumor specific antibodies, receptors which target tumor surface makers, and markers which bind to tumor specific receptors would potentially enjoy the heist benefit since they both physically and chemically target the tumor cells, para [0128]) or electrical permeability enhancer (e.g., the microneedle array being used to delivery bioactive agents by electric field, such as iontophoresis, paras [0033, 0078, 0099]) that induces a reversible increase in the permeability of one or more barrier cells of the epidermis to at least one or more bioactive agents (para [0002]). Also see the depth of insertion into the skin about 0.3 mm = 300 µm, see paras [0084, 0086], which is in the requirement ranges 1-500 µm, as required in the claimed invention. Note: the limitation “... that induces a reversible increase in the permeability of one or more barrier cells of the epidermis to at least one or more bioactive agents” is a result of using delivery device (such as microneedle arrays or needle device) being inserted into the one or more layer of epidermis (e.g. the formulations are delivered at a targeted depth under the stratum corneum and encompassing the epidermis and upper dermis, para [0082]) with combine of using one or more reversible permeability enhancers. (b) administering a total liquid dosage (total amount of injection) in between 2 and 50,000 sub-doses of the one or more bioactive agents at a controlled administration flow rate (in certain flow rate) through the delivery device, para [0013, 0098-0099]. For example: each of the microneedle arrays holds at least one small sub-doses (compare with a total liquid dosage = total amount of each sub-doses contained in the microneedle arrays) for inserting into one or more sites of lymphadenitis; wherein each sub-dose of the one or more bioactive agents is independently administered, in an administering step, to a plurality of independent depths within the epidermis prior to any subsequent diffusion or movement of the one or more bioactive agents within the epidermis, (e.g., the formulations are delivered at a targeted depth at the epidermis, about 0.025-2.5 mm, para [0080, 0082]); Note: each of the microneedle arrays holds at least one sub-dose of the bioactive agent. Therefore, wherein each sub-dose of the one or more bioactive agents is independently administered to a plurality of independent depths within the epidermis prior to any subsequent diffusion or movement of the one or more bioactive agents within the epidermis. wherein the plurality of independent depths within the epidermis is from about 1 µm to about 500 µm beyond a most superficial surface layer of the epidermis of the subject (e.g., the formulations are delivered at a depth just under the stratum corneum encompassing the epidermis and upper dermis, about 0.025-2.5mm = 25-2500 µm, para [0082], which is in the requirement ranges 1-500 µm in the claimed invention. For example: to target the Langerhan’s cells in the dermal space of human skin, delivery would need to encompass, at least, in part, the epidermal tissue depth typically ranging from 0.025-0.2 mm = 25-2500 µm in humans, para [0082]) ; wherein following the administering, the one or more bioactive agents moves or diffuses deeper through the epidermis through a basal layer of the epidermis and into at least a portion of underlying viable dermis to achieve an uptake of a portion of the one or more bioactive agents by one or more susceptible lymphatic capillary plexus. In this case, a person skilled in the art would recognize that after the step of delivering agents at a target site, the agents are not staying in one area, but will spreading out, i.e., moving or diffusing wider and deeper through the epidermis or further deep underlying viable dermis or into lymphatic vessel, also see para [0015, 0024]. In addition, the limitation above is considered as functional limitation, or the resulting of after administering the one or more bioactive agent at the epidermis layer and into at least a portion of underlying viable dermis to achieve an uptake of a portion of the one or more bioactive agents by one or more susceptible lymphatic capillary plexus; wherein after administration and uptake, the one or more bioactive agents circulates through the blood vasculature or lymphatic vasculature to one or more tumors, para [0015, 0024,0055, 0059, 0067]. It is noted that this limitation is a considered as a functional limitation or a result of delivering the one or more bioactive agent by using the delivery device (having between 2 and 50,000 delivery/needle structures). In this case, Pettis discloses a same concept of using microneedle arrays (having between 2 to 50,000 delivery/needle structures) for delivering one or more bioactive agent in combine with one or more permeability enhancers into the epidermis tissue and therefore, the bioactive agents is moving and diffusing deeper through the epidermis through a basal layer of the epidermis and into at least a portion of underlying viable dermis and through to one or more tumors and thereby -65-38108-491administering the one or more bioactive agents to the one or more sites of lymphadenitis, and after administration and uptake, the bioactive agents moves in circulation through the blood vasculature or lymphatic vasculature to one or more tumors. Pettis does not disclose the limitation that wherein administration of one or more bioactive agents achieves a dermal interstitial fluid pressure in the underlying dermis beneath a site of administration of about 1 mmHg to about 15 mmHg. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the values above, since it has been held that discovering these values (e.g., 1 mmHg to about 15 mmHg) of a result effective variable involves only routine skill in the art. For example, the dermal interstitial fluid pressure value depends on the skin characteristic of each patient (children, adult, male, female or old patient) and depends on using pressure/force being injected into the target epidermis. Pettis does not disclose a method of using a greater concentration of the one or more bioactive agents is delivered to the one or more tumors compared to intravenous, intradermal, or subcutaneous delivery of the identical one or more bioactive agents. Weadock discloses a method of treating a subject with tumor disease by administering one or more bioactive agent to the tumor comprising a step of delivering a higher concentration of bioactive agent, i.e., chemotherapeutic agent to lymphatic tissue near a tumor for reducing a chance of tumor cells metastasizing into the nearby lympho-vascular system, regional lymph nodes, col. 10, line 60-col. 11, line 3. Giving such a teaching by Weadock, a person having ordinary skill in the art would have easily recognizes that modifying the method of treating/delivering bioactive agents to the tumor cell of Pettis with including a step of delivering a greater/higher concentration of bioactive agent, as taught by Weadock, would provide the benefit of reducing a chance of tumor cells metastasizing into the nearby lympho-vascular system, regional lymph nodes. Note: Pettis using a microneedle arrays device having 2-5000 delivery structures, i.e., microneedles, to deliver at tumor site. With the said of teaching by Weadock above, Pettis in view of Weadock is using the microneedle arrays device with greater concentration to deliver at the tumor sites, and thereby, a person skilled in the art would recognize that using multiple microneedles with greater concentration to deliver at the tumor sites will bring a good result of reducing of spreading of the cancer than using only one of device intravenous, intradermal or subcutaneous delivery at one small area of the insertion of the intravenous, intradermal or subcutaneous delivery device with the same bioactive agent. Regarding claim 2, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis discloses that wherein the total liquid dosage of the one or more bioactive agents administered to the plurality of independent depths, i.e. depths of an insertion of the plurality of independent microneedles, within the epidermis comprises administration to a depth within at least a portion of non-viable epidermis (e.g. formulations are delivered at a depth of 0.5mm-2.5mm = 500-2500µm, para [0082]; or inserting the tip of the needle into the skin to a depth of 1.5mm = 1500 µm, para [0084], which is outside of epidermis layer) and/or at least a portion of viable epidermis (e.g. the formulations are delivered at a depth just under the stratum corneum encompassing the epidermis and upper dermis, about 0.025-2.5mm = 25-2500 µm, para [0082]). Note: the thickness of the epidermis is in between 75-150µm, para [0005]; or about 1-150 µm, as required in the claims 3, 5-6 of the current application. Thus, if the depth of the insertion in between 75-150 µm is within epidermis, i.e., viable epidermis. If the depth of the insertion is not in the range of 75-150 µm, then the depth of the insertion is within a portion of non-viable epidermis, i.e., stratum corneum or dermis or subcutaneous layer. Regarding claim 3, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis discloses that wherein the total liquid dosage of the one or more bioactive agents is administered to a plurality of depths within the epidermis consisting only of one or more viable epidermal layers (e.g., the formulations are delivered at a depth just under the stratum corneum encompassing the epidermis and upper dermis, about 0.025-2.5mm = 25-2500 µm, para [0082]) and not a non-viable epidermal layer, i.e., stratum corneum layer. Regarding claim 4, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis discloses that wherein the plurality of depths within the viable epidermis is from about 1 µm to about 250 µm (e.g., the formulations are delivered at a depth just under the stratum corneum encompassing the epidermis and upper dermis, about 0.025-2.5mm = 25-2500 µm, para [0082]) beyond the deepest non-viable epidermal layer (i.e., stratum corneum layer) but still within the viable epidermis. Regarding claim 5, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis discloses that wherein the average of the plurality of independent depths exhibits a combined average sub-dose delivery depth within the epidermis of about 70 pm to about 175 pm (e.g. the formulations are delivered at a depth just under the stratum corneum encompassing the epidermis and upper dermis, about 0.025-2.5mm = 25-2500 µm, para [0082]) beyond the most superficial surface layer of the epidermis. In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the parameter of a combined average sub-dose delivery depth within the epidermis of about 70-175 µm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. For example: each patient has different thickness value of the epidermis tissue and depend on a target treatment area in deep or shallow area. Regarding claim 6, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis discloses that wherein the plurality of independent depths has a combined average depth of administration within the epidermis (e.g., the formulations are delivered at a depth just under the stratum corneum encompassing the epidermis and upper dermis, about 0.025-2.5mm = 25-2500 µm, para [0082]), wherein each independently administered sub-dose is at a depth within the epidermis that is deeper, shallower, or the same. In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the parameter of a combined average sub-dose delivery depth within the epidermis, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. For example: each patient has different thickness value of the epidermis tissue and depend on a target treatment area in deep or shallow area. Regarding claim 7, as best as understood, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis also discloses that wherein a frequency of each of the independent sub-dose administration depths within the viable epidermal layer (at an insertion depth is about 0.025-2.5mm = 25-2500 µm, para [0082]) and/or a non-viable epidermal layer (at an insertion depth is 0.5mm-2.5mm = 500-2500µm, para [0082]; or at an insertion depth of 1.5mm = 1500 µm, para [0084]), which is outside of epidermis layer exhibits a Gaussian distribution (normal distribution of the microneedle array) of depths. Regarding claim 8, Pettis in view of Weadock discloses all the claimed subject matter as required. Pettis also discloses that wherein the delivery device comprises an array comprising between 2 and 50,000 of the delivery structures in fluid communication with the one or more bioactive agents in a liquid carrier vehicle, wherein the delivery device comprises a means for controlling the administration flow rate including at least one component selected from the group consisting of a pump, a fluid delivery rate controller, a syringe (Fig. 10), a pen, an elastomer membrane, or any combination thereof, see para [0090]; wherein the delivery structures comprise a means. i.e. microneedles for penetrating at least a most superficial layer of the epidermis (at insertion depth of 0.025-2.5mm, para [0082]); and wherein the one or more bioactive agents in the liquid carrier vehicle is delivered by the delivery structures to the plurality of independent depths within a viable epidermis of the subject, thereby administering between 2 and 50,000 sub-doses of the one or more bioactive agents. Regarding claim 9, Pettis in view of Weadock discloses all the claimed subject matter as required in the claims 1 & 8 above except for the limitation that a controlled administration flow rate of the bioactive agent of about 0.1 to 100 µl/hr per delivery structure of the delivery structures. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to provide a flow rate of a controlled administration of bioactive agent at 0.1 to 100 µl/hr per delivery structure, since it has been held that discovering these values of a result effective variable involves only routine skill in the art. For example: it depends on type of skin of children, male, female... it also depends on ages, and depends on each treatment of the disease. Regarding claim 10, Pettis in view of Weadock discloses all the claimed subject matter as required in the claims 1 & 8 above. Pettis further discloses that wherein the delivery structures, i.e., microneedles comprise a standard, i.e., cylindrical in nature or nonstandard geometric shape, pyramidal, rectangular, octagonal, wedged, and other geometrical shapes para [0080]. Regarding claim 11, Pettis in view of Weadock discloses all the claimed subject matter as required in the claim 1 above except the limitation that wherein the overall controlled administration flow rate of the one or more bioactive agents to the plurality of depths within the epidermis is from about 0.02 µl/hr/cm2 to about 50,000 µl/hr/cm2 based on the total surface area of a delivery device that is in contact with the skin of the subject. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the values above, since it has been held that discovering these values of the flow rate (e.g., 0.02-50µl/hr/cm2) of a result effective variable involves only routine skill in the art. For example, the flow rate based on the total surface area that depends on the size of the tumors, the treatment of each condition of a patient. Regarding claim 14, Pettis in view of Weadock discloses all the claimed subject matter as required in the claim 1 above. Pettis discloses that wherein the one or more bioactive agents is delivered to a tissue volume of the epidermis encompassing the one or more bioactive agents prior to any subsequent diffusion or movement of the one or more bioactive agents within the epidermis of about 0.7 mm3 to about 2,500 mm3 (e.g., the injection volume is nor more than 100µL = 100 mm3, para [0079], or 75 µL = 75 mm3, para [0255]). In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the values above, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In addition, it depends on the treatment of each patient such as number of doses, or pressure/force being injected into the target epidermis. Regarding claim 15, Pettis in view of Weadock discloses all the claimed subject matter as required in the claim 1. Pettis discloses that wherein a concentration of the one or more bioactive agents within the one or more tumors is about 5-10 folds, para [0064] which is in the required ranges of 1.25-fold to about 50-fold more than intravenous, intradermal, or subcutaneous delivery of the one or more bioactive agents. In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the values above, since it has been held that discovering these values (e.g., 1.25-fold to about 50-fold) of a result effective variable involves only routine skill in the art. Regarding claim 16, Pettis in view of Weadock discloses all the claimed subject matter as required in the claim 1. Pettis discloses that wherein the bioactive agent is useful for retarding progression of, delaying onset of, prophylaxis of, amelioration of or reducing symptoms of the disease comprising the one or more tumors, paras [0038-0041]. Regarding claim 17, Pettis in view of Weadock discloses all the claimed subject matter as required in the claim 1. Pettis discloses that wherein the one or more bioactive agents is continuously administered to a subject for a time period of about 10 mins, para [0089], which is in the ranges of 0.1 hours = 6 mins to about 96 hours. In addition, the Fig. 4 shows the treatment about 3hrs to 4wks, or the Fig. 5 shows the treatment about 1hr-5hrs. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pettis et al. (US 2005/0180952) in view of Weadock et al. (US 10,376,674) and further in view of Ross (US 2013/0144257). Pettis in view of Weadock discloses all the claimed subject matter as required in the claim 1 above except for the limitation the physical permeability enhancers (of the microneedle arrays) comprises a nanostructured or nanotopography surface. Ross discloses a microneedle transdermal device 10 comprising: a microneedle arrays 12/22 with permeability enhancer (e.g. the microneedle array being used by electric field, such as iontophoresis for delivering bioactive agents); wherein the physical permeability enhancers comprise a nanostructured or nanotopography surface 26, see abstract, Fig. 3. It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the microneedle device of Pettis in view of Weadock with providing a physical permeability enhancer with a nanostructured or nanotopography surface, as taught by Ross, in order to allow the surface of the microneedle being interacted with the cells of the dermal barrier and improve efficiency of delivery and uptake of the bioactive agents, para [0071] in Ross. Examiner Notes Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Quynh-Nhu H. Vu/ Quynh-Nhu H Vu Primary Examiner, Art Unit 3783
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Prosecution Timeline

Mar 29, 2024
Application Filed
Jul 14, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
68%
Grant Probability
96%
With Interview (+27.5%)
3y 6m (~1y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 991 resolved cases by this examiner. Grant probability derived from career allowance rate.

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