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 2/24/2026. As directed by the amendment: claims 42 and 87 have been amended, claim 50 and 89-90 have been cancelled. Thus, claims 42-43, 46-49, 80-81, 83, 85-88, and 91-93 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the preceding 112a rejection on page 5:
Applicant's present amendment resolves the preceding office actions stated 112a rejection of the claims
Regarding applicant’s argument regarding the independent claims on page 5-7:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
“a cantilevered ring”
However, examiner’s preceding and present office action is clear in that Daddonna’s fig 1+38 demonstrates that its piston 134 inclusive of its release member 142, may be considered a cantilevered ring in the manner by which piston 134 forms a circular ring around member 142 and a flange (not enumerated) of piston 134 protrudes outward from the central member 14.
Applicant instead discusses reasons why a force member 130 cannot be considered a cantilevered ring, making it unclear to examiner whether applicant had adequately and completed reviewed the examiner’s office action.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
“the microprojection array is releasably detached from the device”
In this regard, applicant provides arguments as to why applicant’s invention constitutes an advantage over the prior art, citing their own disclosure.
In response to applicant's argument that the present invention provides a solution for microprojection array delivery which prevents bruising of the patient’s skin, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Examiner notes that the prior art of Daddona does disclose that in its embodiment of fig 1 that its microprojection array is releasably detached from the device in that upon piston 134 impacting section 138 of member 132, section 138 breaks which permits microneedles 108 to be propelled toward impacting/piercing the statum corneum 109, see paragraph 70-74 of Daddona. Fig 49 shows a similar embodiment to the embodiment of fig 1 where section 138 and the attached microneedles are releasably detached from the applicator.
In light of examiner’s arguments above, and examiner's rejection as necessitated by the amendment, below, the rejection of the presently amended claims in view of the prior art of record, stands.
Regarding applicant’s argument regarding dependent claims on page 7-10:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
In light of examiner’s arguments above, and examiner's rejection as necessitated by the amendment, below, the rejection of the presently amended claims in view of the prior art of record, stands.
Regarding claims 46-49, applicant particularly argues that examiner has not clearly linked the teachings of the prior art to the variable in the claim. Applicant asserts that because the kinetic energy by which a microprojection array impacts a skin layer is not the only variable which could impact penetration depth (e.g. detailing that momentum, needle geometry, and the viscoelastic nature of skin also impact this result) then the routine optimization presented in the rejection of record would not be taught/suggested by the prior art. Applicant also alleges that the prior art favor “heavier & lower velocity arrays” as opposed to the “lighter & higher velocity array” of applicant’s invention, however applicant has not provided sufficient detail nor arguments in this regard as to suggest that the ideal kinetic energy/momentum (formed by the mass of the array moving at a speed) of the prior art or present invention do not overlap nor that a person of ordinary skill in the art would not be motivated by the teachings in the prior art to make such a modification.
Examiner notes that not only is it is incredibly well understood by a person of ordinary skill in the art that kinetic energy and momentum are defined as some proportion of a speed and a mass of an element, such that routinely optimizing the kinetic energy of an element would obviously involve varying either or both of a speed and/or mass of that element, paragraph 65-66 detail an equation which demonstrates the relation ship between speed, mass, and kinetic energy.
Further examiner notes, that determining a result effective variable such that one would be motivated to routinely optimize this variable to effect a result, does not necessitate that all possible result effective variables be identified and considered during such an optimization, merely that the identified variable, such as an element having a kinetic energy (defined by its speed and mass), would effect the result of adequate skin penetration.
Accordingly, examiner has demonstrated, as supported by the prior art, that kinetic energy, based on a mass of an element moving at a speed, is a result effective variable impacting penetration depth such that varying a defined component of kinetic energy, such as mass or speed, will routinely optimize this kinetic energy for the desired effect of optimal penetration depth. Thus the combination of the prior art references of record stands.
Regarding claims 80-81, applicant particularly argues that for the same reasons as provide in their arguments pertaining to claims 46-49, instead relating to the mass component of kinetic energy, a person of ordinary skill in the art would not be motivated by the teachings in the prior art to make such a modification.
See examiner’s discussion above detailing the manner by which the prior art clearly links how a heavy or light mass impacts kinetic energy, which was clearly demonstrated as a result effective variable impacting penetration depth. Thus the combination of the prior art references of record stands for rejection the limitations of the present claim.
Regarding claims 87, applicant particularly argues the array holder of Daddona does not disclose the claimed tether.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., low mass tether) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
See examiner's rejection as necessitated by the amendment, below, detailing the prior art relied upon for disclosing/teaching the limitations of the presently amended claim.
Regarding claims 91-92, applicant particularly argues the cited references do not disclose nor teach the claimed applicator configuration with a set amount of force.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art relied upon for disclosing/teaching the limitations of the presently amended claims.
Regarding claims 93, applicant particularly argues the piston of the prior art remains attached to the microprojection array after impacting the array such that the mass of the piston impacts the skin surface.
However, applicant ignores that in the embodiment of Daddonna relied upon, fig 1, its microprojection array is releasably detached from the device in that upon piston 134 impacting section 138 of member 132, section 138 breaks which permits microneedles 108 to be propelled toward impacting/piercing the statum corneum 109, see paragraph 70-74 of Daddona. Fig 49 shows a similar embodiment to the embodiment of fig 1 where section 138 and the attached microneedles are releasably detached from the applicator. Such that the mass of microneedles 108 and frangible section 138 impact the skin, and not piston 134. Thus the combination of the prior art references of record stands for rejection the limitations of the present claim.
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 “the applicator further comprises a tether attached to the microprojection array such that the microprojection array is discharged from the device while being attached to the tether.” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 42-43, 46-49, 80-81, 85-86, 88 and 91-93 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150038897 A1, henceforth written as Daddona.
Regarding Claim 42
Daddona discloses:
A method for applying a microprojection array to skin surface comprising:
(microneedle array portion 108a; fig 1)
providing an applicator comprising
(applicator 100; fig 1)
a housing having a top and a bottom, --
(housing 102 having a top (not enumerated) and bottom (not enumerated) ; fig 1)
--a cantilevered ring having a primed position prior to activation of the applicator and a fired position after activation of the applicator and the microprojection array,
(hole (not enumerated) in center portion 128 retains the piston 134 via the release member 142, best illustrated in the embodiment of fig 5-6 as translating between the primed and fired position of applicator 100; fig 1; fig 1+38 demonstrate that piston 134 inclusive of its release member 142, may be considered a cantilevered ring in the manner by which piston 134 forms a circular ring around member 142 and a flange (not enumerated) of piston 134 protrudes outward from the central member 142)
wherein the microprojection array has a front surface and a rear surface,
(microneedle array portion 108a has a front surface with microneedles 108, and a rear surface including the frangible section 138 of the diaphragm member 132; fig 1)
wherein the microprojection array comprises a plurality of solid microprojections on the front surface,
(paragraph 51-53+76-78+81; microneedles 108 are demonstrated as a series of solid microneedles, such as being made of a solid titanium; fig 1)
wherein the microprojections are coated with a non-liquid coating,
(paragraph 53+78; solid coating is obtained on the microneedles 108 via drying a formulation upon it)
placing the applicator on the skin surface such that the bottom of the applicator housing is in contact with the skin surface;
(paragraph 52-54; describing use of applicator 100 to contact skin for dispensing the medication contained therein; fig 1)
and – [transitioning] the cantilevered ring from the primed position to the fired position [by] activating the cantilevered ring [to strike] -- the rear surface of the microprojection array and propels the microprojection array into the skin surface surface such that the microprojection array is releasably detached from the device.
(paragraph 56+70-74; piston 134 impacts section 138 of member 132 to propel microneedles 108 and section 138 to impact and pierces the stratum corneum 109; fig 49)
Daddona discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the top of the housing has a flexible section that when collapsed actuates the applicator,
and collapsing the flexible section of the housing which transitions the cantilevered ring from the primed position to the fired position, activating the cantilevered ring which -- the rear surface of the microprojection array and propels the microprojection array into the skin surface.
However, Daddona teaches a further embodiment:
wherein the top of the housing has a flexible section that when collapsed actuates the applicator, and collapsing the flexible section of the housing which transitions the cantilevered ring from the primed position to the fired position, activating the cantilevered ring which strikes -- the rear surface of the microprojection array and propels the microprojection array into the skin surface.
(paragraph 94; flexible cover 406 on housing 102 is elastically deformed, therein collapsed, to only trigger activation of the needle delivery when a force applied to the applicator 100 is sufficient to both move the release member to a point at which delivery is triggered and normalize a target surface for microneedle delivery by the interaction of the target surface with a curved wall 402; fig 4)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the elastically deforming flexible cover and target size normalizing ring taught by the further embodiment of Daddonna to the disclosure of Daddona presently relied upon, in order to advantageously arrive at an invention which can normalize a target surface for microneedle delivery, see paragraph 94 of Daddona, therein improving the efficacy of the invention.
Regarding claim 43, the modified device of Daddona discloses:
The method of claim 42 wherein the microprojection array is propelled without attachment to the applicator.
(paragraph 71; piston 134 impacting section 138 propels needles 108 and breaks the frangible section 138 such that needles 108 are not attached directly to the applicator and may penetrated the skin of a patient)
Regarding Claim 46,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona is silent regarding:
The method of claim 42, wherein the microprojection array attains a velocity of greater than about 20 m/s.
However, Daddona teaches:
wherein the microprojection array attains a velocity
(paragraph 58+66-68+101; the velocity and mass, and also the kinetic energy, by which microneedles 108 impact the skin of the patient controls the depth by which the microneedles 108 penetrate the skin and with an appropriately deep microneedle the therapeutic agents coated thereon may be permitted to dissolve into the interstitial fluid of the skin and adequately distribute the therapeutic media to the patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the amount of kinetic energy imbued to an impacted microprojection array is a result effective variable, formed from the speed and mass of a moving element, which determines whether the microprojection array is plunged to an appropriate depth within a patient's skin to the modified apparatus disclosed by Daddona, by routinely optimizing the velocity and thus kinetic energy which the microprojection array obtains during therapeutic media delivery, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which plunges its microprojection array to an appropriate depth to adequately distribute therapeutic media to a patient's interstitial fluid, see paragraph 101 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with under-delivery therapeutic treatments such as worsening condition and death.
Regarding Claim 47,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona is silent regarding:
The method of claim 42, wherein the microprojection array attains a velocity of greater than about 25 m/s.
However, Daddona teaches:
wherein the microprojection array attains a velocity
(paragraph 58+66-68+101; the velocity and mass, and also the kinetic energy, by which microneedles 108 impact the skin of the patient controls the depth by which the microneedles 108 penetrate the skin and with an appropriately deep microneedle the therapeutic agents coated thereon may be permitted to dissolve into the interstitial fluid of the skin and adequately distribute the therapeutic media to the patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the amount of kinetic energy imbued to an impacted microprojection array is a result effective variable, formed from the speed and mass of a moving element, which determines whether the microprojection array is plunged to an appropriate depth within a patient's skin to the modified apparatus disclosed by Daddona, by routinely optimizing the velocity and thus kinetic energy which the microprojection array obtains during therapeutic media delivery, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which plunges its microprojection array to an appropriate depth to adequately distribute therapeutic media to a patient's interstitial fluid, see paragraph 101 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with under-delivery therapeutic treatments such as worsening condition and death.
Regarding Claim 48,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona is silent regarding:
The method of claim 42, wherein the microprojection array attains a velocity from about 20 to about 50 m/s
However, Daddona teaches:
wherein the microprojection array attains a velocity
(paragraph 58+66-68+101; the velocity and mass, and also the kinetic energy, by which microneedles 108 impact the skin of the patient controls the depth by which the microneedles 108 penetrate the skin and with an appropriately deep microneedle the therapeutic agents coated thereon may be permitted to dissolve into the interstitial fluid of the skin and adequately distribute the therapeutic media to the patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the amount of kinetic energy imbued to an impacted microprojection array is a result effective variable, formed from the speed and mass of a moving element, which determines whether the microprojection array is plunged to an appropriate depth within a patient's skin to the modified apparatus disclosed by Daddona, by routinely optimizing the velocity and thus kinetic energy which the microprojection array obtains during therapeutic media delivery, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which plunges its microprojection array to an appropriate depth to adequately distribute therapeutic media to a patient's interstitial fluid, see paragraph 101 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with under-delivery therapeutic treatments such as worsening condition and death.
Regarding Claim 49,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona is silent regarding:
The method of claim 42, wherein the microprojection array attains a velocity from about 20 to about 26 m/s
However, Daddona teaches:
wherein the microprojection array attains a velocity
(paragraph 58+66-68+101; the velocity and mass, and also the kinetic energy, by which microneedles 108 impact the skin of the patient controls the depth by which the microneedles 108 penetrate the skin and with an appropriately deep microneedle the therapeutic agents coated thereon may be permitted to dissolve into the interstitial fluid of the skin and adequately distribute the therapeutic media to the patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the amount of kinetic energy imbued to an impacted microprojection array is a result effective variable, formed from the speed and mass of a moving element, which determines whether the microprojection array is plunged to an appropriate depth within a patient's skin to the modified apparatus disclosed by Daddona, by routinely optimizing the velocity and thus kinetic energy which the microprojection array obtains during therapeutic media delivery, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which plunges its microprojection array to an appropriate depth to adequately distribute therapeutic media to a patient's interstitial fluid, see paragraph 101 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with under-delivery therapeutic treatments such as worsening condition and death.
Regarding Claim 80,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona in view Poon is silent regarding:
The method of claim 42, wherein the microprojection array has a mass of between about 0.1 gram and 0.8 grams.
However, Daddona teaches:
wherein the microprojection array has a mass
(paragraph 58+66-68+101; the velocity and mass, and also the kinetic energy, by which microneedles 108 impact the skin of the patient controls the depth by which the microneedles 108 penetrate the skin and with an appropriately deep microneedle the therapeutic agents coated thereon may be permitted to dissolve into the interstitial fluid of the skin and adequately distribute the therapeutic media to the patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the amount of kinetic energy imbued to an impacted microprojection array is a result effective variable which determines whether the microprojection array is plunged to an appropriate depth within a patient's skin to the modified apparatus disclosed by Daddona, by routinely optimizing the mass of the microprojection array obtains during therapeutic media delivery, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which plunges its microprojection array to an appropriate depth to adequately distribute therapeutic media to a patient's interstitial fluid, see paragraph 101 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with under-delivery therapeutic treatments such as worsening condition and death.
Regarding Claim 81,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona in view Poon is silent regarding:
The method of claim 42, wherein the microprojection array has a mass of between about 0.1 gram and 0.6 grams.
However, Daddona teaches:
wherein the microprojection array has a mass
(paragraph 58+66-68+101; the velocity and mass, and also the kinetic energy, by which microneedles 108 impact the skin of the patient controls the depth by which the microneedles 108 penetrate the skin and with an appropriately deep microneedle the therapeutic agents coated thereon may be permitted to dissolve into the interstitial fluid of the skin and adequately distribute the therapeutic media to the patient)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the amount of kinetic energy imbued to an impacted microprojection array is a result effective variable which determines whether the microprojection array is plunged to an appropriate depth within a patient's skin to the modified apparatus disclosed by Daddona, by routinely optimizing the mass of the microprojection array obtains during therapeutic media delivery, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which plunges its microprojection array to an appropriate depth to adequately distribute therapeutic media to a patient's interstitial fluid, see paragraph 101 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with under-delivery therapeutic treatments such as worsening condition and death.
Regarding claim 85, Daddona discloses:
The method of claim 42 wherein the non-liquid coating is a vaccine antigen.
(paragraph 78-79; microneedles 108 may be coated with a vaccine antigen such as nucleic acid)
Regarding claim 86, Daddona discloses:
The method of claim 85 wherein the vaccine antigen is a nucleic acid.
(paragraph 78-79; microneedles 108 may be coated with a nucleic acid based vaccine)
Regarding claim 88, Daddona discloses:
The method of claim 42 wherein the microprojections are from 250 to 600 um in length.
(paragraph 76; microneedles 108 have a length dimension of 400 um)
Regarding Claim 91,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona is silent regarding:
The method of claim 42 wherein the flexible section of the applicator is collapsed with about 15 to about 25 newtons of force.
However, Daddona teaches:
wherein the flexible section of the applicator is collapsed a -- force
(paragraph 94; flexible cover 406 triggers therapeutic media delivery only when a force applied to the applicator 100 is sufficient to both move the release member to a point at which delivery is triggered and normalize a target surface for microneedle delivery by the interaction of the target surface with a curved wall 402; fig 4)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the force to which the claimed flexible section is depressed is a result effective variable which determines whether a trigger point of device's delivery method has been reached and further that a target site has been normalized to improve medicament and needle delivery to the modified apparatus disclosed by Daddona in view of Poon, by routinely optimizing the force which the claimed flexible section is depressed by to reach both injection ready conditions, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which can adequately normalize a target surface for injection and subsequently deliver that injection when the normalizing force has been reached, see paragraph 94 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with off target or poor delivery of therapeutic treatments such as worsening condition and death.
Regarding Claim 92,
The modified device of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Daddona is silent regarding:
The method of claim 42 wherein the flexible section of the applicator is collapsed with about 15 to about 25 newtons of force.
However, Daddona teaches:
wherein the flexible section of the applicator is collapsed a -- force
(paragraph 94; flexible cover 406 triggers therapeutic media delivery only when a force applied to the applicator 100 is sufficient to both move the release member to a point at which delivery is triggered and normalize a target surface for microneedle delivery by the interaction of the target surface with a curved wall 402; fig 4)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Daddona's teachings that the force to which the claimed flexible section is depressed is a result effective variable which determines whether a trigger point of device's delivery method has been reached and further that a target site has been normalized to improve medicament and needle delivery to the modified apparatus disclosed by Daddona in view of Poon, by routinely optimizing the force which the claimed flexible section is depressed by to reach both injection ready conditions, see MPEP 2144.05(ii), in order to advantageously arrive at an invention which can adequately normalize a target surface for injection and subsequently deliver that injection when the normalizing force has been reached, see paragraph 94 of Daddona, and therein improve the efficacy of the invention and reducing the likelihood risks associated with off target or poor delivery of therapeutic treatments such as worsening condition and death.
Regarding claim 93, the modified device of Daddona discloses:
The method of claim 42, wherein a mass of the cantilevered ring does not impact the skin surface as the microprojection array is propelled into the skin surface.
(fig 4 illustrates that aside from the normalizing curved wall 402 the only other element to contact the skin surface of a patient is that of microneedles 108 and the base surface of array 108a they are disposed upon, accordingly the piston 134, and therein also its mass, does not impact the skin of the patient.)
Claim(s) 83 are rejected under 35 U.S.C. 103 as being unpatentable over Daddona and further in view of Traverso et al. (Pub. No. 2013/0165772).
Regarding claim 83,
The modified device of Daddona is silent regarding:
wherein the microprojection array has from about 1000 to about 5000 microprojections.
However, Traverso et al. teaches
a device (Fig. 9) having a plurality of microneedles (see Fig. 9 and [0064]) having about 1000 to about 5000 microprojections (see [0064]).
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 device taught by Daddona by forming the device to have about 5000 microprojections as taught by Traverso et al. because Traverso et al. teaches that about 5000 microprojections is known in the art for a microneedle device that is used in various medical applications (see [0005] and [0064] of Traverso).
Claims 87 is rejected under 35 U.S.C. 103 as being unpatentable over Daddona in view of US 20110092884 A1, henceforth written as Kang.
Regarding Claim 87
The modified invention of Daddona discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, it is silent regarding:
wherein the applicator further comprises a tether attached to the microprojection array such that the microprojection array is discharged from the device while being attached to the tether.
However, Kang teaches a microneedle applicator comprising:
a tether attached to the microprojection array such that the microprojection array is discharged from the device while being attached to the tether.
(paragraph 124; some parts of needle array 100 communicate with a drug supply passage 1530, a tether, to supply needle array 100 with drugs 1520 stored within a drug delivery device 1500 while needles 100 are driven/discharged by its actuator unit 400; fig 37)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Kang’s teachings of supplying a needle patch with a manually distributable supply of drug to the invention disclosed by the modified invention of Daddona, such that Kang’s drug supply passage 1530 spans from Daddona’s microneedle array portion 108a toward Kang’s drug supply stored in Daddona’s drug delivery device, the applicator 100, for a user to actuate Kang’s piston 1510 and deliver drugs via Daddona’s microneedle array portion 108a, in order to advantageously arrive at an invention with means for distributing multiple sources of media thus improving the versatility of the invention for administering multi-medicament therapeutic regiments that could save a user’s life and improve the effective treatment, see paragraph 124 of Kang.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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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.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783