DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 6 and 30 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.
Claim 6 is rejected under 35 U.S.C. § 112(b) as indefinite because the claim recites a “membrane locker” without clear antecedent basis in independent claim 1. Claim 1 recites “a membrane assembly movable with respect to the housing,” but does not introduce a “membrane locker.”
Claim 30 is rejected under 35 U.S.C. § 112(b) as indefinite because it recites “the medicament delivery system” although claim 28 introduces “a medicament delivery device.” Claim 29 also refers to a membrane assembly attached to the housing and does not introduce a “medicament delivery system.” The claim therefore lacks clear antecedent basis for “the medicament delivery system.”
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, 4, 5, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Junger et al. (US 2018/0015271A1; hereinafter “Junger”) in view of the publication by Ameri et al. (Human Growth Hormone Delivery with a microneedle Transdermal System; hereinafter “Ameri”) and Hekal (US2004/0122175A1).
Independent claim 1 recites a medicament delivery device comprising a housing; desiccant positioned within the housing; a biasing member positioned within the housing above the desiccant; a medicament-containing patch positioned within the housing; a membrane having a lower surface configured to contact skin of a patient; and a membrane assembly movable with respect to the housing, wherein movement of the biasing member causes the patch to
move with respect to the housing to administer medicament.
In relation to independent claim 1, Junger discloses the following limitations:
A medicament delivery device comprising a housing.
Junger discloses a micro projection array medicament-delivery applicator and expressly states that its applicators “provide application of microprojection arrays to skin for the delivery of substances” and may include “one or more cantilevered rings or domes placed within a housing or sterile barrier” (Junger ¶ [0010]). Junger further discloses a device “[having] a housing having an upper and lower portion and having an internal face and an external face wherein the external face has a flexible section that when collapsed actuates the device” (Junger ¶ [0013]).
Desiccant positioned within the housing.
Junger discloses desiccant in the device, stating that “a desiccant is included inside the device” and that “a desiccant is included in the housing and/or molded parts of the device” (Junger ¶¶ [0037]–[0038]). Junger also states that “[a] desiccant film may be included in the microprojection array applicator to maintain the internal environment and water content of the coating” and that “[t]he desiccant may be incorporated into the housing or any moulded materials in the device” (Junger ¶ [0140]). To the extent Junger does not expressly specify the claimed desiccant as positioned below the biasing member, Hekal fills the moisture-control gap by disclosing desiccant-entrained polymer structures for controlled environments, including that “component C may be an absorbing material such as desiccant” and that the composition is useful in “shaped articles such as containers and packaging for items requiring controlled environments” (Hekal ¶ [0002]).
A biasing member positioned within the housing above the desiccant.
Junger discloses a biasing member in the housing, stating that the device includes “a biasing member supported by the housing and movable from a first position to a second position upon activation of the trigger” and that the biasing member “urges the microprojection array through the skin contact membrane and into engagement with a skin surface through the opening” (Junger ¶ [0089]). Junger further discloses that “the biasing member is a cantilevered ring” (Junger ¶ [0090]). Junger does not expressly recite the relative vertical placement “above the desiccant,” but Ameri provides a reason to combine desiccant with a spring-actuated microneedle patch applicator because Ameri discloses a “ZP-patch system” in which “the applicator … is actuated through spring force” and the “drug-coated microneedles physically break the stratum corneum and penetrate the epidermis/dermis” (Ameri, p. 221). Ameri also discloses patch components including “a polycarbonate ring,” an “adhesive patch,” “3 Å molecular sieve desiccant co-molded into the polycarbonate ring,” and “an aluminum foil pouch” (Ameri, p. 223).
A patch positioned within the housing, at least a portion of the patch containing medicament. Junger discloses that “the term patch and microprojection array are used interchangeably” and that the patch includes structures “capable of piercing the stratum corneum to facilitate the transdermal delivery of prophylactic or therapeutic agents” (Junger ¶ [0095]). Ameri discloses the medicament-containing patch more specifically because “rhGH liquid formulation was coated onto titanium microneedles by dip-coating and drying,” and the study used “rhGH coated microneedle patches.” (Ameri, Abstract, p. 220.)
A membrane having a lower surface configured to contact skin of a patient, and a membrane assembly movable with respect to the housing.
Junger discloses a “skin contact membrane” in the applicator (Junger ¶ [0013]). Junger further discloses that “a membrane is introduced between the microprojection array and the skin surface to which the array is applied” and that the “use of a membrane results in an even surface for application regardless of skin condition or thickness and provides even penetration of the micro projections across the skin surface” (Junger ¶ [0138]). Junger discloses a skin contact base attached to the housing because the device may include “a skin contact applicator base that attaches to the housing” (Junger ¶ [0013]).
Wherein movement of the biasing member causes the patch to move with respect to
the housing to administer the medicament to a patient.
Junger discloses the operative movement because the biasing member “urges the microprojection array through the skin contact membrane and into engagement with a skin surface through the opening” (Junger ¶ [0089]). Junger also discloses that the method includes “collapsing the flexible section of the housing, thereby pushing down on the patch guide and activating the cantilevered ring which strikes the back of the microprojection array and pushes the microprojection array through the membrane and into the skin surface” (Junger ¶ [0054]).
Based on the above comments, for an artisan skilled in the art, it would have been obvious to combine Junger’s spring/cantilever-ring microneedle applicator with Ameri’s drug-coated microneedle
patch and co-molded molecular-sieve desiccant ring, and with Hekal’s desiccant entrained polymer composition, because Junger itself identifies moisture control for coated patches as a design concern, stating that desiccant may “maintain the internal environment and water content of the coating” (Junger ¶ [0140]). Ameri confirms the same stability objective in a closely related microneedle drug-patch system, explaining that “ZP-hGH patches stored in sealed nitrogen purged foil pouches with desiccant were stable at 40 °C storage for at least six months” (Ameri, Coclusions, p. 231). A person of ordinary skill would have had reason to incorporate Hekal-type desiccant polymer material into Junger/Ameri’s housing or ring to preserve moisture-sensitive medicament coatings during storage and transport.
In relation to claims 4 and 5, these claims depend from claims 3 and 1, respectively. Claim 4 recites that the actuator includes at least one rib configured to be bent over an outer edge of the biasing member. Claim 5 recites an actuator attached to the housing above the biasing member, wherein at
least a portion of the actuator is configured to crimp an outer edge of the biasing member.
The rejections of claims 1 and 3 are incorporated. In relation to the Rib/crimp structure at an outer edge of the biasing member, Junger discloses cantilevered rings and actuator structures in which “the outer cantilevered ring is an energy storing element that provides the speed that moves the microprojection array forward upon buckling,” and the design uses cantilevers that “enable the amplification of the movement generated by the buckling of the ring toward the patch” (Junger ¶ (0119]). In relation to the extent Junger does not expressly disclose a rib bent over, or a crimped actuator portion over, the outer edge of the biasing member, Hekal discloses mechanical retention structures suitable for fixing an insert within a container, stating that a plug may be fixed by “a Snug preSS fit” or “mechanically connected in such manners as adhesives, prongs, lips or ridges that extend about the plug 55 to hold the plug 55 in place” (Hekal ¶ [0072]). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use rib, lip, ridge, press-fit, or crimp-like retention at an outer edge of Junger’s cantilevered ring because Junger relies on controlled buckling of a ring-shaped biasing member and Hekal teaches mechanical retention features that extend about an insert to prevent dislocation. Applying known retaining features to hold the outer edge of a spring/dome would have predictably maintained alignment during actuation.
In relation to claims 10 and 11, these claims depend from claim 1. Claim 10 recites that the desiccant is formed of a resin or copolymer, a channeling agent, and a molecular sieve. Claim 11 recites the specific proportions and named components: 23% by weight PP Bormed RF830MO, 8% by weight
PEG 4000S Clariant, and 69% by weight Molecular Sieve 4A. The rejection of claim 1 is incorporated.
In relation to a resin or copolymer, a channeling agent, and a molecular sieve, Hekal discloses a three-component desiccant polymer composition. Hekal states that hydrophilic agents include “channeling agents” and that the hydrophilic agent may form “the interconnecting channeled structure” in a “three phase system of a water-insoluble polymer, hydrophilic agent and an absorbing material” (Hekal ¶¶ [0044]–[0045]). Hekal further discloses that the absorbing material may include “one or more desiccating compounds” and that “[e]xamples of these physical absorption desiccants include molecular sieves” (Hekal ¶¶ [0046], [0048]). Hekal specifically discloses a composition including “molecular sieves (i.e. component C), polypropylene (i.e. component A) and polyglycol (i.e. component B)” (Hekal ¶ [0052]). In relation to the claimed percentages and component classes, Hekal’s disclosed ranges
substantially overlap the claimed percentages because Hekal discloses “from about 30-80
wt%, or from about 40-70 wt% of the desiccant,” “from about 20-40 wt%” polypropylene, and “from about 5-20 wt%” polyglycol. (Hekal ¶ [0052].) The claimed 69% molecular sieve, 23% polypropylene resin, and 8% PEG channeling agent fall within or immediately adjacent to these disclosed ranges. Hekal also discloses “about 52.82% (w/w) of a desiccant of molecular sieve” in a polypropylene/polyethylene glycol blend. (Hekal ¶ [0081].)
Based on the above teachings, it would have been obvious to use Hekal’s resin/channeling agent/molecular-sieve desiccant polymer in the Junger/Ameri applicator because Junger seeks to include desiccant in the housing or molded device parts and Ameri confirms that molecular-sieve desiccant is used in a microneedle patch ring. Hekal provides the known material architecture for entraining molecular sieve in a polymer body with a channeling agent to maintain moisture control.
Claims 2, 28, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Junger et al. (US 2018/0015271A1; hereinafter “Junger”) in view of the publication by Ameri et al. (Human Growth Hormone Delivery with a microneedle Transdermal System; hereinafter “Ameri”) and Hekal (US2004/0122175A1), as discussed above, and in further view of Pace et al. (US 9,693,713B2; hereinafter “Pace”).
In relation to claim 2, this claim depends from claim 1 and further recites that the desiccant is in the form of a ring or torus. The rejection of claim 1 is incorporated. In relation to the desiccant being in the form of a ring or torus, Junger discloses desiccant in the housing but does not expressly disclose a toroidal desiccant. Pace fills this gap by disclosing an annular desiccant body: “[h]oused within the casing 404 is a desiccant body 412” and “the desiccant body 412 can have an annular shape so that the desiccant body 412 can be disposed within the casing 404” (Pace, col. 8, ll. 39–42). Pace also discloses “a desiccant ring 612 to protect the sensor assembly 608 from moisture” (Pace, col. 10, ll. 22–23). Ameri independently confirms the desirability of a desiccant integrated with a ring in a microneedle patch system by disclosing “3 A molecular sieve desiccant co-molded into the polycarbonate ring.” (Ameri, p. 223.)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to form the desiccant of claim 1 as an annular ring because Junger seeks internal moisture control, Pace teaches that an annular desiccant fits in a casing without adding height, and Ameri uses a molecular-sieve desiccant in a polycarbonate ring in a drug-coated microneedle patch system. This combination predictably preserves a dry internal atmosphere while maintaining a compact, central patch-delivery architecture.
Independent claim 28 recites a method of making a cannular-free and needle-free medicament delivery device, including inserting a fixed desiccant ring into a housing, inserting a medicament containing patch into an interior portion of the housing with the patch movable relative to
the housing, and attaching a biasing member configured to move the patch to administer medicament.
In relation to the step of inserting a desiccant ring into a housing, the desiccant ring fixed with respect to the housing, Junger discloses desiccant in the housing or molded parts of the device (Junger ¶¶ [0037]–[0038], [0140]). Pace discloses an annular desiccant body disposed within a casing (Pace, col. 8, ll. 39–40). Hekal discloses fixing a desiccant plug within a container, stating that the plug “may be coupled to an interior Surface of the container body 60 so that the plug 55 is fixed relative to the container 60,” (Hekal ¶ [0076]) including by “a snug press fit” or “prongs, lips or ridges” (Hekal ¶ [0072]). In relation to the step of inserting a patch containing medicament into an interior portion of the housing, the patch movable with respect to the housing, Junger discloses a microprojection patch housed inside the applicator prior to activation, and states that in the primed position “the microprojection array is housed inside the applicator housing where it is recessed therein and away from the skin” (Junger ¶ [0118]). Ameri discloses that “rhGH liquid formulation was coated onto titanium microneedles by dip-coating and drying” (Ameri, Abstract) and that the “rhGH-coated microneedle array was assembled with adhesive and retainer ring” (Ameri, p. 225). In relation to the step of attaching a biasing member configured to move the patch with respect to the housing, Junger discloses the biasing/cantilevered ring and motion because “the biasing member urges the microprojection array through the skin contact membrane and into engagement with a skin surface” (Junger ¶ [0089]). Based on the above teachings, it would have been obvious to assemble the device by inserting a fixed annular desiccant, inserting the medicament patch, and attaching the biasing member because Junger and Ameri disclose the same functional assembly—protected microneedle patch, housing, spring-force actuation, and desiccant moisture control—while Pace and Hekal provide known annular/fixed desiccant structures.
In relation to claim 29, this claim depends from claim 28 and further recites attaching a membrane assembly to the housing. The rejection of claim 28 is incorporated. In relation to the step of
attaching a membrane assembly to the housing, Junger discloses that the device includes “a skin contact membrane” and “a skin contact applicator base that attaches to the housing” (Junger ¶ [0013]). Junger further states that the skin-contact membrane may be held by a membrane support that attaches to the skin applicator base and that “the skin contact applicator base is attached to the flexible applicator top to provide a sealed applicator” (Junger ¶ [0119]).
Based on the above teachings, the motivation is the same as for claim 28, with the added reason
that Junger’s membrane provides an even skin-contact surface and controlled penetration, as Junger states that the “use of a membrane results in an even surface for application.” (Junger ¶ [0138].)
In relation to claim 30, this claim depends from claim 29 and further recites inserting the medicament delivery system into packaging to maintain a sterile nature of the medicament delivery system. The rejections of claims 28 and 29 are incorporated. In relation to the step of packaging to maintain sterility, Junger discloses that “the applicators of the present invention can be sterile and permit the packaging of the device in a sealed container to prevent contamination” (Junger ¶ [0141]). Ameri discloses actual packaging of the microneedle patch, stating that the “patch in retainer ring was packaged in an aluminum pouch … purged with dry nitrogen and heat-sealed” (Ameri, p. 225). Horvath further discloses a sterile medicament-delivery package because “the apparatus may include an envelope” and “[t]he envelope may sterilely surround the chassis” (Horvath ¶ [0044]).
Based on the above teachings, it would have been obvious to package the assembled microneedle medicament-delivery device in sterile sealed packaging because Junger expressly teaches sealed packaging to prevent contamination, Ameri uses sealed nitrogen-purged pouches for drug-coated microneedle patches, and Horvath confirms sterile envelope packaging for medicament-delivery apparatus. The combination predictably maintains sterility and moisture stability during storage and transport.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Junger et al. (US 2018/0015271A1; hereinafter “Junger”) in view of the publication by Ameri et al. (Human Growth Hormone Delivery with a microneedle Transdermal System; hereinafter “Ameri”) and Hekal (US2004/0122175A1), as discussed above, and in further view of Simons et al. (US 2009/0198189A1; hereinafter “Simons”).
In relation to claim 3, this claim depends from claim 1 and further recites an actuator attached to the housing above the biasing member, the actuator including a deflectable portion attached to and movable with respect to the remainder of the actuator via one or more hinges, the deflectable portion contacting the biasing member to administer medicament. The rejection of claim 1 is incorporated. In relation to an actuator attached to the housing above the biasing member and including a deflectable portion, Junger discloses an actuator/flexible housing portion because the housing has “a flexible section that when collapsed actuates the device” (Junger ¶ [0013]). Junger further discloses that when the flexible section is collapsed “the patch guide is forced downward” and the “cantilevered ring is activated by the patch guide” (Junger ¶ [0013]). In relation to the deflectable portion being attached via one or more hinges, Junger does not expressly require a hinge for the deflectable actuator portion. However, Simons fills this gap in the microneedle applicator context by disclosing “at least one connecting member having a first portion affixed through a first hinge to the base and a second portion affixed to the array component” (Simons ¶ [0006]). Simons further discloses movement between two
positions because the connecting member “has a first equilibrium position with the microneedle array in a recessed position within the device and a second equilibrium position with the microneedle array positioned so as to be able to contact a skin surface.” (Simons ¶ [0006].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use hinge-supported movement in Junger’s deflectable actuator because both references address controlled micro needle array movement from a protected/recessed position toward skin. The hinge provides a predictable mechanical degree of freedom for a deflectable actuator or connecting member while preserving the protected first position and deployed second position disclosed by Junger and Simons.
In relation to claim 12, this claim depends from claim 1 and recites that the housing includes three spaced-apart ribs extending upwardly therefrom, and that the ribs combine to center the biasing
member within the device. The rejection of claim 1 is incorporated. In relation to the three spaced-apart ribs extending upwardly and centering the biasing member, Junger discloses that the device uses a patch guide and dome/cantilevered ring alignment to ensure correct movement, and that the patch guide “may provide guidance for the coated patch (microprojection array)” (Junger ¶ [0118]). Simons discloses guide structures in microneedle applicators, including figures showing “internal guides” and
“an external guide” (Simons ¶¶ [0028]–[0029]). To the extent the base combination does not expressly disclose exactly three upward ribs centering a biasing member, using three spaced guide ribs is a predictable mechanical implementation of known guide structures for centering a movable ring or patch component in a housing.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to add three spaced centering ribs to the Junger housing because Junger’s device depends on correct alignment of the patch guide, dome, and microprojection array, and Simons teaches guide structures for
microneedle applicators. Three ribs are a conventional self-centering arrangement that would have predictably maintain concentricity while minimizing material and contact area.
Claims 6, 7, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Junger et al. (US 2018/0015271A1; hereinafter “Junger”) in view of the publication by Ameri et al. (Human Growth Hormone Delivery with a microneedle Transdermal System; hereinafter “Ameri”) and Hekal (US20040122175A1), as discussed above, and in further view of Vetter et al. (US 2004/0140285A1; hereinafter “Vetter”).
In relation to claims 6-9, claim 6 depends from claim 1 and recites a membrane locker movable along a longitudinal axis and including spaced-apart grooves around a periphery to permit fluid passage when stacked beneath a second device. Claim 7 recites a first and second position and a spacer received between the housing and membrane locker. Claim 8 recites first and second configurations for pre-aseptic and post-aseptic filling with a gap configured to receive a spacer. Claim 9 recites that the gap is closed in the second configuration. The rejection of claim 1 is incorporated. In relation to a membrane locker movable with respect to the housing along a longitudinal axis, Junger discloses a skin-contact membrane and a skin-contact applicator base attached to the housing (Junger ¶ [0013]). Junger also discloses that the applicator may include “a skin contact membrane provided in the opening” and a patch guide “movably mounted within the housing” (Junger ¶ [0089]). To the extent Junger does not use the term “membrane locker,” the base/membrane assembly performs the same support and skin contact function. In relation to spaced-apart grooves around a periphery configured to permit passage of fluid therethrough, Junger does not expressly disclose peripheral grooves in a membrane locker. However, Vetter fills this gap by disclosing channels for sterilizing-fluid passage, stating that “channels are provided, through which the medium used for sterilizing, e.g., steam, can be brought to otherwise inaccessible locations” (Vetter ¶ [0004]). Vetter further states that “the channels run through this element” and that “the channels are used for guiding the Sterilizing medium between two parts” (Vetter ¶¶ [0006], [0008]). Vetter’s channels are functionally analogous to grooves that permit gas/steam/fluid passage through a stacked or assembled medical-device interface. In relation to a spacer or gap between first and second configurations for aseptic filling, Junger discloses spacing structures for stacked dome systems, stating that three domes “are stacked with a fixed gap to each other” and “are spaced apart by respective spacers” (Junger ¶ [0122]). Vetter discloses preassembly, sterilization, and final assembly, stating that the parts are placed in “the initial position, in which the later contact surfaces of the sealing element are still accessible to a sterilizing medium,” then sterilized, and finally
“moved into their final positions in a final assembly step” (Vetter ¶ [0011]). Vetter also discloses transfer “from a room that does not have aseptic conditions to another room that is subject to aseptic clean room connections” (Vetter ¶ [0012]). In relation to the gap being closed in the second configuration, Vetter discloses that after sterilization the parts are “moved into their final positions in a final assembly step” (Vetter ¶ [0011]). This fills the gap for a pre-assembly gap that is closed after aseptic processing.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to provide fluid-passage grooves/channels and a spacer-maintained gap in Junger’s membrane/base interface because Junger expressly contemplates sterile packaging and a membrane/base structure,
while Vetter teaches maintaining access for sterilizing medium before moving parts to a final assembled position. The combination would have predictably permitted sterilizing gas or air passage during filling/sterilization and then final closure to preserve sterility and moisture control.
Claims 24, 25, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Junger et al. (US 2018/0015271A1; hereinafter “Junger”) in view of the publication by Ameri et al. (Human Growth Hormone Delivery with a microneedle Transdermal System; hereinafter “Ameri”) and Hekal (US2004/0122175A1), as discussed above, and in further view of Pace et al. (US 9,693,713B2; hereinafter “Pace”) and Simons et al. (US 2009/0198189A1; hereinafter “Simons”).
Independent claim 24 recites a medicament delivery device comprising a housing; a ring/torus desiccant positioned within the housing and surrounding an interior portion; the desiccant formed of a resin or copolymer, channeling agent, and molecular sieve; a biasing member above the desiccant; a medicament-containing patch surrounded by the interior portion of the housing; and an actuator with a deflectable portion movable relative to the remainder of the actuator and configured to contact the biasing member.
In relation to the housing, biasing member, patch, and actuator, Junger discloses a housing having “a flexible section that when collapsed actuates the device,” a patch guide forced downward by that flexible section, a cantilevered ring activated by the patch guide, and “a microprojection array that is contacted by the cantilevered ring when the ring is activated” (Junger ¶ [0013]). Junger also discloses that a biasing member in the housing “urges the microprojection array through the skin contact membrane and into engagement with a skin surface” (Junger ¶ [0089]). In relation to Desiccant in ring or torus form surrounding an interior portion, Junger discloses desiccant “inside the device” and “in the housing and/or molded parts of the device” (Junger ¶¶ [0037]–[0038]). Pace fills the annular/ring form by disclosing that “the desiccant body 412 can have an annular shape” and that a support can “extend up through the desiccant body 412” (Pace, col. 8, ll. 41–45). Ameri likewise discloses “3 Å molecular sieve desiccant co-molded into the polycarbonate ring” (Ameri, p. 223). In relation to desiccant formed of resin/copolymer, channeling agent, and molecular sieve, Hekal discloses a three-phase desiccant composition including “molecular Sieves (i.e. component C), polypropylene (i.e. component A) and polyglycol (i.e. component B)” (Hekal ¶ [0052]). In relation to the actuator deflectable portion movable relative to the remainder of the actuator, Junger discloses a flexible section that actuates the device when collapsed (Junger ¶ [0013]). To the extent a hinge-like movable relationship is required, Simons discloses “at least one connecting member having a first portion affixed through a first hinge to the base and a second portion affixed to the array component” (Simons ¶ [0006]).
Based on the above comments, for an artisan skilled in the art, it would have been obvious to combine Junger’s applicator architecture with Ameri’s drug-coated microneedle/desiccant-ring patch system, Hekal’s desiccant-entrained polymer, Pace’s annular desiccant body, and Simons’s hinge supported movement because each reference addresses compact protected medical device storage and controlled microneedle deployment. The combination would have yielded the predictable benefit of spring-actuated delivery while preserving a low-moisture internal environment around a moisture-sensitive medicament patch.
In relation to claims 25-27, claim 25 depends from claim 24 and recites a membrane locker configured to support a membrane designed to contact a user's skin and attached to the housing. Claim 26 depends from claim 25 and recites longitudinal movement and spaced-apart grooves permitting
fluid passage. Claim 27 depends from claim 26 and recites pre-aseptic and post-aseptic filling configurations with a gap configured to receive a spacer. The rejection of claim 24 is incorporated. In relation to a membrane locker supporting a membrane and attached to the housing, Junger discloses a skin-contact membrane and “a skin contact applicator base that attaches to the housing” (Junger ¶ [0013]). Junger also states that “a membrane is introduced between the microprojection array and the skin surface to which the array is applied” (Junger ¶ [0138]). In relation to longitudinal movement and grooves permitting fluid passage, Junger discloses movable patch-guide structures within the housing, but does not expressly disclose peripheral grooves in a membrane locker. Vetter fills this gap by disclosing that “channels are provided, through which the medium used for sterilizing, e.g., steam, can be brought to otherwise inaccessible locations,” and that projections/recesses guide sterilizing medium
in the contact area (Vetter ¶¶ [0004], [0008]). In relation to pre-aseptic and post-aseptic filling configurations with spacer/gap, Junger discloses devices in which components “are stacked with a fixed gap to each other” and separated by “respective spacers” (Junger ¶ [0122]). Vetter discloses preassembly and final assembly around sterilization, with parts in “the initial position” accessible to sterilizing medium and then moved “into their final positions in a final assembly Step” (Vetter ¶
[0011]).
Based on the above teachings, it would have been obvious to add Vetter-style fluid-passage
channels and preassembly/final-assembly spacing to Junger’s membrane/base arrangement because both references seek sterile medical-device assembly. The combination would have permitted sterilizing gas or air to access otherwise shielded contact regions before final closure.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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