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 .
Election/Restrictions
Claims 12, 21, 23, and 32 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/29/2025.
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, 2, 3, 6, 7, 8, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1).
In relation to claim 1, Stemme discloses a micro-needle protruding from a support member, wherein the needle has a needle body portion, a closed pointed tip portion, and an inner lumen extending through the support member and into the protruding needle, with at least one side opening
communicating with the inner lumen (Abstract).
"a base disposed at a proximal end of the microneedle body": Stemme discloses "a
support member" from which the micro-needle protrudes (Abstract). The support
member functions as a base at the proximal end of the microneedle structure.
"a tip disposed at the distal end of the microneedle body": Stemme discloses "a
closed pointed tip portion" (Abstract).
"a shaft having a longitudinal body disposed between the base and the tip":
Stemme discloses "a needle body portion" extending between the support member
(base) and the pointed tip portion (Abstract).
"wherein the base has a width greater than the width of the tip": This is inherent in
Stemme's structure, as the support member (base) is necessarily broader than the
pointed tip to provide structural support for the protruding needle (FIG. 7).
"at least one lumen defining a channel providing fluid communication and passage
disposed within at least the shaft of the microneedle body": Stemme discloses "an
inner lumen extending through the support member and into the protruding needle"
(Abstract). The specification further states: "The hole serves as a liquid channel
connecting the back side of the chip to the front side" (specification describing FIG. 3).
"an opening defined at the distal end of the lumen and at a loci of the shaft":
Stemme discloses "at least one side opening communicating with the inner lumen"
where "the needle body portion has at least one side opening" (Abstract). The
specification describes that side openings are formed in the needle body (shaft) and
states: "side openings in the walls" are created during the fabrication process
(specification describing FIG. 3e).
Stemme does not explicitly disclose:
• "wherein the opening is off-set from the central longitudinal axis of the tip": While
Stemme discloses side openings in the needle body, it does not explicitly state that
these openings are offset from the central longitudinal axis of the tip.
Lim discloses a plastic microneedle comprising a body portion tapering from a larger end
toward a tip portion, at least one side port formed in the body portion, and a lumen extending from the larger end and within the body portion, wherein the side port extends into the lumen such that "a fluid discharge direction from the side port is inclined with reference to a longitudinal direction of the lumen" (Claim 1). This inclined fluid discharge direction inherently means that the side port opening is positioned offset from the central longitudinal axis, as the discharge would be perpendicular to the longitudinal axis if the opening were centered.
Based on the above observations, it would have been obvious to an artisan skilled in the art at the time of filing to modify the microneedle of Stemme to include an offset opening as taught by Lim. Both references are directed to hollow microneedles with side openings for transdermal drug delivery applications. The artisan would have been motivated to implement the modification in order to:
Control the direction of fluid delivery into tissue;
Reduce the risk of clogging, as side openings offset from the central axis are less prone
to blockage than tip openings; and
Increase the area of drug exposure to tissue, which is explicitly mentioned as an
advantage in Stemme's specification.
The combination would simply involve positioning Stemme's side opening with an offset
configuration as taught by Lim, which would be a predictable design choice yielding
predictable results in the field of microneedle design.
In relation to claim 2, Stemme explicitly discloses that "an inner lumen extending through the support member and into the protruding needle" (Abstract). The specification further describes: "[t]he hole serves as a liquid channel connecting the back side of the chip to the front side" and "[a] circular (or any other suitable cylindrical shape) high aspect ratio hole is etched into the back side of the wafer" which extends through the support member (base) to the needle body (shaft) (specification describing FIG. 3a-b). This disclosure clearly teaches a lumen body extending through the base (support member)
to the shaft (needle body portion) of the microneedle, as required by Claim 2. Therefore, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 3, Stemme discloses "a closed pointed tip portion" (Abstract), meaning the tip does not have an opening. Since Stemme's lumen communicates with side openings in the needle body rather than at the tip, and the tip is closed, the lumen necessarily terminates proximate to
(near) the tip without extending through it. The specification confirms this: "side openings in the walls"
are formed in the needle body, and the process can result in "a side hole placed above the needle base" (specification describing FIG. 3). The fact that the tip is closed means the lumen terminates before
reaching the tip apex, thus terminating proximate to the tip. Therefore, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 6, Stemme discloses a support member (base) from which a needle body portion (shaft) protrudes. The support member is inherently broader than the needle body to provide
structural support. This is evident from the figures and the description of the fabrication process where a cross-shaped mask on the front side creates the needle structure protruding from the wafer (support member). Therefore, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 7, Stemme discloses a microneedle fabricated from a single silicon wafer using a deep reactive ion etching (DRIE) process. The specification describes: "The detailed process flow yielding side-opened micro needle is depicted in FIG. 3" where the support member, needle body, and pointed tip are all formed from the same silicon wafer through etching processes (specification describing FIG. 3). Since the entire structure is fabricated from a single piece of silicon material through etching, the base (support member), shaft (needle body portion), and tip (pointed tip portion) are integral—formed as one continuous piece. Therefore, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 8, Stemme explicitly discloses "a closed pointed tip portion" (Abstract). The specification further describes that "The oxidation growth and removal also sharpens the tip apex of the needle" (specification describing FIG. 3g-h). This clearly teaches a sharp, pointed apex. Therefore, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 9, as established in the rejection of Claim 1, Stemme in view of Lim teaches a microneedle with an offset opening. However, neither reference explicitly discloses an offset of "about
25 microns." However, the specific dimension of 25 microns would have been obvious to one of ordinary skill in the art as a matter of routine optimization. Stemme discloses in column 2, lines 35-36, microneedles that are approximately 210 μm long with side openings. The offset distance would be selected based on the following factors:
the diameter of the lumen (which affects fluid flow);
the structural integrity of the needle wall;
the desired direction of fluid discharge; and
the need to avoid the central longitudinal axis while maintaining sufficient wall
thickness.
An offset of 25 microns for a microneedle of approximately 200 microns in length
represents a reasonable proportion that would be arrived at through routine experimentation. One of ordinary skill in the art would recognize that the offset dimension is a result of ordinary design choices to balance fluid flow, structural integrity, and manufacturing constraints, and would arrive at the claimed 25 micron offset through routine optimization.
In relation to claim 10, Stemme discloses a microneedle with "a closed pointed tip portion" and describes that "The oxidation growth and removal also sharpens the tip apex of the needle" (specification describing FIG. 3g-h). Stemme does not explicitly disclose a radius of curvature of 500 nm.
However, the specific radius of curvature of 500 nm would have been obvious to one of ordinary skill
in the art. The purpose of a microneedle is to penetrate tissue with minimal force and pain. A sharper tip (smaller radius of curvature) achieves this goal more effectively. The radius of curvature of 500 nm is within the range achievable by the oxidation and etching processes described by Stemme. The specification states that oxidation "sharpens the tip apex," and one of ordinary skill in the art would understand that the degree of sharpness (radius of curvature) is controlled by process parameters such as oxidation time and temperature. A radius of curvature of 500 nm (0.5 microns) for a microneedle tip is a predictable result of optimizing the sharpening process to achieve effective tissue penetration while
maintaining structural integrity. This dimension represents a balance between maximum sharpness for easy penetration and sufficient tip strength to avoid breakage, which would be arrived at through routine optimization by one of ordinary skill in the art.
Claims 4, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1), as discussed above, and in further view of Cho (US 6,767,341).
In relation to claim 4, Stemme discloses a support member (base) from which the microneedle protrudes. The support member has a lumen extending through it for fluid communication. Stemme does not explicitly describe configuring the base to mount a medical instrument. However, Cho discloses microneedles with "a broad base formed of a substrate" (Claim 1(b)). Cho discloses an "apparatus for conveying a fluid transcutaneously, comprising: a substrate, said substrate comprising at least one inlet, and a plurality of outlets in fluid communication with said at least one inlet" (Claim 5). This substrate with inlet serves as a mounting interface for fluid delivery systems. Therefore, it would have been obvious to one of ordinary skill in the art to configure the base (support member) of Stemme to mount a medical instrument as taught by Cho. Both references are directed to hollow microneedles for transdermal drug delivery. The motivation would be to provide a practical means of connecting the microneedle to a drug delivery system, which is the intended use of both devices. This would be a predictable combination of known elements yielding predictable results.
In relation to claim 14, Stemme discloses a microneedle with a pointed tip that is sharpened through oxidation processes. However, Stemme does not explicitly disclose a maximum tip diameter of 10-20 microns. Cho discloses microneedles with specific dimensional ranges, including a height of "about 50 μm to about 100 μm" (Claim 2). While Cho does not explicitly state a tip diameter of 10-20 microns, the disclosure of microneedles with heights in the 50-100 μm range implies
proportionally small tip dimensions. Therefore, it would have been obvious to one of ordinary skill in the art to design the tip of Stemme's microneedle to have a maximum diameter of 10-20 microns. The motivation would be to: (1) minimize tissue damage and pain during insertion, (2) ensure the microneedle can penetrate the stratum corneum effectively, and (3) maintain structural integrity while maximizing sharpness. Moreover, the specification of this application itself indicates that "the microneedle may have a maximum tip diameter of about 10-20 microns" depending on the application (specification; paragraph [0012]), suggesting this is a range of suitable values rather than a critical limitation. A tip diameter of 10-20 microns for a microneedle with a shaft length of 200-400 microns represents a reasonable taper ratio that would be arrived at through routine design optimization. One of ordinary skill in the art would understand that the tip diameter must be small enough for effective penetration but large enough to maintain structural strength, and would arrive at the claimed range through routine experimentation.
In relation to claim 15, Stemme does not disclose a microneedle wherein the shaft has a tapered longitudinal, cylindrical body configured with a taper along a portion of its length. However, Cho explicitly discloses "a generally conical-shaped body" (Claim 1(a)). A conical shape is inherently tapered, with the diameter decreasing from the base toward the tip. Cho further describes that the microneedle has "a concave curved surface defined adjacent the tip" (Claim 1(d)), indicating a tapered profile. Therefore, for an artisan skilled in the art, modifying the microneedle disclosed by Stemme with a shaft having a tapered longitudinal, cylindrical body configured with a taper along a portion of its length, as taught by Cho, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to incorporate the enhancement because using this enhancement would have improved the penetration qualities to the microneedle.
6. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1), as discussed above, and in further view of Cho (US 6,767,341) and Lee et al. (US 2010/0030152A1; hereinafter “Lee”).
In relation to claim 5, as discussed in claim 4, Stemme in view of Cho teaches a microneedle with a base configured to mount a medical instrument. Lee explicitly discloses "a microneedle mount which has a number of needles to deliver drugs and is connected to a syringe" (paragraph [0013]). Lee further describes that the microneedle mount includes "a syringe connector" for connection to a syringe (paragraph [0014]). Accordingly, it would have been obvious to one of ordinary skill in the art that the medical instrument for mounting to the microneedle base would be a syringe. Syringes are the most common and well-known medical instruments for fluid injection and are routinely used with needles
for drug delivery. Lee confirms that connecting microneedles to syringes was well-known in the art at the time of filing. The combination would simply involve using a conventional syringe as the medical instrument, which would be an obvious design choice.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1), as discussed above, and in further view of Allen et al. (US 8,708,966; hereinafter “Prausnitz”).
In relation to claim 11, Stemme discloses microneedles that are "approximately 210 μm long" (specification). Stemme does not explicitly disclose a shaft length of 350 microns. However, Prausnitz discloses microneedles with various length ranges:
"the microneedles are between 1 μm and 1 mm long, inclusive" (Claim 7)
• "the microneedles are between 10 μm and 500 μm long, inclusive" (Claim 8)
• "the microneedles are between 30 μm and 200 μm long, inclusive" (Claim 9)
Based on the above observations, it would have been obvious to one of ordinary skill in the art to modify the length of Stemme's microneedle to be 350 microns. The motivation would be to optimize the penetration depth for specific applications. Prausnitz teaches that microneedle lengths in the range of 10-500 μm are suitable for transdermal applications, with the specific length selected based on the target tissue layer. A shaft length of 350 microns falls within the known range taught by Prausnitz and
represents a predictable scaling of Stemme's 210 μm design. One of ordinary skill in the art would understand that the microneedle length is selected based on: (1) the depth of the target tissue layer (stratum corneum, epidermis, or dermis), (2) the need to avoid deeper structures like blood vessels and nerves, and (3) manufacturing constraints. Selecting a length of 350 microns would be a routine design choice to achieve penetration into the dermis (which is 1-3 mm thick according to Prausnitz) while avoiding excessive depth.
Claims 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1), as discussed above, and in further view of Mahurkar (US 4,134,402).
In relation to claims 13 and 16, Stemme does not disclose a microneedle having an additional lumen (two lumens). However, Mahurkar demonstrates the conventionality of designing a needle with multiple lumens. Accordingly, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 17, the combination of Stemme, Lim, and Mahurkar, teaches or suggests a microneedle with two lumens having openings at different locations. However, this combination does not explicitly disclose that these openings are diametrically opposed. However, it would have been obvious to one of ordinary skill in the art to position the first locus and second locus diametrically opposed (180 degrees apart) on the microneedle. The motivation would have been to:
Balance fluid dynamics: Diametrically opposed openings would create balanced
pressure distribution around the needle, preventing lateral forces that could cause the
needle to deflect or bend during fluid delivery;
Maximize tissue coverage: Positioning openings on opposite sides of the needle would
maximize the tissue area exposed to delivered fluids;
Structural symmetry: Diametrically opposed lumens would maintain structural
symmetry, preserving the mechanical strength of the needle;
Manufacturing simplicity: Creating two holes diametrically opposed would be a
straightforward extension of Stemme's fabrication process.
The concept of diametrically opposed openings or channels is common in medical devices,
including multi-lumen catheters and needles. One of ordinary skill in the art would have recognized this as a conventional design choice for achieving balanced fluid delivery and structural integrity.
Claims 18, 19, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1) and Mahurkar (US 4,134,402), as discussed above, and in further view of Cho (US 6,767,341).
In relation to claim 18, Stemme discloses a microneedle with a pointed tip that is sharpened through oxidation processes. However, Stemme does not explicitly disclose a maximum tip diameter of 10-20 microns. Cho discloses microneedles with specific dimensional ranges, including a height of "about 50 μm to about 100 μm" (Claim 2). While Cho does not explicitly state a tip diameter of 10-20 microns, the disclosure of microneedles with heights in the 50-100 μm range implies proportionally small tip dimensions. Therefore, it would have been obvious to one of ordinary skill in the art to design the tip of Stemme's microneedle to have a maximum diameter of 10-20 microns. The motivation would be to: (1) minimize tissue damage and pain during insertion, (2) ensure the microneedle can penetrate the stratum corneum effectively, and (3) maintain structural integrity while maximizing sharpness. Moreover, the specification of this application itself indicates that "the microneedle may have a maximum tip diameter of about 10-20 microns" depending on the application (specification; paragraph [0012]), suggesting this is a range of suitable values rather than a critical limitation. A tip diameter of 10-20 microns for a microneedle with a shaft length of 200-400 microns represents a reasonable taper ratio that would be arrived at through routine design optimization. One of ordinary skill in the art would understand that the tip diameter must be small enough for effective penetration but large enough to maintain structural strength, and would arrive at the claimed range through routine experimentation.
In relation to claim 19, Stemme does not disclose a microneedle wherein the shaft has a tapered longitudinal, cylindrical body configured with a taper along a portion of its length. However, Cho explicitly discloses "a generally conical-shaped body" (Claim 1(a)). A conical shape is inherently tapered, with the diameter decreasing from the base toward the tip. Cho further describes that the microneedle has "a concave curved surface defined adjacent the tip" (Claim 1(d)), indicating a tapered profile. Therefore, for an artisan skilled in the art, modifying the microneedle disclosed by Stemme with a shaft having a tapered longitudinal, cylindrical body configured with a taper along a portion of its length, as taught by Cho, would have been considered obvious in view of the demonstrated conventionality of this enhancement. Moreover, the artisan would have been motivated to incorporate the enhancement because using this enhancement would have improved the penetration qualities to the microneedle.
In relation to claim 20, Stemme does not disclose a microneedle having a taper comprising a gradual taper having a gradual decrease in diameter along the length of the microneedle. However, Cho discloses "a generally conical-shaped body" (Claim 1(a)). A conical shape inherently has a gradual taper with a gradual decrease in diameter from the base to the tip. This is the geometric definition of a cone.
Cho further describes that the conical body has "a concave curved surface defined adjacent the tip" (Claim 1(d)), which indicates a smooth, gradual transition rather than an abrupt change in diameter.
Therefore, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
In relation to claim 22, Stemme discloses:
"a distal portion comprises a narrow sharp tip": Stemme discloses "a closed pointed
tip portion" (Abstract), which is inherently narrow and sharp;
"the proximal end comprises a wide base": Stemme discloses a support member
(base) at the proximal end, which is wider than the needle body as discussed in the
rejection of Claim 6;
"a shaft between the tip and the base": Stemme discloses "a needle body portion"
(shaft) extending between the support member (base) and the pointed tip portion
(Abstract).
Based on the above comments, since this enhancement would have been considered well known in the art at the time of filing, for an artisan skilled in the art, its use or implementation in the invention would have been an alternative in the design of the apparatus.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1) and Mahurkar (US 4,134,402), as discussed above, and in further view of Lee et al. (US 2010/0030152A1; hereinafter “Lee”).
In relation to claim 24, Stemme discloses a microneedle with a base (support member) as discussed in previous rejections. However, Stemme does not explicitly disclose configuring the base to physically engage a driver device. Lee explicitly discloses "a gun which has functions of inserting the microneedle mount into the skin and injecting the drugs supplied to the syringe" (Abstract). Lee further describes that the microneedle mount includes "a gun connector" for physical engagement with the
gun (driver device) (specification). Lee's gun (driver device) is "capable of creating temporary perforations in an anatomic membrane" by inserting the microneedles into the skin to create holes (Abstract). Accordingly, it would have been obvious to one of ordinary skill in the art to configure the base of Stemme's microneedle to physically engage a driver device as taught by Lee. The motivation would be to:
Control insertion force and speed: A driver device provides consistent, controlled
insertion, reducing variability and improving patient comfort;
Enable rapid insertion: Rapid insertion reduces pain perception and is particularly
important for arrays of multiple microneedles; and
Ensure proper penetration depth: A driver device can be calibrated to achieve the
desired penetration depth consistently.
Both Stemme and Lee are directed to microneedles for transdermal applications. Combining Stemme's microneedle structure with Lee's driver device engagement mechanism would be a predictable combination yielding the expected result of controlled, consistent microneedle insertion.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1) and Mahurkar (US 4,134,402), as discussed above, and in further view of Wang et al. (US 2008/0269666A1; hereinafter “Wang”).
In relation to claim 25, Stemme does not explicitly disclose simultaneous injection and withdrawal functions. Wang discloses "methods are provided for fluid extraction from a biological tissue which include the steps of inserting at least one hollow microneedle into the biological tissue; partially retracting the at least one microneedle from the tissue; and withdrawing at least one biological fluid from the biological tissue via the partially retracted at least one microneedle" (paragraph [0018]). Wang also discloses methods for "delivering a drug to or withdrawing a fluid from a biological tissue" (Abstract), indicating that microneedles can be used for both injection and withdrawal functions. Based on the above observations, it would have been obvious to one of ordinary skill in the art to configure the two-lumen microneedle suggested by the combination of Stemme, Lim and Mahurkar, to simultaneously inject and withdraw fluids as taught by Wang. The motivation would be to:
Maintain fluid balance: Simultaneous injection and withdrawal can maintain constant
pressure and volume in a confined space, which is important for delicate anatomic
membranes;
Enable dialysis or exchange: Withdrawing old fluid while injecting fresh fluid enables
therapeutic exchange or dialysis-like functions; and
Diagnostic sampling during treatment: Withdrawing fluid during drug injection allows
real-time monitoring of drug concentration or tissue response.
The combination would involve using one lumen of multi-lumen microneedle for injection (as Stemme already teaches for drug delivery) and the other lumen for withdrawal (as Wang teaches). This would be a straightforward application of Wang's teaching to the multi-lumen structure suggested by the combination of Stemme, Lim, and Mahurkar.
In relation to claim 26, Stemme in view of Wang teaches a microneedle configured to simultaneously inject and withdraw fluids from an anatomic membrane. However, the references do not specifically identify the inner ear membrane as the target. However, it would have been obvious to one of ordinary skill in the art to apply the microneedle of Stemme in view of Wang to the inner ear membrane. The motivation would be to:
Treat inner ear disorders: The inner ear is a known target for drug delivery to treat
conditions such as hearing loss, tinnitus, and balance disorders;
Overcome delivery barriers: The inner ear is isolated from systemic circulation by the
blood-labyrinth barrier, making local delivery via microneedle injection an attractive
approach; and
Minimize systemic side effects: Local delivery to the inner ear reduces systemic drug
exposure and associated side effects.
Wang explicitly states that the methods are applicable to "biological tissue, such the skin,
sclera, cornea, and conjunctiva" (Abstract), demonstrating that the microneedle technology
was contemplated for various anatomic membranes beyond just skin. One of ordinary skill in the art would have recognized that the microneedle of Stemme in view of Wang could be applied to the inner ear membrane, with the only modification being the selection of appropriate dimensions for the specific anatomy. This represents a new use of a known device, which is generally not patentable. The microneedle structure and function remain the same; only the target anatomic location changes.
In relation to claim 27, Stemme in view of Wang teaches a microneedle with the capability to withdraw fluid. Claim 27 simply specifies that one lumen is connected to a suction device (vacuum source) for this purpose. Accordingly, it would have been obvious to one of ordinary skill in the art to connect one lumen of the microneedle to a suction device to enable aspiration. Wang teaches "withdrawing at least one biological fluid from the biological tissue via the partially retracted at least one microneedle" (paragraph [0018]). One of ordinary skill in the art would understand that withdrawing fluid requires applying negative pressure (suction), which is conventionally achieved using a suction device such as a vacuum source or syringe operated in withdrawal mode. This is basic medical device operation that would be well within the knowledge of one of ordinary skill in the art. The specification of Stemme describes that the lumen serves as "a liquid channel" for fluid communication, and one of ordinary skill in the art would recognize that this channel can be used for both delivery (positive pressure) and withdrawal (negative pressure/suction).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1) and Mahurkar (US 4,134,402), as discussed above, and in further view of Lee et al. (US 2010/0030152A1; hereinafter “Lee”).
In relation to claim 28, Stemme discloses a microneedle with a lumen for fluid delivery. The specification states that the needles "are well suited for transdermal microfluidic applications, e.g. drug- or vaccine delivery" (column 1, lines 4-7). Lee explicitly discloses "a microneedle mount which has a number of needles to deliver drugs and is connected to a syringe" (paragraph [0013]). This clearly teaches connecting the microneedle to a syringe for injection. Accordingly, it would have been obvious to one of ordinary skill in the art to connect one lumen of Stemme's microneedle to an injection device such as a syringe, as taught by Lee. The motivation would be to provide a practical means of delivering fluid through the microneedle for the intended drug delivery application. Syringes are the most common and well-known injection devices in medical practice. One of ordinary skill in the art would immediately recognize that to use Stemme's microneedle for its intended purpose (drug delivery), it would need to be connected to a fluid source such as a syringe.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Stemme et al. (US 7,258,805 B2; hereinafter “Stemme”) in view of Lim (US 2009/0326415 A1) and Mahurkar (US 4,134,402), as discussed above, and in further view of Lee et al. (US 2010/0030152A1; hereinafter “Lee”) and Wang et al. (2008/0269666A1; hereinafter “Wang”).
In relation to claim 29, Stemme teaches or suggests a microneedle with the basic structural elements. Lee discloses a driver device (gun) that engages with a microneedle mount to create perforations in tissue. Wang discloses simultaneous injection and withdrawal functions using microneedles. Accordingly, it would have been obvious to one of ordinary skill in the art to combine these teachings to create a medical device comprising:
1. A multi-lumen microneedle (Stemme modified as discussed in Claim 16);
2. Engaged with a driver device (Lee); and
3. Configured for simultaneous injection and withdrawal (Wang).
The motivation would be to create an integrated medical device system that provides:
Controlled, consistent insertion (driver device from Lee)
Dual functionality for therapeutic exchange (simultaneous injection/withdrawal from
Wang);
Efficient drug delivery with minimal tissue trauma (microneedle structure from
Stemme)
Each element performs its known function, and the combination would yield predictable
results. This represents a straightforward combination of known elements according to established methods.
In relation to claim 30, Stemme in view of Lee and Wang teaches a medical device with a microneedle capable of simultaneous injection and withdrawal. Claim 30 simply specifies that the target membrane is the round window membrane of the inner ear. For the same reasons discussed in the rejection of Claim 26, it would have been obvious to apply this device to the round window membrane of the inner ear. The round window membrane is a known anatomic target for inner ear drug delivery, and applying the device to this specific location would be an obvious use of a known device for its intended purpose.
In relation to claim 31, as established in the rejection of Claim 29, Stemme in view of Lee and Wang teaches a medical device with a microneedle engaged with a driver device. Claim 31 specifies that
these are "separate components" that form a "modular system." Lee explicitly describes a modular configuration where "a microneedle mount which has a number of needles to deliver drugs and is connected to a syringe, a gun which has functions of inserting the microneedle mount into the skin" (Abstract). This clearly indicates that the microneedle mount and the gun (driver device) are separate components that are connected together. Accordingly, it would have been obvious to one of ordinary skill in the art to configure the microneedle and driver device as separate, engageable components forming a modular system. The motivation would be to:
Enable sterilization and reuse: Separable components allow the microneedle (which
contacts tissue) to be disposable while the driver device (which does not contact tissue)
can be reused;
Facilitate manufacturing: Modular design allows the microneedle and driver to be
manufactured separately and assembled later;
Allow customization: Different microneedle configurations can be used with the same
driver device, or vice versa; and
Simplify replacement: Worn or damaged components can be replaced individually.
Modular design is a fundamental principle in medical device engineering and was well established in the art before the filing of this application. Applying this principle to the combination of
Stemme, Lee, and Wang would be an obvious design choice.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783