DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The listing of claims filed 21 April 2025, are examined. Claims 1-20 are pending.
Claim Objections
Claims 5, 7, 14 and 20 are objected to because of the following informalities:
Claims 5 and 7 recite “between about 1 and about 1000 micron.” The applicant should correct “1000 micron” to “1000 microns” or “1000 µm”.
Claim 14 recites, “long enough for transdermal delivery of a therapeutic or a transdermal delivery of a therapeutic or a cosmetic agent…”. The second occurrence of “or a transdermal delivery of a therapeutic” is duplicative and appears to be a drafting error. The applicant is required to correct the recitation, for example, to, “long enough for transdermal delivery of a therapeutic or cosmetic agent …”.
Claim 20 recites that “the microparticle is made by one or more members of a group consisting of gelatine … and metal.” The recited group consists of materials, rather than manufacturing processes. The applicant should amend “made by” to “made from” or “made of,” for example, “the microparticle is made from one or more materials selected from the group consisting of …”. This correction is consistent with the disclosure that the microparticle can be made from the expressly identified materials.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
During examination, claims are given their broadest reasonable interpretation consistent with the specification. If, after application of that standard, a person of ordinary skill in the relevant art would reasonably read the claim language as having more than one materially different interpretation such that the metes and bounds cannot be ascertained, a rejection under §112(b) is appropriate (see In re Packard, 751 F.3d 1307, 1311-14, 110 USPQ2d 1785, 1787-89 (Fed. Cir. 2014); MPEP § 2173, § 2173.02).
Claims 1-20 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, regards as the invention.
Independent claim 1 recites “a plurality of spikes,” followed by “the spikes extend from an outer surface of the body”, but thereafter recites in the singular that “the spike comprises: a rod portion; and an end portion”. As presently drafted, it is unclear whether each spike of the claimed plurality must comprise the subsequently recited rod portion/end portion structure, whether only one spike must possess that structure, or whether some unspecified subset of the plurality must do so. The distinction changes the structural scope of the claimed microparticle.
The specification describes the disclosed embodiment more specifically, wherein each spike comprises a rod portion and an end portion. Thus, if the applicant intends every spike of the plurality to possess the recited structure, the claim should recite, for example, “wherein each spike comprises …”. The same singular/plural ambiguity independently occurs in claims 5 and 7 (“a plurality of spikes” followed by “the spike comprises”). Accordingly, claims 1, 5, and 7 are indefinite for this reason, and dependent claims 2-4, 6, and 8-20 respectively inherit the ambiguity.
Claims 2, 6, and 16 recite, “the general diameter of the spike is about 0.03 mm.” The term “general diameter” does not identify what dimension is being measured. The claimed spike comprises at least a rod portion and an end portion. Claim 5 requires the rod portion to taper from a larger base end surface to a smaller top end surface and claim 7 defines the rod portion as having a partial-cone body with differently sized top and base end surfaces. Thus, the spike would not possess a single constant diameter. “General diameter” could reasonably refer to, among other possibilities, the diameter at the rod base, the diameter at the rod top, a diameter at an intermediate position, the maximum transverse diameter, the diameter of the end portion, or an average or nominal diameter. The specification repeats the expression “general diameter of the spike” at but does not identify the measurement location or calculation by which that diameter is determined. Thus claims 2, 6, and 16 are therefore indefinite for this additional reason.
Claim 9 recites, “the base end surface tapers towards the top end surface”. Claim 7 defines a rod portion having a partial cone body with a top end surface and a larger base end surface. A surface identified as the “base end surface” is not itself the intervening structure extending between the base and top end surfaces. The specification similarly identifies the partial cone body 17a as having a large flat end surface 17a2 constituting the base and a small flat end surface 17a1 constituting the top.
It therefore appears that the applicant may intend to require that the partial cone body or rod portion tapers from the base end surface toward the top end surface, rather than that the base end surface itself tapers. As presently written, however, the claim does not clearly identify the structure that undergoes the taper. As such, claim 9 is further rejected as indefinite for this reason. Removing the word surface, for example, may aid in claim clarity.
In addition, the relationship between the intermediate cross-section and the end surfaces in claims 10-12 lacks sufficient clarity. Claim 10 recites, “a cross-section of the rod portion between the top end surface and the base end surface has a shape that is different from a shape of the top end surface and the base end surface”. The claim does not identify the orientation of the intermediate cross-section. This omission is material in view of the structure incorporated from claim 7. The top and base end surfaces have circular edges. A transverse section through a partial-cone body and parallel to those end surfaces would ordinarily also be circular, whereas the specification expressly describes the longitudinal section of the partial-cone body as trapezoidal. Claim 11 specifies that the unidentified cross-section has a trapezium shape but still does not expressly identify which plane through the rod constitutes the cross-section. Claim 12 inherits the same ambiguity. Claims 10-12 therefore are rejected for this additional reason.
Claim 16 is additionally rejected as indefinite for unclear antecedent reference for “the sphere”. Claim 16 depends directly from claim 7 and recites, “the diameter of the sphere is about 0.3 millimetre (mm) …”. Claim 7 does not introduce “a sphere.” It recites “a body,” a plurality of spikes, a rod portion having a partial cone body, and an end portion having a curved outer surface. Claim 7 does not characterize the body as spherical, while the specification separately describes the microparticle body as “mostly” spherical and describes a spike end portion as capable of having a partial-spherical shape. Thus, claim 16 does not clearly state whether “the sphere” is intended to introduce a new requirement that the claim 7 body is spherical, refer inferentially to that body without expressly imposing the spherical-body limitation, or refer to another spherical feature (see MPEP §2173.05(e)). The applicant may clarify the claim, for example, by reciting “wherein the body has a spherical shape and a diameter of about 0.3 mm,” if that is the intended scope and adequate support exists.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. § 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. § 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 is rejected for failing to further limit the subject matter of the claim upon which it depends because it is presented in dependent form but does not specify a further limitation of the subject matter of claim 7. A dependent claim must include every limitation of the claim from which it depends and add a limitation that excludes at least some subject matter otherwise encompassed by the parent claim (see MPEP §608.01(n); Pfizer, Inc. v. Ranbaxy Laboratories Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006)).
Claim 13 recites, “The microparticle according to claim 7, wherein the spikes have the same or different lengths”. Claim 7 requires a plurality of spikes but imposes no relationship among their respective lengths. Any plurality of spikes necessarily falls within the alternatives stated in claim 13, wherein the spike lengths are either the same or they differ. Thus, under the ordinary breadth of “same or different,” claim 13 does not exclude any subject matter otherwise encompassed by claim 7. Accordingly, claim 13 fails to further limit claim 7 as required by §112(d).
Claim 14 adds an additional functional spike-length requirement and therefore is not separately rejected under §112(d) as depending from rejected claim 13, because it adequately cures the defect. The applicant may overcome the rejection, for example, by canceling claim 13, rewriting the claim in independent form if otherwise appropriate, or amending the claim to recite an actual further limitation, such as that all spikes have substantially the same length or that at least two identified spikes have different lengths.
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.
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.
For purposes of examination, the phrase “cross-section of the rod portion has a shape of a trapezium” is construed, in view of the claim language distinguishing the circular top and base end surfaces from the trapezium lying “between” those surfaces, as referring to a longitudinal or axial section through the rod portion. An axial section through a circular conical frustum necessarily has two parallel end edges and two straight tapered side edges (i.e., the recited trapezium). The trapezium is relied upon only as the necessary axial geometry of the expressly disclosed circular frustum.
The term “distributed evenly” is construed as encompassing a substantially symmetrical or regularly distributed arrangement. The claimed “formed by compression moulding” does not impart a presently claimed structural characteristic beyond the structural limitations separately recited.
The recitation that the “microparticle has a size between about 1 and about 1000 micron” is construed as referring to an overall linear dimension of the microparticle. Accordingly, Kang et al. (US20200121900A1) substrate diameter is not treated as though it were necessarily the same parameter. Tadros et al. (US20190015651A1), is instead relied upon because Tadros et al., expressly defines and discloses the overall “greatest dimension” of the complete microneedle particle.
The phrase “general diameter of the spike” is not construed as synonymous with tip-apex diameter. Xu et al. (US20070060867A1), is relied upon because Xu et al., explicitly gives the diameter of a single microneedle as 30-300 μm while separately identifying its much smaller tip dimensions, as detailed below.
Claim 1 is rejected under 35 U.S.C. § 103 as being unpatentable over Kang et al. (US20200121900A1, published 23 April 2020; hereinafter “Kang”), in view of Nagai et al. (US20190134368A1, published 09 May 2019; hereinafter “Nagai”).
Kang teaches a microparticle comprising a body having essentially the shape of a sphere and a plurality of spikes extending from the outer surface of the body (Abstract). In particular, Kang describes a device comprising a substantially spherical substrate from which a plurality of microneedles project and explains that “substantially spherical” includes spherical and nearly spherical substrates (¶[0037]-[0040]). Kang further teaches that the microneedles may have suitable three-dimensional shapes, including conical shapes (¶[0042]-[0044]). Kang does not expressly disclose the instant claimed division of a spike into a tapered rod portion and a distal end portion, with the rod having the claimed trapezium axial section. Nagai teaches the missing structural architecture.
Nagai discloses a truncated-circular-cone frustum having a circular upper surface and circular lower surface and a distal tip foundation formed on the upper surface of the frustum (Figs. 2-4, 25-26 as described in ¶[0025]-[0027] and ¶[0049]-[0050]; Modification Example M, ¶[0121]-[0124]). Thus, Nagai teaches a tapered rod/support portion extending between circular end surfaces together with a structurally distinct distal portion attached to its upper end. Nagai further teaches that providing the distal foundation increases the contact area and fixing force at the distal interface and reduces detachment (Modification Examples L-M, ¶[0119]-[0124]). Under the construction stated above, an axial section through Nagai’s circular truncated-cone frustum necessarily forms a four-sided trapezium having the upper and lower end edges parallel. This is a necessary geometric consequence of the expressly disclosed solid rather than an inference that the feature merely might be present.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use Nagai’s known tapered-frustum/support-and-distal-portion architecture in forming the projecting microneedles of Kang. Kang specifically permits selection of suitable microneedle geometries, including tapered/conical geometries, while Nagai teaches a particular tapered support geometry and distal interface designed to provide a mechanically secure projecting microneedle structure. The proposed modification therefore applies a known structural technique for constructing microneedle projections to Kang’s known spherical microneedle carrier for its established mechanical-support function.
The rationale is not merely that Kang and Nagai occupy the same field. Nagai supplies an identified structural reason for the frustum/distal-interface architecture (i.e., improved contact and fixing at the distal interface and reduced detachment), while Kang clearly contemplates selection of microneedle geometry suitable for reliable skin penetration. The factual findings therefore provide the articulated reasoning with rational underpinning required by In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), and endorsed by KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
A person of ordinary skill would have had a reasonable expectation of success in doing so because the proposed modification concerns the geometric construction of a projecting microneedle and does not require a change in Kang’s basic mechanism of skin penetration or transdermal administration. Both references demonstrate fabrication of micron-scale tapered microneedle structures, and nothing identified in either reference indicates incompatibility between the tapered support geometry and Kang’s spherical carrier. Accordingly, instant claim 1 would have been obvious over Kang in view of Nagai.
Claims 1 and 2 rejected under 35 U.S.C. § 103 as being unpatentable over Kang et al. (US20200121900A1, published 23 April 2020; hereinafter “Kang”), in view of Nagai et al. (US20190134368A1, published 09 May 2019; hereinafter “Nagai”), as applied to claim 1 above, in further view of Xu et al. (US20070060867A1, published 15 March 2007; hereinafter “Xu”).
Kang, in view of Nagai, teaches the limitations of instant claim 1, as described above, from which instant claim 2 depends, however do not explicitly teach the specific limitations of instant claim 2. Instant claim 2 specifically requires approximately a 0.3 mm sphere diameter, a 0.1 mm spike length, and a 0.03 mm general spike diameter.
Kang discloses a substantially spherical substrate having an average diameter of 0.05-100 mm, including 0.05-10 mm, which encompasses a 0.3 mm body diameter (¶[0041]). Kang further discloses microneedle heights of 10-3000 μm and, more particularly, 50-500 μm, both of which encompass 100 μm or 0.1 mm (¶[0042]).
Xu discloses that the diameter of a single microneedle is typically 30-300 μm (¶[0032]), thereby including 30 μm or 0.03 mm, and further discloses microneedle lengths of 20-500 μm (¶[0032]) and an embodiment having a shaft height of about 100 μm (¶[0032], needle shaft 7). Xu distinguishes this microneedle diameter from the substantially smaller diameter of its sharp distal tip (¶[0032]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to select a 0.3 mm spherical-body diameter and 0.1 mm needle length from Kang’s encompassing ranges and a 0.03 mm needle diameter from Xu’s encompassing 30-300 μm diameter range. A prior-art range that encompasses the claimed value ordinarily establishes a prima facie case of obviousness absent evidence of criticality or unexpected results (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003); MPEP § 2144.05).
The record also supplies an independent technical reason for these dimensional selections. Kang relates needle height to the required depth of therapeutic/cosmetic administration and avoidance of nerves, pain, and bleeding (¶[0042]), while Xu relates microneedle diameter and length to sufficient skin penetration and maintenance of mechanical integrity (¶[0032]). Thus, these are dimensions recognized in the art as affecting the operative mechanical and penetration properties of microneedles (see In re Applied Materials, Inc., 692 F.3d 1289, 1295-97 (Fed. Cir. 2012)). One of ordinary skill in the art therefore would have had reason to select workable values within the disclosed ranges through routine engineering according to desired penetration depth and mechanical strength. Thus, instant claim 2 therefore would have been obvious.
Claims 1, 3 and 4 are rejected under 35 U.S.C. § 103 as being unpatentable over Kang et al. (US20200121900A1, published 23 April 2020; hereinafter “Kang”), in view of Nagai et al. (US20190134368A1, published 09 May 2019; hereinafter “Nagai”), as applied to claim 1 above, in further view of Tadros et al. (US20190015651A1, published 17 January 2019; hereinafter “Tadros”).
Kang, in view of Nagai, teaches the limitations of instant claim 1, as described above, from which instant claims 3 and 4 depend, however do not explicitly teach the specific limitations of instant claims 3 and 4.
Instant claim 3 requires the rod axis to extend about perpendicularly to the outer surface of the body. Kang teaches microneedles projecting outwardly from a substantially spherical substrate and uses the resulting thorny particle for multidirectional interaction with skin (¶[0037]-[0044]). Kang does not, however, expressly state that each longitudinal axis is perpendicular to the local spherical surface. Tadros establishes that the conventional microneedle orientation relative to its supporting substrate was substantially perpendicular and further teaches free-standing microneedle particles having projections extending in different planes (¶[0004]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to retain that conventional substantially normal orientation when arranging microneedles about Kang’s curved carrier (i.e., orient each needle generally along the local surface normal) because such an arrangement preserves the conventional relationship between the support surface and the penetrating longitudinal axis while allowing the spherical particle to provide skin-facing needles in different orientations (¶[0049]). This is an obvious geometric adaptation of the known perpendicular orientation to a curved rather than planar carrier and does not depend upon an assertion that perpendicular orientation is inherent in every spike extending from a sphere. The modification would have been expected to succeed because it alters only orientation of otherwise conventional projecting microneedles and requires no new operating principle.
Instant claim 4 requires the spikes to be distributed evenly across the body’s outer surface. Kang teaches plural microneedles distributed on a spherical carrier, permits control of their spacing and density, and recognizes microneedle density as relevant to efficient skin piercing and structural integrity (¶[0044]). Tadros teaches microneedles extending from a core so as to impart a symmetrical structure to a microneedle particle (¶[0060]) and gives substantially tetrahedral and substantially octahedral multidirectional arrangements as specific examples(¶[0074]; Figs. 5-7).
Under a broad reasonable interpretation of “distributed evenly” as a substantially regular or symmetrical distribution, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to arrange Kang’s microneedles substantially symmetrically around the spherical carrier in view of Tadros. Kang is intended to provide a freely movable, multidirectional microneedle article; distributing the penetrating structures substantially symmetrically would predictably reduce dependence of penetration behavior on which side of the particle contacts the tissue. This constitutes an articulated functional reason for the distribution rather than an assertion that symmetry necessarily equals mathematical uniformity (see KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 416-421 (2007)). Accordingly, instant claims 3 and 4 would have been obvious.
Claims 5, 7-15, and 17-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Kang et al. (US20200121900A1, published 23 April 2020; hereinafter “Kang”), in view of Nagai et al. (US20190134368A1, published 09 May 2019; hereinafter “Nagai”), Lalwani et al. (WO2019136133A1, published 11 July 2019; hereinafter “Lalwani”), and Tadros et al. (US20190015651A1, published 17 January 2019; hereinafter “Tadros”).
Kang teaches a microparticle having a body and a plurality of spikes extending from the body’s outer surface (¶[0037]-[0044]). Nagai teaches the recited tapered rod architecture. Nagai discloses a frustum-shaped protrusion constituting a truncated circular cone having a circular top surface, a circular bottom surface, and a taper between the larger lower portion and smaller upper portion (Figs. 2-4, as described in ¶[0025]-[0027]). Nagai further teaches attaching a distinct distal structure to the upper surface of that frustum (Figs. 25-26, as described in ¶[0049]-[0050]; Modification Example M, ¶[0121]-[0124]).
Lalwani further supplies a stronger teaching for the claimed curved distal end than Nagai’s embedded tip foundation. Lalwani teaches a microneedle having a distal tip whose geometry approximates a hemisphere (i.e., a curved distal outer surface) and teaches that such tip geometry can reduce insertion force and minimize tissue damage (¶[0063]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to provide the distal end of the Nagai-type tapered support used in the Kang particle with Lalwani’s known curved/approximately hemispherical microneedle end. Both Nagai and Lalwani concern the geometry of microneedle structures intended to penetrate biological tissue. Lalwani expressly identifies the functional reason for its distal geometry as controlling insertion force and tissue damage. Thus, the proposed modification is predicated on an explicit penetration-related reason for using the curved distal end identified in the prior art.
A person of ordinary skill would reasonably have expected success in doing so because Lalwani treats tip curvature, tip diameter, shaft diameter, and taper as conventional geometric design parameters for microneedles and expressly fabricates such complex micron-scale geometries. The modification leaves the basic skin-penetrating function unchanged and predictably alters only the shape of the distal end.
Instant claim 7 additionally requires the microparticle, rather than merely its body, to have a size between about 1 and about 1000 μm. Tadros discloses the overall greatest dimension of the microneedle particles defines that dimension on a tip-to-tip or tip-to-opposite-core basis, and discloses ranges encompassing dimensions at and below 1000 μm, including a particle dimension of about 1000 μm (¶[0065]). Thus, the comparison is between the claimed overall particle size and a prior-art overall particle dimension. The overlapping/encompassing dimensional disclosure establishes a prima facie case of obviousness for this limitation (see In re Peterson, 315 F.3d 1325, 1329-1331 (Fed. Cir. 2003)). Accordingly, instant claim 7 would have been obvious.
Instant claim 8 requires the curved outer surface to comprise a partial sphere.
Lalwani teaches that the geometry of the distal tip of the microneedle can be characterized as approximating a hemisphere (¶[0063]). A hemisphere is a partial sphere. Unlike Nagai’s tip foundation, this surface is expressly positioned at the distal end of the microneedle. Accordingly, instant claim 8 therefore would have been obvious.
Instant claim 9 further recites tapering toward the top end surface. Nagai discloses the selected frustum geometry as a truncated circular cone extending from the wider lower region toward the smaller upper surface (Figs. 2-4). Accordingly, the tapered relationship would have been obvious for the reasons stated for instant claim 7.
Instant claims 10-12 require a rod cross-section between the circular top and base surfaces that differs in shape from those end surfaces, specify that the section is a trapezium, and further require four straight sides with one pair of opposite sides parallel.
Under the axial/longitudinal construction stated above, Nagai’s circular truncated-cone rod necessarily has precisely this geometry, wherein the top and bottom surfaces are circular, while an axial plane through the frustum produces four straight boundary edges, the top and bottom edges forming one parallel pair.
Because this geometrical relationship necessarily follows from the expressly disclosed circular frustum, reliance upon it satisfies the inherency requirement that the feature necessarily be present (see In re Oelrich, 666 F.2d 578, 212 USPQ 323 (C.C.P.A. 1981); In re Robertson, 169 F.3d 743, 49 USPQ2d 1949 (Fed. Cir. 1999)). The rejection does not assert that a transverse cross-section through the same frustum is trapezoidal. Thus, instant claims 10-12 would have been obvious.
Kang states that the individual microneedles may have the same or different heights (¶[0042]). Tadros likewise teaches independently selected microneedle lengths (¶[0062]). Thus, instant claim 13 would have been obvious. Kang teaches that microneedle height may be selected to permit administration of a therapeutic or cosmetic agent while remaining sufficiently short to avoid contacting nerves, thereby reducing pain and bleeding (¶ 0042]). This substantially corresponds to the additional functional limitation of instant claim 14 and thus, instant claim 14 would have been obvious. Kang teaches therapeutic or cosmetic agents that may be coated on the microneedles and/or substrate, encapsulated in the device, or co-formulated with the device (¶[0054]-[0056]). Instant claim 15 therefore would have been obvious.
Instant claim 17 recites the approximately perpendicular axis limitation addressed with respect to instant claim 3. Tadros’s substantially perpendicular conventional orientation and its multidirectional free-standing particle teachings render a substantially local-normal/radial orientation on Kang’s spherical carrier obvious for the reasons stated above. Instant claim 18 recites the evenly distributed limitation addressed with respect to instant claim 4. Kang’s control of microneedle spacing/density combined with Tadros’s expressly symmetrical, substantially tetrahedral/octahedral multidirectional particle configurations would have made a substantially regular distribution around the spherical carrier obvious for the reasons stated above. Kang identifies gelatin, gelatin methacrylate hydrogel, hyaluronic acid, silicone, polymer, sugar, glass, ceramic, and metal as materials from which its microneedle device can be formed (¶[0045]; claim 2). The limitation of instant claim 20 is therefore taught by Kang.
Regarding instant claim 5, for the reasons set forth above, Kang teaches a spherical or substantially spherical body carrying outwardly projecting microneedles; Nagai teaches a tapered circular-frustum rod having circular top and base surfaces with the base larger than the top; Lalwani teaches an exposed distal microneedle end having an approximately hemispherical or partial-spherical outer surface; and Tadros teaches an overall microneedle-particle dimension falling within the claimed 1-1000 μm range.
Nagai’s Modification Example M further teaches a base material comprising the foundation, frustum-shaped protrusions, and distal tip foundations, with the distal foundation formed on and projecting from the upper surface of the frustum. Thus, the reference teaches or at minimum would have suggested forming the support and attached distal region as integral portions of the microneedle-support structure. Kang likewise teaches fabrication of its three-dimensional spherical microneedle structure using a three-dimensional mold, supporting one-piece formation of the body/projection structure. The axial section of the circular frustum necessarily forms the claimed trapezium for the reasons stated above.
Instant claim 5 additionally states that the microparticle “is formed by compression moulding of a pliable moulding material.” However, claim 5 is a claim to the microparticle as a product, not a method of manufacture. Under the product-by-process doctrine, patentability of such a product is determined based upon the product itself; a product that is the same as or obvious from a prior-art product is not rendered patentable merely because it is recited as having been produced by a different process (see In re Thorpe, 777 F.2d 695, 697-98 (Fed. Cir. 1985); MPEP § 2113). Process language must, however, be given effect to the extent it imparts a structural or functional difference to the claimed product.
Here, the claim does not recite a structural characteristic of the finished microparticle that results uniquely from compression molding and that is absent from the otherwise obvious product. The recited resulting structural features (i.e., sphere, integral rod/end relationships, taper, circular end surfaces, trapezium axial section, and particle size) are separately accounted for by the references above. Accordingly, the recited manufacturing does not distinguish the product.
However, evidentiary reference Nguyen et al. (US20190269895A1, published 05 September 2019; hereinafter “Nguyen”) additionally confirms that compression molding polymeric microneedle structures was conventional. Nguyen compression molds PLGA or other polymer films into microneedle molds by heat pressing at the polymer’s melting or glass-transition temperature under vacuum so that the softened polymer fills the mold cavities (Fig. 6, steps 125-135). This disclosure is cited as corroborating the state of the art, not as an assertion that Nguyen itself expressly compression molds Kang’s complete thorny spherical particle. Accordingly, instant claim 5 would have been obvious.
Instant claim 19 similarly recites that the microparticle of claim 7 is “formed by compression moulding of a polymer.” Kang teaches polymer as a material for its microneedle device (¶[0045]). The resulting product structure of instant claim 7 is obvious for the reasons stated above. For the reasons stated for instant claim 5, the product is not rendered patentably distinct merely by reciting a compression-molding manufacturing history where no additional structural difference resulting from that process is claimed. Yet, evidentiary reference Nguyen independently establishes that compression molding polymers such as PLGA into microneedle molds was an established fabrication technique before the instant effective filing date (Fig. 6, steps 125-135), further confirming that the recited process itself was not technologically unconventional. Thus, instant claim 19 therefore would have been obvious.
Claims 5-7, and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Kang et al. (US20200121900A1, published 23 April 2020; hereinafter “Kang”), in view of Nagai et al. (US20190134368A1, published 09 May 2019; hereinafter “Nagai”), Lalwani et al. (WO2019136133A1, published 11 July 2019; hereinafter “Lalwani”), and Tadros et al. (US20190015651A1, published 17 January 2019; hereinafter “Tadros”), as applied to claims 5 and 7 above, in further view of Xu et al. (US20070060867A1, published 15 March 2007; hereinafter “Xu”).
Kang, in view of Nagai, Lalwani, and Tadros teach the limitations of instant claims 5 and 7, as described above, from which instant claims 6 and 16 depend, respectively, however do not explicitly teach the specific limitations of instant claims 6 and 16. Instant claims 6 and 16 each require approximately a 0.3 mm sphere diameter, 0.1 mm spike length, and 0.03mm general spike diameter. Kang’s disclosed spherical-substrate diameter of 0.05-100 mm encompasses 0.3 mm, and Kang’s disclosed microneedle heights of 10-3000 μm, including 50-500 μm, encompass 100 μm or 0.1 mm (¶[0041]-[0042]).
Xu explicitly discloses a microneedle length of 20-500 μm and a diameter of a single microneedle of 30-300 μm (¶[0032]), thereby encompassing both a 100 μm length and the instant claimed 30 μm or 0.03 mm general microneedle diameter. Xu’s pertinent 30-300 μm disclosure is directed to the diameter of the microneedle itself.
The claimed values lie within express prior art ranges of the same dimensional variables, thereby supporting a prima facie case under In re Peterson, 315 F.3d 1325, 1329-1331 (Fed. Cir. 2003).
Moreover, the combined prior art supplies the requisite functional relationship. Kang relates length to penetration depth, nerve avoidance, pain and bleeding, while Xu relates needle dimensions to penetration and mechanical integrity. Thus, selection of workable values within those disclosed ranges would have represented predictable optimization of recognized microneedle parameters rather than hindsight selection of an unrecognized variable (see In re Applied Materials, 692 F.3d 1289, 1295-1298 (Fed. Cir. 2012); In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
Thus, instant claims 6 and 16 would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date. Kang supplies the spherical, freely movable microneedle carrier and identifies microneedle shape, height, spacing, density, materials, and agent incorporation as design variables. Nagai supplies a specific tapered frustum/support architecture and identifies a mechanical reason for its distal-interface construction. Lalwani supplies a distal curved/approximately hemispherical microneedle tip and expressly relates that geometry to insertion force and tissue damage. Tadros supplies free-standing multidirectional and symmetrical microneedle-particle arrangements and an overall particle-dimension disclosure. Xu supplies a genuine microneedle-diameter range encompassing 30 μm and connects microneedle dimensions with penetration and mechanical integrity.
The proposed modifications preserve the ordinary skin-penetrating function of the microneedles and use known microneedle geometries and dimensions for the functions the respective references attribute to them. Thus, this rejection rests on specific factual findings supporting both a reason for the modifications and a reasonable expectation that the resulting structures would operate for their intended penetrating function. The combinations are based on the identified penetration, mechanical-support, dimensional, and distribution considerations disclosed in the references themselves.
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
