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
Applicant’s election without traverse of Species B, claims 1-9 in the reply filed on January 12, 2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 January 12, 2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simmers (US 9782574).
Regarding claim 1, Simmers discloses a skin grafting system comprising: a plurality of hollow microneedles (108, Figure 3, C:20, L:2-4) actuatable between a retracted position (figure 4) and an extended position (Figure 3); a rigid member coupled to the plurality of hollow microneedles (carrier 124, Figures 2, 4, 5, C:7, L:16-24); and a latch assembly (locking mechanism 145, Figures 4, 5) comprising at least one latch (144, C:15, L:16-20) coupled to the latch assembly, wherein the at least one latch is configured to inhibit movement of the rigid member when the plurality of hollow microneedles are in the extended position (C:15, L:30-65, P1, figure 3, C:14, L:40-45).
Regarding claim 2, Simmers discloses all of the limitations set forth in claim 1, wherein the at least one latch is movable during actuation of the plurality of hollow microneedles and is one of pivotally coupled or slidably coupled to the latch assembly (Figures 4, 5) .
Regarding claim 3, Simmers discloses all of the limitations set forth in claim 1, wherein the latch assembly further comprises a spring (142) disposed between a pair of latches (figure 5, spring is in the middle of the latches from left to right).
Regarding claim 4, Simmers discloses all of the limitations set forth in claim 3, wherein the latch assembly further comprises a body (143) centrally disposed between the pair of latches, and wherein the latches corresponding to the pair of latches are horizontally opposed about the body (figure 1).
Regarding claim 5, Simmers discloses all of the limitations set forth in claim 4, wherein the latches are configured to slide horizontally between a latched position and an unlatched position (C:15, L:35-40, latches are rotated to align with apertures which comprises a horizontal component of movement), the latched position corresponding to the plurality of hollow microneedles being in the extended position (C:15, L:30-65, P1, figure 3, C:14, L:40-45).
Regarding claim 7, Simmers discloses all of the limitations set forth in claim 4, further comprising a guide plate (121) configured to engage with a guide profile (aperture 123) formed into the pair of latches such that the latches slide horizontally between a latched position and an unlatched position (latches are rotated to align with apertures which comprises a horizontal movement; C:15, L:35-40).
Regarding claim 8, Simmers discloses all of the limitations set forth in claim 7, further comprising a shaft (143) coupled to the guide plate, wherein the shaft is slidably coupled to the body via a shaft aperture (123) within the body.
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.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Simmers (US 9782574) as applied to claim 4 above, and further in view of Poon et al (US 20160271380)
Regarding claim 6, Simmers discloses all of the limitations set forth in claim 4, wherein the spring is arranged between the pair of latches and configured to bias the latches to a latched position (figures 1, 4, 5) and that the spring can be a leaf spring, coiled spring, hinged spring (C:12, L:24-34), but not specifically a double torsion spring. However, Poon teaches it was known in the art for microneedle applicators having biasing elements for advancing and retracting elements within the device to utilize a double torsion spring as an art-recognized equivalent biasing element for leaf springs and coil springs at the time of the invention. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to configure the device of Simmers in order to alternatively use a double torsion spring, as an art-recognized equivalent biasing mechanism at the time of the invention taught by Poon, since it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Regarding claim 9, Simmers discloses all of the limitations set forth in claim 8, further comprising a coil spring (142, C:12, L:24-34) configured to bias the guide plate upwards such that the latches remain in the latched position (C:15, L:30-65, P1, figure 3, C:14, L:40-45), but does not specifically disclose the spring is disposed within the shaft. However, Poon teaches it was known in the art at the time of the invention to make a biasing element for biasing a plunger for advancing and retracting a microneedle array to abut the internal wall of a housing (paragraph 0115) in order for the plunger and the microneedle array holder to move relative to the housing together (paragraph 0115). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to configure the device of Simmers such that the spring alternatively disposed within a shaft of the actuator, as taught as a known configuration for microneedle advancing and retracting mechanisms at the time of the invention by Poon, since it has been held that rearranging parts of an invention involves only routine skill in the art and each of the elements merely perform the same function as they did separately.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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