DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/25 has been entered.
Priority
As set forth previously, for purposes of prior art, the claim(s) are examined with an earliest priority date of 5/13/10.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 149-155, 157, 159, 160, 162, 164, 165, 167, and 169-174 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frederickson (US 20100222743 A1) in view of Cunningham (US 20020169393 A1).
For claim(s) 149, 159, and 160, Frederickson teaches A device for withdrawing blood from the skin and/or from beneath the skin of a subject [entire disclosure – see at least abstract], the device comprising:
an actuator; [137, 125]
a flexible concave member [166], wherein the flexible concave member is moveable between a first configuration and a second configuration upon actuation of the device; [Figs. 6c-e]
at least one cutter [174], wherein the at least one cutter is in a first position before actuation of the device and in a second position after actuation of the device, [Figs. 6c-e]
wherein, upon actuation of the device, the at least one cutter moves from the first position to the second position at a speed of at least 1 cm/s. [¶56]
Frederickson fails to teach the retraction mechanism configured to move the at least one cutter away from the skin.
Cunningham teaches a device for withdrawing blood from a subject [abstract] including a retraction mechanism [68] configured to move a cutter away from a subject’s skin.
It would have been obvious to one of ordinary skill at the time the invention was made to modify the device of Frederickson to incorporate the retraction mechanism of Cunningham in order to increase the comfort and reliability of blood sampling. As motivated by Cunningham ¶¶10-13, Frederickson ¶33.
For claim(s) 150 and 161, Frederickson teaches The device of claim 149,
wherein actuation of the device causes the at least one cutter from the first position to the second position at a speed of at least 10 cm/s. [¶56]
For claim(s) 151 and 159, Frederickson teaches The device of claim 149,
wherein actuation of the device causes the at least one cutter to move from the first position to the second position at a speed of an acceleration of at least 100,000 meters/second2. [the structure of Frederickson is capable of such an acceleration]
For claim(s) 152 and 162, Frederickson teaches The device of claim 149, wherein the first position and the second position of the at least one cutter are separated by a distance of no more than 5 mm. [there are at least two positions of 166 and 174 between the positions of Figs. 6c-e that are 5 mm apart]
For claim(s) 153 and 163, Frederickson teaches The device of claim 149, wherein the actuator is able to move the at least one cutter from the first position to the second position in a period of time of less than 0.002 seconds. [the structure of Frederickson is capable of such a movement interval]
For claim(s) 154 and 164, Frederickson teaches The device of claim 149, wherein the actuator is able to move the at least one cutter from the first position to the second position with a force sufficient to insert the at least one cutter into the skin to a depth of at least 60% of the length of the at least one cutter. [full insertion shown in Fig. 6f]
For claim(s) 155 and 165, Frederickson teaches The device of claim 149, wherein the at least one cutter is a microcutter. [¶50]
For claim(s) 156 and 166, Frederickson teaches The device of claim 149, wherein the device is configured such that movement of the flexible concave member from the first configuration to the second configuration inserts the at least one cutter into the subject's skin. [Figs. 6c-f]
For claim(s) 157 and 167, Frederickson teaches The device of claim 149, wherein the device is configured such that movement of the flexible concave member from the first configuration to the second configuration and moves the at least one cutter from the first position to the second position. [Figs. 6c-e]
For claim(s) 170 and 173, Frederickson teaches
wherein the flexible concave member is configured to be pushed using a hand or a finger contacting the flexible concave member directly. [¶49]
For claim(s) 171 and 174, Frederickson teaches
wherein in the first configuration, the flexible concave member has a dome shape. [137 in Fig(s). 6B]
For claim(s) 169 and 172, the motivated combination of Frederickson and Cunningham teaches
wherein the flexible concave member is configured to spontaneously return from the second configuration back to the first configuration. [via spring 68 of Cunningham in the structure of Frederickson] As motivated in claim(s) 149 and 159.
Response to Arguments
Applicant's arguments filed 11/14/25 have been fully considered but they are not persuasive.
Applicant argues in remarks p. 7-8 that modifying Frederickson in view of Cunningham would render Frederickson unsuitable for its intended purpose of drug delivery and impermissibly change its principle of operation. Examiner respectfully disagrees.
Applicant specifically argues that Frederickson teaches embodiments where a patch of microneedles remains adhered to the skin and as such Frederickson would not seek to modify the device to retract the needles. Examiner respectfully submits that Applicant’s argument is a mischaracterization of the Frederickson reference. Frederickson states in ¶33
“In some instances, the microneedle arrays may be applied as part of a microneedle device which, for example, may be in the form of a patch designed to adhere to skin and help keep the array in intimate contact with the skin.’
(emphasis)
Frederickson accordingly states that the microneedles may be left adhered to the skin via a patch in some instances. This use of “some instances” and “may” in the Frederickson reference is not negligible. The Frederickson reference does not limit itself to only embodiments where the microneedles must remain in the skin after initial actuation. MPEP § 2143.01 states
I. PRIOR ART SUGGESTION OF THE CLAIMED INVENTION NOT NECESSARILY NEGATED BY DESIRABLE ALTERNATIVES
The disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004), the claims of a utility patent application were directed to a shoe sole with increased traction having hexagonal projections in a "facing orientation." 391 F.3d at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal projections in a facing orientation with a utility patent having other limitations of the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the combination was improper because (1) the prior art did not suggest having the hexagonal projections in a facing (as opposed to a "pointing") orientation was the "most desirable" configuration for the projections, and (2) the prior art "taught away" by showing desirability of the "pointing orientation." 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. The court stated that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." Id. In affirming the Board’s obviousness rejection, the court held that the prior art as a whole suggested the desirability of the combination of shoe sole limitations claimed, thus providing a motivation to combine, which need not be supported by a finding that the prior art suggested that the combination claimed by the applicant was the preferred, or most desirable combination over the other alternatives. Id. See also In re Urbanski, 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016).
Applicant’s position is inconsistent with such guidance. Frederickson’s optional use of an adhered patch does not serve as proper evidence of nonobviousness.
Conclusion
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791