DETAILED ACTION
This action is responsive to the “RESPONSE TO NON-FINAL OFFICE ACTION UNDER 37 C.F.R. § 1.111” filed 26 February 2026. The Examiner acknowledges the amendments to claims 1, 59, and 71. Claims 1, 59-61, 64-68, 70-71, 73-75, and 77-79 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 59 and 65 is/are objected to because of the following informalities:
Claim 59 should read “[[a]] the deployment direction” [line 2].
Claim 65 should read “a device interface to provide a seal against skin” [lines 1-2].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 65-66, 70, 73-75, and 77-79 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernstein (US-20130158468-A1).
Regarding claim 1, Bernstein teaches
A device for receiving fluid from a subject, comprising:
a base including an opening to receive fluid into the device [the device includes an interface 105 (see FIGS. 2, 4 and 5) that is able to help the device apply a vacuum to the skin and/or at the opening 130 (Bernstein ¶0067)];
a flow activator being arranged to cause fluid to be released from the subject [the flow activator 90 includes one or more needles. As described in more detail below, the needles may be extended from the opening 130 to pierce a subject's skin, and then retracted back into the opening to allow blood or other fluid to enter the opening 130 (Bernstein ¶0048)];
a carrier that holds the flow activator prior to actuation of the device [effector 50 (Bernstein Figs. 5, 7B, 13); As shown in FIG. 13, a post 94 is coupled to the membrane 72, the flow activator 90 and the deployment actuator 60, and may be made relatively stiff or non-compliant, e.g., to help transmit movement from the deployment actuator 60 to the flow activator 90 with little loss (Bernstein ¶0086, Figs. 5, 7B, 13); For example, FIG. 26A shows a schematic arrangement in which a post 94 used to connect a flow activator (not shown) to a membrane 72 and/or a deployment actuator 60 may be made by an adhesive 400 (Bernstein ¶0090); the deployment actuator 60 includes a central hole 66 and lobes 62 that are held within the grooves 56 of the effector body 50 (Bernstein ¶0058, Fig. 7B), wherein the flow activator 90 being coupled to post 94, membrane 72, and deployment actuator 60 via an adhesive (see also embodiments depicted in Bernstein Figs. 26A-D regarding the post 94 being fixed attached to deployment actuator 60), wherein the deployment actuator 60 is held by the effector 50, is considered to read on the broadest reasonable interpretation of the carrier “hold[ing]” the flow activator; the Examiner’s interpretation is further based on the plain definition of hold referring to “to support in a particular position or keep from falling or moving” (see https://www.merriam-webster.com/dictionary/hold) and based on Applicant’s disclosure of how the carrier “holds” the flow activator: “This upward movement of the spring pushes a carrier holding the deployment actuator up with the spring, causing the flow activator, which is coupled to the deployment actuator, to retract as well” (Applicant’s Specification p. 7:26-28); “The carrier 50 holds the deployment actuator 60 such that movement of the carrier 50 moves the deployment actuator 60 along with the carrier… The top of the post 94 that couples the deployment actuator to the flow activator can also be seen in FIG. 15 (Applicant’s Specification p. 15:9-11, 14-15), emphasis applied by Examiner];
a deployment actuator configured to deform to store energy and configured to release stored energy to move the flow activator in a deployment direction toward the subject [the deployment actuator 60 has a generally domed shape (e.g., as in a Belleville spring)… The deployment actuator 60 may initially be arranged in a concave-down configuration shown in FIG. 4 and moved to a concave-up configuration, e.g., by a user pressing the device actuator 10 to cause a release element 30 to push a center portion of the deployment actuator 60 downwardly. The deployment actuator 60 may be made of a suitable material and configuration to rapidly move from the concave-down to concave-up configurations so as to rapidly extend the flow activator 90 from the opening 130 and pierce a subject's skin or other surface. While the deployment actuator 60 in this embodiment is arranged as a flexible spring with a dome shape, the deployment actuator 60 may be of any suitable shape and/or size (Bernstein ¶0052); the deployment actuator 60 may be arranged to relatively rapidly move from the concave-down to concave-up configuration, quickly inserting the flow activator 90 into skin or another surface (Bernstein ¶0055), wherein the Examiner notes that the deployment actuator being a spring configurable between a concave-down and concave-up configuration is considered to define an element that is configured to deform to store energy and configured to release stored energy to move];
a plurality of posts and a corresponding plurality of openings, wherein relative movement between the plurality of posts and the corresponding plurality of openings limits rotation of the carrier as the carrier moves relative to the base [the device 1 includes an effector 50 that includes a retraction actuator 40 and a deployment actuator 60 and that is movable in up and down directions relative to the base 100 along effector guides 104 (Bernstein ¶0052, Figs. 3, 5, 8); see Annotated Fig. 1, wherein the Examiner notes that the effector guides 104 are depicted as allowing the effector 50 to slide up and down relative to the interface 105 (base), but due to the interfacing between the effector 50 and the effector guides 104 would prevent rotation of the effector about an axis defined through the central hole 66];
a retraction actuator positioned between the carrier and the base such that the retraction actuator is configured to move the carrier in a retraction direction away from the opening [The retraction actuator 40 is attached to the deployment actuator 60 via the effector body 50 so that when the retraction actuator 40 is released upon actuation of the device actuator 10, the retraction actuator 40 (and other portions of the effector 50) can move away from the opening 130 along the effector guides 104 (Bernstein ¶0053); FIGS. 15-18 show yet another embodiment that is very similar to that of FIGS. 1-10, but in which the latch arrangement used to hold the retraction actuator 40 in an initial, compressed state is modified (Bernstein ¶0087, Figs. 15-18), wherein the Examiner notes that as depicted in at least Fig. 17, the retraction actuator 40 is positioned between the effector 50 (carrier) and the interface 105 (base)]; and
a vacuum source, wherein vacuum is generated from the vacuum source during actuation of the device [the device may include a vacuum source. Vacuum (a pressure below ambient) may help facilitate fluid flow into the opening 130 of the device, and/or may help draw skin into the opening 130 for contact with the flow activator 90, and/or may help facilitate fluid flow from the opening 130 to a chamber 140].
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Annotated Fig. 1. The Examiner has annotated Bernstein Fig. 7B to identify protruding arms of effector 50 that comprise the grooves 56, wherein the Examiner notes that the claimed “openings” are not defined relative to any particular structure, such that the protruding arms of the effector 50 (carrier) define open spaces between each arm, such that the defined open spaces may be considered to be a “corresponding opening” based on the BRI of “opening” [something that is open: such as: an open width” see https://www.merriam-webster.com/dictionary/opening].
Regarding claim 65, Bernstein teaches
The device of claim 1, further comprising a device interface that provides a seal against skin [The device 1 may be deployed as a patch or other similar arrangement, e.g., where the interface 105 includes an adhesive so that the device 1 can be adhered to a user's skin (Bernstein ¶0101)].
Regarding claim 66, Bernstein teaches
The device of claim 65, wherein the device interface comprises an adhesive [Bernstein ¶0101].
Regarding claim 70, Bernstein teaches
The device of claim 1, wherein the flow activator comprises one or more needles [Bernstein ¶0048].
Regarding claim 73, Bernstein teaches
The device of claim 1, wherein the carrier holds the deployment actuator and wherein the carrier holds the flow activator via the deployment actuator [Bernstein ¶¶0058, 0086, Fig. 7B].
Regarding claim 74, Bernstein teaches
The device of claim 73, wherein the deployment actuator moves with the carrier [The retraction actuator 40 is attached to the deployment actuator 60 via the effector body 50 so that when the retraction actuator 40 is released upon actuation of the device actuator 10, the retraction actuator 40 (and other portions of the effector 50) can move away from the opening 130 along the effector guides 104 (Bernstein ¶0053)].
Regarding claim 75, Bernstein teaches
The device of claim 1, further comprising an intermediate post, wherein the flow activator is coupled to the intermediate post, and wherein the carrier holds the flow activator via the intermediate post [the flow activator 90 may be mechanically coupled to the deployment actuator 60 via a transmission structure 94 such as a post, a rod, or other (Bernstein ¶0086), see Examiner’s interpretation of the carrier holding the flow activator as recited in claim 1 above].
Regarding claim 77, Bernstein teaches
The device of claim 1, wherein the flow activator is moveable relative to the carrier [Bernstein ¶¶0058, 0086, wherein as the flow activator 90 is directly coupled to the deployment actuator, which is configurable between a concave-up and concave-down position, the flow activator 90 is considered to be movable relative to the effector 50 (carrier)].
Regarding claim 78, Bernstein teaches
The device of claim 1, wherein the flow activator moves relative to the carrier as the flow activator is deployed in the deployment direction toward the subject [Bernstein ¶0052, wherein as the flow activator 90 is directly coupled to the deployment actuator, which is configurable between a concave-up and concave-down position, the flow activator 90 is considered to be moved relative to the effector 50 (carrier) when the deployment actuator switched between the concave-down to concave-up position].
Regarding claim 79, Bernstein teaches
The device of claim 1, wherein the carrier is slidable relative to the plurality of posts [Bernstein ¶0052].
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 59-61, 64, 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein, as applied to claim 1 above, in view of Roe (US-20040127818-A1, previously presented).
Regarding claims 59-61 [rejected together, wherein claim 61 is considered to incorporate the subject matter of claims 59-60 therein], Bernstein teaches
The device of claim 1, wherein the flow activator is configured to move in the deployment direction in response to actuation of the device [Bernstein ¶¶0048, 0052].
However, Bernstein fails to explicitly disclose further comprising a first cantilevered arm that is curved about an axis parallel to a deployment direction; further comprising a cylindrical body, wherein the first cantilevered arm is cantilevered from the cylindrical body; and wherein the cylindrical body includes an opening passing through the cylindrical body in the deployment direction.
Roe is directed towards a bodily fluid sampling device [bodily fluid sampling device 40 (Roe Figure 1)], wherein Roe discloses a first cantilevered arm [arm 66 (Roe Figure 1)] that is curved about an axis parallel to a deployment direction [the arm 66 of the adjuster 44 slides within the slot 64 of the outer expression member 46 (Roe ¶0068), wherein the arm 66 having a thickness is considered to curve about an axis parallel to a deployment direction]; a cylindrical body [inner adjustment member 62 (Roe Figure 1), wherein the inner adjustment member 62 being threaded is considered to read on being cylindrical], wherein the first cantilevered arm is cantilevered from the cylindrical body [the reference member 48 can be threaded and the inner adjustment member 62 can have corresponding grooves (Roe ¶0064); wherein as seen in Figure 1, the arm 66 cantilevers from inner adjustment member 62]; and wherein the cylindrical body includes an opening [aperture 88 (Roe Figure 1)] passing through the cylindrical body in the deployment direction [an aperture 88 through which tip 58 of the lancet 50 extends (Roe ¶0065)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein to employ a first cantilevered arm that is curved about an axis parallel to a deployment direction and a cylindrical body, wherein the first cantilevered arm is cantilevered from the cylindrical body; and wherein the cylindrical body includes an opening passing through the cylindrical body in the deployment direction, as taught by Roe, so as to incorporate elements that would allow for user control of the penetration depth of the flow activator [Rotating the outer adjustment member 60 changes distance D1, thereby changing the penetration depth of the lancet 50 (Roe ¶0065), wherein the first cantilevered arm 66, cylindrical body 62, and opening 88 form the adjustment member 60 of Roe].
Regarding claim 64, Bernstein in view of Roe teaches
The device of claim 59, wherein prior to actuation of the device, the first cantilevered arm is in a relaxed state [wherein the arm 66 of Roe being in a stable state is considered to read on being in a relaxed state].
Regarding claims 59 and 67 [rejected together, wherein claim 67 is considered to incorporate the subject matter of claim 59 therein], Chickering in view of Roe teaches
The device of claim 1, wherein the flow activator is configured to move in the deployment direction in response to actuation of the device [Bernstein ¶¶0048, 0052].
However, Bernstein fails to explicitly disclose further comprising a first cantilevered arm that is curved about an axis parallel to a deployment direction and a second cantilevered arm that is curved in a direction that partially surrounds the axis.
Roe is directed towards a bodily fluid sampling device [bodily fluid sampling device 40 (Roe Figure 1)], wherein Roe discloses a first cantilevered arm [arm 66 (Roe Figure 1)] that is curved about an axis parallel to a deployment direction [the arm 66 of the adjuster 44 slides within the slot 64 of the outer expression member 46 (Roe ¶0068), wherein the arm 66 having a thickness is considered to curve about an axis parallel to a deployment direction]; and a second cantilevered arm [outwardly extending flange 68 (Roe Figure 1)] that is curved in a direction that partially surrounds the axis [The inner adjustment member 62 further incorporates an outwardly extending flange 68 (Roe ¶0063), wherein outwardly extending flange 68 having a thickness extending perpendicular to the deployment direction is considered to read on being curved in a direction that partially surrounds the axis].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Chickering so as to incorporate a first cantilevered arm that is curved about an axis parallel to a deployment direction and a second cantilevered arm that is curved in a direction that partially surrounds the axis, as taught by Roe, so as to incorporate elements that would allow for user control of the penetration depth of the flow activator [Rotating the outer adjustment member 60 changes distance D1, thereby changing the penetration depth of the lancet 50 (Roe ¶0065), wherein the first cantilevered arm 66 and second cantilevered arm 68 form the adjustment member 60 of Roe].
Claim(s) 68 and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein, as applied to claim 1 above, in view of Chickering (US-20120010529-A1, previously presented).
Regarding claim 68, Bernstein teaches
The device of claim 1.
However, Bernstein fails to explicitly disclose wherein movement of the carrier toward the base compresses the retraction actuator.
Chickering discloses a device for receiving fluid from a subject, comprising a base [surface 1104 (Chickering Figs. 11-12)], a carrier [holders 1124 (Chickering Figs. 11-12); a plurality of tabs (or the essentially circular perimeter of) the device are supported within holders 1124, and the center, snap dome portion of the device is operably linked to device actuator 1116, such that movement of the central portion of snap dome 1122 and the periphery of the snap dome can be controlled independently of each other. Holders 1124 are directly connected to or otherwise operably linked to a retraction actuator 1126 which, in the device illustrated, can be a ring-shaped structure positioned under and supporting holders 1124. Holders 1124 can be individual holders and/or a ring-like structure surrounding the periphery of snap dome 1122 (Chickering ¶0086, Figs. 11-12), wherein as depicted in Chickering Figs. 12A-B, the holders 1124 (not specifically identified in Figs. 12A-B, but Figs. 12A-B are understood to refer to device 1150 if Fig. 11) are operably coupled to move the substance transfer component 1108] operably coupled to a flow activator [substance transfer component 1108 (Chickering Figs. 11-12)], and a retraction actuator disposed between the base and the carrier [retraction actuator 1126 drives holder 1124 upwardly, retracting structure 1122 and device actuator 1116 from substance transfer component 1108 (Chickering ¶0097, Figs. 11-12)], wherein movement of the carrier toward the base compresses the retraction actuator [The retraction actuator 1126 may include any suitable retraction component. Again, in the device illustrated, retraction actuator 1126 can itself be a reversibly deformable structure such as a leaf spring, coil spring, foam, or the like. During use, when device actuator 1116 is driven downwardly, retraction actuator 1126 is first compressed and, depending upon the size and arrangement of components 1126, 1124, 1122, 1116 and 1108, during compression, substance transfer component 1108 can be driven downwardly to some extent. At the point at which retraction actuator 1126 is compressed and provides a sufficient resistance force, deployment actuator 1122 can be urged from its first configuration through an unstable configuration and can return to its second configuration, driving substance transfer component 1108 against the skin. Then, upon release of user pressure (or other actuation, which can be automatic) from actuator 1116, retraction actuator 1126 can expand and, with structure 1122 optionally remaining in its second, downwardly-driven low-energy configuration, actuator 1116 can be retracted and substance transfer component 1108 retracted from the skin (Chickering ¶0097, Figs. 11-12)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein to employ wherein movement of the carrier toward the base compresses the retraction actuator, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for user control of the retraction] [MPEP § 2143(I)(D)].
Regarding claim 71, Bernstein teaches
The device of claim 1, further comprising a pusher [actuator 10 (Bernstein Fig. 4); an effector may be arranged to cause deployment and/or retraction movement of a flow activator. For example, an effector may include both a deployment actuator and a retraction actuator… the device 1 includes an effector 50 that includes a retraction actuator 40 and a deployment actuator 60 and that is movable in up and down directions relative to the base 100 along effector guides 104… The deployment actuator 60 may initially be arranged in a concave-down configuration shown in FIG. 4 and moved to a concave-up configuration, e.g., by a user pressing the device actuator 10 to cause a release element 30 to push a center portion of the deployment actuator 60 downwardly (Bernstein ¶0052); depression of the actuator 10 causes an effector 50 (which may include a snap dome actuator like that discussed above) to deploy a flow activator 90 (e.g., including a plurality of needles) to move downwardly toward the user's skin (Bernstein ¶0101)].
However, Bernstein fails to explicitly disclose wherein in response to actuation of the device, the pusher causes the carrier to move toward the opening.
Chickering discloses a device for receiving fluid from a subject, comprising a base [surface 1104 (Chickering Figs. 11-12)], a carrier [holders 1124 (Chickering ¶0086, Figs. 11-12), wherein as depicted in Chickering Figs. 12A-B, the holders 1124 (not specifically identified in Figs. 12A-B, but Figs. 12A-B are understood to refer to device 1150 if Fig. 11) are operably coupled to move the substance transfer component 1108] operably coupled to a flow activator [substance transfer component 1108 (Chickering Figs. 11-12)], and a retraction actuator disposed between the base and the carrier [retraction actuator 1126 (Chickering ¶0097, Figs. 11-12)], wherein actuation of the device of Chickering, defined as movement of the carrier via a pusher [transfer component actuator/device actuator 1116 (Chickering Figs. 11-12); When device actuator 1116 is actuated by a user (e.g., when proximal portion 1118 is depressed downwardly as shown in the figure), distal portion 1120 engages skin insertion objects 1108 (optionally via flexible structure 1112) to drive it toward the skin (Chickering ¶0095)] toward the base causes the carrier to move towards an opening of the base and compress the retraction actuator [Chickering ¶0097, Figs. 11-12].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bernstein to employ wherein in response to actuation of the device, the pusher causes the carrier to move toward the opening, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enable actuation of flow activators to draw blood] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 5-6, filed 26 February 2026, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 102 [and § 103 regarding claims dependent from claim 1] have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bernstein (US-20130158468-A1).
The Applicant asserts that the amendment to claim 1 to recite “a deployment actuator configured to deform to store energy and configured to release stored energy to move the flow activator in a deployment direction toward the subject” is not inherently or expressly disclosed, or rendered obvious by the previously applied Chickering, wherein the Applicant notes that the distal portion 1120 of the device actuator 1116 of Chickering [corresponding to the claimed deployment actuator] is not configured to deform to store energy and configured to release stored energy to move the flow activator in a deployment directed as recited in amended claim 1. Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Bernstein is presently applied to teach the argued amended subject matter regarding “a deployment actuator configured to deform to store energy and configured to release stored energy to move the flow activator in a deployment direction toward the subject” [deployment actuator 60 (Bernstein ¶¶0052, 0055].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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