DETAILED ACTION
This office action is responsive to the amendment filed 6/13/2025. It is noted that the dependency of Claim 16 has been amended to depend on elected Claim 1. Claims 1-2, 4-6, 11-13, 16-18, and 21-24 remain pending and under prosecution.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112(f).
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) 1, 2, 4-6, 12-13, 16, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Curry et al (US Pub No. 20110288574) in view of Cusack et al (US Pat No. 5314441 – cited by applicant).
In regard to Claims 1, 4-6, and 12, Curry et al disclose a device for testing bodily fluid from a patient, the device comprising:
a housing 3802 including a base having an opening (bottom of Figure 33) extending therethrough along a plane, best seen in Figure 33 (0160);
a skin-piercing assembly 500 positioned at least partially within the housing, best seen in Figure 16 and 20 – “sharp 124 of an inserter, such as inserter 500 depicted in FIGS. 13-17” (0140), and defined to include the driver apparatus 3800 of Figures 32-43 (0159),
wherein the skin- piercing assembly includes a drive body 3808 (cam) having a projection extending therefrom – indicated by the circle in the replicated Figure 37 below – and a rotation axis extending parallel to the plane, best seen in Figure 37-43 (0160-0163),
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a skin-piercing feature 124 attached to drive body – “actuator 3806 contacts actuator 114 (substantially identical to actuator 514) of inserter 500 to drive the sharp and sensor downward towards the subject's skin” (0164), and
a first biasing member 3814 coupled to the drive body, best seen in Figure 37 (0162);
a plunger 3806 positioned at least partially within the housing, best seen in Figure 37 (0161);
an actuator 3804 operably coupled to the plunger – “A loading element 3804 is provided which is longitudinally movable with respect to housing 3802. Depression of the loading element causes a rotor 3808 to rotate against the bias of a torsion spring (not shown)” (0160), best seen in Figure 32-33, and
configured to move the plunger 3806 from a first position (Figure 38) to a second position (Figure 41) in a direction along a vertical axis orthogonal to the plane – “As cam 3808 rotates, it pushes down on actuator 3806 (FIGS. 39-40)” (0163); and
a second biasing member 3820 (compression spring) operably coupled between the actuator and the housing, best seen in Figure 37 (0161),
wherein the second biasing member is configured to exert a biasing force against the plunger in a direction away from and orthogonal to the base to bias the plunger toward the first position – “Return spring 3820 pushes actuator 3806 back up, releasing pressure on the inserter” (0163), and wherein—
in the first position, the projection is engaged (by trigger 3810 – see Figure 37 replicated above) and the first biasing member 3814 is maintained in a biased configuration – “loading element 3804 (not shown) is pressed, causing arming button 3812 to be pushed down, winding shaft 3816 and thus torsion spring 3814” (0161),
movement of the plunger 3806 occurs from the first position to the second, best seen in Figure 37-41 (0163), and
the first biasing member 3814 to rotate the drive body 3808 about the rotation axis to drive the skin-piercing feature at least partially through the opening in the base – “Cam 3808 is then driven forward by torsion spring 3814 (FIG. 38)” (0162, 0160), best seen in Figure 38-41, and
the rotation axis of the drive body remains aligned with the vertical axis as the plunger moves from the first position to the second position – cam 3808 does not move vertically, best seen in Figure 38-41.
However, Curry et al do not expressly disclose in the first position, the plunger is configured to engage the projection to maintain the first biasing member in a biased configuration, and movement of the plunger from the first position to the second position disengages the plunger from the projection to permit the first biasing member to rotate the drive body about the rotation axis to drive the skin-piercing feature at least partially through the opening in the base.
Cusack et al disclose an analogous device for withdrawing bodily fluid from a patient, the device comprising:
a housing 16 including a base 12 having an opening 44 extending therethrough along a plane, best seen in Figure 1 and 7A-C (Col.4: 44-65);
a skin-piercing assembly 92 positioned at least partially within the housing, wherein the skin-piercing assembly includes a skin-piercing feature 104 and a first biasing member 122, best seen in Figure 7A-B (Col.7: 67-Col.10: 30),
the skin-piercing assembly includes a projection 98 extending therefrom and a rotation axis extending parallel to the plane, best seen in Figure 7A (Col.7: 67-Col.10: 30);
a plunger 14, 22 positioned at least partially within the housing, best seen in Figures 7 A-B;
an actuator 20 operably couped to the plunger and configured to move the plunger from a first position (Figure 7A) to a second position (Figure 7B); and wherein—
in the first position, the plunger is configured to engage the projection to maintain the first biasing member in a biased configuration – “before the lancet device 10 is used, the trigger hook projection 98 on the arm member 92 engages the distal end 118 of the trigger plunger 14. In this set position, the two ends of torsional wire spring 122 are biased near one another and energy is stored within the torsional wire spring 122” (Col.8: 54-58), best seen in Figure 7A, and
movement of the plunger from the first position to the second position disengages the plunger from the projection to permit the first biasing member 122 to drive the skin-piercing feature at least partially through the opening in the base – “Once the trigger hood projection 98 clears the distal end 118 of the trigger plunger 14, the pivot arm member 92 is free to move under the influence of the torsional wire spring 122” (Col.9: 19-22), best seen in Figure 7B, and
the first biasing member 122 is a torsion spring (Col.8: 38-52).
5. Cusack et al disclose the device of claim 1 wherein the plunger 14, 22 includes a trigger portion 118, and wherein the trigger portion engages the projection 98 in the first position to maintain the first biasing member in the biased configuration, best seen in Figure 7A (Col.8: 53-Col.9: 15).
6. Cusack et al disclose the device of claim 5 wherein movement of the plunger 14, 22 from the first position (Figure 7A) to the second position (Figure 7B) (a) drives the trigger portion 118 against the projection 98 against the biasing force of the first biasing member 122 (Col.8: 53-Col.9: 15), and then
(b) drives the trigger portion past the projection to permit the first biasing member 122 to drive the skin-piercing feature at least partially through the opening in the base 12 (Col.9: 16-29).
Thus, Cusack et al teach that it is well-known in the art to provide an analogous mechanism for engaging the projection using the plunger with a trigger portion to maintain the first biasing member in a biased configuration, and movement of the plunger from the first position to the second position disengages the plunger from the projection to permit the first biasing member to rotate the drive body about the rotation axis to drive the skin-piercing feature at least partially through the opening in the base as desired.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Curry et al such that the plunger is configured to engage the projection to maintain the first biasing member in a biased configuration, and movement of the plunger from the first position to the second position disengages the plunger from the projection to permit the first biasing member to rotate the drive body about the rotation axis to drive the skin-piercing feature at least partially through the opening in the base as taught by Cusack et al as an equally as effective mechanism to engage the projection and maintain the first biasing member in a biased configuration and then for subsequent driving of the skin-piercing feature into the skin as desired by Curry et al.
2. Curry et al disclose the device of claim 1 wherein movement of the actuator 3804 in the direction along the vertical axis toward the base drives the plunger 3806 from the first position (Figure 38) to the second position (Figure 41) – “As cam 3808 rotates, it pushes down on actuator 3806 (FIGS. 39-40)” (0163).
In regard to Claims 13 and 16, Curry et al in combination with Cusack et al disclose the invention above but do not expressly disclose the skin-piercing feature is a blade.
Cusack et al teach that it is well-known in the art to provide an analogous bodily fluid withdrawal device comprising a skin-piercing feature is a blade 104, best seen in Figure 1 and 7A-C (Col.4: 44-65), wherein a portion of the cutting edge is directly bonded to drive body 92, i.e. gluing, best seen in Figure 5A (Col.7: 28-31), as an effective configuration to pierce the skin for sampling.
Therefore, it would have been obvious to one of ordinary skill in the art at the of filing to modify Curry et al as modified by Cusack et al such that the skin-piercing feature is a blade and is bonded to the drive body in the manner taught by Cusack et al as an equally as effective configuration for the skin-piercing feature of Curry et al.
21. Curry et al disclose the device of claim 1 wherein movement of the actuator 3804 in the direction along the vertical axis toward the base drives the plunger 3806 from the first position (Figure 38) to the second position (Figure 41) against the bias of the second biasing member 3820, best seen in Figure 41-43.
22. Curry et al disclose the device of claim 1, wherein the first biasing member 3814 is operably coupled between the drive body 3808 and the housing 3802, best seen in Figure 33-34.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Curry et al in view of Cusack et al as applied to claim 1 above, and further in view of Moga et al (US Pub No. 20130211289).
Curry et al in combination with Cusack et al disclose the invention above but do not expressly disclose a flexible sealing member coupled to the housing and positioned to define a sealed volume within the housing.
Moga et al teach that it is well-known in the art to provide an analogous device for withdrawing bodily fluid comprising a flexible sealing member 243 coupled to the skin-piercing assembly 247 within the housing 246 and positioned to define a sealed volume within the housing, wherein the movement of the skin-piercing assembly toward the opening reduces the volume of the lumen, and wherein the movement of the skin-piercing assembly away from the opening increases the volume of the lumen to draw the vacuum within the lumen (0056), as an effective manner of maintain the vacuum in the lumen.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Curry et al as modified by Cusack et al to include a flexible sealing member in the manner above as taught by Moga et al above to provide an effective mechanism to maintain vacuum in the lumen of the device for sampling of the bodily fluid.
Claim(s) 17-18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Curry et al in view of Cusack et al as applied to claim 1 above, and further in view of Krasnow et al (US Pub No. 20160256095).
In regard to Claims 17-18, Curry et al in combination with Cusack et al disclose the invention above but do not expressly disclose a flexible membrane coupled to the base of the housing across the opening or a reservoir releasably coupled to the housing.
Krasnow et al teach that it is well-known in the art to provide an analogous device for withdrawing bodily fluid comprising a flexible membrane 143 coupled to base of housing 110 and covering at least a portion of opening 123, best seen in Figure 1B and 2A-D (0042-0043), wherein skin-piercing feature 120 is driven by plunger 130 to drive the skin-piercing feature at least partially through the opening in the base to puncture the flexible membrane to expose the suction in the device after piercing for collection of the bodily fluid (0046).
Krasnow et al also teach a reservoir 141, 440 releasably coupled to the housing, best seen in Figure 2A-D and 4 (0042, 0047, 0059 – blood storage element 440 such as capillary tube is releasably coupled, 0036 – elements can be removable) and a fluidic channel 145 configured to direct bodily fluid from the opening to the reservoir, best seen in Figure 2A-D (0042, 0047), to effectively lead the collected bodily fluid to the reservoir for storage and subsequent sampling.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Curry et al as modified by Cusack et al such that there is included a flexible membrane that is pierced by the skin-piercing feature and a reservoir releasably coupled to the housing with a fluidic channel configured to direct bodily fluid from the opening to the reservoir, as taught by Krasnow et al, to effectively maintain the suction as well as sterility of the device with the flexible membrane prior to sampling, and to effectively lead the collected bodily fluid with the fluidic channel to the reservoir for storage and subsequent sampling after piercing by Curry et al, wherein in combination, in the second position, the plunger is configured to disengage the projection to permit the fist biasing member to rotate the drive body about the rotation axis as disclosed by Curry et al as modified by Cusack et al in the manner above.
23. Krasnow et al disclose the device of claim 18 wherein: the fluidic channel 145 extends lengthwise along a fluidic channel axis, best seen in Figure 2A-D; and
the skin-piercing feature is a blade 104 having a cutting edge as taught by Cusack et al,
wherein the first biasing member 3814 of Curry et al is configured to rotate the drive body 3808 of Curry et al about the rotation axis (0160, 0162) to drive the blade along a blade path that is orthogonal to a direction of the fluidic channel axis defined by Krasnow et al in Figures 2A-D when modified in the manner above.
However, the combination of Curry et al, Cusack et al, and Krasnow et al do not expressly disclose the blade path is a circumferential blade path.
Cusack et al teach that it is well-known in the art to provide an analogous device for withdrawing bodily fluid from a patient, the device comprising the skin piercing feature 104 driven along a blade path that is a circumferential blade path to effectively pierce the subject’s skin, best seen in Figure 7A-C, that is orthogonal to the plane of the base.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Curry et al as modified by Cusack et al and Krasnow et al to have the blade path be a circumferential blade path that is orthogonal to a direction of the fluidic channel axis defined by Krasnow et al in Figures 2A-D when modified in the manner above, as taught by Cusack et al, as an equally as effective blade path for the skin piercing feature of Curry et al.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Curry et al in view of Cusack et al as applied to claim 1 above, and further in view of Beyerlein et al (US Pub No. 20190000365 – cited by applicant).
Curry et al in combination with Cusack et al disclose the invention above but do not expressly disclose a reservoir releasably coupled to the housing, wherein the reservoir extends outside the housing when the reservoir is coupled to the housing; and a fluidic channel configured to direct bodily fluid from the opening to the reservoir.
Beyerlein et al teach that it is well-known in the art to provide an analogous device for withdrawing bodily fluid from a patient comprising a reservoir 180 releasably coupled to housing 102, wherein the reservoir extends outside the housing when the reservoir is coupled to the housing, best seen in Figure 3A and 5A; and a fluidic channel 146 configured to direct bodily fluid from the opening 140 of the device to the reservoir – “Fluidic communication can be established between a channel 146 of the device and a channel 185 of the cartridge when the ports 148 and 184 are coupled to each other. As shown in FIG. 3A, the channel 146 can extend towards the port 144 which is adjacent to the opening 140 of the recess 136. Blood can be drawn from the penetrated skin of the subject, and transported through the channels 146 and 185 into the cartridge with aid of vacuum, pressure differentials, and gravitational force” (0248).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Curry et al as modified by Cusack et al such that the device includes a reservoir releasably coupled to the housing, wherein the reservoir extends outside the housing when the reservoir is coupled to the housing; and a fluidic channel configured to direct bodily fluid from the opening to the reservoir as taught by Beyerlein et al, to effectively collect bodily fluid from the subject as desired.
Response to Arguments
Applicant’s arguments with respect to claim(s) above 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.
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791