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 . Claims 1-7, 9-14, 17-22 and 24 are currently pending, with claims 1-7, 9-14 being withdrawn (below).
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7 and 9-14, drawn to a wearable sensor patch, classified in A61B5/14514.
II. Claims 17-22 and 24, drawn to a second wearable sensor patch, classified in A61B5/14514..
The inventions are independent or distinct, each from the other because:
Inventions of Group I and II are directed to related wearable sensor patches. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different designs based on different figures as they have different ejection systems and different failsafe’s that are not able to be interchanged. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with John Herman on 05/30/2025 a provisional election was made without traverse to prosecute the invention of Group II, claims 17-22 and 24. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-7 and 9-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the inferred four springs of claim 18 (plurality of springs of claim 17 plus the first and second springs of claim 18) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 17 is objected to because of the following informalities: the latch of lines 7-10 details that it activates the multiple-spring microprobe insertion mechanism, however it is an integral part of the mechanism, so the limitation reads that it imitates itself. The limitation should be rephrased to indicate that the latch is operated to activate the springs or so another sub element within the mechanism as per the specification. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: in line two, resists should be amended to resist. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 the applicant regards as his invention.
Claim 18 is 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 details a first and second spring, however it is unclear if those are of the plurality of springs already detailed as part of the multiple-spring microprobe array.
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 non-obviousness.
Claims 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker et al. WO 2017/070360 (hereinafter Schoonmaker) in view of Flaherty et al. US Publication 2004/0010207 (hereinafter Flaherty).
Regarding claim 17, Schoonmaker discloses a wearable sensor patch (Figures 1, 7, 28-29, [0008]-[0010]), comprising: a casing (housing described in [0008] see also Figures 3, 28-29 and claim 1); a movable microprobe platform movably positioned within the casing ([0008][0010][0036] which detail the sensor being within a cannula/needle that is deployable through the casing, see also Figures 28-29, where platform is simply read as a protruding structure on which something can stand, so the pushrod that the sensor is on such as 86 or even the needle the sensor is attached to 72 can act as a platform), wherein the movable microprobe platform includes a microprobe system (the sensor itself as per [0008][0206]-[0212][0218]); and a multiple-spring microprobe array insertion mechanism, comprising: a plurality of springs (Figure 28 at springs 272, 274), and the plurality of springs acts on the movable microprobe platform with a combined force of the plurality of springs so as to deploy the movable microprobe platform (each spring mentioned above takes part in deploying and retracting the microprobe platform), but is silent on the latch.
Flaherty teaches a transcutaneous sensing system that includes an ejection system that has a latch operable to activate the multiple-spring microprobe array insertion mechanism ([0008][0010]-[0012][0014] and element 86), wherein, when the latch is operated so as to activate the multiple-spring microprobe array insertion mechanism (Figures 7C-D at 86). It would have been obvious to the skilled artisan before the effective filing date to utilize the latch as taught by Flaherty with the device of Schoonmaker in order to allow the device to eject the array.
Regarding claim 21, Schoonmaker discloses multiple springs as mentioned above, however is silent on the exact level of force (in grams). Given the Applicant includes no criticality for the exact range (50+ grams), and given that Schoonmaker details utilizing enough force for insertion and then retraction as well as a secondary set of springs to allow a smooth sequence for both ([0232]-[0233]) it would have been obvious to the skilled artisan before the effective filing date to optimize the needed combined force of at least 50grams a matter of routine experimentation.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker in view of Flaherty, and in further view of Wu et al. US Patent 11,867,721 (hereinafter Wu).
Regarding claims 18-19, Schoonmaker discloses the use of two springs above (but is silent on the spring motion limiter). Wu teaches a probe deployable via two springs that also includes a spring motion limiter (element 222 as per Figure 2I-1), wherein the multiple-spring microprobe array insertion mechanism includes a first spring and a second spring (mentioned above by Schoonmaker, pending the 112 rejection, but Wu also teaches the use of two springs at 201, 202), and wherein the spring motion limiter is configured to limit a travel of the first spring such that the first spring stops applying force to the movable microprobe platform when the first spring contacts the spring motion limiter while the second spring continues to be in contact with the movable microprobe platform and to apply a force of the second spring to the movable microprobe platform (Figure 2I-1, which shows the first spring at 202 will eventually be unable to extend past the gap created for the stop 222, while the second spring 201 with the probe can continue on). It would have been obvious to the skilled artisan before the effective filing date to utilize the spring and stopper configuration as taught by Wu with the device of Schoonmaker as predictable results would have ensued (allow for control over how far and by how much each spring extends during use). Further, the springs are taught above via Schoonmaker which details the springs can include a variety of options regarding force based the desired outcome ([0231] which discloses the springs can include any materials, spring types, or pitch to achieve the desired outcomes regarding ejection and retraction). Though the exact detail is not provided, given that springs are incredibly well-known to have variances in them to affect a specific end result (force), and that Schoonmaker acknowledges this ([0231]), it would have been further obvious to the skilled artisan before the effective filing date to make minor adjustments to the springs (pitch, material choice, type) to afford the desired outcome given routine experimentation.
Regarding claim 20, Schoonmaker discloses the two springs as mentioned above however the exact relative force is not explicitly detailed. Schoonmaker simply details that the applied force for ejection is sufficient for ample insertion through the desired tissue ([0231][0233]), and that the exact force can be supplemented as desired (more or less force, or with more springs or less springs). The skilled artisan before the effective filing date would have determined the claimed relativity does not amount to much more than routine experimentation so long as the device is able to fully insert and retract the sensor as disclosed. Both the prior art, Schoonmaker, and the present applicant desire the same predictable result.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker in view of Flaherty, and in further view of Gray et al. US Publication 2021/0005224 (hereinafter Gray).
Regarding claim 22, Schoonmaker discloses the springs (as mentioned above) and that any type of spring can be utilized ([0235]), but is silent on the torsion spring. Gray teaches an analyte sensing device that includes a spring based insertion system that that includes torsion springs ([0011][0039][0189]). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the torsion spring as taught by Gray in lieu of the springs of Schoonmaker as they are art recognized equivalents and would have produced predictable results (affording insertion and retraction of the sensors).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Schoonmaker in view of Flaherty, and in further view of Sund et al. US 9,867,949 (hereinafter Sund).
Regarding claim 24, Schoonmaker is silent on a safety mechanism. Sund teaches a delivery system that includes a safety mechanism configured to prevent unintended release of the insertion mechanism (column 3 lines 1-40, element 80). The problem to be solved is the same, prevention of undesired deployment of the mechanism. Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the safety mechanism as taught by Sund with the device of Schoonmaker for the same predictable results as mentioned above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794