DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Preliminary Amendment, filed 18 March 2025, the status of the claims is as follows:
Claims 2-27 are new; and
Claim 1 is cancelled.
Election/Restriction
3. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 2-19, drawn to a sensor inserter assembly, classified in A61B5/14503.
II. Claims 20-27, drawn to method for applying an on-skin component, classified in A61B 5/14865.
4. The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus can be used as a safety mechanism for securing a person into a piece of equipment.
5. 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:
a. the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
6. Applicant is advised that the reply to this requirement to be complete must include (i) an election of a 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.
7. The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
8. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
9. During a telephone conversation with Alan Chang on 21 November 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 2-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 20-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 7, 13, 16, and 17 are 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 pre-AIA the applicant regards as the invention.
Claim 7 recites the limitation “the first configuration” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Also, it is not clear form the claims what configurations the sensor inserter assembly could be in (Does the claim mean that the on-skin component in the proximal position or the distal position? However, the claim refers to the sensor inserter assembly.).
Claim 13 recites the limitation “wherein the distally-extending member comprises at least one leg of the sensor inserter assembly.” The structure described is unclear as to whether “the sensor inserter assembly” is the whole system. The distally-extending member is already a structure of the assembly such that the reference to the “sensor inserter assembly” is circular.
Claim 16 recites the limitation “wherein the first resistance feature comprises a distally-facing surface of the sensor inserter assembly.” The structure described is unclear as to whether “the sensor inserter assembly” is the whole system. The distally-extending member is already a structure of the assembly such that the reference to the “sensor inserter assembly” is circular.
Claim 17 recites the limitation “wherein the first resistance feature is distal to an adhesive disposed on a distally-facing surface of the on-skin component.” In light of the specification and drawings, the language is unclear on the structure that is more distal than the adhesive. For example, Figure 125, the adhesive 818 is on the bottom of on-skin component 134y and the only structure that is more distal is the distally-extending sensor 138 (see at least paragraphs 666-671 of published applications). The sensor 138 has not been described as the first resistance feature such that the structure that meets the claim limitation is unclear. Additionally, claim 1 defines the first resistance feature as configured to prevent movement of the on-skin component in a proximal direction at least when the on-skin component is in the distal position. Claim 17, however, does not include such limiting language such that the first resistance feature must always be distal to the adhesive. Clarification is needed. Thus, the claim is rendered indefinite.
Claim Rejections - 35 USC § 102
12. 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.
13. 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.
14. Claims 2-10 and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohkoshi et al., U.S. Patent Application Publication No. 2014/0187876 A1 (“Ohkoshi”).
As to Claim 2, Ohkoshi teaches the following:
A sensor inserter assembly (“sensor inserting device”) 10 for applying an on-skin component to a skin of a host (see “The present invention generally relates to a sensor inserting device for inserting a detector of a sensor which measures biological information of a person to be measured into a body of the person to be measured, and an operating method of the device.” in para. [0002]), comprising:
an on-skin component (“head (movable unit) 30” and “base 42”) 30/42 being movable in at least a distal direction from a proximal position (see fig. 15) to a distal position (see fig. 16),
a first securing feature (“fixing member”) 38 configured to releasably secure the on-skin component 30 in the proximal position (see “Further, the device body 18 is provided with a fixing member 38 which supports the head 30 at a predetermined height in the device body 18 before the inserting operation of the sensor 12 and the insertion needle 32 (movement of the head 30) and a guiding member (guide member) 40 which guides the sensor 12 and the insertion needle 32 during the inserting operation.” in para. [0058]),
a second securing feature (“dwelling member”) 24 configured to secure the on-skin component 30 in the distal position (see “Further, the dwelling member 24 includes a base (base portion) 42 arranged in the slider mechanism 28, an engaging arm (engaging plate) 44 pivotally engaged with the base 42, and an adhesive sheet 46 (adhesive portion) adhering to the bottom surface (distal end surface) of the base 42.” in para. [0059]; and see “Now, the dwelling member 24 which allows the sensor unit 50 to dwell on the skin S of the patient and the transmitter 16 which is connected to the sensor unit 50 will specifically be described. As described above, the dwelling member 24 is a member which supports and allows the sensor unit 50 and the transmitter 16 to dwell on the skin S of the patient. The dwelling member 24 includes the base 42 arranged in the slider mechanism 28, the engaging arm 44 rotatably supported by the base 42, and the adhesive sheet 46 (see FIG. 3) which sticks on the skin S of the patient and allows the base 42 to dwell on the skin S of the patient.” in para. [0131]), and
a first resistance feature (“swingably engaging plate”) 172 configured to prevent movement of the on-skin component 30 in a proximal direction at least when the on-skin component 30 is in the distal position (see “One end of the swingably engaging plate 172 is connected to the upper end of the first guide arm 166, and the other end of the swingably engaging plate 172 can swing about the connecting portion. That is, before the inserting operation of the sensor unit 50 and the insertion needle 32, the swingably engaging plate 172 spreads out in the width direction so that the other end makes contact with the inner surface of the extending portion 82. Then, by the inserting operation (movement of the head 30 toward the distal end direction), the swingably engaging plate 172 swings toward the closing direction (direction toward the first guide arm 166) by making contact with the head side inserting hole 142, thereby allowing the head 30 to pass. Further, when the head 30 moves toward the proximal end direction, the other end of the swingably engaging plate 172 makes contact with the head side guide 136, thereby transmitting the force of motion toward the proximal end direction from the head 30 to the guiding member 40, so that the guiding member 40 moves toward the proximal end direction with the head 30.” in para. [0122]; and see “During the movement of the head 30, swingably engaging plate 172 of the first guide arm 166 swings toward the closing direction (direction toward the first guide arm 166) by contacting the first head side inserting hole 142a so as to allow the head 30 to pass.” in para. [0158]; and see figs. 15, 16, and 18).
As to Claim 3, Ohkoshi teaches the following:
wherein the first resistance feature 172 is configured to prevent movement of the on-skin component 30 in a proximal direction when the on-skin component 30 is secured in the distal position (see para. [0122] and [0158], and figs. 15, 16, and 18).
As to Claim 4, Ohkoshi teaches the following:
wherein the first securing feature 38 is configured to releasably secure the on-skin component 30 to a needle assembly (“insertion needle”) 32 (see [0058] and figs. 3-5).
As to Claim 5, Ohkoshi teaches the following:
wherein the on-skin component 30 comprises a sensor module (“sensor unit”) 50 (see fig. 3).
As to Claim 6, Ohkoshi teaches the following:
wherein the sensor module 30 comprises a sensor (“detector”) 14 and a plurality of electrical contacts (“connecting member 54” including “sensor connecting portion 68” and “connecting terminal 70”) 54 (see “The sensor side connecting terminal 70 possesses a trapezoidal shape in which the thickness is greater at the proximal end side and taperingly decreases from approximately the middle portion toward the distal end side. On the tapered surface 70a, a conductive terminal which is electrically connectable to the transmitter 16 is provided. When the sensor 12, the engaging member 52, and the connecting member 54 are integrated as in the manner mentioned above (that is, when the sensor 12 and the connecting member 54 are layered or positioned in an overlying or overlapping relationship), the contact surface of the connecting member 54 and the sensor base 56 becomes electrically conductive so that the sensor unit 50 can transmit the blood sugar level (current value) detected by the detector 14 to the connecting member 54.” in para. [0074] and fig. 5).
As to Claim 7, Ohkoshi teaches the following:
wherein the sensor 14 is electrically coupled to at least one of the electrical contacts 54, at least when the sensor inserter assembly 10 is in the first configuration (insertion position) (see para. [0074] and figs. 5 and 18).
As to Claim 8, Ohkoshi teaches the following:
wherein the on-skin component 30 comprises a base (“elliptical plate (head base)”) 134 (see “As shown in FIGS. 8A and 8B, the head 30 includes an elliptical plate (head base) 134 having an elliptical shape in a plan view,…” in para. [0104]).
As to Claim 9, Ohkoshi teaches the following:
wherein the on-skin component 30 comprises a transmitter (“transmitter”) 16 (see para. [0060]).
As to Claim 10, Ohkoshi teaches the following:
wherein the second securing feature 24 is configured to secure the on-skin component 30 to a second on-skin component (“base”) 42 (see fig. 3).
As to Claim 12, Ohkoshi teaches the following:
at least one distally-extending member (“pair fixing member side arms”) 152, and wherein the first securing feature 38 comprises a surface (not labeled, inner engaging surface of “pair fixing member side arms 152”) of the distally-extending member 152 configured to frictionally engage with a corresponding structure (“a pair of head side arms”) 138 of the on-skin component 30 (see “The pair of fixing member side arms 152 is formed at sides of the fixing member side inserting hole 156, in the right-and-left width direction (Y direction), in a plate-like shape with a smaller thickness in the front-and-rear direction and extends upward by a predetermined distance. On the upper portion of the fixing member side arm 152, a supporting protrusion 158 with which the head side hook 146 of the head side arm 138 engages is inwardly formed. The pair of the fixing member side arms 152 is arranged to be offset to each other in the front-and-rear direction, in a side view, corresponding to the arrangement of the head side arm 138. Further, the supporting protrusion 158 is formed in a tapered shape in which the width increases inward from a predetermined location close to the upper portion so that tilting toward the inner side is restrained, thereby providing further firm engagement of the head side hook 146.” para. [0117]; and see fig. 3).
As to Claim 13, Ohkoshi teaches the following:
wherein the distally-extending member 152 comprises at least one leg of the sensor inserter assembly (“pair fixing member side arms 152” is one of many legs within “sensor inserting device 10”, see fig. 3).
As to Claim 14, Ohkoshi teaches the following:
wherein the distally-extending member 152 comprises a needle (“insertion needle”) 32 (see fig. 3).
As to Claim 15, Ohkoshi teaches the following:
wherein the second securing feature 42 comprises an adhesive (“adhesive sheet”) 46 disposed on a distally-facing surface (“floor”) 190 of the on-skin component 30/42 (see “Further, the dwelling member 24 includes a base (base portion) 42 arranged in the slider mechanism 28, an engaging arm (engaging plate) 44 pivotally engaged with the base 42, and an adhesive sheet 46 (adhesive portion) adhering to the bottom surface (distal end surface) of the base 42.” in para. [0059] and fig. 3).
As to Claim 16, Ohkoshi teaches the following:
wherein the first resistance feature 38 comprises a distally-facing surface (not labeled, bottom surface of “middle disk (fixing base) 150”) of the sensor inserter assembly 10 (see fig. 3).
As to Claim 17, Ohkoshi teaches the following:
wherein the first resistance feature 38 is distal to an adhesive (“adhesive sheet”) 46 disposed on a distally-facing surface (“floor”) 190 of the on-skin component 30/42 (see figs. 3 and 18).
As to Claim 18, Ohkoshi teaches the following:
a pusher (“push handle”) 22 configured to move the on-skin component 30/42 from the proximal position to the distal position (see figs. 15 and 16).
As to Claim 19, Ohkoshi teaches the following:
a decoupling feature (“return spring”) 36 configured to decouple the pusher 22 from the on-skin component 30/42 at least after the on-skin component 30/42 is in the distal position (see para. [0162] and fig. 18).
Claim Rejections - 35 USC § 103
15. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
16. 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.
17. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ohkoshi, as applied to claim 2 above, and further in view of Bonnecase et al., U.S. Patent Application Publication No. 2003/0100040 A1 (“Bonnecaze”).
As to Claim 11, Ohkoshi teaches the sensor inserter assembly 10 as discussed above for claim 2. Ohkoshi further teaches at least one distally-extending leg (“pair fixing member side arms”) 152, but does not teach the following:
wherein the first securing feature comprises an adhesive disposed on a distally-facing surface of the leg.
However, Bonnecaze teaches methods for affixing pieces to each other within the system including frictional fasteners and adhesives (see para. [0239]). Adhesive is an alternative method of affixing one piece to another within a sensor inserter assembly. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify Ohkoshi with the adhesive as taught by Bonnecaze because it is the simple substitution for one known method of affixing for another to yield predictable results of pieces affixed to each other.
Conclusion
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 11/21/2025