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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/2025 has been entered.
Response to Amendment
The amendment filed on 10/13/2025 has been entered. Claims 1-21 are pending in the application. Claim 21 is new.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 6-7, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mercereau et al. (US 6,450,937 B1).
Regarding claim 1, Mercereau discloses an apparatus (see Figs. 1-12) comprising:
a deployable element (tube 24), the deployable element (tube 24) having a distal end configured to be deployed subcutaneously and positioned to extend through skin (skin 60) of a user (see Figs. 10-12, col. 5 lines 55-59, tube 24 is configured to be inserted through the subcutaneous tissue/skin);
an introducer (needle 18) having a distal end configured to be deployed subcutaneously and positioned to extend through the skin (skin 60) of the user (see Figs. 1 and 9-12, col. 5 lines 55-64, needle 18 is configured to be inserted through the subcutaneous tissue/skin); and
a base (needle head 22) having an opening (opening of needle head 22) through which the distal end of the deployable element (tube 24) and the distal end of the introducer (needle 18) are configured to extend (see Figs. 10-12),
wherein the distal end of the deployable element (tube 24) is positioned during deployment to extend a first depth through the skin (skin 60) of the user upon deployment (see Figs. 3 and 11, tube 24 is capable of being inserted through the skin up to the entire length of the tube 24 such that the first amount is considered the length of the tube 24), and the distal end of the introducer (needle 18) is positioned during deployment to extend a second depth through the skin (skin 60) of the user upon deployment (see Figs. 2 and 10-12, needle 18 is capable of being inserted through the skin up to the entire length of the needle 18 such that the second amount is considered the length of the needle 18),
wherein the second depth is less than the first depth (see Figs. 2-3 and 10-12, needle 18 is shorter than tube 24 such that the second depth is less than the first depth).
Regarding claim 3, Mercereau discloses the apparatus of claim 1, wherein the introducer (needle 18) is configured to penetrate outermost layers of the skin (skin 60) of the user comprising stratum corneum through dermis layers (see col. 4 lines 24-27).
Regarding claim 6, Mercereau discloses the apparatus of claim 1, wherein the deployable element (tube 24) is configured to continue to extend after the introducer (needle 18) reaches a maximum deployment distance of the introducer (needle 18) (see Figs. 1-3 and 10-12, col. 7 lines 25-36; since tube 24 is longer than needle 18, tube 24 can continue to extend further than needle 18).
Regarding claim 7, Mercereau discloses the apparatus of claim 1, wherein the deployable element (tube 24) is a cannula (see Figs. 1 and 3, a tube is a cannula), a conduit (see Figs. 1 and 3, a tube is a conduit), or a needle (see Figs. 1 and 3, tube 24 can be considered a blunt needle as it penetrates through the skin) (note: only one of a cannula, a conduit, a needle, or a sensor is required by the claim since this limitation is written in the alternative).
Regarding claim 21, Mercereau discloses the apparatus of claim 1, wherein the distal end of the introducer (needle 18) is configured to penetrate the skin (skin 60) of the user before the distal end of the deployable element (tube 24) extends through the skin (skin 60) of the user (see Figs. 10-12, col. 7 lines 25-36).
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.
Claims 2, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1), as applied to claim 1 above, in view of Cole et al. (US 2015/0306307 A1).
Regarding claim 2, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state wherein the deployable element is configured to extend into the skin of the user to a depth of 2-10 mm.
Cole teaches an apparatus (see Fig. 11) wherein the deployable element (catheter 66) is configured to extend into the skin of the user to a depth of 2-10 mm (see par. [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the deployable element of the apparatus of Mercereau such that the deployable element is configured to extend into the skin of the user to a depth of 2-10 mm, as taught by Cole, because Mercereau teaches that the length of the deployable element can be adjusted based on the target location within the patient (see Mercereau col. 6 lines 42-49) and Cole teaches that this length would be appropriate for deployable elements where the target location is within the skin (see Cole par. [0046]-[0047]).
Regarding claim 5, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state wherein the introducer is configured to automatically retract through the opening in the base after reaching a maximum deployment distance of the introducer.
Cole teaches an apparatus (see Figs. 11-12A) wherein the introducer (needle 70) is configured to automatically retract through the opening (exit hole 591) in the base (base floor 59) after reaching a maximum deployment distance of the introducer (needle 70) (see Figs. 11-12A, par. [(0056]-[0057]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Mercereau to attach the apparatus of Mercereau to an insertion device 7 of Cole such that the introducer is configured to automatically retract through the opening in the base after reaching a maximum deployment distance of the introducer, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 17, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state a linear deployment mechanism configured to cause the deployment element and the introducer to extend.
Cole teaches an apparatus (see Figs. 5-12) comprising a linear deployment mechanism (insertion mechanism 7) configured to cause the deployment element (catheter 66) and the introducer (needle 70) to extend (see Figs. 7-12, par. [0051]-[0057]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Mercereau to attach the apparatus of Mercereau to an insertion device 7 of Cole such the apparatus further comprises a linear deployment mechanism configured to cause the deployment element and the introducer to extend, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1), as applied to claim 1 above, in view of Damiano et al. (US 2018/0117296 A1).
Regarding claim 4, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state wherein the introducer is configured to extend into the skin of the user to a depth of 1-3 mm.
Damiano teaches an apparatus (see Figs. 3A-B) wherein the introducer (microneedle) is configured to extend into the skin of the user to a depth of 1-3 mm (see par. [0144]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the introducer of the apparatus of Mercereau such that the introducer is configured to extend into the skin of the user to a depth of 1-3 mm, as taught by Damiano, because Mercereau teaches that the length of the introducer can be adjusted based on the target location within the patient (see Mercereau col. 6 lines 42-49) and Damiano teaches that this length would be appropriate for introducers where the target location is within the skin (see Damiano par. [0144]).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1), as applied to claim 1 above, in view of Cargill et al. (US 2022/0265210 A1).
Regarding claim 8, Mercereau discloses the apparatus of claim 8. However, Mercereau fails to state wherein the deployable element is a glucose sensor configured to perform continuous glucose monitoring or a ketone sensor.
Cargill teaches an apparatus (see Fig. 5) wherein the deployable element (sensing cannula 320) is a glucose sensor configured to perform continuous glucose monitoring (see par. [0075], note: only one of a glucose sensor or a ketone sensor is required by the claim since this limitation is written in the alternative).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the deployable element of Mercereau with a glucose sensor configured to perform continuous glucose monitoring, as taught by Cargill, in order to allow the apparatus to deploy an element that would function to allow both drug delivery and glucose sensing on a single element (see Cargill par. [0058]).
Regarding claim 20, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state wherein the deployable element comprises one or more electrically conductive signal traces connected to embedded electronics hardware.
Cargill teaches an apparatus (see Fig. 5) wherein the deployable element (sensing cannula 320) comprises one or more electrically conductive signal traces connected to embedded electronics hardware (circuit 346) (see par. [0075]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Mercereau to substitute the deployable element of Mercereau with a sensor and to modify the apparatus to comprise one or more electrically conductive signal traces connected to embedded electronics hardware, as taught by Cargill, in order to allow the apparatus to deploy an element that would function to allow both drug delivery and glucose sensing on a single element (see Cargill par. [0058]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1), as applied to claim 1 above, in view of Turner et al. (US 2021/0236771 A1).
Regarding claim 9, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state a rotary mechanism having an outer circumference, wherein the deployable element is wrapped around at least a first portion of the outer circumference, the rotary mechanism configured to rotate the deployable element around the outer circumference and configured to selectively constrain the deployable element so that a rotation of the deployable element is converted into a linear motion.
Turner teaches an apparatus (see Figs. 1-3) comprising a rotary mechanism (spool, see par. [0030]) having an outer circumference (outer circumference of spool, see par. [0030]), wherein the deployable element (catheter 4) is wrapped around at least a first portion of the outer circumference (outer circumference of spool, see par. [0030]), the rotary mechanism (spool, see par. [0030]) configured to rotate the deployable element (catheter 4) around the outer circumference (outer circumference of spool, see par. [0030]) and configured to selectively constrain the deployable element (catheter 4) so that a rotation of the deployable element (catheter 4) is converted into a linear motion (see Figs. 1-3, par. [0030]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Mercereau to include a rotary mechanism having an outer circumference, wherein the deployable element is wrapped around at least a first portion of the outer circumference, the rotary mechanism configured to rotate the deployable element around the outer circumference and configured to selectively constrain the deployable element so that a rotation of the deployable element is converted into a linear motion, as taught by Turner, in order to allow the apparatus to store the deployable element and insert the deployable element with a single hand (see Turner par. [0030] and [0035]-[0036]).
Claims 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1) in view of Turner et al. (US 2021/0236771 A1), as applied to claim 9 above, further in view of Cole et al. (US 2015/0306307 A1).
Regarding claim 10, modified Mercereau teaches the apparatus of claim 9 substantially as claimed. However, modified Mercereau fails to state an introducer spring that is coiled around a fixed point on the apparatus.
Cole teaches an apparatus (see Figs. 5-7) comprising an introducer spring (spring 30) that is coiled around a fixed point (first post 22) on the apparatus (see Fig. 6, par. [0048]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to attach to an insertion device 7 of Cole such that the apparatus further comprises an introducer spring that is coiled around a fixed point on the apparatus, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 11, modified Mercereau teaches the apparatus of claim 10 substantially as claimed. However, modified Mercereau fails to state a cowling enclosing at least a second portion of the rotary mechanism; a retaining block configured to secure the introducer to the cowling; and one or more escapement clips provided in corresponding recesses of the retaining block and configured to secure the introducer spring.
Cole teaches an apparatus (see Figs. 1-7) comprising a cowling (cover 2) enclosing at least a second portion of the rotary mechanism (insertion mechanism 7) (see Figs. 1-2); a retaining block (uprights 56/58) configured to secure the introducer (needle 70) to the cowling (cover 2) (see Figs. 5 and 7-8, par. [0061]); and one or more escapement clips (leg 34) provided in corresponding recesses (notch 52) of the retaining block (uprights 56/58) and configured to secure the introducer spring (spring 30) (see Fig. 7, par. [0069]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to attach to an insertion device 7 of Cole such that the apparatus further comprises a cowling enclosing at least a second portion of the rotary mechanism; a retaining block configured to secure the introducer to the cowling; and one or more escapement clips provided in corresponding recesses of the retaining block and configured to secure the introducer spring, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 12, modified Mercereau teaches the apparatus of claim 10 substantially as claimed. However, modified Mercereau fails to state wherein the introducer spring comprises an introducer spring interface configured to mate with a corresponding interface on the introducer.
Cole teaches an apparatus (see Figs. 5-7) wherein the introducer spring (spring 30) comprises an introducer spring interface (end of spring 30 interfacing with carriage 10) configured to mate with a corresponding interface (carriage 10) on the introducer (needle 70) (see Fig. 5, spring 30 connects to carriage 10 which connects to needle 70).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to attach to an insertion device 7 of Cole such that the introducer spring comprises an introducer spring interface configured to mate with a corresponding interface on the introducer, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 13, modified Mercereau teaches the apparatus of claim 9 substantially as claimed. However, modified Mercereau fails to state wherein the rotary mechanism is a sheave assembly.
Cole teaches an apparatus (see Figs. 5-12) wherein the rotary mechanism (insertion mechanism 7) is a sheave assembly (see Figs. 5-12, par. [0047], insertion mechanism 7 includes a scotch yoke which is a wheel/sheave mechanism).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to attach to an insertion device 7 of Cole such that the rotary mechanism is a sheave assembly, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 14, modified Mercereau teaches the apparatus of claim 9 substantially as claimed. However, modified Mercereau fails to state a torsion spring configured to supply energy to rotate the rotary mechanism.
Cole teaches an apparatus (see Figs. 5-7) comprising a torsion spring (spring 30) configured to supply energy to rotate the rotary mechanism (insertion mechanism 7) (see Fig. 6, par. [0046]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to attach to an insertion device 7 of Cole such that the apparatus further comprises a torsion spring configured to supply energy to rotate the rotary mechanism, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 15, modified Mercereau teaches the apparatus of claim 9 substantially as claimed. However, modified Mercereau fails to state a stop plate configured to control an extent to which the deployable element extends beyond the opening.
Cole teaches an apparatus (see Figs. 5-12) comprising a stop plate (carriage 10) configured to control an extent to which the deployable element (catheter 66) extends beyond the opening (exit hole 591) (see Figs. 10-12, par. [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to attach to an insertion device 7 of Cole such that the apparatus further comprises a stop plate configured to control an extent to which the deployable element extends beyond the opening, as taught by Cole, in order to provide an automatic mechanism for inserting and retracting the apparatus (see Cole par. [0047] and [0056]-[0057]).
Regarding claim 16, modified Mercereau teaches the apparatus of claim 9 substantially as claimed. However, modified Mercereau fails to state a fluid conduit configured to connect the deployable element to a reservoir.
Cole teaches an apparatus (see Figs. 5-12) comprising a fluid conduit (fluid line 14) configured to connect the deployable element (catheter 66) to a reservoir (reservoir 4) (see Figs. 10-12A, par. [0043] and [0057]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of modified Mercereau to include a fluid conduit configured to connect the deployable element to a reservoir, as taught by Cole, in order to allow the apparatus to further function as a fluid delivery apparatus (see Cole par. [0043] and [0057]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1), as applied to claim 1 above, in view of Bene et al. (US 2014/0088550 A1).
Regarding claim 18, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state at least one convex or concave protrusion provided on the base, wherein the at least one convex or concave protrusion is sized and shaped to cause the skin of the user to be tensioned in a vicinity of the opening when the base is pushed against the skin.
Bene teaches an apparatus (see Fig. 17) comprising at least one convex or concave protrusion (outer ring 296) provided on the base (base 132), wherein the at least one convex or concave protrusion (outer ring 296) is sized and shaped to cause the skin of the user to be tensioned in a vicinity of the opening (opening for needle 292) when the base (base 132) is pushed against the skin (see Fig. 17, par. [0072]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of Mercereau to include a protrusion, as taught by Bene, in order to ensure proper seating and depth of the deployable element and the introducer (see Bene par. [0072]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mercereau et al. (US 6,450,937 B1), as applied to claim 1 above, in view of Gillett et al. (US 2018/0280608 A1).
Regarding claim 19, Mercereau discloses the apparatus of claim 1. However, Mercereau fails to state wherein the deployable element has a laminated composition comprising at least one polymer, at least one metal, and a coating.
Gillett teaches an apparatus (see Fig. 1A) wherein the deployable element (cannula 102) has a laminated composition comprising at least one polymer, at least one metal, and a coating (see par. [0068], cannula 102 is made of a stainless steel coated/laminated with a polymer).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the deployable element of Mercereau to have a laminated composition comprising at least one polymer, at least one metal, and a coating, as taught by Gillett, in order to allow the deployable element to be soft but semi-rigid to promote insertion into the skin (see Gillett par. [0084]).
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
In regards to independent claim 1, Applicant argues that the amendments to the claim including “wherein the distal end of the deployable element is positioned during deployment to extend a first depth through the skin of the user upon deployment, and the distal end of the introducer is positioned during deployment to extend a second depth through the skin of the user upon deployment, wherein the second depth is less than the first depth” overcomes the Mercereau reference. However, this argument is not found persuasive. The Examiner interprets that this language of “during deployment” and “upon deployment” can simply mean “while the deployable element (or the introducer, respectively) is being inserted”. This language does not appear to overcome Mercereau because, as described in the rejection of claim 1 above, the deployable element (tube 24) is capable of being deployed/inserted to a greater depth than the introducer (needle 18) due to the deployable element (tube 24) being longer than the introducer (needle 18). The language of “during deployment” and “upon deployment” does not appear to narrow the claim in the manner which Applicant may intend.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783