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 .
Response to Amendment
The amendment filed on 5/4/2026 has been entered. Claims 1-21 are pending in the application.
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 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmid (US 2016/0361013 A1).
Regarding claim 1, Schmid discloses an apparatus (see Figs. 1-6) comprising:
a deployable element (needle 174), the deployable element (needle 174) having a distal end configured to be deployed subcutaneously and positioned to extend through skin of a user (see Figs. 2 and 4, par. [0065]-[0066]);
an introducer (cannula 176) having a distal end configured to be deployed subcutaneously and positioned to extend through the skin of the user (see Figs. 2 and 4, par. [0065]-[0066]);
a base (housing 104) having an opening (see Figs. 2 and 4, opening of housing 104 for transcutaneous access tool 172) through which the distal end of the deployable element (needle 174) and the distal end of the introducer (cannula 176) are configured to extend (see Figs. 22 and 4, par. [0064]); and
an insertion mechanism (insertion mechanism 180) comprising a release (spring-biased linkage mechanism 182) and coupled with the introducer (cannula 176) and the deployable element (needle 174), the insertion mechanism (insertion mechanism 180) configured so that upon activation of the release (spring-biased linkage mechanism 182) to deploy the deployable element (needle 174) and introducer (cannula 176), the distal end of the deployable element (needle 174) is moved to extend a first depth through the skin of the user, and the distal end of the introducer (cannula 176) is moved to extend a second depth through the skin of the user, wherein the second depth is less than the first depth (see Fig. 4, par. [0064], [0067]-[0069], the cannula 176 extends less deep into the skin than the needle 174).
Regarding claim 3, Schmid discloses the apparatus of claim 1, wherein the introducer (cannula 176) is configured to penetrate outermost layers of the skin of the user comprising stratum corneum through dermis layers (see par. [0065]-[0066], cannula 176 is configured to be inserted into the subcutaneous layer such that it would penetrate through the stratum corneum through dermis layers which are external to the subcutaneous layer).
Regarding claim 6, Schmid discloses the apparatus of claim 1, wherein the deployable element (needle 174) is configured to continue to extend after the introducer (cannula 176) reaches a maximum deployment distance of the introducer (cannula 176) (see Figs. 2 and 4, needle 174 extends further beyond the maximum deployment distance of cannula 176).
Regarding claim 7, Schmid discloses the apparatus of claim 1, wherein the deployable element (needle 174) is selected from the group consisting of a cannula, a conduit, a needle, and a sensor (see Figs. 2 and 4, par. [0066], needle 174 is hollow such that it can be considered a cannula, conduit, or needle).
Regarding claim 17, Schmid discloses the apparatus of claim 1, further comprising a linear deployment mechanism (sliding members 184 and 186) configured to cause the deployable element (needle 174) and the introducer (cannula 176) to extend (see Figs. 1-6, par. [0067]-[0069]).
Regarding claim 18, Schmid discloses the apparatus of claim 1, further comprising at least one convex or concave protrusion (see Figs. 2, 4, and 6, protrusion which defines opening of housing 104 for transcutaneous access tool 172) provided on the base (housing 104), wherein the at least one convex or concave protrusion (see Figs. 2, 4, and 6, protrusion which defines opening of housing 104 for transcutaneous access tool 172) is sized and shaped to cause the skin of the user to be tensioned in a vicinity of the opening (see Figs. 2 and 4, opening of housing 104 for transcutaneous access tool 172) when the base (housing 104) is pushed against the skin (see Figs. 2, 4, and 6, housing 104 has a protrusion which defines an opening for transcutaneous access tool 172, the protrusion would tension the skin when pressed against the skin).
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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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Cole et al. (US 2015/0306307 A1).
Regarding claim 2, Schmid discloses the apparatus of claim 1. However, Schmid fails to expressly 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 Figs. 1-2 and 8-12) wherein the deployable element (needle 70) is configured to extend into the skin of the user to a depth of 2-10 mm (see par. [0047], about 5.3 mm is taught).
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 Schmid to include wherein 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 this is the preferred subcutaneous insertion depth (see Cole par. [0047]) for wearable insulin pumps for diabetes management (see Cole par. [0007]-[0010], Schmid par. [0062]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Damiano et al. (US 2018/0117296 A1).
Regarding claim 4, Schmid discloses the apparatus of claim 1. However, Schmid 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 introducer of the apparatus of Schmid to be configured to extend into the skin of the user to a depth of 1-3 mm, as taught by Damiano, because Damiano teaches that this is an acceptable range for insertion for subcutaneous injections (see Damiano par. [0144]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Nielsen et al. (US 2011/0137255 A1).
Regarding claim 5, Schmid discloses the apparatus of claim 1. However, Schmid 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.
Nielsen teaches an apparatus (see Figs. 23A-B) wherein the introducer (cannula 651) is configured to automatically retract through the opening (opening 621) in the base (base plate 620) after reaching a maximum deployment distance of the introducer (cannula 651) (see Figs. 23A-B, par. [0097]-[0099]).
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 Schmid to include wherein 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 Nielsen, in order to retract the introducer prior to removal of the apparatus from the skin (see Nielsen par. [0099]).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Cargill et al. (US 2022/0265210 A1).
Regarding claim 8, Schmid discloses the apparatus of claim 1. However, Schmid 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 modify the deployable element of Schmid to be a glucose sensor configured to perform continuous glucose monitoring, as taught by Cargill, in order to allow for drug delivery and glucose sensing on a single component (see Cargill par. [0058]).
Regarding claim 20, Schmid discloses the apparatus of claim 1. However, Schmid 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 deployable element of Schmid to comprise one or more electrically conductive signal traces connected to embedded electronics hardware, as taught by Cargill, in order to allow for drug delivery and glucose sensing on a single component (see Cargill par. [0058]).
Claims 9-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Turner et al. (US 2021/0236771 A1).
Regarding claim 9, Schmid discloses the apparatus of claim 1, further comprising a rotary mechanism (linkages 183a-b) having an outer circumference (see Figs. 1, 3, and 5), the rotary mechanism (linkages 183a-b) configured to selectively constrain the deployable element (needle 174) to conduct a linear motion of the deployable element (needle 174) (see 1-6, par. [0067]-[0069]).
However, Schmid fails to state 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) wherein the deployable element (catheter 4) is wrapped around at least a first portion of the outer circumference (outer circumference of spool, par. [0030]), the rotary mechanism (spool, par. [0030]) configured to rotate the deployable element (catheter 4) around the outer circumference (outer circumference of spool, 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 rotary mechanism of the apparatus of Schmid such that 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 and insert a catheter which can be directly attached to the fluid source (see Turner par. [0030] and [0035]).
Regarding claim 10, modified Schmid teaches the apparatus of claim 9 substantially as claimed. Schmid further teaches an introducer spring (helical torsion spring 181) that is coiled around a fixed point on the apparatus (see Figs. 1, 3, and 5, par. [0068]).
Regarding claim 12, modified Schmid teaches the apparatus of claim 10 substantially as claimed. Schmid further teaches wherein the introducer spring (helical torsion spring 181) comprises an introducer spring interface (distal portion of helical torsion spring 181) configured to mate (via linkages 183a-b and sliding member 184) with a corresponding interface (sliding member 186) on the introducer (cannula 176) (see Figs. 1-6, par. [0067]-[0069]).
Regarding claim 13, modified Schmid teaches the apparatus of claim 9 substantially as claimed. Modified Schmid further teaches wherein the rotary mechanism is a sheave assembly (see Turner Figs. 1-3. Turner par. [0030] describes a wheeled sheave assembly for introducing catheter 4, see previous modifications in rejection of claim 9 above).
Regarding claim 14, modified Schmid teaches the apparatus of claim 9 substantially as claimed. Schmid further teaches a torsion spring (helical torsion spring 181) configured to supply energy to rotate the rotary mechanism (linkages 183a-b) (see Figs. 1, 3, and 5, par. [0068]).
Regarding claim 15, modified Schmid teaches the apparatus of claim 9 substantially as claimed. Schmid further teaches a stop plate (sliding member 184) configured to control an extent to which the deployable element (needle 174) extends beyond the opening (see Figs. 2 and 4, opening of housing 104 for transcutaneous access tool 172) (see Figs. 1-6, par. [0067]-[0069]).
Regarding claim 16, modified Schmid teaches the apparatus of claim 9 substantially as claimed. Schmid further teaches a fluid conduit (tubing 178) configured to connect the deployable element (needle 174) to a reservoir (see Figs. 1-6, par. [0066], needle 174 is fluidly connected to cannula 176 which is fluidly connected to tubing 178).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1) in view of Turner et al. (US 2021/0236771 A1), as applied to claim 10 above, further in view of Cole et al. (US 2015/0306307 A1).
Regarding claim 11, modified Schmid teaches the apparatus of claim 10 substantially as claimed. However, modified Schmid 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. 1-8) 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 Schmid to include 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 support for securing the rotary mechanism and the introducer spring to the apparatus (see Cole par. [0050]-[0051], [0061], [0069]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Gillett et al. (US 2018/0280608 A1).
Regarding claim 19, Schmid discloses the apparatus of claim 1. However, Schmid 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 Schmid 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]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US 2016/0361013 A1), as applied to claim 1 above, in view of Mercereau et al. (US 6,450,937 B1).
Regarding claim 21, Schmid discloses the apparatus of claim 1. However, Schmid fails to state wherein the distal end of the introducer is positioned so as to penetrate the skin of the user before the distal end of the deployable element extends through the skin of the user.
Mercereau teaches an apparatus (see Figs. 1-12) wherein the distal end of the introducer (cannula 12) is positioned so as to penetrate the skin of the user before the distal end of the deployable element (tube 24) extends through the skin of the user (see Figs. 10-11, col. 5 lines 54-64).
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 Schmid to include wherein the distal end of the introducer is positioned so as to penetrate the skin of the user before the distal end of the deployable element extends through the skin of the user, as taught by Mercereau, in order to allow a beveled cutting edge of the introducer to penetrate the skin and form an opening in the skin to guide insertion of the deployable element (see Mercereau col. 5 lines 54-64).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on 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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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