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 .
Election/Restrictions
Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/25/2026.
Applicant’s election without traverse of Claims 1-3, in the reply filed on 02/25/2026 is acknowledged.
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.
Claims 29-30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites the limitation “(…) the pin” in line 1. Claim 29 depends on claim 28. It is not clear whether:
The claimed pin is the same as pin of drive wheel (seen in line 2 of claim 28) or
The claimed pin is the same pin of second link (seen in claim 29).
Instant specification discloses that second link comprises a first pin 482 in engagement with slot 484 and second pin 486 to mate with the engagement hole 442 (please see Fig 6 and 9A; [0065]). Neither pin 482 or 484 slides on cam slot 472.
For examination purposes, the pin will be interpreted as option (a): “The claimed pin is the same as pin of drive wheel (seen in line 2 of claim 28)”.
Claim 30 recites the limitation "the drive assembly" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9, 12-13, 20-22, 30-31, and 67-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiIanni et al. (US 20140128839 A1).
Regarding claim 1, Dilanni discloses an integrated sensor and infusion device (fluid delivery device 300, Fig 18), the device comprising: a reservoir assembly comprising a reservoir (fluid reservoir, [0006]) configured to retain medicament therein (insulin; [0006]); a sensor electronics assembly configured to receive signals from a sensor (main sensor area + circuit board ; [0043]); and an insertion assembly comprising: a carrier assembly (assembly comprised of sliding member 386 + cannula 376 + test strip 320) comprising a cannula carrier (sliding member 386, Fig 22), an infusion cannula (cannula 376, Fig 23) extending downwardly away from the cannula carrier (386) (Fig 22), and a sensor electrode (test strip 320, Fig 23) extending downwardly away from the cannula carrier (386) at a position laterally spaced apart from the infusion cannula (376) (Fig 23), wherein the infusion cannula (376) is fluidically coupled to the reservoir ([0041]; cannula 376 delivers fluid (insulin), which is stored in the reservoir); a trocar assembly (assembly comprised of sliding member 384, Fig 20 + first needle/trocar 374, Fig 21 + trocar 375, Fig 21) comprising a trocar link (sliding members 384, Fig 22), a first trocar (first needle/trocar 374, Fig 19) configured to removably engage the infusion cannula (376), and a second trocar (trocar 375, Fig 19) configured to removably engage the sensor electrode (test strip 320, Fig 23) ([0042]-[0043]), the trocar assembly (384 + 374+ 375) removably coupled to the carrier assembly (386+376+320) ([0042]-[0043]); and a drive assembly (1001+ 1003 +1004, Annotated Fig 1) comprising a torsion spring (torsional spring 1001, similar to spring 181, Annotated Fig 1; [0043]) coupled to the trocar assembly (384+374+375) such that, when actuated, the torsion spring (1001, Annotated Fig 1) rotates to drive the trocar assembly (384+374+375) and the carrier assembly (386+376+320) axially downward to insert the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) into a user's skin ([0042]-[0043]).
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Regarding claim 2, Dilanni discloses the device of claim 1, wherein each of the components of the device (300) are configured to be housed within a device housing (housing 1002, Annotated Fig 1, similar to housing 104, Fig 1) prior to insertion of the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) into the user's skin, and wherein the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) extend out of the housing for insertion into the user's skin (Fig 21) ([0042]).
Regarding claim 3, Dilanni discloses the device of claim 1, wherein a first amount of rotation (rotation of torsional spring representative of insertion movement) by the torsion spring (1001, Annotated Fig 1) drives the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) into the user's skin, and wherein a second amount of rotation (rotation of torsional spring representative of retraction movement) retracts the first trocar (374) and the second trocar (375) from the user's skin while leaving the infusion cannula (376) and the sensor electrode (320) in the user's skin([0042]-[0043]).
Regarding claim 9, Dilanni discloses the device of claim 1, wherein the drive assembly (1001+ 1003 +1004, Annotated Fig 1) further comprises a scissor assembly (first linkage 1003 and second linkage 1004, Annotated Fig 1, similar to 183a, 183b, Fig 3) coupled to the torsion spring (1001, Annotated Fig 1) via a drive wheel (1005, Annotated Fig 1), the scissor assembly (1003 + 1004, Annotated Fig 1) comprising a first link (1003, Annotated Fig 1) coupled to the trocar link (384) at a first region (1006, Annotated Fig 1) and a second link (1004, Annotated Fig 1) coupled to the trocar link (384) at a second region, wherein the torsion spring (1001, Annotated Fig 1), when actuated, is configured to rotate the drive wheel to cause, via the scissor assembly (1003+1004, Annotated Fig 1), the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) to be inserted into the user's skin ([0042]-[0043]).
Regarding claim 12, Dilanni discloses the device of claim 9, wherein the drive assembly (1001+1003+1004, Annotated Fig 1), when actuated, moves the scissor assembly (1003+1004, Annotated Fig 1) from an unfired position (Fig 18) in which the infusion cannula (376) and sensor electrode (320) are disposed within a housing (1002, Annotated Fig 1) of the device (300) to an inserted position (Fig 20) in which the infusion cannula (376) and sensor electrode (320) extend beyond the housing (1002, Annotated Fig 1) of the device (300).
Regarding claim 13, Dilanni discloses the device of claim 12, wherein, in the unfired position (Fig 18), the first link (1003, Annotated Fig 1) and second link (1004, Annotated Fig 1) assume an expanded state (state of lateral expansion, Fig 18) in which they extend along non-parallel axes (Fig 18, position of first 1003 and second 1004 links extend along non-parallel axis), and wherein, in the inserted position (Fig 20), the first link (1003, Annotated Fig 1) and the second link (1004, Annotated Fig 1) assume a collapsed state (linear, laterally collapsed state) in which they extend parallel to one another (both first and second links adopt a linear state where their axis are parallel).
Regarding claim 20, Dilanni discloses an integrated sensor and infusion device (fluid delivery device 300, Fig 18), comprising: a torsion spring (1001, Annotated Fig 1); a scissor assembly (1003+1004, Annotated Fig 1) coupled to the torsion spring (1001, Annotated Fig 1), the scissor assembly (1003+1004, Annotated Fig 1) comprising a first link (1003, Annotated Fig 1) and a second link (1004, Annotated Fig 1); a slide (sliding member 384) having first (first needle/trocar 374, Fig 21) and second trocars (needle/trocar 375, Fig 21) coupled thereto, the slide (384) coupled to the first link (1003, Annotated Fig 1) at a first region (region 1006, Annotated Fig 1) and coupled to the second link (1004, Annotated Fig 1) at a second region (region 1007, Annotated Fig 1); an infusion cannula (cannula 376, Fig 20) removably coupled to the first trocar (374); and a sensor electrode (test strip 320, Fig 21) removably coupled to the second trocar (375), wherein the torsion spring (1001, Annotated Fig 1), when actuated, is configured to cause, via the scissor assembly (1003+1004, Annotated Fig 1), the slide (384) to move axially (Fig 18 and 20 show the axial displacement of slide 384) to drive the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) into a user's skin ([0042]-[0043]).
Regarding claim 21, Dilanni discloses the device of claim 20, wherein each of the components of the device (300) are configured to be housed within a device housing (1002, Annotated Fig 1) prior to insertion of the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) into the user's skin ([0042]-[0043]), and wherein the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) extend out of the housing (1002, Annotated Fig 1) for insertion into the user's skin ([0042]-[0043]).
Regarding claim 22, Dilanni discloses the device of claim 20, wherein a first amount of rotation (rotation of torsional spring representative of insertion movement) by the torsion spring (1001, Annotated Fig 1) drives the first trocar (374), the infusion cannula (376), the second trocar (375), and the sensor electrode (320) into the user's skin ([0042]-[0043]), and wherein a second amount of rotation (rotation of torsional spring representative of retraction movement) retracts the first trocar (374) and the second trocar (376) from the user's skin while leaving the infusion cannula and the sensor electrode (320) in the user's skin([0042]-[0043]).
Regarding claim 30, Dilanni discloses the device of claim 20, wherein the drive assembly (1001 + 1003+ 1004, Annotated Fig 1), when actuated, moves the scissor assembly (1003 + 1004, Annotated Fig 1) from an unfired position (Fig 18) in which the infusion cannula (376) and sensor electrode (320) are disposed within a housing (1002, Annotated Fig 1) of the device (300) to an inserted position (Fig 20) in which the infusion cannula (376) and sensor electrode (320) extend beyond the housing (1002, Annotated Fig 1) of the device (300).
Regarding claim 31, Dilanni discloses the device of claim 30, wherein, in the unfired position (Fig 18), the first link (1003, Annotated Fig 1) and second link (1004, Annotated Fig 1) assume an expanded state (state of lateral expansion, Fig 18) in which they extend along non-parallel axes (Fig 18, position of first 1003 and second 1004 links extend along non-parallel axis), and wherein, in the inserted position (Fig 20), the first link (1003, Annotated Fig 1) and the second link (1004, Annotated Fig 1) assume a collapsed state (linear, laterally collapsed state) in which they extend parallel to one another(both first and second links adopt a linear state where their axis are parallel; please see Fig 20).
Regarding claim 67, Dilanni discloses an integrated sensor and infusion device (fluid delivery device 300, Fig 18), the device comprising : insertion means comprising (assembly comprised of sliding member 386 + cannula 376 + test strip 320): a first carrier means (sliding member 386, Fig 22) for carrying an infusion means (cannula 376, Fig 23) and a sensing means (test strip 320, Fig 23); a second carrier means (sliding members 384, Fig 22) for carrying a first insertion means (first needle/trocar 374, Fig 19) configured to couple to the infusion means (376) and a second insertion means (trocar 375, Fig 19) configured to couple to the sensing means (320); and a drive means (1001+1003+1004, Annotated Fig 1) configured to drive the second carrier means (384) and the first carrier means (386) axially downward to insert the infusion means (376) and the sensing means (320) into a user's skin ([0042]-[0043]).
Regarding claim 68, Dilanni discloses the device of claim 67, wherein the drive means (1001+1003+1004, Annotated Fig 1) is further configured to retract the second carrier means (384) axially upward while leaving the first carrier means (386) in the axially downward position (Fig 22) with the infusion means (376) and sensing means (320) inserted into the user's skin ([0042]-[0043], Fig 23).
Regarding claim 69, Dilanni discloses the device of claim 67, wherein the infusion means (376) comprises a cannula (376) fluidically coupled to a reservoir ([0041]; cannula 376 delivers fluid (insulin), which is stored in the reservoir 1000, Annotated Fig 1).
Regarding claim 70, Dilanni discloses the device of claim 67, wherein the sensing means (320) comprises a sensor electrode (test strip 320 comprises sensors 320a-b; [0043]; [0031]: test strip is configured to test for a concentration level of glucose in the blood of a patient).
Regarding claim 71, Dilanni discloses the device of claim 67, wherein the first insertion means (374) comprises a first trocar (needle/trocar 374) ([0042]).
Regarding claim 72, Dilanni discloses the device of claim 67, wherein the second insertion means (375) comprises a second trocar (trocar 375; [0042]) .
Regarding claim 73, Dilanni discloses the device of claim 67, wherein the drive means (1001+1003+1004, Annotated Fig 1) comprises a torsion spring (torsion spring 1001, is similar to torsion spring 281 and 181 of previous embodiments; [0042]: insertion mechanism 380, similar to the first described embodiment above).
Regarding claim 74, Dilanni discloses the device of claim 73, wherein the drive means (1001+1003+1004, Annotated Fig 1) comprises a scissor assembly (1003+1004, Annotated Fig 1) coupled to the torsion spring (1001, Annotated Fig 1).
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 10, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over DiIanni et al. (US 20140128839 A1) in view of Scott et al. (WO 2020216617 A1).
Regarding claim 10, Dilanni discloses the device of claim 9 wherein the drive wheel (1005, Annotated Fig 5) is disposed within a housing (housing 1002, Annotated Fig 1). Dilanni is silent wherein the drive wheel comprises a pin received within a cam slot of the first link, such that rotation of the drive wheel causes the pin to slide within the cam slot and causes the first link to rotate relative to the drive wheel housing.
Scott teaches a device (Fig 14) comprising a drive wheel (rotatable drum insert body 37a’, Fig 14) disposed within a housing (drum 36a, Fig 11) and the drive wheel (37a’) comprises a pin (protrusion 37a-3’, Fig 14) received within a cam slot (slit 39b’, Fig 14) of the first link (member actuator 39’, Fig 14), such that rotation of the drive wheel (37a’) causes the pin (37a-3’) to slide within the cam slot (39b’) and causes the first link (39’) to rotate relative to the drive wheel housing (36a) (page 17, lines 17-29).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dilanni with similar driving wheel coupled to the spring and non-integrally connected to the first link via a pin/slot as taught by Scott for the purpose of providing reduction of shock loading which results in a smoother operation and interaction between components (page 17, lines 17-29).
Regarding claim 28, Dilanni discloses the device of claim 20, wherein the scissor assembly (1003 +1004, Annotated Fig 1) is coupled to the torsion spring (1001, Annotated Fig 1) via a drive wheel (1005, Annotated Fig 1). Dilanni is silent regarding the drive wheel disposed within a drive wheel housing and the drive wheel comprises a pin received within a cam slot of the first link, such that rotation of the drive wheel causes the pin to slide within the cam slot and causes the first link to rotate relative to the drive wheel housing.
Scott teaches a device (Fig 14) comprising a drive wheel (rotatable drum insert body 37a’, Fig 14) disposed within a drive wheel housing (drum 36a, Fig 11) and the drive wheel (37a’) comprises a pin (protrusion 37a-3’, Fig 14) received within a cam slot (slit 39b’, Fig 14) of the first link (member actuator 39’, Fig 14), such that rotation of the drive wheel (37a’) causes the pin (37a-3’) to slide within the cam slot (39b’) and causes the first link (39’) to rotate relative to the drive wheel housing (36a) (page 17, lines 17-29).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dilanni with similar driving wheel coupled to the spring and connected to the first link via a pin/slot as taught by Scott for the purpose of providing reduction of shock loading which results in a smoother operation and interaction between components (page 17, lines 17-29).
Regarding claim 29, Dilanni/Scott discloses the device of claim 28, wherein the second link (1004, Annotated Fig 1) comprises a pin (1008, Annotated Fig 1). Dilanni is silent wherein the pin extending into the cam slot of the first link such that rotation of the first link causes the pin to slide within the cam slot.
Scott teaches a device (Fig 14) comprising a drive wheel (rotatable drum insert body 37a’, Fig 14) disposed within a drive wheel housing (drum 36a, Fig 11) and the drive wheel (37a’) comprises a pin (protrusion 37a-3’, Fig 14) received within a cam slot (slit 39b’, Fig 14) of the first link (member actuator 39’, Fig 14), such that rotation of the drive wheel (37a’) causes the pin (37a-3’) to slide within the cam slot (39b’) and causes the first link (39’) to rotate relative to the drive wheel housing (36a) (page 17, lines 17-29).
Dilanni/Scott as modified discloses wherein a pin (1008, Annotated Fig 1, from Dilanni) extending into the cam slot (similar slot 39b’ as taught by Scott) of the first link (1003, Annotated Fig 1; from Dilanni) (1008 extends into the depth of the slot’s region) such that rotation of the first link (1003, Annotated Fig 1; from Dilanni) causes the pin (similar pin as protrusion 37a-3’, Fig 14 from Scott; please see U.S.C. 112(b) rejection, page 2-3) to slide within the cam slot (similar slot 39b’ as taught by Scott).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dilanni with similar driving wheel coupled to the spring and connected to the first link via a pin and slot as taught by Scott for the purpose of providing reduction of shock loading which results in a smoother operation and interaction between components (page 17, lines 17-29).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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