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Claims 31-34 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/22/2026.
Applicant’s election without traverse of Group I (claims 14-15, 17-23, 35-38, and 40-47) in the reply filed on 04/22/2026 is acknowledged.
Although claims 19, 21, 41, and 47 were in the group of claims believed to encompass the elected species as remarked by the applicant, the claims are withdrawn from consideration by the examiner as they are not directed towards the elected species. Regarding claim 19, the elected species in FIGS. 17-28 does not show the at least one engagement feature as a drive screw and the driving mechanism as a driving screw (as shown in FIGS. 36-38). Regarding claim 21, the elected species in FIGS. 17-28 does not show the first and second directions as orthogonal to another (as shown in FIG. 41). Regarding claim 41, the elected species in FIGS. 17-28 does not show the first and second axes as orthogonal (as shown in FIG. 41). Regarding claim 47, the elected species in FIGS. 17-28 does not show the driving mechanism comprising a drive screw in threaded engagement with the first and second needle supports (as shown in FIGS. 36-38).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/08/2024 and 03/17/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because on page 32/35 in the drawings, FIG. 38 and FIG. 39 have been duplicated from page 31/35. This duplication of pages does not meet the requirements set forth by MPEP §608.02.V.(u), wherein “the different views must be numbered in consecutive Arabic numerals”, as the number 38 and 39 repeat.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The recitation, in claim 14, of “a driving mechanism…configured to drive the first needle support in a first direction, and to drive the second needle support in a second direction” has been interpreted as structurally a component coupled to the first and second needles which drives the first needle towards the distal end and the second needle towards the proximal end [0050].
The recitation, in claim 17, of “at least one engagement feature configured to engage with the driving mechanism” has been interpreted as structurally features configured to interact with one another such as protrusions and recessions, screws and threads, zipper type features, or any other complimentary engagement features [0071] in which a driving motion is supported.
The recitation, in claim 35, of “the fluid delivery mechanism configured to retain a fluid comprising a medication and having a movable stopper therein” has been interpreted as structurally all components that make up the cartridge of FIG. 12, which includes the septum seal, septum, hub of fluid housing, fluid housing, and stopper. Also a part of the cartridge components is any mechanical, electrical, or human-activated drive system [0060].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 14-15, 17-23, 35-38, and 40-47 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. The term “fluid delivery mechanism” is not clearly defined by the claim or specification. It is unclear to the examiner as to what part or parts of the device constitute the “fluid delivery mechanism”, and further how or where these parts are supposed to couple to the needle assembly housing. The examiner suggests defining the parts of the “fluid delivery mechanism” in the specification and drawings. For the purposes of examination, the examiner will interpret “fluid delivery mechanism” to be all components that make up the cartridge of FIG. 12, which includes the septum seal, septum, hub of fluid housing, fluid housing, and stopper. Also a part of the cartridge components is any mechanical, electrical, or human-activated drive system [0060].
Claims 36, 37, and 40 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.
Claims 36, 37, and 40 recite the limitation "the first configuration". There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner will interpret “the first configuration” to be the initial position.
Claims 36, 37, and 40 recite the limitation "the second configuration". There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner will interpret “the second configuration” to be the final position.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 14, 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Arnitz et al. (United States Patent Application Publication No. US 2013/0006213 A1; herein, Arnitz), and further in view of Cowe et al. (United States Patent Application Publication No. US 2019/0328973 A1; herein, Cowe).
Regarding claim 14, Arnitz discloses a needle assembly for a drug delivery device (Annotated on Fig. 5 below), comprising:
a needle assembly housing (removal device 116) configured to couple to a fluid delivery mechanism of a drug delivery device (Annotated on Fig. 5 below);
a first needle (second needle element 140);
a second needle (first needle element 138);
a movable connector (fluidic device 142) coupling the first needle to the second needle (Fig. 5), wherein the first needle, the second needle, and the movable connecter are in fluid communication with one another (Fig. 5) and in selective fluid communication with the fluid delivery mechanism ([0116], fluid connection between components established during application); and
a driving mechanism (drives 144, 146) supported by the needle assembly housing and configured to drive the first needle support in a first direction ([0117], the protected region 166 can subsequently be perforated by means of the drives 144 and/or 146), and to drive the second needle support in a second direction ([0117], the drive 146 can perforate the second sealing element 128 that can be perforated, followed by a perforation of part of the skin).
PNG
media_image1.png
553
858
media_image1.png
Greyscale
Arnitz does not disclose the first needle coupled to a first needle support and the second needle coupled to a second needle support. However, Cowe teaches the first needle coupled to a first needle support (FIG. 6(b), needle holder 132) and the second needle coupled to a second needle support (FIG. 6(b), disc-shaped holder 168). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needles of the assembly disclosed by Arnitz to include needle supports as taught by Cowe in order to retain a hypodermic injection needle ([0096]).
Regarding claim 20, in the modified assembly of Arnitz, Arnitz does not disclose the first direction and the second direction are both approximately co-linear and approximately opposite to one another.
However, in an alternative embodiment of Arnitz, Arnitz teaches the first direction and the second direction are both approximately co-linear and approximately opposite to one another (Annotated on Fig. 1 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly disclosed by the modified Arnitz to have the needle assembly move in a co-liner and opposite manner as taught by the alternative embodiment of Arnitz in order that fluid transport occurs after perforation of seals ([0103]-[0105]).
PNG
media_image2.png
820
535
media_image2.png
Greyscale
Regarding claim 22, in the modified assembly of Arnitz, Arnitz discloses the movable connector is configured to flex in response to movement of at least one of the first needle support and the second needle support relative to one another (Fig. 5, [0104], “fluidic device 142 can comprise a tube system with at least one tube and/or another fluid conductor, for example a tube system with one or more tubes made of plastic”, plastic tubing is known in the art to be flexible).
Regarding claim 23, in the modified assembly of Arnitz, Arnitz discloses the movable connector comprises a flexible tube configured to maintain a fluid coupling between the first needle and the second needle throughout movement of the first needle support and the second needle support (Fig. 5, [0104], “fluidic device 142 can comprise a tube system with at least one tube and/or another fluid conductor, for example a tube system with one or more tubes made of plastic”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Arnitz in view of Cowe as applied to claim 14 above, and further in view of McLoughlin et al. (United States Patent Application Publication No. US 2018/0104413 A1; herein McLoughlin).
Regarding claim 15, in the modified assembly of Arnitz, Arnitz does not disclose a motor configured to actuate the driving mechanism to drive the first needle and the second needle. However, McLoughlin teaches a motor (FIG. 32, first motor 82) configured to actuate the driving mechanism to drive the first needle and the second needle (FIG. 32, [0406], “The first motor 82 (e.g. stepper motor) selectively transfers drive via first gear 82a to a first drive transfer element in the form of worm 82b. That worm 82b interacts with a rack locating on the back of cassette unit holder 75 to axially move the cassette unit holder 75 and cassette unit 1 and syringe 10 held thereby within the frame 77 from a rest position, in which the needle 14 with tip 15 of the syringe 10 is within the drive unit housing 71 to a use position, in which the needle 14 with tip 15 protrudes from the needle delivery aperture 76a of the drive unit housing”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly disclosed by the modified Arnitz to include a motor as taught by McLoughlin in order to selectively drive the needle ([0406]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Arnitz in view of Cowe as applied to claim 14 above, and further in view of Painchaud et al. (United States Patent Application Publication No. US 2019/0321075 A1; herein, Painchaud).
Regarding claim 17, in the modified assembly of Arnitz, Arnitz does not disclose each of the first needle support and the second needle support comprises at least one engagement feature configured to engage with the driving mechanism. However, Painchaud teaches each of the first needle support and the second needle support comprises at least one engagement feature (Fig. 3, first and second rack elements 37,39) configured to engage with the driving mechanism (Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle supports taught by Cowe in the assembly disclosed by the modified Arnitz to have at least one engagement feature as taught by Painchaud in order to push the pushing rod or needle from the initial position to the final position ([0053]).
Regarding claim 18, in the modified assembly of Arnitz, Arnitz does not disclose the at least one engagement feature is a recess and the driving mechanism comprises a protrusion configured to interface with the recess, wherein the first and second directions are along a first axis and the at least one engagement feature is defined about a second axis orthogonal to the first axis. However, Painchaud teaches the at least one engagement feature is a recess (Fig. 3, first and second rack elements 37,39 have recesses) and the driving mechanism comprises a protrusion (Fig. 3, first and second set of gear teeth 43, 45 have protrusions) configured to interface with the recess (Fig. 3), wherein the first and second directions are along a first axis (Annotated on Fig. 3 below) and the at least one engagement feature is defined about a second axis orthogonal to the first axis (Annotated on Fig. 3 below, recesses of first and second rack elements 37,39 are orthogonal to labeled axes). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle supports taught by Cowe in the assembly disclosed by the modified Arnitz to have at least one engagement feature that is a recess interface with a protrusion of the driving mechanism as taught by Painchaud in order to push the pushing rod or needle from the initial position to the final position ([0053]).
PNG
media_image3.png
498
1113
media_image3.png
Greyscale
Claims 35, 40, 43, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Arnitz, and further in view of Cowe.
Regarding claim 35, Arnitz teaches a drug delivery device (device 110) comprising:
a device housing (housing 174);
the fluid delivery mechanism (Annotated on Fig. 5 below) having at least one container within the device housing (container 118), the fluid delivery mechanism configured to retain a fluid comprising a medication (fluid medium 112) and having a movable stopper therein (Fig. 5, plunger stopper 188),
the fluid delivery mechanism configured to move the stopper ([0128], stopper 188 is driven into the interior of container 118); and
the needle assembly of claim 14 (Annotated on Fig. 5 below).
PNG
media_image1.png
553
858
media_image1.png
Greyscale
In the needle assembly of claim 14, Arnitz does not disclose the first needle coupled to a first needle support and the second needle coupled to a second needle support. However, Cowe teaches the first needle coupled to a first needle support (FIG. 6(b), needle holder 132) and the second needle coupled to a second needle support (FIG. 6(b), disc-shaped holder 168). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needles of the device disclosed by Arnitz to include needle supports as taught by Cowe in order to retain a hypodermic injection needle ([0096]).
Regarding claim 40, in the modified device of Arnitz, Arnitz does not disclose the first and second needles move along a first and second axis respectively when the needle assembly moves from the first configuration to the second configuration, wherein the first and second axes are generally parallel. However, in an alternative embodiment of Arnitz, Arnitz teaches the first and second needles move along a first and second axis respectively when the needle assembly moves from the first configuration to the second configuration (Annotated on Fig. 1 below), wherein the first and second axes are generally parallel (Annotated on Fig. 1 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to have the needles move on separate parallel axes as taught in an alternative embodiment of Arnitz in order that fluid transport occurs after perforation of seals ([0103]-[0105]).
PNG
media_image4.png
820
535
media_image4.png
Greyscale
Regarding claim 43, in the modified device of Arnitz, Arnitz discloses a first end of the needle assembly housing comprises a seal (Fig. 5, sealing element 128 comprised of sealing film 136) and the at least one container comprises a septum (Fig. 5, stopper 150 and protected region 166 with sealing element 126 comprised of sealing film 134) proximate the second end of the needle assembly housing (Fig. 5).
Regarding claim 44, in the modified device of Arnitz, Arnitz discloses the needle assembly is configured to move from a first configuration to a second configuration (move from Fig. 5 to post-perforation [0117]), wherein in the first configuration each of the first needle and the second needle has a retracted position within the needle assembly housing (Fig. 5), and in the second configuration the first needle is extended in the first direction to pierce the seal ([0117], “the drive 146 can perforate the second sealing element 128 that can be perforated, followed by a perforation of part of the skin”) and the second needle is extended in the second direction to pierce the septum ([0117], “The protected region 166 can subsequently be perforated by means of the drives 144 and/or 146.”) such that the first needle, the second needle, and the movable connecter are in fluid communication with the at least one container of the fluid delivery mechanism ([0117], following perforations an injection of the fluid medium 112 is pushed into the tissue of the user).
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Arnitz in view of Cowe as applied to claim 35 above, and further in view of McLoughlin.
Regarding claim 36, in the modified device of Arnitz, Arnitz does not disclose a first motor, wherein the first motor is configured to move the needle assembly from the first configuration to the second configuration. However, McLoughlin teaches a first motor (FIG. 32, first motor 82), wherein the first motor is configured to move the needle assembly from the first configuration to the second configuration (FIG. 32, [0406], “The first motor 82 (e.g. stepper motor) selectively transfers drive via first gear 82a to a first drive transfer element in the form of worm 82b. That worm 82b interacts with a rack locating on the back of cassette unit holder 75 to axially move the cassette unit holder 75 and cassette unit 1 and syringe 10 held thereby within the frame 77 from a rest position, in which the needle 14 with tip 15 of the syringe 10 is within the drive unit housing 71 to a use position, in which the needle 14 with tip 15 protrudes from the needle delivery aperture 76a of the drive unit housing”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to include a motor to drive the needles as taught by McLoughlin in order to selectively drive the needle ([0406]).
Regarding claim 37, in the modified device of Arnitz, Arnitz discloses a first motor (Fig. 5, drive 180) configured to drive the fluid through the fluid delivery mechanism ([0128]-[0129], “there is an actuation of the drive 180 and an increase in the internal pressure of the container 118”).
The modified Arnitz does not disclose a second motor configured to move the needle assembly from the first configuration to the second configuration. However, McLoughlin teaches a second motor (FIG. 32, first motor 82) configured to move the needle assembly from the first configuration to the second configuration (FIG. 32, [0406], “The first motor 82 (e.g. stepper motor) selectively transfers drive via first gear 82a to a first drive transfer element in the form of worm 82b. That worm 82b interacts with a rack locating on the back of cassette unit holder 75 to axially move the cassette unit holder 75 and cassette unit 1 and syringe 10 held thereby within the frame 77 from a rest position, in which the needle 14 with tip 15 of the syringe 10 is within the drive unit housing 71 to a use position, in which the needle 14 with tip 15 protrudes from the needle delivery aperture 76a of the drive unit housing”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to include a motor as taught by McLoughlin in order to selectively drive the needle ([0406]).
Claims 38 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Arnitz in view of Cowe as applied to claim 35 above, and further in view of Both et al. (United States Patent No. US 8,303,535 B2; herein, Both).
Regarding claim 38, in the modified device of Arnitz, Arnitz does not disclose an indicator configured to signal a user when the fluid is driven through the needle assembly. However, Both teaches an indicator (status indicator 28) configured to signal a user when the fluid is driven through the needle assembly (col. 5 line 63-col. 6 line 2, status indicator 28 provides a dispensing status signal). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to include an indicator as taught by Both in order to provide the user with visual signals regarding the state of the device (col. 6 line 41-col. 7 line 11). This can act as an additional safety mechanism for the user when working with the needle.
Regarding claim 42, in the modified device of Arnitz, Arnitz does not disclose a skin sensor configured to indicate whether the drug delivery device is appropriately positioned against a skin of a patient. However, Bother teaches a skin sensor (body sensor 24) configured to indicate whether the drug delivery device is appropriately positioned against a skin of a patient (col. 6 lines 41-48, device will not start if not properly attached to skin of user). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to include a skin sensor as taught by Both in order to ensure that the actuation and control components, after receiving a start command, will not engage or use the sterile fluid path components unless the device is in contact with the body of the user (col. 4 lines 29-67).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Arnitz in view of Cowe as applied to claim 44 above, and further in view of Davies et al. (United States Patent Application Publication No. US 2012/0226238 A1; herein, Davies).
Regarding claim 45, in the modified device of Arnitz, Arnitz discloses the first needle, the second needle, and the movable connecter are not in fluid communication with the at least one container of the fluid delivery mechanism (Fig. 5). Arnitz does not disclose the needle assembly is configured to move from the second configuration to the first configuration after a fluid delivery event, wherein in the second configuration the first needle is retracted in the second direction and removed from the seal, and the second needle is retracted in the first direction and removed from the septum. However, Davies teaches the needle assembly is configured to move from the second configuration to the first configuration after a fluid delivery event (FIG. 6 dose injection state to a post-injection state), wherein in the second configuration the first needle is retracted in the second direction and removed from the seal ([0062], needle guard 90 retracts second needle 80 after injection), and the second needle is retracted in the first direction and removed from the septum ([0077], Proximal movement of the needle guard 90 causes the first needle 40 to penetrate the first pierceable seal 48. Examiner interprets then distal movement of the needle guard, such as to retracts the second needle 80, would cause the first needle 40 to be removed from the first pierceable seal 48.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to move the needles from a second configuration to a first configuration as taught by Davies in order to prevent a user from re-using a non-sterile medicated module and reduce the risk of a potential inadvertent needle stick ([0082]).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Arnitz in view of Cowe as applied to claim 35 above, and further in view of Painchaud.
Regarding claim 46, in the modified device of Arnitz, Arnitz does not disclose each of the first needle support and the second needle support comprise a rack, and the driving mechanism is a pinion gear configured to drivably engage with each of the racks of the first needle support and the second needle support, respectively. However, Painchaud teaches each of the first needle support and the second needle support comprise a rack (Fig. 3, first and second rack elements 37,39), and the driving mechanism is a pinion gear (Fig. 3, pinion 41) configured to drivably engage with each of the racks of the first needle support and the second needle support, respectively (Fig. 3, [0053]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by the modified Arnitz to have a rack and pinion configuration as taught by Painchaud in order to push the pushing rod or needled from the initial position to the final position ([0053]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights