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 .
Acknowledgments
In the reply, filed on June 24, 2026, Applicant cancelled claims 1-8 and 26-27.
Applicant amended claims 9, 12-14, and 25.
Applicant added new claim 28.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 9-25) and Species III (Figures 32-39) in the reply filed on June 24, 2026, is acknowledged.
Information Disclosure Statement
The information disclosure statement filed January 6, 2025, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 8679070 has been provided with the incorrect name of patentee of Juerg et al. The correct name of patentee for US 8679070 is Clavadetscher et al. It is unclear whether Applicant is intending to cite US 8679070 or another document to Juerg et al
The citation for US 20120041387 has been provided with the incorrect name of patentee of Ulrich et al. The correct name of patentee for US 20120041387 is Bruggemann et al. It is unclear whether Applicant is intending to cite US 20120041387 or another document to Ulrich et al
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed January 6, 2025, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copy of CA 2839196 has been provided
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a first magnetic element” (claim 19, line 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The disclosure is objected to because of the following informalities:
The Cross-Reference to Related Applications section is missing a statement that the application is a 371 of PCT/US2022/040831, filed 08/19/2022, and priority to US 63/260,471, filed 08/20/2021.
Appropriate correction is required.
Claim Objections
Claims 21-23 and 25 are objected to because of the following informalities:
In regards to claim 21, line 3, “the disposable unit” should be changed to “the disposable portion”.
In regards to claim 22, line 2, “the disposable unit” should be changed to “the disposable portion”.
In regards to claim 23, line 2, “disposition” should be changed to “the disposition”.
In regards to claim 23, line 2, “the disposable unit” should be changed to “the disposable portion”.
In regards to claim 25, line 6, “wherein_upon” should be changed to “wherein upon”.
Appropriate correction is required.
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.
Claim 25 is 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.
In regards to claim 25, lines 2 and 6-7 recite “the syringe assembly”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 25, line 6 recites “the therapeutic agent”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 9-14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elahi et al (US 9,289,558).
In regards to claim 9, Elahi et al teaches a therapeutic agent delivery device (Figures 1-4), comprising:
a disposable portion (124), comprising:
a first housing (102)
a therapeutic agent container assembly (cartridge) carried by the first housing (column 7, lines 27-28), the therapeutic agent container assembly comprising:
a chamber comprising a passageway (chamber) (column 7, lines 28-29)
a needle (needle) in communication with the passageway (column 4, lines 27-31)
a reusable portion (122) is configured to detachably carry the disposable portion, the reusable portion comprising:
a second housing (110)
a securing mechanism (128) carried in the second housing
wherein one of the disposable portion and the securing mechanism comprises a track (128), the other of the disposable portion and the securing mechanism comprises a protrusion (126) being movable along the track, and wherein the securing mechanism is actuatable to move the protrusion along the track and thereby secure the disposable portion to the reusable portion (column 9, lines 5-9)
In regards to claim 10, Elahi et al teaches wherein the securing mechanism comprises a cylinder (108), the cylinder is configured to detachably receive the disposable portion and rotate relative to the second housing to actuate the securing mechanism and thereby secure the disposable portion to the reusable portion (column 8, lines 41-48).
In regards to claim 11, Elahi et al teaches wherein the therapeutic agent delivery device is elongated along a longitudinal axis extending between the disposable portion and the reusable portion, the cylinder is rotatable relative to the second housing about a securing rotation axis, the securing rotation axis being substantially parallel to the longitudinal axis (Figures 1-4).
In regards to claim 12, Elahi et al teaches wherein the cylinder is rotated relative to the second housing in a first instance to actuate the securing mechanism and thereby secure the disposable portion in the reusable portion (column 8, lines 41-48), and the cylinder is rotated relative to the second housing in a second instance to disengage the securing mechanism and thereby permit the disposable portion to be detached from the reusable portion (column 9, lines 52-56).
In regards to claim 13, Elahi et al teaches wherein the cylinder is rotated relative to the second housing in a first direction in the first instance (column 8, lines 41-48) and the cylinder is rotated relative to the second housing in the first direction in the second instance (108 is capable of being further rotated in the first direction).
In regards to claim 14, Elahi et al teaches wherein the cylinder is rotated relative to the second housing in a first direction in the first instance (column 8, lines 41-48) and the cylinder is rotated relative to the second housing in a second direction in the second instance, the second direction being opposite the first direction (108 is capable of being rotated in a second direction being opposite the first direction).
In regards to claim 16, Elahi et al teaches wherein the track comprises a helical portion (132) and a transverse portion (134) coupled to the helical portion, and the securing mechanism is actuatable to move the protrusion along the transverse portion of the track and thereby secure the disposable portion in the reusable portion (Figure 2).
In regards to claim 17, Elahi et al teaches wherein the securing mechanism is further actuatable to move the protrusion along the helical portion of the track and thereby permit the disposable portion to be detached from the reusable portion (Figure 4).
In regards to claim 18, Elahi et al teaches wherein the securing mechanism comprises the track and the disposable portion comprises the protrusion, the track is a securing track (134), the securing mechanism further comprises a leading track (132) fixed relative to the second housing, and the securing track is selectively alignable with the leading track to permit the protrusion to move from the leading track to the securing track (Figure 2).
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 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Elahi et al, as applied to claim 9 above, and further in view of Eich et al (US 2004/0178255).
In regards to claim 19, Elahi et al does not teach wherein the reusable portion further comprises a first magnetic element, the disposable portion further comprises a second magnetic element, the second magnetic element magnetically coupling with the first magnetic element to hold the disposable portion to the reusable portion. Eich et al teaches a therapeutic agent delivery device (Figures 1-3) wherein a reusable portion (6) further comprises a first magnetic element (3), a disposable portion (1) further comprises a second magnetic element (2), the second magnetic element magnetically coupling with the first magnetic element to hold the disposable portion to the reusable portion (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion and the disposable portion, of the device of Elahi et al, to comprise a first magnetic element and a second magnetic element, respectively, as taught by Eich et al, as such will allow for various types of disposable portions to be automatically recognized and differentiated by the reusable portion, and will minimize incorrect or erroneous recognition and/or use of disposable portions (paragraph [0007]).
In regards to claim 20, in the modified device of Elahi et al and Eich et al, Elahi et al does not teach wherein the second magnetic element magnetically couples with the first magnetic element to hold the disposable portion to the reusable portion before the securing mechanism secures the disposable portion in the reusable portion. Eich et al teaches wherein the second magnetic element magnetically couples with the first magnetic element to hold the disposable portion to the reusable portion before a securing mechanism (threads) secures the disposable portion in the reusable portion (Figure 1)(paragraph [0027]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second magnetic element, of the modified device of Elahi et al and Eich et al, to magnetically couple with the first magnetic element to hold the disposable portion to the reusable portion before the securing mechanism secures the disposable portion in the reusable portion, as taught by Eich et al, as such will allow for various types of disposable portions to be automatically recognized and differentiated by the reusable portion, and will minimize incorrect or erroneous recognition and/or use of disposable portions (paragraph [0007]).
In regards to claim 21, in the modified device of Elahi et al and Eich et al, Elahi et al does not teach wherein the reusable portion further comprises a sensor configured to detect the second magnetic element and thereby detect disposition of the disposable unit in the reusable portion. Eich et al teaches wherein the reusable portion further comprises a sensor (3) configured to detect the second magnetic element and thereby detect disposition of the disposable unit in the reusable portion (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion, of the modified device of Elahi et al and Eich et al, to further comprise a sensor, as taught by Eich et al, as such will allow for various types of disposable portions to be automatically recognized and differentiated by the reusable portion, and will minimize incorrect or erroneous recognition and/or use of disposable portions (paragraph [0007]).
In regards to claim 22, Elahi et al does not teach wherein the reusable portion further comprises a sensor configured to detect disposition of the disposable unit in the reusable portion. Eich et al teaches a therapeutic agent delivery device (Figures 1-3) wherein a reusable portion (6) further comprises a sensor (3) configured to detect disposition of a disposable unit (1) in the reusable portion (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable portion, of the device of Elahi et al, to further comprise a sensor, as taught by Eich et al, as such will allow for various types of disposable portions to be automatically recognized and differentiated by the reusable portion, and will minimize incorrect or erroneous recognition and/or use of disposable portions (paragraph [0007]).
In regards to claim 23, in the modified device of Elahi et al and Eich et al, Elahi et al does not teach wherein upon the sensor detecting disposition of the disposable unit in the reusable portion, the securing mechanism is actuated to move the protrusion relative to the track and thereby secure the disposable portion in the reusable portion. Eich et al teaches wherein upon the sensor detecting disposition of the disposable unit in the reusable portion, a securing mechanism (threads) is actuated to move a protrusion (of threads of 1) relative to a track (of threads of 6) and thereby secure the disposable portion in the reusable portion (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device, of Elahi et al and Eich et al, to upon the sensor detecting disposition of the disposable unit in the reusable portion, the securing mechanism is actuated to move the protrusion relative to the track and thereby secure the disposable portion in the reusable portion, as taught by Eich et al, as such will allow for various types of disposable portions to be automatically recognized and differentiated by the reusable portion, and will minimize incorrect or erroneous recognition and/or use of disposable portions (paragraph [0007]).
In regards to claim 24, in the modified device of Elahi et al and Eich et al, Elahi et al does not teach wherein the sensor is a magnetic field sensor. Eich et al teaches wherein the sensor is a magnetic field sensor (3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor, of the modified device of Elahi et al and Eich et al, to be a magnetic field sensor, as taught by Eich et al, as such will allow for various types of disposable portions to be automatically recognized and differentiated by the reusable portion, and will minimize incorrect or erroneous recognition and/or use of disposable portions (paragraph [0007]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Elahi et al, as applied to claim 9 above, and further in view of Adams et al (US 2012/0323177).
In regards to claim 25, Elahi et al teaches wherein the first housing comprises a distal end (Figure 4), the securing mechanism is configured to release the disposable portion and thereby permits the disposable portion to be detached from the reusable portion (Figure 4). However, Elahi et al is silent about the syringe assembly is translatable relative to the first housing from a stowed configuration to a deployed configuration and back to the stowed configuration, in the stowed configuration the needle being disposed proximally relative to the distal end of the first housing, in the deployed configuration the needle is at least partially extended distally from the distal end of the first housing and the therapeutic agent can be delivered, and wherein upon the syringe assembly is translated from the deployed configuration back to the stowed configuration. Adams et al teaches a therapeutic agent delivery device (Figures 1-19) wherein a first housing (50) comprises a distal end, a syringe assembly (110) is translatable relative to the first housing from a stowed configuration (Figures 14-16) to a deployed configuration (Figures 17-18) and back to the stowed configuration (Figure 19), in the stowed configuration a needle (114) being disposed proximally relative to the distal end of the first housing (Figures 14-16, 19), in the deployed configuration the needle is at least partially extended distally from the distal end of the first housing and a therapeutic agent can be delivered (Figures 17-18), and wherein upon the syringe assembly is translated from the deployed configuration back to the stowed configuration (Figures 17-19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe assembly, of the device of Elahi et al, to be translatable relative to the first housing from a stowed configuration to a deployed configuration and back to the stowed configuration, as taught by Adams et al, as such will provide the needle between a protected position and an injection position for delivering the therapeutic agent to a user (paragraphs [0070][0073]), wherein the protected position would prevent an accidental needlestick to the user.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 15, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a therapeutic agent delivery device, as claimed, specifically including wherein the securing mechanism further comprises a rotary actuator, the rotary actuator being actuatable to rotatably drive the cylinder relative to the second housing, the rotary actuator is configured to actuate the securing mechanism and whereby the disposable portion is secured to the reusable portion.
Elahi et al teaching a securing mechanism (128/108); however, Elahi et al does not teach wherein the securing mechanism further comprises a rotary actuator, the rotary actuator being actuatable to rotatably drive the cylinder relative to the second housing, the rotary actuator is configured to actuate the securing mechanism and whereby the disposable portion is secured to the reusable portion.
Thus, claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim 9 and intervening claim 10.
Claim 28 is allowed.
In regards to claim 28, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a therapeutic agent delivery device, as claimed, specifically including a rotary actuator, the rotary actuator actuatable to rotatably drive the cylinder relative to the second housing to secure the disposable portion to the reusable portion.
Elahi et al teaches a therapeutic agent delivery device (Figures 1-4), comprising:
a disposable portion (124), comprising a first housing (102), a therapeutic agent container assembly (cartridge) carried by the first housing (column 7, lines 27-28)
a reusable portion (122) is configured to detachably carry the disposable portion, the reusable portion comprising a second housing (110), a securing mechanism (128) carried in the second housing, a cylinder (108) configured to detachably receive the disposable portion and rotate relative to the second housing to actuate the securing mechanism and thereby secure the disposable portion to the reusable portion (column 8, lines 41-48)
wherein one of the disposable portion and the securing mechanism comprises a track (128), the other of the disposable portion and the securing mechanism comprises a protrusion (126) being movable along the track, and wherein the securing mechanism is actuatable to move the protrusion along the track and thereby secure the disposable portion to the reusable portion (column 9, lines 5-9)
Elahi et al does not teach a rotary actuator, the rotary actuator actuatable to rotatably drive the cylinder relative to the second housing to secure the disposable portion to the reusable portion.
Thus, claim 28 is allowed.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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