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 .
Claims 1-23 are examined in this office action.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities:
In claim 8, “the piston mechanism comprises comprising” in line 1 should read “the piston mechanism comprises” or “the piston mechanism, comprising”
In claim 9, “further comprising and end-of-does (EOD) switch” in line 1 should read “further comprising an end-of-dose (EOD) switch”.
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 14 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.
Claim 14 recites the limitation "the at least one groove" in line 4. 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.
Claim(s) 1, 3, 5-7, and 10 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Scheurer (EP 4691515 A1).
Regarding claim 1, Scheurer discloses a system for delivering medicament (Fig. 1), comprising:
an external housing (second reservoir unit 2' and drive unit housing 101 Figs. 1&3);
a medicament container sled within the external housing (reservoir holder 205, Fig. 1);
a drive holder (drive unit housing 101, Fig. 3);
a medicament container (medicament reservoir 3', Fig. 5) comprising a plunger (bung 31', Fig. 5) and an internal volume to hold medicament (medicament reservoir 3', Fig. 5); and
a drive mechanism (drive housing 115 and threaded rod 114, Fig. 4);
wherein the drive mechanism is configured to enter the driver holder and to be securely retained in the drive holder ("The drive mechanics are contained in a drive housing 115 … which may be … snapped … in the drive unit housing 101." - Para [0034]).
Regarding claim 3, Scheurer discloses the system (Fig. 1), as recited above, wherein
the medicament container (reservoir holder 205, Fig. 1) is configured to enter the medicament container sled (housing of second reservoir unit 2', Fig. 1) and to be retained in the medicament container sled via a snap-fit mechanism on the medicament container sled ("… a reservoir holder 205, which is preferably … snapped or otherwise fixed onto said housing …" - Para [0034]).
Regarding claim 5, Scheurer discloses the system (Fig. 1), as recited above, wherein
the drive holder (drive unit housing 101, Fig. 3) is configured to engage the drive mechanism (drive housing 115 and threaded rod 114, Fig. 4) via a snap-fit connection ("The drive mechanics are contained in a drive housing 115 … which may be … snapped … in the drive unit housing 101." - Para [0040]).
Regarding claim 6, Scheurer discloses the system (Fig. 1), as recited above, wherein
the drive holder (drive unit housing 101 of drive unit 1, Fig. 3) is secured within the external housing (second reservoir unit 2', Fig. 1) with at least one of a threaded connector, a snap-fit connection, a friction-fit, a mechanical stop, or a welded connection ("On the proximal part of the housing 101, engagement means 108 are formed … that can engage counter engagement means 210, 210' of the first and second reservoir unit … forming a releasable snap connection." - Para [0039]).
Regarding claim 7, Scheurer discloses the system (Fig. 1), as recited above, wherein
the external housing (second reservoir unit 2' and drive unit housing 101 Figs. 1&3) comprises a long axis (See annotated Fig. 5) and a rear opening (See annotated Fig. 5), and wherein the medicament container sled (reservoir holder 205, Fig. 1) and drive holder (drive unit housing 101, Fig. 3) are aligned with the drive housing (drive housing 115, Fig. 4) and the rear opening (See annotated Fig. 5) such that the medicament container and drive mechanism can be inserted through the rear opening to assemble the system ("On the left side, convex guide wall 211' is formed, which helps the user guide the relative alignment between drive unit 1 and second reservoir unit 2' during attachment." - Para [0041]) ("On the right side, a chamber provides access for the medicament reservoir 3'" - Para [0041]).
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Regarding claim 10, Scheurer discloses the system (Fig. 1), as recited above, wherein the external housing comprises:
a top cover (See annotated Fig. 1); a bottom cover (See annotated Fig. 1); and an end cap (drive unit housing 101, Fig. 3).
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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.
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheurer (EP 4691515 A1) in view of Cowe et al. (US Pub No. 2022/0126021 A1).
Regarding claim 2, Scheurer in view of Cowe discloses the system (Scheurer, Fig. 1), as recited above wherein the drive mechanism (Scheurer, drive housing 115, Fig. 4) comprises:
a drive housing (Scheurer, drive housing 115, Fig. 4); and
a piston mechanism (Scheurer, threaded rod 114 and segmented plunger rod 116, Fig. 4).
Scheurer does not expressly disclose a drive release latch.
Cowe teaches a drive release latch (latch formation 426, Figs. 8A-8E).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Scheurer to include a drive release latch as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 8, Scheurer in view of Cowe discloses the system (Scheurer, Fig. 1), as recited above wherein
the piston mechanism (Scheurer, threaded rod 114 and segmented plunger rod 116, Fig. 4) comprises a driver outer sleeve (Scheurer, drive unit housing 115, Fig. 4).
Scheurer does not expressly disclose a detent.
Cowe teaches a detent (latch formation 426, Figs. 8A-8E).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Scheurer to include a detent as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheurer (EP 4691515 A1) in view of Sukhatme et al. (US Pub No. 20250135105 A1).
Regarding claim 4, Scheurer in view of Sukhatme discloses the system (Scheurer, Fig. 1), as recited above wherein
Scheurer does not expressly disclose that the medicament container sled is configured to move along a long axis of the system to engage the medicament container with a fluid path connector.
Sukhatme teaches that the medicament container sled (plunger holder 204, Fig. 7) is configured to move along a long axis of the system ("In operation, the plunger holder 204 can slide back and forth …" - Para [0048]) to engage the medicament container (fluid delivery device 600, Fig. 6) with a fluid path connector (fluid tube 602, Fig. 7).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Scheurer to include that the medicament container sled is configured to move along a long axis of the system to engage the medicament container with a fluid path connector as taught by Sukhatme for causing the fluid within the barrel 604 to be expelled (Sukhatme, Para [0061]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheurer (EP 4691515 A1) in view of Bazargan et al. (US Pub No. 2016/0367751 A1).
Regarding claim 9, Scheurer in view of Bazargan discloses the system (Scheurer, Fig. 1), as recited above further comprising
Scheurer does not expressly disclose an end-of-dose (EOD) switch assembly comprising an EOD switch and an EOD switch printed circuit board assembly (PCBA), wherein the EOD switch is mounted on the EOD switch PCBA.
Bazargan teaches an end-of-dose (EOD) switch assembly (switch contact pad 1096 and circuit board 1098, Fig. 34) comprising an EOD switch (switch contact pad 1096, Fig. 34) and an EOD switch printed circuit board assembly (PCBA) (circuit board 1098, Fig. 34), wherein the EOD switch is mounted on the EOD switch PCBA (as shown in Fig. 34).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Scheurer to include an end-of-dose (EOD) switch assembly comprising an EOD switch and an EOD switch printed circuit board assembly (PCBA), wherein the EOD switch is mounted on the EOD switch PCBA as taught by Bazargan to initiate an “end of reservoir” alert (Bazargan, Para [0217]).
Claim(s) 11and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US Patent No. 5080653) in view of Lin et al. (US Pub No. 20230146686 A1).
Regarding claim 11, Voss in view of Lin disclose a drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2), comprising:
a drive housing (Voss, syringe chamber 18, Fig. 2), wherein the drive housing comprises at least one ridge (Voss, keyhole seat 60, Fig. 3), at least one protrusion (Voss, pair of lock ribs 68, Fig. 7), and a pair of walls (Voss, opposite side walls 70, Fig. 7), and
a piston mechanism (Voss, piston plunger 28, Fig. 2) comprising a piston (Voss, piston plunger 28, Fig. 2), a drive outer sleeve (Voss, chamber 18, Fig. 2), and
wherein the drive mechanism is configured to fit into a drive holder of an external housing (Voss, "… lock the syringe barrel 20 in a first or normal position seated within the housing chamber 18 …" - Col. 4 Line 6).
Voss does not expressly disclose a drive release latch and a detent and wherein the pair of walls are configured to interact with the drive release latch.
Lin teaches a drive release latch (first claws 34 and second claws 33, Fig. 8) and a detent (limiting ring 6, Fig. 9) and wherein the pair of walls are configured to interact with the drive release latch (See annotated Fig. 8) ("… the first claws 34 are configured to clamp in the first groove 111 …" - Para [0072]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include a drive release latch, and wherein the pair of walls are configured to interact with the drive release latch as taught by Lin for separating the needle base 3 from the needle sleeve 1 (Lin, Para [0074]).
Regarding claim 13, Voss in view of Lin disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
the drive holder (Voss, syringe chamber 18, Fig. 2) comprises at least one snap-fit connector (Voss, "… carries the collar 54 to a tight, essentially snap-fit position seated between the chamber side walls 70." - Col. 5 Line 50) for securing the drive mechanism (Voss, syringe barrel 20, Fig. 2).
Regarding claim 14, Voss in view of Lin disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
upon inserting the drive mechanism (Voss, syringe barrel 20, Fig. 2) into the drive holder (Voss, syringe channel 18, Fig. 2), the drive mechanism is retained in the drive holder by mechanical stops (Voss, retainer key 52 and syringe channel 18, Figs. 2-7) formed by snapping the at least one ridge (Voss, keyhole seat 60, Fig. 3) into the at least one snap-fit (Voss, locater key 58, Fig. 5) and by sliding the at least one protrusion (Voss, pair of lock ribs 68, Fig. 7) into the at least one groove (Voss, notches 74, Fig. 7).
Regarding claim 15, Voss in view of Lin disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the pair of walls comprises first lock grooves and a second lock grooves, wherein the first lock grooves hold the drive release latch at an initial position, wherein the second lock grooves hold the drive release latch at an activated position.
Lin teaches that the pair of walls (See annotated Fig. 8) comprises first lock grooves (first groove 111, Fig. 8) and a second lock grooves (See annotated Fig. 8), wherein the first lock grooves hold the drive release latch at an initial position ("… the first claws 34 are configured to clamp in the first groove 111 …" - Para [0072]), wherein the second lock grooves hold the drive release latch at an activated position ("… after the completion of the injection, because the second claws 33 are locked on the position-limiting member … the first claws 34 slip out of the first groove 111 …" - Para [0074]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the pair of walls comprises first lock grooves and a second lock grooves, wherein the first lock grooves hold the drive release latch at an initial position, wherein the second lock grooves hold the drive release latch at an activated position as taught by Lin for separating the needle base 3 from the needle sleeve 1 (Lin, Para [0074]).
Claim(s) 12 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US Patent No. 5080653) in view of Lin et al. (US Pub No. 20230146686 A1) and in further view of Bazargan et al. (US Pub No. 2016/0367751 A1).
Regarding claim 12, Voss in view of Lin and Bazargan disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, further comprising:
Voss does not expressly disclose an end of dose (EOD) switch assembly.
Bazargan teaches an end of dose (EOD) switch assembly (switch contact pad 1096) (circuit board 1098, Fig. 34).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include an end of dose (EOD) switch assembly as taught by Bazargan to initiate an “end of reservoir” alert (Bazargan, Para [0217]).
Regarding claim 23, Voss in view of Lin and Bazargan disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the drive mechanism is configured to release the EOD switch assembly upon detecting when a delivery device is nearing an end of desired dose prior to when an end of dose occurs.
Bazargan teaches that the drive mechanism (stopper 1094, Fig. 34) is configured to release the EOD switch assembly (switch contact pad 1096) (circuit board 1098, Fig. 34) upon detecting when a delivery device is nearing an end of desired dose prior to when an end of dose occurs ("… if the switch 1082 is closed, the detection circuit determines that the fluid reservoir 1086 is at the "end of reservoir" state.").
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the drive mechanism is configured to release the EOD switch assembly upon detecting when a delivery device is nearing an end of desired dose prior to when an end of dose occurs as taught by Bazargan to initiate an “end of reservoir” alert (Bazargan, Para [0217]).
Claim(s) 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US Patent No. 5080653) in view of Lin et al. (US Pub No. 20230146686 A1) and in further view of Cowe et al. (US Pub No. 2022/0126021 A1).
Regarding claim 16, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the drive release latch faces a feature of a button sled through a window in the drive holder.
Cowe teaches that the drive release latch (hook 204, Fig. 5) faces a feature of a button sled (trigger button 150, Figs. 8A-8E) through a window in the drive holder (proximal end 112 of the housing body 102, Fig. 5).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the drive release latch faces a feature of a button sled through a window in the drive holder as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 17, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the drive release latch is configured to release the piston upon applying pressure onto the button sled.
Cowe teaches that the drive release latch (latch formation 426, Figs. 8A-8E) is configured to release the piston (piston member 404) ("… the firing pin 324 is shaped to cooperate with the latch formation 426 to release the piston member 404 for proximal movement …" - Para [0016]) upon applying pressure onto the button sled (trigger button 150, Figs. 8A-8F).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the drive release latch is configured to release the piston upon applying pressure onto the button sled as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 18, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that upon applying the pressure onto the button sled, the drive release latch moves from the initial position to the activated position.
Cowe teaches that upon applying the pressure onto the button sled (trigger button 150, Figs. 8A-8F), the drive release latch moves ("The firing pin 324 is shaped to displace the latch formation 426 towards the rear face of the device 100, bending the spring fingers 424, thereby to cause the latch formation 426 to disengage from the stop 299." - Para [0118]) from the initial position (fig. 8D) to the activated position (Fig. 8E).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that upon applying the pressure onto the button sled, the drive release latch moves from the initial position to the activated position as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 19, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the piston is released when the drive release latch is at the activated position. Cowe teaches that the piston is released when the drive release latch is at the activated position ("In this way the drive mechanism 400 of the device 100 is activated, and proximal movement of the piston member 404 under the load of the drive spring can take place." - Para [0118]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the piston is released when the drive release latch is at the activated position as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 20, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the piston is configured to move forward along an axis of the drive mechanism.
Cowe teaches that the piston (piston member 404, Figs. 8A-8E) is configured to move forward along an axis of the drive mechanism ("The drive spring applies a linear driving force to the piston member 404 to urge the piston member 404 along a drive axis …" - Para [0118]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the piston is configured to move forward along an axis of the drive mechanism as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 21, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that upon release, the piston moves forward along the axis to recover a gap between the piston and a plunger of a medicament container.
Cowe teaches that upon release, the piston moves forward along the axis ("The drive spring applies a linear driving force to the piston member 404 to urge the piston member 404 along a drive axis …" - Para [0118]) to recover a gap between the piston (piston member 404, Figs. 8A-8E) and a plunger (stopper 22, Figs. 8A-8E) of a medicament container (syringe 10, Figs. 8A-8E).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that upon release, the piston moves forward along the axis to recover a gap between the piston and a plunger of a medicament container as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Regarding claim 22, Voss in view of Lin and Cowe disclose the drive mechanism (Voss, syringe chamber 18 and piston plunger 28, Fig. 2) as recited above, wherein
Voss does not expressly disclose that the piston is configured to push a medicament container sled along the axis by interacting with the plunger.
Cowe teaches that the piston (piston member 404, Figs. 8A-8E) is configured to push a medicament container sled along the axis ("… the piston member 404 pushes the balls 406 around the guide track 408 … which contacts the shock absorber cup 430 … the shock absorber cup 430 pushes the stopper 22 of the syringe 10 distally to expel medicament …" - Para [0119]) by interacting with the plunger (stopper 22, Figs. 8A-8E).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drive mechanism of Voss to include that the piston is configured to push a medicament container sled along the axis by interacting with the plunger as taught by Cowe so that accidental operation of the device is prevented (Cowe, Para [0112]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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