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 .
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 4 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 4 recites that “the proximal end of the housing is displaceable relative to the distal end of the housing when a distally-directed force is applied by the user during drug delivery.”
This limitation is ambiguous. The plain language of the claim requires that the proximal end and distal end of the same housing are capable of moving axially relative to one another (i.e., that the housing itself is telescoping, collapsible, or otherwise variable in length when force is applied). However, the specification does not clearly describe or show such a structure. Instead, the specification describes a displaceable thumb pad (258) located at the proximal end of the housing, such that the thumb pad and/or proximal end 254 “is displaced distally” when force is applied (see Specification para [0042] and figs. 2-3. It is unclear whether the claim is attempting to recite a collapsible/telescoping housing or merely a movable thumb pad on an otherwise rigid housing.
For the purpose of interpretation, the Examiner considers that this limitation means the housing moves distally with respect to the syringe body (i.e., the plunger housing advances through the syringe barrel while dispensing medicine).
Appropriate action is required.
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 1-2, 4, 6-7, and 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rios (US Patent No. 10,269,266), hereinafter, Rios.
Regarding claim 1, Rios discloses a plunger device (plunger 1010 including plunger head 1012, and plunger shaft portion 1014 in figs. 10) for a drug delivery device (injection system 10 including injection syringe 1000 in figs. 10), comprising:
a plunger rod (plunger shaft portion 1014 in figs. 10) having a proximal end (thumb portion 1012 in fig. 1A) and a distal end configured to be attached to a stopper (distal end of plunger shaft portion 1014 is configured to be attached to piston in fig. 10);
at least one tracking element (resistance strip 1015 in fig. 10) operatively connected to an outer surface of the plunger rod (resistance strip 1015 connected to outer surface of plunger shaft 1014 in fig. 10), the at least one tracking element extending along a longitudinal axis of the plunger rod (resistance strip 1015 in fig. 10 extends along longitudinal axis of plunger shaft 1014 in fig. 10; col 18, lines 3-6);
at least one power supply (battery 1090 in fig. 10) operatively connected to the at least one tracking element (battery 1090 powers the Syringe Dose and Position Apparatus (SDPA) 1080 in fig. 10, which is electronically coupled to the spring-loaded contacts 1037 that engage resistance strip 1015 to complete the sensing circuit in fig. 10; col. 11, lines 32-34; col. 18, lines 11-20 and lines 56-60); and
at least one current sensing device (SDPA 1080 in fig. 10 monitors resistance readings between contacts 1037; col. 18, lines 56-60) operatively connected to the at least one power supply (battery 1090 in fig. 10 is operatively connected to printed circuit board 182 in fig. 3A via SDPA 1080 in fig. 10; col. 10, lines 59-60; ) and configured to detect an electrical contact established between the at least one tracking element (resistance strip 1015 in fig. 10) and a conductive element external to the plunger rod (spring-loaded contacts 1037 mounted on flange 1034 located external to plunger shaft portion 1014 in fig. 10; col. 18, lines 13-18).
Regarding claim 2, Rios discloses the plunger device of claim 1, wherein the plunger rod is configured to be used with a manual syringe (plunger 1010 has a thumb portion 1012 in fig. 10 for manual injection).
Regarding claim 4, Rios discloses the plunger device of claim 1, wherein the proximal end of the housing is displaceable relative to the distal end of the housing when a distally-directed force is applied by the user during drug delivery (plunger 1010 including thumb portion 1012 is configured to move relative to syringe body 1030 during drug delivery; col. 9, lines 44-46 and lines 49-55).
Regarding claim 6, Rios discloses the plunger device of claim 1, wherein the at least one tracking element is a conductive strip (resistance strip 1015 in fig. 10).
Regarding claim 7, Rios discloses the plunger device of claim 1, wherein the at least one power supply comprises a battery (battery 1090 in fig. 10).
Regarding claim 9, Rios discloses the plunger device of claim 1, wherein the at least one tracking element (resistance strip 1015 in fig. 10) extends from the proximal end of the plunger rod to the distal end of the plunger rod (resistance strip 1015 extends along longitudinal axis of plunger shaft portion 1014 to the distal end of plunger 1010; col 18, lines 3-6).
Regarding claim 10, Rios discloses the plunger device of claim 1, further comprising a communication interface (SDPA 1080 including wireless transmitter 193 and receiver 200 generally described in col. 11, lines 25-31; the SDPA is configured to transmit injection data to a remote device) for issuing a signal when the electrical contact has been established between the at least one tracking element (resistance strip 1015 in fig. 10) and the conductive element external to the plunger rod (spring-loaded contacts 1037 located external to plunger shaft portion 1014 in fig. 10; injection data is collected via sensor on plunger shaft portion 1014 and sent to receiver 200 via transmitter 193; col. 11, lines 25-31).
Regarding claim 11, Rios discloses a drug delivery device (injection system 10 including injection syringe 1000 in figs. 10) comprising: a proximal end (proximal end of injection syringe 1000);
a distal end (distal end of injection syringe 1000); and
a barrel (syringe body 1030 in fig. 10) therebetween defining an interior configured to receive a medicament (syringe body 1030 has a needle 1050 for containing injection material or medication in figs. 10; col. 9, lines 47-51), and the plunger device of claim 1 received at least partially within the interior (syringe 1000 has plunger 1010 and is configured to move within the interior of syringe body 1030; col. 9, lines 44-47).
Regarding claim 12, Rios discloses the drug delivery device of claim 11, further comprising a backstop operatively connected to a finger flange provided on the proximal end of the drug delivery device (flange 1034 is located on the proximal end of injection syringe 1000 in fig. 10; col. 10, lines 37-47), the backstop comprising the conductive element (spring-loaded contacts 1037 located external to plunger shaft portion 1014 in fig. 10) external to the plunger rod (flange 1034 is external to plunger shaft portion 1014 in fig. 10; col. 10, lines 37-47).
Regarding claim 13, Rios discloses the drug delivery device of claim 11, further comprising a ring (inner annular portion of flange 1034 is ring-shaped in fig. 10) operatively connected to the drug delivery device (injection system 10 including injection syringe 1000 in figs. 10) and configured to receive the plunger rod, the ring comprising the conductive element external to the plunger rod (spring-loaded contacts 1037 located external to plunger shaft portion 1014 in fig. 10; inner annular portion of flange 1034 encircles the plunger path and has a central opening through which the plunger shaft 1014 translates).
Regarding claim 14, Rios discloses a method of monitoring an injection procedure of a drug delivery device, comprising: providing a drug delivery device as recited in claim 11 (injection system 10 with injection syringe 1000 in figs. 10);
receiving, with the at least one current sensor device (SDPA 1080 in fig. 10 monitors resistance readings between contacts 1037; col 18, lines 56-60), a first signal indicating that the electrical contact between the at least one tracking element (resistance strip 1015 in fig. 10) and the conductive element external to the plunger rod has been established (when plunger shaft 1014 advances, resistance strip 1015 first touches spring-loaded contacts 1037, completes electrical circuit, and SDPA processors initiate closure; col 18. Lines 51-67);
transmitting, with at least one communication interface, the first signal to a remote device (controller receives signal from SDPA; col. 21, lines 37-39);
receiving, with the at least current sensing device (SDPA 1080 in fig. 10 monitors resistance readings between contacts 1037; col 18, lines 56-60), a second signal indicating a resistance of an electrical circuit (resistance of electrical circuit – SDPA processors continuously monitor readings between contact 1037; col. 19, lines 1-6) established between the at least one tracking element (resistance strip 1015 in fig. 10) and the conductive element to the plunger rod (spring-loaded contacts 1037 located external to plunger shaft portion 1014 in fig. 10); and
transmitting, with the at least one communication interface, the second signal to the remote device (controller receives signal from SDPA; col. 21, lines 37-39).
Regarding claim 15, Rios discloses the method of claim 14, wherein the at least one current sensing device (SDPA 1080 in fig. 10 monitors resistance readings between contacts 1037; col 18, line 51 – col. 19, line 6) is configured to receive signals of the resistance of the electrical circuit during the entire injection procedure (controller receives signal from SDPA; col. 21, lines 37-50).
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.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rios.
Regarding claim 5, Rios discloses the plunger device of claim 1 comprising at least one tracking element (resistance strip 1015 in fig. 10) positioned on the outer surface of the plunger rod (resistance strip 1015 on the outer surface of plunger shaft portion 1014 cooperates with two external contacts 1037 in fig. 10 that are located diametrically opposite each other; col. 18, lines 13-18).
Rios does not however, specify the plunger device comprising two tracking elements positioned opposite one another.
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 tracking element of Rios to comprise two tracking elements positioned on the outer surface of the plunger rod opposite one another, as suggested by the two diametrically opposed contacts 1037 already disclosed in Rios (fig. 10). Such a modification would provide redundant electrical contact paths, improve signal reliability, and ensure consistent circuit completion as the plunger advances. This is a simple and predictable design choice with no patentable result. See MPEP 2144.01(VI)(B) (Duplication of parts).
Regarding claim 8, Rios discloses the plunger device of claim 1, but fails to disclose, in the embodiment illustrated in fig. 10, the plunger device further comprising a force sensor configured to identify a pressure applied to the proximal end of the plunger rod.
Rios discloses, in an alternate embodiment, the plunger device further comprising a force sensor (force/pressure sensor 192; col. 10, lines 1-5) configured to identify a pressure applied to the proximal end of the plunger rod (force/pressure sensor 192; col. 10, lines 5-17).
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 plunger device of Rios to contain a force sensor configured to identify a pressure applied to the proximal end of the plunger rod, as described in an earlier embodiment of Rios in fig. 3A.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rios, as applied to claim 1 above, in view of Marcoz (WO Patent Publication No. 2021/094797), hereinafter, Marcoz.
Regarding claim 3, Rios discloses the plunger device of claim 1, wherein the proximal end of the plunger rod (thumb portion 1012 of plunger shaft portion 1014 in figs. 10) that comprises a proximal end configured to be contacted by a user’s thumb during drug delivery (plunger 1010 has a thumb portion 1012 in fig. 10 for manual injection).
Rios does not, however, disclose that the proximal end of the plunger rod comprises a housing comprising a proximal end and a distal end attached to the proximal end of the plunger rod, and a sidewall therebetween defining an interior.
Marcoz teaches that the proximal end of the plunger rod comprises a housing (Marcoz: cap of plunger head 15 houses the communications circuit unit; page 13, lines 7-8) comprising a proximal end and a distal end attached to the proximal end of the plunger rod, and a sidewall therebetween defining an interior (Marcoz: plunger body 9 has a plunger head 15 located at the proximal extremity 16 of said plunger body 9 in figs. 1-3; page 15, lines 23-26; peripheral annular wall 19 is located on plate 18 and extends proximally forming well 20 and encloses an interior space in figs. 1-3; page 15, line 27 – page 16, line 2).
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 proximal end of the plunger rod of Rios to comprise a housing with proximal and distal ends as well as side walls to define an interior, as taught by Marcoz, in order to house internal electronics and communication components while providing ergonomic thumb placement for a user during drug delivery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571)272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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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.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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