DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 12/29/25 has been entered in the case. Claims 1-12 are pending for examination and claims 13-15 are cancelled.
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 3-6 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.
In claim 3, the limitation “a spring-located slotted member” is vague. The original specification does not clearly describe “a spring-loaded slotted member” that designated or being equivalent to any element number in the injector assembly. Examiner has to make a guessing game to find out which element is being equivalent to the claimed “spring-located slotted member”. In addition, it is unclear to Examiner that which element(s), i.e., 48, 50 or 36 is/are being referred to the claimed “spring-located slotted member”? Applicant is requested to clarify and amend the language that relevant or match to the original specification.
Claims 4-5 are rejected due to their dependency.
In claim 6, the limitation “one or more spacers disposed within the body…”is vague. The original specification does not clearly explain or provide enough evidence to support the claimed limitation “one or more spacers disposed within the body. In para [0037], it states that the adapter 200 may serve as a spacer device. However, the Figs. 4-5 shows that the space 200 is located outside of the body of the injector device. Therefore, it is unclear to Examiner that which element is designated for claimed “one or more spacers”.
Furthermore, in the independent claim 1, there are two recitations “body”, i.e., the body of a needle-free injector assembly (in line 3 of the claim 1), and the body of the rod (in line 14 of the claim 1). It is unclear to Examiner that the claimed “the body” being referred to the body/housing of the device or the body of the rod (as previously mentioned in the claim 1).
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-6 & 12 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Frost (US 3,625,208).
Regarding claim 1, Frost discloses a needle-free injection device 10 comprising:
a body 12 & 14 terminating in a nozzle 100;
a fluid reservoir 106 configured to be housed within the body 12 & 14, the fluid reservoir 106 being adapted to receive a fluid injectate;
a plunger 112 configured to be disposed within the fluid reservoir 106;
a shaft 114 to which the plunger 112 is configured to be mounted such that when the shaft 114 is driven forward, the plunger 112 is responsively driven forward;
a spring-driven propulsion system 42 having a first spring 76 (or 82 & 84) adapted configured to be to apply a bias force (when the level 24 in dotted lines that moves towards to the handle 18, see dotted lines in Fig. 1 & Fig. 4) to the shaft 114 and thus to the plunger to cause ejection of the fluid injectate through the nozzle;
a lever 24 adapted to arm the spring-driven propulsion system 42; and
a rod 58 configured to extend between the lever 24 and the shaft 114, the rod 58 further configured to transmit a load force between the lever 24 and the shaft 114 via a body of the rod so as to load the first spring 76 (or 82/84), wherein the load force (Fig. 1) is opposite the bias force (Fig. 4).
Another interpretation: alternatively, a first spring 82/84 is adapted to apply a bias force (in Fig. 4) to the shaft and thus to the plunger to cause ejection of the fluid injectate through the nozzle; a rod 58 configured to transmit a load force (Fig. 1) between the level 24 and the shaft via a body of the rod 58 so as to load the first spring 82/84, wherein the load force (the rod 58, the spring 82/84 as shown in Fig. 1) is opposite the bias force (the rod 58, the spring 82/84 as shown in Fig. 4).
Regarding claim 2, wherein the first spring 76 includes a first end (adjacent to element 60) and a second end (adjacent to element 68), wherein the first spring 76 is coupled to the lever 24 at the first end and coupled to the shaft at the second end (via elements 66 &62), and wherein expansion of the first spring 76 imparts the bias force to the plunger which forcibly propels the plunger towards the nozzle.
Another interpretation: wherein the first spring 82 includes a first end 78 and a second end 86/94, wherein the first spring 82 is coupled to the lever 24 (via element 42) at the first end 86/94 and coupled to the shaft at the second end (via elements 42, 66 & 58), and wherein expansion (in vertical direction) of the first spring imparts the bias force to the plunger which forcibly propels the plunger towards the nozzle.
Regarding claim 3, wherein a coupling 66 between the shaft and a second end of the rod comprises a spring-loaded slotted member 70.
Regarding claim 4, wherein tension on the rod 58 from the spring-loaded slotted member is adapted to bias the lever towards the home position.
Regarding claim 5, wherein the spring-loaded slotted member is adapted to control a degree of compression of the first spring.
Regarding claim 6, wherein the device further comprises one or more spacers 106 disposed within the body and adapted to modify the capacity of the fluid reservoir (when the plunger 112 moves forward for expelling drug).
Regarding claim 12, wherein the rod 58 is substantially axially aligned with the shaft 114 during application of the bias force to the shaft 114.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frost (US 3,625,208) in view Peterson (US 5,649,912).
Regarding claim 7, Frost discloses the invention substantially as claimed except of the limitation that the nozzle comprises a Luer taper that is adapted to receive a space component or vial adapter;
Peterson discloses a needle-less injector comprising: a reservoir 34 has a nozzle 42; wherein the nozzle 42 comprises a Luer taper 35 & 48 that is adapted to receive a space component 10 or vial adapter 10, in Fig. 1.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the nozzle of the reservoir of Frost with including a Luer taper, as taught by Peterson, in order to provide an ampule filling device for needle-free injection device.
Regarding claims 8-9, Frost discloses the invention substantially as claimed except of the limitations such as: a vial adapter that is adapted to be mounted to the nozzle, the vial adaptor comprising a spike connector adapted to provide a fluid path between a vial and the fluid reservoir; wherein the spike connector is removable.
Peterson discloses a needle-less injector comprising: a reservoir 34 has a nozzle 42; wherein the nozzle 42; a vial adapter 10 that is adapted to be mounted to the nozzle 42, the vial adaptor 10 comprising a spike connector 13 adapted to provide a fluid path between a vial 60 and the fluid reservoir 34; wherein the spike connector 13 is removable (from the reservoir 34).
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the needle-free injector device of Frost with including a nozzle including a Luer taper; a vial adapter, as taught by Peterson, in order to provide an ampule filling device for needle-free injection device.
Claims 8-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frost (US 3,625,208) in view Aoki et al. (US 4,936,841)
Regarding claims 8-11, Frost discloses the invention substantially as claimed except of the limitations such as: a vial adapter that is adapted to be mounted to the nozzle, the vial adaptor comprising a spike connector adapted to provide a fluid path between a vial and the fluid reservoir; wherein the spike connector is removable; wherein the spike connector includes a biased structure that extends into the vial adaptor, and which by exerting a pressure against the biased structure permits removal of the spike connector from the vial adaptor; wherein the vial adapter is adapted to function as a spacer device when the spike connector is removed.
Aoki discloses an adapter system 6 & 16 comprising: a vial adaptor 2 that is adapted to be mounted to a nozzle 11, the vial adaptor 2 comprising a spike connector 6 adapted to provide a fluid path (via a needle) between a vial 3 and the fluid reservoir 1; wherein the spike connector 6 is removable, see Fig. 11; wherein the spike connector 6 includes a biased structure 56 & 57 that extends into the vial adaptor 2, and which by exerting a pressure against the biased structure 56 & 57 permits removal of the spike connector 6 from the vial adaptor 2, see Fig. 11; wherein the vial adapter 2 is adapted to function as a spacer device when the spike connector is removed.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the needle-free injector device of Frost with including a vial adapter with spike connector, as taught by Aoki, in order to provide a fluid transfer in between the injection device and the vial.
Claims 1-12 is/are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Landau (US 2005/0209553)
Regarding claim 1, Landau discloses a needle-free injection device 20 in Figs. 1-13 comprising:
a body 30, 32 & 34 terminating in a nozzle 68;
a fluid reservoir 30 housed within the body, the fluid reservoir being adapted to receive a fluid injectate;
a plunger (a cone member attaches to element 64, or element 64) disposed within the fluid reservoir; a shaft 82 to which the plunger is mounted such that when the shaft 82 is driven forward, the plunger is responsively driven forward;
a spring-driven propulsion system 90 having a first spring 90 adapted to apply a bias force (as the cable/rod 10 is advanced within the housing 104, para [0031]) to the shaft 82 and thus to the plunger 64 to cause ejection of the fluid injectate through the nozzle, see Fig. 3;
a lever 28 adapted to arm the spring-driven propulsion system (via elements #84 & #86); and
a rod 100 extending between the lever 28 and the shaft 82,
Note: a cable 100 in Landau has similar structure and functions as the claimed “rod”. Therefore, the cable 100. In this case, a cable in Landau is analogous in structure and has similar function to the claimed “rod”. Therefore, the term cable and the rod are interchangeable and could be used in the injector assembly. Therefore, a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Thus, it is fair enough to call the cable 100 in Landau as a rod.
Wherein the rod 100 further configured to transmit a load force (shown in Fig. 2) between the level 28 and the shaft 82 via a body of the rod 100 so as to load the first spring 90, wherein the load force is opposite the bias force (Fig. 3). For example: the cable/rod 100 is in load force (in Fig. 1) between the level 28 and the shaft 82 via a body of the rod 100; when the foot pedal or lever 28 is release, the cable 100 is advanced within the housing 104, para [0031], at this point, the first spring 90 in bias force (in extends position) in forward direction (in Fig. 3), is opposite to the load force (Fig. 2), and cause the shaft 82 and the plunger 64 move in forward direction to cause ejection of the fluid injectable through the nozzle.
Regarding claim 2, wherein the first spring 90 includes a first end (near element 46) and a second end (near element 84), wherein the first spring 90 is coupled to the lever 28 (via elements 84, 86, 102 & the rod 100) at the first end and coupled to the shaft 82 at the second end (via elements 82, 84 & 86), and wherein expansion of the first spring imparts the bias force to the plunger which forcibly propels the plunger towards the nozzle, see Fig. 3.
Regarding claim 3, wherein a coupling (elements 82, 84 & 86) between the shaft and a second end 102 of the rod comprises a spring-loaded slotted member 140 (where is the ball 102 sits therein).
Regarding claim 4, wherein tension on the rod 100 from the spring-loaded slotted member 140 is adapted to bias the lever towards the home/initial position.
Regarding claim 5, wherein the spring-loaded slotted member 140 is adapted to control a degree of compression of the first spring 90.
Regarding claim 6, wherein the device further comprises one or more spacers 66 (at proximal portion of the space 66) disposed within the body and adapted to modify the capacity/volume of the fluid reservoir (when the plunger moves forward to expel the fluid out from the device).
Regarding claim 7, wherein the nozzle 68 comprises a Luer taper that is adapted to receive a spacer component 62 or vial adapter 150/240 (Figs. 6 & 9).
Regarding claim 8, further comprising a vial adapter 150 (Fig. 5) or 240 (Figs. 9-12) that is adapted to be mounted to the nozzle 68, the vial adapter 150/240 comprising a spike connector 164 (Fig. 5) or 244 (Figs. 9 & 12) adapted to provide a fluid path between a vial and the fluid reservoir.
Regarding claim 9, wherein the spike connector 164/244 is removable.
Regarding claim 10, wherein the spike connector 164 includes a biased structure 168/242 that extends into the vial adaptor, and which by exerting a pressure against the biased structure permits removal of the spike connector from the vial adaptor.
Regarding claim 11, wherein the vial adapter is adapted to function as a spacer device when the spike connector is removed.
Regarding claim 12, wherein the rod 100 is substantially axially aligned with the shaft 82 during application of the bias force to the shaft.
Claims 1-6 & 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hurschman et al. (US 3,797,488) in view of Van Der Gaast (US 3,782,380).
Regarding claim 1, Hurschman discloses an injection device 10 comprising:
Note: it is well-known in the art that the injection device 10 can be modified to be a needle-free injection device for less pain and less fear for patient.
a body 30 & 33 terminating in a nozzle 15;
a fluid reservoir 12 housed within the body 30 & 33, the fluid reservoir 12 being adapted to receive a fluid injectate;
a plunger 20 disposed within the fluid reservoir;
a shaft 47 to which the plunger 20 is mounted such that when the shaft 47 is driven forward, the plunger 20 is responsively driven forward;
a spring-driven propulsion system 48 having a first spring adapted to apply a bias force to the shaft and thus to the plunger 20 to cause ejection of the fluid injectate through the nozzle;
a lever 49 (including elements 52 & 53) adapted to arm the spring-driven propulsion system 48; and
a rod 57 extending between the lever 49 and the shaft 47, the rod 57 configured to transmit a load force between the lever 49 and the shaft 47 via a body of the rod so as to load the first spring 48, wherein the load force is opposite the bias force.
Hurschman does not disclose that the injection device is a needle-less injection.
Van Der Gaas discloses a needle-free injection device 10 comprising:
a body terminating in a nozzle; a fluid reservoir 14 housed within the body, the fluid reservoir being adapted to receive a fluid injectate; a plunger 36.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the fluid reservoir (or the injection device) of Hurschman with obtaining a needle-less injector, as taught by Van Der Gaas, in order to reduce pain and anxiety to a patient.
Evidence: Weston (US 5,891,086) states that the needle-less injector offers the possibility of less pain and tissue damage, col. 3, lines 22-23. Woodward (US 2010/0056554) states in para [0097] that a needle-less injector device may then be used to treat breakthrough pain attacks.
PNG
media_image1.png
377
609
media_image1.png
Greyscale
Regarding claim 2, wherein the first spring 48 includes a first end (near element 32 in Fig. 1) and a second end (adjacent to element 59 in Fig. 1), wherein the first spring 48 is coupled to the lever at the first end (via an axial bore 31 & pulley 53) and coupled to the shaft at the second end (via a head portion 46, in Figs.1-2), and wherein expansion of the first spring imparts the bias force to the plunger 20 which forcibly propels the plunger towards the nozzle.
Regarding claim 3, wherein a coupling 46 & 59 between the shaft 47 and a second end of the rod comprises a spring-loaded slotted member 59 (and/or 46 & pin 58).
Regarding claim 4, wherein tension on the rod 57 from the spring-loaded slotted member is adapted to bias the lever towards a home/initial position, see Fig.1.
Regarding claim 5, wherein the spring-loaded slotted member 59 (and/or 46 & 58) is adapted to control a degree of compression of the first spring.
Regarding claim 6, wherein the device further comprises one or more spacers (i.e., an interior space of the fluid reservoir) disposed within the body and adapted to modify the capacity of the fluid reservoir (when the plunger is moving forward for expelling a drug).
Regarding claim 12, wherein the rod 57 is substantially axially aligned with the shaft during application of the bias force to the shaft.
Claims 7-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hurschman et al. (US 3,797,488) in view of Van Der Gaast (US 3,782,380) and further in view Peterson (US 5,649,912).
Regarding claim 7, Hurschman in view of Van Der Gaast discloses the invention substantially as claimed except of the limitation that the nozzle comprises a Luer taper that is adapted to receive a space component or vial adapter;
Peterson discloses a needle-less injector comprising: a reservoir 34 has a nozzle 42; wherein the nozzle 42 comprises a Luer taper 35 & 48 that is adapted to receive a space component 10 or vial adapter 10, in Fig. 1.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the nozzle of the reservoir of Hurschman in view of Van Der Gaast with including a Luer taper, as taught by Peterson, in order to provide an ampule filling device for needle-free injection device.
Regarding claims 8-9, Hurschman in view of Van Der Gaast discloses the invention substantially as claimed except of the limitations such as: a vial adapter that is adapted to be mounted to the nozzle, the vial adaptor comprising a spike connector adapted to provide a fluid path between a vial and the fluid reservoir; wherein the spike connector is removable.
Peterson discloses a needle-less injector comprising: a reservoir 34 has a nozzle 42; wherein the nozzle 42; a vial adapter 10 that is adapted to be mounted to the nozzle 42, the vial adaptor 10 comprising a spike connector 13 adapted to provide a fluid path between a vial 60 and the fluid reservoir 34; wherein the spike connector 13 is removable (from the reservoir 34).
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the needle-free injector device of Hurschman in view of Van Der Gaast with including a nozzle including a Luer taper; a vial adapter, as taught by Peterson, in order to provide an ampule filling device for needle-free injection device.
Claims 8-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hurschman et al. (US 3,797,488) in view of Van Der Gaast (US 3,782,380) and further in view in view Aoki et al. (US 4,936,841)
Regarding claims 8-11, Hurschman in view of Van Der Gaast discloses the invention substantially as claimed except of the limitations such as: a vial adapter that is adapted to be mounted to the nozzle, the vial adaptor comprising a spike connector adapted to provide a fluid path between a vial and the fluid reservoir; wherein the spike connector is removable; wherein the spike connector includes a biased structure that extends into the vial adaptor, and which by exerting a pressure against the biased structure permits removal of the spike connector from the vial adaptor; wherein the vial adapter is adapted to function as a spacer device when the spike connector is removed.
Aoki discloses an adapter system 6 & 16 comprising: a vial adaptor 2 that is adapted to be mounted to a nozzle 11, the vial adaptor 2 comprising a spike connector 6 adapted to provide a fluid path (via a needle) between a vial 3 and the fluid reservoir 1; wherein the spike connector 6 is removable, see Fig. 11; wherein the spike connector 6 includes a biased structure 56 & 57 that extends into the vial adaptor 2, and which by exerting a pressure against the biased structure 56 & 57 permits removal of the spike connector 6 from the vial adaptor 2, see Fig. 11; wherein the vial adapter 2 is adapted to function as a spacer device when the spike connector is removed.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the needle-free injector device of Hurschman in view of Van Der Gaast with including a vial adapter with spike connector, as taught by Aoki, in order to provide a fluid transfer in between the injection device and the vial.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,045,911. Although the conflicting claims are not identical, they are not patentably distinct from each other because they are not structurally distinguishable from the claims in the patents.
Response to Arguments
Applicant's arguments filed 12/29/25 have been fully considered but they are not persuasive.
1) Applicant argues on pages 6-7 of the Remarks 12/29/25 that element 58 of Frost is not shown or described as “configured to transmit a load force between the level and the shaft via a body of the rod so as to load the first spring, wherein the load force is opposite the bias force.
In response, Frost states in col. 2, lines that: … circumposed about the rod 58 between the rear surface of the camming-and-abutment element 66 and the opposed surface of the rear wall 48 of the actuating bracket 42 is a compression spring 76 which serves the purpose of storing axially imposed energy during an initial portion pivotal movement of the actuator lever 24, and subsequently forcibly releasing and urging the actuating rod 58 axially downwardly, see FIG. 1, during operation of the device.
In other words, when the level 24 is compressed toward to a handle 18, a force (in between the level 24 and the shaft 114) is released and pushing the rod 58 axially downward/forward to the injection site. Therefore, the rod 58 is configured to transmit a load force (see Fig. 1) between the level 24 and the shaft 114 via a body of the rod 58 so as to load the first spring 76, wherein the load force is opposite the bias force (when the level moves towards to the handle 18, see dotted lines in Fig. 1 & Fig. 4).
Alternatively, a first spring 82/84 is adapted to apply a bias force (in Fig. 4) to the shaft and thus to the plunger to cause ejection of the fluid injectate through the nozzle; a rod 58 configured to transmit a load force (Fig. 1) between the level 24 and the shaft via a body of the rod 58 so as to load the first spring 82/84, wherein the load force (the rod 58, the spring 82/84 as shown in Fig. 1) is opposite the bias force (the rod 58, the spring 82/84 as shown in Fig. 4).
2) Applicant argues on page 8 of the Remarks 12/29/25 that element 100 in prior art Landau is described as a “cable” and not “a rod” that extends between the lever and the shaft, as recited in claim 1.
In response, a cable 100 in Landau has similar structure and functions as the claimed “rod”. Therefore, the cable 100. In this case, a cable in Landau is analogous in structure and has similar function to the claimed “rod”. Therefore, the term cable and the rod are interchangeable and could be used in the injector assembly. Therefore, a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Thus, it is fair enough to call the cable 100 in Landau as a rod.
3) Applicant argues that Landau’s cable is not described as a “rod configured to transmit a load force between the lever ad the shaft via a body of the rod so as to load the first spring”. Applicant further states that Landau does not disclose the feature of “a rod extending between the lever and the shaft, the rod configured to transmit a load force between he elver and the shaft via a body of the rod so as to load the first spring, wherein the load force is opposite the bias force”, as recited in claim 1.
In response, Landau clearly shows that the rod 100 further configured to transmit a load force (shown in Fig. 2) between the level 28 and the shaft 82 via a body of the rod 100 so as to load the first spring 90, wherein the load force is opposite the bias force (Fig. 3). For example: the cable/rod 100 is in load force (in Fig. 1) between the level 28 and the shaft 82 via a body of the rod 100; when the foot pedal or lever 28 is release, the cable 100 is advanced within the housing 104, para [0031], at this point, the first spring 90 in bias force (in extends position) in forward direction (in Fig. 3), is opposite to the load force (Fig. 2), and cause the shaft 82 and the plunger 64 move in forward direction to cause ejection of the fluid injectable through the nozzle.
3) Applicant argues that the office action does not provide any documentary evidence that it is well-known in the art that the injection can be modified to be a needle-free injection device for less pain and less fear for patient.
In response, Examiner would like to submit the evidence below (prior art Weston and Woodward) to support the statement that the needle-less provides less pain and less fear for patient. Weston (US 5,891,086) states that the needle-less injector offers the possibility of less pain and tissue damage, col. 3, lines 22-23. Woodward (US 2010/0056554) states in para [0097] that a needle-less injector device may then be used to treat breakthrough pain attacks.
With common sense in the needle-less injector is providing benefits of less pain and less fear factor for patient, therefore, a person skilled in the art would recognize that the needle injector in Hurschman can be provided as a needle-less injector, as taught by Van Der Gaas, in order to reduce pain and anxiety to a patient.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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.
/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783