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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/5/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 8/5/2025. As directed by the amendment: claim 1 has been amended; claim 13 has been been cancelled; and claim 20 has been added. Thus, claims 1-2, 7-12, 15, and 20 are presently pending in this application.
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, the motor being associated with a base station that receives line power in claim 20 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.
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.
Claims 1-2, 7-8, 10-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’Antonio et al. (US 6056716 A1).
Regarding claim 1, D’Antonio discloses an apparatus (Fig. 2AA) comprising:
a needle free injector (Fig. 2AA) including:
a housing (220),
a chamber (122, Fig. 1A) in the housing (Fig. 2AA) for holding an injectate,
a nozzle (101) to discharge the injectate(Col 11, lines 37-39), the nozzle formed by an opening in the chamber (Fig. 1A),
a plunger (124) slidably disposed within the chamber (Figs. 2AA-2BB),
a spring (227) coupled between the plunger and the housing (Fig. 2AA), the spring being configured to apply a spring force to the plunger to discharge the injectate from the chamber through the nozzle (Col 11, lines 35-39), and
a controller (Figs. 3-4) configured by computer executable code to execute a reset mode including applying a resetting force to compress the spring such that mechanical energy is stored in the spring for use in discharging the injectate (Col 11, lines 57-60, Cols 16-17, lines 65-45, Cols 18-19, lines 55-33); and
a motor (221) engaged with the spring to apply the resetting force to compress the spring after the spring has applied the spring force to the plunger (Col 11, lines 14-21).
Regarding claim 2, D’Antonio discloses the apparatus of claim 1, wherein the motor is configured to generate a torque after having engaged the spring, the torque generating a corresponding force that resets the spring (Col 11, lines 14-21, Col 11, lines 35-39, Col 11, lines 57-60, Cols 16-17, lines 65-45, Cols 18-19, lines 55-33. Because the motor 221 causes rotation of shaft 222 in order to advance the ram 224, which would require generating a torque, which in turn would compress the spring, thus resetting the spring).
Regarding claim 7, D’Antonio discloses the apparatus of claim 1, wherein the controller is further configured by computer executable code to execute an injection mode wherein the spring applies a net force to drive the plunger at a target velocity (Col. 11, lines 14-43).
Regarding claim 8, D’Antonio discloses the apparatus of claim 7, wherein the controller is further configured to modulate the spring force with the motor to control the net force according to a target velocity profile (Col. 11, lines 14-43, Cols 16-17, lines 65-45).
Regarding claim 10, D’Antonio discloses the apparatus of claim 1, wherein the motor is an electric motor (221, Col 10, line 1).
Regarding claim 11, D’Antonio discloses the apparatus of claim 1, wherein the motor includes a rotary motor (Col 10, lines 1-17).
Regarding claim 12, D’Antonio discloses the apparatus of claim 1, wherein the spring is a helical spring (227, Fig. 2AA, Col 11, lines 16-17).
Regarding claim 15, D’Antonio discloses the apparatus of claim 1, wherein the controller is disposed in the housing (Cols. 9-10, lines 65-1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over D’Antonio et al. (US 6056716 A1) in view of Dixon (US 4722728 A).
Regarding claim 9, D’Antonio discloses the apparatus of claim 7, wherein the spring is a helical spring (Col 11, lines 16-17) that is configured to apply a linear force to the plunger (Col 11, lines 35-39), wherein the linear force provides a high initial pressure (Col 11, lines 39-42) for jet injection (Col 9, lines 63-65).
D’Antonio is silent regarding wherein the linear force is between two hundred newtons and three hundred newtons.
In analogous art, Dixon teaches a spring that generates an axial force of about 41kg-45kg (Col 2, lines 62-67, 41kg-45kg falls within the 200N-300N range).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the linear force of D’Antonio to incorporate the teachings of Dixon to incorporate being between two hundred newtons and three hundred newtons in order to minimize bruising of the skin and minimize discomfort during the injection (Col 2, lines 62-67).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over D’Antonio et al. (US 6056716 A1) in view of Landau et al. (US 20020151839 A1).
Regarding claim 20, D’Antonio discloses the apparatus of claim 1, but is silent regarding wherein the motor is associated with a base station that receives line power.
In analogous art, Landau teaches an apparatus (12), wherein the apparatus is associated with a base station (92) that receives line power (144, Paragraph [0047]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of D’Antonio to incorporate the teachings of Landau to incorporate a base station that receives line power in order to energize the apparatus/injection to prepare it for administering an injection (Abstract, Paragraph [0002]). The modification of D’Antonio in view of Landau would teach the motor being associated with the base station because the base station of Landau would receive the needle-free injector of D’Antonio, which includes the motor.
Response to Arguments
Applicant’s amendments to the claims have overcome the 112 rejections, however, upon further consideration, a new ground(s) of rejection is made in view of D’Antonio et al. (US 6056716 A1).
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783