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 .
Response to Amendment
This office action is responsive to the amendment filed on 6/17/2026. As directed by the amendment: claim 1 has been amended; claim 20 has been cancelled; and no claims have been added. Thus, claims 1-2, 7-12, and 15 are presently pending in this application.
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 1-2, 7-12, and 15 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.
Claim 1, line 7 recites “the nozzle including a head that narrows to the opening”, however it is unclear how the nozzle can be formed by an opening in the chamber, as recited in lines 5-6, and have a head that narrows to that same opening. The specification discloses, in paragraph [0030], that the injector head 104 includes a chamber 106 and a nozzle at a distal end 110 of the chamber. It further discloses that the nozzle 108 includes a head 112 and an opening 114 and that the outer diameter of the head 112 of the nozzle 108 narrows to the opening 114. For purposes of examination, the examiner will interpret the claim as being “the nozzle including a head that narrows to an opening of the nozzle”.
Dependent claims are rejected by virtue of their dependency on the independent claims.
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.
Claims 1-2, 7-8, 10-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over D’Antonio et al. (US 6056716 A1) in view of Hein, Jr. (US 2635602 A).
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), and the nozzle including a head (Image 1) that narrows to an opening of the nozzle (Image 1),
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).
Image 1:
[AltContent: textbox (Opening)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Head)]
PNG
media_image1.png
551
530
media_image1.png
Greyscale
D’Antonio is silent regarding the nozzle with an inner diameter of 50 micrometers to 300 micrometers.
In analogous art, Hein, Jr. teaches a nozzle (19) with an inner diameter of 50 micrometers to 300 micrometers (Col 2, lines 28-32).
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 nozzle of D’Antonio to incorporate the teachings of Hein, Jr. to incorporate having an inner diameter of 50 micrometers to 300 micrometers in order to allow for liquid streams, when projected with sufficient velocity, to penetrate the epidermis and lodge in tissues underlying the same (Col 2, lines 28-32).
Regarding claim 2, D’Antonio in view of Hein, Jr. disclose 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, D’Antonio).
Regarding claim 7, D’Antonio in view of Hein, Jr. disclose 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, D’Antonio).
Regarding claim 8, D’Antonio in view of Hein, Jr. disclose 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, D’Antonio).
Regarding claim 10, D’Antonio in view of Hein, Jr. disclose the apparatus of claim 1, wherein the motor is an electric motor (221, Col 10, line 1, D’Antonio).
Regarding claim 11, D’Antonio in view of Hein, Jr. disclose the apparatus of claim 1, wherein the motor includes a rotary motor (Col 10, lines 1-17, D’Antonio).
Regarding claim 12, D’Antonio in view of Hein, Jr. disclose the apparatus of claim 1, wherein the spring is a helical spring (227, Fig. 2AA, Col 11, lines 16-17, D’Antonio).
Regarding claim 15, D’Antonio in view of Hein, Jr. disclose the apparatus of claim 1, wherein the controller is disposed in the housing (Cols. 9-10, lines 65-1, D’Antonio).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over D’Antonio et al. (US 6056716 A1) in view of Hein, Jr. (US 2635602 A) further in view of Dixon (US 4722728 A).
Regarding claim 9, D’Antonio in view of Hein, Jr. disclose the apparatus of claim 7, wherein the spring is a helical spring (Col 11, lines 16-17, D’Antonio) that is configured to apply a linear force to the plunger (Col 11, lines 35-39, D’Antonio), wherein the linear force provides a high initial pressure (Col 11, lines 39-42, D’Antonio) for jet injection (Col 9, lines 63-65, D’Antonio).
D’Antonio in view of Hein, Jr. are 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).
Response to Arguments
Applicant's amendment to claim 1 has overcome the 102 rejection however, upon further consideration, a new ground(s) of rejection is made in view of Hein, Jr. (US 2635602 A).
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 HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Thursday-Thursday 12-8 ET.
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, 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.
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.
/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights