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 .
This is the first office action in response to the above identified patent application filed on 01/16/2024. Claims 1-11, 13-17, 38-46 and 48-56 are currently pending and being examined.
Drawings
The drawings are objected to because of the following problems:
In Figure 19, element 1424 should be 1429. Compare Figures 19 with Figures 18B and 20. For clarification, refer to marked-up figure 19 below. Reference numeral 1424 is not mentioned in the specification at all. Appropriate correction is required.
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In Figure 20, element 1425 should be 1423. Compare Figures 20 with Figures 18B and 19. For clarification, refer to marked-up figure 20 below. Appropriate correction is required.
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In Figure 18B, element 1455 and 1423 are pointing to the wrong elements. Compare Figures 18B with Figures 19 and 20. For clarification, refer to marked-up figure 18B below. Appropriate correction is required.
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Note: The drawings objections above are just some examples of the problems noticed by the examiner. Applicant should carefully review each and every figure for additional problems.
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 § 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 16, 17 and 44-46 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.
Claims 16 and 17 recites "The system of claim , wherein…." in line 1 respectively. It is presumed that claims 16 and 17 should read --The system of claim 14, wherein…-- for proper clarity and antecedent basis. Appropriate correction is required.
Claim 44 recites the limitation "the syringe flange holder" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 45 recites the limitation "the plunger retainer holder" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 46 depend from Claim 45 and are rejected accordingly.
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 38 is rejected under 35 U.S.C. 102a1 as being anticipated by O’Connor (US 2020/0197611).
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In regards to Independent Claim 1, and with particular reference to Figures 12-17 with marked-up figure 17 shown immediately above, O’Connor discloses a housing compartment (housing and housing compartment(s) shown in figure 12 but not labeled) for receiving a fluid filled syringe 310 and a needle assembly 314 to form a system 300 for intradermal or subdermal fluid delivery into a site injection (abstract states “to puncture a patient’s skin to deliver the therapeutic fluid”), the housing compartment comprising:
a flange holder system (316, 332),
a plunger retainer system (362, refer to marked-up figure 17), and
an actuator 350 of an injection mechanism that expels a controlled dose fluid (figure 15 showing fluid delivery at whatever preselected dosage of fluid in the syringe),
wherein the flange holder system comprises a movable flange holder 316 and a flange holder hard stop 322 and
the plunger retainer system comprises a moveable plunger retainer 362 and a plunger retainer hard stop (as shown in marked-up figure 17 above), and
wherein the flange holder 316 and the plunger retainer 362 are each movable (compare figures 14 and 15 showing the flange holder 316 and the plunger retainer 362 moving) in a proximal direction along a central axis of the housing compartment;
wherein actuation of the injection mechanism via the actuator 350 results in the flange holder 316 and the plunger retainer 361 moving in the proximal direction until the flange holder 316 contacts the flange holder hard stop 322 halting the proximal movement of the flange holder 316 (as shown in figure 15); and
wherein when the flange holder 316 contacts the flange holder hard stop 322 (as shown in figure 15), the plunger retainer 362 continues to move in the proximal direction until the plunger retainer 362 contacts the plunger retainer hard stop halting the proximal movement of the plunger retainer (as shown in figures 16 and 17).
Note: Applicant shall notice that simply affixing a name “flange holder, flange holder hard stop, plunger retainer, plunger retainer hard stop” to the claimed apparatus does not impose any structural limitations upon the claimed apparatus or serve to distinguish the invention from the prior art apparatus. By analogy, the structure shown by the prior art would not undergo a metamorphosis to a new apparatus by simply affixing a new/different name to any of its components. Therefore, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than by simply affixing a name.
Allowable Subject Matter
Claims 1-11, 13-15 and 50-56 are allowed.
Claims 16 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Claims 16 and 17 should be amendment to depend from claim 14.
Claims 39-43, 48 and 49 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
With respect to independent claim 1, the prior art of record does not teach in combination with the other claimed limitations of the independent claim(s) “ a fluid-filled syringe comprising a flange and a plunger, wherein the flange is situated within the flange holder and plunger is situated in the plunger retainer; wherein actuation of the injection mechanism via the actuator results in the flange holder and the plunger retainer moving in the proximal direction resulting in moving the fluid-filled syringe inclusive of the flange and the plunger, and the needle assembly in the proximal direction until the flange holder contacts the flange holder hard stop halting the proximal movement of the flange and the needle assembly; wherein when the flange holder contacts the flange holder hard stop, the plunger retainer continues to move in the proximal direction resulting in the plunger to continue to move in the proximal direction until the plunger retainer contacts the plunger retainer hard stop halting the proximal movement of the plunger; and wherein the continued proximal movement of the plunger after the halting of the proximal movement of the flange and the needle assembly results in expulsion of the controlled dose of fluid from the fluid-filled syringe via the needle of the needle assembly”.
With respect to independent claim 50, the prior art of record does not teach in combination with the other claimed limitations of the independent claim(s) “ a fluid-filled syringe comprising a flange and a plunger, wherein the flange is situated within the flange holder and plunger is situated in the plunger retainer; wherein actuation the actuator results in the flange holder and the plunger retainer moving in the proximal direction resulting in moving the fluid-filled syringe inclusive of the flange and the plunger, and the needle assembly in the proximal direction until the flange holder contacts the flange holder hard stop halting the proximal movement of the flange and the needle assembly, wherein movement of the flange holder in the proximal direction results in the needle of the needle assembly inserting into the site of injection at a particular depth; wherein when the flange holder contacts the flange holder hard stop, the plunger retainer continues to move in the proximal direction resulting in the plunger to continue to move in the proximal direction until the plunger retainer contacts the plunger retainer hard stop halting the proximal movement of the plunger; and wherein the continued proximal movement of the plunger after the halting of the proximal movement of the flange and the needle assembly results in the expulsion of a controlled dose of fluid from the fluid-filled syringe via the needle of the needle assembly”.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741