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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on October 24, 2025 is acknowledged.
Claims 7-16 are withdrawn from further consideration by the Examiner pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 24, 2025. Applicant indicated claims 1-20 read on the elected species, however, features in claims 7-16 to the flange, nib, and needle engagement mechanism are found across the embodiments shown in non-elected Figs. 11-13.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 2210. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 11420. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to because in Fig. 11E 11420 has no line, Fig. 12A includes 11350 which should be 12350 and there is a line with no number. 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.
Specification
The disclosure is objected to because of the following informalities: [153] in line 6 there is no space between stopper and 11300.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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(s) 1-6 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlyon (US 2012/0220950 A1).
With regard to claims 1 and 2, Carlyon teaches a syringe comprising: a container for containing a primary fluid, the container comprising a proximal end and a distal end and having a distal end opening at the distal end (Fig. 5 container member 112, distal end 120, proximal end opposite); a stopper movably arranged within the container (Fig. 5 member 126), and a plunger engageable with the stopper and configured to apply a force to the stopper to move the stopper within the container (Fig. 5 member 124, see transition to Fig. 5A); wherein the stopper comprises at least one secondary fluid chamber configured to contain a secondary fluid and at least one fluid flow path for secondary fluid to exit the at least one secondary fluid chamber (Fig. 5 chamber 144, [0042] opening created when the distal end of the stopper is pierced); wherein the plunger is movably engageable with the stopper between a first engagement position and a second engagement position, wherein, when the plunger is in the first engagement position the plunger is configured to move the stopper towards the distal end of the container, to expel primary fluid from the container through the distal end opening (Fig. 5, [0041], [0042]); and wherein, when the plunger moves from the first engagement position to the second engagement position, at least a portion of the plunger enters into the at least one secondary fluid chamber in the stopper the plunger to expel secondary fluid from the at least one secondary fluid chamber through the fluid flow path towards the distal end opening, to expel at least a portion of a residual volume of primary fluid through the distal end opening (Fig. 5A, [0041], [0042], 142 is part of the plunger which moves further into the chamber in the stopper to dispense the secondary fluid which would also necessarily flush any residual volume).
With regard to claim 3, see [0042] and transition from Fig. 5 to Fig. 5A.
With regard to claims 4 and 5, the frangible shoulder is taken as the deformable member (Figs. 5 and 5A at 128).
With regard to claim 6, see Figs. 5 and 5A wall 126a of the stopper engages distal stop 162.
With regard to claim 17, Carlyon teaches a plunger system for a syringe, the plunger system comprising: a stopper (Fig. 5 member 126) configured to be movably arranged within a container of the syringe; and a plunger engageable with the stopper and configured to apply a force to the stopper to move the stopper within the container (Fig. 5 member 124, see transition to Fig. 5A), wherein the container is configured for containing a primary fluid, the container comprising a proximal end and a distal end and having a distal end opening at the distal end, wherein the stopper comprises at least one secondary fluid chamber configured to contain a secondary fluid and at least one fluid flow path for secondary fluid to exit the at least one secondary fluid chamber (Fig. 5 chamber 144, [0042] opening created when the distal end of the stopper is pierced) wherein the plunger is movably engageable with the stopper between a first engagement position and a second engagement position, wherein, when the plunger is in the first engagement position, the plunger is configured to move the stopper towards the distal end of the container, to expel primary fluid from the container through the distal end opening (Fig. 5, [0041], [0042]); and wherein, when the plunger moves from the first engagement position to the second engagement position, the plunger is configured to expel secondary fluid from the at least one secondary fluid chamber through the fluid flow path towards the distal end opening, to expel at least a portion of a residual volume of primary fluid through the distal end opening (Fig. 5A, [0041], [0042], 142 is part of the plunger which moves further into the chamber in the stopper to dispense the secondary fluid which would also necessarily flush any residual volume).
With regard to claim 18, Carlyon teaches a plunger system, the plunger system comprising: a stopper (Fig. 5 member 126); and a plunger engageable with the stopper and configured to apply a force to the stopper (Fig. 5 member 124, see transition to Fig. 5A), wherein stopper comprises at least one fluid chamber configured to contain a fluid (Fig. 5 chamber 144, [0042]); and wherein the plunger is configured to expel fluid from the at least one fluid chamber (see transition to Fig. 5A, [0041], [0042]).
With regard to claim 19, Carlyon teaches a method of expelling fluid from a syringe according claim 1, the method comprising: engaging the plunger with the stopper (Fig. 5 the plunger and stopper have necessarily been engaged); applying a first force to the plunger to at least partially transmit the first force to the stopper to move the stopper within the container towards the distal end of the container, expelling primary fluid from the container through the distal end opening Fig. 5, [0041], [0042]); and applying a second force to the plunger to expel secondary fluid from the at least one secondary fluid chamber towards the distal end opening, expelling a residual volume of primary fluid through the distal end opening (Fig. 5A, [0041], [0042], 142 is part of the plunger which moves further into the chamber in the stopper to dispense the secondary fluid which would also necessarily flush any residual volume).
With regard to claim 20, see [0042] and transition from Fig. 5 to Fig. 5A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 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, Kevin Sirmons can be reached at 571-272-4965. 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.
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783