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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 11/03/2025. Claims 1-20 are currently pending and being examined.
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 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.
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 with traverse in the reply filed on 11/03/2025.
In reference to applicant’s argument that “These are not separate inventions but rather design choices within a single inventive concept.” Examiner respectfully disagrees the these are clearly separate inventions. If they were not separate inventions then the examiner could reject one embodiment with nothing more than a piece of prior art identical to one of applicant’s other embodiments. Hypothetically no attorney would accept a rejection of fig 7 with piece of art identical to fig 13, such a rejection would not be accepted by applicant and USPTO operating procedures. Furthermore the abundance of claims, features, and embodiments are clearly an examination burden, as previously stated in the Requirement for Restriction mailed 09/03/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “said first volume” in line 8. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said first adjustable volume”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 recites “said primary chamber” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said primary fluid chamber”. Appropriate correction is required.
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 “first volume is in fluid communication with said primary fluid chamber” 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 § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Haber (USPN 5,298,023) in view of Lynn (USPN 5,743,886).
In reference to independent claim 1, Haber discloses an apparatus for regulating fluid flow rate from a fluid dispensing device (fig 31) comprising:
a) a primary fluid chamber (654, fig 31b);
b) an outlet (needle assembly 451) in fluid communication with said primary fluid chamber (654, fig 31b);
c) a pump member (464, 514, 512, and 506) for displacing fluid from said primary fluid chamber (654) through said outlet (451);
d) a secondary chamber (520-496 and 510);
e) a dividing member (500) movably disposed in said secondary chamber (end of 510);
f) a first adjustable volume (520 and 496) on a first side of said dividing member (below 500), wherein and
g) a second adjustable volume (510) on a second side of said dividing member (500); wherein said dividing member (500) moves to increase said first adjustable volume (520 and 496) when fluid displaced through said outlet exceeds a predetermined flow rate (when the flow rate is too high it indicates the pressure to high which moves the plate up against the spring 504), however
Haber does not teach said first volume is in fluid communication with said primary fluid chamber.
Lynn, a similar syringe, teaches a first volume (66, fig 6C) is in fluid communication with said primary fluid chamber (primary fluid chamber 68, col 15 lines 21-29 disclose “When the injection of the fluid within the secondary reservoir 68 is complete, the divider piston 58 has reached the venting position and engages the seats 109. At this point, further advancement of the piston 38 causes the saline solution in the primary reservoir 66 to flow through the slots 104 and through the flush flow space 116 to flush around the lower face 59 of the divider piston 58 and out the distal conduit 18 and to flush the deadspace of the intravenous tubing and catheter with saline.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the slots 104 of Lynn in the apparatus of Haber “to specifically allow the aspiration of a capacitance storage volume of a flush volume, which can later be used to flush the deadspace of the reservoir and the deadspace of a tubing system and catheter” col 4, lines 28-31; Lynn.
In reference to dependent claim 6, Haber discloses a fluid flow rate regulating syringe comprising:
a) a barrel (494, fig 31) defining an inner chamber (654);
b) an outlet (needle assembly 451) in fluid communication with said inner chamber of said barrel (when the needle assembly is extended it is fed by 654);
c) a plunger (464, 514, 512, and 506) movably disposed in said barrel for displacing fluid through said outlet (col 16, lines 67-5 discloses “A needle assembly 451, assuming one is not already mounted to assembly 428, is then mounted to septum cap 446. The injection is then given by pressing on accumulator stem assembly 494 in distal direction 524, thereby forcing accumulator piston 464 in distal direction 524 to expulse the mixed pharmaceutical.”);
d) a secondary chamber (520-496 and 510);
e) a dividing member (500) movably disposed in said secondary chamber (520-496 and 510);
f) a first adjustable volume (beneath 500) on a first side of said dividing member (500); and
g) a second adjustable volume on a second side (above 500) of said dividing member (500); wherein said dividing member moves to increase said first adjustable volume when fluid displaced through said outlet exceeds a predetermined flow rate (when the flow rate is too high it indicates the pressure to high which moves the plate up against the spring 504).
Haber does not teach said first volume is in fluid communication with said primary fluid chamber.
Lynn, a similar syringe, teaches a first volume (66, fig 6C) is in fluid communication with said primary fluid chamber (primary fluid chamber 68, col 15 lines 21-29 disclose “When the injection of the fluid within the secondary reservoir 68 is complete, the divider piston 58 has reached the venting position and engages the seats 109. At this point, further advancement of the piston 38 causes the saline solution in the primary reservoir 66 to flow through the slots 104 and through the flush flow space 116 to flush around the lower face 59 of the divider piston 58 and out the distal conduit 18 and to flush the deadspace of the intravenous tubing and catheter with saline.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the slots 104 of Lynn in the apparatus of Haber “to specifically allow the aspiration of a capacitance storage volume of a flush volume, which can later be used to flush the deadspace of the reservoir and the deadspace of a tubing system and catheter” col 4, lines 28-31; Lynn.
In reference to dependent claim 2, Haber in view of Lynn discloses the apparatus of claim 1, Haber discloses the apparatus further comprising a biasing member (504) for resisting movement of said dividing member (500).
In reference to dependent claim 3, Haber in view of Lynn discloses the apparatus of claim 2, Haber discloses the apparatus wherein said biasing member comprises a constant force compression spring (504 is a spring, see fig 31a).
In reference to dependent claim 4, Haber in view of Lynn discloses the apparatus of claim 1, Haber discloses the apparatus wherein said fluid dispensing device comprises a syringe (first line of abstract states “A multiple pharmaceutical syringe”).
In reference to dependent claim 5, Haber in view of Lynn discloses the apparatus of claim 1, Haber discloses the apparatus further comprising a flow restriction (channel that connects 464 to 451) disposed between said primary chamber (654) and said outlet (needle of 451).
In reference to dependent claim 7, Haber in view of Lynn discloses the fluid regulating syringe of claim 6, Haber discloses the apparatus further comprising a biasing member (504) for resisting movement of said dividing member (500).
In reference to dependent claim 8, Haber in view of Lynn discloses the fluid regulating syringe of claim 7, Haber discloses the apparatus wherein said biasing member (504) comprises a constant force compression spring (504 is a spring, see fig 31a).
In reference to dependent claim 9, Haber in view of Lynn discloses the fluid regulating syringe of claim 6, Haber discloses the apparatus further comprising a flow restriction (channel that connects 464 to 451) disposed between said inner chamber of said barrel (654) and said outlet (needle of 451).
In reference to dependent claim 10, Haber in view of Lynn discloses the fluid regulating syringe of claim 6, Haber discloses the apparatus wherein said secondary chamber (520-496 and 510) is disposed within said plunger (464, 514, 512, and 506).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bottger (USPAP 2011/0092906) discloses a multiple chamber device.
Thorne (USPN 7,789,862) discloses a sequential dispensing system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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.
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/C.W.N/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783