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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/8/2026 – requesting the Reply filed 4/1/2026 be entered – has been entered.
Claim Status
Claim 3 has been provided with the status indicator of “Withdrawn”, but it should be provided with the status indication of “Original” since it reads on the elected invention. For the sake of examination, claim 3 is not withdrawn from consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: The term “barrel” should be inserted between the terms “the” and “interior” on line 5 to match the language used throughout the rest of the claim. The punctuation used throughout the claim is incorrect and the following amendments should be made: the comma on line 2, the first comma on line 3, the comma on line 18, the comma on line 31, the comma on line 32, the comma on line 34, and the comma on line 35 should be removed; a comma should be inserted after the term “closed” on line 30 and after the term “open” on line 33. The term “a” should be inserted before the term “volume” on lines 23 and 28 in order to be grammatically correct. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The term “the” in the phrase “the proximal end” on line 2 should be replaced with the term “a” since this is the first time that a proximal end of the primary plunger is being introduced. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite that “the outlet lumen comprises channels”. However, this limitation is not supported by the original disclosure because, although the disclosure supports channels 67 being present, they are not disclosed in the Specification or shown in the Drawings as being a feature of the outlet lumen 32. Rather, paragraph 50 of the Specification – the only location where the channels are discussed – states “a variable volume, annular-shaped, primary chamber 66 […] is in fluid communication with the outlet lumen 32, via channels 67”, and “isolating the primary chamber 66 from the channels 67 and the outlet lumen 32” and Fig 1 – the only figure that labels the channels 67 – shows then to be located on the barrel’s distal end 28. Based on this, the disclosure does not support the channels being a component of the outlet lumen as now claimed. Accordingly, this limitation constitutes new matter. Claims 3-5 and 20 are rejected due to their dependence on claim 1.
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.
Claim 5 is 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 5 recites that “an inner surface of the distal end of the secondary chamber” setting forth that the “secondary chamber” is a structure. However, claim 1 defines the “primary fluid chamber” as being “within the barrel interior”, setting forth that it is a space formed by a structure, not a structure itself. Based on this definition of the “primary fluid chamber” in claim 1, one of ordinary skill in the art would interpret the “secondary fluid chamber” as being a space formed by a structure, not a structure itself. Because the “fluid chamber” appears to be a space in claim 1 and a structure in claim 5, it is unclear as to how to interpret claim 5 for the sake of examination. For the sake of examination, the ”secondary chamber” is interpreted as being the space within a structure. Accordingly, it is suggested to amend claim 5 to recite “further comprising an inner barrel forming the secondary fluid chamber, the inner barrel including an inner surface that defines a seating surface” and to amend line 5 to refer to “the substantially cylindrically shaped barrel” instead of “the barrel” so as to avoid any antecedent basis issues resulting from the suggested amendment. .
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (PG PUB 2012/0197232) in view of Casiello et al. (PG PUB 2016/0030708).
Re claim 1, Lee discloses a syringe (as seen in Fig 18A; it is noted that all reference characters cited below refer to Fig 18A unless otherwise noted) comprising: a substantially cylindrically shaped barrel 10, which defines an inner side wall (labeled in annotated Fig A below), the barrel having an open proximal end (directed upward inn Fig 18A), and a distal end (directed downward in Fig 18A), the distal end of the barrel including a connector 20 (seen in Fig 18A but not labeled; labeled in Fig 1) defining an outlet lumen 22 (seen in Fig 18A but not labeled; labeled in Fig 1) therethrough, the outlet lumen in fluid communication with an interior of the barrel (as seen in Fig 18A), the interior defined by the open proximal end, the distal end, and the inner side wall (as seen in Fig 18A); nested primary and secondary plungers 30,60, disposed within the barrel interior (although Fig 18A only shows the primary plunger 30 within the barrel interior, one of ordinary skill in the art would recognize that secondary plunger 30 would also be disposed within the barrel interior once depressed), respectively having primary and secondary plunger rods (the body of 30 itself, the body of 60 itself) capable of selective translation within the barrel interior along a common axis (extending vertically in Fig 18A) (Para 73,77); a primary stopper (labeled in annotated Fig A below) coupled to a distal end (directed downward in Fig 18A) of the primary plunger (as seen in Fig 18A), the primary stopper having a proximal end surface (facing upward in Fig 18A) facing the proximal end of the barrel and a distal end surface (facing downward in Fig 18A) facing the distal end of the barrel, the primary stopper defining a through aperture (though which projection 42 (labeled in Fig 1) extends in Fig 18A) between its proximal and distal end surfaces (as seen in Fig 18A), in fluid communication with the outlet lumen (as seen in Fig 18A); a secondary stopper (labeled in annotated Fig A below) coupled to a distal end (directed downward in Fig 18A) of the secondary plunger (as seen in Fig 18A), the secondary stopper having a distal end surface (facing downward in Fig 18a) facing the distal end of the barrel (as seen in Fig 18A); a resealable valve 1800 disposed within the barrel interior, axially offset, along the common axis, toward the distal end of the barrel away from the distal end surface of the secondary stopper (as seen in Fig 18A), the resealable valve having an inlet (directed upward in Fig 18A) in fluid communication with the distal end surface of the secondary stopper (Para 95) and an outlet (directed downward in Fig 18A) in fluid communication with the outlet lumen (Para 95); a primary fluid chamber (within which fluid 20 is held in Fig 18A) within the barrel interior, defined between the distal end surface of the primary stopper and the distal end of the barrel (as seen in Fig 18A), volume of the primary fluid chamber being selectively variable by translation of the primary plunger rod (Para 73); a secondary fluid chamber (within which fluid 20 is held in Fig 18A) that is nested within the primary fluid chamber in radially spaced relationship (the secondary fluid chamber is formed by the interior surface of the body 30; therefore, it is radially spaced from the first chamber by the thickness of the wall of body 30, as seen in Fig 18A), defined between the distal end surface of the secondary stopper and the valve inlet, in fluid communication with the valve inlet (as seen in Fig 18A), volume of the secondary fluid chamber being selectively variable by translation of the secondary plunger rod (Para 77); wherein, when the valve is closed the secondary fluid chamber is isolated from the outlet lumen, so that translation of the primary plunger rod only aspirates fluid into or dispenses fluid out of the primary chamber, via the outlet lumen (Para 96); and wherein, when the valve is open the secondary fluid chamber is fluid communication with the outlet lumen, so that translation of the secondary plunger rod dispenses fluid out of the secondary chamber, via the outlet lumen (Para 96). Lee does not disclose that the outlet lumen comprises channels configured to aspirate fluid into or dispense fluid out of the primary fluid chamber. Casiello, however, teaches a syringe 110 (Fig 12, with Fig 13 showing a detailed view of the distal end of the syringe 110; it is noted that all reference characters cited below refer to Fig 12,13 unless otherwise noted) comprising a substantially cylindrically shaped barrel 113 defining an inner side wall (the cylindrical wall forming the barrel 113) forming a fluid chamber (the space within the barrel 113) and a connector (the tip structure defining lumen 122 in Fig 13) defining an outlet lumen 122 that comprises channels (Para 39 states that “the lumen 122 at the distal end of the syringe is rifled to initiate the spiral flow”; the space between the rifles are “channels”) configured to aspirate fluid into or dispense fluid out of the fluid chamber (Para 39) for the purpose of creating a spiral flow so that the syringe can be used to deliver high pressured and high flow rated fluid (Para 29). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lee to include the outlet lumen with channels, as taught by Casiello, for the purpose of creating a spiral flow that allows the syringe to be used with high pressured and high flow rated fluid (Para 29).
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Re claim 3, Lee discloses the valve comprising a duckbill valve (Para 97).
Re claim 4, Lee discloses an inner surface (labeled in annotated Fig A above) of the distal end of the barrel defines a seating surface for abutting engagement with the distal end surface of the primary stopper when the primary stopper is completely advanced within the barrel, thereby isolating the primary chamber from the outlet lumen and the outlet of the valve (due to the matching shapes of the inner surface and the distal face of the primary stopper, as seen in Fig 18A).
Re claim 5, Lee discloses an inner surface (labeled in annotated Fig A above) of the distal end of the secondary chamber defines a seating surface for abutting engagement with the distal end surface of the secondary stopper when the secondary stopper is completely advanced within the barrel, thereby isolating the secondary chamber from the outlet lumen and the outlet of the valve (due to the matching shapes of the inner surface and the distal face of the secondary stopper, as seen in Fig 18A).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (PG PUB 2012/0197232)/Casiello et al. (PG PUB 2016/0030708) in view of Kapelowitz (US Pat 3,680,558).
Re claim 20, Lee/Casiello discloses all the claimed features except that the primary plunger comprises a flange at a proximal end. Kapelowitz, however, teaches a substantially similar syringe 10 (Fig 1-4; it is noted that all reference characters cited below refer to Fig 1-4) comprising a barrel 12, a primary plunger 18+28 with a rod 18 and a stopper 28, and a secondary plunger (40 + the stopper labeled in Fig B below) with a rod 40 and a stopper (labeled in Fig B below) nested within the primary plunger, wherein the primary plunger includes a flange 20 at a distal end thereof (as seen in Fig 1-4) for the purpose of aiding in allowing a user to operate the primary plunger (Col 3, Lines 33-34). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lee/Casiello to include the primary plunger with a flange at a proximal end, as taught by Kapelowitz, for the purpose of aiding in allowing a user to operate the primary plunger (Col 3, Lines 33-34).
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Double Patenting
The non-statutory double patenting rejection set forth in the last Office Action is withdrawn as the amendments filed 4/1/2026 differentiate the present claims from the co-pending claims of application no. 18/071,893.
Response to Arguments
Applicant's arguments filed 4/1/2026 have been fully considered.
Applicant’s argument that element 30 of Lee is not a “plunger” because (a) it lacks flanges or a thumb press and (b) a user cannot make contact with element 30 when it is fully displaced within barrel 10, the Examiner respectfully disagrees as the definition of a plunger does not require flanges or a thumb press, nor does it require the user be able to make contact therewith when it is fully displaced within a barrel – rather, the broadest reasonable interpretation of a “plunger” is “a device (as a piston in a pump) that acts with a plunging motion”1. Therefore, this argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 “plunger”. Merriam-Webster Online Dictionary.<<https://www.merriam-webster.com/dictionary/plunger>>
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