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 .
Claim Objections
Claim 1 is objected to because of the following informalities: The term “the” In the phrase “the interior” on line 8 should be replaced with the term “an” since this is the first time this feature is being introduced. The term “circumscribes” on line 14 should be replaced with the term “circumscribing” in order to be grammatically correct. The phrase “the proximal end” on line 17 should be amended to recite “the open proximal end” to match the language used in the rest of the claim. The comma on line 19 should be removed in order to be grammatically correct. The commas surrounding the phrase “axially offset” on lines 23-24 should be removed in order to be grammatically correct. The phrase “the secondary fluid chamber” should be inserted after the comma on line 37 in order to be grammatically correct. The phrase “the valve inlet” on line 38 should be amended to recite “the inlet of the valve . Appropriate correction is required.
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, 3-5 and 20 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 recites “the inner side wall” on line 9, but this phrase lacks proper antecedent basis because it is unclear if this phrase refers to the “inner side wall” of the outer barrel (introduced on lines 2-3) or the “inner side wall” of the inner barrel (introduced on line 8). For the sake of examination, it is interpreted as referring to that of the inner barrel.
Claim 1 recites that the outer barrel defines “an inner side wall” and the inner barrel has “an inner and outer side walls”. Because the claim has been amended to recite that the outer barrel surrounds the inner barrel, it is unclear how the side wall of the outer barrel can be an “inner” side wall. Additionally, the drawings disclose the inner barrel only having one side wall, not both an inner side wall and an outer side wall. Because of this, it appears that Applicant has acted as their own lexicographer to define the term “wall” contrary to its ordinary meaning – which is a structure having surfaces – to actually mean “surface”. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term.1 Therefore, the term “wall” is indefinite because the specification does not clearly redefine the term.
For the sake of examination, the “inner side wall” of the outer barrel is interpreted as being “a side wall having an inner surface” and the “inner and outer side walls” of the inner barrel is interpreted as being “a side wall having an inner surface and an outer surface”. Specifically, claim 1 is interpreted as reciting the following:
Lines 2-3: “a side wall”
Line 6: “an inner surface of the of the outer barrel”
Line 8: “a side wall[[s]]”
Line 9: “an inner surface of the of the inner barrel”
Lines 29-30: “the inner surface of the
Line 30: “an outer surface of the
Line 35: “the inner surface of the
In order to overcome this rejection, Applicant can either (a) amend claim 1 in the manner set forth above and amend the Specification to align with this language (to ensure the Specification provides proper antecedent basis for this suggested claim language; i.e. instead of referring to an “inner side wall” and an “outer side wall”, refer to an inner surface and an outer surface) or (b) amend the specification to clearly redefine the term “wall” and set forth the uncommon definition (i.e. state “Throughout this disclosure, the term “wall” means “surface”). The Examiner highly suggests Applicant chose route (a).
Claim 1 recites “the distal end of the inner barrel” on line 24. This phrase lacks proper antecedent basis because the claim does not previously set forth that the inner barrel includes “a distal end”. Since the claim does previously set forth that the inner barrel includes a “distal tip” (see line 7), it is unclear if line 24 was intended to refer to “the distal tip” (instead of “the distal end”) or to introduce “a distal end” (instead of “the distal end”). In order to overcome this rejection, it is suggested to amend line 24 to recite either “the distal [[end]] tip” or “[[the]] a distal end”.
Claims 3-5 and 20 are rejected due to their dependence on claim 1.
Claim 4 recites that “the primary chamber comprises a seating surface on the distal end of the outer barrel” and Claim 5 recites that “the secondary chamber comprises a seating surface on the distal tip of the inner barrel”. However, claim 1 sets forth that the primary and secondary chambers are spaces “defined within boundaries” of structures, and are not structures themselves. Since the chambers are not structures, it is unclear how the chambers can comprise seating surfaces – which are structures – as claimed. In order to overcome this rejection, it is suggested to amend claim 4 to recite “wherein the distal end of the outer barrel forms distal tip of the inner barrel forms a seating surface
Allowable Subject Matter
Claims 1, 3-5 and 20 would be allowable if rewritten or amended to overcome the objections and 35 U.S.C. 112(b) rejections set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of independent claim 1 could not be found nor was suggested in the prior art of record.
The amendments to independent claim 1 filed 7/9/2026 require the syringe to include an inner barrel and the primary plunger to circumscribe the inner barrel. These requirements overcome the Lee et al. reference (PG PUB 2012/0197232 – cited as the primary reference in the last Office Action) because Lee’s inner barrel 30 functions as the primary plunger; therefore, Lee does not disclose a syringe having two barrels and two plungers, wherein one of the plungers circumscribes an inner one of the barrels as claimed. Additionally, it would not have been obvious to one of ordinary skill in the art to modify Lee to include an additional plunger as doing so would alter the intended operation of Lee’s syringe.
Wright et al. (PG PUB 2006/0062736) discloses a syringe (Fig 5; reference numbers can be seen in Fig 1-5) comprising an outer barrel 3, an inner barrel 6, a primary plunger (outer 44) nested within the outer barrel and circumscribing the inner barrel, a secondary plunger (inner 44) nested within the inner barrel and the primary plunger, a primary stopper 42 defining a through aperture (Para 216), a secondary stopper 41, a valve 10 disposed within the interior of the inner barrel (as seen in Fig 4), a primary fluid chamber 7, and a secondary fluid chamber 14. However, the valve is a frangible seal (Para 210) and the plungers are integrated such that they move in unison. Therefore, the valve is not “resealable” and the valve and the plungers/stoppers do not allow for the syringe to operate in such a manner that “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” as claimed. It would not be obvious to one of ordinary skill in the art to modify Wright’s frangible seal and integrated plungers as doing so would render Wright inoperable for its intended purpose.
Scribben et al. (WO 2013/070692) also discloses a syringe (Fig 10) substantially similar in structure and operation to Wright, rendering it also insufficient to read on the claimed invention for the same reasons.
These three references are the closest prior art of record. Although it would have been obvious to one of ordinary skill in the art to modify each of them in view of the previously-cited Casiello et al. reference (PG PUB 2016/0030708 – cited as the secondary reference in the last Office Action) to include a plurality of channels, this combination would still not teach the invention of claim 1 due to Lee lacking a secondary plunger and Wright and Scribben lacking a resealable valve and the claimed operational capability highlighted above.
Election/Restrictions
As set forth above, the subject matter of claim 1 is allowable except for the presence of various objections and 112(b) rejections. In view of the indication of allowable subject matter, the restriction requirement among species, as set forth in the Office action mailed on 7/29/2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is maintained because the nonelected claims do not require all the limitations of an allowable claim. Accordingly, claims 2 and 6-19 remain withdrawn and will be cancelled by Examiner’s Amendment if they remain present in Applicant’s next reply.
Response to Arguments
Applicant’s arguments filed 7/9/2026 have been fully considered but are moot in view of the above indication of allowable subject matter.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 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.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
Prosecution Insights