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 .
Status of Claims
As directed by the amendment filed on 30 January 2026: claim(s) 1 have been amended.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive.
Regarding the argument on pg. 5 of Remarks that “Arocha does not describe a carpule which is partitioned longitudinally and asymmetrically”, Arocha's carpule 70 is a single "dual-chambered carpule" ([0083]; FIG. 7) which is partitioned longitudinally by the connecting means 73 and the walls of each cylinder 71/72 (see FIG. 7). Arocha further discloses asymmetry of the partitions with different diameter ([0098], it provides a syringe double-carpule assembly having the same length and where the diameter of one carpule is smaller than the other (8:1 ratio)). Additionally, it is noted that the features upon which applicant relies (i.e., “an aspiration cartridge syringe for use with a single carpule” & “single carpule which is partitioned within the chamber and along the long axis of the single carpule”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument on pg. 6 of Remarks that “Arocha fails to describe the claimed longitudinally slotted plunger stem forming two asymmetrically divided plunger stem portions”, Arocha discloses the claimed longitudinally slotted plunger stem (comprised of dual stems 14 and 16 and the slot therebetween; FIG. 2). Arocha's divided plunger stem portions 14/16 are at least asymmetric in length ("stem 14 having a different length than stem 16" [0066]). Additionally, it is noted that the features upon which applicant relies (i.e., “a single plunger which is slotted, and the slot is formed off-center forming the asymmetrically slotted plunger stem to matingly engage the asymmetrically partitioned carpule”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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(s) 1-5 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arocha (US 20150065993 A1).
Regarding Claim 1, Arocha discloses a mixing cartridge syringe (see Abstract) comprising:
i) a cartridge syringe comprising a single barrel ("syringe housing forming the body or barrel of the syringe" [0049]; FIG. 2) for receiving a partitioned carpule ("capable of receiving at least one carpule" [0049]; FIG. 2), said carpule being partitioned longitudinally ("Cylinders 71 and 72 are connected to one another by connecting means 73" [0083]; FIG. 7) and asymmetrically ("diameter of one carpule is smaller than the other" [0098]) to form a first reservoir for containing a drug solution and a second reservoir for containing a buffering solution ("two cylinders 71 and 72" & "medicament or diluent" [0083]-[0084]);
ii) a longitudinally slotted plunger stem ("plunging actuator 17" [0065]; FIG. 2) forming two asymmetric plunger stem portions ("stem 14 having a different length than stem 16" [0066]; FIG. 2) which separately and matingly engage a sliding cap ("sliding plug" [0055]-[0056]; FIG. 2) on a distal end of each of the first and second reservoirs for expelling the contents therefrom ([0055]-[0056]; FIG. 2), and
iii) a mixing chamber ("mixing chamber 32" [0070]; FIG. 2) for receiving and mixing the drug solution and the buffering solution expelled from the partitioned carpule ("for receiving and adequately mixing the fluids dispensed from the pierced carpule chambers" [0020]), the mixing chamber containing a turbulence apparatus disposed therewithin ("mixing chamber can further include a turbulence-forming structure" [0061] & [0082]), said turbulence apparatus being operable to facilitate mixing of the drug solution and the buffering solution within the mixing chamber before administering the drug solution and buffer solution to a patient ("to facilitate mixing of the compositions or solutions when delivered from their respective carpules or carpule chambers" [0061] & [0082]).
Regarding Claim 2, Arocha discloses the mixing chamber 32 is in fluid communication with the first reservoir 26 through a first conduit comprising a first piercing needle 30 operable to traverse an end cap 31 on the proximal end of the first reservoir ([0077]; FIG. 6) and is in fluid communication with the second reservoir through a second conduit comprising a second piercing needle operable to traverse an end cap on the proximal end of the second reservoir ([0077]; FIG. 6).
Regarding Claim 3, Arocha discloses each plunger stem portion of the slotted plunger stem comprises a harpoon on its proximal end ("inferior end of each plunger stem comprises a penetrating means 24, e.g., a pointed or sharpened end integral with or affixed to, the stem for penetrating into the carpule plug" [0068]; FIG. 2).
Regarding Claim 4, Arocha discloses the turbulence apparatus 40 is distinct and separate from the mixing chamber 32 ([0061] & [0082]; FIG. 6).
Regarding Claim 5, Arocha discloses the turbulence apparatus is formed from an inert material ("turbulence-forming structure is preferably an inert material" [0082]).
Regarding Claim 9, Arocha discloses an exit port ("exit port or nozzle 36" [0071]; FIG. 6) connectable with a hypodermic transfer needle ("hypodermic needle 34" [0079]; FIG. 6).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arocha in view of Renfro (US 20080144433 A1).
Regarding Claims 6-8, Arocha fails to specify the inert material is steel wool, polymeric, or plastic. However, Renfro teaches “a mixing apparatus 10 for mixing two or more fluids” [0030]; FIG. 1) wherein the inert material (“mesh mixing section 38” [0031]; FIG. 2) is steel wool, polymeric, or plastic ([0031]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Arocha to incorporate the teachings of Renfro to require “no reciprocating or rotating mixing action and whereby the mixture may be accurately dispensed substantially while mixing is taking place” ([0005]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781