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 Group III and Species A3 in the reply filed on 01/05/2026 is acknowledged.
Claims 1, 3-28, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/05/2026.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in AU on 12/11/2019 & 10/06/2020. It is noted, however, that applicant has not filed a certified copy of the AU 2019904695 or AU 2020903614 application as required by 37 CFR 1.55.
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: 91, 93, and 17 in reference to Fig. 30 on pages 78-79.
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 because several of the reference numerals are called by different names. For example, reference numeral 98 appears to be referred to as a first chamber and a new active agent chamber, reference numeral 108 appears to be referred to as a first port, an inlet port, and an active agent chamber opening, and reference numeral 110 appears to be referred to as a second port, an outlet port, and a dilution chamber opening. It is noted that the plurality of names adds unnecessary confusion and ambiguity to understanding the invention. Applicant is advised to simplify the naming of each reference numeral.
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 § 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.
Claim 38 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 38 recites a second active agent chamber opening, however it is unclear why the term “second” is being used to define an active agent chamber opening when no “first” active agent chamber opening has been defined. It appears as though a first active agent chamber opening is missing. Clarification is required.
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.
Claims 34, 35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2018/0093040 to Thorne, JR. et al. (“Thorne”).
Regarding claim 34, Thorne teaches a medication delivery apparatus (Figs. 28-33) comprising an active agent chamber (154’’) for receiving a pharmaceutical preparation (it is noted that the pharmaceutical preparation is not positively recited & Thorne is capable of receiving a pharmaceutical preparation in the active agent chamber), a first plunger (plunger attached to syringe handle 50, Fig. 28) received in the active agent chamber, a dilution chamber (152’’) for receiving a diluent (it is noted that the diluent is not positively recited & Thorne is capable of receiving a diluent in the diluent chamber), and a second plunger (100’’) received in the dilution chamber, wherein the dilution chamber is arranged to receive pharmaceutical preparation ejected from the active agent chamber by movement of the first plunger (Figs. 28-30) and wherein the dilution chamber comprises a dilution chamber opening (opening at distal end of syringe) for delivering contents of the dilution chamber to a patient, and the second plunger comprises a one-way valve (100’) configured to control a flow of pharmaceutical preparation from the active agent chamber to the dilution chamber in response to pressure applied by movement of the first plunger ([0172]), and wherein the one-way valve is configured to enable fluid to flow from the active agent chamber to the dilution chamber and to inhibit fluid in the dilution chamber from entering the active agent chamber ([0169]), such that the concentration of the pharmaceutical preparation contained in the dilution chamber increases during a process of infusion to the patient (since the pharmaceutical preparation has not been positively recited, limitations based on the pharmaceutical preparation will not given patentable weight, in any case, assuming a pharmaceutical preparation being in the active agent chamber, the concentration would increase in the dilution chamber and would be capable of being infused as forced is continually applied to the plunger assembly 50).
Regarding claim 35, Thorne teaches the medication delivery apparatus of claim 34 as shown above, Thorne further teaching the apparatus being configured to mix pharmaceutical preparation with diluent in the dilution chamber simultaneously with ejecting diluted pharmaceutical preparation through the dilution chamber opening (it is noted again that since the pharmaceutical preparation and the diluent are not positively recited, limitations pertaining to the pharmaceutical preparation and the diluent will not be given patentable weight, in any case, assuming a pharmaceutical preparation and a diluent, as the two are being mixed between Figs. 29-30, continuous force 322/324 being applied is capable of simultaneously ejecting the mixture, if desired).
Regarding claim 37, Thorne teaches the medication delivery apparatus of claim 34 as shown above, wherein the active agent chamber and dilution chamber are formed in a container (150”), the first plunger and the second plunger are each configured to be displaced with respect to a longitudinal axis of the container (Figs. 28-33), and the second plunger (100”) is positioned between the first plunger (plunger attached to 50) and the dilution chamber opening (distal opening of syringe).
Claim Rejections - 35 USC § 103
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 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 36 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2018/0093040 to Thorne, JR. et al. (“Thorne”) in view of U.S. Patent No. 5,630,800 to Blank et al. (“Blank”).
Regarding claim 36, Thorne teaches the medication delivery apparatus of claim 34 as shown above, but does not explicitly teach a diluent in the dilution chamber.
Blank teaches a dilution chamber (chamber below 40 in Fig. 4) being filled with diluent (30b) and contains substantially no gas (Fig. 4) in combination with an active agent chamber (chamber above 40) filled with a pharmaceutical preparation (30a). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a diluent in the dilution chamber and pharmaceutical preparation in the active agent chamber in Thorne as taught by Blank to yield the predictable result of providing two substances that need to be mixed prior to injection. Both Thorne and Blank are used to mix two substances prior to infusion, Blank merely shows one art-recognized alternative example of substances that require mixing prior to injection.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2018/0093040 to Thorne, JR. et al. (“Thorne”) in view of U.S. Patent Publication No. 2008/0208137 to Fago.
Regarding claim 38, Thorne teaches the medication delivery apparatus of claim 34 as shown above, but does not teach the second active agent chamber opening.
Fago teaches an active agent chamber (28, Fig. 8) comprising a second active agent chamber opening (100) in a wall of the container, the active agent chamber is capable of receiving a pharmaceutical preparation through the second active agent chamber opening. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the second active chamber opening of Fago into the wall of the container of Thorne to yield the predictable result of providing a means to fill or refill the active agent chamber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783