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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 9/22/25, amended claim(s) 1 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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 “a first cannula secured at one end proximate said opening of said luer and extending into said piston and extendable into said channel as said plunger unit is inserted farther into said cylindrical body, and a second cannula positioned freely and slidably within said first cannula, said first cannula attached at a second end to said plunger unit such that movement of said plunger unit forces fluid through said first cannula causing said second cannula to move within said first cannula and at least partially out of said first cannula into a vein or catheter” of claim 1 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 § 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.
Claim(s) 1 and 3 is/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.
For claim 1, the claim language “a first cannula secured at one end proximate said opening of said luer and extending into said piston and extendable into said channel as said plunger unit is inserted farther into said cylindrical body, and a second cannula positioned freely and slidably within said first cannula, said first cannula attached at a second end to said plunger unit such that movement of said plunger unit forces fluid through said first cannula causing said second cannula to move within said first cannula and at least partially out of said first cannula into a vein or catheter” appears to be new matter. Applicant’s specification discloses, at para [0077] of the specification as originally filed:
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Therefore, either cannula 305 or cannula 310 corresponds to the claimed “first cannula” and the other of cannula 305 or cannula 310 corresponds to the claimed “second cannula.” The claim requires that the “first cannula” be “attached at a second end to said plunger unit” and that the “second cannula” be “positioned freely and slidably within said first cannula.” However, the above disclosure identifies that a single cannula, i.e., cannula 305, meets both of these requirements. Therefore, the specification does not support two cannulas performing both of these requirements. As a result, the claim language and the specification appear to contradict one another leading to the claim subject matter being new matter.
The above is further compounded by the fact that cannula 305 doesn’t appear to be “secured at one end proximate said opening of said luer.”
Dependent claim 3 fails to cure the deficiencies of independent claim 1, thus claim(s) 1 and 3 is/are rejected under 35 U.S.C. 112(a).
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(s) 1 and 3 is/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.
For claim 1, the claim language “a first cannula secured at one end proximate said opening of said luer and extending into said piston and extendable into said channel as said plunger unit is inserted farther into said cylindrical body … said first cannula attached at a second end to said plunger unit” is ambiguous. It is unclear what the scope of the claim language is since the claimed first cannula is “extendable into said channel as said plunger unit is inserted farther into said cylindrical body” as well as “attached at a second end to said plunger unit.” For reference, claim 1 earlier recites that the claimed “channel” is included in an “adapter portion” and that the adapter portion is in included in the “plunger unit.” So what is the metes and bounds of a “first cannula” that is both extendable into a plunger unit as the plunger unit moves (i.e., “is inserted”), but also fixed to the plunger unit? This is further ambiguous in view of the cannula also being “secured at one end proximate said opening of said luer.” So if the cannula is secured at one end at a luer and secured at a second end to the plunger unit, how can the plunger unit even move? The device would then be non-operational. But the examiner does not want to read out any part of the claim language, as every part of the claim must have at least some meaning, but that meaning is ambiguous in view of the limitations recited above. The claim is examined as meaning that the second cannula is attached to the plunger unit and that the first cannula is attached proximate of the luer so that the claim language makes sense.
Dependent claim 3 fails to cure the ambiguity of independent claim 1, thus claim(s) 1 and 3 is/are rejected under 35 U.S.C. 112(b).
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.
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) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0221578 to Hopkins in view of U.S. Patent Application Publication No. 5,961,472 to Swendson et al. (hereinafter “Swendson”) and U.S. Patent Application Publication No. 2016/0287793 to Olson et al. (hereinafter “Olson”).
For claim 1, Hopkins discloses a syringe assembly (Abstract) comprising:
a syringe (Examiner’s Note: made up of the elements that it is recited as being) including a cylindrical body (312/412) (Figs. 17-23) (para [0093]) with a luer at a first end (320) (Figs. 17-23) (para [0096]), said luer having an exit opening (unlabeled, but as can be seen in Figs. 19-23);
a plunger unit (Examiner’s Note: defined by the elements it includes) including an adapter portion (generally the adapter structure that encompasses 349, 354, 356, 360, 362) (Figs. 21-22) (para [0095], [0098], and [0103]) and a receiving cavity (318) (Figs. 21-22) (para [0095]), a first end of said adapter portion retaining a piston (354) (Figs. 21-22) (para [0095]), said plunger unit insertable into a second end of said syringe and slidable within said cylindrical body during which said piston creates a seal with an interior surface of said cylindrical body (as can be seen in Figs. 17-23) (also see para [0095] and [0098]), said adapter portion including a channel (the channel that includes 356 all the way up until 349) (Figs. 21-22) (para [0098]) extending along its length to an opening at a bottom of said receiving cavity for insertion of an intermediary connector or valve (349 interacting with 362) (Figs. 21-22) (para [00103]); and
a first cannula (337) (Figs. 17-23) (para [0095]-[0096]) secured at one end proximate said exit opening of said luer (as can be seen in Figs. 19-23) and extending into said piston and extendable into said channel as said plunger unit is inserted farther into said cylindrical body, and a second cannula (343) (Figs. 17-23) (para [0098]) positioned freely and slidably within said first cannula (as can be seen in Figs. 19-23), said second cannula attached at a second end to said plunger unit (as can be seen in Figs. 17-23) such that (Examiner’s Note: functional language, i.e., capable of) movement of said plunger unit forces fluid through said first cannula causing said second cannula (Examiner’s Note: this claim language interpreted in light of para [0077] of Applicant’s specification as originally filed) (see Figs. 19-20) (para [0100]-[0101]) to move within said first cannula (as can be seen in Figs. 19-23).
Hopkins does not expressly disclose the first cannula extending into said piston and extendable into said channel as said plunger unit is inserted farther into said cylindrical body.
However, Swendson teaches a lumen (44) (Figs. 1-2) that extends from a distal exit opening of a device (unlabeled, but as can be seen in Figs. 1-2) into a piston (42) (Figs. 1-2) and that the lumen is extendable the entire length of the piston, including any channel intermediate to the proximal and distal ends of the piston, including as said plunger/piston is inserted farther into a cylindrical body (as can be seen in Figs. 1-2).
It would have been obvious to a skilled artisan to modify Hopkins such that the lumen, and the first cannula that defines such a lumen, extends from a distal exit opening of Hopkin’s device (i.e., where the luer is) all the way through Hopkins’ piston and Hopkins’ channel to mimic the length of extension of the lumen in the piston of Swendson’s device. Such a modification would result in Hopkins having the first cannula extending into said piston and extendable into said channel as said plunger unit is inserted farther into said cylindrical body. A skilled artisan would have found it obvious to make such a modification for the obvious advantage of preventing mixing of fluid from Hopkins’ second fluid reservoir with fluid form the first fluid reservoir if Hopkins’ element 392 is depressed before all the fluid from the first fluid reservoir is expressed.
Hopkins and Swendson do not expressly disclose at least partially out of said first cannula into a vein or catheter.
However, Olson teaches a second cannula (14) (Fig. 1) (para [0073]) capable of moving at least partially out of a first cannula (18) (Fig. 1) (para [0073]) into a vein or catheter (para [0074] and [0085]-[0086]).
It would have been obvious to a skilled artisan to modify Hopkins to include at least partially out of said first cannula into a vein or catheter, in view of the teachings of Olson, for the obvious advantage of sealing the first cannula with a plug to prevent contamination and then being able to push that plug out or pierce it with the second cannula (see para [0074] and [0086] of Olson).
For claim 3, Hopkins further discloses wherein said fluid comprises saline (see Figs. 19-20) (para [0100]-[0101]).
Response to Arguments
Applicant’s arguments filed 9/22/25 have been fully considered.
However, the arguments appear to be overshadowed by the newly necessitated 112(a)/112(b) rejections. Once those issues are resolved, then a more clear path can be made for defining over the current rejection. However, it is noted that Olson is not relied upon for teaching “movement of said plunger unit forces fluid through said first cannula causing said second cannula to move within said first cannula.” Hopkins is relied upon for that portion of the claim language. Therefore, it also appears that the response may not be addressing the rejection of record.
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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 379