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 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, 8, and 14 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 “said luer including a tip portion through which a cannula exit opening and two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid through a fluid de-accelerator,” as recited in claims 1, 8, and 14, and “a fluid de-accelerator positioned in line with said two ports,” as recited in claim 14 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 Objections
Claim(s) 20 objected to because of the following informalities: claim 20 is both “(previously presented)” and “(canceled)”.
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.
Claim(s) 1-20 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 claims 1, 8, and 14, the claim language “said luer including a tip portion through which a cannula exit opening and two side ports, continuously formed, communicate with an interior of said cylindrical body,” appears to be new matter. The examiner could not find where the cannula exit opening and the two side ports are through a tip portion of the luer. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claims.
Dependent claim(s) 2-7, 9-13, and 15-20 fail to cure the deficiencies of independent claim(s) 1, 8, and 14, thus claim(s) 1-20 is/are rejected under 35 U.S.C. 112(a).
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(s) 1-20 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 claims 1, 8, and 14, the claim language “a tip portion through which a cannula exit opening and two side ports, continuously formed, communicate with an interior of said cylindrical body,” and “such that side ports openings are proximal to said cannula exit opening” is ambiguous. These two phrases are dichotomous making the scope of the claim unclear because it cannot be resolved of how they can both be true statements (especially in light of Applicant’s specification). Fig. 22A shows the two side ports being continuously formed with the cannula exit opening
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Fig. 22B shows the side ports being proximal of the cannula exit opening. The response filed 9/22/25 identifies Fig. 22A as support for the newly amended claim language of “continuously formed.”
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However, as can be seen in Fig. 22B, there is an annular wall around the cannula exit opening that is not shown in Fig. 22A that would make the side ports not continuous with the cannula exit opening. Additionally, the fact that the side ports are not flush with the cannula exit opening, but instead spaced apart from the cannula exit opening, breaks any continuity that the side ports could share with the exit opening. Therefore, the claim appears to be claiming something that cannot exist. The examiner doesn’t know how to give an interpretation that doesn’t ignore at least part of the claim language.
Dependent claim(s) 2-7, 9-13, and 15-20 fail to cure the ambiguity of independent claim(s) 1, 8, and 14, thus claim(s) 1-20 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) 1-20 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. 2006/0009713 to Flaherty, U.S. Patent Application Publication No. 2007/0265577 to Uematsu et al. (hereinafter “Uematsu”), and U.S. Patent Application Publication No. 2013/0331817 to Woehr.
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. 17-31) (para [0093] and [017]) with a luer at a first end (320/420) (Figs. 17-31) (para [0096] and [110]), said luer including a tip portion through which a cannula exit opening communicates with an interior of said cylindrical body of said syringe (unlabeled, but as can be seen in Figs. 19-23 and 26-31);
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 / 449, 454, 456, 460, 462) (Figs. 21-22 and 28-29) (para [0095], [0098], [0103], [0109], [0111], and [0113]) and a receiving cavity (318/418) (Figs. 21-22 and 28-29) (para [0103] and [0112]), a first end of said adapter portion retaining a piston (354/454) (Figs. 21-22 and 28-29) (para [0095] and [0109]), 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. 17-31) (also see para [0095], [0098], [0109], and [0113]); and
a cannula (343/443) secured at one end proximate said exit opening of said luer tip (as can be seen in Figs. 17-31) and extending into said piston (para [0098] and [0113]) and extendable into said channel as said plunger unit is inserted farther into said syringe (para [0098] and [0113]).
Hopkins does not expressly disclose two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid in and out of said cylindrical body, said side ports positioned such that side ports openings are proximal to said cannula exit opening.
However, Flaherty teaches two side ports (10) (Figs. 1-2) (para [0029]) communicate with an interior of a cylindrical body of a syringe (2) (Figs. 1-2) (para [0029]) so that said side ports may direct (Examiner’s Note: functional language, i.e., capable of) fluid in and out of said cylindrical body (as can be seen in Figs. 1-2), said side ports positioned such that side ports openings are proximal to said cannula exit opening (as can be seen in Figs. 1-2).
Additionally, Uematsu teaches a cannula exit opening (3022b) (Fig. 7) (para [0087]) and two side ports (3021bA and 3021bB) (Fig. 7) (para [0087]) continuously formed (as can be seen in Fig. 7).
It would have been obvious to a skilled artisan to modify Hopkins to include two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid in and out of said cylindrical body, said side ports positioned such that side ports openings are proximal to said cannula exit opening, in view of the teachings of Flaherty and Uematsu, for the obvious advantage of venting the cylindrical body.
Hopkins, Flaherty, and Uematsu do not expressly disclose a fluid de-accelerator.
However, Woehr teaches a fluid de-accelerator (36 and 40) (as best seen in Fig. 5) (para [0041] and [0043]) (also see “wide flow pattern” in para [0004]) positioned between said two ports and said interior of said cylindrical body of said syringe (as can be seen in Fig. 5) so that fluid is directed through said fluid de-accelerator in and out of the cylindrical body and the side ports (para [0043] and [0051]).
It would have been obvious to a skilled artisan to modify Hopkins to include a fluid de-accelerator, in view of the teachings of Woehr, for the obvious advantage of modulating the fluid flow so that turbulent flow can be avoided.
For claim 2, Hopkins further discloses wherein said cylindrical body is pre-filled with a flush, medicament or other fluid (para [0044]).
For claim 3, Hopkins, as modified, further discloses wherein said two side ports are spaced 180° about said exit opening (as can be seen in Fig. 3 of Woehr).
For claim 4, Hopkins, as modified, further discloses wherein said two side ports serve to (Examiner’s Note: functional language, i.e., capable of) decrease pull pressure related to said plunger (as can be seen in Figs. 3 and 5 of Woehr).
For claim 5, Hopkins, as modified, further discloses wherein said two side ports serve to (Examiner’s Note: functional language, i.e., capable of) prevent cell damage to ingested blood fluids (as can be seen in Figs. 3 and 5 of Woehr).
For claim 6, Hopkins, as modified, further discloses wherein said two side ports facilitate pre-filling said syringe (Examiner’s Note: functional language, i.e., capable of) (as can be seen in Figs. 3 and 5 of Woehr).
For claim 7, Hopkins, as modified, further discloses wherein said two side ports facilitate pre-filling said syringe (Examiner’s Note: functional language, i.e., capable of) (as can be seen in Figs. 3 and 5 of Woehr).
For claim 8, 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. 17-31) (para [0093] and [017]) with a luer at a first end (320/420) (Figs. 17-31) (para [0096] and [110]), said luer including a tip portion through which a cannula exit opening communicates with an interior of said cylindrical body of said syringe (unlabeled, but as can be seen in Figs. 19-23 and 26-31);
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 / 449, 454, 456, 460, 462) (Figs. 21-22 and 28-29) (para [0095], [0098], [0103], [0109], [0111], and [0113]) and a receiving cavity (318/418) (Figs. 21-22 and 28-29) (para [0103] and [0112]), a first end of said adapter portion retaining a piston (354/454) (Figs. 21-22 and 28-29) (para [0095] and [0109]), 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. 17-31) (also see para [0095], [0098], [0109], and [0113]), said adapter portion including a channel (356/456) (Figs. 21-22 and 28-29) (para [0098] and [0113]) extending along a length thereof to an opening at a bottom of said receiving cavity, said opening for insertion of an intermediary connector or valve (360/460) (Figs. 18 and 25) (para [0098] and [0113]); and
a cannula (343/443) secured at one end proximate said exit opening of said luer (as can be seen in Figs. 17-31) and extending into said piston (para [0098] and [0113]) and extendable into said channel as said plunger unit is inserted farther into said syringe (para [0098] and [0113]).
Hopkins does not expressly disclose two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid in and out of said cylindrical body, said side ports positioned such that side ports openings are proximal to said cannula exit opening.
However, Flaherty teaches two side ports (10) (Figs. 1-2) (para [0029]) communicate with an interior of a cylindrical body of a syringe (2) (Figs. 1-2) (para [0029]) so that said side ports may direct (Examiner’s Note: functional language, i.e., capable of) fluid in and out of said cylindrical body (as can be seen in Figs. 1-2), said side ports positioned such that side ports openings are proximal to said cannula exit opening (as can be seen in Figs. 1-2).
Additionally, Uematsu teaches a cannula exit opening (3022b) (Fig. 7) (para [0087]) and two side ports (3021bA and 3021bB) (Fig. 7) (para [0087]) continuously formed (as can be seen in Fig. 7).
It would have been obvious to a skilled artisan to modify Hopkins to include two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid in and out of said cylindrical body, said side ports positioned such that side ports openings are proximal to said cannula exit opening, in view of the teachings of Flaherty and Uematsu, for the obvious advantage of venting the cylindrical body.
Hopkins, Flaherty, and Uematsu do not expressly disclose a fluid de-accelerator.
However, Woehr teaches a fluid de-accelerator (36 and 40) (as best seen in Fig. 5) (para [0041] and [0043]) (also see “wide flow pattern” in para [0004]) positioned between said two ports and said interior of said cylindrical body of said syringe (as can be seen in Fig. 5) so that fluid is directed through said fluid de-accelerator in and out of the cylindrical body and the side ports (para [0043] and [0051]).
It would have been obvious to a skilled artisan to modify Hopkins to include a fluid de-accelerator, in view of the teachings of Woehr, for the obvious advantage of modulating the fluid flow so that turbulent flow can be avoided.
For claim 9, Hopkins further discloses wherein said cylindrical body is pre-filled with a flush, medicament or other fluid (para [0044]).
For claim 10, Hopkins, as modified, further discloses wherein said two side ports serve to (Examiner’s Note: functional language, i.e., capable of) decrease pull pressure related to said plunger (as can be seen in Figs. 3 and 5 of Woehr).
For claim 11, Hopkins, as modified, further discloses wherein said two side ports serve to (Examiner’s Note: functional language, i.e., capable of) prevent cell damage to ingested blood fluids (as can be seen in Figs. 3 and 5 of Woehr).
For claim 12, Hopkins, as modified, further discloses wherein said two side ports facilitate pre-filling said syringe (Examiner’s Note: functional language, i.e., capable of) (as can be seen in Figs. 3 and 5 of Woehr).
For claim 13, Hopkins, as modified, further discloses wherein said two side ports facilitate pre-filling said syringe (Examiner’s Note: functional language, i.e., capable of) (as can be seen in Figs. 3 and 5 of Woehr).
For claim 14, 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. 17-31) (para [0093] and [017]) with a luer at a first end (320/420) (Figs. 17-31) (para [0096] and [110]), said luer including a tip portion through which a cannula exit opening communicates with an interior of said cylindrical body of said syringe (unlabeled, but as can be seen in Figs. 19-23 and 26-31);
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 / 449, 454, 456, 460, 462) (Figs. 21-22 and 28-29) (para [0095], [0098], [0103], [0109], [0111], and [0113]) and a receiving cavity (318/418) (Figs. 21-22 and 28-29) (para [0103] and [0112]), a first end of said adapter portion retaining a piston (354/454) (Figs. 21-22 and 28-29) (para [0095] and [0109]), said plunger unit insertable into a second end of said syringe and slidable within said cylindrical body during which said piston creates a fluid seal with an interior surface of said cylindrical body (as can be seen in Figs. 17-31) (also see para [0095], [0098], [0109], and [0113]), said adapter portion including a channel (356/456) (Figs. 21-22 and 28-29) (para [0098] and [0113]) extending along a length thereof to an opening at a bottom of said receiving cavity, said opening for insertion of an intermediary connector or valve (360/460) (Figs. 18 and 25) (para [0098] and [0113]); and
a cannula (343/443) secured at one end proximate said exit opening of said luer (as can be seen in Figs. 17-31) and extending into said piston (para [0098] and [0113]) and extendable into said channel as said plunger unit is inserted farther into said syringe (para [0098] and [0113]).
Hopkins does not expressly disclose two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid in and out of said cylindrical body, said side ports positioned such that side ports openings are proximal to said cannula exit opening.
However, Flaherty teaches two side ports (10) (Figs. 1-2) (para [0029]) communicate with an interior of a cylindrical body of a syringe (2) (Figs. 1-2) (para [0029]) so that said side ports may direct (Examiner’s Note: functional language, i.e., capable of) fluid in and out of said cylindrical body (as can be seen in Figs. 1-2), said side ports positioned such that side ports openings are proximal to said cannula exit opening (as can be seen in Figs. 1-2).
Additionally, Uematsu teaches a cannula exit opening (3022b) (Fig. 7) (para [0087]) and two side ports (3021bA and 3021bB) (Fig. 7) (para [0087]) continuously formed (as can be seen in Fig. 7).
It would have been obvious to a skilled artisan to modify Hopkins to include two side ports, continuously formed, communicate with an interior of said cylindrical body of said syringe so that said side ports may direct fluid in and out of said cylindrical body, said side ports positioned such that side ports openings are proximal to said cannula exit opening, in view of the teachings of Flaherty and Uematsu, for the obvious advantage of venting the cylindrical body.
Hopkins, Flaherty, and Uematsu do not expressly disclose a fluid de-accelerator.
However, Woehr teaches a fluid de-accelerator (36 and 40) (as best seen in Fig. 5) (para [0041] and [0043]) (also see “wide flow pattern” in para [0004]) positioned in line with two ports (as can be seen in Fig. 5) so that fluid is directed through said fluid de-accelerator in and out of the cylindrical body and the side ports (para [0043] and [0051]).
It would have been obvious to a skilled artisan to modify Hopkins to include a fluid de-accelerator, in view of the teachings of Woehr, for the obvious advantage of modulating the fluid flow so that turbulent flow can be avoided.
For claim 15, Hopkins further discloses wherein said cylindrical body is pre-filled with a flush, medicament or other fluid (para [0044]).
For claim 16, Hopkins, as modified, further discloses wherein said two side ports are spaced 180° about said exit opening (as can be seen in Fig. 3 of Woehr).
For claim 17, Hopkins, as modified, further discloses wherein said two side ports serve to (Examiner’s Note: functional language, i.e., capable of) decrease pull pressure related to said plunger (as can be seen in Figs. 3 and 5 of Woehr).
For claim 18, Hopkins, as modified, further discloses wherein said two side ports serve to (Examiner’s Note: functional language, i.e., capable of) prevent cell damage to ingested blood fluids (as can be seen in Figs. 3 and 5 of Woehr).
For claim 19, Hopkins, as modified, further discloses wherein said two side ports facilitate pre-filling said syringe (Examiner’s Note: functional language, i.e., capable of) (as can be seen in Figs. 3 and 5 of Woehr).
For claim 20, Hopkins, as modified, further discloses wherein said two side ports facilitate pre-filling said syringe (Examiner’s Note: functional language, i.e., capable of) (as can be seen in Figs. 3 and 5 of Woehr).
Response to Arguments
Applicant’s arguments filed 9/22/25 have been fully considered.
With respect to the objection to the drawings, the amendments to the claims are not persuasive to overcome this objection. Fig. 25 appears to be the only figure showing the fluid de-accelerator and Fig. 25 doesn’t show the tip portion of the luer, the cannula exit opening, or the two side ports. The other figures that show these elements don’t show the fluid de-accelerator. Therefore, the drawings don’t appear to show the claimed subject matter.
With respect to the 112(a) rejection(s), one of the rejections is withdrawn and one of the rejections is maintained in view of Applicant’s amendments and arguments. With respect to the rejection that is maintained, the examiner still cannot find support for the claim language, including the term “continuously formed,” as the specification doesn’t use that term. If Applicant believes that the claimed subject matter is not new matter, then the examiner respectfully requests Applicant’s assistance in determining where support may be found.
With respect to the 103 rejection(s), Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 9/22/25.
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.
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, Robert Chen can be reached on (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791