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 .
Claims 14, 18, and 22 are cancelled.
Claims 1-13, 15-17, and 19-21 are amended.
Claims 1-13, 15-17, and 19-21 are being examined in this Office Action.
Claim Objections
Claims 8, 12, and 13 are objected to because of the following informalities:
Claim 8 recites the limitation “wherein in assembled state” in line 2. This should read “wherein in an assembled state”.
Claim 12 recites the limitation “the syringe assembly according to any claim 7” in lines 1-2. This should read “the syringe assembly according to
Claim 12 additionally recites “a non-retracted state of plunger” in lines 5-6. This should read “a non-retracted state of the plunger”.
Claim 15 recites the limitation “when the plunger is fully inserted into the barrel and a dead volume of the syringe assembly is 0 mL” in lines 4-6. This should read “when the plunger is fully inserted into the barrel,
Claim 17 recites the limitation “The syringe assembly according to claim7” in lines 1-2. There should be a space between “claim7”.
Any remaining claims are objected to by virtue of their dependence on an objected claim.
Appropriate correction 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verhoeven et al. (Pub. No. US 20150094667 A1, herein Verhoeven).
Regarding Claim 1, Verhoeven discloses a plunger for a syringe assembly (Fig. 2), the plunger comprising:
an axially elongated plunger body (300) with a piston (310) at or near a distal end of the plunger (Fig. 2);
a visible marking connected to or provided on the plunger body (324, Fig. 3, Paragraph [0031]);
wherein the visible marking is positioned at a distance of the piston (324 positioned at y1 in annotated Fig. 2 below).
PNG
media_image1.png
397
510
media_image1.png
Greyscale
Regarding Claim 4, Verhoeven discloses the plunger according to claim 1, wherein the marking is a printed marking (“Each graduation 324 may, for instance, be printed on one of these faces 322, as in the depicted embodiment (see FIGS. 2-3)” – Paragraph [0031]).
Regarding Claim 6, Verhoeven discloses the plunger according to claim 1, further comprising a thickened proximal end section (350), and wherein the distance between the piston and the marking (y1, see annotated Fig. 2) is smaller than a distance between the thickened proximal end section and the marking (y2, annotated Fig. 2).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeven in view of Sigg et al. (US 9220631 B2, herein Sigg).
Regarding Claim 2, Verhoeven discloses the plunger according to claim 1,
Verhoeven does not expressly disclose wherein the piston has a curved end section.
Sigg teaches wherein the piston (26) has a curved end section (16, Col. 12 Lines 11-12, Figs. 2 and 5).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger disclosed by Verhoeven wherein the piston has a curved end section so that the curved end section is able to fully contact the end of the syringe body, fully expelling the fluid within the chamber (Sigg, Col. 1 Lines 55-58).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeven in view of Leary (Pub. No. US 20160166774 A1).
Regarding Claim 5, Verhoeven discloses the plunger according to claim 1.
Verhoeven does not expressly disclose wherein the marking is a connectable marking connectable to the plunger body.
Leary teaches wherein the marking (528) is a connectable marking connectable to the barrel body (“Each of the removable labels can be attached to the syringe body 510 (and/or any opaque label coupled thereto) by any suitable mechanism, such as, for example, by an adhesive, a perforated joint, or the like” – Paragraph [0082]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger disclosed by Verhoeven wherein the marking is a connectable marking as taught by Leary and is applied to the plunger body to provide a user with instruction associated with the medicament when viewed (Leary, Paragraph [0041]).
Claim(s) 3, 7, 9, 11, 12, 15-17, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeven in view of Creaturo (Pub. No. US 20130204225 A1).
Regarding Claim 3, Verhoeven discloses the plunger according to claim 1,
Verhoeven does not expressly disclose wherein the plunger comprises a single marking.
Creaturo teaches wherein the plunger (401) comprises a single marking (405, “the plunger 401 preferably comprises a clear and conspicuous substantially permanent indication 405 of at least the medication name 406, dosage strength, recommended dosage to weight 408, or weight range 409 or the medication contained in the syringe.” – Paragraph [0045]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger disclosed by Verhoeven wherein the plunger comprises a single marking as taught by Creaturo so that a user is able to avoid administration errors in the dosage of the medication (Creaturo, Paragraph [0045]).
Regarding Claim 7, Verhoeven discloses a syringe assembly (Fig. 2), comprising:
a barrel (210), comprising a barrel body (212) with an axial passage therethrough (214), wherein the barrel body is at least partially transparent (“the barrel body 212 may be transparent to enable a clinician to visually assess the contents of the barrel bore 214” – Paragraph [0024]);
a plunger according to claim 1 (Fig. 3), which plunger is arranged to be at least partially inserted into the axial passage of the barrel body (Fig. 1C);
wherein the marking of the plunger is visible through at least part of the barrel body (via 226, Paragraph [0026], Fig. 1A).
Verhoeven does not expressly disclose wherein the barrel comprises at least one marking.
Creaturo teaches wherein the barrel (402) comprises at least one marking (100, Paragraph [0045], Fig. 5).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe assembly disclosed by Verhoeven wherein the barrel comprises at least one marking as taught by Creaturo so that a user is able to determine a dosage to administer to a patient (Creaturo, Paragraph [0045]).
Regarding Claim 9, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 7, wherein in assembled state (Verhoeven, Fig. 1C), the marking of the plunger contacts an inner wall of the barrel body (Verhoeven, plunger 300 with graduations 324 appear to be in contact with inner wall of barrel body 212 in Fig. 1C unless otherwise stated in the art).
Regarding Claim 11, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 7, wherein the barrel is filled with less than 1 mL of liquid medicament for use in ophthalmology (Verhoeven, Paragraph [0002]). Examiner notes that the limitation “wherein the barrel is filled with less than 1 mL of liquid medicament for use in ophthalmology” is intended use and given limited patentable weight as the prior art is capable of being filled with less than 1 mL of liquid and used in ophthalmologic procedures.
Regarding Claim 12, modified Verhoeven in view of Creaturo discloses the syringe assembly according to any claim 7, wherein the plunger is arranged to be inserted into the barrel body at a proximal end of the barrel body (Verhoeven, at 212a), and at least part of the piston of the plunger can extend out of the distal end of the barrel body in a non-retracted state of plunger (Verhoeven, graduation 324 of plunger 300 extending out of barrel body 212 and visible through window 226 when plunger is not retracted, Fig. 1A, Paragraph [0026]).
Regarding Claim 15, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 7, wherein the marking of the plunger (Creaturo, 405) is aligned with the at least one marking of the barrel (Examiner interprets when the plunger 401 of Creaturo is fully inserted into the syringe barrel 402, the indicia 405 are aligned along a longitudinal axis below the indicia 100 of the syringe barrel 402), when the plunger is fully inserted into the barrel and a dead volume of the syringe assembly is 0 mL (Verhoeven, when plunger 300 is fully inserted into the barrel body 212, Examiner interprets the dead volume of the syringe assembly to be 0 mL since there appears to be no space for fluid to be within the distal end of the syringe 100 in Fig. 1C).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe assembly disclosed by Verhoeven wherein the marking of the plunger is aligned with the at least one marking of the barrel as taught by Creaturo so that a user is able to see the marking of the plunger through the barrel body and determine that a volume of the fluid inside is 0 mL when the plunger is fully inserted into the barrel.
Regarding Claim 16, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 7, wherein the marking of the plunger (Creaturo, 405) is aligned with at least one marking of the barrel (Examiner interprets when the plunger 401 of Creaturo is fully inserted into the syringe barrel 402, the indicia 405 are aligned along a longitudinal axis below the indicia 100 of the syringe barrel 402) when 0.05 mL or less of volume is available for liquid in the barrel (Creaturo, when 0.05 mL of liquid is within barrel 402, plunger 401 would still be aligned longitudinally with indica 100 in Fig. 5), distally from the piston of the plunger (Creaturo, Fig. 5).
Therefore, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the syringe assembly disclosed by Verhoeven wherein the marking of the plunger is aligned with at least one marking of the barrel when 0.05 mL or less of volume is available for liquid in the barrel, distally from the piston of the plunger as taught by Creaturo so that a user is able to determine the amount of fluid drawn within the barrel body.
Regarding Claim 17, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim7, wherein the barrel comprises a connection flange (Verhoeven, “The distal end 212b of the barrel body 212 itself may taper into a hollow tip, which may provide a point of attachment for a needle (not shown).” – Paragraph [0023], Fig. 2) with a skirt part (See annotated Verhoeven Fig. 2 above) at a distal end of the barrel (Verhoeven, Fig. 2), and wherein the marking of the plunger (Verhoeven, 324) is misaligned with the skirt part when the plunger is fully inserted into the barrel (Verhoeven, 324 are not aligned below skirt part when plunger 300 is fully inserted into barrel body 212 in Fig. 1C).
Regarding Claim 19, Verhoeven discloses a barrel for a syringe assembly (Fig. 2), the barrel comprising a barrel body (212), with an axial passage therethrough (214), wherein:
the barrel body is at least partially transparent (“the barrel body 212 may be transparent to enable a clinician to visually assess the contents of the barrel bore 214” – Paragraph [0024]).
Verhoeven does not expressly disclose the barrel comprises a zero marking on the barrel body, which zero marking is positioned a distance from a distal end of the barrel body.
Creaturo teaches the barrel (402) comprises a zero marking on the barrel body (See annotated Fig. 5 below, units increment in .25 mL, one can assume this is the starting point for fluid volume and the amount of fluid at that point would be assumed to be 0 mL), which zero marking is positioned a distance from a distal end of the barrel body (x1, annotated Fig. 5).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel for a syringe assembly disclosed by Verhoeven wherein the barrel comprises a zero marking on the barrel body, which zero marking is positioned a distance from a distal end of the barrel body as taught by Creaturo so that a user is able to determine a dosage contained within the syringe (Creaturo, Paragraph [0045]).
PNG
media_image2.png
899
701
media_image2.png
Greyscale
Regarding Claim 20, modified Verhoeven in view of Creaturo discloses the barrel according to claim 19, further comprising:
a connection flange with a skirt part (See annotated Creaturo Fig. 5 above) wherein the zero marking is positioned at a distance from the connection flange (Creaturo, annotated Fig. 5), and the connection flange is positioned between the distal end of the barrel body and the zero marking (Creaturo, x2, annotated Fig. 5).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel disclosed by Verhoeven further comprising a connection flange with a skirt part wherein the zero marking is positioned at a distance from the connection flange, and the connection flange is positioned between the distal end of the barrel body and the zero marking as taught by Creaturo so that a user is able to determine a dosage contained within the syringe (Creaturo, Paragraph [0045]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeven in view of Creaturo further in view of Leary.
Regarding Claim 8, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 7.
Modified Verhoeven in view of Creaturo does not expressly disclose wherein in assembled state, an annular spacing is present between the marking of the plunger and an inner wall of the barrel body.
Leary teaches wherein in assembled state (Fig. 7), an annular spacing is present between the marking of the plunger (246) and an inner wall of the barrel body (inside of 215, Examiner interprets an annular spacing is present in Fig. 7 between the indicia 246 located on the outer surface 245 of the plunger 240 and the inner wall of 215 of the syringe body 210).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe assembly disclosed by modified Verhoeven in view of Creaturo wherein in assembled state, an annular spacing is present between the marking of the plunger and an inner wall of the barrel body as taught by Leary so that the marking on the plunger is not in constant contact with the inner wall of the plunger body, preventing gradual wearing of the marker.
Claim(s) 10, 13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verhoeven in view of Creaturo further in view of Schootstra et al. (AU 2019300986 A1, herein Schootstra).
Regarding Claim 10, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 7.
Modified Verhoeven in view of Creaturo does not expressly disclose further comprising a needle hub with a needle, which needle hub is arranged to be connected to the barrel, at a distal end of the barrel.
Schootstra teaches a needle hub (102, Fig. 3) with a needle (needle extending from second opening 136 in Fig. 3), which needle hub is arranged to be connected to the barrel (via 304, Fig. 3), at a distal end of the barrel (106, Fig. 3).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe assembly disclosed by Verhoeven in view of Creaturo further comprising a needle hub with a needle, which needle hub is arranged to be connected to the barrel, at a distal end of the barrel as taught by Schootstra so that a user is able to minimize a dead volume within the syringe, improving accuracy of the amount of fluid inside the syringe (Schootstra, Page 6 Paragraph 7).
Regarding Claim 13, modified Verhoeven in view of Creaturo discloses the syringe assembly according to claim 12.
Modified Verhoeven does not expressly disclose further comprising a needle hub with a needle, which needle hub is arranged to be connected to the barrel, at a distal end of the barrel, wherein the needle hub comprises a pocket at a proximal end of the needle hub, which pocket is arranged for accommodating at least part of the piston of the plunger in the non-retracted state of the plunger.
Schootstra teaches a needle hub (102, Fig. 3) with a needle (needle extending from second opening 136 in Fig. 3), which needle hub is arranged to be connected to the barrel (via 304, Fig. 3), at a distal end of the barrel (106, Fig. 3), wherein the needle hub comprises a pocket (similar to 103 seen in Fig. 2C, however this space is filled in with piston 108 in Fig. 3) at a proximal end of the needle hub (portion where 108 resides in 102, Fig. 3), which pocket is arranged for accommodating at least part of the piston of the plunger in the non-retracted state of the plunger (Fig. 3).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe assembly disclosed by modified Verhoeven in view of Creaturo further comprising a needle hub with a needle, which needle hub is arranged to be connected to the barrel, at a distal end of the barrel, wherein the needle hub comprises a pocket at a proximal end of the needle hub, which pocket is arranged for accommodating at least part of the piston of the plunger in the non-retracted state of the plunger as taught by Schootstra so that a user is able to minimize a dead volume within the syringe, improving accuracy of the amount of fluid inside the syringe (Schootstra, Page 6 Paragraph 7).
Regarding Claim 21, modified Verhoeven in view of Creaturo discloses the barrel according to claim 19.
Modified Verhoeven in view of Creaturo does not expressly disclose wherein a volume of the axial passage through the barrel is smaller than 0.5 mL.
Schootstra teaches wherein a volume of the axial passage through the barrel is smaller than 0.5 mL (“Syringes such as the syringe 104 in the arrangement 100 of the present invention are often used for very small volumes of liquid, typically smaller than 1 mL, or even as small as 0.5 mL, or even more as small as 0.3 mL. With these small volumes, the dead volume is preferred to be as small as possible, especially small compared to the fluid volume that is to be ejected from the arrangement 100. Because the sizes of the syringe may differ per application, the dead volume may also be specified as a percentage of the maximum fluid capacity of the barrel. For example, an embodiment of the barrel holds a maximum fluid volume of 0.3 mL” – Page 6 Paragraphs 7-8).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel disclosed by modified Verhoeven in view of Creaturo wherein a volume of the axial passage through the barrel is smaller than 0.5 mL as taught by Schootstra so that an appropriate amount of liquid may be dispensed for the corresponding procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights