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 .
Response to Amendment
This office action is responsive to the amendment filed on 12/23/2025. As directed by the amendment: claims 20, 23, 26, 30, 38-39 have been amended; claim 25 has been cancelled; and no claims have been added. Thus, claims 2-24 and 26-40 are presently pending in this application.
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.
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.
Claims 20-24, 26, 28-29, 31, 33, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Korisch et al. (US 5951526 A) in view of Tsai et al. (US 20160081849 A1) further in view of Kayden (US 2295849 A).
Regarding claim 20, Korisch discloses a method comprising:
(a) grasping an assembly (Fig. 1), the assembly including:
(i) a dose clip assembly (16/18), the dose clip assembly including:
(1) a first member (16), and
(2) a second member (18) coupled with the first member (Fig. 3), and
(ii) a syringe (14), the syringe including:
(1) a barrel (20), and
(2) a plunger (26/28), the plunger being slidably disposed in the barrel (Figs. 3-5);
(b) the barrel being filled with a fluid and the plunger being located at a first longitudinal position (Fig. 3);
(c) inserting the barrel of the syringe into the first member of the dose clip assembly (Fig. 3);
(e) with the barrel of the syringe disposed in the first member of the dose clip assembly, and with the second member being in a first position relative to the first member, advancing the plunger distally relative to the barrel to a second longitudinal position, the plunger engaging the second member in the second longitudinal position, the second member in the first position preventing further distal advancement of the plunger relative to the barrel (Figs. 3-4);
(f) moving the second member relative to the first member from the first position to a second position, the second member in the second position no longer preventing further distal advancement of the plunger relative to the barrel (Fig. 5); and
(g) with the second member in the second position, advancing the plunger distally relative to the barrel from the second longitudinal position to a third longitudinal position (Fig. 5).
Korisch is silent regarding
(b) retracting the plunger proximally relative to the barrel to thereby draw fluid from a fluid source into the barrel, the plunger being retracted to a first longitudinal position;
(d) decoupling the fluid source from the barrel, and
after the act of advancing the plunger distally relative to the barrel to the second longitudinal position, the second member further preventing proximal retraction of the plunger relative to the barrel.
In analogous art, Tsai teaches
(b) retracting a plunger (406) proximally relative to a barrel (408) to thereby draw fluid from a fluid source (474) into the barrel, the plunger being retracted to a first longitudinal position (Paragraph [0141], Fig. 12A);
(d) decoupling the fluid source from the barrel (Paragraph [0141], Fig. 12A).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Korisch to incorporate the teachings of Tsai to incorporate (b) retracting the plunger proximally relative to the barrel to thereby draw fluid from a fluid source into the barrel, the plunger being retracted to a first longitudinal position; (d) decoupling the fluid source from the barrel in order to fill the barrel and prepare the syringe for use (Paragraph [0141]).
In analogous art, Kayden teaches a catch (36).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the second member of Korisch to incorporate the teachings of Kayden to incorporate a catch (36) in order to engage the plunger (Page 2, lines 19-25) and therefore prevent unwanted retraction of the plunger. The modification of Korisch in view of Tsai further in view of Kayden would teach after the act of advancing the plunger distally relative to the barrel to the second longitudinal position, the second member further preventing proximal retraction of the plunger relative to the barrel because the second member of Korisch would have the catch, as taught by Kayden, engaging the end of the plunger, therefore preventing proximal retraction of the plunger relative to the barrel.
Regarding claim 21, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, the second member being in the second position during the act of inserting the barrel of the syringe into the first member of the dose clip assembly (Fig. 1, Col 4, lines 30-37, one of ordinary skill in the art would recognize that in order to place the preassembled plunger and syringe into the holder, the second member must not be in the first position (which would obstruct placing the preassembled plunger and syringe into the holder, therefore the most ideal position would be the second position (which would not obstruct placing the preassembled plunger and syringe into the holder, Korisch).
Regarding claim 22, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, Korisch in view of Kayden are silent regarding further comprising coupling the barrel with a fluid delivery instrument.
Tsai teaches further comprising coupling the barrel with a fluid delivery instrument (1000).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Korisch in view of Tsai further in view of Kayden to incorporate the teachings of Tsai to incorporate coupling the barrel with a fluid delivery instrument for use in any suitable procedure calling for delivery of a predetermined amount of fluid (Paragraph [0143]).
Regarding claim 23, Korisch in view of Tsai further in view of Kayden disclose the method of claim 22, but Korisch in view of Kayden are silent regarding the act of coupling the barrel with a fluid delivery instrument being performed after the act of decoupling the fluid source from the barrel and before the act of advancing the plunger distally relative to the barrel to the second longitudinal position.
Tsai teaches the act of coupling the barrel with a fluid delivery instrument being performed after the act of decoupling the fluid source from the barrel and before the act of advancing the plunger distally relative to the barrel to the second longitudinal position (Figs. 36A-36E).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified method of Korisch in view of Tsai further in view of Kayden to incorporate the teachings of Tsai to incorporate the act of coupling the barrel with a fluid delivery instrument being performed after the act of decoupling the fluid source from the barrel and before the act of advancing the plunger distally relative to the barrel to the second longitudinal position in order to prepare the apparatus for delivery of the drug.
Regarding claim 24, Korisch in view of Tsai further in view of Kayden disclose the method of claim 23, but Korisch in view of Kayden are silent regarding the act of advancing the plunger distally relative to the barrel to the second longitudinal position providing a priming of a fluid path from the barrel to a fluid delivering portion of the fluid delivery instrument.
Tsai teaches the act of advancing the plunger distally relative to the barrel to the second longitudinal position providing a priming of a fluid path from the barrel to a fluid delivering portion of the fluid delivery instrument (Paragraph [0179]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Korisch in view of Tsai further in view of Kayden to incorporate the teachings of Tsai to incorporate the act of advancing the plunger distally relative to the barrel to the second longitudinal position providing a priming of a fluid path from the barrel to a fluid delivering portion of the fluid delivery instrument in order to expel air and/or some fluid from the device such that the device contains no air and only contains fluid in the barrel, thus being considered being in a primed state (Paragraph [0179]).
Regarding claim 26, Korisch in view of Tsai further in view of Kayden disclose the method of claim 25, the second member including a catch (36, Kayden), the catch preventing proximal retraction of the plunger relative to the barrel (36 engaging the top of 15 would prevent proximal retraction of the plunger, Kayden).
Regarding claim 28, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, the act of moving the second member relative to the first member from the first position to the second position comprising pivoting the second member relative to the first member (Figs. 3-5, Korisch).
Regarding claim 29, Korisch in view of Tsai further in view of Kayden disclose the method of claim 28, the second member remaining pivotably coupled with the first member after the act of moving the second member relative to the first member from the first position to the second position (Figs. 3-4, Korisch).
Regarding claim 31, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, further comprising moving the second member from the second position to the first position before performing the act of advancing the plunger distally relative to the barrel to the second longitudinal position (Figs. 1 and 3-4, Col 4, lines 30-37, one of ordinary skill in the art would recognize that in order to place the preassembled plunger and syringe into the holder, the second member must not be in the first position (which would obstruct placing the preassembled plunger and syringe into the holder, therefore the most ideal position would be the second position (which would not obstruct placing the preassembled plunger and syringe into the holder. Once the preassembly plunger and syringe are placed into the holder, the second member would be placed into the first position as shown in Fig. 3, Korisch).
Regarding claim 33, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, but Korisch in view of Kayden are silent regarding the act of retracting the plunger proximally relative to the barrel to thereby draw fluid from the fluid source into the barrel further comprising retracting the plunger from a fourth longitudinal position to the first longitudinal position.
Tsai teaches the act of retracting the plunger proximally relative to the barrel to thereby draw fluid from the fluid source into the barrel further comprising retracting the plunger from a fourth longitudinal position (Fig. 36A) to the first longitudinal position (Fig. 36B).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Korisch in view of Tsai further in view of Kayden to incorporate the teachings of Tsai to incorporate the act of retracting the plunger proximally relative to the barrel to thereby draw fluid from the fluid source into the barrel further comprising retracting the plunger from a fourth longitudinal position to the first longitudinal position in order to drawing fluid from a fluid source into the barrel (Paragraph [0177]).
Regarding claim 35, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, but Korisch in view of Kayden are silent regarding the act of decoupling the fluid source from the barrel being performed before the act of inserting the barrel of the syringe into the first member of the dose clip assembly (The modification of Korisch in view of Tsai further in view of Kayden would teach the act of decoupling the fluid source from the barrel being performed before the act of inserting the barrel of the syringe into the first member of the dose clip assembly because the syringe is filled and then placed into the syringe holder).
Regarding claim 36, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, the acts of moving the second member relative to the first member from the first position to the second position and advancing the plunger distally relative to the barrel from the second longitudinal position to the third longitudinal position being performed using only a single hand (Col 5, lines 22-30, Korisch).
Regarding claim 37, Korisch in view of Tsai further in view of Kayden disclose the method of claim 20, the fluid source comprising a fluid selected from the group consisting of a leading bleb fluid and therapeutic agent (Col 4, line 29, Korisch).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 20160081849 A1) in view of Bowman et al. (US 20180126085 A1) further in view of Kayden (US 2295849 A).
Regarding claim 38, Tsai discloses a method comprising:
(a) grasping an assembly (1100, Figs. 29-36G), the assembly including:
(i) a dose clip assembly (1300/1400), the dose clip assembly including:
(1) a first member (1300), and
(2) a second member (1400) coupled with the first member (Fig. 29), and
(ii) a syringe (1200), the syringe including:
(1) a barrel (1210), and
(2) a plunger (1220), the plunger being slidably disposed in the barrel (Figs. 3-5);
(b) retracting the plunger proximally relative to the barrel to thereby draw fluid from a fluid source (1600) into the barrel, the plunger being retracted to a first longitudinal position (Figs. 36A-36B, Paragraph [0177]);
(c) inserting the barrel of the syringe into the first member of the dose clip assembly (Fig. 36C, Paragraph [0177]);
(d) decoupling the fluid source from the barrel (Paragraph [0177]);
(e) with the barrel of the syringe disposed in the first member of the dose clip assembly, and with the second member being in a first position relative to the first member, advancing the plunger distally relative to the barrel to a second longitudinal position, the plunger engaging the second member in the second longitudinal position, the second member in the first position preventing further distal advancement of the plunger relative to the barrel (Fig. 36E, Paragraph [0179]),
(f) moving the second member relative to the first member from the first position to a second position (Fig. 36F); and
(g) with the second member in the second position, advancing the plunger distally relative to the barrel from the second longitudinal position to a third longitudinal position (Figs. 36F-36G).
Tsai is silent regarding
the act of moving the second member relative to the first member from the first position to the second position comprising pivoting the second member relative to the first member about a longitudinally-extending axis.
In analogous art, Bowman teaches
(i) a dose clip assembly (2500), the dose clip assembly including:
(1) a first member (2510), and
(2) a second member (2520) coupled with the first member (Figs. 25A-25B), and
(ii) a syringe (Paragraph [0106]), the syringe including:
(e) with the syringe engage with the first member of the dose clip assembly, and with the second member being in a first position relative to the first member, advancing the plunger distally relative to the barrel to a second longitudinal position, the plunger engaging the second member in the second longitudinal position, the second member in the first position preventing further distal advancement of the plunger relative to the barrel (Paragraph [0106]),
(f) moving the second member relative to the first member from the first position to a second position (Paragraph [0106]); and
(g) with the second member in the second position, advancing the plunger distally relative to the barrel from the second longitudinal position to a third longitudinal position (Paragraph [0106]),
the act of moving the second member relative to the first member from the first position to the second position comprising pivoting the second member relative to the first member about a longitudinally-extending axis (Paragraph [0106]).
Bowman teaches that base 2510 bears against the finger flange (Paragraph [0106]) and is silent to inserting the barrel of the syringe into the first member.
However, Tsai teaches inserting the barrel of the syringe into the first member (Paragraph [0173]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first member of Bowman to incorporate the teachings of Tsai to incorporate being able to insert the barrel of the syringe into the first member in order to prevent longitudinal movement between the first member and the barrel (Paragraph [0173]).
Tsai in view of Bowman are silent regarding
the second member further preventing proximal retraction of the plunger relative to the barrel.
In analogous art, Kayden teaches a catch (36).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the second member of Bowman to incorporate the teachings of Kayden to incorporate a catch (36) in order to engage the plunger (Page 2, lines 19-25) and therefore prevent unwanted retraction of the plunger. The modification of Tsai in view of Bowman further in view of Kayden would teach the second member further preventing proximal retraction of the plunger relative to the barrel because the second member of Bowman would have the catch, as taught by Kayden, engaging the end of the plunger, therefore preventing proximal retraction of the plunger relative to the barrel.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 20160081849 A1) in view of Bowman et al. (US 20180126085 A1).
Regarding claim 39, Tsai discloses a method comprising:
(a) grasping an assembly (1100, Figs. 29-36G), the assembly including:
(i) a dose clip assembly (1300/1400), the dose clip assembly including:
(1) a first member (1300), and
(2) a second member (1400) coupled with the first member (Fig. 29), and
(ii) a syringe (1200), the syringe including:
(1) a barrel (1210), and
(2) a plunger (1220), the plunger being slidably disposed in the barrel (Figs. 36A-36G);
(b) retracting the plunger proximally relative to the barrel to thereby draw fluid from a fluid source (1600) into the barrel along a longitudinal axis, the plunger being retracted to a first longitudinal position (Figs. 36A-36B), the fluid source comprising a fluid selected from the group consisting of a leading bleb fluid and therapeutic agent (Paragraph [0171]);
(c) inserting the barrel of the syringe into the first member of the dose clip assembly (Fig. 36C, Paragraph [0177]);
(d) decoupling the fluid source from the barrel (Paragraph [0177]);
(e) advancing the plunger distally relative to the barrel to a second longitudinal position (Fig. 36E);
(f) moving the second member relative to the first member from the first position to a second position, the second member in the second position no longer preventing further distal advancement of the plunger relative to the barrel (Figs. 36E-36F); and
(g) with the second member in the second position, advancing the plunger distally relative to the barrel from the second longitudinal position to a third longitudinal position (Fig. 36G).
Tsai is silent regarding the act of moving the second member relative to the first member from the first position to the second position comprising pivoting the second member relative to the first member about a pivot axis.
In analogous art, Bowman et al. (US 20180126085 A1) teaches
(i) a dose clip assembly (2500), the dose clip assembly including:
(1) a first member (2510), and
(2) a second member (2520) coupled with the first member (Figs. 25A-25B), and
(ii) a syringe (Paragraph [0106]), the syringe including:
(e) advancing a plunger distally relative to a barrel to a second longitudinal position (Paragraph [0106]);
(f) moving the second member relative to the first member from a first position to a second position, the second member in the second position no longer preventing further distal advancement of the plunger relative to the barrel (Paragraph [0106]); and
(g) with the second member in the second position, advancing the plunger distally relative to the barrel from the second longitudinal position to a third longitudinal position (Paragraph [0106]),
the act of moving the second member relative to the first member from the first position to the second position comprising pivoting the second member relative to the first member about a pivot axis (Paragraph [0106]).
The substitution of one known material (plunger rod stop device of Bowman) for another (dosage spacers as taught in Tsai) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since Bowman teaches administering dosages and the substitution of plunger rod stop as taught in Bowman would have yielded predictable results, namely, a dosaging device of Tsai that would allow for administration of different amounts of fluid. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Bowman teaches that base 2510 bears against the finger flange (Paragraph [0106]) and is silent to inserting the barrel of the syringe into the first member.
However, Tsai teaches inserting the barrel of the syringe into the first member (paragraph [0173]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first member of Bowman to incorporate the teachings of Tsai to incorporate being able to insert the barrel of the syringe into the first member in order to prevent longitudinal movement between the first member and the barrel (Paragraph [0173]).
Regarding claim 40, Tsai in view of Bowman discloses the method of claim 39, the pivot axis being parallel to the longitudinal axis (Paragraph [0106], Bowman).
Allowable Subject Matter
Claim 30 is allowed.
Claims 27, 32, and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 27, although Korisch in view of Tsai further in view of Kayden teach the limitations of claim 26 as described above, Korisch in view of Tsai further in view of Kayden are silent to the act of advancing the plunger distally relative to the barrel to the second longitudinal position comprising traversing a cam surface of the catch with a portion of the plunger in combination with the limitations of claims 26 and 20.
As to claim 32, although Korisch in view of Tsai further in view of Kayden teach the limitations of claim 20 as described above, Korisch in view of Tsai further in view of Kayden are silent to the first member arresting distal movement of the plunger upon the plunger reaching the third longitudinal position, such that the first member prevents further distal advancement of the plunger relative to the barrel in combination with the limitations of claim 20.
As to claim 34, although Korisch in view of Tsai further in view of Kayden teach the limitations of claim 33 as described above, Korisch in view of Tsai further in view of Kayden are silent to the fourth longitudinal position being distal to the third longitudinal position in combination with the limitations of claims 33 and 20.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant’s amendment to claims 38 and 39 have overcome the prior art of record, however upon further consideration, a new ground(s) of rejection is made in view of Bowman et al. (US 20180126085 A1).
In response to applicant's arguments, on pages 11-12, that “Korisch’s plunger must be retracted inorder for the stop (54) to pivot from the first position… to the second position…”, the Examiner respectfully disagrees. There is no evidence in the prior art that the plunger 28 must be retracted in order for the stop 54 to pivot from the first position to the second position. Applicant merely alleges that plunger 28 must be retracted without identifying any evidence in the reference. For example, the stop may instead be flexible enough to pivot from the first position such that the plunger 28 would not need to be retracted. Further, assuming arguendo that Korisch’s plunger 28 must be retracted in order for stop 54 to pivot, the around it would be retracted would be negligible such that the catch of Kayden may still be used to prevent further retraction beyond whatever minimal amount of retracted needed to allow for pivoting to the second position.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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