DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-11), species B (teeth and tooth spaces between longitudinal ribs), and species D (removable pin insertable into barrel/plunger opening) in the reply filed on 4/29/2026 is acknowledged. Claims 1-11, 18, and 22 are pending in the application. Claims 12-17 and 19-21 are cancelled.
Claim Objections
Claims 1-7 and 9 are objected to because of the following informalities:
-Claim 1, line 2: please correct “proximal and distal ends” to “a proximal end and a distal end”
-Claim 1, line 3: please correct “therebetween” to “between the proximal end and the distal end”
-Claim 1, lines 3-4: please correct “relatively high-viscosity fluid” to “a relatively high-viscosity fluid”
-Claim 1, line 4: please correct “therein” to “in the barrel body”
-Claim 1, line 8: please correct “the syringe” to “the medical syringe”
-Claim 2, line 2: please correct “the pawl body” to “the cylindrical pawl body”
-Claim 2, lines 2-3: please correct “the pawl body” to “the cylindrical pawl body”
-Claim 2, line 4: please correct “therethrough” to “through the opening”
-Claim 3, line 2: please correct “the pawl body” to “the cylindrical pawl body”
-Claim 3, line 2: please correct “it” to “the at least one pawl arm”
-Claim 3, line 2: please correct “teeth” to “the plurality of teeth”
-Claim 4, lines 2-3: please correct “the pawl body” to “the cylindrical pawl body”
-Claim 5, line 2: please correct “each tooth rack” to “each of the plurality of toothed racks”
-Claim 6, line 1: please correct “each toothed rack” to “each of the plurality of toothed racks”
-Claim 6, line 3: please correct “the associated the toothed racks” to “an associated one of the plurality of toothed racks”
-Claim 7, line 2: please correct “each pawl tooth” to “the pawl tooth of each of the plurality of pawl arms”
-Claim 7, line 3: please correct “the associated tooth space of the rack” to “the tooth spaces of the associated one of the plurality of toothed racks”
-Claim 9, line 2: please correct “the medical grade adhesive is” to “the medical grade adhesive fluid is”
Appropriate correction is required.
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.
Claims 4-7 and 9 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.
Claim 4 introduces the limitation “a plurality of pawl arms”. It is unclear whether this limitation is intended to further define that the at least one pawl arm introduced in claim 2 includes a plurality of pawl arms, or whether “a plurality of pawl arms” is intended to be a separate/additional structure relative to the at least one pawl arm of claim 2. For examination purposes, the Examiner interprets “wherein the pawl includes a plurality of pawl arms” in claim 4 as “wherein the at least one pawl arm includes a plurality of pawl arms”.
Claims 5-7 are rejected by virtue of their dependency on rejected claim 4.
Claim 5 rejects the limitation “the pawl arms”. In light of the 112(b) rejection of claim 4 above, it is further unclear whether “the pawl arms” in claim 5 are intended to refer to the at least one pawl arm of claim 2 or the plurality of pawl arms in claim 4 or whether “the pawl arms” in claim 5 are intended to introduce a new set of pawl arms. For examination purposes, the Examiner interprets “the pawl arms” in claim 5 as “the plurality of pawl arms”.
Claims 6-7 are rejected by virtue of their dependency on rejected claim 5.
Claim 6 rejects the limitation “each pawl arm”. In light of the 112(b) rejections of claims 4-5 above, it is further unclear whether “each pawl arm” in claim 6 is intended to refer to the at least one pawl arm of claim 2, the plurality of pawl arms in claim 4, or the pawl arms in claim 5, or whether “each pawl arm” in claim 6 is intended to introduce a new set of pawl arms. For examination purposes, the Examiner interprets “each pawl arm” in claim 6 as “each of the plurality of pawl arms”.
Claim 7 is rejected by virtue of their dependency on rejected claim 6.
Claim 9 recites the limitation “further comprising medical grade adhesive fluid”. It is unclear whether this limitation is intended to further define that the relatively high-viscosity fluid introduced in claim 1 is a medical grade adhesive, or whether the medical grade adhesive fluid is a separate/additional fluid than the relatively high-viscosity fluid. It is further unclear whether claim 9 intends to positively recite the medical grade adhesive fluid. For examination purposes, the Examiner interprets “further comprising medical grade adhesive fluid” in claim 9 as “further comprising the relatively high-viscosity fluid, wherein the relatively high-viscosity fluid is a medical grade adhesive fluid”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 8, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanley et al. (US 2020/0147323 A1).
Regarding claim 1, Shanley discloses a medical syringe (system 500, see Figs. 6-15C, par. [0042]) comprising:
a barrel including a barrel body (syringe body 510) having proximal (end of syringe body 510 nearest finger flange 540, see Fig. 6) and distal ends (end of syringe body 510 nearest needle assembly 590) and a longitudinal axis extending therebetween (see Fig. 6), wherein the barrel body (syringe body 510) is configured to hold a volume of relatively high-viscosity fluid therein (see par. [0041]-[0042]);
a plunger including a plunger body (plunger member 550) longitudinally slidable distally in the barrel body (syringe body 510) to dispense the relatively high-viscosity fluid from the barrel (see Figs. 6-7, par. [0041]-[0042], [0045]); and
a ratchet (ratchet surface 552 and ratchet pawl 542) configured to enable repeated dispensing of a fixed amount of the relatively high-viscosity fluid from the syringe to a target site within a patient (see par. [0045]), the ratchet (ratchet surface 552 and ratchet pawl 542) including
a toothed rack (ratchet surface 552) extending along the plunger body (plunger member 550) and including a plurality of teeth (plurality of teeth 554) spaced apart from one another along the plunger body (plunger member 550) (see Figs. 6-7, par. [0043], [0045]), and
a pawl (ratchet pawl 542) connected to the barrel and engageable with the toothed rack (ratchet surface 552) (see Figs. 6-11, par. [0043]-[0045]).
Regarding claim 2, Shanley discloses the medical syringe set forth in claim 1, wherein the pawl (ratchet pawl 542) includes a cylindrical pawl body (upper cylindrical portion of ratchet pawl 542) and at least one pawl arm (pawl arms defined around plurality of slots 561) coupled to the pawl body (upper cylindrical portion of ratchet pawl 542), wherein the pawl body (upper cylindrical portion of ratchet pawl 542) defines an opening (central opening of ratchet pawl 542 for receiving plunger member 550) aligned with the longitudinal axis of the barrel body (syringe body 510) and configured to receive the plunger (plunger member 550) and the toothed rack (ratchet surface 552) therethrough (see Figs. 7-10, par. [0045], see annotated Fig. 7 below).
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Annotated Fig. 7
Regarding claim 3, Shanley discloses the medical syringe set forth in claim 2, wherein the at least one pawl arm (pawl arms defined around plurality of slots 561) is resiliently deflectable radially outward relative to the pawl body (upper cylindrical portion of ratchet pawl 542) as it engages the teeth (plurality of teeth 554) of the toothed rack (ratchet surface 552) during distal sliding movement of the plunger (plunger member 550) in the barrel body (syringe body 510) dispensing the relatively high-viscosity fluid from the barrel (see Figs. 7-10, par. [0041], [0045], see annotated Fig. 7 above).
Regarding claim 4, Shanley discloses the medical syringe set forth in claim 2, wherein the pawl (ratchet pawl 542) includes a plurality of pawl arms (pawl arms defined around plurality of slots 561) spaced apart circumferentially from one another about the pawl body (upper cylindrical portion of ratchet pawl 542) (see Figs. 7-10, par. [0045], see annotated Fig. 7 above).
Regarding claim 8, Shanley discloses the medical syringe set forth in claim 1, further comprising an anti-backoff mechanism configured to inhibit the plunger (plunger member 550) from sliding proximally within the barrel body (syringe body 510) (see Figs. 7-11, par. [0045], teeth 554 and reduced diameter section 543 are shaped such that they only allow the plunger member 550 to move distally within the syringe body 510).
Regarding claim 10, Shanley discloses the medical syringe set forth in claim 1, wherein the toothed rack (ratchet surface 554) is integrally formed with the plunger body (plunger member 550) (see Figs. 6-7, par. [0043], [0045].
Regarding claim 11, Shanley discloses the medical syringe set forth in claim 1, wherein the pawl (ratchet pawl 542) is integrally formed with the barrel body (syringe body 510) (see Figs. 6-7, 10-12, par. [0043]-[0046], note: the Examiner interprets “integrally formed” as including parts which form a complete unit)
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.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Shanley et al. (US 2020/0147323 A1), as applied to claim 4 above, in view of Samuel (US 2014/0288507 A1).
Regarding claim 5, Shanley discloses the medical syringe set forth in claim 4. However, Shanley fails to state wherein the toothed rack includes a plurality of toothed racks, each toothed rack associated with one of the pawl arms.
Samuel teaches a medical syringe (see Figs. 1-6, par. [0014]) wherein the toothed rack (splines 42+44+46+48 having teeth defined around recesses 50) includes a plurality of toothed racks (splines 42+44+46+48 having teeth defined around recesses 50), each toothed rack (splines 42+44+46+48 having teeth defined around recesses 50) associated with one of the pawl arms (tabs 28) (see Figs. 1-6, par. [0024]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical syringe of Shanley to separate the toothed rack into a plurality of toothed racks each associated with one of the pawl arms, as taught by Samuel, in order to allow that rotation of the plunger relative to the barrel disengages the toothed rack from the pawl such that the plunger can be held in a locked position when not in use (see Samuel par. [0024]).
Regarding claim 6, modified Shanley teaches the medical syringe set forth in claim 5 substantially as claimed. Modified Shanley further teaches wherein each toothed rack (Shanley, ratchet surface 552 separated into plurality of toothed racks, see previous modifications in rejection of claim 5 above) defines tooth spaces between the teeth (see Shanley Fig. 7, teeth 554 are spaced from each other), wherein each pawl arm (Shanley, pawl arms defined around plurality of slots 561) includes a pawl tooth (Shanley, reduced diameter section 543 of each pawl arm defined around plurality of slots 561) configured for incremental reception in the tooth spaces (see Shanley Fig. 7, teeth 554 are spaced from each other) of the associated the toothed racks (Shanley, ratchet surface 552 separated into plurality of toothed racks, see previous modifications in rejection of claim 5 above) as the plunger (Shanley, plunger member 550) slides distally within the barrel body (Shanley, syringe body 510) to dispense the relatively high-viscosity fluid from the barrel (see Shanley par. [0041], [0045], Samuel par. [0024], see previous modifications in rejection of claim 5 above to separate the ratchet surface 552 of the plunger member 550 into a plurality of ratchet surfaces).
Regarding claim 7, modified Shanley teaches the medical syringe set forth in claim 6 substantially as claimed. Modified Shanley further teaches an anti-backoff mechanism configured to inhibit each pawl tooth (Shanley, teeth 554) from withdrawing in a proximal direction from within the associated tooth space (see Shanley Fig. 7, teeth 554 are spaced from each other) of the rack (Shanley, ratchet surface 552 separated into plurality of toothed racks, see previous modifications in rejection of claim 5 above) (see Shanley Figs. 7-11, Shanley par. [0045], teeth 554 and reduced diameter section 543 are shaped such that they only allow the plunger member 550 to move distally within the syringe body 510).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shanley et al. (US 2020/0147323 A1), as applied to claim 1 above, in view of Grates et al. (US 2018/0310943 A1).
Regarding claim 9, Shanley discloses the medical syringe set forth in claim 1. However, Shanley fails to expressly state a medical grade adhesive fluid received in the barrel body, wherein the medical grade adhesive is suitable for closing a lower extremity vein.
Grates teaches a medical syringe (see Fig. 1, par. [0049]) comprising a medical grade adhesive fluid received in the barrel body (materials reservoir 58), wherein the medical grade adhesive is suitable for closing a lower extremity vein (see par. [0002], [0041], [0048]-[0049]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical syringe of Shanley to include a medical grade adhesive fluid received in the barrel body, wherein the medical grade adhesive is suitable for closing a lower extremity vein, as taught by Grates, in order to allow the medical syringe to be used for additional procedures such as delivering a medical adhesive to close a vein to treat venous reflux (see Grates par. [0002], [0041], [0048]-[0049]).
Claims 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shanley et al. (US 2020/0147323 A1), as applied to claim 1 above, in view of Sealfon (US 4,698,055 A).
Regarding claim 18, Shanley discloses the medical syringe set forth in claim 1. However, Shanley fails to expressly state a plunger lock releasably locking the plunger on the barrel.
Sealfon teaches a medical syringe (see Figs. 1-2 and 4, col. 3 lines 11-25) comprising a plunger lock (pin 58 and holes 52+54+56) releasably locking the plunger (plunger 28) on the barrel (barrel 12) (see Figs. 1-2 and 4, col. 4 lines 6-27).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical syringe of Shanley to include a plunger lock releasably locking the plunger on the barrel, as taught by Sealfon, in order to function as an additional safety feature to ensure that the plunger is not prematurely activated (see Sealfon, col. 4 lines 6-27).
Regarding claim 22, modified Shanley teaches the medical syringe set forth in claim 18 substantially as claimed. Modified Shanley further teaches wherein the plunger lock (Sealfon, pin 58 and holes 52+54+56) comprises a removable pin (Sealfon, pin 58) extending through aligned openings (Sealfon, holes 52+54+56) in the barrel (Shanley, syringe body 510) and the plunger (Shanley, plunger member 550) (see Shanley Fig. 6, Sealfon Figs. 1-2 and 4, Sealfon col. 4 lines 6-27, see previous modifications in rejection of claim 18 above to include the pin 58 and holes 52+54+56 of Sealfon on the plunger member 550 and syringe body 510 of Shanley).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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