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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/28/2024 and 04/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 3-12 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 3 recites the limitation "the proximal end portion" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets the “proximal end portion” as the “proximal end member” as previously recited in claim 1.
Accordingly, claims 4 and 7-12 are rejected due to dependency on claim 3.
Claim 5 recites the limitation "the proximal end portion" in line 3. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets the “proximal end portion” as the “proximal end member” as previously recited in claim 1.
Accordingly, claim 6 is rejected due to dependency on claim 5.
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, 2, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaillancourt US 5,100,389 A (hereinafter Vaillancourt), as cited in the IDS.
Regarding claim 1, Vaillancourt discloses a syringe 10 (Fig. 1-3 – infusion pump 10) comprising:
a syringe barrel 11 (Fig. 1 – tubular housing 11) comprising an open distal end 15 (Fig. 1 – outlet aperture 15), a proximal end (Col. 4, line 52 – “a proximal end of the housing 11”), and a sidewall 11 (Fig. 1) extending between the open distal end 15 (Fig. 1) and the proximal end (Fig. 1) and defining a chamber 31 (Fig. 1 – fluid chamber 31);
a stopper 19 (Fig. 1 – piston 19) disposed within the chamber 31 (Fig. 1) in sealing engagement with the sidewall 11 (Fig. 1, and Col. 4, line 38-40 – “the piston 19 has a resilient annular portion 22 at the distal end for sealingly engaging the housing 11 within the inner bore”); and
wherein the syringe 10 (Fig. 1) is configured to hold a medicinal fluid in the chamber 31 (Fig. 2, and Col. 5, line 42 – “fluid within the fluid chamber 31”) of the syringe barrel 10 (Fig. 2) between the stopper 19 (Fig. 2) and the open distal end 15 (Fig. 2 – fluid between the piston 19 and the outlet aperture 15) of the chamber 31 (Fig. 2),
characterized in that:
the syringe 10 (Fig. 1) further comprises a biasing member 25 (Fig. 1 – spring 25) configured to move the stopper 19 (Fig. 1) from a first position (Fig. 2 shows a filled condition) to a second position (Fig. 3 shows a dispensing condition);
a locking assembly 13+26+29 (Fig. 1 – end cap 13, sleeve 26, and tab 29) comprising:
a proximal end member 13 (Fig. 1 – end cap 13) covering the proximal end of the syringe 10 (Fig. 1, and Col. 4, line 20-21 – “the housing 11 is formed of a cylindrical barrel having end caps 12, 13 at the respective ends”); and
a locking member 26+29 (Fig. 3 – sleeve 26 and tab 29) connected to the stopper 19 (Fig. 3),
wherein at least a portion of the locking member 26+29 (Fig. 3) engages the proximal end member 13 (Fig. 1-2) to hold the stopper in the first position (Fig. 2, and Col. 5, line 44-45 – “the proximal end cap 13 serves as a mount for the preloaded spring 25 and sleeve 26”), disengagement of the portion of the locking member 26+29 (Fig. 3, Fig. 5) from the proximal end member 13 (Fig. 3 and Fig. 5) frees the stopper 19 (Fig. 3), and the stopper 19 (Fig. 3) is moved to the second position (Fig. 2) by the biasing member 25 (Fig. 3, and Col. 6, line 24-31 – “…ready for use, the tab 29 is rotated from the position shown in FIG. 4 to the position shown in FIG. 5 to release the preloaded spring 25. The spring then presses the sleeve 26 against the piston 19 to impose a biasing force on the piston 19”).
Regarding claim 2, Vaillancourt discloses the invention of claim 1. Vaillancourt further discloses wherein the locking member 26+29 (Fig. 3) comprises a tab 29 (Fig. 1-3) and a connection rod 21 (Fig. 3 – mounting shaft 21) extending between the tab 29 (Fig. 1-3) and the stopper 19 (Fig. 1-3).
Regarding claim 13, Vaillancourt discloses the invention of claim 1. Vaillancourt further discloses wherein the stopper 19 (Fig. 3) moves in a continuous manner from the first position (Fig. 2) to the second position (Fig. 3) expelling the fluid from the syringe 10 (Fig. 2-3) in a continuous flow (Claim 1 – “during movement of said piston from said filled position to said empty position while effecting a continuous flow rate…”).
Regarding claim 14, Vaillancourt discloses the invention of claim 1. Vaillancourt further discloses wherein the biasing member 25 (Fig. 1-3) comprises a compression spring (Fig. 2-3).
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.
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.
Claims 3, 4, 7, 8, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt.
Regarding claim 3, Vaillancourt discloses the invention of claim 2. Vaillancourt further discloses wherein, when the locking member 26+29 (Fig. 3) is engaged with the proximal end portion 13 (Fig. 3; see 112(b) rejection above), the tab 29 (Fig. 2) engages a proximal exterior surface of the proximal end portion 13 (Fig. 1-2 and Fig. 4 – the tab rests against the exterior surface of end cap 13 to lock the infusion pump).
However, Vaillancourt does not disclose the connection rod extends through an opening in the proximal end portion.
Vaillancourt, in another embodiment, teaches the connection rod 36 (Fig. 6-7 – rod 36) extends through an opening 30 (Fig. 6-7 – slot 30) in the proximal end portion 13 (Fig. 6-7 – end cap 13).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection rod of Vaillancourt to extend through an opening of the proximal end portion, also as taught by Vaillancourt, in order to allow for selective passage through the slot upon rotation of said locking member (Col. 6, line 1-3 of Vaillancourt). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection rod of Vaillancourt to extend through the end cap’s opening, as taught by Vaillancourt, as Vaillancourt teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 4, Vaillancourt discloses the invention of claim 3. Vaillancourt further discloses wherein the tab 29 (Fig. 4) is sized and/or shaped such that the tab 29 (Fig. 4) cannot pass through the opening 30 (Fig. 4 – tab 29 does not pass through the slot 30).
Regarding claim 7, Vaillancourt discloses the invention of claim 3. Vaillancourt further discloses wherein at least a portion of the tab 29 (Fig. 2 and Fig. 4) has a shape corresponding to a shape of at least a portion of the opening 30 (Fig. 4 and Fig. 5, Col. 5, line 27-30 – “a tab 29 which is secured to a proximal end of the sleeve 26 and which is sized to selectively pass through a slot 30”), and
the locking member 26+29 (Fig. 3) is transitionable from a locked position (Fig. 2 shows a filled position), where the tab 29 (Fig. 3) of the locking member 26+29 (Fig. 3) engages the proximal end portion 13 (Fig. 4-5) to a release position (Fig. 3 and Fig. 5) where the tab 29 (Fig. 3 and Fig. 5) of the locking member 26+29 (Fig. 3) passes through the opening 30 (Fig. 3 and Fig. 5) in the proximal end portion 13 (Fig. 3 and Fig. 5, and Col. 5, line 32-37 – “When turned from the position illustrated in FIG. 4 to the position illustrated in FIG. 5, wherein like references characters indicate like parts as above, the tab 29 is able to slide through the slot 30 to release the spring 25 from the preloaded condition”).
Regarding claim 8, Vaillancourt discloses the invention of claim 7. Vaillancourt further discloses wherein rotation of the locking member 26+29 (Fig. 3-5) with respect to the proximal end portion 13 (Fig. 4-5) transitions the locking member 26+29 (Fig. 3-5) from the locked position (Fig. 2 and Fig. 4) to the released position (Fig. 3 and Fig. 5, and Col. 5, line 32-37 – “When turned from the position illustrated in FIG. 4 to the position illustrated in FIG. 5, wherein like references characters indicate like parts as above, the tab 29 is able to slide through the slot 30 to release the spring 25 from the preloaded condition”).
Regarding claim 9, Vaillancourt discloses the invention of claim 7. Vaillancourt further discloses wherein the proximal end portion 13 (Fig. 3) is contained within the chamber 31 (Fig. 1-3) at the proximal end of the syringe barrel 10 (Fig. 1-3 – end cap 13 is inserted into the interior of tubular housing 11) and the locking member 26+29 (Fig. 3) further comprises a locking member cap 13 (Fig. 3) covering the proximal end portion (Fig. 1, and Col. 4, line 20-21 – “the housing 11 is formed of a cylindrical barrel having end caps 12, 13 at the respective ends”; see rejection of claim 1), the locking member cap 13 (Fig. 3) engaging the tab 29 (Fig. 4 – tab 29 abuts the surface of end cap 13).
Regarding claim 11, Vaillancourt discloses the invention of claim 9. Vaillancourt further discloses wherein protrusions (Fig. 1-3 – radially outward side flange of end cap 13) extend from the locking member cap 13 (Fig. 1-3), define a recess 30 (Fig. 1-5 – slot 30) having a cross-section corresponding to a cross-section of the tab 29 (Fig. 4-5, and Col. 5, line 30-32- “As indicated in FIG. 4, the slot 30 is of rectangular shape while the tab 29 is of similar rectangular shape”), and engage the tab 29 (Fig. 5, and Col. 5, line 32-36 – “When turned from the position illustrated in FIG. 4 to the position illustrated in FIG. 5, wherein like references characters indicate like parts as above, the tab 29 is able to slide through the slot 30”).
Regarding claim 12, Vaillancourt discloses the invention of claim 9. Vaillancourt further discloses wherein the portion of the opening 30 (Fig. 4-5) is a slit (Fig. 4-5) and the portion of the tab 29 (Fig. 4-5) is a bar (Fig. 4-5, and Col. 5, line 30-32- “As indicated in FIG. 4, the slot 30 is of rectangular shape while the tab 29 is of similar rectangular shape”).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt in view of Garcia Diaz et al. US 2021/0085872 A1 (hereinafter Garcia Diaz).
Regarding claim 5, Vaillancourt discloses the invention of claim 2. However, Vaillancourt does not disclose wherein the tab is releasably attached to the connection rod and detachment of the tab from the connection rod disengages the locking member from the proximal end portion.
Garcia Diaz, in the same field of endeavor of spring-loaded syringe (Fig. 21), teaches wherein the tab 185 (Fig. 21 – safety lock 185) is releasably attached to the connection rod (Fig. 21 – safety lock 185 is inserted against the plunger rod 175 to the left) and detachment of the tab 185 (Fig. 21) from the connection rod (Fig. 21 – the vertical rod of plunger 175) disengages the locking member 175 (Fig. 21 – assist plunger 175) from the proximal end portion (Fig. 21, and Col. 97-98 – “assist plunger 175 of spring-loaded syringe assist device 170 to drive plunger 130 of syringe 20 distally”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tab of Vaillancourt to be releasably attached to the connection rod as taught by Garcia Diaz, in order to allow the spring to unload and drive the rod for drug dispense (Par. 98 of Garcia Diaz). Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the tab of Vaillancourt to attach and detach, since The Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 6, Vaillancourt in view of Garcia Diaz discloses the invention of claim 5. The combination further discloses wherein the tab 29 (Fig. 1-3 of Vaillancourt) is attached to the connection rod 21 (Fig. 1-3 of Vaillancourt) by a breakable connection (Fig. 1-3 of Vaillancourt modified by Garcia Diaz) by which the tab 29 (Fig. 1-3 of Vaillanco) can be detached from the connection rod 21 (Fig. 1-3 of Vaillancourt).
Examiner notes that once the modification is made as discussed in claim 5, the tab of Vaillancourt is detachable from the connection rod.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt as applied to claim 9 above, and further in view of Argentine US 2006/0186143 A1 (hereinafter Argentine).
Regarding claim 10, Vaillancourt discloses the invention of claim 9. However, Vaillancourt does not disclose wherein rotation of the locking member cap with respect to the syringe barrel transitions the locking member from the locked position to the release position.
Examiner notes that the current mechanism of Vaillancourt requires the locking member 29 to rotate instead of the locking member cap 13.
Argentine, in the same field of endeavor of device for dispensing materials such as a syringe (Par. 2), teaches wherein rotation of the locking member cap 210 (Fig. 2-3 – knob 210) with respect to the syringe barrel 710 (Fig. 2 – syringe 710) transitions the locking member 410+442 (Fig. 2-3 – carriage 410 and tab 442) from the locked position to the release position (Par. 46 – “Upon appropriate rotation of knob 210 to an open position 210b, tabs 442 can release from knob 210 and pass through opening 220 so as to release carriage 410”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking member cap of Vaillancourt such that it rotates to unlock the locking member as taught by Argentine, in order to ultimately drive the spring to dispense material from the syringe chamber (Par. 46 of Argentine).
Additionally, Examiner contends one of ordinary skill in the art would have had the technological capability to realize that there are an identified and limited number of ways that Vaillancourt’s the tab 29 and the slot 30 can engage with each other, i.e. the tab rotates to fit through the slot 30 of end cap 13 as disclosed by Vaillancourt, or vice versa, the end cap/knob 210 rotates to fit the tab 442 through the opening 220 of the end cap/knob 210 as taught by Argentine, or both components rotate to pass through each other. As such, as there are only a finite number of solutions, one of ordinary skill in the art would have had a reasonable expectation of success by selecting from this finite list, and thus it would have been obvious to try the end cap as the rotating component and the locking member as the stationary component because there is a finite number of identified, predictable solutions. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. (see MPEP § 2143, E.).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt in view of Bergens et al. US 2001/0005781 A1 (hereinafter Bergens).
Regarding claim 15, Vaillancourt discloses the invention of claim 1. However, Vaillancourt does not disclose wherein the biasing member comprises a viscous damper.
Bergens, in the same field of endeavor of auto-injector (Title), teaches wherein the biasing member (Par. 19 – “autoreturn mechanism”) comprises a viscous damper (Par. 21 – “According to the invention at least one damper shall be present”, and Par. 23 – “viscous dampers, as described, are preferred”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biasing member of Vaillancourt to further include a viscous damper as taught by Bergens, in order to absorb work/energy (Par. 21-22 of Bergens), and give full control over the force increase as during movement of the injection head (Par. 24 of Bergens).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gabriel et al. US 2019/0091412 A1 teaches an injection with rotating knob.
Liu et al. US 8,412,310 B2 teaches a syringe with locking component and bias member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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