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is in response to the Applicant’s amendment filed 14 July 2026 wherein Claim 4 is amended, Claims 5 – 10 and 19 are withdrawn, Claims 21 – 27 are newly added, and Claims 11 – 17 are cancelled. Therefore Claims 1 – 10 and 18 – 27 are currently pending wherein Claims 5 – 10 and 19 are withdrawn therefrom.
The Applicant’s claim amendment dated 14 July 2026 is non-compliant with 37 CFR 1.121(c)(4)(i) because cancelled Claims 11 – 17 have been presented with claim text.
Election/Restrictions
Applicant’s election of Species A in the reply filed on 14 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5 – 10 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 14 July 2026.
Drawings
The drawings are objected to because of the following:
Figure 10 includes reference numeral 115. This reference numeral is believed to be incorrect. Reference numeral 115 labels the distal end of the syringe barrel 102. However, what is shown in Figure 10 at this label location is the proximal end 109 of the syringe barrel. Therefore, the Examiner suggests replacing reference numeral 115 in Figure 10 with reference numeral 109 in Figure 10.
Figure 17D includes reference numeral 1800. This reference numeral is believed to be a typographical error. The Examiner suggests amending this reference numeral to be 180.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
123 as mentioned in at least [0055] of the Specification.
A Specification Objection is made below regarding this Drawing Objection that would make this Drawing Objection moot.
127 as mentioned in [0064] of the Specification.
A Specification Objection is made below regarding this Drawing Objection that would make this Drawing Objection moot.
114 as mentioned in [0068].
A Specification Objection is made below regarding this Drawing Objection that would make this Drawing Objection moot.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
500 as shown in FIGS. 5A and 5D.
600 as shown in FIG. 6.
1200 as shown in FIG. 12.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0033] is suggested to be amended to recite “FIG. [[13A]] 13B is an isometric view of the syringe assembly shown in FIG. 12 the elongate plunger rod inserted in the syringe barrel;” to correct the figure being referred to.
[0055] is suggested to be amended to recite “The proximal end 122 of the elongate plunger rod 120 includes a thumb press [[123]] 125 for a user to apply distally directed force to the thumb press [[123]] 125 to expel fluid 140 from the syringe barrel 102” to resolve a drawing objection above regarding this reference numeral.
[0061] is suggested to be amended to recite “The proximal end 122 of the elongate plunger rod 120 includes a thumb press [[123]] 125 for a user to apply distally directed force to the thumb press [[123]] 125 to expel fluid 140 from the syringe barrel 102” to resolve a drawing objection above regarding this reference numeral.
[0064] is suggested to be amended to recite “engage a plunger rod locking slot 126 as [[127]] shown in FIG. 9B” to resolve the Drawing Objection above regarding this reference numeral.
[0066] is suggested to be amended to recite “The proximal end 122 of the elongate plunger rod 120 includes a thumb press [[123]] 125 for a user to apply distally directed force to the thumb press [[123]] 125 to expel fluid 140 from the syringe barrel 102” to resolve a drawing objection above regarding this reference numeral.
[0068] is suggested to be amended to recite “configured that mount to the syringe barrel 102 adjacent to the pair of gripping flanges 110, 112[[, 114]] and an elongate bracket engagement slot 314
Appropriate correction is required.
Claim Objections
Claims 4 and 11 – 17 are objected to because of the following informalities:
Claim 4 should be amended to recite “pivot the pivotable locking tab between a locked position and an unlocked position into different plunger rod locking slots of the plurality of plunger rod locking slots” to provide proper antecedent basis for this limitation.
Cancelled Claims 11 – 17 are non-compliant with 37 CFR 1.121(c)(4)(i) because they have been presented with claim text. The Examiner suggests amending Claims 11 – 17 such that they are compliant with 37 CFR 1.121(c)(4)(i).
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.
Claim(s) 1 – 4, 18, and 20 – 27 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 1 recites “a plurality of plunger rod locking slots located between the distal end and the proximal end.” It is unclear whether this recitation of “distal end” and “proximal end” is referring to the proximal end and distal end of the syringe barrel or the elongate plunger rod. Therefore Claim 1 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The Examiner suggests amending this to recite “a plurality of plunger rod locking slots located between the distal end of the elongate plunger rod and the proximal end of the elongate plunger rod” to clarify which proximal and distal ends are being referred to.
Claims 2 – 4, 18, and 20 – 27 are rejected under 35 U.S.C. § 112(b) based on their dependency on Claim 1.
Claim 3 recites “further comprising a pivot pin extending from one of the pair of connecting flanges, and the pivotable locking tab further comprising an aperture that engages the pivot pin to secure the pivotable locking tab to the distal end of the syringe barrel.” This claim language conflicts with the claim language of Claim 1. How can the pivotable locking tab be secured to the distal end of the syringe barrel when the pair of connecting flanges extend radially from the open proximal end of the syringe barrel? The Examiner believes Claim 3 incorrectly recites that the pivotable locking tab is secured to the distal end of the syringe barrel. Rather the Examiner believes that this limitation should recite “the pivotable locking tab further comprising an aperture that engages the pivot pin to secure the pivotable locking tab to the [[distal]] proximal end of the syringe barrel.”
Claim 21 recites “each of the plurality of ribs include the plurality of plunger rod locking slots located between the distal end and the proximal end.” It is unclear whether this recitation of “distal end” and “proximal end” is referring to the proximal end and distal end of the syringe barrel or the elongate plunger rod. Therefore Claim 21 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The Examiner suggests amending this to recite “each of the plurality of ribs include the plurality of plunger rod locking slots located between the distal end of the elongate plunger rod and the proximal end of the elongate plunger rod” to clarify which proximal and distal ends are being referred to.
Claim 23 recites “the aperture” and “the pivot pin.” There is insufficient antecedent basis for these limitations in the claim.
Claim 27 recites “wherein when the breakable tamper pin has been captured by the hook, cannot be locked to the proximal end of the syringe barrel.” This claim language is indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined what structure cannot be locked to the proximal end of the syringe barrel? The claim is ambiguous because it does not specifically recite what structure of the device cannot be locked to the proximal end of the syringe barrel.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 – 3 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dao-quan et al. (CN 107961402 A) (hereinafter referred to as “Dao-quan”).
Dao-quan is cited in the IDS dated 2 January 2025. The Examiner has provided a machine translation of the Specification of Dao-quan.
With regards to claim 1, Dao-quan discloses a syringe assembly (see page 2 “a negative pressure aspirator”) comprising:
a syringe barrel (1) having a side wall (see at 1 in Figure 4) with an inside surface defining a chamber (see at 1 in Figure 4) configured to retain and expel a fluid (see page 1 “aspirate liquids or body fluids” and page 2 “The suction port 11 is protruded to suck air or other substances”), an open proximal end (see at 12 in Figure 1) having a pair of gripping flanges (see Examiner annotated Fig. 3 below; hereinafter referred to as “Fig. A”) and pair of connecting flanges (see Fig. A below) extending radially from the open proximal end and a distal end (see at 11 in Figure 1) including a distal wall (11) having a passageway therethrough in fluid communication with the chamber (see page 2 “The suction port 11 is protruded to suck air or other substances”); and
an elongate plunger rod (4) disposed within the syringe barrel (see Figure 4), the elongate plunger rod comprising a distal end (see near 2 in Figure 4) and a proximal end (see near 5 in Figure 4), the distal end including a stopper (2), the elongate plunger rod including a plurality of plunger rod locking slots (see the slots between each pair of locking plates 42) located between the distal end and the proximal end (see Figure 4), and the elongate plunger rod extendible to a plurality of different locked lengths using a locking element (3) mounted to the proximal end of the syringe barrel to engage the plurality of plunger rod locking slots to permit varying amounts of fluid to be aspirated into the syringe barrel without rotating the elongate plunger rod (see Figures 2 – 3 and page 3 “the core rod 4 is provided with a plurality of lock plates 42 spaced along its axial direction, so that the core rod 4 can be locked at different positions to facilitate operation.”).
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With regards to claim 2, Dao-quan discloses the claimed invention of claim 1, and Dao-quan further discloses the locking element (3) further comprising a pivotable locking tab (32, 33) mounted to one of the pair of connecting flanges (see Figure A above) and configured to selectively engage each of the plurality of plunger rod locking slots (see the slots between each pair of locking plates 42) (see Figures 2 – 3 and page 3 “the core rod 4 is provided with a plurality of lock plates 42 spaced along its axial direction, so that the core rod 4 can be locked at different positions to facilitate operation.”).
With regards to claim 3, Dao-quan discloses the claimed invention of claim 2, and Dao-quan further discloses the syringe assembly further comprising a pivot pin (31) extending from one of the pair of connecting flanges (see Figure A above), and the pivotable locking tab (32, 33) further comprising an aperture (see at 31 in Figure 4) that engages the pivot pin to secure the pivotable locking tab to the distal end of the syringe barrel (1).
With regards to claim 23, Dao-quan discloses the claimed invention of claim 2, and Dao-quan further discloses wherein the aperture (see at 31 in Figure 4) is sized and configured to friction fit or compression fit onto the pivot pin (31) (see Figure 4 for the friction or compression fit).
Claim(s) 1, 2, 21, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (US 6,669,667 B1).
With regards to claim 1, Yang discloses a syringe assembly (see Col. 1, line 66 “a safety syringe”) comprising:
a syringe barrel (10) having a side wall (see at 10 in Figure 1) with an inside surface defining a chamber (see at 10 in Figure 1) configured to retain and expel a fluid (see Col. 2, lines 3 – 27), an open proximal end (see near 12 in Figure 1) having a pair of gripping flanges (see Examiner annotated Figure 1 below; hereinafter referred to as “Fig. B”) and pair of connecting flanges (see Fig. B below) extending radially from the open proximal end and a distal end (see near 11 in Figure 1) including a distal wall (see near 11 in Figure 1) having a passageway (see near 11 in Figure 1) therethrough in fluid communication with the chamber (see Col. 2, lines 3 – 27); and
an elongate plunger rod (30) disposed within the syringe barrel (see Figure 2), the elongate plunger rod comprising a distal end (see near 31 in Figure 1) and a proximal end (see near 32 in Figure 1), the distal end including a stopper (31), the elongate plunger rod including a plurality of plunger rod locking slots (33) located between the distal end and the proximal end (see Figure 1), and the elongate plunger rod extendible to a plurality of different locked lengths using a locking element (60) mounted to the proximal end of the syringe barrel to engage the plurality of plunger rod locking slots to permit varying amounts of fluid to be aspirated into the syringe barrel without rotating the elongate plunger rod (see Col. 3, lines 1 – 24).
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With regards to claim 2, Yang discloses the claimed invention of claim 1, and Yang further discloses the locking element (60) further comprising a pivotable locking tab (64) mounted to one of the pair of connecting flanges (see Figure B above) and configured to selectively engage each of the plurality of plunger rod locking slots (33) (see Col. 3, lines 1 – 24).
With regards to claim 21, Yang discloses the claimed invention of claim 1, and Yang further discloses the elongate plunger rod (30) comprising a plurality of ribs (see Col. 2, lines 28 – 37 “radial protrusions (not numbered” and see Figure 1 at 32), and each of the plurality of ribs include the plurality of plunger rod locking slots (33) located between the distal end (see at 31 in Figure 1) and the proximal end (see at 32 in Figure 1).
With regards to claim 22, Yang discloses the claimed invention of claim 21, and Yang further discloses wherein the plurality of ribs (see Col. 2, lines 28 – 37 “radial protrusions (not numbered” and see Figure 1 at 32) comprises four ribs (see Figures 1 – 5 which shows there being four radial protrusions) dividing the elongate plunger rod (30) in cross-section quadrants (see Figures 1 – 5), and the plurality of plunger rod locking slots (33) on each of the four ribs facilitates easier locking of the elongate plunger rod without having to rotate the elongate plunger rod (see Col. 3, lines 1 – 24).
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.
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(s) 4 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bold (US 12,083,318 B1).
With regards to claim 4, Dao-quan discloses the claimed invention of claim 3, however, Dao-quan is silent with regards to the pivotable locking tab further comprising a finger support extending from the pivotable locking tab, the finger support configured to be engaged by a user of the syringe assembly to pivot the pivotable locking tab between a locked position and an unlocked position into different plunger rod locking slots.
Nonetheless Bold, which is within the analogous art of syringe assemblies (see abstract and title), teaches the pivotable locking tab (57, 59) further comprising a finger support (54) extending from the pivotable locking tab (see Figure 14c), the finger support configured to be engaged by a user of the syringe assembly to pivot the pivotable locking tab between a locked position and an unlocked position into different plunger rod locking slots (see Col. 11, line 22 – Col. 12, line 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the pivotable locking tab of Dao-quan in view of a teaching of Bold such that the pivotable locking tab further comprising a finger support extending from the pivotable locking tab, the finger support configured to be engaged by a user of the syringe assembly to pivot the pivotable locking tab between a locked position and an unlocked position into different plunger rod locking slots. One of ordinary skill in the art would have been motivated to make this modification because Bold teaches that the additional length of the finger support/actuator allows for the user to rely on relatively higher leverage through actuation of the finger support/actuator to overcome resistance to release of the locking assembly. See Col. 11, line 22 – Col. 12, line 8 of Bold.
The syringe assembly of Dao-quan modified in view of a teaching of Bold will hereinafter be referred to as the syringe assembly of Dao-quan and Bold.
With regards to claim 24, the syringe assembly of Dao-quan and Bold teaches the claimed invention of claim 4, and, Dao-quan further teaches wherein the pivotable locking tab (32, 33) is engaged by a user rotating the locking element (3) using a thumb or finger to rotate the locking element about the pivot pin (31) (the claim language of “wherein the pivotable locking tab is engaged by a user rotating the locking element using a thumb or finger to rotate the locking element about the pivot pin” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim and is to be limited by structural limitations. MPEP 2114. The Office submits that the syringe assembly of Dao-quan and Bold meets the structural limitations of the claim wherein the pivotable locking tab can be engaged by a user rotating the locking element 3 using a thumb or finger to rotate the locking element about the pivot pin 31 because page 3 of Dao-quan describes the locked and unlocked positioning of the locking device 3.).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dao-quan and Manke et al. (US 2013/0085447 A1) (hereinafter referred to as “Manke”).
With regards to claim 20, Dao-quan discloses the claimed invention of claim 1, however, Dao-quan is silent with regards to further comprising a tamper evident feature comprising an adhesive label attached to one of the pair of the gripping flanges and the elongate plunger rod, which breaks when plunger rod has been moved.
Nonetheless Manke, which is within the analogous art of syringes (see abstract and title), teaches the syringe assembly further comprising a tamper evident feature (72) comprising an adhesive label (see [0058] “a tamper evident band 72”) attached to one of the pair of the gripping flanges (30) and the elongate plunger rod (44) (see [0058] and Figure 16), which breaks when plunger rod has been moved (see [0058] “The tamper evident band 72 is formed of a breakable material that may not be reattached over the syringe assembly 10 once access to the interior of the syringe assembly 10 has been initiated.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the syringe assembly of Dao-quan in view of a teaching of Manke such that the syringe assembly further comprises a tamper evident feature comprising an adhesive label attached to one of the pair of the gripping flanges and the elongate plunger rod, which breaks when plunger rod has been moved. One of ordinary skill in the art would have been motivated to make this modification because Manke teaches that that incorporating a tamper evident feature is beneficial for patient safety and sterility. See [0058] of Manke.
Allowable Subject Matter
Claim(s) 18, 25, 26, and 27 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/06/2026
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