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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 June 2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDSs), submitted on 24 June 2025, 8 July 2025, 26 January 2026, and 2 April 2026 have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 24 June 2025. As directed by the amendment: claims 1, 16, 19-20, and 31 have been amended, claims 12 and 17-18 have been or remain canceled. Thus claims 1-11, 13-16, and 19-31 are presently pending in this application, and claims 6-8, 10-11, 13-16, and 19-28 remain withdrawn. Applicant’s amendments to the Claims have overcome each 35 U.S.C. 112(b) rejection and objections previously set forth in the Final Office Action mailed 1 May 2025.
Response to Arguments
Applicant's arguments filed 24 June 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 11 and 12 of REMARKS that one of ordinary skill in the art would understand the needle14 of Caillouette to define a bore having a size much smaller than 26 French to allow the needle 14 to pierce the target tissue during collection, and a modification would render the syringe unsuitable for Caillouette’s intended purpose of “fine needle aspiration”.
The examiner agrees that the needle of Caillouette would not have a bore of 26 French and it would not be obvious to modify the needle to be so large, however, the claims require the barrel to have a tip defining the bore size. The needle of Caillouette would not be equivalent to a tip of the barrel, instead the extension of the barrel as shown in annotated Fig 1 below of Caillouette would be an equivalent structure, and while the size of this part of the device is not disclosed, it is much larger and it would be obvious to make it 26 French or greater as outlined in the rejection of claim 1 below.
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Applicant’s arguments, see section (E), with respect to the rejection(s) of claim(s) 31 under Caillouette, Nordquest, and Garrison have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Caillouette, Nordquest and Lee (US 2014/0207082 A1) as outlined further below.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Caillouette (US 5246011 A) in view of Nordquest (US 4,743,230 A).
Regarding claim 1, Caillouette discloses an automatically-locking syringe (Fig 1), comprising: a barrel (10 Fig 1) including a tip defining a bore (see the tip and bore through which 15 extends in annotated Fig 1 below); a plunger slidably positioned within the barrel (11 Fig 1), wherein the plunger is movable (Col 2 lines 30-34 “a movable plunger 11 one end of which is sealed in the barrel, typically by an O-ring or the like so that as the plunger slides along the barrel, no fluid can pass the seal”) between a depressed position (Col 2 line 47 “the plunger is in its forward position”) and a withdrawn position (Col 2 lines 50-51 “the plunger is withdrawn toward a rearward position in the barrel”), and wherein the plunger includes a lock feature (21 Fig 1); and a lock plate (including elements 24, 22, 23, and 26 in Fig 2) coupled to the barrel (As shown in Fig 2, the lock plate is coupled to the barrel 10) and having an opening extending therethrough (See the opening through the center of 24 in Figs 1 and 2), wherein the plunger is slidably positioned in the opening (See the plunger 11 in the opening of 24 in Fig 1), wherein the lock plate includes a biasing member (Col 1 line 68 “biased toward the plunger”, Col 3 lines 47-51 “The tab extends beyond the end of the barrel in such a way that the tip or pawl 23 has a radial position inwardly of the maximum extent of the ribs on the plunger so that the pawl is resiliently biased toward the ratchet teeth”, the biasing member is the living hinge formed by the attachment of the tab 22 to the plastic member 24 Fig 2) configured to bias the lock plate to a locking position (“biased toward the plunger” Col 1 line 68 as shown in Figs 1 and 2, Col 3 lines 48-51 “the tip or pawl 23 has a radial position inwardly of the maximum extent of the ribs on the plunger”), and wherein when the plunger is moved from the depressed position to the withdrawn position, the lock feature (21 Fig 1) is configured to engage the lock plate (Col 3 lines 40-45 “A tab 22 on the end of the barrel has an inwardly directed tip 23 which acts as a pawl against the ratchet teeth.”) to drive the lock plate to a position away from the locking position (Col 3 lines 52-56 “When the plunger is withdrawn for creating a low pressure within the syringe, the ratchet teeth move past the pawl” the pawl would flex outward from the radial inward position) to thereby permit the lock feature to pass through the opening (as shown in Fig 1, the lock feature 21 would pass through the opening upon withdrawal of the plunger), and after the lock feature passes through the opening, the biasing member is configured to drive the lock plate to the locking position (after each ratchet tooth is withdrawn rearwardly the pawl would snap back in place into the locking position) to inhibit movement of the plunger from the withdrawn position to the depressed position (Col 3 lines 52-56 “When the plunger is withdrawn for creating a low pressure within the syringe, the ratchet teeth move past the pawl. When the plunger is released, the ratchet teeth prevent air pressure from pushing it forward in the barrel”).
However, Caillouette fails to disclose the bore having a size of about 26 French or greater, and wherein movement of the lock plate to the position away from the locking position moves the opening relative to the plunger.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bore of Caillouette et al. to have a size of about 26 French or greater since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Caillouette et al. would not operate differently with the claimed bore size and since the bore of Caillouette is shown to be much larger than a fine needle the device would function appropriately having the claimed bore size. Further, it appears that applicant places no criticality on the range claimed, indicating simply that “in some embodiments” the tip “can” define a bore having a size of about 26 French or greater (specification pp. [0042]).
Nordquest teaches an automatically locking syringe (Fig 1) wherein movement of the lock plate (37 Fig 4) to the position away from the locking position (the locking position is shown in Figs 3 and 4 with pawl 36 in “the rachet-engaging position” Col 2 lines 49-50) moves the opening (41 Fig 4) relative to the plunger (18 Fig 4). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the lock of modified Caillouette to be structured with the limitations as taught by Nordquest as this provides a readily actuated tab that can be easily pressed by a single hand to unlock the engagement (Col 3 lines 51-59).
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Regarding claim 2, modified Caillouette discloses the syringe of claim 1. Modified Caillouette further teaches wherein the lock feature (21 Fig 1) includes a stop surface extending generally perpendicular to a longitudinal axis of the syringe (See the stop surface in annotated Fig 1 below), and wherein the lock plate is configured to engage the stop surface when (a) the lock plate is in the locking position (when the pawl is biased radially inwardly, Col 3 lines 48-51 “the tip or pawl 23 has a radial position inwardly of the maximum extent of the ribs on the plunger”, the modification in view of Nordquest includes the lock plate 37 Fig 4 configured to engage a stop surface as shown in Fig 4 when locked) and (b) the plunger is in the withdrawn position (the pawl engages the stop surface to maintain the position in the withdrawn position, Col 3 lines 52-56 “When the plunger is withdrawn for creating a low pressure within the syringe, the ratchet teeth move past the pawl. When the plunger is released, the ratchet teeth prevent air pressure from pushing it forward in the barrel”).
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Regarding claim 3, Caillouette discloses the syringe of claim 1. Modified Caillouette further teaches further comprising a button (Nordquest- 46 Fig 3) coupled to the lock plate (Nordquest- as shown in Figs 3 and 4, the button 46 is part of the lock plate assembly 37), wherein the button is actuatable to move the lock plate away from the locking position (Nordquest- Col 3 lines 21-23 “depressing the tab 46 to cause the pawl 36 to be moved out of the way of the threads 32”) to permit movement of the plunger from the withdrawn position to the depressed position (the unlocking of Caillouette permits movement of the plunger from the withdrawn position to the depressed position Col 3 line 68- col 4 line 2 “to pull the tip away from the ratchet teeth and permit the plunger to return toward its forward position.”, the modification in view of Nordquest substitutes the lock plate components with those of Norquest).
Regarding claim 4, modified Caillouette discloses the syringe of claim 1. Modified Caillouette further teaches wherein the biasing member includes at least one of a spring and a living hinge (Nordquest- spring 42 Fig 4).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Caillouette (US 5246011 A) in view of Nordquest (US 4,743,230 A) and Kanner et al. (US 8191457 B2).
Regarding claim 5, modified Caillouette discloses the syringe of claim 1. However, modified Caillouette fails to teach wherein the biasing member is an arm hingedly coupled to the locking plate.
Kanner et al. teaches a biasing member is an arm (276 Fig 7) hingedly (with pivot pin 206 Fig 7) coupled to the locking plate (246 Fig 7). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the biasing member of modified Caillouette to be an arm hingedly coupled to the locking plate as taught by Kanner et al. to allow the structure of the biasing member to interface with a cam (284 Fig 8) to provide more definitive auditory and tactile feedback to the user (Col 8 lines 35-38).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Caillouette (US 5246011 A) in view of Nordquest (US 4,743,230 A) and Pilkington et al. (US 2018/0280623 A1).
Regarding claim 9, modified Caillouette discloses the syringe of claim 1. However, modified Caillouette fails to teach wherein the barrel has a volume of about 60 cc or greater.
Pilkington et al. discloses a syringe barrel has a volume of about 60 cc or greater ([0050] “off-the-shelf syringes are typically available having barrels with a standard volumetric capacity of 20 cc or 60 cc.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the volume as taught by Pilkington et al. in the syringe of modified Caillouette since such a volumetric capacity is standard [0050] and could be used for fat transfer procedures ([0008] “a plunger locking assembly for use in cooperation with a fat transfer syringe”).
Claims 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Caillouette (US 5246011 A) in view of Nordquest (US 4,743,230 A) and Lin (US 2020/0069889 A1).
Regarding claim 29, modified Caillouette discloses the syringe of claim 1. However, modified Caillouette fails to disclose further comprising a vacuum indicator configured to provide a visual indication of whether vacuum pressure exists within the barrel when the plunger is in the withdrawn position.
Lin teaches a vacuum indicator (Fig 1A, the distance between the piston 40 and the plunger 30) configured to provide a visual indication of whether vacuum pressure exists within the barrel when the plunger is in the withdrawn position ([0034] “the device of the present disclosure translates pressure change into human identifiable signal”, “The information of pressure change can be easily obtained by observing the elongated position change between the piston and the plunger.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the syringe of modified Caillouette to include the limitations as taught by Lin to provide the user with a an easily observable visual indication of the pressure.
Regarding claim 30, modified Caillouette discloses the syringe of claim 1. However, modified Caillouette fails to disclose further comprising a vacuum indicator operably coupled to the plunger via a biasing member, wherein, when vacuum pressure is generated within the barrel, the vacuum pressure pulls the vacuum indicator against a biasing force of the biasing member to provide a visual indication that the vacuum pressure exists within the barrel.
Lin teaches a vacuum indicator (Fig 1A, the distance between the piston 40 and the plunger 30) operably coupled to the plunger via a biasing member (the distance between the piston and the plunger is maintained by a biasing member 50 coupled to both 30 and 40 Fig 1A), wherein, when vacuum pressure is generated within the barrel, the vacuum pressure pulls the vacuum indicator against a biasing force of the biasing member to provide a visual indication that the vacuum pressure exists within the barrel (a vacuum pressure in the barrel 20 would pull the plunger toward the tip 202 Fig 4A increasing the length of the biasing member 50). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the syringe of modified Caillouette to include the limitations as taught by Lin to provide the user with a an easily observable visual indication of the pressure.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caillouette (US 5246011 A) in view of Lee (US 2014/0207082 A1).
Regarding claim 31, Caillouette discloses an automatically-locking syringe (Fig 1), comprising: a barrel (10 Fig 1); a plunger slidably positioned within the barrel (11 Fig 1), wherein the plunger is movable (Col 2 lines 30-34 “a movable plunger 11 one end of which is sealed in the barrel, typically by an O-ring or the like so that as the plunger slides along the barrel, no fluid can pass the seal”) between a depressed position (Col 2 line 47 “the plunger is in its forward position”) and a withdrawn position (Col 2 lines 50-51 “the plunger is withdrawn toward a rearward position in the barrel”), and wherein the plunger includes a lock feature (21 Fig 1); wherein the plunger sealing engages the barrel to define a volume of the barrel (Col 2 lines 30-34 “a movable plunger 11 one end of which is sealed in the barrel, typically by an O-ring or the like so that as the plunger slides along the barrel, no fluid can pass the seal”), and wherein the volume is directly proportional to a distance of the plunger from a tip of the barrel (the volume is only contained between the plunger 11 and the tip of the barrel 10as shown in Fig 1, as such the volume would be proportional); and a lock plate (including elements 24, 22, 23, and 26 in Fig 2) coupled to the barrel (As shown in Fig 2, the lock plate is coupled to the barrel 10) and having an opening extending therethrough (See the opening through the center of 24 in Figs 1 and 2), wherein the plunger is slidably positioned in the opening (See the plunger 11 in the opening of 24 in Fig 1), wherein the lock plate includes a biasing member (Col 1 line 68 “biased toward the plunger”, Col 3 lines 47-51 “The tab extends beyond the end of the barrel in such a way that the tip or pawl 23 has a radial position inwardly of the maximum extent of the ribs on the plunger so that the pawl is resiliently biased toward the ratchet teeth”, the biasing member is the living hinge formed by the attachment of the tab 22 to the plastic member 24 Fig 2) configured to bias the lock plate to a locking position (“biased toward the plunger” Col 1 line 68 as shown in Figs 1 and 2, Col 3 lines 48-51 “the tip or pawl 23 has a radial position inwardly of the maximum extent of the ribs on the plunger”), and wherein when the plunger is moved from the depressed position to the withdrawn position, the lock feature (21 Fig 1) is configured to engage the lock plate (Col 3 lines 40-45 “A tab 22 on the end of the barrel has an inwardly directed tip 23 which acts as a pawl against the ratchet teeth.”) to drive the lock plate to a position away from the locking position (Col 3 lines 52-56 “When the plunger is withdrawn for creating a low pressure within the syringe, the ratchet teeth move past the pawl” the pawl would flex outward from the radial inward position) to thereby permit the lock feature to pass through the opening, and after the lock feature passes through the opening (as shown in Fig 1, the lock feature 21 would pass through the opening upon withdrawal of the plunger), the biasing member is configured to drive the lock plate to the locking position (after each ratchet tooth is withdrawn rearwardly the pawl would snap back in place into the locking position) to inhibit movement of the plunger from the withdrawn position to the depressed position (Col 3 lines 52-56 “When the plunger is withdrawn for creating a low pressure within the syringe, the ratchet teeth move past the pawl. When the plunger is released, the ratchet teeth prevent air pressure from pushing it forward in the barrel”).
However, Caillouette fails to disclose a vacuum indicator carried by the plunger proximal to the plunger head and configured to provide a visual indication of whether vacuum pressure exists within the volume when the plunger is in the withdrawn position.
Lee teaches a vacuum indicator (135 Fig 13) carried by the plunger (133 Fig 13) proximal to the plunger head (131 Fig 13) and configured to provide a visual indication of whether vacuum pressure exists within the volume when the plunger is in the withdrawn position ([0107] “enables an operator to confirm the variable pressure situation of a negative pressure or a positive pressure in the internal space of a syringe using gradations”, [0102] “a pressure change can be also confirmed using the gradations 135 of each unit”). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the vacuum indicator with the limitations as taught by Lee in the syringe of Caillouette to provide the ability to accurately determine pressure in the syringe with the naked eye [0011], [0016].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 4:00 PM-9:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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