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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/25/2026 has been entered.
Response to Amendment
The amendment filed on 2/25/2026 has been entered. Claims 1-4, 6-11, 13-17, 19-21 are pending in the application. Claims 5, 12, and 18 are cancelled. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Final Office Action mailed on 11/28/2025.
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 21 is 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 21 recites the limitations “at least one stop on an interior surface of the shell” in line 6 and “a plurality of guide slots on the interior surface of the shell, wherein each guide slot includes a boss” in lines 7-8. It appears that the “at least one stop” and the “boss” may be referring to the same structure (bosses 248). It is unclear whether these limitations were recited twice unintentionally, or whether two separate stops and bosses exist in the invention. For examination purposes, the Examiner interprets that these limitations refer to the same structure.
Claim 21 recites the limitations “a plurality of first trigger fingers at a distal end of the carriage spaced apart from a proximal end of the carriage, the plurality of first trigger fingers being configured to cooperate with trigger-type actuator mechanism, the plurality of first trigger fingers interacting with a shoulder of the distal opening to hold the carriage in the retracted position in which a needle forming part of the insertion needle assembly is sheathed within the housing against a force of a compressed drive spring, the plurality of first trigger fingers being compressed in response to activation of the trigger-type actuator mechanism so as to release the plurality of first trigger fingers from the shoulder of the distal opening and thereby release the carriage for spring-loaded travel toward the proximal opening” in lines 17-26 and “a plurality of trigger arms projecting rearwardly from the platform, the plurality of triggers arms each comprising a second trigger finger that includes strictures that extend laterally away from a centerline of the carriage proximate a distal end of the second trigger fingers, the second trigger fingers being adapted and sized for partial radial compression toward each other and the centerline of the carriage as the second trigger fingers pass through the distal opening when the carriage is displaced from the extended position to the retracted position, and as the retracted position is reached, the second trigger fingers are spring-loaded by resiliency of the plurality of trigger arms to move outwardly to be hooked by an outer face of the shoulder of the distal opening” in lines 33-39. It appears that the “plurality of first trigger fingers” and the “plurality of trigger arms…each comprising a second trigger finger” may be referring to the same structure (trigger arms 130 having trigger fingers 132), especially since both are recited to compress to move through the distal opening and expand to hook onto the shoulder. It is unclear whether these limitations were recited twice unintentionally, or whether two separate sets of trigger arms/fingers exist in the invention. For examination purposes, the Examiner interprets that these limitations refer to the same structure.
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.
Claims 1-4, 6-11, 13-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Safabash et al. (US 2003/0158520 A1) in view of Thomas et al. (US 2014/0348703 A1) and further in view of Howell et al. (US 2015/0250944 A1).
Regarding claim 1, Safabash discloses an insertion device (automatic injector 10) for receiving and moving a needle assembly (insertion set 14) having a medical needle (insertion needle 12) from a retracted position (see Figs. 9 and 11) in which the medical needle (insertion needle 12) is housed in the insertion device (automatic injector 10) to an extended position (see Figs. 5, 7, and 15) in which the medical needle (insertion needle 12) is exposed to a skin of a patient (see Figs. 1-16, par. [0072] and [0076]), the insertion device (automatic injector 10) comprising:
a housing (barrel 28 and main support cap 60) comprising:
a shell (barrel 28) with a distal opening (top opening of main support cap 60) and a proximal opening (bottom opening of barrel 28) spaced apart from the distal opening (top opening of main support cap 60) (see Figs. 1-16);
at least one stop (stops at bottom ends of track slots 52) on an interior surface of the shell (barrel 28) (see Figs. 4-5 and 9, par. [0078]); and
a through groove (cut outs 40) extending through the shell (barrel 28) (see Figs. 2 and 4, par. [0077]-[0078]); and
a carriage (plunger 30) configured to be slidably received within the shell (barrel 28) between an extended position (see Figs. 5, 7, and 15) and a retracted position (see Figs. 9 and 11) (see par. [0076]), the carriage (plunger 30) comprising:
a platform (drive stem 54);
a pushing handle (flanges 46) slidably movable within the through groove (cut outs 40) extending out of the through groove (cut outs 40) beyond an outer surface of the shell (barrel 28) (see Figs. 1-4, 7, 11, and 15, par. [0078]), the pushing handle (flanges 46), when manually activated, causes the carriage (plunger 30) to move from the extended position (see Figs. 5, 7, and 15) towards the distal opening (top opening of main support cap 60) to the retracted position (see Figs. 9 and 11) (see Figs. 5, 7, 9, and 11, par. [0077]-[0078], [0080], and [0084], flanges 46 together with wings 24 can be manually grasped and pushed by a user from an extended position to the retracted position when the insertion set 14 is loaded into the automatic injector 10),
a pillar (plunger head 32) coupled to the platform (drive stem 54) and from which the pushing handle (flanges 46) extends (see Figs. 1-5, 7, 11, and 15, par. [0078]), the pillar (plunger head 32) extending away from the platform (drive stem 54) towards the proximal opening (bottom opening of barrel 28) (see Fig. 7, par. [0079]),
elements (fingers 100) extending from the carriage (plunger 30) towards the proximal opening (bottom opening of barrel 28) having a shape and size so as to secure the needle assembly (insertion set 14) (see Figs. 7, 11, and 15, par. [0084]), the elements (fingers 100) comprising at least one finger (fingers 100) coupled to the pillar (plunger 32) and extending laterally away from the pillar (plunger 32), the at least one finger (fingers 100) being configured to move toward the pillar (plunger 32) when the carriage (plunger 30) is displaced from the extended position (see dashed lines in Fig. 7 in which arms 94 and fingers 100 are displaced radially outwards, par. [0084]) to the retracted position (see Fig. 9, in which arms 94 and fingers 100 are moved inward and are located within the barrel 28, par. [0084]) and to radially expand away from the pillar (plunger 32) when the carriage (plunger 30) is in the extended position (see dashed lines in Fig. 7 in which arms 94 and fingers 100 are displaced radially outwards, par. [0084]) so as to grip the needle assembly (insertion set 14) when in the retracted position (see Fig. 9, in which arms 94 and fingers 100 are moved inward and are located within the barrel 28, par. [0084]) and release the needle assembly (insertion set 14) when in the extended position (see dashed lines in Fig. 7 in which arms 94 and fingers 100 are displaced radially outwards, par. [0084]), the at least one finger (fingers 100) configured to release the needle assembly (insertion set 14) in the extended position (see Figs. 7, 11, and 15, par. [0084]); and
at least one barb (track arms 48) coupled to the platform (drive stem 54) and extending away from the platform (drive stem 54) towards the proximal opening (bottom opening of barrel 28) (see Fig. 5, par. [0078]), the at least one barb (track arms 48) positioned so as to engage the at least one stop (stops at bottom ends of track slots 52) to prevent the carriage (plunger 30) from extending beyond the extended position (see Figs. 4-5 and 9, par. [0078], plunger 30 can only extend until fingers 50 of track arms 48 reach the bottom ends of track slots 52 as shown in Figs. 4-5).
However, Safabash fails to state that the elements have a shape and size so as to secure movable wings of the needle assembly, the at least one finger being made of a flexible material that allows the at least one finger to radially compress toward the pillar when the carriage is displaced from the extended position to the retracted position and to radially expand away from the pillar when the carriage is in the extended position so as to grip the movable wings of the needle assembly when in the retracted position and release the movable wings when in the extended position, the at least one finger configured to release the movable wings of the needle assembly in the extended position.
Thomas teaches an insertion device (see Fig. 6) comprising elements (stops 616) having a shape and size so as to secure movable wings (fingers 614) of the needle assembly (carrier 610), the elements (stops 616) comprising at least one finger (stops 616 are fingers, see Fig. 6) configured to release the movable wings (fingers 614) of the needle assembly (carrier 610) in the extended position (see Fig. 6, par. [0091]).
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 insertion device of Safabash to configure the elements/finger such that they can secure and release wings of a winged needle assembly, as taught by Thomas, in order to allow the device to selectively secure and release additional types of needle assemblies such as needle assemblies having wings (see Thomas par. [0091]).
However, modified Safabash still fails to state the at least one finger being made of a flexible material that allows the at least one finger to radially compress toward the pillar when the carriage is displaced from the extended position to the retracted position and to radially expand away from the pillar when the carriage is in the extended position so as to grip the movable wings of the needle assembly when in the retracted position and release the movable wings when in the extended position.
Howell teaches an insertion device (see Figs. 1A-4C) comprising at least one finger (living-hinged wings 50 with teeth 52) being made of a flexible material that allows the at least one finger (living-hinged wings 50 with teeth 52) to radially compress toward the pillar (body of needle hub retainer 40) when the carriage (needle hub retainer 40, projection 42, wings 50, and teeth 52) is displaced from the extended position (see Figs. 4B-C) to the retracted position (see Fig. 4A) and to radially expand away from the pillar (body of needle hub retainer 40) when the carriage (needle hub retainer 40, projection 42, wings 50, and teeth 52) is in the extended position (see Figs. 4B-C) so as to grip the needle assembly (needle assembly 30) when in the retracted position (see Fig. 4A) and release the needle assembly (needle assembly 30) when in the extended position (see Figs. 4B-C) (see Figs. 4A-C, par. [0030], [0032], [0039]).
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 substitute the pivot-pin hinge of the at least one finger of modified Safabash with a flexible material which radially compresses and expands relative to the pillar to hold and release the needle assembly in the retracted and extended position, respectively, as taught by Howell, in order to form an alternative type of hinge which can similarly function to hold and release the needle assembly as the carriage moves (see Howell par. [0032], [0039]). Since the previous modification in view of Thomas establishes that the elements/at least one finger hold and release the movable wings of the needle assembly, the entire modified device would further teach that the movable wings are gripped in the retracted position and released in the extended position.
Regarding claim 2, modified Safabash teaches the insertion device of claim 1 substantially as claimed. Safabash further teaches a drive (drive spring 36) configured to bias the carriage (plunger 30) relative to the housing (barrel 28 and main support cap 60) (see par. [0076]).
Regarding claim 3, modified Safabash teaches the insertion device of claim 2 substantially as claimed. Safabash further teaches wherein the drive (drive spring 36) comprises a spring (drive spring 36) (see par. [0076]).
Regarding claim 4, modified Safabash teaches the insertion device of claim 1 substantially as claimed. Safabash further teaches a trigger-type actuator (outer retainer sleeve 80, trigger button 38, actuator pin 72, and return spring 86) configured to release the carriage (plunger 30) from the retracted position (see Figs. 9 and 11) (see par. [0080]-[0084]).
Regarding claim 6, modified Safabash teaches the insertion device of claim 1 substantially as claimed. Safabash further teaches wherein the pillar (plunger head 32) comprises a frame (counterbore recess 44) configured to receive the needle assembly (insertion set 14) (see Fig. 3, par. [0078]).
Regarding claim 7, modified Safabash teaches the insertion device of claim 6 substantially as claimed. Safabash further teaches wherein the at least one finger (fingers 100) comprises a plurality of fingers (fingers 100) spaced substantially equidistantly around the pillar (plunger head 32) (see Figs. 7, 11, and 15 which show two fingers 100 spaced substantially equidistantly around the plunger head 32, par. [0084]).
Regarding claim 8, modified Safabash teaches the insertion device of claim 1 substantially as claimed. Safabash further teaches wherein the carriage (plunger 30) further comprises at least one trigger arm (trigger arms 56) coupled to the platform (drive stem 54) and extending away from the platform (drive stem 54) towards the distal opening (top opening of main support cap 60) (see Fig. 7, par. [0079]).
Regarding claim 9, modified Safabash teaches the insertion device of claim 8 substantially as claimed. Safabash further teaches wherein the at least one trigger arm (trigger arms 56) comprises a plurality of trigger arms (trigger arms 56) (see Fig. 7, par. [0079]).
Regarding claim 10, modified Safabash teaches the insertion device of claim 8 substantially as claimed. Safabash further teaches wherein the at least one trigger arm (trigger arms 56) includes at least one trigger finger (trigger fingers 58) spaced distally from the platform (drive stem 54) (see Fig. 7, par. [0079]).
Regarding claim 11, modified Safabash teaches the insertion device of claim 10 substantially as claimed. Safabash further teaches wherein the at least one trigger finger (trigger fingers 58) includes a ramped face oriented towards the shell (barrel 28) (see Fig. 7, par. [0080]).
Regarding claim 13, modified Safabash teaches the insertion device of claim 1 substantially as claimed. Safabash further teaches wherein the at least one barb (track arms 48) comprises a plurality of barbs (track arms 48) (see Fig. 5, par. [0078]).
Regarding claim 14, modified Safabash teaches the insertion device of claim 13 substantially as claimed. Safabash further teaches wherein the at least one stop (stops at bottom ends of track slots 52) comprises a plurality of stops (stops at bottom ends of track slots 52) (see Figs. 4-5 and 9, par. [0078]), wherein each of the plurality of barbs (track arms 48) comprises a respective front end (top end of track arms 48) spaced apart from the platform (drive stem 54), the respective front end (top end of track arms 48) of each of the plurality of barbs (track arms 48) including an edge (latch fingers 50) configured to interact with a different one of the plurality of stops (stops at bottom ends of track slots 52) (see Figs. 4-5, par. [0078]).
Regarding claim 15, modified Safabash teaches the insertion device of claim 6 substantially as claimed. Safabash further teaches wherein the housing (barrel 28 and main support cap 60) further comprises at least one guide slot (the inner curved surface of barrel 28 forms a slot for receiving and guiding fingers 100, see Figs. 7, 11, and 15, par. [0084]) on the interior surface of the shell (barrel 28), the at least one guide slot (inner curved surface of barrel 28) being configured to receive partially therein the at least one finger (fingers 100) (see Figs. 7, 11, and 15, par. [0084], fingers 100 are shown to slide in the inner curved surface of barrel 28).
Regarding claim 16, modified Safabash teaches the insertion device of claim 4 substantially as claimed. Safabash further teaches wherein the trigger-type actuator (outer retainer sleeve 80, trigger button 38, actuator pin 72, and return spring 86) further comprises:
a cap (outer retainer sleeve 80) coupled to the housing (barrel 28 and main support cap 60) (see Fig. 7, par. [0080]);
a button (trigger button 38 and actuator pin 72) positioned within the housing (barrel 28 and main support cap 60) (see Fig. 7, par. [0080], trigger button 38 and actuator pin 72 are located within the outermost surfaces of barrel 28 and main support cap 60); and
a trigger spring (return spring 86) positioned between the button (trigger button 38 and actuator pin 72) and a shoulder (shoulder 70) of the housing (barrel 28 and main support cap 60) (see Fig. 7), the shoulder (shoulder 70) proximate the distal opening (top opening of main support cap 60) of the housing (barrel 28 and main support cap 60) (see Fig. 7), wherein the trigger spring (return spring 86) is configured to urge the button (trigger button 38 and actuator pin 72) towards a distal end (top end of outer retainer sleeve 80) of the cap (outer retainer sleeve 80) (see Fig. 7, par. [0081]-[0082]).
Regarding claim 17, modified Safabash teaches the insertion device of claim 16 substantially as claimed. Safabash further teaches wherein the carriage (plunger 30) further comprises:
at least one trigger arm (trigger arms 56) coupled to the platform (drive stem 54) and extending away from the platform (drive stem 54) towards the distal opening (top opening of main support cap 60) (see Fig. 7, par. [0079]), and wherein the at least one trigger arm (trigger arms 56) includes at least one trigger finger (trigger fingers 58) spaced distally from the platform (drive stem 54), each of the at least one trigger finger (trigger fingers 58) including a respective ramped face oriented towards the shell (barrel 28) (see Fig. 7, par. [0079]-[0080]); and
wherein the button (trigger button 38 and actuator pin 72) further comprises:
a sleeve (actuator pin 72) including a tapered face (see Figs. 7-8, actuator pin 72 tapers from lands 76 to tip 88) oriented away from the shell (barrel 28) (see Fig. 7), the tapered face (see Figs. 7-8, actuator pin 72 tapers from lands 76 to tip 88) configured to interact with the respective ramped face of each of the at least one trigger finger (trigger fingers 58) so as to cause the at least one trigger finger (trigger fingers 58) to flex inward away from the shell (barrel 28) when the button (trigger button 38 and actuator pin 72) is depressed, thereby releasing the carriage (plunger 30) (see Figs. 7-8, par. [0082]).
Regarding claim 19, modified Safabash teaches a method of inserting a medical needle (insertion needle 12) into a patient (see Figs. 1-16, par. [0076]) comprising:
obtaining the insertion device (automatic injector 10) of claim 1 (see claim 1 rejection above);
positioning the insertion device (automatic injector 10) proximate the skin of the patient (see Figs. 9, 11, and 15, par. [0076]-[0077]);
actuating the insertion device (automatic injector 10) to cause the carriage (plunger 30) to move from the retracted position (see Figs. 9 and 11) to the extended position (see Figs. 5, 7, and 15) (see par. [0076]).
Regarding claim 20, modified Safabash teaches a method of inserting a medical needle (insertion needle 12) into a patient (see Figs. 1-16, par. [0076]), the method comprising:
obtaining the insertion device (automatic injector 10) of claim 17 (see claim 17 rejection above);
positioning the insertion device (automatic injector 10) proximate the skin of the patient (see Figs. 9, 11, and 15, par. [0076]-[0077]);
depressing the button (trigger button 38 and actuator pin 72) to cause the needle assembly (insertion set 14) to move from the retracted position (see Figs. 9 and 11) to the extended position (see Figs. 5, 7, and 15) (see par. [0076] and [0082]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Safabash et al. (US 2003/0158520 A1) in view of Howell et al. (US 2015/0250944 A1).
Regarding claim 21, Safabash discloses an apparatus (see Figs. 1-16, par. [0072] and [0076]) comprising:
a trigger-type actuator mechanism (outer retainer sleeve 80, trigger button 38, actuator pin 72, and return spring 86) (see par. [0080]-[0084]);
a housing (barrel 28 and main support cap 60) comprising:
a shell (barrel 28) with a distal opening (top opening of main support cap 60) and a proximal opening (bottom opening of barrel 28) spaced apart from the distal opening (top opening of main support cap 60) which seats the trigger-type actuator mechanism (outer retainer sleeve 80, trigger button 38, actuator pin 72, and return spring 86) (see Figs. 1-16);
at least one stop (stops at bottom ends of track slots 52) on an interior surface of the shell (barrel 28) (see Figs. 4-5 and 9, par. [0078], see first 112(b) rejection of claim 21 above); and
a plurality of guide slots (track slots 52) on an interior surface of the shell (barrel 28), wherein each guide slot (track slots 52) includes a boss (boss at bottom end of track slots 52) (see Figs. 4-5 and 9, par. [0078]); and
a carriage (plunger 30) configured to be slidably received within the shell (barrel 28) between an extended position (see Figs. 5, 7, and 15) and a retracted position (see Figs. 9 and 11) (see par. [0076]), the carriage (plunger 30) comprising:
a pillar (plunger head 32) at a center of the carriage (plunger 30) (see Figs. 5, 7, 9, 11);
a plurality of fingers (fingers 100) attached to and extending laterally away from the pillar (plunger head 32), the plurality of fingers (fingers 100) being positioned equidistantly around the pillar (plunger head 32) and configured to releasably receive and retain an insertion needle assembly (insertion set 14) (see Figs. 7, 11, and 15, par. [0084]);
a plurality of first trigger fingers (trigger fingers 58) at a distal end of the carriage (plunger 30) spaced apart from a proximal end of the carriage (plunger 30) (see Fig. 5), the plurality of first trigger fingers (trigger fingers 58) being configured to cooperate with the trigger-type actuator mechanism (outer retainer sleeve 80, trigger button 38, actuator pin 72, and return spring 86), the plurality of first trigger fingers (trigger fingers 58) interacting with a shoulder (shoulder 70) of the distal opening to hold the carriage (plunger 30) in the retracted position (see Figs. 9 and 11) in which a needle forming part of the insertion needle assembly (insertion set 14) is sheathed within the housing (barrel 28 and main support cap 60) against a force of a compressed drive spring (spring 36) (see Figs. 9 and 11, par. [0080]-[0082]), the plurality of first trigger fingers (trigger fingers 58) being compressed in response to activation of the trigger-type actuator mechanism (outer retainer sleeve 80, trigger button 38, actuator pin 72, and return spring 86) so as to release the plurality of first trigger fingers (trigger fingers 58) from the shoulder (shoulder 70) of the distal opening and thereby release the carriage (plunger 30) for spring- loaded travel toward the proximal opening (see Figs. 5, 7, 9, and 11, par. [0080]-[0084]);
a platform (drive stem 54) that is adjacent to a distal end of the pillar (plunger head 32) (see Figs. 5 and 7); a
a plurality of barbs (track arms 48) projecting proximally from the platform (drive stem 54), each barb (track arms 48) including an edge (fingers 50) at a proximal end thereof, the plurality of barbs (track arms 48) being received within the plurality of guide slots (track slots 52) and configured such that the edges (fingers 50) engage the bosses (boss at bottom end of track slots 52) within the guide slots (track slots 52) to limit travel of the carriage (plunger 30) and prevent the carriage (plunger 30) from extending beyond the extended position (see Figs. 4-5 and 9, par. [0078]);
a plurality of trigger arms (trigger arms 56) projecting rearwardly from the platform (drive stem 54) (see Figs. 5 and 9), the plurality of trigger arms (trigger arms 56) each comprising a second trigger finger (trigger fingers 58) that includes strictures that extend laterally away from a centerline of the carriage (plunger 30) proximate a distal end of the second trigger fingers (trigger fingers 58) (see Figs. 5, 7, and 9, par. [0079]-[0080]), the second trigger fingers (trigger fingers 58) being adapted and sized for partial radial compression toward each other and the centerline of the carriage (plunger 30) as the second trigger fingers (trigger fingers 58) pass through the distal opening when the carriage (plunger 30) is displaced from the extended position (see Figs. 5, 7, and 15) to the retracted position (see Figs. 9 and 11), and as the retracted position (see Figs. 9 and 11) is reached, the second trigger fingers (trigger fingers 48) are spring-loaded by resiliency of the plurality of trigger arms (trigger arms 56) to move outwardly to be hooked by an outer face of the shoulder (shoulder 70) of the distal opening (see Figs. 5, 7, and 9, par. [0079]-[0080], see second 112(b) rejection of claim 21 above).
However, Safabash fails to teach the plurality of fingers being made of a flexible material to allow them to expand and draw back radially away from and towards the pillar.
Howell teaches an apparatus (see Figs. 4A-B) comprising a plurality of fingers (wings 50 and teeth 52) made of a flexible material to allow them to expand and draw back radially away from and towards the pillar (needle hub retainer 40) (see Figs. 4A-B, par. [0032] and [0039]).
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 apparatus of Safabash to include that the plurality of fingers are made of a flexible material to allow them to expand and draw back radially away from and towards the pillar, as taught by Howell, as an alternative type of hinge for the fingers to selectively secure and release the needle assembly (see Howell par. [0032] and [0039]).
Response to Arguments
Applicant's arguments filed 2/25/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 1 (regarding Safabash and Thomas not teaching the at least one finger being made of a flexible material which radially compresses/expands) have been fully considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claim 1 (regarding Safabash’s “at least one finger 94” including a pivot pin and being incompatible with a modification to include a flexible/compressible material) have been fully considered but are not persuasive. While Safabash does teach arms 94 which pivot as a hinge around pin 98 (see Safabash par. [0084]), it appears that this configuration could be substituted with another known type of hinge such as a flexible living-hinge as taught by Howell. Safabash does not teach away from the use of living-hinges. Further, Howell’s flexible living hinge (as described in the rejection of claim 1 above) functions in a similar manner as Safabash in that the finger(s) expand to release the needle assembly in the extended position (see Safabash par. [0084], Howell par. [0039]) and the finger(s) close to retain the needle assembly in the retracted position (see Safabash par. [0084], Howell par. [0032]). The Examiner does not agree with Applicant’s assertions that such a modification would change the principle of operation and render the device of Safabash unsatisfactory for its intended purpose because it appears that the modification would involve substituting a known pin-based hinge for a known flexible living-hinge which would allow the at least one finger to open and close in a similar manner and Safabash does not appear to teach away from such a modification. Therefore, the Examiner interprets that such a modification is proper.
Applicant’s arguments with regards to claim 21 (regarding the addition of barbs which are structurally separate from the plurality of trigger arms) have been fully considered but are moot. Claim 21 includes two issues of clarity (see both 112(b) rejections of claim 21 above), including one regarding the interpretation of the plurality of trigger arms. Given the 112(b) rejections and the Examiner’s interpretation of the claims, it appears that Safabash would still teach each of the plurality of barbs and the plurality of trigger arms (see 103 rejection of claim 21 above).
Applicant’s arguments with respect to claim 21 (regarding Safabash’s “at least one finger 94” including a pivot pin and being incompatible with a modification to include a flexible/compressible material) have been fully considered but are not persuasive. These arguments are similar to the arguments described above regarding claim 1, and the Examiner interprets the rejection of claim 21 to be proper for the same reasons described above.
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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/AVERY SMALE/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights