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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/12/2025 has been entered.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered.
Regarding claim 1, Applicant argues that none of the references cited disclose or teach the arrangement of a barrel comprising a cylindrical fluid chamber, a finger flange, and first and second walls extending tangentially from the cylindrical fluid chamber, forwardly from the finger flange, and in parallel, wherein the fluid chamber, the finger flange, and the first and second walls are unitarily molded. This argument is not convincing. As discussed in the prior Office action, Hwang discloses the cylindrical fluid chamber, first wall, and second wall extending tangentially from the fluid chamber and parallel to each other as can be seen in fig. 10, and Wilkinson further teaches the finger flange being unitary with the fluid chamber and first and second walls as can be seen in figs. 1 and 2. These limitations were address in the prior rejection with regard to claims 1 and 11.
Applicant further argues that there is no motivation to combine the references to arrive at the structural relationship of the barrel of the syringe as claimed. This argument is not convincing as motivation for suggested combinations can be found in the prior office action.
Applicant argues that Hwang discloses projections, but that the projections do not extend from the finger flange, and Wilkinson does not disclose any flat walls, and combining Wilkinson with the flat single wall in Halbach would not provide the secondary barrel portion which encloses or encapsulates the actuator rod. Halbach is relied upon to teach the volumetric scale on the wall, and not the wall itself and therefore this argument regarding Halbach is not convincing. Hwang and Wilkinson teach similar structures for guiding a safety device over a needle and Wilkinson teaches that the guide walls extend along the length of the barrel to provide an extended guide surface for the shield.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al (US 2003/0229316) in view of Wilkinson et al (US 2005/0159706).
Regarding claim 1, Hwang discloses a device comprising a barrel 14 comprising a cylindrical fluid chamber, a first wall 24 unitarily molded to and extending tangentially from the cylindrical fluid chamber, and a second wall 24 unitarily molded to and extending tangentially from the cylindrical fluid chamber and parallel to the first wall (figs. 3, 10; page 2, para. 0026), a needle 12 coupled to the barrel and disposed in fluid communication with the cylindrical fluid chamber (fig. 3), and a needle safety device 26 disposed between the first wall and the second wall and slidably engaging each of the first wall and the second wall (figs. 3, 10) between a first stop position (fig. 3) and a second stop position (fig. 4), wherein a front tip of the needle is exposed when the needle safety device is in the first stop position (fig. 3), and at least a portion of the needle safety device is disposed forwardly of the front tip of the needle when the needle safety device is in the second stop position (fig. 4), and wherein the needle safety device engages a slide stop 52, 54 disposed on the first wall and the second wall to prevent subsequent rearward movement of the needle safety device after the needle safety device is moved to the second stop position (page 3, paras. 0037-0039).
Claim 1 differs from Hwang in calling for the device to be a syringe. Wilkinson teaches a device having a barrel, first and second walls, a needle, and a needle safety device similar to that of Hwang and the claimed invention, but further that the needle and safety device are located on a syringe (fig. 1) rather than a blood collection or infusion device disclosed by Hwang. Similar safety concerns regarding sterility and accidental sticks apply to both infusion/collection devices and syringes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hub of Hwang to be a syringe barrel as taught by Wilkinson because the needle safety device of Hwang is useful for protecting the needle of any medical device including a syringe or an infusion/collection device.
Claim 1 further calls for a finger flange, the first wall and the second wall unitarily molded to the finger flange and the cylindrical barrel. Wilkinson further teaches a finger flange disposed at a rear end of the cylindrical fluid chamber, wherein the cylindrical fluid chamber is unitary with the finger flange, the first wall and the second wall, and wherein the walls extend forwardly from the finger flange (figs. 1, 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the unitary finger flange taught by Wilkinson in the combination described above with regard to claim 1 because the finger flange assists the user in easily operating the syringe for movement of the plunger during injection. Additionally, it would have been obvious to extend the walls such that they extend forwardly from the flange as taught by Wilkinson to provide a path for the needle shield that is protected from lateral forces that may damage the shield and prevent it from being extended to the safety position. The claim language “unitarily molded” is interpreted to be a product-by-process limitation. Such limitations are not limited to the recited steps, but rather to the structure implied by the steps. See MPEP 2113. In this case, the structure implied by the step of unitarily molded is a unitary barrel and finger flange. As can be seen in fig. 2 of Wilkinson, the cross-hatching on the barrel and flange imply that these elements are unitary and therefore meet the structure implied by “unitarily molded”.
Regarding claim 2, Hwang discloses an activation handle 40 and a needle tip shield 18 (fig. 4).
Regarding claim 3, Hwang discloses that the needle safety device comprises a pair of longitudinally extending channels (fig. 3: channel formed between vertical portion 40 and side ribs 42).
Regarding claim 4, Hwang discloses that the longitudinally extending channels are disposed on opposite sides of the activation handle (figs. 3).
Regarding claim 5, Hwang discloses that each of the first wall and the second wall comprises a longitudinally extending rail (fig. 10: inward projecting wall above groove 34) and is configured to slidably engage one of the longitudinally extending channels of the needle safety device to allow the needle safety device to slide between the first stop position and the second stop position (figs. 3, 4).
Regarding claim 6, Hwang discloses that the needle tip shield 18 at least partially surrounds the front tip of the needle when the needle safety device is in the second stop position (fig. 4).
Regarding claim 10, Hwang discloses that the first wall and the second wall extend to only one side of the cylindrical fluid chamber (fig. 10).
Regarding claim 11, Wilkinson further teaches that the finger flange is disposed at a rear end of the cylindrical fluid chamber (fig. 1) to provide a surface against which the user may apply pressure to move the syringe plunger. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe described in claim 10 above to include the finger flange at the rear end of the fluid chamber as taught by Wilkinson to increase ease of use of the syringe for delivery of an injection. The claim language “unitarily molded” is interpreted to be a product-by-process limitation. Such limitations are not limited to the recited steps, but rather to the structure implied by the steps. See MPEP 2113. In this case, the structure implied by the step of unitarily molded is a unitary barrel and finger flange. As can be seen in fig. 2 of Wilkinson, the cross-hatching on the barrel and flange imply that these elements are unitary and therefore meet the structure implied by “unitarily molded”.
Regarding claim 12, Hwang discloses that the first wall and the second wall are unitarily molded with the barrel (page 2, para. 0026), and Wilkinson teaches that the flange is unitary with the barrel as discussed above with regard to claim 11. Therefore, the resulting combination described in claim 11 includes the walls, barrel, and flange all unitarily molded to each other.
Claim(s) 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Wilkinson as applied to claim 1 above, and further in view of Halbach (US 11,246,989).
Claim 8 differs from the teachings above in calling for a volumetric scale disposed on at least one of the first wall and the second wall. Halbach teaches a syringe having a wall extending laterally from the barrel, the wall comprising a volumetric scale to allow the user to readily view the scale and provide an accurate dose (col. 3, lines 19-35; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Hwang in view of Wilkinson to include a volumetric scale on the wall as taught by Halbach to increase ease of use for the patient and help prevent dosing errors.
Regarding claim 9, Halbach further discloses that the volumetric scale is not disposed on the cylindrical fluid chamber (fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include this feature in the combination described above with regard to claim 8 so that the scale is located only on the flat surface thereby reducing possibilities that the user may misread the markings and deliver an incorrect dose.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson in view of Halbach in view of Hirsch et al (US 6,213,987).
Regarding claim 13, Wilkinson discloses a syringe 20 comprising a barrel 24 comprising a fluid chamber comprising the cylindrical outer sidewall (fig. 1), a finger flange disposed annularly around the cylindrical outer side wall of the fluid chamber (fig. 1), a first wall extending laterally outward from the cylindrical outer sidewall and forwardly from the finger flange (fig. 1: one side of wall 23), and a second wall extending laterally outward from the cylindrical outer sidewall and forwardly from the finger flange (fig. 1: other side of wall 23), wherein the cylindrical sidewall of the fluid chamber, the finger flange, the first wall and the second wall form a unitary barrel of the syringe (figs. 1, 2), a needle 26 coupled to the barrel and in fluid communication with the fluid chamber (fig. 1), and a needle safety device 22 configured to slide forwardly in a channel formed between he first wall and the second wall from a first use position in which the front tip of the needle is exposed (fig. 1) to a second safe position in which a front tip of the needle is at least partially covered by the needle safety device (fig. 2).
Claim 13 calls for the first and second walls to be parallel to each other. Wilkinson is silent regarding this feature, but appears to show the outwardly extending portions of the first wall and the second wall running parallel to each other. It would have been a matter of obvious design choice to form these walls parallel with a curved connecting portion, rather than as walls curved inwardly because doing so would not change the operation of the device and applicant has not described the parallel walls as having a particular purpose or benefit. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the walls of Wilkinson are either parallel as shown, or that it would have been obvious to modify them to be parallel because doing so would have been a matter of obvious design choice.
Claim 13 differs from the Wilkinson in calling for a volumetric scale disposed on at least one of the first wall and the second wall. Halbach teaches a syringe having a wall extending laterally from the barrel, the wall comprising a volumetric scale to allow the user to readily view the scale and provide an accurate dose (col. 3, lines 19-35; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Wilkinson to include a volumetric scale on the wall as taught by Halbach to increase ease of use for the patient and help prevent dosing errors.
Claim 13 further calls for the fluid chamber, the first wall and the second wall to be unitarily molded. This is interpreted to be a product-by-process limitation. Such limitations are not limited to the recited steps, but rather to the structure implied by the steps. See MPEP 2113. In this case the structure implied by unitarily molded is a unitary structure. Wilkinson teaches that the barrel, the first wall and the second wall are unitary (fig. 1) and therefore the device of Wilkinson meets the structure implied by “unitarily molded.”
Claim 13 further calls for the needle safety device to engage a slide stop disposed on at least one of the first wall and the second wall to prevent subsequent rearward movement of the needle safety device after the needle safety device is moved to the second safe position. Hirsch teaches a needle safety device that engages a slide stop 22 after the needle safety device is moved to the second safe position in order to prevent the needle from becoming uncovered after use (col. 3, lines 17-22; Fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wilkinson to include a slide stop which engages the protrusion 56 on the safety device of Wilkinson as taught by Hirsch to prevent the used needle from becoming uncovered and thereby prevent accidental sticks. Hirsch teaches the stop on the bottom wall rather than the side wall, however, moving the stop to the side wall would have been a matter of obvious design choice as the stop would work equally well at any location around the inner perimeter of the guide walls and Applicant has not provided any specific reason or benefit for the position of the slide stop.
Regarding claims 14 and 15, Halbach teaches that the volumetric scale may be presented on the outwardly facing surface of the front and rear wall adjacent to the cylindrical sidewall (col. 6, lines 5-8). This allows the user to readily read the markings regardless of the orientation in which the user is gripping the syringe, including in either the left or right hand. This teaching applied to the syringe of Wilkinson would result in the volumetric scale on the first and second walls as those are the outwardly facing front and rear surfaces. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Wilkinson to include the volumetric scale on the first wall and the second wall as Halbach teaches the markings on the frontward and rearward faces as this ensures the user can view the volumetric scale regardless of the orientation in which they grip the syringe.
Regarding claim 16, Wilkinson discloses that the first wall and the second wall extend longitudinally along the cylindrical sidewall (fig. 1).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson in view of Halbach as applied to claim 16 above, and further in view of Hwang.
Claim 17 calls for the first wall to comprise a longitudinally extending rail disposed on an inwardly facing surface of the first wall and the second w2all to comprise a longitudinally extending rail disposed on an inwardly facing surface of the second wall. Hwang teaches a needle safety assembly comprising a first wall and a second wall, the walls each comprising a longitudinally extending rail extending from the inwardly facing surface (fig. 10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the walls of Halbach to have inwardly extending rails as taught by Hwang so that the walls can provide a secure surface for receiving the needle shield and reducing lateral play on the shield.
Regarding claim 18, Hwang further teaches a needle safety device having an activation handle 40 having a first channel on the first side and a second channel on a second side (fig. 3: channel between vertical portion 40 and later portion 42). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the safety assembly of Wilkinson to have first and second channels as taught by Hwang to engage the rails and provide engaging portions to guide the shield from the first position to the second position without allowing for lateral movement.
Regarding claim 19, Hwang further teaches that the rails and the walls are engaged with each other to provide a slidable interface for the needle safety device (fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include these engaging features taught by Hwang in the combination described above with regard to claim 18 to allow the shield to slide between the retracted position and the extended position in a guided manner to prevent lateral movement of the shield.
Regarding claim 20, Hwang further teaches an activation surface 28 disposed along the activation handle and above the first channel and the second channel (fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wilkinson to include this feature so that the user can control activation of the shield and thereby ensure that the shield does not deploy unintentionally.
Conclusion
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783