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 Arguments
Applicant's arguments filed 3/16/2026 have been fully considered.
Applicant argues that Hwang fails to teach the rear end of the barrier arm engaging a projection, and Wilkinson also fails to remedy this shortcoming. The examiner agrees with this characterization of Hwang and Wilkinson. Therefore, the amendment to claim 1 overcomes the prior rejection. However, previously cited Hirsch et al (US 6,213,987) teaches a slide stop 21 engaging the rear end of the shield arm (fig. 6).
Information Disclosure Statement
The IDSes filed 2/19/2026 and 6/30/2026 include numerous documents where the document number and the provided inventor and publication date do not correspond. These documents have been lined through.
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 Hirsch et al (US 6,213,987) in view of Wilkinson et al (US 2005/0159706).
Regarding claim 1, Hirsch discloses a syringe, comprising: a barrel 1 comprising a cylindrical fluid chamber, a finger flange 6, a first wall 15 and a second wall 15 (figs. 2, 3) extending parallel to each other (fig. 3) and extending tangentially from the cylindrical fluid chamber (fig.2), a needle 3 coupled to the barrel and disposed in fluid communication with the cylindrical fluid chamber (fig. 1); and a needle safety device 23 disposed between the first wall and the second wall and slidably engaging each of the first wall and the second wall between a first stop position (fig. 1) and a second stop position (fig. 1), wherein a front tip of the needle is exposed when the needle safety device is in the first stop position (fig. 1), wherein 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. 2), and wherein a rear end of the needle safety 24 device engages a slide stop 21 to prevent subsequent rearward movement of the needle safety device after the needle safety device is moved to the second stop position (col. 3, lines 17-22).
Claim 1 differs from Hirsch in calling for the first wall to be unitarily molded to each of the cylindrical fluid chamber and the finger flange and extending tangentially from the cylindrical fluid chamber and forwardly from the finger flange, and the second wall to be unitarily molded to each of the cylindrical fluid chamber and the finger flange and extending tangentially from the cylindrical fluid chamber, forwardly from the finger flange. 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. Wilkinson teaches a syringe having a safety device wherein the syringe includes a first wall and a second wall extending tangentially from the barrel and fowardly from the flange (fig. 1), wherein these elements for a unitary structure with the cylindrical barrel. This configuration ensures that the needle remains protected after use and prevents reuse of the syringe barrel thereby preventing the spread of disease. Furthermore, it has been held that he use of a one piece construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice. See MPEP 2144.04(V)(B). 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 device of Hirsch to make the first and second walls integral with the syringe barrel as taught by Wilkinson to prevent removal of the needle shield and reuse of the syringe, and further because doing so would have been a matter of obvious engineering choice.
Wilkinson further teaches that the slide stop is located on the wall (fig. 2). 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 slide stop of Hirsch to be located on either the first and second wall as taught by Wilkinson as the stop would work equally well in either location and the bottom wall of Hirsch is eliminated in the modification described above in which the first and second walls are integral with the barrel and thereby to preserve the function of the stop the location will be moved as taught by Wilkinson.
Regarding claim 2, Hirsch discloses an activation handle 31 and a needle tip shield 25 (fig. 2).
Regarding claim 3, Hirsch discloses that the needle safety device comprises a pair of longitudinally extending channels (fig. 4: channel formed by rails 15A).
Regarding claim 4, Hirsch discloses that the longitudinally extending channels are disposed on opposite sides of the activation handle (figs. 3).
Regarding claim 5, Hirsch discloses that each of the first wall and the second wall comprises a longitudinally extending rail 27 (fig. 6) 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, 6).
Regarding claim 6, Hirsch discloses that the needle tip shield 25 at least partially surrounds the front tip of the needle when the needle safety device is in the second stop position (fig. 2).
Regarding claim 10, Hirsch in view of Wilkinson as discussed above with regard to claim 1 teach that the first wall and the second wall extend to only one side of the cylindrical fluid chamber (Wilkinson fig. 2).
Regarding claim 11, Hirsch discloses that the finger flange 6 is disposed at a rear end of the cylindrical fluid chamber (fig. 3) to provide a surface against which the user may apply pressure to move the syringe plunger, and the flange is integral with the cylindrical fluid chamber (col. 2, lines 57-60). 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. This is the structure disclosed by Hirsch.
Regarding claim 12, Hirsch discloses that the flange is unitary with the cylindrical chamber as discussed above with regard to claim 11. Wilkinson teaches that the first wall, the second wall, and the cylindrical chamber are unitary as discussed with regard to claim 1 above. Therefore, the resulting combination includes the fluid chamber, the finger flange, the first wall and the second wall being unitary. 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 is unitary as discussed above.
Claim(s) 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirsch 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 Hirsch 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) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirsch in view of Wilkinson in view of Halbach.
Regarding claim 13, Hirsch discloses a syringe, comprising: a barrel 1 comprising a fluid chamber comprising a cylindrical outer sidewall (fig. 1), a finger flange 6 disclosed annularly around the cylindrical outer sidewall of the fluid chamber (fig. 3), a first wall 15 and a second wall 15 (figs. 2, 3) extending parallel to each other (fig. 3), the finger flange and the barrel being unitarily formed (col. 2, lines 56-57), a needle 3 coupled to the barrel and disposed in fluid communication with the cylindrical fluid chamber (fig. 1); and a needle safety device 23 configured to slide forwardly in a channel formed between the first sidewall and the second side wall (figs. 3, 4, 6) from a first use position in which a 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), wherein a rear end of the needle safety 24 device engages a slide stop 21 to prevent subsequent rearward movement of the needle safety device after the needle safety device is moved to the second stop position (col. 3, lines 17-22).
Claim 13 differs from Hirsch in calling for the first wall and the second wall to be unitarily molded to each of the cylindrical fluid chamber and the finger flange. 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. Wilkinson teaches a syringe having a safety device wherein the syringe includes a first wall and a second wall extending tangentially from the barrel and fowardly from the flange (fig. 1), wherein these elements for a unitary structure with the cylindrical barrel. This configuration ensures that the needle remains protected after use and prevents reuse of the syringe barrel thereby preventing the spread of disease. Furthermore, it has been held that he use of a one piece construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice. See MPEP 2144.04(V)(B). 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 device of Hirsch to make the first and second walls integral with the syringe barrel as taught by Wilkinson to prevent removal of the needle shield and reuse of the syringe, and further because doing so would have been a matter of obvious engineering choice.
Wilkinson further teaches that the slide stop is located on the wall (fig. 2). 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 slide stop of Hirsch to be located on either the first and second wall as taught by Wilkinson as the stop would work equally well in either location and the bottom wall of Hirsch is eliminated in the modification described above in which the first and second walls are integral with the barrel and thereby to preserve the function of the stop the location will be moved as taught by Wilkinson.
Claim 13 differs from Hirsch 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 Hirsch 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 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 Hirsch in view 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 Hirsch in view 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, Hirsch discloses that the first wall and the second wall extend longitudinally along the cylindrical sidewall (fig. 1).
Regarding claim 17, Hirsch discloses that the first wall and the second wall include longitudinally extending rails 15A on an inwardly facing surface of the wall (fig. 4).
Regarding claim 18, Hirsch discloses that the needle safety device includes an activation handle 28 having a first channel disposed on a first side and a second channel disposed on a second side (fig. 6: channels formed between horizontal portion 27 and vertical portion 28).
Regarding claim 19, Hirsch discloses that the rails are configured to engage the channels to provide a slidable surface for the needle safety device (figs. 3, 4, 6).
Regarding claim 20, Hirsch discloses that the needle safety device comprises an activation surface 31 above the first channel and the second channel (fig. 6).
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach or fairly suggest the combination of the rail and the stop as claimed, in combination with the features of the invention, substantially as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
