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
The amendment filed 05 February 2026 has been entered. Claim(s) 1-14 remain pending in the application with claims 1-4 and 11-14 withdrawn as directed to a non-elected species. Applicant’s amendments to the claims have overcome each and every objection to the claims previously set forth in the Office Action mailed 05 September 2025.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5-10 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Suzuki (US 20020156424 A1).
Regarding claim 5, Suzuki discloses a needle guard (Needle covering member 30) comprising:
a housing (32);
a first wing extending through a first opening in the housing (One manipulation piece of the pair of manipulation pieces 34 which extends through a first opening in the housing 32);
a second wing extending through a second opening in the housing (The other manipulation piece of the pair of manipulation pieces 34 which extends through a second opening in the housing 32); and
a hollow tube attached to the housing (Syringe 20),
wherein a middle portion of the first wing is pivotally attached to the housing and the first wing is configured to move independently between a first position and a second position (See Figs. 1-4—applying a force along the manipulation lines G to the manipulation pieces 34 causes the lower stopper portions 34a to release and expose a needle 10, while, when no force is applied along the manipulation lines G, the stopper portions of the manipulation pieces house the needle in a stopped state; paragraph 0023, 0066-0067), and
wherein a middle portion of the second wing is pivotally attached to the housing and the second wing is configured to move independently between a first position and a second position (See Figs. 1-4—applying a force along the manipulation lines G to the manipulation pieces 34 causes the lower stopper portions 34a to release and expose a needle 10 while, when no force is applied along the manipulation lines G, the stopper portions of the manipulation pieces house the needle in a stopped state; paragraph 0023, 0066-0067).
It is noted with respect to each wing moving “independently” that each wing moves at an end to support the capture or release the needle based on the movement of an opposite end of that wing (See Figs. 1-4 and Paragraphs 0065-0067, 0070-0075 which demonstrate that a load must be applied to each respective wing, such that the wings each may be seen to move independently versus an alternative configuration which moves both wings based on a load applied to only one wing).
Regarding claim 6, Suzuki discloses the needle guard of claim 5. Suzuki additionally discloses wherein the housing and hollow tube are configured to receive a needle therethrough (Paragraph 0023; needle 10).
Regarding claim 7, Suzuki discloses the needle guard of claim 6. Suzuki additionally discloses wherein a surface of the first and second wings does not contact an outer surface of the needle when in the first position (paragraph 0023, 0029-- the stopped state by the stopper portion (34a) is released the protector (32) from, to which it has been brought, by manipulating the manipulation piece (34) and exposing the needle (10) covered with the protector (32) through the housing opening (32a) such when being released from the stopped state, the manipulation pieces would not contact an outer surface of the needle; also shown in an disengaged configuration in Fig. 2).
Regarding claim 8, Suzuki discloses the needle guard of claim 7. Suzuki additionally discloses wherein the surface of the first and second wings contacts the outer surface of the needle when in the second position (Figs. 1, 3-4; paragraph 0023-0024, 0058-0061-- After injection, in order to prevent a needle prick accident, the needle (10) is housed again in the protector (32), and the stopper portion (34a) is made to intersect the needle (10) so that the needle (10) may not be exposed).
Regarding claim 9, Suzuki discloses the needle guard of claim 6. Suzuki additionally discloses wherein the first and second wings lock a portion of the needle within the housing when in the second position (Figs. 1, 3-4; paragraph 0023-0024, 0058-0061-- After injection, in order to prevent a needle prick accident, the needle (10) is housed again in the protector (32), and the stopper portion (34a) is made to intersect the needle (10) so that the needle (10) may not be exposed).
Regarding claim 10, Suzuki discloses the needle guard of claim 6. Suzuki additionally discloses wherein a sharpened distal end of the needle is locked within the housing when the first and second wings are in the second position (Figs. 1, 3-4; paragraph 0023-0024, 0058-0061-- After injection, in order to prevent a needle prick accident, the needle (10) is housed again in the protector (32), and the stopper portion (34a) is made to intersect the needle (10) so that the needle (10) may not be exposed).
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.
Claim(s) 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders (cited above).
Regarding claim 5, Sanders discloses a needle guard (Needle safety device 10), comprising:
a housing (Housing 20 and retractable sleeve 50);
a first wing extending (Wing 70) through a first opening in the housing (Opening in sidewall 56, Figs. 20A-20B); and
a hollow tube attached to the housing (Hub 40; paragraph 0100-0101—hub 40 configured to couple to a syringe…hub 40 may be configured to be removable or permanently attached to a syringe, or alternatively, hub 40 may be integrally formed with a syringe…),
wherein a middle portion (A middle portion of the wing stretching from proximal end 91 through pivot point of flap 76, seen as an elongated portion beginning at the recess 56 in Figs. 20A-20B) of the first wing is pivotally attached to the housing (Paragraph 0165—Proximal end 91 of the locking member 70 is connected to a sidewall 56…) and the first wing is configured to move independently between a first position and a second position (See Figs. 20A-20B).
Sanders does not disclose that this embodiment includes a second wing extending through a second opening in the housing, wherein a middle portion of the second wing is pivotally attached to the housing and the second wing is configured to move independently between a first position and a second position.
However, while Sanders does not disclose a second wing having the same structure and movability as the first wing as claimed, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the needle guard of Sanders to include such as a second wing as a matter of duplication of parts. It is noted that the courts have held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced.” See MPEP 2144.04 VI. B. Duplication or Rearrangement of Parts. In this case, the result produced by duplicating the wing structure would not be new and unexpected as it would instead serve as merely another needle retaining structure which would prevent accidental needle-sticks as evidenced by the embodiment of Fig. 19 of Sanders which includes two wing structures for retaining a needle in the housing.
Furthermore, it is noted that such a wing would necessarily operate independently, as the first wing is described by Sanders in a configuration where it is the only wing and thus moves independently, and that a duplication of this element to provide an additional wing would follow the same structure and ability to be moved between positions without affecting other elements (such as the first wing).
Regarding claim 6, Sanders discloses the needle guard of claim 5. Sanders additionally discloses wherein the housing and hollow tube are configured to receive a needle therethrough (Needle 42 having distal tip 44).
Regarding claim 7, Sanders discloses the needle guard of claim 5. Sanders additionally discloses wherein a surface of the first and second wings does not contact an outer surface of the needle when in the first position (See Fig. 20A—the inner surface of the wing 70 does not contact the needle in the first position).
Regarding claim 8, Sanders discloses the needle guard of claim 5. Sanders additionally discloses wherein the surface of the first and second wings contacts the outer surface of the needle when in the second position (see Fig. 20B—the inner surface of wing 70 will contact the outer surface of the needle in the second position if the needle if pushed forward, preventing accidental needle sticks; paragraph 0165--When the needle cannula 42 is removed from the subject or patient, and the sheath or sleeve 50 moves in a distal direction, and the V-shaped biasing member slides past the needle cannula 42 the locking member 70 in the form of a lockout latch covers the distal tip 44 of the needle cannula 42 in the extended position).
Regarding claim 9, Sanders discloses the needle guard of claim 5. Sanders additionally discloses wherein the first and second wings lock a portion of the needle within the housing when in the second position (see Fig. 20B—the inner surface of wing 70 will contact the outer surface of the needle in the second position if the needle if pushed forward, preventing accidental needle sticks; paragraph 0165--Locking member 70 in the form of a lockout latch is able to clip over the distal tip 44 of the needle cannula 42 thereby passively locking out the safety needle device 10 and preventing needle stick injury to the practitioner).
Regarding claim 10, Sanders discloses the needle guard of claim 5. Sanders additionally discloses wherein a sharpened distal end of the needle is locked within the housing when the first and second wings are in the second position(see Fig. 20B—the inner surface of wing 70 will contact the outer surface of the needle in the second position if the needle if pushed forward, preventing accidental needle sticks; paragraph 0165--Locking member 70 in the form of a lockout latch is able to clip over the distal tip 44 of the needle cannula 42 thereby passively locking out the safety needle device 10 and preventing needle stick injury to the practitioner…The locking member 70 in the form of the lockout latch inhibits reuse of the safety needle device 10 by inhibiting further translational movement of the retractable sleeve 50 within the housing body 23 by covering the distal tip 44 of the needle cannula 42 in the extended position).
Response to Arguments
Applicant's arguments filed 05 February 2026 with respect to the rejections of the claims under 35 U.S.C. 102 in view of Suzuki have been fully considered but they are not persuasive.
Applicant argues that the wings or manipulation pieces of Suzuki do not disclose “extending through” respective openings in the housing because of descriptions of the pieces as “integrated into the protector”, “provided” at the manipulation opening, and “parts projecting from the manipulation opening”.
However, the integration of the manipulation pieces with the housing does not preclude these pieces from extending through openings in the housing. Contrary to applicant’s arguments, “extending through” does not require that the wings be separate structural elements that pass-through openings in the housing wall, but merely requires that the claimed element includes some portion which passes through an opening. Figs. 1-4, particularly Figs. 1a and 3a-3c, of Suzuki demonstrate various configurations of manipulation pieces 34 which show an elongated structure which clearly passes through an opening in the housing while attaching at a midway point of the piece. Furthermore, the description of “parts projecting from the manipulation opening” refers not to the entire manipulation piece, but to a part of each manipulation piece which projects outwardly to be manipulated by a user, such that there remains an additional part of each manipulation piece which passes through the opening and into the inner part of the housing to engage with the needle as evidenced by the figures and the full context of paragraphs 0066-0067. This is additionally supported by paragraph 0059 and 0089, which describes opposing ends of each manipulation piece as projecting from the manipulation opening and from the housing space, respectively, such that the pieces each project in both directions, which may be seen as extending through the opening. Additionally “provided” merely describes the location of the manipulation pieces at the opening versus at some alternative position of the housing and makes no indication of whether the pieces do or do not pass through the opening itself.
Applicant's arguments filed 05 February 2026 with respect to the rejections of the claims under 35 U.S.C. 103 in view of Sanders have been fully considered but they are not persuasive.
The applicant argues that the inclusion of independent movement of the first and second wings in the claims would produce an unexpected result which would be fundamentally different from the functional capability of duplicating Sanders’ single wing mechanism.
However, it is not seen that it would be an unexpected function for such a duplication to produce independently moving wings. A second wing produced via duplication would necessarily operate independently, as the first wing is described by Sanders in a configuration where it is the only wing and thus moves independently, and duplication of this element to provide an additional wing would follow the same structure and ability to be moved between positions without affecting other elements (such as the first wing).
Applicant’s arguments, see page 6-7 of applicant's remarks, filed 05 February 2026, with respect to the rejection of the claims under 35 U.S.C. 102 in view of Sanders have been fully considered and are persuasive. The rejection of claims 5-10 under 35 U.S.C. 102 in view of Sanders has been withdrawn.
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 ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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