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 .
Acknowledgment
Claims 6, 13, 15are amended and field on 6/16/2026
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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.
Claim(s) 1-5, 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sacco (US. 5061248)
Re Claim 1, Sacco discloses a safety device (10, Fig. 1-2) for a drug delivery system (lower portion of 12, abstract), the safety device comprising: a first member (30) including a first arm (rim of 30, Fig. 2) having a first end (close to 33, Fig. 2), a second end (close to 52), and a length extending therebetween (Fig. 2), the second end of the first member defining a first wall region (56), the first member further including a first guard (portion from rim 30 to 40) positioned at or near the second end of the first arm (Fig. 2); a second member (rim of 31, Fig.2) adapted to be rotatably coupled with the first member (Col. 2, lines 25-41, Fig.2), the second member including a second arm ( 31) having a first end (close to 35), a second end (close to 50), and a length extending therebetween (Fig. 2), the second end of the second member defining a second wall region (wall of 55), a second guard positioned (portion from rim 31 to 41) at or near the second end of the second arm (Fig.2), and a needle guide member (left and right of 28) positioned at or near the second end of the second arm (Fig. 2); wherein upon rotatably positioning the second end of the first member near or adjacent to the second end of the second member (Fig. 2), the first wall region of the first member and the second wall region of the second member cooperate to define a container connector receptacle (41 and 40 connect top 12 and or IV container Col, 1, line 66 up to Col 2, lines 5), and the first guard of the first member and the second guard of the second member cooperate to define a hand guard (disc 30, 31, Col. 2, lines 16-26).
Re Claim 2, Sacco discloses wherein the needle guide member includes a body defining an opening (41, 40, Fig. 2) therethrough dimensioned to slidably receive and align a needle ( lower portion of 12).
Re Claim 3, Sacco discloses wherein the needle guide member includes a first side having a tapered guiding region (tapers ribs 41).
Re Claim 4, Sacco discloses wherein at least one of the first wall region or the second wall region includes at least one locking ledge (50, 52).
Re Claim 5, Sacco discloses wherein the first end of the first member is adapted to pivot relative to the first end of the second member (36 is a hinge, Col. 2, lines 35-41).
Re Claim 7, Sacco discloses wherein the hand guard comprises a disk extending in a radial direction (30 , 31, Fig. 2).
Re Claim 8, Sacco discloses wherein at least one of the first guard or the second guard includes a notched region (lower portion of 41 and 40) positioned along an outer periphery thereof to accommodate at least a portion of a second container connector ( connected that are hole by 25 and outer of lower portion of 12).
Re Claim 9, Sacco discloses wherein the safety device is constructed from a plastic material (Col. 2, lines 35-41).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sacco in view of Raines (US. 20030105449A1).
Re Claim 6, Sacco fails to disclose wherein the first end of the first member includes a throughbore and the first end of the second member includes a throughbore, the safety device further comprising a rod member adapted to be inserted through the through bore of the first member and the throughbore of the second member.
However, Raines discloses a needle shield (Figs. 1-3) and wherein the first end of the first member (22) includes a throughbore (hole 29) and the first end (close to 26) of the second member (26, 20) includes a throughbore (28), the safety device further comprising a rod member (24) adapted to be inserted through the through bore of the first member and the throughbore of the second member (Fig, 1)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify hinge of Sacco so that the first end of the first member includes a throughbore and the first end of the second member includes a throughbore, the safety device further comprising a rod member adapted to be inserted through the through bore of the first member and the throughbore of the second member as taught by Raines for the purpose of allowing easy with low friction movement between the first and second members (Raines, ¶0023).
Claim(s) 10-13, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sacco in view of Giuliano et al. (US. 20050059952A1) (“Giuliano”).
Re Claim 10, Sacco discloses a drug delivery system including: a prefilled delivery container ( IV container Col, 1, line 66 up to Col 2, lines 5) and a safety device (10, Fig. 1-2) for a drug delivery system (lower portion of 12, abstract), the safety device including a first member (30) including a first arm (rim of 30, Fig. 2) having a first end (close to 33, Fig. 2), a second end (close to 52), and a length extending therebetween (Fig. 2), the second end of the first member defining a first wall region (56), the first member further including a first guard (portion from rim 30 to 40) positioned at or near the second end of the first arm (Fig. 2); a second member (rim of 31, Fig.2) adapted to be rotatably coupled with the first member (Col. 2, lines 25-41, Fig.2), the second member including a second arm ( 31) having a first end (close to 35), a second end (close to 50), and a length extending therebetween (Fig. 2), the second end of the second member defining a second wall region (wall of 55), a second guard positioned (portion from rim 31 to 41) at or near the second end of the second arm (Fig.2), and a needle guide member (left and right of 28) positioned at or near the second end of the second arm (Fig. 2); wherein the first wall region of the first member and the second wall region of the second member cooperate to define a container connector receptacle (41 and 40 connect top 12 and or IV container Col, 1, line 66 up to Col 2, lines 5) adapted to accommodate at least a portion of the container connector (iv bag and the connector is the upper portion of 12), and the first guard of the first member and the second guard of the second member cooperate to define a hand guard (disc 30, 31, Col. 2, lines 16-26), but it fails to discloses that the container including a container body defining an interior cavity and at least one opening to permit access to the interior cavity; a container connector operably coupled with the at least one opening to selectively restrict access to the interior cavity.
However, Giuliano discloses I.V container (Fig. 1-6, abstract, ¶0040) including a container body (body of 10) defining an interior cavity ( chamber 22, ¶0040) and at least one opening (24 or 26) to permit access to the interior cavity (¶0040, ¶0045); a container connector (50 or 44) operably coupled with the at least one opening to selectively restrict access to the interior cavity (¶0044, ¶0045).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify hinge of Sacco so that the container including a container body defining an interior cavity and at least one opening to permit access to the interior cavity; a container connector operably coupled with the at least one opening to selectively restrict access to the interior cavity as taught by Giuliano for the purpose of accessing the chamber as desired from the self-sealed opening (Giuliano, ¶0040).
Re Claim 11, Sacco discloses wherein the needle guide member includes a body defining an opening (41, 40, Fig. 2) therethrough dimensioned to slidably receive and align a needle ( lower portion of 12).
Re Claim 12, Sacco discloses wherein the needle guide member includes a first side having a tapered guiding region (tapers ribs 41).
Re Claim 13, Sacco discloses wherein at least one of the first wall region or the second wall region includes at least one locking ledge (50, 52) adapted to retain and permit axial movement of the at least a portion of the container connector (are capable to retain and permit axial movement (thread portion is capable to be coupled to the container connector).
Re Claim 16, Sacco discloses wherein the hand guard comprises a disk extending in a radial direction (30 , 31, Fig. 2).
Re Claim 17, Sacco discloses wherein the prefilled delivery container further includes a second container connecter ( connector hold by hand 25, Fig. 1) and wherein at least one of the first guard or the second guard includes a notched region (lower portion of 41 and 40) positioned along an outer periphery thereof to accommodate at least a portion of a second container connector ( connected that are hole by 25 and outer of lower portion of 12).
Re Claim 9, Sacco discloses wherein the safety device is constructed from a plastic material (Col. 2, lines 35-41).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sacco in view of Giuliano and further in view of Raines (US. 20030105449A1).
Re Claim 14, Sacco discloses wherein the first end of the first member is adapted to pivot relative to the first end of the second member (36 is a hinge, Col. 2, lines 35-41), but it fails to disclose that the second member includes a throughbore.
However, Raines discloses a needle shield (Figs. 1-3) and wherein the first end of the first member (22) includes a throughbore (hole 29) and the first end (close to 26) of the second member (26, 20) includes a throughbore (28), the safety device further comprising a rod member (24) adapted to be inserted through the through bore of the first member and the throughbore of the second member (Fig, 1)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify hinge of Sacco so that that the second member includes a throughbore as taught by Raines for the purpose of allowing easy with low friction movement between the first and second members (Raines, ¶0023).
Re Claim 15, Sacco fails to disclose wherein the first end of the first member includes a throughbore and the first end of the second member includes a throughbore , the safety device further comprising a rod member adapted to be inserted through the throughbore of the first member and the throughbore of the second member.
However, Raines discloses a needle shield (Figs. 1-3) and wherein the first end of the first member (22) includes a throughbore (hole 29) and the first end (close to 26) of the second member (26, 20) includes a throughbore (28), the safety device further comprising a rod member (24) adapted to be inserted through the through bore of the first member and the throughbore of the second member (Fig, 1)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify hinge of Sacco so that the first end of the first member includes a throughbore and the first end of the second member includes a throughbore, the safety device further comprising a rod member adapted to be inserted through the through bore of the first member and the throughbore of the second member as taught by Raines for the purpose of allowing easy with low friction movement between the first and second members (Raines, ¶0023).
Response to Arguments
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive.
The applicant argues that Sacco’s throughbore will not slide along the line due to the ribs 41 which serve to grip the line and lack ant tapered guiding surface. This is found not persuasive as the claim was not claiming such function “slide along the line and guiding the line. However, the ribs 41 has a tapered and just before firmly attached to the line, the it can be position and move along the line to the right position.
- the applicant is asked to further define the device structurally and/ or further define the function of the guide ..etc.
Conclusion
THIS ACTION IS MADE FINAL. 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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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