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 17 July 2025 have been fully considered are not persuasive. Applicant argues the cited prior art does not teach “wherein a portion of the sealing element configured to be inserted into the opening of the cylindrical container is arranged inside the mounting portion” stating that since the sealing element (67) of Jansen is located on the actuating portion the device cannot read on the amended claim language. Examiner respectfully disagrees. While the sealing element is formed on the actuating portion, this is exactly what the Applicant shows in figure 3 in which the sealing element is formed on the actuating portion as well. It appear Applicant is attempting to show that figure 3 would have the interior portion of the sealing element that is introduced into the opening 34 a certain degree/depth as allegedly showing the “sealing element” arranged inside the mounting portion. However, this is not the only interpretation of the claim limitation. As show in the annotated figure below, the sealing element portion (67) is arranged to be inserted into the opening of the cylindrical container and arranged radially inside the mounting portion (see annotated figure below, 67 is radially interior to the mounting portion). It would appear this is the only arrangement that would be supported by the figures and specification since the specification does not appear to show a portion of the sealing element would be inserted a certain degree above an element on the mounting portion. The only portion cited as support for the amendment (figure 3) does not even show the device being connected to show degree of insertion.
Further Ryan would still apply in this case when combined with the prior art since Ryan provides protrusions on the thread to facilitate engagement of the two elements using threads more securely ([0127], [0133]). It would have been obvious to a person of ordinary skill in the art to modify the outer thread of Iwase with the Ryan thread protrusion to further secure the threads.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 9, 11-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen (US 6196998) in view of Iwase (US 2017/0197035) further in view of Ryan (US 2017/0203092).
Regarding claim 1, Jansen discloses a closure piece (26) for a releasable closure of an opening (opening of 22) at a distal end of a cylindrical container (12) for pharmaceutical preparations, the closure piece comprising: a cylindrical closure cap (58, figure 5) having a cylindrical cavity (inside cavity of 58, figure 5) configured to receive and retain a sealing element (56, figure 5), the closure cap comprising a mounting portion (upper portion of 58 as depicted in figure 5) which, in a mounted position, faces the container (figure 5, the upper portion faces the container); and the sealing element with a sealing portion (upper portion of 56 as depicted in figure 5, which is arranged at least partially inside the mounting portion (figure 5, the upper portion is inside the mounting portion), an outer edge of the sealing element (tip of projection 50, figure 5) having a rearward offset in relation to an outer edge of the mounting portion (the edge offset from the edge of the mounting portion (see annotated figure below), the sealing element portion (67) is arranged to be inserted into the opening of the cylindrical container and arranged radially inside the mounting portion (see annotated figure below, 67 is radially interior to the mounting portion).
Jansen does not disclose the closure cap has an outer thread configured to connect to a Luer lock fastening of the container, wherein the outer thread is configured according to the standard ISO 594-2, wherein at least one punctiform elevation is extends from a surface of a thread flank of a thread turn of the outer thread.
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Iwase teaches a needle assembly wherein the closure cap has an outer thread (21) configured to connect to a Luer lock fastening (23) of the container (figure 2 and 4), wherein the outer thread is configured according to the standard ISO 594-2 (the thread necessarily conforms to the standard for luer taper for syringes and needles and other medical equipment).
Iwase provides an outer thread and a fastening device on the syringe in order to secure the syringe ([0102]). It would have been obvious to a person of ordinary skill in the art to modify the thread and securing system of Jansen with the thread system of Iwase to secure the needle and connector. Since Jansen already has a functionally equivalent securing system, the modification with Iwase would not hinder the operation of Jansen.
Jansen and Iwase teaches the outer thread, neither teach wherein at least one punctiform elevation extends from a surface of a thread flank of a thread turn.
Ryan discloses thread connectors relatively pertinent to problem posed by Applicant of using threads to connect two elements. Ryan teaches wherein at least one punctiform elevation (3040, figure 23B, [0133]) extends from a surface (surface adjacent the thread) of a thread flank (i.e., a side of the thread) of a thread turn of the outer thread (figure 2).
Ryan provides protrusions on the thread to facilitate engagement of the two elements using threads more securely ([0127], [0133]). It would have been obvious to a person of ordinary skill in the art to modify the outer thread of Iwase with the Ryan thread protrusion to further secure the threads.
Regarding claim 2, Jansen does not explicitly teach wherein the rearward offset of the outer edge of the sealing element in relation to the outer edge of the mounting portion measures at least 0.5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the Jansen offset to have a rearward offset of at least .5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Jansen would not operate differently with the claimed offset and since an end of the needle is intended to reside within the closure cap and the sealing element sealing the needle, the device would function appropriately having the claimed offset.
Regarding claim 3, Jansen discloses wherein the closure cap further comprises an actuating portion (see annotated figure above) arranged opposite the mounting portion, wherein the sealing element is arranged at least partially inside the actuating portion (see annotated figure above, the seal is inside the actuating portion), and wherein the outer edge of the sealing element has a rearward offset in relation to an outer edge (74, see offset in annotated figure above).
Regarding claim 4, while Jansen discloses an outer rib (87), Jansen does not disclose wherein an injection point is arranged at a position on a circumferential surface of the actuating portion of the closure cap at an axial distance from the outer rib.
Iwase teaches a needle assembly wherein an injection point (35, [0060], figure 2) is arranged at a position on a circumferential surface (outer surface of 15) of the actuating portion (opposite to the mounting end depicted in figure 2) of the closure cap. The injection point would be spaced an axial distance from the outer rib when combined with Jansen.
Iwase provides an injection hole to allow communication through the hole to the interior of the connector ([0060]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Jansen with the injection point of Iwase in order to allow communication of material through to the interior of the connector.
Regarding claim 5, Jansen discloses wherein the actuating portion comprises at least two elongate outer ribs (87, figure 3) arranged axially in their main orientation and protruding radially outwards from a circumferential surface (inward surface) of the actuating portion (figure 3 shows the ribs extend radially outward then the circumferential surface).
Regarding claim 6, Jansen does not explicitly teach wherein a ratio of a length of the sealing element to a length of the closure cap is at most 95%.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the Jansen device to have a ratio of a length of the sealing element to a length of the closure cap is at most 95%, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Jansen would not operate differently with the claimed ratio and offset and since an end of the needle is intended to reside within the closure cap and the sealing element sealing the needle, the device would function appropriately having the claimed dimensions.
Regarding claim 7, Jansen discloses the sealing element is made of elastomeric material (col 5, lines 3-7).
Regarding claims 9 and 11-12, Jansen does not disclose wherein the closure cap has an outer thread configured to connect to a Luer lock fastening of the container, wherein the outer thread is configured as a trapezoidal thread, wherein an axial bulge is provided on a portion of the thread turn lying next to a thread entry, wherein the thread turn comprises a bevel.
Iwase teaches a needle assembly wherein the closure cap has an outer thread (21) configured to connect to a Luer lock fastening (23) of the container (figure 2 and 4), wherein the outer thread is configured as a trapezoidal thread (figure 3, 21 appears to be trapezoidal), wherein an axial bulge is provided on a portion of the thread turn lying next to a thread entry (the thread buldges out in order to have corresponding thread enter, figures 2-3), wherein the thread turn comprises a bevel (figure 3 shows the thread with beveled surface).
Iwase provides an outer thread and a fastening device on the syringe in order to secure the syringe ([0102]). It would have been obvious to a person of ordinary skill in the art to modify the thread and securing system of Jansen with the thread system of Iwase to secure the needle and connector. Since Jansen already has a functionally equivalent securing system, the modification with Iwase would not hinder the operation of Jansen.
Regarding claim 13, Jansen discloses wherein the closure cap has a continuous opening (figure 5) but does not explicitly teach wherein a wall thickness of the closure cap at least one of is at most 1.5 mm at a thickest point or varies by not more than 0.5 mm as seen along a length of the closure cap.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the Jansen device to have a wall thickness of the closure cap at least one of is at most 1.5 mm at a thickest point or varies by not more than 0.5 mm as seen along a length of the closure cap, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Jansen would not operate differently with the thickness since an end of the needle is intended to reside within the closure cap and the sealing element can seal the needle if properly spaced, the device would function appropriately having the claimed dimensions.
Regarding claim 14-15, Jansen discloses wherein the continuous opening of the closure cap has at least two elongate inner ribs (80) arranged axially in their main orientation and protruding inwardly on an inner wall, and the width or cross section of the inner ribs is constant over at least 50% of the length of the two ribs (figure 5, ribs appear to have same width/cross sectional dimension), but does not teach wherein the inner ribs have a width of less than 1 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the Jansen inner ribs to have a width of less than 1 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Jansen would not operate differently with the rib width since the ribs are meant to secure the sealing element and properly seal the opening of the syringe, the device would function appropriately having the claimed dimensions.
Regarding claim 16, Jansen does not explicitly teach wherein an axial distance between an outer stop (85) and an inner stop (44) of the closure cap measures 2.85 mm with a tolerance of +/- 0.2 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the Jansen axial offset to measures 2.85 mm with a tolerance of +/- 0.2 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Jansen would not operate differently with the axial distance since an end of the needle is intended to reside within the closure cap and the sealing element can seal the needle if properly spaced, the device would function appropriately having the claimed dimensions.
Regarding claim 19, Jansen discloses a method for contamination-free, releasable closure of a distal end of a cylindrical container (12) for pharmaceutical preparations, the method comprising: closing the distal end of the container with a closure piece (26, figure 5), the closure piece comprising: a cylindrical closure cap (58, figure 5) having a cylindrical cavity (inside cavity of 58, figure 5) configured to receive and retain a sealing element (56, figure 5), the closure cap comprising a mounting portion (upper portion of 58 as depicted in figure 5) which, in a mounted position, faces the container (figure 5, the upper portion faces the container); and the sealing element with a sealing portion (upper portion of 56 as depicted in figure 5, which is arranged at least partially inside the mounting portion (figure 5, the upper portion is inside the mounting portion), an outer edge of the sealing element (tip of projection 50, figure 5) having a rearward offset in relation to an outer edge of the mounting portion (the edge offset from the edge of the mounting portion (see annotated figure above), the sealing element portion (67) is arranged to be inserted into the opening of the cylindrical container and arranged radially inside the mounting portion (see annotated figure below, 67 is radially interior to the mounting portion).
Jansen does not disclose wherein the closure cap has an outer thread configured to connect to a luer lock fastening of the container, wherein the outer thread is configured according to the standard ISO 594-2, wherein at least one punctiform elevation extends from a surface of a thread flank of a thread turn.
Iwase teaches a needle assembly wherein the closure cap has an outer thread (21) configured to connect to a Luer lock fastening (23) of the container (figure 2 and 4), wherein the outer thread is configured according to the standard ISO 594-2 (the thread necessarily conforms to the standard for luer taper for syringes and needles and other medical equipment).
Iwase provides an outer thread and a fastening device on the syringe in order to secure the syringe ([0102]). It would have been obvious to a person of ordinary skill in the art to modify the thread and securing system of Jansen with the thread system of Iwase to secure the needle and connector. Since Jansen already has a functionally equivalent securing system, the modification with Iwase would not hinder the operation of Jansen.
Jansen and Iwase teaches the outer thread, neither teach wherein at least one punctiform elevation extends from a surface of a thread flank of a thread turn.
Ryan discloses thread connectors relatively pertinent to problem posed by Applicant of using threads to connect two elements. Ryan teaches wherein at least one punctiform elevation (3040, figure 23B, [0133]) extends from a surface (surface adjacent the thread) of a thread flank (i.e., a side of the thread) of a thread turn of the outer thread (figure 2).
Ryan provides protrusions on the thread to facilitate engagement of the two elements using threads more securely ([0127], [0133]). It would have been obvious to a person of ordinary skill in the art to modify the outer thread of Iwase with the Ryan thread protrusion to further secure the threads.
Regarding claim 20, Jansen does not explicitly teach wherein at least one of a tightening torque or an opening torque has a slight variance of +/- 1.0 N*cm in relation to a respectively required torque.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the Jansen to have an opening or tightening torque of +/- 1.0 N*cm in relation to a respectively required torque, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Jansen would not operate differently with tightening/opening torque since the required torque would allow the device to close/open as desired by the user, the device would function appropriately having the claimed torque.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Iwase further in view of in view of Ryan further in view of Okihara (US 2016/0184529).
Regarding claim 17-18, Jansen, Iwase and Ryan do not specifically disclose wherein the closure piece comprises a color-stable plastic and wherein a color of the closure piece is green grey and corresponds to the tone RAL 7009 according to the RAL color system. However, it would have been obvious to a person of ordinary skill in the art to select a desired color for the closure in accordance to tone. There does not appear to be any functional relationship between the color and the product.
Okihara teaches a syringe (10) with a cap (34) wherein the material used is a color stable plastic ([0039], [0045], acrylic is color stable).
Okihara provides suitable materials in order to achieve a desired material property ([0039], [0012]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Jansen with material of Okihara in order to achieve desired material property.
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/ Primary Examiner, Art Unit 3781