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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 November 2025 has been entered.
Drawings
The drawings were received on 24 October 2025. These drawings are unacceptable and have not been entered. There drawings are not in compliance with 37 CFR 1.121(d) as not all figures appearing on the immediate prior entered version of the sheets are included. No replacement sheet has the figure appearing on the immediate prior entered version of the sheet. It appears that original sheet one which had two figures has been improperly broken out into multiple sheets.
The legends are not approved by the Office. Legends should contain as few words as possible and only be present where necessary for understanding of the drawing. See MPEP 608.02 V. (o).
The drawings are objected to as failing to comply with C.F.R 1.84(u)(1) because the different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear. MPEP 608.02 V. See original sheet 1/4.
The drawings are objected to as failing to comply with C.F.R 1.84(u)(2) because the view numbers must be larger than the numbers used for reference characters. MPEP 608.02 V.
The drawings are objected to as failing to comply with 37 C.F.R. 1.84(q) because lead lines must not cross each other. MPEP 608.02 V. See original sheet 1.
The drawings are objected to as failing to comply with C.F.R 1.84(h)(3) because the plane upon which a sectional view is taken should be indicated on the view from which the section is cut by a broken line. The ends of the broken line should be designated by Arabic or Roman numerals corresponding to the view number of the sectional view, and should have arrows to indicate the direction of sight. Hatching must be used to indicate section portions of an object, and must be made by regularly spaced oblique parallel lines spaced sufficiently apart to enable the lines to be distinguished without difficulty. MPEP 608.02 V. See B of original sheet 1.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “13” has been used to designate both cutout and leg portion in figure 1A.
Specification
The substitute specification filed 24 October 2025 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: markings do not show all the changes relative to the immediate prior version of the specification of record dated 14 July 2025.
The disclosure is objected to because of the following informalities: as the drawing amendment dated 24 October 2025 was not entered, the figure numbers do not align between the specification and drawings. Examiner notes that the description at paragraph 0021 line 8 referring to figure 1 did not amend the figure number like the remainder of the specification.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klumpen (US 20120205374).
Claim 1: Klumpen discloses a closure 10 (rubber stopper) [P. 0032] comprising: a canopy portion having an upper surface and a lower surface; and a leg portion provided on the lower surface of the canopy portion, wherein the leg portion has a tapered base portion [see fig. 1] at an axial center of the canopy portion on a lower surface side of the canopy portion, and has a ring-shaped convex portion provided on an outer peripheral surface of the leg portion, wherein the leg portion has an inner end arc at an inner end thereof (see annotated fig. 3 below and fig. 1).
Klumpen does not disclose a curvature radius R1 of the tapered base portion being 2mm or more and 4mm or less
It would have been an obvious matter of design choice to have made the curvature radius of the tapered base portion be in the range of 2mm or more and 4mm or less since it has been held that changing the size or range of an article is not ordinarily a matter of invention. Appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also MPEP 2144.04. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have made the curvature radius of the tapered base portion be in the range of 2mm or more and 4mm or less in order to provide space for specific needle diameters to be inserted and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In. re Aller, 105 USPW 233.
Examiner notes that no criticality has been established for the claimed range.
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Claim 8: Klumpen discloses wherein the leg portion has a cutout at least at one place (see annotated fig. 3 above and fig. 1).
Claim 10: Klumpen discloses wherein the closure 10 (rubber stopper) is configured to seal a lyophilized drug product (see annotated fig. 3 above and fig. 1).
Claim 11: Klumpen discloses wherein either a start point or an end point of an arc including an apex of the tapered base portion and extending along an inner wall of the leg portion is located on a tangent line extending toward the axial center, and the tangent line includes a start point of the inner end arc provided at the inner end of the leg portion (see annotated fig. 3 above and fig. 1).
Claim 12: Klumpen discloses the claimed invention except wherein a radius of curvature of the inner end arc is 0.1mm to 1.0mm.
It would have been an obvious matter of design choice to have made the radius of curvature of the inner end arc be in the range of 0.1mm to 1.0mm since it has been held that changing the size or range of an article is not ordinarily a matter of invention. Appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also MPEP 2144.04. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have made the radius of curvature of the inner end arc be in the range of 0.1mm to 1.0mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In. re Aller, 105 USPW 233.
Examiner notes that no criticality has been established for the claimed range.
Claim(s) 1-5, 7, 8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sudo (US 20060054586) further in view of Klumpen (US 20120205374).
Claim 1: Sudo discloses a rubber closure 3 (rubber stopper) comprising: a head portion 9 (canopy portion) having an upper surface and a lower surface; and a leg portion 10 provided on the lower surface of the head portion 9 (canopy portion), wherein the leg portion 10 has a tapered base portion at an axial center of the head portion 9 (canopy portion) on a lower surface side of the head portion 9 (canopy portion), and has a ridge (ring-shaped convex portion) provided on an outer peripheral surface of the leg portion 10, wherein the inner circumferential edge 5 of the lower end wall 7 of the leg portion 10 can be located on an inner side than the inner circumferential edge 6 of the flat surface 4 of the container (see P. 0032, fig. 3C, and annotated fig. 2A below).
Sudo does not disclose wherein a curvature radius R1 of the tapered base portion is 2mm or more and 4mm or less or wherein the leg portion has an inner end arc at the inner end thereof.
Klumpen discloses a closure 10 having a leg portion with an inner end arc at an inner end thereof (see annotated fig. 3 above and fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner end of the leg portion 10 to have an inner end arc, as taught by Klumpen, in order to better distribute stresses, reduce stress concentrations, reduce shrinkage stress, and improve molding by better filling the mold.
It would have been an obvious matter of design choice to have made the curvature radius of the tapered base portion be in the range of 2mm or more and 4mm or less since it has been held that changing the size or range of an article is not ordinarily a matter of invention. Appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also MPEP 2144.04. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have made the curvature radius of the tapered base portion be in the range of 2mm or more and 4mm or less in order to provide space for specific needle diameters to be inserted and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In. re Aller, 105 USPW 233.
Examiner notes that no criticality has been established for the claimed range.
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Claim 2: The combination discloses wherein a length P of an inner wall of the leg portion 10 is greater than 100% and less than 160% with respect to a length D of the leg portion 10 itself (see fig. 2A).
Examiner notes that no criticality has been established for the claimed range.
Claim 3: The combination discloses wherein a distance R2 between a start point and an end point of an arc including an apex of the tapered base portion is 8 mm or less as the start point and end point of the arc including the apex of the tapered base portion is less than half a circle the distance R2 must be less than twice the radius of curvature of the tapered base portion, such that when the radius of curvature is 2mm or more and 4mm or less the start point and end point of the arc including the apex of the tapered base portion must be less than twice 4mm which is less than 8mm (see annotated fig. 2A above).
Examiner notes that no criticality has been established for the claimed range.
Claim 4: The combination discloses wherein the head portion 9 (canopy portion) has a conical recess 12 (recessed portion) at the axial center on an upper surface side of the head portion 9 (canopy portion), and an outer diameter R3 of the conical recess 12 (recessed portion) is in the range of 90% or less with respect to the distance R2 (see annotated fig. 2A above).
Examiner notes that no criticality has been established for the claimed range.
Claim 5: The combination discloses wherein the head portion 9 (canopy portion) has a needle sticking portion configured to receive a needle, and a thickness E of the needle sticking portion is within the range of 60% or more and less than 100% of a thickness C of the head portion 9 (canopy portion) (see annotated fig. 2A above).
Examiner notes that no criticality has been established for the claimed range.
Claim 7: The combination discloses wherein the thickness E of the needle sticking portion is within the range of 15% or more and 40% or less with respect to a length D of the leg portion 10 itself (see annotated fig. 2A above).
Examiner notes that no criticality has been established for the claimed range.
Claim 8: The combination discloses wherein the leg portion 10 has a cut-off portion (cutout) at least at one place (see P. 0036).
Claim 10: The combination discloses wherein the rubber closure 3 (rubber stopper) is configured to seal lyophilized preparations (lyophilized drug product) (see P. 0036 and fig. 1A-3).
Claim 11: The combination discloses wherein either a start point or an end point of an arc including an apex of the tapered base portion and extending along an inner wall of the leg portion 10 is located on a tangent line extending toward the axial center, and the tangent line includes a start point of the inner end arc provided at the inner end of the leg portion 10 (see annotated fig. 3 above and fig. 1).
Claim 12: The combination discloses the claimed invention except wherein a radius of curvature of the inner end arc is 0.1mm to 1.0mm.
It would have been an obvious matter of design choice to have made the radius of curvature of the inner end arc be in the range of 0.1mm to 1.0mm since it has been held that changing the size or range of an article is not ordinarily a matter of invention. Appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also MPEP 2144.04. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have made the radius of curvature of the inner end arc be in the range of 0.1mm to 1.0mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In. re Aller, 105 USPW 233.
Examiner notes that no criticality has been established for the claimed range.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sudo (US 20060054586) and Klumpen (US 20120205374) as applied to claim 5 above, and further in view of Norville (WO 9415850).
Claim 6: Sudo does not disclose wherein the thickness E of the needle sticking portion is 3 mm or less.
Norville teaches a rubber closure 10 comprising a flange portion 16 having an upper surface and a lower surface; a hollow plug portion 18 provided on the lower surface of the flange portion 16, wherein the hollow plug portion 18 has a rounded surface at the center on a lower surface side of the flange portion having a radius R, wherein the flange portion 16 has a central diaphragm portion 14 into which a needle can be stuck, and a thickness D.sub.2 is 0.03 inches (.762 mm) which is 60% of a thickness F.sub.2 of 0.050 inches (1.27 mm) (see fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have made the thickness of the needle sticking portion be 0.03 inches (.762 mm), as taught by Norville, in order to reduce the distance a needle must travel through the rubber closure 3 (rubber stopper) to make extraction easier for a user.
Examiner notes that no criticality has been established for the claimed range.
Response to Arguments
The drawing objections in paragraph 9 of office action dated 21 August 2025 are withdrawn in light of the amended disclosure filed 24 October 2025.
The specification objections in paragraph 11 of office action dated 21 August 2025 are withdrawn in light of the amended disclosure filed 24 October 2025.
The claim objections in paragraph 12 of office action dated 21 August 2025 are withdrawn in light of the amended claims filed 24 October 2025.
The 35 U.S.C. § 112 rejections in paragraphs 13-24 of office action dated 21 August 2025 are withdrawn in light of the amended claims filed 24 October 2025.
In response to applicant’s statement that the amendments made in the substitute specification filed on July 14, 2025 have also been included in the presently filed substitute specification for clarity and to ensure entry of the same, the Examiner responds that the substitute specification dated 14 July 2025 was entered. In order to be proper the substitute specification dated 24 October 2025 must show all the changes relative to the immediate prior version of the specification of record dated 14 July 2025.
Applicant’s arguments, see page 13, filed 24 October 2025, with respect to the rejection(s) of claim(s) 1 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Klumpen (US 20120205374) and additionally in view of Sudo (US 20060054586) further in view of Klumpen (US 20120205374).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2002014124, US 5823373, US 5983770, US 6286699, US 8684204, US 20160051446, US 20100050575, US 2002014124, US 20120248057, and US 20130119011 are considered pertinent to inner end arcs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLAN D STEVENS whose telephone number is (571)270-7798. The examiner can normally be reached Monday-Friday 12-8 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at (571)270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLAN D STEVENS/Primary Examiner, Art Unit 3736