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 .
Drawings
The drawings were received on 30 April 2026. These drawings are acceptable.
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 in figure 5 and leg portion in figure 2.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Q-Q.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: P-P. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: non-ring shaped convex portion.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 and 13-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the apex portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is led to be indefinite as it is unclear if the apex portion is a newly recited structure or refers back to the apex of claim 1. In light of the original disclosure and in order to apply art the claim will be interpreted as the latter.
Claim 13 recites the limitation "the center point" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is led to be indefinite as it is unclear if “an outer peripheral surface” of lines 12-13 is a newly recited structure or refers back to “an outer peripheral surface” of lien 7. In light of the original disclosure and in order to apply art the claim will be interpreted as the latter.
Claims 14 and 18 are led to be indefinite as claim 14 recites a “non-ring-shaped convex portion” and claim 18 recites the “ring-shaped convex portion”. It is unclear if the claims are reciting two distinct shaped convex portions, if the claims are both meant to both recite non-ring-shaped convex portions, or if the claims are both meant to recite ring-shaped convex portions. In light of the original disclosure, which recites “ring-shaped convex portion”, and in order to apply art the claims will be interpreted as the latter.
Claim 18 recites the limitation "the ring-shaped convex portion" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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, 10, and 12-19 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 at least one annular protrusion provided on an outer peripheral surface of the leg portion on the lower surface side of the canopy portion, a curvature radius R1 of the tapered base portion [fig. 1], the leg portion has an inner end arc at an inner end thereof; the curvature radius R1 is a radius corresponding to an arc including an apex of the tapered base portion [fig. 1], the arc including the apex of the tapered base portion has a start point and an end point, the start point and the end point defining an R stop portion 1, an inner wall of the leg portion continuously extends from one of the start point and the end point of the R stop portion 1 to a distal end of the leg portion, and the one of the start point and the end point of the R stop portion 1 and a point on the inner end arc corresponding to an R stop portion 2, the point being one of two points on the inner end arc and being located on a side of the R stop portion 1, are located on a tangent line extending toward the axial center (see annotated fig. 3 below and fig. 1).
Klumpen does not disclose the 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 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 13: Klumpen discloses wherein the center point of the curvature of radius R1 is located on a perpendicular line drawn from the apex of the tapered base portion toward a center of the leg portion (see annotated fig. 3 above and fig. 1).
Claim 14: 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 at least one annular protrusion provided on an outer peripheral surface of the leg portion on the lower surface side of the canopy portion, a curvature radius R1 of the tapered base portion [fig. 1], the leg portion has an inner end arc at an inner end thereof, and the leg portion has at least one ring-shaped convex portion on an outer peripheral surface thereof (see annotated fig. 3 & 4 below and fig. 1).
Klumpen does not disclose the 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 15: Klumpen discloses wherein the leg portion has an inner wall that smoothly extends from the tapered base portion toward a distal end of the leg portion (see annotated fig. 3 above).
Claim 16: Klumpen does not disclose the curvature radius R1 being 2.5 mm to 3.5 mm.
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 2.5 mm to 3.5 mm 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 2.5 mm to 3.5 mm 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.
Claim 17: 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 18: Klumpen discloses wherein the ring-shaped convex portion is provided between the tapered base portion and a distal end of the leg portion (see annotated fig. 3 above).
Claim 19: Klumpen discloses wherein the annular protrusion is provided adjacent to the tapered base portion (see annotated fig. 3 and 4 above).
Claim(s) 1-5, 7, 8, 10, 12, and 13 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 (at least one annular protrusion) provided on an outer peripheral surface of the leg portion 10 on the lower surface side of the head portion 9 (canopy portion), a curvature of radius R1 of the tapered base portion, 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, the curvature of radius R1 is a radius corresponding to an arc including an apex of the tapered base portion, the arc including the apex of the tapered base portion has a start point and an end point, the start point and the end point defining an R stop portion 1, an inner wall of the leg portion continuously extends from one of the start point and the end point of the R stop portion 1 to a distal end of the leg portion, and the one of the start point and the end point of the R stop portion 1 is located on a tangent line extending toward the axial center (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, the leg portion has an inner end arc at an inner end thereof, and a point on the inner end arc corresponding to an R stop portion 2, the point being one of two points on the inner end arc and being located on a side of the R stop portion 1, being located on the tangent line extending toward the axial center.
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.
The combination results in a point on the inner end arc corresponding to an R stop portion 2, the point being one of two points on the inner end arc and being located on a side of the R stop portion 1, being located on the tangent line extending toward the axial center.
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 the start point and the end point of the arc including the apex portion 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 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 13: The combination discloses wherein the center point of the curvature of radius R1 is located on a perpendicular line drawn from the apex of the tapered base portion toward a center of the leg portion (see annotated fig. 2A above).
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 paragraphs 4-8 of office action dated 1 December 2025 are withdrawn in light of the amended disclosure filed 30 April 2026.
The specification objections in paragraph 11 of office action dated 1 December 2025 are withdrawn in light of the amended disclosure filed 30 April 2026.
Applicant's arguments filed 30 April 2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that reference character 13 is only used to designate a cutout, the Examiner responds that the cutout is not visible in figure 2 and as such reference character 13 of figure 2 cannot be directed to the cutout.
In response to applicant’s argument that the arrowed line in FIG. 3 of Klumpen, as labeled as “tangent line” by the Examiner in the Office Action, does not specify a tangent line in the mathematical sense on a curved surface, but merely indicates a general shape or directional outline of the tapered portion and/or the inner arc portion and that FIG. 3 does not disclose, teach, or suggest the “tangential” relationship required by claim 11 in the sense that a tangent line of a curved surface is geometrically tangential to another surface, the Examiner initially responds that claim 11 has been canceled. Claim 1 requires “the one of the start point and the end point of the R stop portion 1 and a point on the inner end arc corresponding to an R stop portion 2, the point being one of two points on the inner end arc and being located on a side of the R stop portion 1, are located on a tangent line extending toward the axial center”. This limitation does not require the tangent line to be physical or defined in relation to any structures of the rubber stopper, other than that the one of the start point and the end point of the R stop portion 1 and a point on the inner end arc corresponding to an R stop portion 2, the point being one of two points on the inner end arc and being located on a side of the R stop portion 1 exist on that tangent line. As a line exists between any two points, if the two points exist a tangent line must necessarily exist between them. However, en arguendo, the point on the inner end arc corresponding to an R stop portion 2, the point being one of two points on the inner end arc and being located on a side of the R stop portion 1 and one of the start point and the end point of the R stop portion 1 exist at the transition of the linear portion of the inner wall with an inner end arc and the radius of the arc of the tapered base portion, respectively. As such, the linear portion of the inner wall exists on a tangent line which extends between the inner end arc and the radius of the arc of the tapered base portion. As such, the point on the inner end arc corresponding to an R stop portion 2 and one of the start point and the end point of the R stop portion 1, which exist at the ends of the linear portion of the inner wall also exist on the tangent line.
In response to applicant’s argument that FIG. 3 of Klumpen does not clearly and unambiguously show: which curved surface, at which position on that curved surface, with respect to which surface, a tangential relationship is established, the Examiner invites applicant to review annotated figure 3 which clearly indicates and displays the required geometry of claim 1.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a tangential relationship forming a smooth, continuous boundary) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5110621 and JP 2002165861 are considered pertinent to protrusions and convex portions.
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 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
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