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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-4, 6-11, 16-19 in the reply filed on 14 July 2025 is acknowledged. Claims 12-14, 20-22 are withdrawn.
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.
Claim 4 and 6 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 4 recites the limitation "the first elastic element" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 4 is dependent on claim 3 but not dependent on claim 2 which recites the first elastic elements. In an effort to compact prosecution, the limitation is interpreted as –a first elastic element--.
Claim 6 recites the limitation "the engagement structure" in line 3. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution, the limitation is interpreted as –the elastic structure--.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 6-9, 11, 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haber (US 5647845).
Regarding claim 1, Haber discloses a coupling device (20) for an adapter (2) for a vial (100) for a medical liquid wherein the coupling device is configured to connect the adapter to the vial (figure 1) and wherein the coupling device comprises an elastic structure (28 and 30, elastic structure bending as seen in figures 3-5) adjusting the adapter to accommodate different vial sizes (col 5, lines 53-57).
Regarding claim 2, Haber discloses wherein the elastic structure comprises:
a first elastic element (28) connected to a base body (26) of the coupling device, the first elastic element being elastically adjustable to accommodate different vial sizes (col 5, lines 53-57) and
a second elastic element (30) connected to the first elastic element and configured to hold the vial (figures 3-5).
Regarding claim 3, Haber discloses an engagement structure (30) configured to lock on the vial when connecting the vial to the adapter (figures 3-5).
Regarding claim 4, Haber discloses wherein the engagement structure is elastically supported by the first elastic element (28) for adjusting the coupling device to different vial sizes (col 5, lines 53-57).
Regarding claim 6, Haber discloses wherein the elastic structure comprises at least one elastic arm (28) being resilient in a direction that is radial with respect to a diameter of the neck of the vial (figures 3-5).
Regarding claim 7-8, Haber discloses wherein at least one elastic arm has a surface that is an lower surface (lower surface of 28 and 30) with respect to a longitudinal direction corresponding to a direction from a bottom of the neck of the vial when the coupling device is connected to the vial (figure 7), which the lower surface is configured to engage in a narrow portion in a region of the neck (figure 7) when the vial is connected to the adapter (col 6, lines 64-67 to col 7, lines 1-3) and configured to elastically deform the arm when the vial is connected to the adapter by sliding on a surface of the portion of the vial until the elastic arm engages the vial (figures 3-5).
Regarding claim 9, the limitation “coupling device is configured to connect the adapter according to standard ISO 8362-1 or 8536-1” is a statement of intended use. The prior art device of Haber is fully capable of fitting to those standards and the intended use do not appear to structurally deviate from what is disclosed from Haber.
Regarding claim 11, Haber further discloses the coupling device is continuously adjustable by the elastic structure to accommodate a range of diameters of the neck of the vial wherein the range is 10mm to 35mm (col 7, lines 4-7 and col 6, lines 55-60).
Regarding claim 16, Haber discloses wherein the engagement structure is configured to lock on the vial in a narrowed portion in a region of a neck of the vial (col 6, lines 64-67 to col 7, lines 1-3).
Regarding claim 17, Haber discloses wherein the first elastic element comprises a curved flat spring (figures 3-5, the elastic structure is resilient deforming to accommodate the vial and then coming back to shape).
Regarding claim 18, Haber discloses wherein the at least one elastic arm comprises a flat spring (figures 3-5, the elastic structure is resilient deforming to accommodate the vial and then coming back to shape).
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.
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 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Haber.
Regarding claims 10 and 19, Haber further discloses the coupling device is adjustable by elastic structure to accommodate at least two different diameters of the neck (col 7, lines 4-7 and col 6, lines 55-60), but fails to disclose at least two diameters selected from the group consisting of 13mm, 20mm, 28mm and 32mm (claim 10) and the at least two different diameters are 13 mm and 20 mm, or the at least two different diameters are 28 mm and 32 mm. (claim 19).
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 device of Haber to have a diameter selected from the group consisting of 13mm, 20mm, 28mm and 32mm and further the at least two different diameters are 13 mm and 20 mm, or the at least two different diameters are 28 mm and 32 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 Haber would not operate differently with the claimed diameter and since Haber discloses diameters including 10 mm and 20mm the device would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (page 14, last paragraph).
Conclusion
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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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/Primary Examiner, Art Unit 3781