DETAILED ACTION
This is in response to the Amendment filed 8/20/2026 wherein claims 1-8 are presented for examination.
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 8/20/2026. These drawings are acceptable.
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 1-8 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.
Regarding claim 1, the phrase "preferably" (Claim 1, line 5) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-8 are rejected for the same reasons above based on their dependency to claim 1.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert (US 2001/0003150) in view of Banik (US 11,278,681).
Regarding Independent Claim 1, Imbert teaches (Figures 1-10) a closure system (see Figures 1-4) for a syringe body (12) prefilled with a medicament or medical active substance (see Paragraph 0027), with a closure cap (58) having a rigid carrier cap (formed of a rigid thermoplastic material; see Paragraph 0031 and Figure 6) which is provided with an external thread (82) in a contact region (where 22, 64, 72 and 44 overlap and are in contact; see Figure 4) and has an inner channel (76) which extends in a longitudinal direction (see Figures 1, 4, and 6) and in which a sealing plug (56) made of a material which is softer and more deformable (an elastomeric material; see Paragraph 0028) than the rigid carrier cap (at 58) and is arranged (see Figures 1 and 4), wherein the inner channel (76) provided in the rigid carrier cap (at 58) is provided with latching segments (78 and 80) arranged on an inner circumference (see Figure 6), and wherein the sealing plug (56) has a latching edge (inner circumference edge 70, 68) adapted thereto and extending around an outside (see Figures 4-6) and dimensioned such that the sealing plug (56) is fixed in a latching manner after being inserted into the inner channel (76; see Figures 4-6) and with an outer cap (44) surrounding the closure cap (58) which has a receiving basket (the cavity having threads 52; see Figures 1, 4, and 7) for the closure cap (58) arranged at an end (at the end of syringe 12; see Figures 1-7).
Imbert does not teach, as discussed so far, wherein the outer cap is arranged inside an outer casing.
Banik teaches (Figures 1-6) a closure system (10’) for a syringe (100), wherein the closure system (10’) including an outer cap (12’) surrounding a closure cap (20’) which has a receiving basket (the cavity having threads 26; see Figures 4-6) arranged at the end (at the end of syringe 100; see Figures 4-6) inside an outer casing (40’).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Imbert to have the outer cap is arranged inside an outer casing, as taught by Banik, in order to provide a clear evidence of attempted access to the contents of the syringe and/or tampering (see Column 7, lines 50-57 of Banik).
Regarding Claim 2, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert further teaches (Figures 1-10) the rigid carrier cap of the closure cap (at 58) is made of plastic (formed of a rigid thermoplastic material; see Paragraph 0031 and Figure 6).
Regarding Claim 3, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert further teaches (Figures 1-10) the rigid carrier cap of the closure cap (at 58) is provided on an outer circumference (see Figure 6) with a number of longitudinally extending grip grooves (84), in a handling region (at region e; see Figure 6) which is arranged offset from (offset along a longitudinal axis of the closure system 54; see Figure 4) the contact region (where 22, 64, 72 and 44 overlap and are in contact; see Figure 4) as viewed in the longitudinal direction (see Figures 4 and 6).
Regarding Claim 4, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert further teaches (Figures 1-10) where the extending thread (82) of the closure cap (at 58) is designed as a Luer thread (see Paragraph 0034).
Regarding Claim 5, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert further teaches (Figures 1-10) wherein the closure cap (at 58) is obtained by production using a two-component injection molding process (see Paragraphs 0011 and 0041).
It is noted, in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has been given very little patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product (in this case, the closure cap), does not depend on its method of production (i.e. two-component injection molding process), In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985). Further, where a product by process claim is rejected over a prior art product that appears to be identical, although produced by a different process, the burden is upon the applicants to come forward with evidence establishing an unobvious difference between the two. See In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Additionally, it has been held in re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). “[I]t is the patentability of the product claimed (in this case the closure cap) and not of the recited process steps (in this case the two-component injection molding process) which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” (see MPEP 2113).
Regarding Claim 6, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert further teaches (Figures 1-10) a tapering mouth region (122) of the syringe body (112). However, Imbert in view of Banik does not teach, as discussed so far, a threaded adapter piece which comprise an outer casing having an internal thread adapted to the external thread of the rigid carrier cap, and which further comprises a clamping ring which can be pushed onto a tapering mouth region of the syringe body, wherein the clamping ring is provided with a number of circumferentially arranged clamping springs.
Banik teaches (Figures 1-6) a threaded adapter piece (20’) which comprises another outer casing (at 12’) having an internal thread (26) adapted to an external thread (24) of a carrier cap (12’), and which further comprises a clamping ring (30) which can be pushed on to a tapering mouth region (102) of the syringe body (100), wherein the clamping ring (30) is provided with a number of circumferentially arranged clamping springs (32).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Imbert in view of Banik to have the threaded adapter piece which is provided in an outer casing with an internal thread adapted to the external thread of the carrier cap, and which has a clamping ring which can be pushed onto a tapering mouth region of the syringe body and is provided with a number of circumferentially arranged clamping springs, as taught by Banik, in order to achieve a non-removable and substantially non-rotatable discharge port of the syringe relative to the adapter body (see Column 6, lines 17-34 of Banik).
Regarding Claim 7, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert teaches (Figures 1-10) a threaded adapter piece (44) of which is made of plastic (Paragraph 0026).
It is noted that it has been held to be within the general skill of a worker in the art to select a known material (or material compound) on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 8, Imbert in view of Banik teaches the invention as claimed and as discussed above. Imbert in view of Banik does not teach, as discussed so far, the outer cap of which forms a tamper-evident closure for the closure cap.
Banik teaches (Figures 1-6) an outer cap (40’) of which forms a tamper-evident closure for the closure cap (10’).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Imbert in view of Banik to have the outer cap of which forms a tamper-evident closure for the closure cap, as taught by Banik, in order to provide a clear evidence of attempted access to the contents of the syringe and/or tampering (see Column 7, lines 50-57 of Banik).
Response to Arguments
Applicant's arguments filed 8/20/2026 have been fully considered but they are not persuasive. Applicant argues that the prior art does not teach a latching system between the sealing plug and the carrier cap which, after engagement of these components, secures them safely together and inhibits longitudinal displacement therebetween. Applicant also argues that the prior art does not teach a “snap in” type of premounting of the components before further use: the sealing plug may be introduced into the inner channel in the carrier cap until the two latching elements snap in and thereby fix the components relative to each other, such that in subsequent mounting steps the entire cap system may be handled as a unity. In response, it is noted that these features are not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As detailed in the body of the rejection above Imbert and Banik teach all structural elements recited in the claimed invention.
Conclusion
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS P BURKE whose telephone number is (571)270-5407. The examiner can normally be reached M-F 8:30-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS P BURKE/Primary Examiner, Art Unit 3741
