DETAILED ACTION
This is in response to the Patent Application filed 1/12/2024 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 are objected to as failing to comply with 37 CFR 1.84(p)(1) because the numerals are not plain and legible.
The drawings are objected to as failing to comply with 37 CFR 1.84(m) because the shading used in Figures 5, 10, 13, and 15a-18b reduces legibility. The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color.
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.
Claim Objections
Claims 1-8 are objected to because of the following informalities:
“Closure system” (Claim 1, line 1) is believed to be in error for - - A closure system - -;
“the carrier cap” (Claim 1, line 5; Claim 2, line 1; Claim 3, lines 1-2; Claim 6, line 3) is believed to be in error for - - the rigid carrier cap - -;
“Closure system” (Claim 2, line 1; Claim 3, line 1; Claim 4, line 1; Claim 5, line 1; Claim 6, line 1; Claim 7, line 1; and Claim 8, line 1) is believed to be in error for - - The closure system - -; and
“according to claim 1 to 4, where” (Claim 5, lines 1-2) is believed to be in error for - - according to claim 1, where - -.
Appropriate correction is required.
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).
Claim 1 recites the limitation "its" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the outside" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the end" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-8 are rejected for the same reasons above based on their dependency to claim 1.
Regarding claim 2, the phrase "preferably" (Claim 2, line 2) 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).
Claim 3 recites the limitation "its" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 3, the phrase "preferably" (Claim 3, line 3) 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).
Claim 6 recites the limitation "an outer casing" in line 2. It is unclear if the outer casing recited in claim 6 is referring to the same outer casing recited in claim 1 or if it is referring to a different outer casing.
Claim 6 recites the limitation "a threaded adapter piece which is provided in an outer casing with an internal thread" in lines 2-3. It is unclear if the internal thread is provided on the threaded adapter piece or the outer casing.
Claim 7 is rejected for the same reasons above based on its 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 carrier cap (at 58) and is arranged (see Figures 1 and 4), wherein the inner channel (76) provided in the carrier cap (at 58) is provided with latching segments (78 and 80) arranged on its 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 the 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 the 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 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 carrier cap of the closure cap (at 58) is provided on its 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 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.
Banik teaches (Figures 1-6) a threaded adapter piece (20’) which is provided in (see Figure 4) an outer casing (40’) with an internal thread (26) adapted to an external thread (24) of a carrier cap (12’), and which has a clamping ring (30) which can be pushed on to a tapering mouth region (102) of the syringe body (100) and 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).
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