DETAILED ACTION
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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(s) 16 and dependents is/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 16, Applicant recites “a lower elastic modulus than the elastic modulus of the first material”. However, the use of the definite article “the” is improper as no “an elastic modulus of the first material” has been previously introduced and while any uniform material will be understood to have an elastic modulus, the first material has not been demonstrated to be uniform such that it is inherent that it comprises a singular “the elastic modulus”.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2005-34419 (“Nishimura”).
Regarding Claim 1, Nishimura discloses a device (6) comprising:
a body (2) defining a containment volume (21, 24) for a fluid for medical use, said body comprising a terminal (22, 221), said terminal defining a conduit configured to put said containment volume into communication with an outside (see Fig. 1 and 11);
a cap support (7) integral with said body (here Applicant appears to be using a very broad definition of “integral” to simply mean connected to or integrated with (see e.g. where Applicant says “the tip cap is integral with said cap support” in the first stable position, but also asserts – see e.g. Clm. 7 – that the tip cap may be reversibly toggled to an external position where the tip cap is removed from and spatially separated from the cap support) and disposed outside said containment volume (see Fig. 1), said cap support defining an internal volume housing said terminal (see Fig. 3 – i.e. the cap support encircles the terminal);
a tip cap (8) associable with said cap support by first constraint means (i.e. the frictional engagement between the outer surface of the tip cap and convex portions 73)) and associable with said terminal by second constraint means (i.e. cooperative sealing abutment between 812, 813 and 222, frictional engagement between 81 and 724), said tip cap being configured to assume at least a first stable position (Fig. 3) in which the tip cap is integral with said cap support (see Fig. 3), in said first stable position a first portion of the tip cap being housed in the internal volume of said cap support (see Fig. 3), and wherein the containment volume is in communication with the outside when said tip cap assumes said first stable position and wherein the first stable position allows the passage of a sterilizing or sanitizing gas from the outside towards the containment volume (see Q(R); Fig. 3; Abstract), so as to determine a sterilization of the device while keeping the tip cap integral with the device (see Fig. 3).
Regarding Claim 2, Nishimura discloses said tip cap is configured to assume also a second stable position (see Fig. 4) in which the tip cap is integral with said terminal and completely housed in said internal volume of said cap support (see Fig. 4).
Regarding Claim 3, Nishimura discloses the containment volume is sealed when said tip cap assumes said second stable position (Abstract; See Fig. 4).
Regarding Claim 4, Nishimura discloses in said first stable position a second portion (see generally 82 – Fig. 3, wherein the concentric end tip rises above the rim of the cap support) of the tip cap emerges from the internal volume of the cap support.
Regarding Claim 5, Nishimura discloses a system comprising: the device having the tip cap positioned in the first stable position (see Fig. 3; see also generally Fig. 11);
a control volume (i.e. the sterilizer) sized to contain, and containing, the device and a gas (e.g. high pressure steam or a hydrogen peroxide gas) within the control volume that has at least been partially aspirated from the control volume (see Fig. 3);
the sterilizing gas within the control volume and the containment volume (see Fig. 3 – see also Background of the Art which describes the typical sterilization procedure).
Regarding Claim 6, Nishimura discloses the device further comprises one or more recesses formed in at least one of external lateral surface of the tip cap (see e.g. at 83) and an inner lateral surface (721) of the cap support, and the system further comprises the sterilizing gas being present within the one or more recesses (see Fig. 3 – Q(R)).
Regarding Claim 15, Nishimura discloses a device (6) comprising:
a body (2) defining a containment volume (21, 24) for a fluid for medical use, said body comprising a terminal (22, 221), said terminal defining a conduit configured to put said containment volume into communication with an outside (see Fig. 3, 11);
a cap support (7) integral with said body and disposed outside said containment volume, said cap support defining an internal volume housing said terminal (see Fig. 3);
a tip cap (8) associable with said cap support by first constraint means (821, 73) and associable with said terminal by second constraint means (812, 813/222, 811/724), said tip cap being configured to assume at least:
- a first stable position (Fig. 3) in which the tip cap is integral with said cap support, in said first stable position a first portion of the tip cap being housed in the internal volume of said cap support and a second portion of said tip cap emerging from the internal volume of said cap support (see Fig. 3); and
- a second stable position (see Fig. 4) in which the tip cap is integral with said terminal and completely housed in said internal volume of said cap support;
wherein the containment volume is in communication with the outside when said tip cap assumes said first stable position (see Fig. 3) and is sealed when said tip cap assumes said second stable position (see Fig. 4).
Claim Rejections - 35 USC § 103
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.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2005-34419 (“Nishimura”) as applied above, and further in view of U.S. Patent No. 6,613,406 (“Yaniger”).
Regarding Claim 16, Nishimura discloses that the tip cap can be made of a “combination” of materials including combinations of softer, more elastic materials (e.g. various rubbers) and harder, stiffer materials (e.g. PVC and polyamides). However, Yaniger discloses a related tip cap/stopper (100) which comprises an insert structure formed of a first material and a coating formed of a second material having a lower elastic modulus (Col. 2, Ln. 47-57). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the tip cap of Nishimura to comprise a stiffer insert structure with a softer elastomeric coating, as disclosed by Yaniger, in order to give the tip cap improved strength for manipulation including sliding of the tip cap into sealing apposition while providing an enhanced soft, elastic sealing surface to ensure that the seal of the nozzle/tip is maintained once the tip cap is deployed.
Regarding Claim 17, Nishimura, as modified by Yaniger, obviates a configuration wherein the coating is provided about the tip of the cap, inclusive to the side surfaces thereof, in order to engage the cap support to create a friction fit for sealing where when applied to the tip cap it will serve to enhance friction between the tip cap and surface (73) as to define a constraint means resisting transition from the unsealed to sealed positions.
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2005-34419 (“Nishimura”) and U.S. Patent No. 6,613,406 (“Yaniger”) as applied above, and further in view of U.S. Publication No. 5,624,402 (“Imbert”).
Regarding Claims 18 and 20, Nishimura, as modified by Yaniger, discloses the invention substantially as claimed except that that the tip cap comprises a “blind cavity” comprising the coating arranged thereat. However, Imbert discloses a related tip cap (56) which may be formed with a blind cavity (60) which is configured to receive by insertion, at least when the tip cap is in the second stable position, at least one end portion of the terminal to define a fluid-tight closing between the external environment and the containment volume (see Fig. 8), said blind cavity being arranged in the first portion of the tip cap and oriented towards the terminal, at least one end portion of the first portion of the tip cap being constrained by pressure, at least when the tip cap is in the second stable position, between an external lateral surface of the terminal and the inner surface of the cap support or an inner surface of the collar (see Fig. 8). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the tip cap of modified Nishimura with a blind cavity, as disclosed by Imbert, the blind cavity including the sealing coating, as disclosed by Yaniger, in order to provide an improved sealing about the external geometry of the terminal as well as the internal geometry thereby ensuring that in the second position the interior contents of the terminal are hermetically sealed.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2005-34419 (“Nishimura”), U.S. Patent No. 6,613,406 (“Yaniger”), and U.S. Publication No. 5,624,402 (“Imbert”) as applied above, and further in view of WO 97/20587 (“Schulz”).
Regarding Claim 21, Nishimura, as modified by Yaniger, discloses the invention substantially as claimed except that the cap support is integral with the body by means of third constraint means and wherein the cap support comprises a plurality of ridges emerging from an inner side surface of the cap support and arranged in the internal volume of the cap support itself, the ridges joining by interference an external lateral surface of a collar defining at least part of the third constraint means. Nishimura describes a third constraint means (5, 71), but not one of ridges emerging from an inner side surface of the cap support. However, Schulz discloses a related cap support (40) configured to affix to a related terminal, wherein the cap support is integral with the body by means of third constraint means (45, 46) and wherein the cap support comprises a plurality of ridges (see Fig. 2) emerging from an inner side surface of the cap support and arranged in the internal volume of the cap support itself (see Fig. 2), the ridges joining by interference an external lateral surface of a collar defining at least part of the third constraint means (see Fig. 1). It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the internal thread of the cap support of Nishimura with an ridge arrangement that affixes to the external lateral surface of the collar, as disclosed by Yaniger, in order to provide a simple substitution of equivalent cap support locking arrangements to obtain a predictable and expected securement of the cap to the terminal.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2005-34419 (“Nishimura”) and U.S. Patent No. 6,613,406 (“Yaniger”) as applied above, and further in view of WO 97/20587 (“Schulz”)
Regarding Claim 19, Nishimura, as modified by Yaniger, discloses the invention substantially as claimed except that the cap support is integral with the body by means of third constraint means and wherein the cap support comprises a plurality of ridges emerging from an inner side surface of the cap support and arranged in the internal volume of the cap support itself, the ridges joining by interference an external lateral surface of a collar defining at least part of the third constraint means. Nishimura describes a third constraint means (5, 71), but not one of ridges emerging from an inner side surface of the cap support. However, Schulz discloses a related cap support (40) configured to affix to a related terminal, wherein the cap support is integral with the body by means of third constraint means (45, 46) and wherein the cap support comprises a plurality of ridges (see Fig. 2) emerging from an inner side surface of the cap support and arranged in the internal volume of the cap support itself (see Fig. 2), the ridges joining by interference an external lateral surface of a collar defining at least part of the third constraint means (see Fig. 1). It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the internal thread of the cap support of Nishimura with an ridge arrangement that affixes to the external lateral surface of the collar, as disclosed by Yaniger, in order to provide a simple substitution of equivalent cap support locking arrangements to obtain a predictable and expected securement of the cap to the terminal.
Allowable Subject Matter
Claim(s) 7, 8, 10-14 is/are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/03/2026
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