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 with traverse of Species 7 (Figure 7) in the reply filed on 5/18/2026 is acknowledged. The traversal is on the ground(s) that the different portion and frangible portion arrangements shown in FIGS. 1-10 result in a serious search or examination burden. Applicant notes that the Office has not indicated any different classifications or field of searches that would be required, nor has the Office presented any evidence that the subject matter of the claims is recognized as divergent. Instead, the Office suggests that different inventions require a different field of search, but does not identify such distinct inventions. Accordingly, no different fields of search or inventions are identified for the different species identified. This is not found persuasive because as stated in the restriction requirement mailed 7/8/2024, the indicated species (Species 1-10) are independent or distinct because each species has different first/second end portion arrangements and frangible portions arrangements, in addition to being not obvious variants of each other based on the current record. The distinct species require a different field of search (e.g., employing different search strategies or search queries for the different structural features (e.g., different end portion arrangements, etc.) of the distinct species). In the reply filed 5/18/2026, Applicant indicated that claims 1-6 and 15-20 correspond to the elected species. Therefore, claims 7-14 are withdrawn from consideration.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1-6 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tennican (US 2009/0093757).
Regarding claim 1, Tennican discloses a medical packaging capable of holding a sterile single-use medical device, wherein the medical device has at least one operative part which in use is a key part for direct contact to a patient and further has at least one controlling part for controlling the at least one operative part, the packaging including: a body (at 600 in Fig. 12) forming an enclosing volume (at 610) capable of holding a single-use medical device in a sterile condition, the body having at least one first end portion (left end of Fig. 12, to the left of 602), at least one second end portion (right end of Fig. 12, to the right of 602) and at least one openable connection (at 602) between the at least one first end portion and one or more of the at least one second end portion to allow the at least one first end portion to be disconnected from the at least one second end portion wherein: the at least one first end portion is sized and shaped for substantially covering one or more operative parts of the single-use medical device (e.g., at 206); at least part of one or more of the at least one second end portion is sized and shaped for substantially covering one or more controlling parts (e.g., at 100/300) of the single-use medical device; the at least one openable connection is able to have the at least one first end portion displaced into an open state at time of use to allow the at least one operative part of the single-use medical device to be revealed and usable directly on the patient (See [0063]); and the at least one second end portion remains substantially covering one or more controlling parts of the single-use medical device and allows the at least part of the at least one operative part to be controlled by the at least one controlling part while the at least one controlling part remains substantially within the at least one second end portion (See [0063]), wherein the at least one second end portion is movable by the body being transformable to allow alteration of a footprint of the single-use medical device to enable operative use of the single-use medical device while the one or more controlling parts remain substantially within the second end portion of the body.
Regarding claim 2, Tennican discloses the body is substantially flexible to allow user to hold and operate the enclosed sterile single-use medical device without the device still substantially enclosed in the packaging body (See [0063]-[0064]).
Regarding claim 3, Tennican discloses the transformability is by variable connected materials forming an expandible sealed connection to the second end portion without substantially hindering the user using the one or more controlling parts in the single second end portion to control the one or more operative parts when revealed and usable directly on the patient.
Regarding claim 4, Tennican discloses the at least one or more first or second end portions includes a shape corresponding to the shape of a controlling part of the single- use medical device.
Regarding claim 5, Tennican discloses the at least one openable connection on the at least one first end portion of the body is at least one frangible connection extending on at least part of the at least one first end portion and the at least one second end portion wherein the at least one first end portion is openable with the user holding the at least one second end portion.
Regarding claim 6, Tennican discloses the openable connection is at a marked frangible operating line (at 602) that substantially overlies the end of the key part of the device such that the frangible operating line provides an indicating line that can indicate the end of the key part that is not to be touched by the user and defining the key part allowable to be in direct contact with the patient.
Regarding claim 15, Tennican discloses a medical packaging (See Fig. 12) for holding a sterile single-use medical device, wherein the medical device has at least one operative part which in use is a key part for direct contact to a patient and further has at least one controlling part for controlling the at least one operative part, the packaging including: a body (at 600 in Fig. 12) forming an enclosing volume (at 610) able to hold a single-use medical device in a sterile condition, the body having at least one first end portion (left end of Fig. 12, to the left of 602), at least one second end portion (right end of Fig. 12, to the right of 602) and at least one openable connection (at 602) between the at least one first end portion and one or more of the at least one second end portion to allow the at least one first end portion to be disconnected from the at least one second end portion wherein: the at least one first end portion is sized and shaped for substantially covering one or more operative parts (e.g., at 206) of the single-use medical device; at least part of one or more of the at least one second end portion is sized and shaped for substantially covering one or more controlling parts (e.g., 100/200) of the single-use medical device; the at least one openable connection is able to have the at least one first end portion displaced into an open state at time of use to allow the at least one operative part of the single-use medical device to be revealed and usable directly on the patient (See [0063]); and the at least one second end portion remains substantially covering one or more controlling parts of the single-use medical device and allows the at least part of the at least one operative part to be controlled by the at least one controlling part while the at least one controlling part remains substantially within the at least one second end portion (See [0063]), wherein the second end portions is movable relative to the at least one openable connection by the body being transformable to allow alteration of the footprint of the single-use medical device to enable operative use of the single-use medical device while the one or more controlling parts remain substantially within the plurality of second end portions of the body.
Regarding claim 16, Tennican discloses the at least part of the at least one second end portion, which is sized and shaped for substantially covering the at least one controlling part of the single-use medical device, is changeable or relatively moveable to allow controllable usage of the at least one operative part by the at least one controlling part, while retaining coverage over substantially all of the at least one controlling part of the single-use medical device.
Regarding claim 17, Tennican discloses the at least one second end portion is changeable by being flexible.
Regarding claim 18, Tennican discloses a medical packaging (See Fig. 12) capable of holding a sterile single-use medical device, wherein the medical device has at least one operative part which in use is a key part for direct contact to a patient and further has at least one controlling part for controlling the at least one operative part, the packaging including: a body (at 600 in Fig. 12) forming an enclosing volume (at 610) capable of holding a single-use medical device in a sterile condition, the body having at least first end portion (left end of Fig. 12, to the left of 602), at least one second end portion (right end of Fig. 12, to the right of 602) wherein: the at least one first end portion is sized and shaped for substantially covering one or more operative parts of the single-use medical device; the at least one second end portion is sized and shaped for substantially covering one or more controlling parts of the single-use medical device; and the at least one second end portion remains substantially covering one or more controlling parts of the single-use medical device and allows the at least part of the at least one operative part to be controlled by the at least one controlling part while the at least one controlling part remains substantially within the at least one second end portion wherein the medical packaging is for covering the single use medical device and the openable connection of packaging includes a plurality of marked frangible operating lines (perforation lines at 602) on the body of the packaging indicating the respective use that is not to be touched by the user and defining the particular key part allowable to be in direct contact with the patient for the respective predefined use.
Regarding claim 19, the packaging of Tennican is capable of being used for covering a syringe having a plunger, a barrel and an operative dispensing end and includes a non-resilient enclosing body substantially following the shape of the syringe having: at least one first end portion attached to at least one second end portion; and at least one frangible connection over the operative dispensing end which allows operatively effective filling and dispensing function of the syringe, and the at least one second end portion including a transformable part able to follow the change of volume of the syringe by the insertion and retraction of the plunger in the barrel with the transformable part being in the form of a variable connected material forming an expandible sealed connection to the at least one second end portion; wherein the user is not substantially hindered using the one or more controlling parts in the at least one second end portion to control the one or more operative parts when revealed and usable directly on the patient, and wherein the covering of the one or more controlling parts including the plunger and barrel of the syringe and the one or more openable frangible connections indicating the respective use that is not to be touched by the user and defining the particular key part allowable to be in direct contact with the patient for the respective predefined use.
Regarding claim 20, the packaging of Tennican is capable of holding a single-use medical device that is a fixed article having no moving parts and the packaging of the single use fixed article has an openable connection of packaging which includes a plurality of marked frangible operating lines (perforation lines at 602) on the body of the packaging indicating the respective use that is not to be touched by the user and defining the particular key part allowable to be in direct contact with the patient for the respective predefined use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735
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