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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS(s) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is invited to point out any particular reference(s) in the IDS that they believe may be of particular relevance to the instant claimed invention in response to this Office Action. See also MPEP 2004, example 13, it is desirable to avoid the submission of long lists of documents if it can be avoided. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Election/Restrictions
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025.
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 11/26/2025 is acknowledged.
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, 2 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammer (5,133,454).
Claim 1
Hammer discloses a packaging to facilitate a sterile connection, the packaging comprising an outer pouch (10); a lid (41) configured to seal the outer pouch and create a sterile interior (see column 2 lines 16-18); and a component holder (defined by panel 21 in combination with brackets 31 and 32) housed within the outer pouch, wherein the component holder comprises a board (21) that extends longitudinally; a first set of arms (31) extending from the board that holds a first device part (50); and a second set of arms (32) extending from the board that holds a second device part (defined by portion next to end 49) (see figure 4).
Claim 2
Hammer further discloses the component holder is configured to maintain an orientation of the first device part and the second device part (see figure 4).
Claim 9
Hammer further discloses the first set of arms and the second set of arms removably hold the first device part and the second device part (see figure 4 and column 2 lines 30-32).
Claim 10
Hammer further discloses the first set of arms and the second set of arms each comprise a set of two rounded arms that extend from the board. Each of the first and second set of arms comprise a rounded interior surface to engage with the article (see figure 4).
Claim 11
Hammer further discloses the lid comprises a planar piece of flexible material figure 1). Hammer discloses the lid is a layer of sealing paper (see column 2 line 16).
Claim 12
Hammer further discloses the lid is comprised of a flexible material such that the lid is peelable from the outer pouch (see figure 1 and column 2 lines 16-19 and lines 28-29).
Claim 13
Hammer further discloses the board is affixed to the lid (see column 2 lines 16-17 and figure 1).
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Hammer (5,133,454) as applied to claim 1 above, and further in view of Fentress (US 2005/0033237).
Claim 3
Hammer further discloses the first and second device parts are formed from a single catheter component. Hammer does not disclose the component holder is configured to permit a connection between the first device part and the second device part. However, Fentress discloses a catheter assembly (110) formed from a two-piece assembly comprising a hub portion (120) and a catheter portion (150) (see figure 3 and [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hammer replacing the catheter for the catheter disclosed by Fentress since a simple substitution of one catheter for another is within the skills of an ordinary artisan in the art.
Claim 4
Hammer as modified by Fentress discloses the component holder is capable to permit the connection between the first device part and the second device part while the outer pouch remains sealed by the lid. The component holder of Hammer does not have any structural feature that prevents the first device part to be connected to the second device part.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hammer (5,133,454) and Fentress (US 2005/0033237) as applied to claim 4 above, and further in view of Guenther (8,261,910).
Claim 5
Hammer does not disclose the component holder comprises a buckling point configured to yield in a predetermined location, bringing the first set of arms and the second set of arms closer together, when forces greater than a predetermined force act upon the component holder. However, Guenther discloses a holding component (12) for an elongated object (8) comprising a buckling point/folding zone (33) configured to yield in a predetermined location (30), bringing a first set of arms (36a and 36b) and a second set of arms (46a and 46b) closer together, when forces greater than a predetermined force act upon the component holder (see figures 12, 13 and column 6 lines 35-40). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the holding component of Hammer having a folding zone as taught by Guenther to provide flexibility to the holder component when the catheter is attached. After Hammer is modified by Guenther, when the component holder is folded along the folding zone, the set of first and second arms will be closer to one another.
Claim 6
Guenther discloses the buckling point/folding zone (33) comprises a thinned section of the component holder located between the first set of arms and the second set of arms (see figures 12 and 13). After Hammer is modified by Guenther, the buckling point/folding zone will be defined as a thinned section in the board of the component holder, and between the first and second set of arms.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hammer (5,133,454) and Fentress (US 2005/0033237) as applied to claim 4 above, and further in view of Sandel (US 2006/0042977).
Claim 7
Hammer further discloses the component held with the holder component is a needle and a catheter (see abstract). Hammer does not disclose the component holder comprising a sliding portion configured to slide a first section of the board relative to a second section of the board, bringing the first set of arms and the second set of arms closer together, when forces greater than a predetermined force act upon the component holder. However, Sandel discloses a tray (80) for holding a surgical instrument, the tray comprising a sliding portion/rail (96) configured to slide a first section (84) relative to a second section (86) (see figures 6, 7, [0027] and [0028]). Sandel further discloses the first and second sections can be pull apart from each other to reach a desired length (see [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the holding component of Hammer having portions slidable one over another for having the component holder to adjust to any desired length depending on the size of the surgical instrument held in the holder component. After Hammer is modified by Sandel, with the sliding action, the first set of arms and the second set of arms could be closer together, when forces greater than a predetermined force act upon the component holder.
Claim 8
Sandel further discloses the sliding portion comprises the first section and the second section at least partially overlapping. After Hammer is modified by Sandel, the sliding portion will be located between the first set of arms and the second set of arms.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hammer (5,133,454) as applied to claim 1 above, and further in view of Sorenson (4,106,621).
Claim 14
Hammer discloses packages for catheters made from plastic material are known and common (see column 1 lines 13-14). Hammer does not explicitly disclose the material for the outer pouch, wherein the pouch is transparent or semitransparent. However, Sorenson discloses package (10) for carrying a venipuncture device (12), wherein the package comprises a blister portion (24) formed from transparent plastic material (see column 4 lines 6-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer pouch of Hammer formed from transparent plastic material as taught by Sorenson since it is well-known and common blister portions of a package made from plastic material, and the plastic be transparent for visual access to the interior of the package.
Claim 15
Hammer as modified discloses the outer pouch being transparent. Hammer does not disclose the outer pouch capable to be deformed. However, Sorensen discloses the blister portion comprising a handle restraining portion (34) used to prop up the venipuncture device so as to fully expose a handle of the device (see figure 3 and column 4 lines 53-57). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer pouch of Hammer including a handle restraining portion as taught by Sorenson for easy access and removal of the article/catheter enclosed within the package.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAFAEL A. ORTIZ whose telephone number is (571)270-5240. The examiner can normally be reached Monday - Friday 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at 571-270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAFAEL A. ORTIZ
Primary Examiner
Art Unit 3736
/RAFAEL A ORTIZ/Primary Examiner, Art Unit 3736