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 § 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, 2, 4 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buyce et al., US 6,554,218.
Regarding claim 1, Buyce discloses a holder [configured to hold an elongated medical body], comprising: a first outer member (2) having a first perimeter, a first inner surface (on an interior of the member 2; see figure 2) and a first outer surface (outer top surface of the body portion 10 of 2), at least a portion of the first outer member (2) lying in a first plane; a second outer member (3) having a second perimeter, a second inner surface (of the member 3, on its interior side; see figure 2) and a second outer surface (outer top surface of the body portion 11 of 3), at least a portion of the second outer member (3) lying in a second plane; a core (16, 17) extending between the first and second outer members (2, 3) at a location interior to the first and second perimeters, wherein the first and second outer members (2, 3) are maintained with the first and second inner surfaces (of the members 2 and 3, respectively) in opposition about the core (16, 17) with the first and second planes oriented generally in parallel and spaced apart (see figures 2-6); and a compressible material (an elastomeric material 5, 6; inherent feature of the elastomeric material having the compressibility feature since elastomers generally deform under compressive load and recover when the load is removed) disposed on (see figure 4) at least a portion of one of the first and second inner surfaces (figure 4); [wherein the compressible material (5, 6) and the first inner surface or the second inner surface (of 2 and 3, respectively) are configured to press and hold therebetween such portions of the elongated medical body (such as a cable 8 in figure 3) that are in contact with the compressible material (5, 6) and the first or second inner surface (of 2 and 3, respectively) when the elongated medical body (such as the cable 8) is advanced therebetween towards the core (16, 17) and is in engagement with the compressible material (5, 6)].
Claim language set in brackets [] set forth above and below in this office action are considered by the examiner to be intended use that fails to further limit the structure of the claimed invention. Since the claimed invention is directed solely to that of the holder, the prior art must only be capable of performing the functional recitations in order to be applicable, and in the instant case, the examiner maintains that the cable management spool disclosed by Buyce et al. (US 6,554,218), is indeed capable of the intended use statements. Note that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
Regarding claim 2, Buyce discloses the holder of claim 1 further comprising: a writable surface (a flat outer surface of 10) disposed on the outer surface (of 10) of one of the first and second outer members (2, 3).
Regarding claim 4, Buyce discloses the holder of claim 1 wherein the core (16, 17) further comprises a first connector (16) attached to one of the first (2) and second outer members, wherein the first connector (16) is connected to the other of the first and second outer members (3).
Regarding claim 5, Buyce discloses the holder of claim 1 wherein the first and second inner surfaces (of the members 2 and 3, respectively) are configured to form a funnel cross sectional shape (see figures 3-6; the funnel shape is provided with the outer members 2, 3 narrowing into a channel for the cable 8 to be held within by the inner surfaces of said members 2, 3).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3, 6-8, 10-12, 15, 16 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buyce et al., US 6,554,218.
Regarding claim 3, Buyce discloses the holder (1) of claim 1 further comprising: retainers (45, 52, 47) disposed on one of the outer surfaces of the first and second outer members (2, 3) [wherein the retainers are configured to attach to one of the first and second outer surfaces (3) and to a surface (44) not forming part of the holder (1)].
Buyce does not explicitly disclose an adhesive disposed on one of the outer surfaces of the first and second outer members (2, 3) [wherein the adhesive is configured to attach to one of the first and second outer surfaces and to a surface not forming part of the holder].
The examiner takes Official Notice that adhesives are well known in the art for mounting devices such as a holder by attaching two surfaces together. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the retainers of Buyce with an adhesive since it is well known in the art to utilize the adhesive as an alternative method for mounting the holder onto another surface.
Regarding claim 6, Buyce discloses a holder [configured to hold an elongated medical body], comprising: a first outer member (2) having a first inner surface (an inner surface of 10 of 2; figure 2), and a first outer surface (an outer surface of 10 of 2), a second outer member (3) having a second inner surface (an inner surface of 11 of 3; figure 2) and a second outer surface (an outer surface of 11 of 3), wherein each of the first and second outer members (2, 3) have an outer perimeter (figure 2), a center (figure 2), and a surface (see edges 14, 15) that tapers from the outer perimeter to a point between the outer perimeter and the center defining a funnel (see figures 3 and 4) [configured to capture the elongated medical body]; a core structure (16, 17) extending between the first and second outer members (2, 3); two holding members (5, 6) respectively placed between the inner surfaces (of 10 and 11, respectively) of the first and second outer members (2, 3), and wherein the holding members (5, 6) each comprises a compressible material (an elastomeric material; inherent feature of the elastomeric material having the compressibility feature since elastomers generally deform under compressive load and recover when the load is removed) [and configured to press and hold therebetween the elongated medical body (such as the cable 8)]. Buyce further discloses retainers (45, 52, 47) [configured to adhere the holder (1) to a first surface (44)] and wherein the retainers are configured to attach to one of the first and second outer surfaces (of 11 of 3) and has an exposed adherent side (extending away from the second outer surface), [wherein the exposed adherent side of the retainers is configured to attach to a surface (44) not forming part of the holder (1)].
Buyce does not explicitly disclose an adhesive member [configured to adhere the holder to a first surface] and wherein the adhesive member is configured to attach to one of the first and second outer surfaces (of 10 or 11) and has an exposed adherent side, [wherein the exposed adherent side of the adhesive is configured to attach to a surface not forming part of the holder]. The examiner takes Official Notice that adhesives are well known in the art for mounting devices such as a holder by attaching two surfaces together. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the retainers of Buyce with an adhesive since it is well known in the art to utilize the adhesive as an alternative method for mounting the holder onto another surface.
Regarding claim 7, Buyce teaches the holder of claim 6, wherein the core structure (16, 17) comprises a first connection member (16) coupled to the first outer member (2) and a second connection member (17) coupled to the second outer member (3).
Regarding claim 8, Buyce teaches the holder of claim 6, further comprising a writable surface (capable of being written on) on the first and second outer surfaces (2 or 3).
Regarding claim 10, Buyce teaches the holder of claim 6, wherein the attachment of the first and second outer members (2, 3) defines a space (between said members 2, 3 and for the holding members 5, 6 to engage the elongated body 8) [suitable for holding the elongated medical body (8) between the two holding members (5, 6)].
Regarding claim 11, Buyce teaches the holder of claim 6. Buyce does not expressly teach wherein two holding members (5, 6) further comprise a foam material. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to consider a foam material as a substitution for the elastomeric material of the holding members (5, 6), since it has been held to be within the general skill of a worker in the art to select a known (commercially available elastomeric foam) material 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 12, Buyce teaches the of claim 6 except for wherein the two holding members (5, 6) further comprise a silicone material. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to consider silicone as the material for said holding members, since it has been held to be within the general skill of a worker in the art to select a known (commercially available) material 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 15, Buyce teaches the holder of claim 6, wherein at least one of the first and second outer members includes a recess (formed by the outer perimeter of the first outer member 2 defining a recessed top surface; see figure 3) on its outer surface relative to its outer edge (figure 3), wherein the recess (of 2) comprises a recess surface (the top recessed surface) [configured to receive labeling or the adhesive member].
Regarding claim 16, Buyce teaches the hold of claim 7, wherein the first connection member (16) comprises two openings (27) and the second connection member (17) comprises two prongs (25), wherein the two prongs (25) are configured to securely fit into and attach to the two openings (27).
Buyce does not expressly teach wherein the first connection member (16) comprises the two prongs and the second connection member (17) comprises the two openings. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to reversely place the prongs on the first connection member (16) and the openings on the second connection member (17), since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Regarding claim 20, Buyce teaches the holder of claim 8 except for wherein a writable surface comprises a label adhered to the outer surface of the respective outer member. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a label adhered to the outer surface since it has been held that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947)
Regarding claim 21, Buyce teaches the holder of claim 6, except for wherein the adhesive member maintains its adhesive qualities upon multiple attachments and detachments from the first surface. However, it would have been obvious to a person having ordinary skill to select an adhesive material with sufficient tackiness to survive multiple attachment and detachment cycles since it has been held to be within the general skill of a worker in the art to select a known (commercially available) material 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 22, Buyce teaches the holder of claim 6, [wherein the adhesive member is configured to removably attach to the first surface, and wherein the first surface is a drape, a garment, a table, or surgical tray].
Regarding claim 23, Buyce teaches the holder of claim 6, further comprising a secondary attachment mechanism (45, 52, 47) attached to either the first outer member or the second outer member (3), [wherein the secondary attachment mechanism is configured to attach to a drape or a garment].
Claim(s) 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buyce, US 6,554, 218 in view of Lampropoulos, US 2016/0206394.
Regarding kit claims 31-34, in view of the structure disclosed by Buyce and Lampropoulos, it would have been obvious to one having ordinary skill in the art at the time the invention was made to break the components down and assemble them into kit form.
Regarding claims 31-34: Buyce discloses the holder of claim 1 as rejected above, and recessed top surfaces on the outer members (2, 3) for labeling and/or writing onto.
Lampropoulos (US 2016/0206394) teaches a holder comprising at least one elongated medical body (50), wherein the at least one elongated medical body is a guidewire (50) and the use of a writing utensil (a marker; see paragraph [0043]) to place a label on a tab (140) of the holder.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the holder of Buyce to include the writing utensil and the guidewire taught by Lampropoulos in order to provide a kit having the holder and other medical accessory components to be used in a cardiac medical procedure.
The combination does not expressly teach the kit further comprising and an instrument pad (cleansing reagent) [for wiping an elongated medical body], wherein the instrument pad is an antiseptic instrument pad and the kit further comprising a pouch card configured for selective attachment to the holder, wherein the pouch card is removably fastened to an attachment mechanism.
The examiner takes Official Notice that an antiseptic instrument pad and a pouch card are well known in the art for medical operations. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of the combination of Buyce, Palmer and Lampropoulos to further include the antiseptic instrument pad and the pouch card in order to provide a cleaning reagent for the guidewire and a sanitary bag for the medical operation.
Response to Arguments
Applicant's arguments filed October 15, 2025 have been fully considered but they are not persuasive. It is noted that applicant has amended claim 1 to further require the configuration of “press and hold” between the compressible material and the first inner surface or the second inner surface that was not previously recited in the claim. Said amendment has necessitated a new ground of rejection in view of Buyce wherein the inner surfaces are reconsidered as surfaces of the members 2 and 3.
In response to applicant's argument that Buyce (US 6,554,218) discloses a cable management spool for storing electrical cords and not for holding an elongated medical body, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the flaps 5, 6 of Buyce read on the compressible material of claim 1, the flaps are fully capable of the claimed configuration even though they are otherwise intended for separating the inside of the storage cavities to conceal the cable 8 in the device. In other words, the flaps 5, 6 are disposed as claimed and are configured for pressing and holding the elongated medical body as claimed. The examiner further notes figure 3 of Buyce illustrating the flap (6) and the second inner surface (of the member 3) are configured to press and hold therebetween portions of an elongated medical body.
With regards to claim 6, applicant has argued similarly wherein the holding members are configured for pressing and holding the elongated medical body and the flaps (5, 6) of Buyce is not capable of the configuration to hold and press the cord. Instead, the flaps (5, 6) are for separating the inside of the storage cavities from the outside of the device. The argument is found not persuasive in view of the response to claim 1 above wherein the flaps 5, 6 are fully capable of the claimed configuration (to press and hold) an elongated medical body (figure 3 of Buyce better illustrate the press and hold feature of the flap against an elongated body 8).
Regarding claim 21, the adhesive qualities have been addressed in the rejection as set forth above. It is noted that applicant has amended claim 6 to include features not previously presented (in a combination manner) and therefore necessitating a new ground of rejection as set forth above for the claim 21.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROWLAND DO whose telephone number is (571)270-5737. The examiner can normally be reached Monday-Thursday 8:30 - 7:00 PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason San can be reached at (571) 272-6531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.D./ Examiner, Art Unit 3677
/JASON W SAN/ SPE, Art Unit 3677
Prosecution Insights