DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 17 is objected to because of the following informalities: the limitation, “…the straps…” should read “…the at least one strap…”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: the limitation, “…the strap…” should read “…the at least one strap…”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2, 5-6, 9-10, 13-14 and 16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Barber U.S. Patent No. (4,928,677).
With respect to claim 2, Barber discloses an extremity support (10, figs.1-5) for use in intravenous (IV) therapy; as to the limitation “for use in intravenous therapy”, 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; furthermore, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim comprising:
a stabilizer (10),
at least one window (see reproduced image of fig.1 below), and
at least one strap (54, fig.1);
wherein when the extremity support (10) is affixed to an extremity (as shown in fig.4), the at least one window allows for visualization and palpation of the extremity without removal of the extremity support (as shown in phantom in fig.4); and
wherein the at least one strap (54) braces the extremity against the stabilizer (as shown in fig.4) and inhibits movement of the extremity; Barber discloses in ([Col.3], lines 53-54) the stabilizer (10) allowing limited use of the hand, as such, inhibits the extremity’s movement.
As to the claim recitation “wherein:(a) the at least one window allows for visualization and palpation of the extremity without removal of the extremity support”; one of ordinary skill in the art [a health care practitioner] administering an intravenous catheter to the forearm of the user would know how to adjust and configure the strap of Barber such that the window allows for visualization and palpation as well as assess the extremity without removing the extremity support.
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With respect to claim 5, Barber discloses the stabilizer (10) further comprises at least one anchor (44, 48, fig.1); and wherein the strap (54) is affixed to the anchor (as shown in fig.5).
With respect to claim 6, Barber discloses the extremity support (10) is an arm support (as shown in fig.4).
With respect to claim 9, Barber discloses the stabilizer is plastic ([Col.5], lines 40-42).
With respect to claim 10, Barber discloses the stabilizer (10) is wire (12, fig.1) and ([Col3], lines 65-67).
With respect to claim 13, Barber discloses the stabilizer (10) is contoured to fit a patient's extremity (as shown in fig.4).
With respect to claim 14, Barber discloses the stabilizer (10) is the shape of an hourglass (as shown in fig.1; the stabilizer (10) encompasses an hourglass profile having two wide ends connected by a narrow middle portion; as such, meets the claim limitation.
With respect to claim 16, Barber discloses the extremity support comprises one strap (54, fig.1).
Claim(s) 2-3 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Williams U.S. Patent No. (6,723,061).
With respect to claim 2, Williams discloses an extremity support (10, figs.1-4) for use in intravenous (IV) therapy; as to the limitation “for use in intravenous therapy”, 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; furthermore, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim, comprising:
a stabilizer (100, fig.1),
at least one window (as shown in the reproduced image of fig.1 below), and
at least one strap (190, 180 and 170, fig.3);
wherein when the extremity support is affixed to an extremity (as shown in fig.1),
the at least one window allows for visualization and palpation of the extremity without removal of the extremity support (as shown in fig.1); and
wherein the at least one strap (190, 180 and 170, fig.3) braces the extremity against the stabilizer and inhibits movement of the extremity ([Col.5], lines 28-31).
As to the claim recitation “wherein:(a) the at least one window allows for visualization and palpation of the extremity without removal of the extremity support”; one of ordinary skill in the art [a health care practitioner] administering an intravenous catheter to the forearm of the user would know how use the window for visualization and palpation without removing the extremity support.
With respect to claim 3, Williams discloses the extremity support comprises three straps (190, 180 and 170, fig.3).
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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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Morgan et al. U.S. Patent No. (4,503,849).
With respect to claim 4, Barber substantially discloses the invention as claimed except the stabilizer further comprises at least one slit to accommodate the strap.
Morgan et al., however, teaches an arm restraint for sampling blood for temporarily restraining a patient's arm while drawing either venous or arterial blood is described. The restraint includes a rigid member with a concave cross section to accept an arm from the upper part of the arm to below the wrist. Adjustable and removable straps are at each end of the rigid member with securing straps attached through slots or slits (24) in the rigid member substantially in the middle of the rigid member (abstract) and (figs.1 and 4).
In view of the teachings of Morgan et al., it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the stabilizer of Barber by incorporating at least one slit to accommodate the strap in order to secure the stabilizer to the anatomy of the user.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Calvert U.S. Patent No. (5,728,053).
With respect to claim 7, Barber substantially discloses the invention as claimed except the extremity support is a leg support.
Calvert however, teaches a rigid support mounted to protect the site of a connection to a catheter or other in-dwelling treatment assembly (abstract) comprising frame sections (8 and 10, fig.2). The shape of the frame sections 8 and 10 may also be tailored or customized to mount to other treatment sites 4, such as at the upper arm, leg or to the trunk of the body ([Col.3], lines 40-47).
In view of the teachings of Calvert, it would have been obvious to one of ordinary skill in the art at the time of the invention to customize the extremity support of Barber as a leg support in order to be mounted to other treatment site ([Col.3], lines 41-43).
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Schaeffer U.S. Patent No. (5,577,516).
With respect to claim 8, Barber substantially discloses the invention as claimed except the stabilizer is transparent.
Schaeffer however, teaches an intravenous catheter support (fig.1) comprising a stabilizer or plate (14) comprising a generally longitudinally extending sheet of material and, as seen in FIG. 2a, is generally curved in transverse cross-section. Preferably, the material is a generally rigid material capable of having pressure applied thereto and also capable of applying pressure to the area of the body portion proximate the wound in a generally uniform manner. The generally rigid material may comprise polycarbonate, rubber, dense foam, acrylic, polystyrene, plastic, synthetic resin, composite material, sheet aluminum, sheet metal, or combinations thereof. As will be recognized, however, the pressure plate 14 may also comprise any other suitable materials. More preferably, the pressure plate 14 comprises is transparent to permit observation therethrough ([Col.3], lines 53-67).
In view of the teachings of Schaeffer, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the stabilizer of Barber to comprise a transparent material to permit observation therethrough.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Yattavong U.S. Patent No. (6,328,706).
With respect to claim 11, Barber substantially discloses the invention as claimed except the stabilizer comprises at least two windows.
Yattavong however, teaches a stabilizer (10, figs.1a-3) comprising at least two windows (see reproduced image of fig.3 below).
In view of the teachings of Yattavong, it would have been obvious to one of ordinary skill in the art to modify the stabilizer of Barber by incorporating at least two windows to the stabilizer of Barber for viewing different portions of the anatomy of the user.
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Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Jackson U.S. Patent No. (2, 318, 864).
With respect to claim 12, Barber substantially discloses the invention as claimed except the stabilizer further comprises ventilation holes.
Jackson, however, teaches a stabilizer (figs.1-10) comprising slots 34 and 36 are provided for two purposes, one of which is to provide ventilation ([Page2, right column], lines 66-67).
In view of the teachings of Jackson, it would have been obvious to one of ordinary skill in the art to modify the stabilizer of Barber by incorporating ventilation holes to provide ventilation in order for the skin of the anatomy to breathe.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Cruz U.S. Patent No. (6540710).
With respect to claim 15, Barber substantially discloses the invention as claimed except the stabilizer further comprises padding.
Cruz however, teaches a stabilizer (10) comprising at least one window (as shown in the reproduced image of fig.2 below), and (iii) at least one strap (shown in figs.7-8) that is configured to secure the extremity support to the patient's extremity (shown in phantom in figs.7-8); wherein the stabilizer (10) further comprises padding ([Col.2], lines 43-44).
In view of the teachings of Cruz, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the stabilizer of Barber by incorporating padding to provide comfort to the anatomy of the user.
Claim 17-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber as applied to claim 2 above, and further in view of Calvert U.S. Patent No. (5728053).
With respect claim 17, Barber substantially discloses the invention as claimed except the at least one strap is mesh, cloth, stretch warp, burn net, gauze, cotton cloth, or nylon.
Calvert however, teaches in an analogous art an extremity support comprising a stabilizer (shown in figs.1 and 4) comprising straps made from cloth, stretch warp ([Col.5], lines 35-37).
In view of the teachings of Calvert, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify at least one strap of Barber by forming the strap of a stretch warp in order to adjust the tension of the strap when wrapped around the anatomy of the user.
With respect to claim 18, the combination of Barber/Calvert substantially discloses the invention as claimed. Calvert further teaches the at least one strap comprises elastic ([Col.5], lines 35-37) in order to adjust the tension of the strap when wrapped around the anatomy of the user.
Claims 19-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barber U.S. Patent No. (4,928,677) in view of Yattavong U.S. Patent No. (6,328,706).
With respect to claim 19, Barber substantially discloses an arm support (figs.1-5) for use in intravenous (IV) therapy; as to the limitation “for use in intravenous therapy”, 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; furthermore, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim, comprising:
a stabilizer (10),
at least one window (as shown in the reproduced image of fig.1 below), and
at least one strap (54, fig.1);
wherein the stabilizer (10) further comprises at least one opening (openings in D rings 44 and 48, fig.5) to accommodate the strap and at least one anchor (D-rings 44 and 48, fig.5);
wherein the strap (54) is affixed to the anchor (as shown in fig.5); and
wherein when the extremity support is affixed to an extremity, the window (as shown in the reproduced image of fig.1 below) allow for visualization and palpation of the extremity without the removal of the extremity support; and
wherein the at least one strap (54) braces the extremity (as shown in fig.4) against the stabilizer (10) and inhibits movement of the extremity Barber discloses in ([Col.3], lines 53-54) the stabilizer (10) allowing limited use of the hand, as such, inhibits the extremity’s movement.
As to the claim recitation “wherein:(a) the window allows for visualization and palpation of the extremity without removal of the extremity support”; one of ordinary skill in the art [a health care practitioner] administering an intravenous catheter to the forearm of the user would know how to adjust and configure the strap of Barber such that the window allows for visualization and palpation as well as assess the extremity without removing the extremity support.
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Barber substantially discloses a window (as shown in the reproduced image of fig.1 above); the window allows for visualization and palpation of the patient's arm without the removal of the arm support except at least two windows.
Yattavong however, teaches a stabilizer (10, figs.1a-3) comprising at least two windows (see reproduced image of fig.3 below).
In view of the teachings of Yattavong, it would have been obvious to one of ordinary skill in the art to modify the stabilizer of Barber by incorporating at least two windows to the stabilizer of Barber for viewing different portions of the anatomy of the user.
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With respect to claim 20, the combination of Barber/Yattavong substantially discloses the invention as claimed. Yattavong further teaches the extremity support comprises two straps (16-17, fig.3, as well as in the reproduced image of fig.3 above).
Response to Arguments
Applicant’s arguments, see pages 1-6, filed 07/20/2026, with respect to the rejection(s) of claim(s) 1-3, 5-6, 8, 12 and 15-16 rejected under pre-AIA 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Barber. The Office maintains the teaching references to cure the deficiencies of Barber.
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 OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
