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 § 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) 1, 3-5, 7, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0043130 (“Jones”) in view of U.S. Publication No. 2007/0244423 (“Zumeris”) and U.S. Publication No. 2018/0168668 (“Zheng”).
Regarding Claim 1, Jones discloses a vascular access catheter (50, 14) stabilization device (10, 16), comprising:
A hub engagement portion (16, 30, 22 – see Fig. 2) comprising a housing (16) enclosing an acoustic wave generator (Par. 7, 38, 44, 45 – re: “piezoelectric element that imparts vibrational energy” which is understood to reference the “acoustic energy” imparting function by generating vibrational energy which is conducted as sound waves) and adapted to additionally surround at least a portion of a hub (14) of the vascular access catheter (see Fig. 2); and
A base (12) adapted for removable attachment to a patient’s skin (Par. 35).
Jones discloses that the acoustic wave generator comprises a driver which is electrically connected to a piezoelectric element (Par. 38, 45) and indicates that at least some of these components may be located within the housing (Par. 38). However, Cameron fails to explicitly disclose that this piezoelectric element comprises a “plate” as opposed to some other type of piezoelectric element. However, Zumeris discloses that such piezoelectric elements can be embodied as “thin plate piezo” elements (Par. 86) connected to the electric driver (300). Zumeris discloses that contact between the piezo (210, 220) and the catheter (100) can be ensured by providing a compressible cushioning spacer (230, 240) within the housing (250, 260) with the cushioning spacer (230) being provided between an upper housing shell (250) and the piezo (210, 22 – see Par. 149, 150, 152, 157).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the piezoelectric element of the invention of Cameron to comprise an electrically driven, thin-plate piezoelectric element positioned within the upper housing with a compressible cushioning spacer provided within the upper housing between the housing upper shell and the piezo, as disclosed by Zumeris, in order to provide the piezoelectric element in a form explicitly recognized in the art for its utility in imparting vibrational energy to a catheter with a minimal form factor where the cushioning spacer ensures adequate contact between the piezoelectric element and the catheter/hub while accounting for variance in catheter hub sizes, seating of the two housing components together, and positioning of the catheter within the housing during assembly.
Cameron, in view of Zumeris, discloses the invention substantially as claimed except that that the driver is “enclosed” within the housing. Rather Zumeris discloses the driver to be provided external to the housing (see Fig. 15). Likewise, Cameron appears to illustrate that the diver element is provided externally to the housing (see “flexible cable 56” which provides connection of “external technology” for an “active element 54”), although Cameron does contemplate that some driving components may be located within the housing (see Par. 38). However, Zheng discloses that related drivers (406, B) for piezoelectric based ultrasonic transducers (400) can be integrated into the housing (410) so as to also be enclosed therein (see Fig. 4).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to integrate the driver components into the housing of modified Cameron, as disclosed by Zheng, in order to allow the device to be self-contained thereby reducing the need for external control modules and ensuring compactness of the system as an integrated module.
Regarding Claim 3, Cameron, particularly in view of Zumeris, discloses the driver comprises a power source (e.g. battery 302 – Zumeris) for supplying electric current and a control unit (i.e. the CPU of the driver 300 - Zumeris) for controlling the transmission of the electric current to piezoelectric plate (Par. 169 – Zumeris).
Regarding Claim 4, Cameron discloses the piezoelectric element (particularly embodied as a “plate” in view of Zumeris) is positioned within the housing to be in contact with the hub of the vascular access catheter when the hub of the vascular access catheter is enclosed within the housing (Par. 45 – Fig. 2).
Regarding Claim 5, Cameron discloses the piezoelectric element (embodied as a plate in view of Zumeris) has a size and shape (see e.g. the circular shape 210 of the plate in Zumeris – considering also the corresponding shape of the housing and hub of the invention of Cameron) corresponding to an upper surface of at least a section of a portion of the hub of the vascular access catheter enclosed within the housing (see Fig. 1 and 2), and contact between the piezoelectric plate and the hub of the vascular access catheter is sufficient to allow transmission of acoustic waves generated in the piezoelectric plate to the hub of the vascular access catheter (Par. 38, 45). The instant shape selected to ensure proper contact between the piezoelectric element and the hub geometry in the invention of modified Cameron constitutes an obvious design choice in specifically resolving the instant invention to practice whereby such changes in shape are obvious when they affect only predictable and expected results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Here selecting a shape for the piezoelectric element in the invention of modified Cameron which corresponds to the shape of the housing and hub ensures only the predictable and expected results of ensuring that the piezoelectric element fits within the housing and that it makes proper contact with a sufficient surface area of the hub in order to convey the acoustic energy thereto in a predictable and expected fashion.
Regarding Claim 7, Cameron, as modified (see particularly Zumeris) discloses the cushioning spacer is positioned between the driver and the piezoelectric plate (see Fig. 9A – Zumeris).
Regarding Claim 16, Cameron discloses the base includes an adhesive pad (Par. 25)
Regarding Claim 17, Cameron the acoustic waves generated by the acoustic wave generator have a frequency in the ultrasonic range above 20 kHz (see Par. 7).
Claim(s) 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0043130 (“Jones”) in view of U.S. Publication No. 2007/0244423 (“Zumeris”) and U.S. Publication No. 2018/0168668 (“Zheng”) as applied above, and further in view of U.S. Publication No. 2008/0132848 (“Wright”).
Regarding Claim 8, Cameron discloses the housing comprises a top wall (see Fig. 3 – i.e. the wall toward the top of the page circa 26), a bottom wall (see Fig. 3 – i.e. the wall toward the bottom of the page circa 18) and two side wall (22). Cameron fails to disclose the housing further comprises distinct proximal and distal walls with the proximal wall and the distal wall each have an opening to allow the vascular access catheter to pass through the housing when the hub of the vascular access catheter is at least partially surrounded by the housing. However, Wright discloses a related device (e.g. 320) comprising a housing having a top wall (328), a bottom wall (326), a distal wall (see Fig. 32 – i.e. the face of 328 closest to the plane of the page – see circa 360), a proximal wall (i.e. the side opposite that visible in Fig. 32 – see circa 360), and two side walls (see the left and right sides of 328 which depend downward to the left and right flanges which carry 370), with the proximal and distal walls each having an opening to allow the vascular access catheter to pass therethrough (see Fig. 31). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct a catheter retaining having an acoustic generator as disclosed by Cameron, having the shape described by Wright, in order to create a retainer which can hold a catheter having a different shaped hub, whereby it has been held that such changes in shape are obvious when they impart only expected and predictable results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 9, Cameron, as modified by Zumeris and Zheng, discloses the driver (see Zheng which obviates internalizing the driver components within the housing), the piezoelectric plate (see Zumeris which obviates embodying the piezoelectric element as a plate), and the cushioning spacer (see Zumeris which obviates including a cushioning spacer to ensure proper contact between the piezo and the cathter) are contained in an upper portion (16) of the housing between the top wall (see 26) and the hub (14) of the vascular access catheter (see Fig. 2 – Cameron).
Regarding Claim 10, Cameron, as modified by Wright, discloses the bottom wall has a recess that is sized and shaped to receive at least a portion of the hub of the vascular access catheter (see Fig. 31, 32 – Wright).
Regarding Claim 11, Cameron, as modified by Wright, discloses the recess comprises areas that receive wings extending from a shaft portion of the hub of the vascular access catheter and surround edges of the wings to stabilize the hub of the vascular access catheter within the housing (see Fig. 31, 32 – Wright).
Regarding Claim 12, Cameron, as modified by Wright, discloses wherein the housing comprises a first part including the top wall and a second part including the bottom wall (see Fig. 31, 32 – Wright), and the first part of the housing is removably connected to or locked to the second part of the housing (see Fig. 32 – Wright).
Regarding Claim 13, Cameron, as modified by Wright, discloses a connection between the first part of the housing and the second part of the housing comprises one or more protrusions on the first part of the housing or the second part of the housing that are received within corresponding openings in the other of the first part of the housing and the second part of the housing (see Wright at 370, 340).
Regarding Claim 14, Cameron, as modified by Wright, discloses the one or more protrusions comprise a flexible beam (e.g. 370– Wright) attached to the housing at one end and, at the other end, has a tab having a bottom surface extending substantially perpendicularly from the flexible beam and an angled top surface (see Fig. 35 – Wright).
Regarding Claim 15, Cameron, as modified by Wright, discloses flanges extend substantially perpendicularly from each side wall of each of the first part of the housing and the second part of the housing and the connection or locking of the first part of the housing to the second part of the housing is provided via the flanges (see Fig. 35 – Wright).
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 7) that “Cameron does not teach or suggest a compressible cushioning spacer within the housing to maintain the piezoelectric plate in contact with the hub of the vascular access catheter.” However, this is not persuasive inasmuch as Cameron was never purported to be relied upon to teach such an element. Rather such an element is obviated through consideration of the Zumeris reference. Specifically, the disclosure of Cameron is limited to what extent it particularly resolves the inclusion of the piezoelectric element within the disclosed housing. As such, the ordinary artisan would rely upon other prior art references to determine, specifically, how such a piezoelectric element might be embodied within the housing. Such a reference is Zumeris which discloses a upper housing component (250) which has a thin plate piezeoelectric element (210, 220) disposed therein such that when paired with a housing lower component (260) the piezoelectric element might be induced to bare against a retained catheter (100). In order to ensure proper contact between the catheter and the piezo Zumeris discloses that the housing may be provided with a cushioning spacer (230) positioned between the housing upper component and the retained catheter (see Fig. 9A) so that good contact can be made between the catheter and piezo irrespective of differences in size and mounting (Par. 149, 150, 152). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the upper housing of Cameron to include a cushioning spacer between the housing and the piezo, as disclosed by Zumeris, such that when loading the catheter hub within the housing good contact can be made between the piezo and the catheter hub irrespective of differences in hub size and loading thereby ensuring that efficacious contact is made to transfer the acoustic energy from the piezo into the catheter hub.
Applicant argues (Pg. 9) “However, this direct attachment does not include a structure that could be mapped to a compressible cushioning spacer within the housing as recited in claim 1.” However, this is not persuasive. Here Zumeris, like Cameron, discloses a “case” (re: housing) respective upper (250 -see Fig. 15) and lower (260 – see Fig. 15) components in which a catheter (100) is received in order to be brought into apposition with a piezoelectric transducer (210, 220). These components correspond to the housing upper (16) and lower (18, 30, 22) components in Cameron which form the housing/case which secures the catheter hub (14). Here, the ordinary artisan would, in view of Zumeris bee compelled to affix the piezoelectric element to the underside of the upper housing element (16) using a cushioning spacer (as disclosed by Zumeris) such that during assembly (see Fig. 2) the piezo electric element can move to ensure adequate contact between the piezo and the hub – much like how a battery compartment typically includes spring elements such that the contacts may be pressed against the battery under force to thereby ensure adequate electric contact. Zumeris provides the teaching, suggestion, and motivation for such a modification to Cameron and such modifications would have been clearly obvious to the ordinary artisan.
Examiner further notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the idea of floating the piezo element within the upper shell of the housing/casing to order to allow the element to move in and out during assembly to account for differences in catheter size and how the catheter is aligned/secured within the housing and how the two housing haves are aligned is clear concept that the ordinary artisan would have immediately recognized and appreciated as being useful in application to the invention of Cameron. Specifically, in Cameron allowing the piezo to float within the underside of the upper housing half (16) will ensure that slight variances in hub dimensions do no effect the degree to which the piezo bears against the surface of the catheter hub, will ensure that if the hub is slightly misaligned within the housing contact between the piezo and the hub is still made in an efficacious manner, and ensure that if the two hub halves are slightly out of alignment contact between the piezo and the hub will still be made in an efficacious manner. Examiner submits that the construction described by Zumeris is similar to the way springs are used in battery compartments to ensure that the battery makes good, quality contact with the conductors.
With respect to the elastic acoustic layer (220) in Zumeris, this layer may be understood as optional when applying the teachings of Zumeris to a flat surface (in Cameron) instead of a curved surface (see Par. 152 – where the elements are provided separately to be assembled by the user as needed). Furthermore, to the extent that these elements conduct the acoustic energy they can be considered part of the piezoelectric plate within the context of the claim, whereby integrating them as part of the piezoelectric plate is not precluded by the claims. As such, even in the event that a user, in reducing the invention of modified Cameron decide to add an elastic acoustic layer (220 – Zumeris) because they are adhered to the piezo during assembly and contribute to the function of the piezo (i.e. transferring acoustic energy) they may properly be considered part of the piezo plate as opposed to separate and distinct elements which do not conduct the acoustic energy (re: the foam 230). However, as noted above, it would have been obvious for one having ordinary skill in the art at the time the invention was made to place a foam layer inbetween the housing top portion (26) of Cameron and the piezoelectric element (see generally 54 Cameron) such that the piezo essentially floats within the housing, whereby the foam is compressed a distance during installation of the catheter within the housing to ensure optimal bearing of the piezoelectric element against the catheter hub irrespective of changes in catheter hub size, how well the hub is aligned and seated within the housing, and how well the top housing component is aligned and seated with the lower housing component.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/03/2026
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