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 .
Election/Restrictions
Applicant's election with traverse of Group I (Clm. 1-17) in the reply filed on 06 October 2025 is acknowledged. The traversal is on the ground(s) that a burdensome search has not been demonstrated. This is not found persuasive. Examiner submits that the reasons recited under Heading 5 of the requirement should not be considered in a vacuum, but rather must be considered in association with the rationales cited in Par. 2 and 4 of the requirement. Here Examiner has clearly noted the divergence in the claimed subject matter and demonstrated why, because of this divergence, classification of the two inventions is distinctive, why the inventions (particularly as they present in two different statutory categories) have a separate status in the art, how the inventions will require a different field of search, and why the prior art applicable to one invention would not likely be applicable to the other invention. Specifically, as noted by Examiner the method is specifically directed toward a method of “preventing infections” with a “vascular access catheter”. This particularly limits the acoustic wave generator to have a particular utility and specifically requires a “vascular access catheter” to be part of the claimed workpiece. The apparatus, on the other hand, prescribes absolutely no utility to the claimed “acoustic wave generator” and does not positively require the “vascular access catheter” to be part of the claimed workpiece. Rather the only particular utility associated with the device is directed toward “stabilization” of the catheter hub. As such, the device MUST be classified based upon this utility (see e.g. A61M2039/0261 – i.e. holding devices for an access site or A61M25/02 – i.e. catheter holding devices) and the method is best classified based on the specific, particular claimed utility of preventing infection (e.g. A61M2039/0285, A61M2025/0019, A61M25/0017). This is clearly demonstrative of BOTH divergent classifications and separate statuses in the prior art. As further noted by Examiner, the acoustic wave generator of the apparatus could have a completely separate utility that is not suitable for disinfection, e.g. a diagnostic transducer (A61B8/00), breaking up clots, ablating tissue (A61B18/00), an acoustic alarm (A61M2205/18), encouraging tissue growth (A61N7/00)…etc. Likewise, since the “vascular access catheter” is not positively required the apparatus, even if directed toward preventing infection, could be provided in association with other indwelling appliances such as electrical leads, urinary catheters…etc. The device recited in the method provides absolutely no considerations as to anchoring the catheter, but is instead directed toward the function of the acoustic wave generator to transmit acoustic waves as “mechanical vibrations” in the vascular catheter to serve as “a method of preventing infections”. This utility NEVER appears in association with the device claims and the device recited in the method is never provided with considerations of affixing the catheter to the patient’s skin. While a search for the two inventions may have some overlap, the claimed inventions fail to recite a clear, common nexus of potential novelty or non-obviousness and therefore search will be expected to deviate from a generic broad concept of an “acoustic wave generator” (which could be preventing infection, tissue ablation, diagnostic imaging, an acoustic alarm…etc. based on the breadth to which it is recited in association with the device).
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
Claim(s) 9 and dependents is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 9, Applicant recites the limitation “wherein the driver, the piezoelectric plate, and the cushioning spacer are…” However, neither Claim 9 nor parent Claims 8 and 1 previously introduce these elements. Rather these elements are not introduced until Claims 2 (the driver and the plate) and 6 (the cushioning). It is therefore unclear if this claim is intending to separately introduce these elements or if this claim (and Claim 8) were intended to be dependent on Claim 6 so as to introduce all of the required elements.
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, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2017/0043130 (“Cameron”).
Regarding Claim 1, Cameron discloses a vascular catheter stabilization device (10, 16), comprising:
A hub engagement portion (16, 30, 22) comprising a housing (16) enclosing an acoustic wave generator (Par. 7, 38, 44, 45 – re: “piezoelectric element that imparts vibrational energy” which in understood to reference the “acoustic energy” imparting function) and adapted to additionally surround (see Fig. 2) at least a portion of a hub (14) of a vascular access catheter; and
a base (12) adapted for removable attachment to a patient's skin.
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 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.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0043130 (“Cameron”) as applied above, and further in view of U.S. Publication No. 2007/0244423 (“Zumeris”) and U.S. Publication No. 2018/0168668 (“Zheng”)
Regarding Claim 2, Cameron discloses the acoustic wave generator comprises a driver electrically connected to a piezoelectric element (Par. 38, 45). However, Cameron fails to explicitly disclose that this piezoelectric element comprises a “plate”. However, Zumeris discloses that such piezoelectric elements can be embodied as “thin plate piezo” elements (Par. 86) connected to the electric driver (300). 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, 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.
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”). 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).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0043130 (“Cameron”), U.S. Publication No. 2007/0244423 (“Zumeris”) and U.S. Publication No. 2018/0168668 (“Zheng”) as applied above, and further in view of WO 2004/002558 (“Klump”).
Regarding Claims 6 and 7, Cameron, as modified by Zumeris, discloses the invention substantially as claimed except that invention further comprises a “compressible cushioning spacer” which “acts to fill any gaps within the housing and assure that the piezoelectric plate positively contacts the hub of the vascular access catheter”. Zumeris does disclose cushioning spacers (230, 240) to fill gaps/spaces within the housing to assure that the piezoelectric plate positively contacts the catheter device (Par. 149, 152) with the foam being positioned between the driver and the plate (see Fig. 9a, 15 – Zumeris, wherein integration of the driver into the housing in view of Zheng would be understood to preserve this relationship to preserve the function of the cushion to enhance engagement between the piezoelectric plate and the received device).
Zumeris fails to explicitly resolve this foam to address “any gaps” within the housing and Zumeris presents with a mismatch between the shape of the cushions and the shape of the housing which still allows some gaps to present (see Fig. 10, 11B). However, Klump discloses a related ultrasonic transducer wherein a foam (39) is provided to fill the space (31) between the ultrasonic transducer assembly and the housing (19) to ensure sufficient coupling wherein the space can be optionally “completely filled” in order to element no excess volumes which might allow for the accumulation of liquid or bacteria in the intermediate space (see Pg. 10-11). It would have been obvious for one having ordinary skill in the art at the time the invention was made to shape the foam of the invention of modified Cameron to completely filly the gaps within the housing, as disclosed by Klump, in order to maximize conformance between the foam and the catheter hub and eliminate any excess gaps which might otherwise allow for the accumulation of fluids or bacteria.
Claim(s) 8, 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0043130 (“Cameron”), 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 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).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0043130 (“Cameron”), U.S. Publication No. 2007/0244423 (“Zumeris”), U.S. Publication No. 2018/0168668 (“Zheng”), and U.S. Publication No. 2008/0132848 (“Wright”) as applied above, and further in view of WO 2004/002558 (“Klump”)
Regarding Claim 9, Cameron discloses that the piezoelectric element are contained in an upper portion of the housing between the top wall and the hub of the vascular access catheter (see Fig. 1). However, Cameron fails to explicitly disclose that the piezoelectric element is a “plate”, that there is a “cushioning spacer”, and that the driver is located in the upper portion of the housing.
However, Zumeris discloses that such piezoelectric elements can be embodied as “thin plate piezo” elements (Par. 86) connected to the electric driver (300). 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, 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.
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”). 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.
Cameron, as modified by Zumeris, discloses the invention substantially as claimed except that invention further comprises a “compressible cushioning spacer” which “acts to fill any gaps within the housing and assure that the piezoelectric plate positively contacts the hub of the vascular access catheter”. Zumeris does disclose cushioning spacers (230, 240) to fill gaps/spaces within the housing to assure that the piezoelectric plate positively contacts the catheter device (Par. 149, 152) with the foam being positioned between the driver and the plate (see Fig. 9a, 15 – Zumeris, wherein integration of the driver into the housing in view of Zheng would be understood to preserve this relationship to preserve the function of the cushion to enhance engagement between the piezoelectric plate and the received device).
Zumeris fails to explicitly resolve this foam to address “any gaps” within the housing and Zumeris presents with a mismatch between the shape of the cushions and the shape of the housing which still allows some gaps to present (see Fig. 10, 11B). However, Klump discloses a related ultrasonic transducer wherein a foam (39) is provided to fill the space (31) between the ultrasonic transducer assembly and the housing (19) to ensure sufficient coupling wherein the space can be optionally “completely filled” in order to element no excess volumes which might allow for the accumulation of liquid or bacteria in the intermediate space (see Pg. 10-11). It would have been obvious for one having ordinary skill in the art at the time the invention was made to shape the foam of the invention of modified Cameron to completely filly the gaps within the housing, as disclosed by Klump, in order to maximize conformance between the foam and the catheter hub and eliminate any excess gaps which might otherwise allow for the accumulation of fluids or bacteria.
Conclusion
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 12/02/2025