DETAILED ACTION
Status of the Application
This office action is a non-final rejection in response to the filing of the applicant’s response to notice of non-compliant amendment of 09/03/2025 and the applicant’s response to the election / restriction requirement filed on 05/05/2025. 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 without traverse of Species A: Fig 1A-1J (Claims 1-3,6,7, and 11-15) in the reply filed on 05/05/2025 is acknowledged. Claims 4,5 and 8-20 has been withdrawn from consideration.
Claim Rejections - 35 USC § 102
3. 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.
4. 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.
5. Claims 1-2,6,7, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinaldi et al, US Patent Application Publication (US 2021/0196989 A1).
Regarding Claim 1, Rinaldi et al discloses an implantable medical device (IMD 1-4, Fig 1-22B, particularly Figs 15A-B, 22A-B) comprising a first substrate (10) based on a biocompatible material (see Fig 7,8, par. [0010]-[0011],[0013]-[0015],[0059], [0093]), wherein the first substrate constitutes a part of a housing of the device (IMD 1-4, Fig 1-22B, particularly Figs 15A-B, 22A-B) and has an external side configured to be put in contact with the biological tissues of a user (body of user Fig 22A-B, par. [0059]), wherein the device (IMD 1-4, Fig 1-22B, particularly Figs 15A-B, 22A-B) comprises at least one ultrasonic transducer (ultrasonic scanner or ultrasonic stethoscope, par. [0091], Figs 22A-B) within a cavity (par. [0073]) created on an internal side of the first substrate, wherein the transducer (ultrasonic scanner or ultrasonic stethoscope, par. [0091], Figs 22A-B) is configured so that no layer of air, of gas or of void separates the transducer (ultrasonic scanner or ultrasonic stethoscope, par. [0091], Figs 22A-B) from the first substrate (see Figs 1-22B; par. [0044],[0059],[0064]-[0068],[0073]-[0075],[0088]-[0094], [0127], [0161],
in addition, 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. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board's finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). "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) (emphasis in original). (see MPEP 2114).
Furthermore, it has been held that a claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Exparte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). (See MPEP 2114)).
Regarding Claim 2, Rinaldi et al discloses the device according to claim 1, wherein the cavity is a non-through cavity in the first substrate on the internal side of the first substrate (see cavity in Figs 7-8, 22A-B; par. [0073],[0074],[0076],[0127]).
Regarding Claim 6, Rinaldi et al discloses the device according to claim 1, additionally comprising, over the upper side of the first substrate (see Fig 7,8, par. [0010]-[0011],[0013]-[0015],[0059], [0093]), interconnecting metal elements respectively connected to first and second electrodes of the transducer (see 18 in Fig 7,8, par. [0043], [0074]).
Regarding Claim 7, Rinaldi et al discloses the device according to claim 6, additionally comprising, over the upper side of the first substrate, a control electronic circuit connected to the first and second electrodes of the transducer via said interconnecting metal elements (see connections of controller in par. [0012]-[0013],[0047],[0049],[0077]-[0078],[0093] and Figs 7-11C).
Regarding Claim 11, Rinaldi et al discloses the device according to claim 1, wherein the transducer comprises a layer based on a piezoelectric material, wherein the transducer is configured so that there is no layer of air, of gas or of void between said piezoelectric layer and the first substrate (see piezoelectric layer in par. [0012],[0016],[0031],[0073]-[0074],[0093],[0127], claim 4 and Figs 7-8).
Regarding Claim 12, Rinaldi et al discloses the device according to claim 11, wherein the piezoelectric layer of the transducer is based on a piezoelectric ceramic, for example on PZT (see piezoelectric layer in par. [0012],[0016],[0031],[0073]-[0074],[0093],[0127]-[0128], claim 4 and Figs 7-8).
Regarding Claim 13, Rinaldi et al discloses the device according to claim 1, additionally comprising an upper cover (14) based on the same material (silicon) as the first substrate (10), for example soldered to the first substrate, that tightly encapsulates internal elements of the device (see Fig 7 in which the silicon oxide layer is upper than substrate 10 and par. [0043],[0074]).
Claim Rejections - 35 USC § 103
6. 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 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.
7. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al, US Patent Application Publication (US 2021/0196989 A1).
Regarding Claim 3, Rinaldi et al discloses the device according to claim 2, except for wherein the first substrate is based on an electrically isolating material, for example on sapphire.
However, Rinaldi et al discloses the well-known use of electric isolating material (see par. [0070], [0110]);
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include wherein the first substrate is based on an electrically isolating material, for example on sapphire, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. In addition, the claimed material does not provide any unexpected results.
8. Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rinaldi et al, US Patent Application Publication (US 2021/0196989 A1) in view of Stigall et al, US Patent Application Publication (US 2019/0053787 A1).
Regarding Claim 14, Rinaldi et al discloses the device according to claim 1;
Rinaldi et al does not clearly discloses a method to manufacture the device according to claim 1 comprising a step of manufacturing said cavity, following by a step of transfer and fixation of the transducer into the cavity.
However, Stigall et al is an analogous art pertinent to the problem to be solved in this application in which discloses a therapeutic ultrasound devices and methods are provided. In one embodiment, a therapeutic ultrasound device includes a housing configured for handheld operation by a user, an ultrasound assembly positioned within the housing and configured to generate ultrasound energy, a battery positioned in the housing and coupled to the ultrasound assembly to power the ultrasound assembly to generate the ultrasound energy, a flexible elongate member configured to be positioned within a body lumen of a patient, and an acoustic transmission member (see Figs 1-6) and further discloses a method to manufacture the device comprising a step of manufacturing said cavity, following by a step of transfer and fixation of the transducer into the cavity (see Figs 1-6 and par. [0024]-[0025],[0027],[0034]-[0035]);
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rinaldi et al with the teachings of Stigall et al by including a method to manufacture the device comprising a step of manufacturing said cavity, following by a step of transfer and fixation of the transducer into the cavity in order to provide a self-contained and disposable therapeutic intraluminal ultrasound device. For example, the therapeutic intraluminal ultrasound device includes an ultrasound assembly, a flexible elongate member, an acoustic transmission member, a battery, and a housing sized and shaped for handheld operation by a user (Stigall et al, par. [0004]).
Regarding Claim 15, Rinaldi et al in view of Stigall et al discloses the method according to claim 14, wherein the cavity is manufactured by laser ablation (see Figs 1-6 and par. [0028]).
Therefore, it would have been an obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rinaldi et al with the teachings of Stigall et al by including wherein the cavity is manufactured by laser ablation in order to provide a self-contained and disposable therapeutic intraluminal ultrasound device. For example, the therapeutic intraluminal ultrasound device includes an ultrasound assembly, a flexible elongate member, an acoustic transmission member, a battery, and a housing sized and shaped for handheld operation by a user (Stigall et al, par. [0004]).
Examiner Note
9. The examiner cites particular columns and lines numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the cited prior art in the PTO-892 form attached.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALFONSO PEREZ BORROTO whose telephone number is (571) 270-1714. The examiner can normally be reached on M-F (9am-4pm).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rexford Barnie can be reached on (571) 272-7492. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Primary Examiner, Art Unit 2836