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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 December 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 11, 12, 22, 23, 28-30, 33, 34, 40, 44, and 100 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally filed specification fails to provide support for an implant device comprising a second controller in communication with the at least one external transmission and/or receiver device and the at least one first controller of the at least one pressure sensor. As shown in originally filed Figure 6, and as discussed in paragraphs [098-099], second controller 604 is not part of the claimed implant device; it is part of an entire system, wherein the implant device and second controller are separate elements with no physical connection.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, 11, 12, 22, 23, 28-30, 33, 34, 40, 44, and 100 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. Claim 1 recites that the at least one first controller and the second controller work in conjunction with the at least one external transmission and/or receiver device and the at least one pressure sensor “to provide for acquiring real-time, non-ionizing, continuous, postoperative monitoring and long-term surveillance.” It is unclear what it means to “provide for acquiring” real-time, non-ionizing, continuous, postoperative monitoring and long-term surveillance. What does it mean to provide for acquiring real-time monitoring? What does it mean to provide for acquiring real-time long-term surveillance? Clarification is requested. Regarding claim 22, the phrase “transmit IBP data” in line 3 lacks proper antecedent basis as it is unclear if the transmitted IBP data is the same as or different than the IBP data of claim 1. For the purpose of examination, the phrase is being interpreted as “transmit the IBP data”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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.
Claims 1, 5, 11, 12, 16, 22, and 100 are rejected under 35 U.S.C. 103 as being unpatentable over Sampath et al.’239 (WO 2018/064239 – previously cited) in view of Hu et al.’103 (US Pub No. 2015/0297103 – previously cited) further in view of Fishman’929 (US Pub No. 2017/0329929).
Regarding claims 1 and 100, Figures 1A and 1B of Sampath et al.’239 disclose an implant device configured for implantation within, beneath, and/or over at least one bodily opening of a subject, the implant device comprising: at least one implant housing configured for implantation within, beneath, and/or over at least one cranial opening or bodily opening of a subject (sections [0008], [0012-0013], and [0033-0035]), comprising a substantially anatomically-compatible shape and fabricated from one or more sonolucent materials that permit transmission of one or more mechanical waves through the one or more sonolucent materials to and/or from intrabodily matter of the subject whereby the implant device forms a synthetic window into the bodily opening of the subject when the implant device is implanted within, beneath, and/or over the cranial/bodily opening, wherein the implant device is configured in communication with at least one external transmission and/or receiver device configured to transmit and/or receive the one or more mechanical waves via the one or more sonolucent materials when the implant device is implanted within, beneath, and/or over a bodily opening of the at least one bodily opening of the subject (sections [0008], [0033], [0036], and [0043]); at least one pressure sensor operably connected to the at least one implant housing, wherein the at least one pressure sensor is configured to sense intracranial pressure (ICP) (which is a type of intrabodily pressure (IBP)) (sections [0054-0055]); and at least one first controller operably connected to the at least one pressure sensor, in which the at least one first controller is configured to selectively effect the at least one pressure sensor to sense the ICP within the subject to generate ICP data when the implant device is implanted within, beneath, and/or over the at least one cranial opening or bodily opening of the subject (the ICP sensors mentioned in section [0055] comprise at least a first controller (processor) that effects the pressure sensors to sense the ICP to generate ICP data). It is noted that the system of Sampath et al.’239 inherently comprises a second controller in communication with the at least one external transmission and/or receiver device.
Sampath et al.’239 discloses all of the elements of the current invention, as discussed above, except for the at least one first controller transmitting the ICP data to at least one ICP data receiver. Hu et al.’103 discloses an implant device configured to monitor ICP, wherein a controller of the implant device transmits ICP data generated by an ICP sensor to an ICP data receiver when the implant device is implanted within, beneath, and/or over a cranial opening of a subject (sections [0007-0011], [0036], [0038], and [0041-0046]). Hu et al.’103 teaches that the transmission of the ICP data generated by the ICP sensor to the ICP data receiver allows for the display, storage, and analysis of physiological data monitored by the implant device (section [0038]). It would have been obvious to one of ordinary skill in the art at the time the invention as effectively filed to have modified the implant device of Sampath et al.’239 to be configured to transmit the generated ICP data to an ICP data receiver, as Hu et al.’103 teaches that this would allow for the display, storage, and analysis of the ICP data. The modification to Sampath et al.’239 would merely be combining prior art elements according to known methods to yield predictable results.
Sampath et al.’239 in view of Hu et al.’103 discloses all of the elements of the current invention, as discussed above, except for the implant device comprising at least one power source operably connected or connectable to the at least one first controller. Hu et al.’103 teaches an implant device comprising at least one power source operably connected or connectable to a first controller, wherein the at least one power source powers various components within the implant device (sections [0009], [0041], and [0069-0070]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the implant device of Sampath et al.’239 in view of Hu et al.’103 to include at least one power source operably connected or connectable to the at least one first controller, as taught by Hu et al.’103, as this would allow the at least one first controller within the implant device to be properly powered.
Sampath et al.’239 in view of Hu et al.’103 discloses all of the elements of the current invention, as discussed above, except for a second controller in communication with the at least one external transmission and/or receiver device and the at least one first controller of the at least one pressure sensor, wherein the at least one first controller and the second controller work in conjunction with the at least one external transmission and/or receiver device and the at least one pressure sensor to provide for acquiring real-time, non-ionizing, continuous, postoperative monitoring and long-term surveillance. Fishman’929 teaches controlling individual components of a system with a central computer (a controller). The central computer controls, communicates, and monitors various sub-components and modules of the system such that it achieves harmonious functionality between the various components (section [0061]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the implant device of Sampath et al.’239 in view of Hu et al.’103 such that it was part of a system comprising a second controller that controls and is in communication with both the at least one external transmission and/or receiver device and the at least one processor, as it would create a system that harmoniously functions together to provide real-time post-operative monitoring, and long-term surveillance. It is noted that the system of Sampath et al.’239 in view of Hu et al.’103 already provides for acquiring real-time, continuous data that is capable of being used for postoperative monitoring and long-term surveillance, and that the system of Sampath et al.’239 in view of Hu et al.’103 is non-ionizing.
Regarding claim 5, Sampath et al.’239 discloses that the at least one pressure sensor and the at least one first controller are at least partially embedded in the at least one implant housing (section [0055]). The implant device of Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 also comprises a power source at least partially embedded in the implant housing (Figure 2 of Hu et al.’103 discloses that its power source is embedded in its implant housing).
Regarding claim 11, the one or more mechanical waves comprise ultrasound waves (sections [0007-0008] and [0033] of Sampath et al.’239).
Regarding claim 12, Sampath et al.’239 discloses that the at least one pressure sensor comprises a microsensor (section [0055]).
Regarding claim 16, the at least one first controller of Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 is operably connected to the ICP data receiver via at least one connection (sections [0041] and [0045] of Hu et al.’103), wherein the at least one first controller is further configured to transmit the ICP data to the ICP data receiver via the connection when the implant device is implanted within, beneath, and/or over the cranial opening or bodily opening of the subject (sections [0007-0011], [0036], [0038], and [0041-0046] of Hu et al.’103).
Regarding claim 22, Hu et al.’103 teaches that the ICP data is transmitted continuously (section [0044]).
Claims 23, 28-30, 33, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929, as applied to claim 1, further in view of Tyler’869 (US Pub No. 2012/0289869 – previously cited).
Regarding claim 23, Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for explicitly stating that the sonolucent materials form at least one lens element. Tyler’869 teaches using known focusing elements, such as an acoustic hyperlens or an acoustic metamaterial, to focus or direct ultrasound saves to one or more brain regions (sections [0050], [0067], and [0122]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sonolucent material of Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 to form a lens element, as Tyler’869 teaches that this would focus or direct ultrasound waves to one or more brain regions of the subject.
Regarding claim 28, the acoustic hyperlens/acoustic metamaterial taught by Tyler’869 is a wave-guide.
Regarding claim 29, Tyler’869 teaches that the lens element comprises an acoustic metamaterial (sections [0050], [0067], and [0122])
Regarding claim 30, section [0050] of Tyler’869 discloses that the lens element comprises at least one metamaterial having a negative refractive index. As evidenced by Byrne et al.’549 (USPN 11,044,549 – previously cited), acoustic metamaterials are made using subwavelength microstructures (col. 4, lines 10-16).
Regarding claim 33, the acoustic metamaterial taught by Tyler’869 is a material that is modified to increase or decrease a speed of sound transmitted through the material.
Regarding claim 44, the at least one implant housing of Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 further in view of Tyler’869 comprises at least one acoustic lens element comprising one or more sonolucent and/or acoustically active materials (taught by the acoustic hyperlens/metamaterial of Tyler’869), wherein the implant device permits at least transcranial therapeutic ultrasound, transcranial diagnostic ultrasound, photoacoustic imaging, electromagnetic wave diagnostic imaging, and/or electromagnetic wave therapeutic intervention of intracranial matter of the subject via the acoustic lens element when the implant device is subgalealy implanted within, beneath, and/or over the at least one cranial opening of the subject (sections [0007-0008], [0036], [0038], and [0050-0051] of Sampath et al.’239).
Claims 34 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 further in view of Tyler’869, as applied to claim 23, further in view of Grunwald et al.’675 (US Pub No. 2009/0005675 – previously cited).
Regarding claims 34 and 40, Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 further in view of Tyler’869 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the lens element comprising at least one diverging lens that transmits sound at a lower speed or a higher speed than a tissue of the subject. Grunwald et al.’675 teaches using a diverging lens to shape an ultrasound signal produced by an ultrasound transducer (section [0110]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the lens element of Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 further in view of Tyler’869 to include at least one diverging lens, as Grunwald et al.’675 teaches that it is known to use a diverging lens to shape an ultrasound signal produced by an ultrasound transducer. The modification to Sampath et al.’239 in view of Hu et al.’103 further in view of Fishman’929 further in view of Tyler’869 would merely be combining prior art elements according to known methods to yield predictable results. It is noted that the diverging lens would transmit sound at either a lower speed or a higher speed than a tissue of the subject.
Response to Arguments
Applicant's arguments filed 17 November 2025 have been fully considered and they are not entirely persuasive.
While amendments made to the claims have overcome some of the previous rejections under 35 U.S.C. 112(b), as discussed in paragraph 6 above, indefiniteness issues remain.
Applicant’s arguments regarding the rejections of the claims in view of the previously cited prior art are moot as the amendments to the claims have warranted new rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gordon et al.’640 (US Pub No. 2018/0055640 – previously cited) teaches a cranial implant comprising a sonolucent material forming at least one lens element (sections [0049-0051]). Lal et al.’381 (US Pub No. 2014/0355381 – previously cited) teaches the use of acoustic metamaterials to guide sonic signals, the acoustic metamaterials acting as an acoustic waveguide to promote more efficient transmission of acoustic waves from one point to another (section [0141]). Tyler’441 (US Pub No. 2011/0178441 – previously cited) teaches using a material having a negative refractive index to focus ultrasound waves used to modulate cellular activity (section [0083]). Willis et al.’375 (US Pub No. 2005/0203375 – previously cited) teaches using a diverging lens with an ultrasound transducer (sections [0094] and [0105]). Witte et al.’147 (US Pub No. 2013/0039147 – previously cited) teaches using two lenses, one converging lens and one diverging lens, to focus ultrasound waves at a desired depth in tissue (section [0107]). Davoyan et al.’124 (US Pub No. 2019/0260124 – previously cited) teaches engineering acoustic metasurfaces with subwavelength microstructures to achieve effective acoustic parameters for an ultrasound transducer (sections [0076-0077]).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791