Patent Application 16097024 - SYSTEMS METHODS AND COMPUTER READABLE MEDIA FOR

Title: SYSTEMS, METHODS, AND COMPUTER READABLE MEDIA FOR ISCHEMIC INJURY PROTECTIVE ULTRASOUND

Application Information

Invention Title: SYSTEMS, METHODS, AND COMPUTER READABLE MEDIA FOR ISCHEMIC INJURY PROTECTIVE ULTRASOUND
Application Number: 16097024
Submission Date: 2025-05-15T00:00:00.000Z
Effective Filing Date: 2018-10-26T00:00:00.000Z
Filing Date: 2018-10-26T00:00:00.000Z
National Class: 601
National Sub-Class: 002000
Examiner Employee Number: 85889
Art Unit: 3797
Tech Center: 3700

Rejection Summary

102 Rejections: 0
103 Rejections: 2

Cited Patents

The following patents were cited in the rejection:

Office Action Text

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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/31/2025 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 1-8, 11 and 30-43 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. Claim 1 is rejected because the specification, as originally filed, fails to describe the image comparison/similarity algorithm in sufficient detail to show possession of the claimed invention. There is no disclosure of identifying an optimal volume region encompassing the spleen tissue as now claimed to demonstrate that Applicant was in possession of the claimed invention. Claim 30 appears to have the same issue.

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 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) 1-6, 11, 30-35, 40, 42 and 44-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/075586 to Patil et al. “Patil” in view of NPL “Ultrasound Modulates the Splenic Neuroimmune Axis in Attenuating AKI” to Gigliotti “Gigliotti”, U.S. Publication No. 2016/0059044 to Gertner and U.S. Publication No. 2016/0300351 to Gazit.
As for Claims 1-6, 30-35 and 44-48, Patil discloses a combined ultrasound imaging and treatment system (Abstract) comprising steps of imaging target tissue region within a human subject (Paragraph [024]) and automatically detecting anatomical structures with a recognition processor for proper delivery of therapy (Paragraph [028]). Patil’s system includes a therapeutic ultrasound probe configured to provide pulses around 5-200 µs at a frequency of less than or equal to 2.5 MHz with a mechanical index (MI) less than or equal to 1.9 (Paragraph [030]). While described embodiments refer to cardiac sonothrombolysis, Patil explains that the system may be used in other areas of the body such as splenic vascular systems (Paragraph [046]). Accordingly, one skilled in the art would have been motivated to have used Patil’s system and method to image and automatically detect the spleen in the image data for determining a treatment location within the spleen. Patil further discloses wherein a user interface is provided for the user to enter treatment parameters such as dosage, time duration, pulse sequence and/or other parameters (Paragraph [032]). It would have been obvious to a person skilled in the art to have varied the treatment time to any amount in order to optimize the treatment.
However, Patil does not expressly disclose where the treatment of the spleen is related to kidney ischemia/reperfusion injury (IRI), where the recognition processing utilizes an image library database and the specific treatment parameters (volumetric sweep) of ultrasound treatment.
Gigliotti teaches from within a similar field of endeavor with respect to therapeutic ultrasound systems and methods were exposure to an ultrasound regimen prevents kidney IRI (Pages 1, 10, 12, 34) and specifically suggests that the spleen is an important target in mediating the protective effect of ultrasound (Pages 3), a critical site for the neural control of inflammation and provides a potential therapeutic target (Page 30) and where the splenic nerve is the proximal target of ultrasound treatment (Page 31). Gigliotti explains where one treatment protocol includes pulsed treatment for 2 minutes with approximately 5 minutes of total ultrasound exposure (Page 34). Given that Gigliotti’s application of ultrasound is to a mouse, one skilled in the art would have been motivated to have increased the duration to achieve a similar therapeutic effect in a human and thus, optimize the treatment.
Accordingly, one skilled in the art would have been motivated to have used Patil’s ultrasound system and method for other conditions such as protection from kidney IRI as described by Gigliotti in order to provide a multi-use treatment device. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for the systematic sweep, Gertner teaches from within a similar field of endeavor with respect to energy treatment systems and methods (Abstract; Paragraphs [0235]-[0236], [0312]-[0315]) where a 3D target region is identified in image data and an ultrasonic treatment plan is determined to best treat the target (Paragraphs [0018], [0074], [0120], [0082]-[0083], [0228], [0231], [0254], [0262]-[0263], [0267]). In one embodiment, the treatment plan includes delivering ultrasound from outside the body from multiple directions to treat a “zone” in a pattern (Paragraphs [0232], [0236], [0369], [0384], [0438]). Examiner notes that the pattern across the zone is considered to read on a sweep in its broadest reasonable interpretation.
Accordingly, one skilled in the art would have been motivated to have modified the treatment protocol to be a pattern of swept ultrasound therapy at locations across the target (e.g. spleen or splenic nerve) in order to effectively treat the desired target.
As for the “library database”, Examiner notes that one skilled in the art would understand that recognition processing would use an image library in order to recognize structures in the image. Nonetheless, Gazit teaches from within a similar field of endeavor with respect to medical image processing (Abstract) where a database (e.g. library) is utilized to automatically segment (e.g. identify) an organ in an image (Fig. 12 and corresponding descriptions). Gazit explains where the organ may include the spleen (Paragraph [0223]).
Accordingly, one skilled in the art would have been motivated to have further modified the recognition processor described by Patil to include a library database of images and an automatic segmentation algorithm configured to match and identify target organs including the spleen in an acquired image as described by Gazit in order to reduce the burden on an inexperienced sonographer and enhance the spleen identification. Examiner notes that the 01/31/2025 declaration also supports this conclusion of obviousness (see 01/31/2025 declaration Pages 2-3, #5-6).

Regarding Claim 11, Gigliotti explains that treatment was applied 24 hrs before bilaterial IRI (Page 12). Accordingly, one skilled in the art would have been motivated to have used the same timing on human subjects in the modified system and method.
As for Claims 40 and 42, Gigliotti explains that the ultrasound pulses were 1 second in duration (e.g. about 3) and the time interval were applied once every 6 seconds (e.g. about 1 second) (Page 34). Examiner notes that one skilled in the art would have found it obvious to combine the treatment techniques to apply a plurality of bursts at each location in the pattern in order to spread the treatment energy out across the region. Such a modification to adjust the particular timing and pattern of the treatment sweep is considered to be an obvious design choice or a routine optimization of the aforementioned sweep.

Claim(s) 6-8, 35-37 and 40-43 is/are also rejected under 35 U.S.C. 103 as being unpatentable over Patil, Gigliotti Gertner and Gazit as applied to claims 6, 8, 35 and 37 above, and further in view of U.S. Publication No. 2005/0043726 to McHale et al. “McHale”.
As for Claims 6-8, 35-37 and 40-43, Patil, Gigliotti Gertner and Gazit disclose a treatment system and method as described above. Patil and Gertner explains that the ultrasound pattern may be adjusted as desired (Patil- Paragraph [032] and Gertner-Paragraph [0438]). Examiner notes that one skilled in the art would have found it obvious to combine the treatment techniques to apply a plurality of bursts at each location in the pattern in order to spread the treatment energy out across the region. Such a modification to adjust the particular timing and pattern of the treatment sweep is considered to be an obvious design choice or a routine optimization of the aforementioned sweep.
Nonetheless, McHale teaches from within a similar field of endeavor with respect to ultrasound treatment where settings such as power density output, predicted power density at the treatment site, distance to the treatment site, treatment duration, modulation frequency, ultrasound frequency, etc. or combinations thereof are used to optimize the treatment (Paragraphs [0177] and [0179]).
Accordingly, one skilled in the art would have been motivated to have optimized the pattern as described by Patil, Gigliotti Gertner and Gazit with any combination of user designed preferences such as a burst pulse sequence between about 3-5 seconds with an interval between bursts of about 1 second and/or a series of pulse repetitions at at least one location (emphasis added) as taught by McHale in order to customize treatment applications.

Response to Arguments
Applicant's arguments filed 01/31/2025 have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment. However, Examiner will address Applicant’s remarks which may still pertain to the current rejection.
For example, regarding the maintained 35 U.S.C. 112(a) rejection, Applicant argues the office has not provided sufficient reasoning as to why one of ordinary skill in the art would fail to recognize in the disclosure as filed the subject matter defined by the claims (REMARKS, Page 11) because one skilled in the art would have been aware of the wide-spread use of computer aided medical image analysis to use various algorithms to determine boundaries of ROIs in three dimensional targets (REMARKS, page 12). Examiner respectfully disagrees. First, it must be noted that the sufficient reasoning for the 35 U.S.C. 112(a) rejection is that the specification, as originally filed, fails to describe the image comparison/similarity algorithm in sufficient detail to show possession of the claimed invention. There is no disclosure of identifying an optimal volume region encompassing the spleen tissue as now claimed to demonstrate that Applicant was in possession of the claimed invention. There are simply no example algorithms for performing the “identifying” step as claimed in the specification as originally filed. Second, it must be noted that consideration of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing the claimed invention to show possession (MPEP 2163). Third, the declaration provided by John A. Hossack is provides no examples of computer implemented algorithms for identifying an “optimal volume region” in the spleen as claimed. Thus, the rejections have been maintained.

Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3793