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 § 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 to restore blood flow (e.g. sonothrombolysis) 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 10/15/2025 have been fully considered but are not persuasive. Regarding the maintained 35 U.S.C. 112(a) rejection, Applicant argues the specification only needs to convey to one skilled in the art that the inventor had possession of the claimed invention and that which is conventional or well known need not be disclosed in detail (REMARKS, Page 7). Applicant also argues the declaration provide by John A. Hossack need not show any reduction to practice of the claimed algorithm (REMARKS, Page 8). Examiner respectfully disagrees.
First, it is acknowledged that MPEP 2163 states “the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing” and that “the specification need not teach what is well known in the art”. MPEP 2161 provides additional guidance for computer implemented inventions stating that the algorithm or steps/procedures taken to perform the claimed function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed and
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure.” Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement”
Applicant fails to point to any mathematical formula, prose, flow chart or any other part of the specification to show possession of the claimed steps of automatically identifying an optimal volume region by performing the image comparison/similarity algorithm and instead relies upon the declaration to show that one skilled in the art would reasonably conclude that the inventor had possession of the claimed invention. However, the declaration fails to provide evidence that conventional and well known comparison similarity algorithms automatically identify an optimal volume region for ultrasound treatment as claimed and merely states that comparison/similarity algorithms “could be” used as part of the presently claimed method (Declaration, Point #5).
As for the prior art rejections, Applicant argues “The Office Action admits that Patil’s focus is on cardiac sonothrombolysis while theorizing that its system may be extrapolated to other areas of the body and other therapeutic uses” (REMARKS, Page 10). Examiner respectfully disagrees with Applicant’s characterization of “theorizing” Patil’s system can be used on other areas of the body because Patil explicitly states
“Although the present system has been described with reference to a cardiac sonothrombolysis ultrasound system, it is also envisioned that the present system can be extended to other areas of the body where sonothrombolysis therapy may be desired. Accordingly, the present system may be used to obtain and/or record image information related to, but not limited to renal, testicular, breast, ovarian, uterine, thyroid, hepatic, lung, musculoskeletal, splenic, cardiac, arterial and vascular systems. Further, the present system may also include one or more programs which may be used with conventional imaging systems so that they may provide features and advantages of the present system” (Paragraph [046]).
Regarding the limitation of protecting a human subject in need thereof from IRI, 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 to restore blood flow (e.g. sonothrombolysis) 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).
Finally, regarding Applicant’s assertion that the declaration does not concede to any aspect of “obviousness” (REMARKS, Page 10), Examiner respectfully notes the declaration suggests that conventional image comparison/similarity algorithms using an image library database could be used to achieve the claimed steps. 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]). 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. The declaration supports this conclusion of obviousness stating that “others in the field would have appreciated that image comparison/similarity algorithms such as those typically used in medical imaging in conjunction with an image library database could be used as part of the claimed method to identify the spleen and an optical volume region encompassing the spleen to receive ultrasound pulses” (Declaration Point #5).
Thus, the rejections have been maintained.
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 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