Prosecution Insights
Last updated: April 19, 2026
Application No. 18/543,277

WEARABLE ULTRASOUND AND PHOTOACOUSTIC DEVICE FOR FETAL AND/OR LABOR MONITORING

Non-Final OA §102§103§112
Filed
Dec 18, 2023
Examiner
KELLOGG, MICHAEL S
Art Unit
3798
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
The Johns Hopkins University
OA Round
1 (Non-Final)
42%
Grant Probability
Moderate
1-2
OA Rounds
4y 6m
To Grant
98%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allow Rate
114 granted / 268 resolved
-27.5% vs TC avg
Strong +56% interview lift
Without
With
+55.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
30 currently pending
Career history
298
Total Applications
across all art units

Statute-Specific Performance

§101
8.2%
-31.8% vs TC avg
§103
34.5%
-5.5% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
33.3%
-6.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 268 resolved cases

Office Action

§102 §103 §112
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 Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder , in each instance either “component” or “device” , which is not preceded by a structural modifier. Such claim limitation(s) is/are: “ an light-guiding component ” ; with the functional limitation “ to guide light energy …” ; in claims 1, 9 , and 16 . “ ultrasound transmission component ” ; with the functional limitation “ to transmit acoustic energy …” ; in claims 1, 9 , and 16 . “ a sensing component ” ; with the functional limitation “ to perform on or more of ultrasound or photoacoustic imaging … ” ; in claims 1, 9 , and 16 . “a control device”; with the functional limitations “generating … an output that indicates the biological response”; in claim 16 . “a monitoring device”’ with the functional limitations “to emit …”, “to transmit …”, and “obtaining … imaging data”; in claim 16. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification reveals that: regarding the light-guiding component , no section of the original disclosure explicitly defines the term . Moreover, the term is only ever described as comprising structure at two points, first in [0075] (citing the paragraph numbers as identified in PGPUB US 20220031224 A1 ; hereinafter) as being an endovaginal light guide which has the same issue (being for endovaginal use does not clarify what structure guides the light) and the second of which is at [0138] and which states that it contains the rubberized ring which does not appear to be sufficient structure for the claimed function. As such there also does not appear to be adequate implicit disclosure of the structure. For examination purposes this component will be treated as being one or more optical fibers as these structures are found in the specification at [0042] and would be fully capable of the claimed function despite not being linked to the term “light-guiding component” . For compact prosecution purposes the examiner recommends replacing the component with one or more optical fibers. regarding the ultrasound transmission component , no section of the original disclosure explicitly defines the term; however, [004 5 ] provides adequate implicit disclosure by way of examples which clarify that the ultrasound transmission component comprises a piezoelectric or thermoelastic element which as per [005 3 ] can be either separate from or the same as the other ultrasonic components and, being open ended, would also cover equivalent structures. regarding the sensing component , no section of the original disclosure explicitly defines the term; however, [004 4 ] provides adequate implicit disclosure by way of the sole example of using one or more piezoelectric elements which as per [005 3 ] can be the same as the other ultrasonic components and therefore presumably can be structured the same as well so as to broaden this exemplary structure as well and, being open ended, would also cover equivalent structures. regarding the control device, no section of the original disclosure explicitly defines the term . In reviewing whether or not there is sufficient implicit disclosure to define the term the examiner notes that while some sections point to a potential interpretation by way of example, see e.g. [0005] which gives the exemplary structure of one or more processors – also depicted and in Fig. 1 as a generic computer arrangement. However and to the contrary, the examiner also notes that some section such as [00 92 ] call into question such an interpretation as this section explicitly states that both the processor and other computer components are optional (e.g. “may include” such components) and provides other structural options . This renders unclear what if any structures are actually required by term . As such and for compact prosecution purposes the examiner will interpret the control device to be one or more processors, similar to the interpretation of related claim 9 , but the examiner further notes that the claim limitation is also subject to a 112(b) rejection and the examiner urges the applicant to consider positively reciting that the control device comprises one or more processors and/or to have a step of providing the control device of claim 9 within claim 16 as this would remedy the issues with the term and cause the term not to be interpreted under 112(f) . regarding the monitoring device, no section of the original disclosure explicitly defines the term . In reviewing whether or not there is sufficient implicit disclosure to define the term the examiner notes that while some sections point to a potential interpretation along the lines of the structures set forth in claim 9, see e.g. [0041] which while optionally worded (e.g. states “may include”) at least gives an exemplary set of structures . However, myriad other sections show additional or contradictory structuring including having less structure or more structures or simply different structures (e.g. thermal/microwave versus light, external versus intravaginal, worn and unworn, combining the US sensing and transmission or not, etc.) which are to numerous and varied to bear specific reference for each instance. Given as much it is unclear what if any structures are actually required by this term. As such and for compact prosecution purposes the examiner will interpret the monitoring device to be the collection of structures utilized in claim 9, but the examiner further notes that the claim limitation is also subject to a 112(b) rejection and the examiner urges the applicant to consider positively reciting that the monitoring device comprises a particular set of structures and/or to have a step of providing the monitoring device of claim 9 within claim 16 as this would remedy the issues with the term and cause the term not to be interpreted under 112(f). If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “ light-guiding component ” in claims 7-8 and 14-15 due to the further inclusion of the structure of an optical fiber bundle and housing . “control device” in claim 9-15 due to the further inclusion of the structure of one or more processors. Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof. If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function. Claim Rejections - 35 USC § 112 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 appl icant regards as his invention. Claim 16-20 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 claims 16, the claims recite a “control device” and “monitoring device”; however, raises two issues of indefiniteness. First, there is no structure provided for the control device and it is unclear whether or not the disparate recited structures (e.g. “a light source of the monitoring device” in line 2) are capable of all claimed functions of the monitoring device such that it is not clear whether or not the invention is whole and complete or whether or not there are gaps in the elements. See MPEP § 2172.01. Secondly, it is abundantly clear that there is some requirement for a structural or cooperative relationship between the claimed elements (e.g. line 2 states “causing, by a control device … to emit pulsed light energy” even though the control device does not contain or comprise the light source that has that functional capability ) but there is no claimed structural or cooperative relationship between these devices rendering clear that even if there are not gaps in the elements there is at least an omission of the structural or cooperative relationships between the claimed elements. See again MPEP § 2172.01. Claims 17-20 are each similarly affected, at least by virtue of dependency. Claim limitation s “control device” and “monitoring device” in claims 16-20 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. More specifically, the specification does not clearly link any structure to the means analog in question as set forth in the claim interpretation section, item E of which is incorporated herein by reference. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Claim Rejections - 35 USC § 102 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 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 -4, 7, 9-11, 14, and 16-18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 20150182123 A1 by Akira Sato (hereafter Sato) . Regarding claim 1 , Sato teaches: 1. A device for noninvasive biological function monitoring, comprising: a light-guiding component to guide light energy toward tissue to cause the light energy to be absorbed by the tissue (see Sato’s Fig. 1 noting at least part 2) ; an ultrasound transmission component to transmit acoustic energy toward the tissue to cause a biological response from the tissue (see Sato’s Fig. 1 noting one or more of parts 3-5) ; and a sensing component to perform one or more of ultrasound or photoacoustic imaging to sense the biological response from the tissue and permit a status of the tissue to be determined (see Sato’s Fig.1 noting at least part 4) , wherein the biological response is sensed based on the light energy absorbed by the tissue during the biological response caused by the acoustic energy transmitted toward the tissue (notably this is worded as a desiderata and holds no patentable weight and thus will be treated as inherent . If the applicant disagrees with the foregoing than they are encouraged to amend the claim to recite a functional limitation on the structure of the light guiding component or ultrasound transmission component as well as to add the subject matter of claim 2 into claim 1 as the claim currently has no means or ability to produce the light that the tissue is supposed to absorb. While the foregoing is a complete reply given the current claim drafting, the examiner notes that it may compact prosecution significantly to note that Sato’s Fig. 1 is a PA probe wher e in parts 1 / 10 produce light, wherein the light is guided through 2-3 and 5 to the tissue where it can be absorbed, and where part 4 is both capable and configured to receive acoustic energy responsive thereto as is both readily apparent from the construction of the Fig itself and as explained textually in [0021]-[0022] ) . Regarding claim 2, Sato teaches: 2. The device of claim 1, further comprising: a light source (see Sato’s Fig. 1 parts 1 or 10) to emit the light energy that the light-guiding component guides toward the tissue as pulsed light energy (see Sato’s [0025]) at multiple near-infrared range (NIR) wavelengths (see Sato’s [0028]) . Regarding claim 3, Sato teaches: 3. The device of claim 2, wherein the light source includes one or more pulsed light-emitting diodes (LEDs) or pulsed laser diodes (PLDs) ( see Sato’s [0025] which covers both ) . Regarding claim 4, Sato teaches: 4. The device of claim 2, wherein the ultrasound transmission component, the sensing component, and the light source are included in a housing (see Sato’s Fig. 1 part 6 housing all of part 7 and note that as per [0052] the light source can be in the PA probe 7) that is wearable on an abdomen or other external body region relative to the tissue associated with the status to be determined (the examiner notes that this is inherent/something that Fig. 1 part 7 is necessarily fully capable of. For compact prosecution purposes the examiner notes that Sato’s method of use (i.e. that which the applicant appears to be addressing given the lack of structure for this function) is to place to probe in contact with the body e.g. see [0002 ] or [0025] ) . Regarding claim 7, Sato teaches: 7. The device of claim 2, wherein the light-guiding component comprises: an optical fiber bundle to guide the light energy emitted by the light source (see Sato’s Fig. 1 part 2) ; and a housing that comprises a transparent or translucent material that enables the light energy to be emitted through the housing toward the tissue (see Sato’s Fig. 1 noting part 6 includes parts 5a-b) . Regarding claim 9, Sato teaches: 9. A system for biological function monitoring (see Sato’s Abstract) , comprising: a photoacoustic monitoring device comprising: a light source (see Sato’s Fig. 1 noting at least parts 1/10) ; a light-guiding component (see Sato’s Fig. 1 noting at least part 2) ; an ultrasound transmission component (see Sato’s Fig. 1 noting one or more of parts 3-5) ; and a sensing component (see Sato’s Fig. 1 noting at least part 4) ; and a control device, wherein the control device includes one or more processors (see Sato’s Fig. 1 noting one or more of parts 9 and 13) to: control the light source to emit light energy as pulsed light energy at multiple near-infrared range (NIR) wavelengths (see Sato’s [0025] and [0028]) , wherein the light-guiding component is arranged to guide the light energy emitted by the light source toward tissue of a patient (see Fig. 1 as depicted or see [0025]) ; control the ultrasound transmission component to transmit acoustic energy toward the tissue (notably this can be identically the same as the foregoing seeing Fig. 1 as depicted or seeing [0025] which covers PA emissions) to incite a biological response from the tissue ( The fact that the US transmission component can emit light to the tissue, that the tissue will respond thermoelasticly to the light in a way the generates sensible US waves, that the sensing component will receive the resultant US waves and perform processing on them to determine data about the biological response such as the concentration distribution of the light absorbing substance or oxygen saturation or oxy-deoxy hemoglobin distribution etc. and that the system will generate an image and display it to a user on monitor 14 containing such data is all covered in Sato’s [0041]-[0042] but is only mentioned by the examiner for compact prosecution purposes as the body’s response and the applicant’s desired result are not examinable limitations of the apparatus being claimed. As such the examiner notes that this limitation and other limitations on the biological response are desiderata holding no patentable weight and can be treated as inherent for examination purposes regardless of the fact that Sato teaches them ) ; receive, from the ultrasound sensing component, one or more of ultrasound or photoacoustic imaging data (see Sato’s [0041]-[0042]) associated with the biological response (as iterated above despite clearly being taught by Sato this holds no patentable weight and can be treated as inherent for examination purposes) , wherein the imaging data is representative of the light energy being absorbed by the tissue during the biological response (this entire clause places no limitation on the structure of the invention nor on the function of any structure in any way that would intelligibly limit the structure and is at best a desiderata of the sort addressed above that can be treated as inherent for examination purposes. The examiner again notes that this was already taught by Sato above (e.g. [0041]-[0042]) which may later become relevant if the claim is redrafted as a method or the like ) ; and generate an output ( see Sato’s [0021] or [0041]-[0042] which cover image generation and even an image of specific biological responses per se ) that indicates the biological response from the tissue of the patient ( as iterated above despite clearly being taught by Sato this holds no patentable weight and can be treated as inherent for examination purposes ) . Regarding claim 10, Sato teaches: 10. The system of claim 9, wherein the light source includes one or more pulsed (see [0025]) light-emitting diodes (LEDs) or pulsed laser diodes (PLDs) (see Sato’s [0025] which covers both) . Regarding claim 11, Sato teaches: 11. The system of claim 9, wherein the ultrasound transmission component, the sensing component, and the light source are included in a housing (see Sato’s Fig. 1 part 6 housing all of part 7 and note that as per [0052] the light source can be in the PA probe 7) that is wearable on an abdomen or other external body region relative to the tissue associated with the imaging data (the examiner notes that this is inherent/something that Fig. 1 part 7 is necessarily fully capable of. For compact prosecution purposes the examiner notes that Sato’s method of use (i.e. that which the applicant appears to be addressing given the lack of structure for this function) is to place to probe in contact with the body e.g. see [0002] or [0025]) . Regarding claim 14, Sato teaches: 14. The system of claim 9, wherein the light-guiding component comprises: an optical fiber bundle to guide the light energy emitted by the light source (see Sato’s Fig. 1 part 2) ; and a housing that comprises a transparent or translucent material that enables the light energy to be emitted through the housing toward the tissue (see Sato’s Fig. 1 noting part 6 includes parts 5a-b) . Regarding claim 16, Sato teaches: 16. A method for monitoring a biological function (see Sato’s Abstract or [0002]) , comprising: causing, by a control device (noting that the control device is an unknown means, then as best understood see Sato’s [0010] which describes that the electronics are controlled to enact the method which appears to be enough to teach the control device. However, and for compact prosecution purposes the examiner notes that a processor 9 specifically controls the light source and a processor 13 specifically controls the US imaging as per Fig. 1. As such the control device will not be further addressed hereafter) , a light source (see Sato’s Fig. 1 noting parts 1/10) of a monitoring device (noting that the monitoring device is an unknown means, as best understood see the rejection of this structure in claim 9 above which is incorporated herein by reference. As such the monitoring device will not be addressed hereafter) to emit pulsed light energy at multiple near-infrared range (NIR) wavelengths ( see Sato’s [0025] and [0028] for pulsing and NIR respectively ) , wherein the light source is coupled to a light-guiding component that guides the light energy toward tissue of a patient to cause the light energy to be absorbed by the tissue (see Sato’s Fig. 1 noting part 2 as depicted) ; causing, by the control device, an ultrasound transmission component (see Sato’s Fig. 1 noting one or more of parts 3-5) of the monitoring device to transmit acoustic energy toward the tissue to cause a biological response from the tissue ( see Sato’s [0002] or [0025] ) ; obtaining, by the control device and from a sensing component (see Sato’s Fig. 1 noting at least part 4) of the monitoring device, one or more of ultrasound or photoacoustic imaging data associated with the biological response (see Sato’s [0041]-[0042]) , wherein the ultrasound or photoacoustic imaging data is generated from the light energy being absorbed by the tissue (see Sato’s [0041]-[0042]) ; and generating, by the control device, an output that indicates the biological response indicated in the ultrasound or photoacoustic imaging data (see Sato’s [0041]-[0042] wherein an image of the same is output to monitor 14) . Regarding claim 17, Sato teaches: 17. The method of claim 16, wherein the light source includes one or more pulsed light-emitting diodes (LEDs) or pulsed laser diodes (PLDs) (see Sato’s [0025] which covers both) . Regarding claim 18, Sato teaches: 18. The method of claim 16, wherein the ultrasound transmission component, the sensing component, and the light source are included in a housing (see Sato’s Fig. 1 part 6 housing all of part 7 and note that as per [0052] the light source can be in the PA probe 7) that is wearable on an abdomen or other external body region relative to the tissue associated with the ultrasound or photoacoustic imaging data (noting that the applicant does not address this as a step or structure but rather something that the housing can do (e.g. that is wearable); the examiner notes that this is inherent/something that Fig. 1 part 7 is necessarily fully capable of. For compact prosecution purposes the examiner notes that Sato’s method of use (i.e. that which the applicant appears to be addressing given the lack of structure for this function) is to place to probe in contact with the body e.g. see [0002] or [0025]) . 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 5-6, 12-13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sato as applied to claim s 2, 11, and 16 above, and further in view of US 20180296180 A1 Frydman et al. (hereafter Frydman ). Regarding claims 5-6, 12-13 and 19, Sato teaches the basic invention as given above in regards to claims 2, 11, and 16 respectively, and Sato additionally necessarily teaches that whatever power source there is should be at least coupled to the housing that includes the electronic components and Sato at least implicitly teaches a wired power source (a power source is inherent as is that the power source is at least coupled to the housed elements as otherwise power could not flow to them, and without the mention of battery or alternative power source a standard wired source is covered by ordinary meaning. Alternatively, see e.g. MPEP 2131.02(III) as wired connections is simply the default way to power things so as to be at once envisaged and/or further alternatively see Sato’s Fig. 1 noting the line that, by ordinary meaning, would be a wire, leading from the transducer 4 to the processor 13 showing there is an electrical connection even if never explicitly textually stated to be a wire) . However, Sato does not mention batteries and there is no reason to presume that any are present without their mention, thus Sato fails to teach that the power supply should be a hybrid supply that comprised batteries of the sort that could delivery power when the wired connection was interrupted as claimed. However, Frydman in the same or related field of US imaging of tissues (see Frydman’s Abstract) teaches the batteries, their uses, and that it is advantageous to include a battery backup (see Frydman’s [0065] which both spells out that single use or rechargeable batteries can be included in the housing as a “ backup power source for the diagnostic system 100 in clinical settings in which power is unavailable or unreliable ”) . Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve the invention of Sato with the use of a hybrid power supply further comprising a backup battery in order to advantageously allow the system to operate in setting where power is unavailable or unreliable. Claim(s) 8, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sato as applied to claim s 7, 14, and 16 above, and further in view of US 20180236270 A1 by Hananel et al. (hereafter Hananel ). Regarding claims 8, 15, and 20 Sato teaches the basic invention as given above in regard to claims 7, 14, and 16 respectively, and Sato goes on to teach that the distance and angle of contact between the light emitted by the invention and the tissue is important to monitor and consider (see e.g. Sato’s [0064]-[0073] wherein Sato explains that the distance and angle of the tissue relative to the invention changes the image and also changes the amount of light that must be emitted to maintain a safe but effective image) however, Sato does not utilize a … ring and structural pattern to indicate a position and angle of the light guiding component in the imaging data and therefore fails to fully teach the limitations of the claim. However Hananel in the same or eminently related field of US emitting devices guided by a secondary imaging modality (see Hananel’s Abstract) solves this problem by incorporating aiming rings (see Fig. 7B noting rings 133 and 134 and the structural pattern on 134) which are imaged by the secondary imaging modality to determine the position and angle of the US and other image modality relative to the tissue (see Hannanel’s [0041], [0046], and [0060]) . For compact prosecution purposes the examiner notes that the base reference already has a secondary imaging modality (i.e. photoacoustic) but that while Hananel’s base embodiment uses X-ray as the second modality that Hananel’s rings and imaging are not limited to being X-ray imaging/fiducials. Specifically Hananel actually states that the imaging can be effectively any modality (see Hananel’s [0026] which iterates that he second modality can be CT, MRI, X-ray, or US, or see [0038] which uses stereoscopic optical imaging) and that the rings in particular can be optically imaged instead of (see Hananel’s [0046] and [0060] noting that the aiming can be done based on the optical markers alone without the need for X-ray) or in addition to (see e.g. [0041] wherein the alignment can be both optically and radiologically measured) and also dedicates an embodiment to dual modality US with no X-ray imaging in particular (see Hananel’s [0068]-[0069] and Fig. 14A where the second US imaging is used to explicitly replace the X-ray per se and where it can be “any generic ultrasound imaging system” as well) all of which go towards showing that there is no barrier to combination based on some of Hananel’s statements or embodiments referring to a second modality that is X-ray instead of US/PA. Lastly, Hananel teaches that such rings are advantageous (see Hananel’s [0041], [0046], and [0060] and note that by using rings one can quickly and easily determine if the US emission is aligned and it not how it is angled. Additionally, the examiner chose to show 7B from among the ring options as the asymmetric notches further advantageously allows the rotation (i.e. allows both direction and angle of any misalignment) to be visibly identifiable) . Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve the invention of Sato with the use of alignment rings as taught by Hananel in order to advantageously allow quick and easy alignment of the US emissions with the target tissue using any other modality such as Sato’s PA imaging or even visual confirmation. In the foregoing the examiner omitted the word “rubberized” because while Hananel teaches that one can provide rings with a structural pattern to indicate position, Hananel does not disclose what materially these rings need to be made of. However, the examiner notes that when presented with an unknown the reader must select from the viable options. To that end, the examiner notes that many rubbers are well known to be US compatible and/or biologically compatible, e.g. silicone rubbers which is US compatible and which exemplif ies biological compatibility. See MPEP 2144.03 and MPEP 2144.07. Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to choose a rubber, such as silicone rubber, for the ring material. At least in light of the legal precedent set forth in MPEP 2144.03 and MPEP 2144.07. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows: US 20160038770 A1 by Tyler et al. is a similar art to Sato which is both expressly intended to be worn and which utilizes therapy US emissions per se of the sort that could be measured with an additional transducer such as Sato’s PA transducer. As such this is both a pertinent potential modifying reference and, depending on future amendments, may later become the primary reference. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Michael S Kellogg whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7278 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-1pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Keith Raymond can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)270-1790 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL S KELLOGG/ Examiner, Art Unit 3798 /KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
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Prosecution Timeline

Dec 18, 2023
Application Filed
Mar 24, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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1-2
Expected OA Rounds
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Grant Probability
98%
With Interview (+55.8%)
4y 6m
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