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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 22, 24-25 and 29-30) in the reply filed on 2/24/2026 is acknowledged. The amendment to claim 29 has been entered, and claim 25 has been cancelled. Applicant cancelled system claims 1-2, 4-6, 8, 11-12, 16-19, 21 and 27 according to remarks filed 2/24/2026; however, claim 27 remained pending in claim set filed 2/24/2026. Examiner withdraws claim 27 from examination in accordance with Applicant’s election of Group II as discussed above. Accordingly, claims 22, 24 and 29-30 remain pending for examination on the merits.
Claim Objections
Claim 22 is objected to because of the following informalities: the claim recites “A a-method for allowing an operator not trained for ultrasound scanning, be it the patient themself or a second person, to obtain and process ultrasound images of a potential POFR or TFRC condition of a human body,” which appears to contain a typographical error and undefined acronyms. The claim language must be amended to correct the typographical error in the preamble and to define the acronyms (i.e., “POFR or TFRC”). Appropriate correction is required.
Claim Interpretation
Claim 22 recites the limitation “a. providing a system comprising a scanner adapted to generate ultrasound images at a depth of up to 15 cm from the epidermis;”. It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
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 applicant regards as his invention.
Claim(s) 22, 24 and 29-30 is/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(s) 24 and 29-30 are also rejected at least by virtue of dependency upon a rejected base claim.
Claim 22 recites the limitations “to obtain and process ultrasound images of a potential POFR or TFRC condition of a human body, comprising: a. providing a system comprising a scanner adapted to generate ultrasound images at a depth of up to 15 cm from the epidermis; wherein the scanner is the component of the system that is moved by an operator over the surface of a patient's body to obtain the ultrasound images, the system being configured to issue instructions to the operator of the system, that allows scans to be performed; […] c. generating an alert if an automated analysis of an image obtained by the scanner determines that the image contains characteristics attributable to a post-operatorial fluid-related condition” which renders the claim indefinite. There is insufficient antecedent basis for these limitations in the claim. The claim introduces limitations in the preamble (i.e., ‘an operator’, ‘ultrasound images’, ‘potential POFR or TFRC condition’) which generate antecedent basis concerns for the subsequent limitations in the claim. In particular, it is unclear if the ‘ultrasound images’ generated by the scanner in the ‘providing a system’ step refers to the ultrasound images in the preamble or to a new and distinct set of ultrasound images. Similarly, the ‘image’ obtained by the scanner in the ‘generating an alert’ step may refer to the ‘ultrasound images’ obtained in either of the preamble or ‘step a.’, or may refer to new images which are different from the ‘ultrasound images’ introduced in either interpretation discussed above. It is also unclear if the ‘operator’ in ‘step a.’ is the same ‘operator’ in the preamble (either the patient or a ‘second person’ or if this is a new operator. Additionally, the ‘post-operatorial fluid-related condition’ in the final ‘step c.’ refers to a new condition or to the ‘potential POFR or TFRC condition’ in the preamble. Furthermore, it is unclear what the limitation “that allows scans to be performed” is referring to: in distinct interpretations this limitation may refer to the ‘system’, to the ‘operator’, or to the ‘scanner’. The claim language must be amended to particularly point out and distinctly claim the subject matter in the limitations. For the purposes of examination the broadest reasonable interpretation of the claim language – including those discussed above – is applied to the limitations.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 22, 24 and 29-30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Salinas et al. (US20210196227A1, 2021-07-01; hereinafter “Salinas”).
Regarding claim 22, Salinas teaches a a-method for allowing an operator not trained for ultrasound scanning, be it the patient themself or a second person, to obtain and process ultrasound images of a potential POFR or TFRC condition of a human body (“A method for diagnosing an injury, comprising: […] applying, from an ultrasound device, a beam to an area of the injury; generating, via processing circuitry of the ultrasound device and based on signals created from reflections of the beam generated by the ultrasound device, image data of the area of the injury; […] providing a diagnosis of the injury based on a result of the processing;” [clm 25]; “The notification engine 110 of the injury diagnosis system 102 generates and stores report data 122 and presents this to the technician […] specific time-sliced images specific to the analyzed area of the patient and including color halos generated by Doppler, a probability prediction of how likely it is that the patient is suffering from internal abnormalities, such as bleeding via a hemorrhage, and diagnosis and alert information regarding the lethality of the injury and potential actions” [0048]; “remote technicians can review data that is being provided by the injury diagnosis system 102 in real-time to allow remote medical experts to provide additional support for the injured patient. For example, a soldier on the battlefield with no medical expertise could receive instruction from remote medical experts on treating the injured soldier.” [0051]; [0042-0088], [fig. 2-3, 6]), comprising:
a. providing a system comprising a scanner adapted to generate ultrasound images at a depth of up to 15 cm from the epidermis; wherein the scanner is the component of the system that is moved by an operator over the surface of a patient's body to obtain the ultrasound images, the system being configured to issue instructions to the operator of the system, that allows scans to be performed (“applying, from an ultrasound device, a beam to an area of the injury; generating, via processing circuitry of the ultrasound device and based on signals created from reflections of the beam generated by the ultrasound device, image data of the area of the injury;” [clm 25]; “an ultrasound device 124 having one or more attached transducer probes 125 can be used to send and receive sounds waves via the piezoelectric effect.” [0043]; “The notification engine 110 of the injury diagnosis system 102 generates and stores report data 122 and presents this to the technician […] These actions can include on-site surgical treatments and instructions specific to the diagnosis or instructions that the patient should be moved immediately and an indication of the closest medical facility for treatment.” [0048]; “The depth can be determined as an average depth for the given patient body type which can be obtained from the anatomy data 114. […] Alternatively, or in addition to, the averaged depth and/or thickness of fat can be determined from the delay of the signal returned to the second transducer based on anatomical consideration of the tissue below the skin surface that is being diagnosed.” [0055]; An ultrasound transducer probe transmits ultrasound waves into the patient and receives a reflected signal to determine the presence of abnormality, wherein the notification engine may generate instructions for the technician to inform diagnosis and treatment [0042-0088], [fig. 2-3, 6]);
b. following the instructions issued by the system (“remote technicians can review data that is being provided by the injury diagnosis system 102 in real-time to allow remote medical experts to provide additional support for the injured patient. For example, a soldier on the battlefield with no medical expertise could receive instruction from remote medical experts on treating the injured soldier.” [0051]; “outputs of the injury diagnosis system 102 based on the diagnosis process […] Accordingly, this is where the image processing engine 108 of the injury diagnosis system 102 has identified areas of potential abnormalities, such as bleeding, based on an analysis of the image data 116. The operator and/or injury diagnosis system 102 can then perform further analysis to identify the likelihood of abnormalities at this location as well as any applicable treatment options.” [0069]; Information is presented to the operator based on the diagnosis process [0042-0088], [fig. 2-3, 6]), and
c. generating an alert if an automated analysis of an image obtained by the scanner determines that the image contains characteristics attributable to a post-operatorial fluid-related condition (“providing a diagnosis of the injury based on a result of the processing; and generating an alert when the diagnosis identifies an abnormality at the area of the injury.” [clm 25]; “The image data 116 includes a linked time-series of images based on readings generated by the ultrasound probe 125 b showing the movement and/or size of fluid at the area of the injury.” [0060]; “Accordingly, this is where the image processing engine 108 of the injury diagnosis system 102 has identified areas of potential abnormalities, such as bleeding, based on an analysis of the image data 116. The operator and/or injury diagnosis system 102 can then perform further analysis to identify the likelihood of abnormalities at this location as well as any applicable treatment options” [0069]; An alert providing diagnosis information regarding movement and size of fluid at an injury area is presented to the technician, as well as instructions for treatments the technician can take based on the diagnosis [0042-0088], [fig. 2-3, 6]).
Regarding claim 24, Salinas teaches the method of claim 22,
Salinas further teaching wherein images generated by the device of claim 1 are relayed to a healthcare professional for evaluation (“One or more computing devices 126, one or more servers 128 and one or more mobile devices 130 can also be connected to the injury diagnosis system 102 either directly or via a network. […] Accordingly, remote technicians can review data that is being provided by the injury diagnosis system 102 in real-time to allow remote medical experts to provide additional support for the injured patient. For example, a soldier on the battlefield with no medical expertise could receive instruction from remote medical experts on treating the injured soldier.” [0051]; [0042-0088], [fig. 2-3, 6], [see claim 1 rejection]).
Regarding claim 29, Salinas teaches the method of claim 22,
Salinas further teaching wherein the examined area is around the heart or around abdominal organs (“For example, a Morison's pouch between the liver and kidney often fills with blood after a blunt force or penetration to the abdomen. A pool of the blood forms on the right side of the abdomen yet the source of the blood is often from lacerations or holes in the spleen which is in the opposite side of the abdomen. The blood flows from the left side to the right side through channels between the organs. The image processing engine 108 can use image segmentation and corresponding pattern recognition to identify the hemorrhage and estimate the size of the pool by reviewing a sequence of patterns caused by the growth of the blood pool, pushing apart of the walls of the organs surrounding the blood pool and based on the shape of the pool.” [0078]; [0042-0088], [fig. 2-3, 6], [see claim 1 rejection]).
Regarding claim 30, Salinas teaches the method of claim 22,
Salinas further teaching wherein the system is adapted to generate alerts when an automatic image-processing component detects a dark area that may be indicative of a POFR or TFRC condition (“The image processing engine 108 processes the image data 116 received by the ultrasound 124 and/or generated by the image generation engine 106 to diagnose an injury of a patient. […] The amount of flow detected by Doppler can be compared by the image processing engine 108 to a predetermined threshold to determine whether the flow constitutes a blood pool indicating a hemorrhage or other injury.” [0047]; “a pattern is obtained by the Doppler around the right kidney of a patient at 10 Hz with a 30 mL pool to the right of the kidney.” [0083]; [0042-0088], [fig. 2-3, 6; see fig.8A reproduced below], [see claim 1 rejection]).
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Pools of blood in a Morrison’s pouch are indicated by the pattern (i.e., dark regions) near kidney of the patient (Salinas [fig. 8A])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
de Jonge et al. (US20170360402A1, 2017-12-21) teaches techniques for guiding an operator to use an ultrasound device. Thereby, operators with little or no experience operating ultrasound devices may capture medically relevant ultrasound images and/or interpret the contents of the obtained ultrasound images [abst].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797