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 § 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 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) 1-6, 10-15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque; Sharif (US 2017/0024903, hereinafter Razzaque ‘903) alone and/or in view of Kamiyama et al. (US 2007/0239006, hereinafter Kamiyama ‘006).
In re claims 1 and 17, Razzaque ‘903 teaches ultrasound imaging apparatus comprising:
a probe configured to transmit an ultrasound signal to an object and detect an echo signal reflected from the object (fig. 5A, 312, 0047);
a display (fig. 5A, 502; 0062-0067);
a communication module (0092-0093);
a memory storing at least one instruction (0092-0093); and
at least one processor (0092-0094) configured to execute the at least one instruction to
generate a first ultrasound image from ultrasound data generated by the probe (0050),
receive sensing data from a sensing apparatus through the communication module, wherein the sensing data is generated by the sensing apparatus detecting at least one part of the object and the (0062-0065; 0068, 0070-0076), note that claim 17 is “[t]he ultrasound imaging apparatus of claim 1, further comprising the sensing apparatus.”
generate, based on the sensing data, a body marker (0047-0050, 304, 306, 318) and a probe marker (0049-0050), wherein the body marker represents a scanning part of the object and wherein the probe marker is positioned on the body marker to represent a position of the probe on the scanning part of the object (0049-0050),
display the first ultrasound image, the body marker, and the probe marker on the display (fig. 5A, 502, 550), and
change the body marker based on a patient's position (0079), wherein the patient’s position comprises at least one of lying facing a ceiling, lying on a right side, or lying on a left side (fig. 5A).
Razzaque ‘903 fails to teach wherein the body marker is drawings or images obtained by simplifying a shape of a scanning part of a patient based on the sensing data; however Razzaque ‘903 teaches the body marker is drawings or images
However, “obtained by simplifying a shape of a scanning part” can be interpreted as non-functional description material (NFDM).
As show above, Razzaque ‘903 teaches everything except “simplifying a shape.”
Under Federal Circuit precedent, because printed matter itself is nonstatutory subject matter, it must have a functional relationship to a substrate in order to have patentable weight. See, e.g., In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) (observing that “printed matter by itself is not patentable subject matter, because [it is] non-statutory,” but finding that because the printed matter at issue – volumetric indicia and a legend – had a “new and unobvious functional relationship” to the claimed measuring receptacle, the printed matter had patentable weight). Consistent with this logic, non-obvious and functional printed matter receives no patentable weight if the difference between the prior art and a claim limitation lies in the printed matter, as opposed to in the functionality. See In re Xiao, 462 Fed. Appx. 947, 950-52 (Fed. Cir. 2011) (Non-precedential) (holding that use of “wildcard position labels,” instead of letters or numbers on combination lock, had no patentable weight, because they performed the same function as a letter or a number on the lock).
While most of the NFDM case law involves printed matter on a product (substrate), our reviewing court has seen no reason for limiting this reasoning to that specific context. In King Pharmaceuticals, the Federal Circuit expressly extended the reasoning to method claims.
The specific question before us is whether an otherwise anticipated method claim becomes patentable because it includes a step of “informing” someone about the existence of an inherent property of that method. We hold it does not. The “informing” limitation adds no novelty to the method, which is otherwise anticipated by the prior art. In other words, in light of our holding that the method of taking metaxalone with food to increase the drug’s bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.
In an analogous context, we have held that “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (alterations added). In such cases, we have recognized that the printed matter is not independently patentable, but have cautioned that the limitation must not be excised from the claim. See id. at 1385 (“[T]he board cannot dissect a claim, excise the printed matter from it, and declare the remaining portion of the mutilated claim to be unpatentable. The claim must be read as a whole.”) (alterations added). Instead, the relevant question is whether “there exists any new and unobvious functional relationship between the printed matter and the substrate.” Id. at 1386 (citing In re Miller, 57 C.C.P.A. 809, 418 F.2d 1392, 1396 (1969)). The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations. See In re Ngai, 367 F.3d at 1339.
Although these “printed matter” cases involved the addition of printed matter, such as written instructions, to a known product, we see no principled reason for limiting their reasoning to that specific factual context. See In re Ngai, 367 F.3d at 1338-39; In re Gulack, 703 F.2d at 1385-87. Rather, we believe that the rationale underlying these cases extends to the situation presented in this case, wherein an instructional limitation is added to a method, as opposed to a product, known in the art. Thus, the relevant inquiry here is whether the additional instructional limitation of claim 21 has a “new and unobvious functional relationship” with the known method of administering metaxalone with food. See In re Ngai, 367 F.3d at 1338 (quoting In re Gulack, 703 F.2d at 1386).
King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1278-79 (Fed. Cir. 2010) (emphasis added). Additionally, the Federal Circuit did not find error in the Board’s extension of this reasoning to computer-implemented (data processing) claims when it affirmed, without opinion, the Board’s decision in Ex parte Mathias, 84 USPQ2d 1276 (BPAI 2005) (informative), aff’d 191 Fed.Appx. 959 (Fed. Cir. 2006) (Rule 36).
The descriptive material, “simplified shape,” have not been shown to have functional relationship with the substrate (the shape). Even if functional, the descriptive material may not be functionally different from Razzaque ‘903. The claimed image differs from Razzaque ‘903 only in the simplicity of the same shape of the same body part, which is not a patentable distinction. The functional relationship is not “new and nonobvious,” the descriptive material has the same functional component as Razzaque ‘903 because Razzaque ‘903 obtains the shape of the patient body part (0047).
It has been repeatedly held that an applicant cannot create a novel product by attaching printed matter to it, even if that printed matter itself is new. See, e.g., Ngai. Thus, adding instructions to a kit that describe a method of using it does not make the kit patentable over the same kit with a different set of instructions. Also, it has been held that the “on screen icon for viewing the score of a broadcast sporting event” is unpatentable, because the particular event is a sporting event does not change the product. It merely describes a new, non-functional feature for a product that already exists. Ex parte Mathias, 84 USPQ2d 1276 (BPAI 2005) (informative), aff’d 191 Fed.Appx. 959 (Fed. Cir. 2006)
There are cases in which the descriptive material can form a functional relationship with the underlying substrate. For example, in In re Miller, the addition of printed matter to the outside of a cup permitted an otherwise ordinary cup to be used like a measuring cup to half recipes. The printed matter in Miller served as a computing or mathematical recipe conversion device permitting a cook to perform calculations automatically with no further thought.
However, the claim before us is more like the claim in Ngai, Mathias, than Miller. The fact that the ““simplifying a shape,” does not change the product. It merely describes a new, non-functional feature for a product that already exists.
Allowing applicant’s particular NFDM to distinguish over Razzaque ‘903 would lead to repeated patenting, or permit a patent to issue where the only distinction over the prior art can be characterized appropriately as non-functional, lead to repeated patent such as someone else could claim that the display attribute for the ROI frame could be a Mario, or Luiji, or Cross, or letter “U” for ultrasound.
The rationale behind this prior art rejection is preventing the repeated patenting of essentially a known product by the mere inclusion of novel non-functional descriptive material. King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (“The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations.”) Cf. In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (“If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.”).
Hence, Razzaque ‘903 anticipates the claim because Razzaque ‘903 teaches each and every limitation of the claim. Any argued difference between the prior art and the claimed invention is simply a substitution of one piece of NFDM (simplified shape) for another piece of NFDM (scanned shape), which does not change the functioning of the changing of the display attribute of the object with respect to the speed of the probe.
Still furthermore, Kamiyama ‘006 teaches wherein the body marker is drawings or images obtained by simplifying a shape of a scanning part of a patient based on the sensing data (fig. 8, Pr, 41, 42; 0097).
It would also have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 to include the features of Kamiyama ‘006 in order to easily capture the examined range or the unexamined range.
In re claim 2, Razzaque ‘903 teaches wherein the at least one processor is further configured to execute the at least one instruction to: change the body marker based on the patient’s position, and at least one of a shape, a type or a scanning direction of the scanning part (0049, 0050, 0054), update the body marker and the probe marker based on the sensing data (0013), synchronize (0050, 0051, 0060, 0066, 0089, when it is real-time, concurrently, or simultaneously, all displays are synchronized to be displayed) the body marker, the probe marker, and the ultrasound image with each other, and display the body marker, the probe marker, and the ultrasound image (0046, 0054, 0079, 0084).
Kamiyama ‘006 also teaches wherein the at least one processor is further configured to execute the at least one instruction to: change the body marker based on the patient’s position, and at least one of a shape, a type or a scanning direction of the scanning part (0085, 0097, 0111, 0114; fig. 10), update the body marker and the probe marker based on the sensing data (0050, 0065, 0113), synchronize (0050) the body marker (fig. 8, 41; 0085, 0097, 0111, 0114), the probe marker (fig. 8, Pr; 0085, 0097, 0111, 0114), and the ultrasound image with each other (fig. 8, 40; 0085, 0097, 0111, 0114), and display the body marker, the probe marker, and the ultrasound image (fig. 8; 0085, 0097, 0111, 0114)
In re claim 3, Razzaque ‘903 teaches wherein the at least one processor is further configured to execute the at least one instruction to select, based on the sensing data (0013, 0014), a candidate body marker from among a plurality of candidate body markers as a body marker (0047, 0054, 0055, identify one or more obstructing objects within the volumetric medical image), and locate the probe marker on the selected body marker (0050), wherein the plurality of candidate body markers are expressed differently according to at least one among a shape, a type, or a scanning direction of the scanning part or a patient's position (0057-0060, different path/scanning path/direction).
In re claim 4, Razzaque ‘903 teaches wherein the body marker and the probe marker are generated by the sensing apparatus (0072, camera-based tracking; 0075, position sensing region), and the at least one processor is further configured to execute the at least one instruction to receive the body marker and the probe marker generated by the sensing apparatus through the communication module (0071-0075; 0092-0093), and display the received body marker and the received probe marker on the display (fig. 5A, 502, 0083).
In re claim 5, Razzaque ‘903 teaches wherein the at least one processor is further configured to execute the at least one instruction to synchronize an operation time of the sensing apparatus with an operation time of the ultrasound imaging apparatus, synchronize an acquisition time of the sensing data with an acquisition time of the first ultrasound image (0050, 0051, 0060, 0066, 0089, when it is real-time, concurrently, or simultaneously, they are all synchronize, and all displays are synchronized to be displayed), and display the body marker and the probe marker generated from the synchronized sensing data together with the first ultrasound image (0046, 0054, 0079, 0084).
In re claim 6, Razzaque ‘903 teaches wherein the at least one processor is further configured to execute the at least one instruction to synchronize the body marker, the probe marker, and the first ultrasound image with each other by using time information included in the sensing data and time information included in the first ultrasound image (0050, 0051, 0060, 0066, 0089, when it is real-time, concurrently, or simultaneously, time information would be the same time, and they are synchronize to be displayed together).
In re claim 10, Razzaque ‘903 teaches wherein a position and an orientation of the probe marker on the body marker are defined based on an anatomical feature of the body marker (0047-0051).
In re claim 11, Razzaque ‘903 fails to teach wherein the at least one processor is further configured to execute the at least one instruction to stop displaying the probe marker in response to determining, based on the sensing data, that the probe deviates from the scanning part.
Kamiyama ‘006 teaches wherein the at least one processor is further configured to execute the at least one instruction to stop displaying the probe marker in response to determining, based on the sensing data, that the probe deviates from the scanning part (0121, note that acoustic coupler is attached to scan part, i.e. breast, see 0060).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 to include the features of Hattori ‘078 in order to prevent drawing and recording of unintended traces.
In re claim 12, teaches wherein the at least one processor is further configured to execute the at least one instruction to generate a Graphic User Interface (GUI) view that displays the body marker and the ultrasound image in such a way as to overlap the body marker with the ultrasound image (fig. 3, fig. 5A; ultrasound fan area is overlap with 318, 0047; 0050), and display the GUI view on the display (fig. 5A, fig. 5B).
In re claim 13, Razzaque ‘903 teaches wherein the at least one processor is further configured to execute the at least one instruction to display, on the body marker, a scan area indicator indicating an area scanned by the probe (0027, 0044, 0045, fig. 2, 212, fig. 5A, ultrasound fan area).
In re claim 14, Razzaque ’903 fails to teach wherein the scanning part is a breast, and the at least one processor is further configured to execute the at least one instruction to change the body marker based on at least one of a shape of the breast, a type of the breast, a scanning direction of the breast, or the patient’s position.
Kamiyama ‘006 teaches wherein the scanning part is a breast, and the at least one processor is further configured to execute the at least one instruction to change the body marker based on at least one of a shape of the breast, a type of the breast, a scanning direction of the breast, or the patient’s position (fig. 8; 0085, 0097, 0111, 0114).
It would also have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 to include the features of Kamiyama ‘006 in order to easily capture the examined range or the unexamined range.
In re claim 15, Razzaque ‘903 teaches wherein the body marker comprises a three-dimensional body marker (0048-0052, 0069, 0070, 3D).
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque ‘903 alone and/or Kamiyama ‘006 in view of Jones et al. (US 2018/0012416, hereinafter Jones ‘416).
In re claim 7, Razzaque ‘903 teaches wherein the sensing apparatus comprises a glass device (0081) and HMD (0087) but fails to teach including a detecting sensor, and the detecting sensor includes at least one of an image sensor, an infrared sensor, a thermal imaging camera, an optical camera, a stereo camera, or an ultrasonic sensor.
Jones ‘416 teaches a glass device (0027-0029) including a detecting sensor, and the detecting sensor includes at least one of an image sensor, an infrared sensor, a thermal imaging camera, an optical camera, a stereo camera, or an ultrasonic sensor (0046, 0052, 0053).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 alone and/or Kamiyama ‘006 to include the features of Jones ‘416 in order to improve the efficiency, productivity, throughput, and/or accuracy, and/or safety of the wearer's performance of a medical procedure, and can reduce mental fatigue by reducing or eliminating a need for the wearer to reference remote display devices haying substantial angular offsets during a medical procedure.
In re claim 16, Razzaque ‘903 teaches wherein the at least one processor is further configured to execute the at least one instruction to transmit the first ultrasound image to the sensing apparatus, through the communication module, and the sensing apparatus is configured to display the body marker and the first ultrasound image (0047-0050, 304, 306, the fan area of ultrasound, 318), fail to teach as Augmented Reality (AR) objects.
Jones ‘416 teaches display as AR objects with HMD that can display acquired video and images (0082-0086, etc.).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 alone and/or Kamiyama ‘006 to include the features of Jones ‘416 in order to improve the efficiency, productivity, throughput, and/or accuracy, and/or safety of the wearer's performance of a medical procedure, and can reduce mental fatigue by reducing or eliminating a need for the wearer to reference remote display devices haying substantial angular offsets during a medical procedure.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque ‘903 alone and/or Kamiyama ‘006, and Jones ‘416 in view of Silva et al. (US 2023/0341932, hereinafter Silva ‘932).
In re claim 8, Razzaque ‘903 teaches the at least one processor is further configured to execute the at least one instruction to update the body marker and the probe marker based on the sensing data while receiving the sensing data (0079, furthermore, the real-time function in 0050 would allow the feature of update here.).
Razzaque ‘903 fails to explicitly teach “stop updating the body marker and the probe marker while reception of the sensing data stops.” However, it would have been obvious as a common sense or a design choice that when nothing is receive, nothing needs to be updated. Furthermore, when the system is turned off (i.e. reception of the sensing data stops), the system cannot be updated (i.e. stop updating anything).
Furthermore, Razzaque ‘903 fails to teach wherein the glass device is configured to transmit the sensing data to the ultrasound imaging apparatus while a user's gaze is directed toward the scanning part, and stop transmitting the sensing data to the ultrasound imaging apparatus while the user's gaze is directed toward another part except for the scanning part.
Silva ’932 teaches:
the processing system 100 provide user input information to the display monitor 310 to update the user interface based on the user input and the position of the cursor 350. As an example, the user performs the user input to start or stop a mapping or registration procedure. Instead of using a mouse or keyboard to interact with a user interface on the display monitor, the user can start or stop the procedure using hands-free input by directing the user's gaze to a virtual button (e.g., an augmented reality graphic) displayed by the HMD 110, or to a button on the display monitor (where the cursor tracks the user's gaze direction as indicated by the marker 340 shown in FIG. 3). Instead of a using a mouse click or pressing a keyboard key, the user provides a hands-free input such as a wink or blink to indicate a selection of a virtual button or a button on the display monitor.
Hence, it would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 alone and/or Kamiyama ‘006, and Jones ‘416 to include the virtual button features (which is NOT the scanning part, body part) of Silva ’932 to control the start and stop function of a system of sending data in order to provide a hands-free input such as a wink or blink to indicate a selection of a virtual button or a button on the display monitor for easy operation.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque ‘903 alone and/or Kamiyama ‘006 in view of Hattori et al. (US 2022/0351078, hereinafter Hattori ‘078).
In re claim 9, Razzaque ‘903 fails to teach wherein the at least one processor is further configured to execute the at least one instruction to input the sensing data to a first artificial intelligence model to obtain the body marker, wherein the sensing data is input to the first artificial intelligence model in a form of a one-dimensional array.
Hattori ‘078 teaches wherein the at least one processor is further configured to execute the at least one instruction to input the sensing data to a first artificial intelligence model to obtain the body marker (fig. 8), wherein the sensing data is input to the first artificial intelligence model in a form of a one-dimensional array (0051, 0055-0056).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Razzaque ‘903 alone and/or Kamiyama ‘006 to include the features of Hattori ‘078 in order to implement creations of a classifier capable of identifying an object (for example, a tissue or a cell) in an image with high accuracy and a learning image database including an image contributing to a continuous improvement in identification accuracy of the classifier.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797
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