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 1-20 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.
Independent claims 1, 12, and 19 are genus claims, specifically, when referencing “a reference value for a characteristic of a video image”. When claiming a genus, Applicant must provide sufficient description of a representative number of species to show the inventor was in possession of the claimed genus. Here, there is only one clear species and another possible species. The clearest species is related to the image brightness. Applicant’s disclosure uses this as the example throughout. The less obvious image characteristic is a relationship between a distance of a distal end of the endoscopic device and a tissue wall of a calyx. The Specification makes some mentions of distance, but there is a lack of description as to how this is obtained or determined based on the image alone. There is also a lack of description as to how this relationship is related to the potential for kidney collapse. With the lack of representative examples provided, a person having ordinary skill in the art would not consider Applicant to have been in possession of the claimed genus.
In addition to providing a genus claim without adequate support, the particular species are also lacking adequate support. Again, the relationship between distance and collapse is not set forth in any detail. Not only does the Specification take for granted that this relationship can be determined from the image, there is no discussion as to what that distance numerical value means relative to collapse.
Similarly, while brightness is mentioned in more detail, the Specification states that the reference value and the new value can have large or small difference or no difference at all and this can still be indicative of a potential collapse. The claim seems to encompass all these possibilities, which would mean that no matter what the two values are, there could be a potential collapse. The Specification does not provide any details as to all the circumstances where this is true, and a person having ordinary skill in the art is left to figure this out without direction. Applicant does not connect the dots between brightness and collapse. Does increase brightness mean there is an increased likelihood in collapse? The disclosure basically says that it depends, but never clearly states how any of these factors are related. A person having ordinary skill has to do the work to find what and when and what values correlate to potential collapse under what conditions. Applicant’s lack of direction amounts to a lack of possession of the claimed invention.
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.
Claims 1-18 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 1-18, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. There is also some uncertainty as to how the word is being used. Does Applicant intend that the warning and reduction in suction are options to be performed following a determination that there is a potential for kidney collapse or that these limitations do not need to be present in the system at all? In the former, the intent would be that the system needs to be able to perform the option when the condition is met. In the latter, the function is purely optional such that the clauses can be deleted from the claim without changing the scope. Appropriate correction is required.
Claims 1 and 12 refer to “a potential for kidney collapse” where it is unclear how this word potential should be treated. The “potential” for kidney collapse is presumably always present. The question is what is the likelihood of collapse given certain conditions. The Examiner assumes that some conditions make it more likely for a collapse, but is there evidence that there are those where there is no potential for a collapse? Apart from the device not being in use, the Examiner assumes that there is always some probability for collapse. Because the Examiner considers there to always be some potential for collapse, the language “whether the device condition is such that there is a potential for kidney collapse” is indefinite. Appropriate correction is required.
Claim 1 also states “wherein the system determines” where referring to “the system” when the system is the apparatus being claimed creates ambiguity as to what is actually performing or configured to perform the function. Can this determination be made by the endoscopic device, the image processor, the video display, or some other as of yet unclaimed element of the system? Because no particular element of the system is performing this function, the limitation is more suited for the preamble. This appears to be an intended use as written. If, for example, the image processor performs this function, then the claim should be amended to make that clear. If some other processing unit is used, then it should be a limitation in the claim. Appropriate correction is required.
Claims 3 and 13 refer to a “distance sufficient to ensure aspiration of the kidney stone under standard suction and/or irrigation-plus-suction condition” without providing some means by which these standards can be considered sufficient. Applicant has not provided a standard that would limit the claim language in any meaningful way. What the distance would be and what the suction and irrigation conditions would be are unknown and not discussed in the Specification. Therefore, a person having ordinary skill in the art would not be able to determine the scope of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) wherein the system determines a reference value for a characteristic of a video image transmitted from the endoscope device, measures how a new value of the characteristic of the video image compares to the reference value, and queries for a device condition to determine whether the device condition is such that there is a potential for kidney collapse.
The limitation of determining a reference value and measuring how a new value compares and querying for a device condition, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “the system” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “the system” language, “determining” in the context of this claim encompasses the user looking at the reference image and comparing it to the new image. Even if pulling from memory, a use can determine that the new image is brighter, duller, or the same. Similarly, querying for the device condition is something a user would do by simply thinking about how the device is being used. Is it being navigated to the desired location? Is it actively removing a kidney stone? Other such questions related to the device condition can be asked and answered by the user.
This judicial exception is not integrated into a practical application because the claims do not improve the ability to determine a potential kidney collapse. Kidney collapse is a known risk when removing kidney stones. The claims are drafted with a high-level of generality (make a comparison between a reference value and a new value and query the general device condition) such that it amounts to no more than mere instructions to apply the exception using a generic system. Accordingly, the abstract idea is not integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because endoscopic device, image processor, and video display are all well-known components of medical imaging equipment. These generic components are not specifically designed for obtaining the image values such that virtually an endoscope system would have the same structure as the claimed elements. Because these are merely generic elements, and as stated above, they are being used to simply compare values, which is a common computer function, they do not amount to significantly more than the judicial exception.
For these reasons, the claims are not patent eligible.
The dependent claims are also rejected as they do not provide features that would change the analysis above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fajardo Vargas et al. (US 2023/0075052); Shah (US 2018/0289394); Look et al. (US 9,248,221).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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