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 .
Notice of Amendment
In response to the amendment filed 12/5/25, cancel claims 2-7, 18, amended claims 1, 10-12, 23-24 and new claim 25 are acknowledged. The following new and reiterated grounds are set forth:
Election/Restrictions
Newly submitted claim 25 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 25 is directed to a processor configured to input the capture image into a trained aspect detection model, which was not previously presented in the original claims, and is directed to a mutually exclusive species. As such, there is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries) and the prior art applicable to one species would not likely be applicable to another species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 25 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 11 objected to because of the following informalities: the claim is grammatically incorrect, as it appears the word “wherein” is missing from line 2. 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.
GROUND 1: Claims 23-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 23-24 recite a method a medical support method/process of outputting permission or non-permission information indicating whether energization on the wire is permitted or not permitted without significantly more. The method is defined in term of certain functions to be performed (e.g. outputting). This judicial exception is not integrated into a practical application fort the following reasons.
The claimed method is limited to outputting permission or non-permission information indicating whether energization on the wire is permitted or not permitted based on a captured image. These functions are capable of being performed in the human mind and carried out by a human being. The claimed method is limited to implementation via a computer system, i.e., implementation via a generic calculating device receiving inputs from computer peripherals in the form of a generic measuring device and a generic detecting device. The recitation of generic computer components (i.e. outputting permission or non-permission information) and generic computer functions does not result in the judicial exception being integrated into a practical application. That is, this does not add a meaningful limitation to the abstract idea because it amounts to simply implementing the abstract idea on a computer.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
GROUND 2: Claims 1, 8-17 and 19-22 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 1 recites a “processor configured to image the luminal organ with the camera to generate a capture images” which leads to confusion as processor 25, as disclosed, does not image the luminal organ. Rather the camera of the duodenoscope 12 is disclosed as imaging the luminal organ. Processor 25 is disclosed as processing the image received from the camera, not as imaging. For example, Figures 2 and 5 illustrate the camera assembly as being separate and distinct from the image processing unit. Thus, the current claim language is unclear. Appropriate clarification and correction is required.
Claims 8-17 and 19-22 are rejected as being necessarily dependent upon claim 1.
GROUND 3: Claims 13 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 and 17 repeat limitations already present in claim 1, from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
GROUND 4: Claim(s) 1, 8-17 and 19-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 8,497,898 to Moriyama et al.
In regard to claims 1, 13, 15, 19 and 22-24, Moriyama et al. disclose a medical support device comprising: a processor 7/51 used for an endoscope apparatus 2 including a camera 6 that images a luminal organ and a treatment tool 4C that is energized in a state of being in contact with a treatment target part included in the luminal organ to cut the treatment target part, wherein the treatment tool includes a conductor 9b that comes into contact with the treatment target part, and an insulating region (i.e. shaft region 31/35c) that is electrically insulated from the conductor insulating the conductor are included as the captured image (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8), and wherein the processor is configured to: image the luminal organ with the camera to generate a captured image; in a case where the insulating region is not included in the captured image, output non-permission information indicating the energization of the conductor is not permitted; and in a case where the treatment target part, the conductor, and the insulating region are included in the captured image, output permission information indicating the energization of the conductor is permitted (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8). Moriyama et al. teach that the treatment tool 9 may or may not be energized based on information obtained from a capture image, but are silent with respect to the treatment instrument specifically comprising a wire. Calabrese et al. teach of an analogous endoscope apparatus including a camera and treatment tool, wherein the treatment tool is not limited and may comprises a guidewire, cutting or grasping forceps, a biopsy device, a snare loop, an injection needle, a cutting blade, scissors, a retractable basket, a retrieval device, an ablation and/or electrophysiology catheter, a stent placement device, a surgical stapling device, a balloon catheter, a laser-emitting device, and/or any other suitable instrument (See Fig. 1 and Col. 4, Lines 7-18). It would have been obvious to one skilled in the art at the time the invention was filed to modify the end effector of Moriyama et al. to be a wire/conductor, or snare, for use in treating a duodenal papilla as taught by Calabrese et al. and is extremely well known in the art.
In regard to claim 8, Moriyama et al. disclose a medical support device, wherein a process based on the captured image is performed as a process required to determine whether or not the energization is permitted in a case in which a first instruction has been received by a receiving device, and the permission and non-permission information is output in a case in which a second instruction has been received by the receiving device (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 9, Moriyama et al. disclose a medical support device, wherein whether or not the energization is permitted is determined on the basis of a size and/or position of the treatment tool included in the captured image (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 10, Moriyama et al. disclose a medical support device, wherein whether or not the energization is permitted is determined on the basis of a size and/or position of the conductor included in the captured image (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 11, Moriyama et al. disclose a medical support device, whether or not the energization is permitted is determined on the basis of a size and/or position of the insulating region included in the captured image (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 12, Moriyama et al. disclose a medical support device, wherein the endoscope apparatus has an insertion portion 2 that is inserted into the luminal organ, the camera is provided in the insertion portion, the insertion portion has an opening 3b and an insertion passage 3 that leads to the opening, the insertion passage has a conductive region, the treatment tool protrudes from the opening through the insertion passage and whether or not the energization is permitted is determined according to an aspect in which the treatment tool is included in the captured image (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 14, Moriyama et al. disclose a medical support device,
wherein the treatment tool is a papillotomy knife including the wire (See Fig. 11 and Col. 17, Lines 10-67). It is noted, the term “papillotomy” within the claim, is considered to be a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 16, Moriyama et al. disclose a medical support device, wherein the processor is configured to: set an energized state in which the energization is performed on the wire on condition that a state of the wire included in the captured image is a treatable state in which the treatment target part is capable of being treated by performing the energization; and set a non-energized state in which the energization is not performed on the wire on condition that the state of the wire included in the captured image is not the treatable state (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 17, Moriyama et al. disclose a medical support device, wherein whether or not the energization is permitted is determined according to an aspect in which the treatment tool is included in the captured image (See Figs. 8-12, 18 and Col. 19, Line 43 – Col. 22, Line 8).
In regard to claim 20, Moriyama et al. disclose a medical support device, wherein the output of the permission and non-permission information is displaying the permission and non-permission information on a screen 8 (see Figs. 2 and 10).
In regard to claim 21, Moriyama et al. disclose a medical support device, wherein the captured image is displayed on a screen 8 (see Figs. 2 and 10).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 8-17 and 19-24 have been considered but are moot in view of the new grounds of rejection.
Moriyama et al. as modified by Calabrese et al. disclose a “processor configured to” permit energization on the wire when the treatment part, conductor and the insulating region are included in the captured image (see Figs. 3-4 and 6) and prevents energization on the wire when the insulating region 35c is not in the capture image (see Figs. 6a-e and Col. 7, Lines 13-17). In other words, if markers 35a-b (i.e. “the insulating region”) are not present in the capture image, the processor outputs non-permission information and prevents energization on the wire. If the entire treatment tool (i.e. wire, conductor and insulating region) is visible in the captured image, then energization on the wire is permitted.
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 MATTHEW J KASZTEJNA whose telephone number is (571)272-6086. The examiner can normally be reached M-F, 7AM--3PM.
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/MATTHEW J KASZTEJNA/Primary Examiner, Art Unit 3993