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
Newly submitted claims 21-25 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-6, drawn to an endoscope, classified in A61B1/00097.
II. Claims 21-25, drawn to an endoscope, classified in A61B5/037.
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different function and are mutually exclusive as Invention II includes a controller configured to acquire an image of the LES and present a pressure valve of the stomach on a display and Invention I does not. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention II would require a search in at least A61B5/037, along with a unique text search. Invention I would not be searched as above and would instead be searched in at least A61B1/00097, along with a unique text search.
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 Accordingly, claims 21-25 are withdrawn from consideration as being directed to a non-elected invention.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.
Response to Amendment
The amendment filed on 12/19/2025 has been entered. Claims 1-25 remain pending in the application. Claims 7-25 remain withdrawn. Applicant’s amendments to the Drawings, Specification, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 9/19/2025. The claim interpretations invoked under 35 USC § 112(f) set forth in the Non-Final Office Action mailed 9/19/2025 have been withdrawn due to Applicant’s amendments.
Response to Arguments
Applicant's arguments, see pages 12-14, filed 12/19/2025 with respect to Claim 1 have been fully considered but they are not persuasive.
Applicant has amended independent claim 1 with a limitation from claim 4 stating that the endoscope includes “an image carrying fiber positioned in a second lumen defined by the body.” The applicant argues that the amended claim 1 overcomes the current grounds of rejection over Pereira in view of Titus. The applicant’s argument is on the grounds that the substitution of the imaging unit of Pereira with the imaging unit of Titus is not simple substitution as these components function in different ways. However, examiner respectfully disagrees. The imaging unit of Pereira and the imaging unit of Titus are both used for the same function of taking images of an area distal to the distal end of the endoscope and displaying them on a display.
In addition, the applicant argues that modifying Pereira with the imaging unit of Titus would destroy the functionality of the pressure sensor. Examiner respectfully disagrees. MPEP § 2145 establishes that "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art” In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981) and “It is not necessary that the inventions of the references be physically combinable to render obvious the invention under review” In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983). Furthermore, Pereira states that the pressure sensor can be located in or on an external surface of the distal end of the scope, as long as the medium is able to contact the active area of the chip sensor (paragraph 0036). Titus states that the instrument channel can extend the full length of the visualization section of the optical coupler (paragraph 0089). Therefore, the optical coupler can be disposed on the distal tip of the endoscope in such a manner that the active area of the chip can make contact with the medium. The combination is still deemed proper and the applicant’s arguments are not persuasive.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first set of a plurality of rings connected to each other by pivot pins” and the “second set of a plurality of rings connected to each other by pivot pins” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities:
In claim 1, line 8, “the controller-receiving” should read “the controller receiving”
In claim 1, line 3, and claim 21, line 3, “the proximal end receiving a fluid from a source of fluid” should read “the proximal end configured to receive a fluid from a source of fluid”. The suggested amendment clarifies that the fluid source is not positively recited in the claim, and that the recitation of the proximal end is intended to describe its capability to receive fluid, rather than requiring an actual fluid source.
Appropriate correction is required.
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 2 and 21 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.
Claims 2 and 21 introduce new matter with the recitation of the limitation wherein the controller being configured to “acquire, using the image carrying fiber, an image of the lower esophageal sphincter (LES).” A processor being configured to acquire an image is not supported by the originally filed claims, specification, or drawings. Therefore, one skilled in the art would not be able to determine that the inventor at the time of filing had possession of the claimed invention. For the purposes of examination, it is assumed applicant intended for the endoscope to acquire an image of the LES.
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 2-4, 22-23, and 25 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 2 recites the limitation "wherein acquiring … the image of a lower esophageal sphincter" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “wherein acquiring … the image of a lower esophageal sphincter” is being interpreted as “wherein the endoscope is configured to acquire an image of a lower esophageal sphincter.”
Claim 2 recites the limitation “a distal end of the body” in lines 2-3. Claim 1 introduces the body having a distal end. It is unclear if applicant is referring to the distal end of the body presented in claim 1 or another distal end. For the purposes of examination, “a distal end of the body” is interpreted as “the distal end of the body.”
Claims 22 and 23 recite the limitation "the image" in l. 1 of claim 22 and l. 1 of claim 23. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the image” is being interpreted as “the image of the LES.”
Claim 25 recites the limitation “a switch” in line 2 and line 4. It is unclear how many switches are included in the claimed invention. For the purposes of examination, “a switch” in line 4 is interpreted as “the switch.”
Claims 3-4 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
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.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0196839 A1 to Pereira et al. (“Pereira”) in view of U.S. Patent Appl. Publ. No. 2012/0209074 A1 to Titus (“Titus”).
Regarding claim 1, Pereira discloses an endoscope (scope device 102; Fig. 1, paragraph 0030) comprising:
a body defining a first lumen (the shaft 106 … includes a working channel 110 extending therethrough; Fig. 1, paragraph 0030), the body having a distal end (the shaft 106 extends from a proximal end coupled to the handle 104 to the distal tip 108; Fig. 1, paragraph 0030) and a proximal end, the proximal end receiving a fluid from a source of fluid (fluid source 130 provide fluid flow through the supply line, the handle 104 and the shaft 106 to the target body cavity; Fig. 1, paragraph 0031);
an imaging unit (the scope device 102, in this embodiment, includes a camera 114; Fig. 1, paragraph 0031);
a pressure sensor located on the distal end of the body (the pressure sensor 136 is positioned at the distal tip 108 of the scope device 102; Fig. 2, paragraph 0034); and
a controller in electrical communication with the pressure sensor (this pressure is translated into an electrical signal which is transmitted to the processing device 116; Fig. 1, paragraph 0035), the controller receiving electrical signals from the pressure sensor and converting the electrical signals into numerical pressure values (the chip sensor 136 may provide a pressure readout 128 from the scope device 102 to the display screen 118 of the processing device 116; Fig. 3, paragraph 0035-0036).
However, Pereira does not explicitly disclose an image carrying fiber positioned in a second lumen defined by the body.
Titus teaches an image carrying fiber positioned in a second lumen defined by the body (the object lens 40 and the image carrying fiber 42 are located in the second lumen 36; Fig. 3, paragraph 0092).
Titus is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a light source and an imaging unit. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the distal imaging unit of Pereira with the proximal imaging unit of Titus, because the substitution of art recognized equivalents as shown by Titus is within the level of ordinary skill in the art. In addition, the substitution of well known equivalent alternative arrangements for imaging and illumination in endoscopes is likely to be obvious when it does no more than yield predictable results.
Regarding claim 2, Pereira, as previously modified by Titus, discloses the endoscope according to claim 1. Pereira, as modified by Titus, discloses wherein acquiring, using the image carrying fiber, the image of a lower esophageal sphincter (LES) occurs when a distal end of the body is positioned in a stomach and faces the LES (the endoscope can be used to take an image of a LES while positioned inside the stomach; endoscope 30; paragraph 0110). The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP § 2114).
Regarding claim 3, Pereira, as previously modified by Titus, discloses the endoscope according to claims 1-2. Pereira further discloses a display for presenting the numerical pressure values (the chip sensor 136 may provide a pressure readout 128 from the scope device 102 to the display screen 118 of the processing device 116; Fig. 3, paragraph 0035-0036); and
a light source (the scope device 102, in this embodiment, includes … a light source 112; Fig. 1, paragraph 0031), and
wherein the display displays images (the display screen 118 provides the user with a live video feed 121 of the target tissue/vessel/cavity from the camera 14 positioned on the distal tip 108 of the scope device 102; Fig. 3, paragraph 0032)
However, Pereira does not explicitly disclose a light transmitting guide positioned in a third lumen defined by the body, and wherein the visualization device displays images received from the image carrying fiber.
Titus teaches a light transmitting guide positioned in a third lumen defined by the body (a light guide 39 is positioned in the first lumen 35 for transmitting light toward a surface area at or beyond the outer surface 14 of the optical coupler 10; Fig. 3, paragraph 0092),
wherein the visualization device displays images received from the image carrying fiber (the lens 40 transmits an optical image to the image carrying fiber 42 which transmits the optical image to an eyepiece or video display in a conventional manner; paragraph 0104).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the distal light source of Pereira with the proximal light source of Titus, because the substitution of art recognized equivalents as shown by Titus is within the level of ordinary skill in the art. In addition, the substitution of well known equivalent alternative arrangements for imaging and illumination in endoscopes is likely to be obvious when it does no more than yield predictable results.
Regarding claim 5, Pereira, as previously modified by Titus, discloses the endoscope according to claim 1. Pereira further discloses wherein the controller executes a program stored in the controller to record the numerical pressure values (the processing device 116 is also capable of tracking and storing data pertaining to the operations of the scope system 100 and each component thereof; Fig. 1, paragraph 0032).
Regarding claim 6, Pereira, as previously modified by Titus, discloses the endoscope according to claims 1 and 5. Pereira further discloses a switch in electrical communication with the controller (the processing device 116 and/or the display screen 118 may include one or more user interface components such as buttons, switches, knobs, or a touch screen interface; Fig. 1, paragraph 0033), wherein the controller executes the program stored in the controller to record a numerical pressure value (the processing device 116 is also capable of tracking and storing data pertaining to the operations of the scope system 100 and each component thereof; Fig. 1, paragraph 0032) when the switch is activated (the user interface allows the user to input/adjust various functions of the scope system 100; Fig. 1, paragraph 0033).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pereira in view of Titus as applied to claims 1-3 above, and further in view of U.S. Patent Appl. Publ. No. 2012/0184818 A1 to Sugisawa et al. (“Sugisawa”).
Regarding claim 4, Pereira, as previously modified by Titus, discloses the endoscope according to claims 1-3. Pereira discloses a flexible endoscope with controlled bending (the handle 104 includes an actuation mechanism which allows the user to control and articulate the shaft 106 when navigating the body lumen; Fig. 1, paragraph 0030). Pereira, as modified by Titus, does not explicitly disclose a first set of a plurality of rings connected to each other by pivot pins which allow the plurality of rings to curl the distal end of the body in an up-and-down direction and a second set of a plurality of rings connected to each other by pivot pins which allow the plurality of rings to curl the distal end of the body in a right-and-left direction.
Sugisawa teaches a first set of a plurality of rings connected to each other by pivot pins which allow the plurality of rings to curl the distal end of the body in an up-and-down direction and a second set of a plurality of rings connected to each other by pivot pins which allow the plurality of rings to curl the distal end of the body in a right-and-left direction (the plurality of joint rings 111 mentioned above are coupled together about the coupling shafts 113 and 115, respectively, that are turnable to each other. The plurality of joint rings 111 can be curved in a desired direction by the pulling of the manipulating wire by the manipulation of an angle knob. A pivot pin 125 is arranged in the coupling shaft 113 (115 is the same), which couples the adjacent joint rings 111 together, to couple both the joint rings 111 turnably; Fig. 8, paragraph 0062-0063).
Sugisawa is considered to be analogous to the claimed invention because it is in the same field of endoscopes with controlled bending. As Pereira is not limited to any specific examples of articulation mechanisms and as an articulation mechanism comprising rings and pivot pins were well known in the art at the time the invention was made, as evidenced by Sugisawa, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pereira, as modified by Titus, to incorporate the teachings of Sugisawa by constructing the articulation mechanism with a plurality of rings connected to each other by pivot pins. Said combination would amount to use of a known element for its intended use in a known environment to accomplish entirely expected result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2023/0089053 A1 to Inoue et al. teaches an endoscope system with a processor configured to measure the pressure inside the stomach as described in the abstract and following descriptive text.
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 OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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