DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 01/02/26 have been entered in the case. Claims 25, 28-29, 32-33, 35, 37, 40, 44, 46-47, 50-52 are pending for examination; claim 24, 48-19 & 53 are withdrawn and claims 1-23, 26-27, 30-31, 36, 41-43, 45 are cancelled.
Correction of Election/Restrictions
Applicant’s election without traverse of species 12, Fig. 14 in the reply filed on 01/17/25. The independent claim 40 (filed in 01/17/25) recites that: an imaging device, wherein deflection of the endoscope moves the imaging device in direction of deflection. This limitation does not include in the elected Species in Fig. 14. Therefore, the Applicant is requested to correct the species selection to align with the invention claimed in claim 40.
During the phone interview on 02/18/26 & 02/19/2026, Examiner believes that the claim 40 is more likely suitable in Fig. 28. However, the Attorney Neil Gershon disagreed with the Examiner and elected species 8 (Fig. 7).
The claims 24, 28, 33, 48-49 & 53 are amended by attorney Gershon as following:
Claim 24 (withdrawn)
Claim 28 (currently amended) The endoscope of claim 40 wherein is configured for one or both of irrigation or aspiration.
Claim 33 (currently amended) The endoscope of claim 40, wherein a distal end of the imaging device is flush with a distal end of the inner tubular member
Claim 48 (withdrawn)
Claim 49 (withdrawn)
Claim 53 (withdrawn)
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 limitation “the second lumen of the inner tubular is configured to receive a cutting wire therein” in claim 46 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Note: the elected Fig. 14 does not include the second lumen; and a cutting wire. Are these limitations, i.e., second lumen & cutting wire being referred to other non-elected figures? In that case, the claim 46 should be withdrawn.
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 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 25, 28-29, 32-33, 35, 37, 40, 44, 46-47, 50-52 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.
The limitation “the imaging device positioned at distal end of the endoscope such that it does not extend beyond the distal most end of the endoscope, the housing of the imaging device in contact with the inner tubular member” in claim 40 is failing to comply with the written description requirement in elected Fig. 7.
Oppositely, the elected Figs. 7 & reproduced Fig. 7A show that the imaging device 46 extends (radially or in vertical direction in Fig. 7) beyond a distal most end of the endoscope;
and when the housing of the imaging device in contact with the inner tubular member 122, as shown in reproduced Fig. 7A, the imaging device 46 extends beyond the distal most end 118 of the endoscope (in radial direction, on the left side of the distal end 118).
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Note: During the interview on 02/18/26-02/20/26, the Examiner believed that the limitation above is suitable in Fig. 28. However, the attorney Gershon disagrees and still elected Fig. 7. Since the Applicant disagrees with Examiner’s statement above, the Applicant is requested to identify the specific claim limitations supported in the elected Fig. 7. The Applicant should amend claimed invention that align with the elected Fig. 7.
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 25, 28-29, 32-33, 35, 37, 40, 44, 46-47, 50-52 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 40 recites the limitation "the distalmost end" in the last three line of the claim 40. There is insufficient antecedent basis for this limitation in the claim.
The other claims 25, 28-29, 32-33, 35, 37, 44, 46-47, 50-52 are being rejected due to their dependency.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 25, 28-29, 32-33, 35, 37, 40, 44, 50-52 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh et al. (US 2010/0331776) in view of Adair (US 6,086,528).
Regarding claim 40, Salahieh discloses a steerable & insertable device 30 into a patient comprising:
Note: it is well-known in the art that the steerable catheter is being used in endoscope. Therefore, the insertable device 30 is fair enough to call as endoscope device.
an outer tubular member 34 having a proximal portion, a distal portion, a distal opening, a longitudinal axis and a first lumen; and
an inner tubular member 36 having a second lumen and a distal opening, the inner tubular member coaxially positioned within the first lumen of the outer tubular member, the inner tubular member disposed in the first lumen of the outer tubular for axial movement of one or both of the inner tubular member and outer tubular member (the D & P arrows, in Fig. 2b, the inner tubular member 36 attached to the outer tubular member 34 (at fixation location 38) so a distal region of the outer tubular member is joined to a distal region of the inner tubular member, para [0067] & Fig. 2b;
wherein axial movement of one or both of the inner tubular member and outer tubular member causes deflection of a distal end of the endoscope wherein one or both of:
a) the inner tubular member is axially movable within the first lumen of the outer tubular member in one axial direction to cause deflection of the distal end of the endoscope laterally in a first direction (in Fig. 2a) and the inner tubular member is axially movable in an opposite axial direction within the outer tubular member to cause deflection of the distal end of the endoscope laterally in a second direction (in Fig. 2b) opposite the first direction; or
b) the outer tubular member is axially movable over the inner tubular member in one longitudinal direction to cause deflection of the distal end of the endoscope laterally in the first direction (in Fig. 2a) and the outer tubular member is axially movable over the inner tubular member in an opposite longitudinal direction to cause deflection of the distal end of the endoscope laterally in the second direction (in Fig. 2b) opposite the first direction; and
Salahieh does not disclose that an imaging device including a housing, the imaging device positioned at a distal end of the endoscope such that it does not extend beyond a distal most end of the endoscope, the housing of the imaging device in contact with the inner tubular member, wherein deflection of the endoscope moves the imaging device in direction of deflection.
Adair discloses an endoscope device 10 comprising: an outer tubular member 12; an inner tubular member 27; an imaging device 20 including a housing (element 25 & a distal portion/sleeve of the inner tubular member) positioned at a distal end of the endoscope such that it does not extend beyond a distal most end of the endoscope, the housing (located at distal portion of the inner tubular member 27) of the imaging device in contact with the inner tubular member 27, wherein deflection of the endoscope moves the imaging device in direction of deflection.
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It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Salahieh with providing an image unit located at distal end of the endoscope that does not extend beyond a distal most end of the endoscope, as taught by Adair, in order to capture an image from a different angle and provide a forward view of body cavity.
Note: the Salahieh discloses that the distal tip region of the endoscope being deflected; wherein the imaging device (as modified by Adair) is located at distal end of the endoscope; therefore, the deflection of the endoscope moves the imaging device in direction of deflection.
Regarding claim 25, Salahieh in view of Adair discloses the invention substantially as claimed. Adair discloses that wherein the imaging device 60 includes a complementary metal oxide semiconductor module, col. 3, lines 45-47.
Regarding claim 28, as mentioned, the claim 28 is amended such as: The endoscope of claim 40 wherein is configured for one or both of irrigation or aspiration.
Salahieh in view of Adair discloses the invention substantially as claimed. Salahieh also discloses that inner tubular member 36 can have at least one slot formed therein, para [0079]. Adair discloses that: in addition to light fibers 27, fluid can be introduced through one or more of the channels 26 in order to flush, col. 5, lines 57-59. It is noted that the channel 26 is located within the inner tubular member. Therefore, Adair (or Salahieh in view of Adair) discloses that the inner tubular or outer tubular member (via slot 510 of the outer tubular member 502 in Salahieh) is configured for irrigation.
Regarding claims 29 & 32, Salahieh in view of Adair discloses the invention substantially as claimed. Salahieh discloses that a guidewire (is same as a removable wire in claim 32) is advanced to a desired location within the subject, para [0132]. It is well-known in the art that the guidewire being used in the endoscope device. Therefore, a person skilled in the art would recognize that the inner/second lumen 36 can be used for passage of a guidewire or removable wire. The removable wire can be performed to ad introduction of the endoscope.
Regarding claim 33, Salahieh in view of Adair discloses the invention substantially as claimed. Adair discloses that in addition to light fibers 27, fluid can be introduced through one or more of the channels 26 (of the inner tubular member) in order to flush, col. 5, lines 57-59. Therefore, a distal end of the imaging device is flush (from the channel 26) with a distal end of the inner tubular member.
Regarding claim 35, Salahieh in view of Adair discloses the invention substantially as claimed. Adair further states that: in addition to light fibers, other device, i.e. guidewire is passed through the small lumens or channels 26, col. 5, lines 24-26. Salahieh also a lubricious inner line being provided for a medical device or instrument to be advanced therethrough, paras [0071-0072]. Therefore, a person skilled in the art would recognize that the channel 26 (as being used for the guidewire channel passing through) is being provided a lubricous inner liner, as suggested by Salahieh, to facilitate guidewire movement easily within the endoscope.
Regarding claim 37, Salahieh in view of Adair discloses the invention substantially as claimed. Salahieh in view of Adair further discloses that wherein the imaging device includes a camera and lighting includes an optical fiber.
Regarding claim 44, Salahieh in view of Adair discloses the invention substantially as claimed. Salahieh in view of Bayer further discloses that wherein the inner tubular member is lockable (at fixation location 38 in Fig. 1-2 in Salahieh) to the outer tubular member.
Regarding claim 50, Salahieh in view of Adair discloses the invention substantially as claimed. Salahieh discloses that wherein the outer tubular member has a distalmost end and the inner tubular member has a distalmost end, and the distalmost end of the inner tubular member is aligned with the distalmost end of the inner tubular member Figs. 2a-2b.
Regarding claim 51, Salahieh in view of Adair discloses the invention substantially as claimed. Adair discloses that wherein the imaging device includes transmission members, i.e., #14, 18 & 19 in Fig. 2A, extending proximally, wherein the transmission members extend through the first lumen in the outer member. Note: Adair discloses the transmission members extend through the inner lumen and also extend through the first lumen 26 in the outer member 12, see Fig. 2A.
Regarding claim 52, Salahieh in view of Adair discloses the invention substantially as claimed. Salahieh discloses that the inner tubular member is formed from a laser cut tube, see Fig. 8.
Claim 46 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh et al. (US 2010/0331776) in view of Adair (US 6,086,528) and further in view of Adair (US 5,325,845) & Itoh (US 3,791,387).
Salahieh in view of Adair’528 discloses the invention substantially as claimed except for the limitations that: wherein the second lumen of the inner tubular member is configured to receive a cutting wire therein;
Adair’845 discloses that an endoscope comprising: an outer tubular member 12; an inner tubular member 18; wherein the inner tubular having a second lumen (an interior space of the wall or the inner tubular member 18; wherein the inner tubular member 18 having multiple lumens therein, see Figs. 7-10); the second lumen of the inner tubular 18 is configured to receive a surgical device (via passage 80 that located inside the second lumen of the inner tubular member). Therefore, the passage 80 (or the second lumen of the inner tubular member) is configured to receive a cutting wire therein, as for intended use purpose.
Itoh discloses an endoscope device 13 comprising: an outer tubular member a main/opearative lumen is configured to receive an accessory, i.e., forceps 2/24 has cutting wire, in Figs. 1, 6 & 27 or basket 101 (Fig. 27) therein.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Salahieh in view of Adair’528 with providing an accessory, i.e. forceps including cutting wire and/or the forceps being formed as a basket that located inside the lumen of the inner tubular member, as taught by Adair’845 & Itoh, in order to grasping, or removing unwanted tissue or sample tissue of a patient for carrying out the sample tissue for diagnostic or therapeutic function, as intended use purpose.
Claim 47 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh et al. (US 2010/0331776) in view of Adair (US 6,086,528) and further in view of Corcoran et al. (US 2006/0241564).
Regarding claim 47, Salahieh in view of Adair discloses the invention substantially as claimed except for the limitations in the claim 47.
Corcoran discloses a steerable catheter device comprising: an outer tubular member 2; an inner tubular member 3 having a second lumen 11 is used for passage of a guidewire, para [0068]; wherein the first lumen of the outer tubular member is lubricated a coating 14 to facilitate movement of the inner tubular member within the outer tubular member, para [0070].
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Salahieh in view of Adair with obtaining a lubricious inner liner being formed between the inner and outer tubular members, as taught by Corcoran, in order to facilitate movement of the inner tubular member within the outer tubular member easily.
Response to Arguments
Applicant’s arguments with respect to claims 25, 28-29, 32-33, 35, 37, 40, 44, 46-47, 50-52 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.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783