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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed 01/30/2024 is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
There appears to be typos in claim 1 that contribute to grammatical errors.
In claim 1, line 9, the limitation reads “a tip material at located at to the distal portion…”. The examiner is interpreting that section to read “a tip material located at the distal portion”.
In the last line of claim 1, the examiner is interpreting “material to circumferentially overlap distal end” to read “material to circumferentially overlap the distal end”.
Appropriate correction is required.
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 dilated portion of claim 9 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 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.
Claim 9 is 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.
Claim 9 recites the limitation specifying wherein particularly a dilated portion of the catheter lumen can store the distal balloon inside while deflated. There is no support in the specification or drawings that supports a dilated portion of the catheter lumen.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-8, 10-20, 22-26 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-8, 10-20, and 22-26 of prior art U.S. Patent No. US11553830B1. This is a statutory double patenting rejection.
Claim 27 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 33 of prior of U.S. Patent No. US11925319B2. This is a statutory double patenting rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. US11553830B1 in view of Poole et al. (US2003/0168068)
The claims of ‘830 disclose all of the limitations of the instant claims except for the limitations of wherein specifically a dilated portion of the catheter lumen stores the distal balloon while deflated.
In the same field of endeavor, Poole teaches a similar endoscopic accessory device for use with an endoscope (liner is used with an endoscope 17 [0100]), the endoscopic accessory device comprising: a wall structure having a proximal portion spaced in a lengthwise direction from a distal portion along an axis (Fig. 10: storage member 116 and first membrane 110 form a wall structure that comprises a proximal portion and a distal portion [0120]), wherein the wall structure includes an interior surface and an exterior surface (Fig. 10: first membrane 110 forms an interior surface, storage membrane 116 forms an exterior surface); a tip material located at the distal portion and having a tip length extending distally beyond the distal end (Fig. 10: distal end 140 is located at the distal portion of the first membrane, is comprised of a material and a length); a catheter lumen extending from the proximal portion to the distal portion (Fig. 10: the liner forms an interior space or lumen in which the endoscope 17 passes through [0121]), a balloon catheter having a distal balloon and slidably moveable through the catheter lumen (balloon 148, which may be stored in endoscope 148, is slidably movable through the interior space or lumen of the liner as the endoscope moves through the liner [0142]), wherein a dilated portion of the catheter lumen stores the distal balloon while deflated (when it is required to remove the endoscope from the membrane 110, the balloon 148 is inflated via the fluid channel 150, balloon 148 may be stored in a deflated state within the endoscope when not in use [0142], and the endoscope is within a dilated or open portion of the first membrane 140 of the liner, thus the balloon is store within the interior space or lumen of the liner). In view of Poole, it would have been obvious to one of ordinary skill in the art before the effective filing date to have included wherein a distal balloon is stored within a dilated portion of a catheter lumen while deflated, as the configuration is a common storage structure for uninflated balloons within the endoscope art and can predictably protect the uninflated balloon from damage while the catheter lumen is traversing a body lumen.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. US11553830B1 in view of Kang (US2013/0225925).
The claims of ‘830 disclose all of the limitations of the instant claims except for the limitations of wherein the barrier is a least one elastomeric bead.
In the same field of endeavor, Kang teaches a similar endoscopic accessory device for use with use with an endoscope (Fig. 4: auxiliary tool 1 to be used with endoscope 100 [0039]), the endoscopic accessory device comprising: a wall structure having a proximal portion spaced in a lengthwise direction from a distal portion along an axis (Fig. 2: auxiliary tool 1 formed of a distal portion 10, and a proximal portion 20 [0039]), wherein the wall structure includes an interior surface and an exterior surface through which the endoscope is inserted (Fig. 2: interior surface is indicated by holding part 24 and hollow part 13; exterior surface is exterior circumferential surface of body 10 and body 20); and a tip material located at the distal portion and having a tip length (Fig. 2: inclined aperture surface 11 forms a distal tip located at the distal end of body 10, and if formed of a material and comprises a length). Kang further teaches the device comprising at least one elastomeric bead on the interior surface of the wall structure that at least one elastomeric bead creates a circumferential fluid seal on the interior surface (Fig. 3A-5: leakage prevention membrane 34 is formed on the interior surface of body 20 and allows an endoscope tube 100 to pass through while preventing fecal matter from leaking out in the reverse direction [0055, 0063]). In view of Kang, it would have been obvious to one of ordinary skill in the art to include at least one elastomeric bead on the interior surface of the wall structure that at least one elastomeric bead creates a circumferential fluid seal on the interior surface, as the elastomeric bead allows relative movement between two tubular structures while maintaining a friction-based airtight seal between the two tubular structures that prevents the unwanted backflow of fluid and debris [0055].
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. US11553830B1 in view of Conteas (US2022/0031151).
Claim 1 of ‘830 disclose all of the limitations of the instant claim except for the device further comprising a raised barrier located at the proximal portion, where the raised barrier forms a fluid barrier when engaged against the endoscope or the tubular structure of the irrigation kit.
In the same field of endeavor, Conteas teaches a similar endoscopic accessory device for use with use with an endoscope (overtube 20 to be used with colonoscope 12 [0061]), the endoscopic accessory device comprising: a wall structure having a proximal portion spaced in a lengthwise direction from a distal portion along an axis (Fig. 4: overtube 20 comprises a wall structure that comprises a distal portion appearing in the upper region of Fig. 4 above outer surface 34, and a proximal portion spaced in the lower region), wherein the wall structure includes an interior surface and an exterior surface through which the endoscope is inserted (Fig. 6: the wall structure of overtube 20 comprises an interior surface through which colonoscope 12 is inserted through, and an exterior surface); a tip material located at the distal portion and having a tip length (Fig. 4: overtube 20 comprises a distal tip that is formed of a tip material and formed of a particular length); a proximal balloon located on the exterior surface of the distal portion (Fig. 8A: inflatable cuff 8A [0073]); and a hub portion at the proximal portion of the wall structure and on the exterior surface (Fig. 7: cylindrical element 38 [0068 & 0071]). Conteas further teaches the device comprising a raised barrier located at the proximal portion, where the raised barrier forms a fluid barrier when engaged against the endoscope or the tubular structure of the irrigation kit (Fig. 5 &6: removable membrane covering 50 located at the proximal portion of overtube 20, which allows insertion and passage of the colonoscope 12 but seals in air and water [0067 & 0070]). In view of Conteas, it would have been obvious to one of ordinary skill in the art to include a raised barrier located at the proximal portion, where the raised barrier forms a fluid barrier when engaged against the endoscope, as the raised barrier allows relative movement between two tubular structures while maintaining a friction-based airtight seal between the two tubular structures that prevents the unwanted backflow of fluid and debris [0070].
Claim 1, 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 39, 40 and 41 of U.S. Patent No. US12,089,814B2 in view of Sato et al. (US2024/0016372).
Claims 39-41 of ‘814 disclose all of the limitations of applicant’s claim 1, 14 and 15 respectively except for the limitation wherein in pre-deployment configuration, the proximal balloon and the inner balloon are uninflated.
In regards to claims 1, 14 and 15, Sato teaches a substantially similar endoscopic accessory device for use with an endoscope (overtube 1 allows an endoscope to pass therethrough [0147]), the endoscopic accessory device comprising: a wall structure having a proximal portion spaced in a lengthwise direction from a distal portion along an axis (Fig. 4: main tube 2 comprises a proximal portion on the left side of the figure and a distal portion on the right side of the figure, along an axis appearing as a dotted line), wherein the wall structure includes an interior surface and an exterior surface (main tube 2 comprises a circumferential surface 2d [0195] and an inner surface that forms the inner lumen 2c [0190]); a tip material located at the distal portion and having a tip length extending distally beyond the distal end (distal end tip 4); a proximal balloon located on the exterior surface of the distal portion (fixing balloon 3 is fixed to an outer circumference of the main tube 2 near the distal end tip 4 [0188]); an inner balloon located on the interior surface and proximally spaced from the distal end (Fig. 8 & 9: airtight balloon 22 inside the inner circumferential surface and is proximal the distal end tip 4 [0256]); and a hub portion at the proximal portion of the wall structure and on the exterior surface (Fig. 4: grip portion 5 is at the proximal portion of main tube 2 and on the exterior surface of the main tube 2 [0235]).
Sato further teaches wherein in a pre-deployment configuration the proximal balloon and the inner balloon are uninflated (Fig. 4 shows a diameter-expanded state of fixing balloon 3, balloon can contract in radial direction, in a pre-deployed state, balloon would be radially contracted [0204]; airtight balloon 22 may be in the uninflated, pre-deployment state, as seen in Fig. 4, or deployed in an expanded state as seen in Fig. 8 and 10). In view of Sato, it would have been obvious to one of ordinary skill in the art to include wherein balloons comprise a pre-deployment, uninflated state, commonly prior to insertion into a body cavity, or within the endoscope overtube art, prior to the insertion of an endoscope through the overtube, for in the pre-deployment state, the uninflated balloons allow relative movement between two tubular structures before the inflation of the balloons creates a friction-based airtight seal between the two tubular structures [0358] that may also hold the two tubular structures stationary relative to one another [0348].
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33 of U.S. Patent No. US11,925,319B2 in view of Sato et al. (US2024/0016372).
Claim 33 of ‘319 disclose all of the limitations of applicant’s claim 1 except for the limitation wherein the device comprises an inner balloon located on the interior surface and proximally spaced from the distal end, a hub portion at the proximal portion of the wall structure and on the exterior surface, wherein in the pre-deployment configuration the proximal balloon and the inner balloon are uninflated.
In regards to claim 1, Sato teaches a substantially similar endoscopic accessory device for use with an endoscope (overtube 1 allows an endoscope to pass therethrough [0147]), the endoscopic accessory device comprising: a wall structure having a proximal portion spaced in a lengthwise direction from a distal portion along an axis (Fig. 4: main tube 2 comprises a proximal portion on the left side of the figure and a distal portion on the right side of the figure, along an axis appearing as a dotted line), wherein the wall structure includes an interior surface and an exterior surface (main tube 2 comprises a circumferential surface 2d [0195] and an inner surface that forms the inner lumen 2c [0190]); a tip material located at the distal portion and having a tip length extending distally beyond the distal end (distal end tip 4); and a proximal balloon located on the exterior surface of the distal portion (fixing balloon 3 is fixed to an outer circumference of the main tube 2 near the distal end tip 4 [0188]).
Sato further teaches wherein the device comprises an inner balloon located on the interior surface and is proximally spaced from the distal end (Fig. 8 & 9: airtight balloon 22 inside the inner circumferential surface and is proximal the distal end tip 4 [0256]), a hub portion at the proximal portion of the wall structure and on the exterior surface (Fig. 4: grip portion 5 is at the proximal portion of main tube 2 and on the exterior surface of the main tube 2 [0235]), wherein in a pre-deployment configuration, a proximal ballon and an inner balloon are uninflated (Fig. 4 shows a diameter-expanded state of fixing balloon 3, balloon can contract in radial direction, in a pre-deployed state, balloon would be radially contracted [0204]; airtight balloon 22 may be in the uninflated, pre-deployment state, as seen in Fig. 4, or deployed in an expanded state as seen in Fig. 8 and 10).
In view of Sato, it would have been obvious to one of ordinary skill in the art to include the hub portion, the inner balloon, and wherein the balloons are uninflated prior to insertion into a body cavity in a pre-deployment state, as the hub portion provides convenient location for an operator to hold the device and also includes connector elements for fluids to inflate the balloons. The advantage of the inner balloon is for maintaining airtightness and liquid tightness so that liquid, gas or the like in the large intestine are prevented from leaking proximally from the device. It is well-known in the endoscope art, particularly that relating to overtubes and endoscopes used for the colon, that balloons may comprise a pre-deployed state wherein the balloons are uninflated, usually prior to insertion into the body cavity, as the balloons are inflated when within the body cavity to expand the body cavity or create a seal.
Allowable Subject Matter
Claims 1-27 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose or fairly suggest either individually or in combination the claimed accessory device comprising, inter alia wherein the wall structure includes an intermediate space therebetween an interior surface and an exterior surface, wherein the tip material comprises a tip width greater than the wall structure width, wherein the wall structure is sufficiently flexible to assume a flat profile across the wall structure width, and wherein in the closed overtube profile the tip width of the tip material permits the tip material to circumferentially overlap the distal end. There is no reason, teaching or suggesting with any prior art of record to modify an endoscope accessory device to include the recited limitations listed above.
The prior art of record also fails to disclose or fairly suggest the methods of preparing a colon for examination as claimed in claims 25 and 26, including inter alia, expanding a second balloon against the wall of a colon and withdrawing the first and the second ballon while engaged against the wall of the colon to prepare the colon for examination, and expanding the second balloon against the wall of the colon and withdrawing the second balloon towards the distal opening to cause the fluid to enter the distal opening and to prepare the colon for examination. The combination of these limitations, in addition to other limitations of the independent claims, are not anticipated by any prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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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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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/08/26