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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of priority document KR 10-2021-0015622 has been received.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claim limitations of “translation drive device” found in Claims 7-9 and 11, and “expansion drive device” found in Claims 7 and 12 are not interpreted under 35 U.S.C. 112(f). That is, although these claims are for a device that performs a particular action, the descriptors “translation drive” and “expansion drive” provide sufficient structural descriptors/terms such that “persons of ordinary skill in the art reading the specification understand the term to have a sufficiently definite meaning as the name for the structure that performs the function”. MPEP 2181(I)(A). Specifically, the expansion drive device is a structure that translates the distal member, and the expansion drive device is a structure that expands the distal member or proximal member.
Double Patenting
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 12,167,834. Although the claims at issue are not identical, they are not patentably distinct from each other because all elements of Claim 1 of the present child patent application are claimed in Claim 1 of parent U.S. Patent No. 12,167,834, such that this is an anticipation-type non-statutory double patenting rejection.
A comparison of Claim 1 of the present patent application 18/979,525 and Claim 1 of parent U.S. Patent No. 12,167,834 is shown in the chart below:
US Patent Application No. 18/979,525
Parent patent 12,167,834
Claim 1.
Claim 1.
A colon linearizing device installed in an endoscope to linearize a colon by performing translation and expansion motions in the colon, the colon linearizing device comprising:
A colon linearizing device installed in an endoscope to linearize a colon by performing translation and expansion motions in the colon, the colon linearizing device comprising:
a ring-shaped proximal member installed to surround an outer circumferential surface of an insertion tube of an endoscope;
a ring-shaped proximal member installed to surround an outer circumferential surface of an insertion tube of an endoscope;
a fixed end secured to the insertion tube;
a fixed end secured to the insertion tube;
a ring-shaped distal member positioned between the proximal member and the fixed end and movably installed along a longitudinal direction of the insertion tube; and
a ring-shaped distal member positioned between the proximal member and the fixed end and movably installed along a longitudinal direction of the insertion tube;
an elastic member connected between the fixed end and the distal member.
an elastic member connected between the fixed end and the distal member;
a translation drive device to translate the distal member, wherein the translation drive device includes a base and a driving block; and an expansion drive device to expand the distal member or the proximal member by supplying air pressure to the distal member or the proximal member, wherein the expansion drive device includes an air tube, wherein, the translation drive device translates the distal member to approach the proximal member by providing power to the distal member, and when the translation drive device does not provide power to the distal member, the distal member is translated in a direction toward the fixed end by the elastic restoring force of the elastic member.
Examiner further points out that although one or more dependent claims of the present patent application 18/979,525 include features shown in italics in Claim 1 of parent U.S. Patent No. 12,167,834, such dependent claims in the present patent application 18/979,525 are not structured in a manner that combines them in the manner shown in Claim 1 of parent U.S. Patent No. 12,167,834. As such, no statutory double-patenting rejection is issued against the present patent application 18/979,525.
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 present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
The rejection of one or more claims herein are based on the annotated Japanese prior art Hayakawa (JP 2006141935 A – “Hayakawa”). As such, references to this cited prior art refer to the attached line/page number annotated translation thereof.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa (JP 2006141935 A – “Hayakawa”) in view of Hibino (US Patent 5,243,967 – “Hibino”).
With regard to Claim 1, Hayakawa discloses:
A colon linearizing device installed in an endoscope to linearize a colon by performing translation and expansion motions in the colon (Hayakawa page 1, lines 18, “The present invention relates to an automatically moving endoscope insertion machine that facilitates insertion of an endoscope.”), the colon linearizing device comprising:
a ring-shaped proximal member (Hayakawa FIG. 2, rear wall 15) installed to surround an outer circumferential surface of an insertion tube of an endoscope (Hayakawa FIG. 2, inner cylinder 12 within rear wall 15; Hayakawa page 4, lines 24-25, “the endoscope fiber is located inside the inner cylinder 12”);
a fixed end (Hayakawa FIG. 1, front wall 14) secured to the insertion tube (Hayakawa FIG. 1, front wall 14 is secured to inner cylinder 12, which is fixed to the endoscope; Hayakawa page 2, lines 23-24, “fixing the endoscope fiber inside the inner cylinder 12”);
a ring-shaped distal member (Hayakawa FIG. 2, forward balloon 10) positioned between the proximal member and the fixed end and movably installed along a longitudinal direction of the insertion tube (Hayakawa FIG. 2 and FIG. 4, showing forward balloon 10 moving along a longitudinal direction of inner cylinder 12, which holds the insertion tube / endoscope fiber); and
a member connected between the fixed end and the distal member (Hayakawa FIG. 2 and FIG. 4, expansion and contraction mantle 11 between fixed end 14 and distal member forward balloon 10).
Hayakawa does not explicitly describe the member connected between the fixed end and the distal member as being elastic (capable of spontaneously returning to its original shape).
Hibino teaches an elastic member (Hibino FIG. 13, elastic member 109) connecting a fixed end (Hibino FIG. 13, balloon 111 when inflated) and a movable distal member (Hibino FIG. 13, balloon 112 when deflated).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Hibino’s spring 109 for Hayakawa’s mantle 11. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of returning a balloon to its original position (Hibino col. 13 lines 60-63, “pressure fluid is discharged from the anterior balloon 111 and elastic actuators 103 in that order. Then, the anterior mounting member 104 is pressed forward by the elastic member 109.”)
With regard to Claim 2, Hayakawa in view of Hibino teach the features of Claim 1, as described above.
Hibino further teaches wherein the proximal member and the distal member are capable of supporting an inside of the colon in an expanding state (Hibino FIG. 13, showing balloons 111 and 112 supporting the interior of duct 126 that is being examined).
With regard to Claim 3, Hayakawa in view of Hibino teach the features of Claim 1, as described above.
Hibino further teaches wherein the elastic member has an elastic restoring force that increases as the distal member approaches the proximal member (Hibino FIG. 13; Hibino col. 12 lines 48-53, “mounting members 104 and 105 are interposed by an elastic member 109 formed with a compression spring which generates force for pressing the elastic actuators 103 in the direction opposite to their contracting direction”).
With regard to Claim 4, Hayakawa in view of Hibino teach the features of Claim 1, as described above.
Hayakawa further discloses:
wherein the proximal member comprises:
a proximal frame (Hayakawa FIG. 4, rear cavity balloon base 3) having a hollow for receiving the insertion tube (Hayakawa FIG. 1, showing hollow within rear cavity balloon base 3); and
a proximal balloon (Hayakawa FIG. 2, rear balloon 4) disposed with both ends in close contact with an outer circumferential surface of the proximal frame and formed of a flexible material (Hayakawa page 2, lines 10-12, “ When air is fed into the air injection tube 1 with positive pressure, the air pressure in the cavity of the cavity balloon base 3 rises and the rear balloon 4 expands.”).
With regard to Claim 5, Hayakawa in view of Hibino teach the features of Claim 4, as described above.
Hayakawa further discloses:
wherein the proximal frame comprises:
a frame body (Hayakawa FIG. 1, interior surface of rear cavity balloon base 3;
a balloon mount recessed from a side surface of the frame body such that the proximal balloon seated therein (Hayakawa FIG. 1, distal surface of interior of rear cavity balloon base 3); and
an air hole (Hayakawa FIG. 1, air inflow hole 2) formed in the frame body to guide air introduced from an outside into a space between the frame body and the proximal balloon (Hayakawa page 2 lines 3-5, “the air injection tube 1 is embedded in the wall surface of the inner cylinder 12, and the rear cavity balloon base is provided. 3 is provided with an air inflow hole 2”).
With regard to Claim 6, Hayakawa in view of Hibino teach the features of Claim 5, as described above.
Hayakawa further discloses wherein the proximal frame further comprises a wire hole formed through the frame body (Hayakawa FIG. 1, passage through rear cavity balloon base 3 for tube 1).
With regard to Claim 7, Hayakawa in view of Hibino teach the features of Claim 1, as described above.
Hibino further teaches wherein the colon linearizing system further comprises:
a translation drive device (Hibino FIG. 13, elastic actuator 103 connected to balloon 111) to translate the distal member; and
an expansion drive device (Hibino FIG. 14 fluid compressor 122) to expand the distal member or the proximal member by supplying air pressure to the distal member or the proximal member (Hibino page “the tubes 114 linking the elastic actuators 103 and balloons 111 and 112 in the moving unit 101 are connected to a compressor 122 via an electromagnetic switching valve of an advance/withdrawal control unit 121”).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa (JP 2006141935 A – “Hayakawa”) in view of Hibino (US Patent 5,243,967 – “Hibino”) and Aoki et al. (US PGPUB 2016/0249900 – “Aoki”).
With regard to Claim 12, Hayakawa in view of Hibino teach the features of Claim 7, as described above.
Hibino further teaches wherein the expansion drive device comprises:
an air tube to supply air pressure to the distal member or the proximal member (Hibino FIG. 14; Hibino col. 13 lines 28-33, “the tubes 114 linking the elastic actuators 103 and balloons 111 and 112 in the moving unit 101 are connected to a compressor 122 via an electromagnetic switching valve of an advance/withdrawal control unit 121”); and
an air pressure controller (Hibino FIG. 14, control circuit 138 controlling compressor 122) to control the pressure in the air tube according to an input time and pressure conditions.
Hayakawa in view of Hibino does not explicitly teach an air pressure sensor to measure pressure in the air tube.
Aoki teaches an air pressure sensor (Aoki FIG. 1, air pressure sensor 23) to measure pressure in the air tube (Aoki paragraph [0095], “pressure of the air (gas) W inside the elastic tube 1, an air pressure sensor 23 which senses the pressure of the air W”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Aoki’s line pressure sensor with the colon linearizing device taught by Hayakawa in view of Hibino. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a colon linearizing device having a reduced chance of exploding/popping a balloon used thereon.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa (JP 2006141935 A – “Hayakawa”) in view of Hibino (US Patent 5,243,967 – “Hibino”) and Shoney (US Patent 3,865,666 – “Shoney”).
With regard to Claim 13, Hayakawa in view of Hibino teach the features of Claim 1, as described above.
Hayakawa further discloses wherein at least one of the distal member and the proximal member comprises:
a frame (Hayakawa FIG. 4, rear cavity balloon base 3) having a hollow for receiving the insertion tube (Hayakawa FIG. 1, showing hollow within rear cavity balloon base 3); and
a balloon (Hayakawa FIG. 2, rear balloon 4) disposed with both ends in close contact with an outer circumferential surface of the frame and formed of a flexible material (Hayakawa page 2, lines 10-12, “When air is fed into the air injection tube 1 with positive pressure, the air pressure in the cavity of the cavity balloon base 3 rises and the rear balloon 4 expands.”).
installing the balloon on a side surface of the frame and fixing both ends of the balloon to the side surface of the frame (Hayakawa FIG. 2, balloon 4 installed within rear cavity balloon base 3); and
installing an air tube (Hayakawa FIG. 1, injection tube 1) capable of supplying air from an outside to a space between the frame and the balloon (Hayakawa page 2, lines 10-12, “ When air is fed into the air injection tube 1 with positive pressure, the air pressure in the cavity of the cavity balloon base 3 rises and the rear balloon 4 expands.”).
Hayakawa in view of Hibino do not explicitly teach a method of manufacturing the colon linearizing device set forth in claim 1, comprising:
manufacturing a mold corresponding to an outer shape of the balloon;
forming the balloon by injecting silicone in the mold and curing the silicone.
Shoney teaches a method of manufacturing the colon linearizing device set forth in claim 1, comprising:
manufacturing a mold corresponding to an outer shape of the balloon (Shoney FIG. 9, mold 100);
forming the balloon by injecting silicone in the mold and curing the silicone (Shoney col. 9 lines 23-41, “Referring to FIG. 9…An uncured elastomeric material, preferably catalyzed, heat curable silicone rubber, is injected through the feed channel 143 to the annulus 142…Thereafter, the mold 100 is split apart, the catheter shaft and molded balloon are removed and the mandrel 128 is withdrawn from the shaft.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Shoney’s molding process with the manufacturing method of a colon linearizing device as taught by Hayakawa in view of Hibino . A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a colon linearizing device constructed of silicone that is “relatively free of susceptibility to encrustation” (see col. 2, lines 61-64 of Shoney).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa (JP 2006141935 A – “Hayakawa”) in view of Hibino (US Patent 5,243,967 – “Hibino”), Shoney (US Patent 3,865,666 – “Shoney”), and Zimmon (US Patent 5,707,355 – “Zimmon”).
With regard to Claim 14, Hayakawa in view of Hibino and Shoney teach the features of Claim 13, as described above.
Hayakawa in view of Hibino and Shoney do not explicitly teach wherein the balloon is capable of expanding in a direction toward an outside diameter of the frame and incapable of expanding in a direction toward an inside diameter of the frame.
Zimmon teaches wherein the balloon (Zimmon FIG. 1 and FIG. 2, balloon 17) is capable of expanding in a direction toward an outside diameter of the frame (Zimmon FIG. 2, frame 21; Zimmon FIG. 2, showing balloon 17 expanding towards outside diameter of flange 21) and incapable of expanding in a direction toward an inside diameter of the frame (Zimmon FIG. 2, showing balloon 17 mounted over tube 12, and thus incapable of expanding in a direction toward an inside diameter of frame 21).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Zimmon’s flange 21 for Hayakawa’s rear cavity balloon base 3 in the colon linearizing device taught by Hayakawa in view of Hibino and Shoney. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a device with a stabilized balloon (see col. 3 lines 56-67 of Zimmon, “flange 21 functions to stabilize the gastric balloon 17”).
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and the double-patenting rejection of base Claim 1 is overcome.
The following is a statement of reasons for the indication of allowable subject matter for dependent Claim 8: No combination of the identified prior art teaches or suggests wherein the translation drive device translates the distal member to approach the proximal member by providing power to the distal member, and when the translation drive device does not provide power to the distal member, the distal member is translated in a direction toward the fixed end by the elastic restoring force of the elastic member. The closest identified prior art includes Hibino (US Patent 5,243,967 – “Hibino”), which teaches a translation drive device (Hibino FIG. 13, elastic actuator 103 connected to balloon 111 and an elastic member (Hibino FIG. 13, elastic member 109). However, Hibino’s elastic member 109 pushes distal/anterior mounting member 104 and proximal/posterior mounting member 105 apart, rather than towards one another. Furthermore, there is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and the double-patenting rejection of base Claim 1 is overcome.
The following is a statement of reasons for the indication of allowable subject matter for dependent Claim 9: No combination of the identified prior art teaches or suggests wherein the translation drive device comprises a vertically moving block capable of sliding relative to the base and connected to the distal member; and an electromagnet module capable of magnetically coupling the driving block and the vertically moving block. Although Hibino FIG. 13 shows an elastic actuator 103 that separates members 104 and 105, the motion caused by actuator 103 is horizontal, rather than vertical, and does not utilize an electromagnet module. Furthermore, there is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Claims 10-11 are deemed allowable based on their dependent on Claim 9. As such, Claims 10-11 are also objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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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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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
Prosecution Insights