DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Invention I and Species F in the reply filed on February 24th, 2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 24th, 2026.
Claim Objections
Claims 2-20 and 12-14 are objected to because of the following informalities: The claims are dependent from non-existent claims, i.e. claim 2 depends from claim 34. Appropriate correction is required. The claims will be rejected as best understood.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the multi-lumen endoscope receiving member" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
Claims 1-4 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 10 of U.S. Patent No. 12,070,197. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-4 and 10 of the current application and the invention of claims 1-4 and 10 of the patent lies in the fact that the invention of claims 1-4 and 10 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-4 and 10 of the patent is in effect a "species" of the "generic" invention of claims 1-4 and 10 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-4 and 10 of the current application are anticipated by claims 1-4 and 10 of the patent, claims 1-4 and 10 are not patentably distinct from claims 1-4 and 10.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,537,238. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-14 of the current application and the invention of claims 1-13 of the patent lies in the fact that the invention of claims 1-13 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-13 of the patent is in effect a "species" of the "generic" invention of claims 1-14 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-14 of the current application are anticipated by claims 1-13 of the patent, claims 1-14 are not patentably distinct from claims 1-13.
Claim Rejections - 35 USC § 103
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 1-3 and 10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards (U.S. Patent 6,405,732) in view of Schaer (U.S. Publication 2004/0082859) and in view of Yamaya (U.S. Patent 7,959,559) and in view of Bregman (U.S. Patent 4,718,406).
Edwards discloses a device (for example see Figure 17) comprising:
(claim 1) an endoscope receiving member (18) including
(claim 1) a first lumen (a first element 36) configured to receive an endoscope (for example one lumens 36 are configured to receive an optic endoscope such as disclosed in U.S. Patent 4,718,406)
(claims 4 and 5) a second lumen (a second element 36)
(claim 5) a third lumen (a third element 36)
(claim 8) wherein the second and third lumens are radially spaced from a central longitudinal axis of the endoscope receiving member
(claim 9) wherein the second and third lumens terminate at distal openings at the end of the endoscope receiving member
(claim 1) a first strip (a first element 44) and a second strip (a second element 44)
(claim 10) wherein the first and second strips are capable of bending to contact a wall of a body lumen
(claim 3) a handle (for example see Figure 10) at a proximal portion of the device
(claim 3) wherein the handle is actuatable to move the first and second strips
(claim 2) wherein the device is configured to access tissue along a wall of a body lumen
Edwards fails to disclose the device further comprising a proximal balloon and a distal balloon, the distal ballon being inflatable beyond a distal end of the endoscope receiving member, and an endoscope disposed within the first lumen.
Regarding the device further comprising a proximal balloon and a distal balloon, Schaer teaches an endoscopic device (for example see Figure 33) including first and second strips (302), wherein the device further comprises a proximal balloon (260a) and a distal balloon (260b) inflatable along a distal portion of the device such that the first and second strips are between the balloons forming a chamber between the balloons in order to dilate a body lumen to a desired level (for example see paragraph 164). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the device of Edwards further comprising a proximal balloon and a distal balloon such that the first and second strips are between the balloons in view of Schaer in order to dilate a body lumen to a desired level. The device of Edwards as modified by Schaer discloses a device wherein the chamber comprises an expanded portion of the proximal and distal balloons when inflated (claim 2).
Regarding the distal balloon being inflatable beyond a distal end of the endoscopic receiving member, Yamaya teaches a device comprising an endoscopic device including a proximal balloon (7) and a distal balloon (6; for example see Figures 4-10), wherein the distal balloon is inflatable beyond the distal end of the device in order to assist in deep insertion of the device into a body lumen. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the device of Edwards further modified by Schaer wherein the distal balloon is capable of being inflatable beyond a distal end of the endoscopic receiving member in view of Yamaya in order to assist in deep insertion of the device into a body lumen.
Regarding the device further comprising an endoscope slidably disposed within the first lumen, Bregman teaches a device comprising an endoscope receiving member (13) including a first lumen, wherein the device further includes an endoscope (14) slidably disposed within the first lumen such that a distal tip of the endoscope is configured to extend into a chamber, i.e. a space beyond the distal end of the endoscope receiving member in order to view the space/chamber beyond the distal end of the receiving member.
Claims 4-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards (U.S. Patent 6,405,732) in view of Schaer (U.S. Publication 2004/0082859) further in view of Yamaya (U.S. Patent 7,959,559) further in view of Bregman (U.S. Patent 4,718,406) further in view of Yoon (U.S. Patent 5,954,731).
The device of Edwards as modified by Schaer as further modified by Yamaya as further modified by Bregman discloses the invention as claimed except the device further comprising a first instrument slidably disposed in the second lumen (claims 4 and 5) and a second instrument slidably disposed in the third lumen (claim 5). Yoon teaches a device comprising an endoscope receiving member (16) including a first lumen (22e) that receives an endoscope (26), a second lumen (18a), and a third lumen (18b), wherein the device further comprises a first independently movable instrument (18a, 130a, 132a, etc.) slidably disposed within the second lumen and a second independently movable instrument (18b, 130b, 132b, etc.) slidably disposed within the third lumen such that the instruments are configured to bend when extends beyond the distal end of the endoscope receiving member into a chamber, i.e. a space beyond the distal end of the endoscope receiving member (for example see Figures 7A-7C), to change a position of the instruments within the chamber in order to perform a surgical procedure within the chamber, i.e. the space beyond the distal end of the endoscope receiving member). It would have been obvious to one having ordinary skill in the art at the time invention was made to provide the device of Edwards as modified by Schaer as further modified by Yamaya as further modified by Bregman wherein the device further includes a first instrument and a second instrument in view of Yoon in order to perform a surgical procedure within the chamber.
Claims 11-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards (U.S. Patent 6,405,732) in view of Schaer (U.S. Publication 2004/0082859) and in view of Yamaya (U.S. Patent 7,959,559).
Edwards discloses a device (for example see Figure 17) comprising:
(claim 11) an endoscope receiving member (18) including
(claim 11) a first lumen (a first element 36) configured to receive an endoscope (for example one lumens 36 are configured to receive an optic endoscope such as disclosed in U.S. Patent 4,718,406)
(claim 14) a second lumen (a second lumen 36) capable of receiving an instrument
(claim 11) a plurality of elongated members (44)
(claim 13) wherein the elongate members are laterally movable to change at least one of a size and shape of a body lumen
(claim 11) a handle (for example see Figure 10) for moving the plurality of elongate members
Edwards fails to disclose the device further comprising a proximal balloon disposed along a portion of the endoscope receiving member, a distal balloon position distal the proximal balloon, wherein the balloons form a chamber and wherein a portion of the chamber extends beyond a distal end of the endoscope receiving member.
Regarding the device further comprising a proximal balloon and a distal balloon, Schaer teaches an endoscopic device (for example see Figure 33) including a plurality of elongated members (302), wherein the device further comprises a proximal balloon (260a) and a distal balloon (260b) inflatable along a distal portion of the device such that the first and second strips are between the balloons forming a chamber between the balloons in order to dilate a body lumen to a desired level (for example see paragraph 164). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the device of Edwards further comprising a proximal balloon and a distal balloon such that the first and second strips are between the balloons in view of Schaer in order to dilate a body lumen to a desired level. The device of Edwards as modified by Schaer discloses a device wherein at least one of a size and a shape of the chamber is adjustable within a body lumen (claim 12).
Regarding a portion of the chamber extending beyond a distal end of the endoscopic receiving member, Yamaya teaches a device comprising an endoscopic device including a proximal balloon (7) and a distal balloon (6; for example see Figures 4-10) defining a chamber between the balloons, wherein the distal balloon is inflatable beyond the distal end of the endoscope receiving member such that a portion of the chamber is beyond the distal end of the endoscope receiving member in order to assist in deep insertion of the device into a body lumen. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the device of Edwards further modified by Schaer wherein the distal balloon is capable of being inflatable beyond a distal end of the endoscopic receiving member such that a portion of the chamber is beyond a distal end of the endoscope receiving member in view of Yamaya in order to assist in deep insertion of the device into a body lumen.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references that the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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