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 .
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 recites ….wherein the first and third flexible elements are moveable together. Claim 15 recites movement of the second flexible element and claim 19 recites movement of the third flexible element. Therefore, the examiner thinks the applicant intended to state that the second and third flexible elements are moveable together in claim 20. Claim 20 will be examiner as best understood by the examiner. Appropriate correction is required.
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.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,344,285. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-20 of the current application and the invention of claims 1-19 of the patent lies in the fact that the invention of claims 1-19 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-19 is in effect a "species" of the "generic" invention of claims 1-20 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 1-20 are anticipated by claims 1-19, claims 1-20 are not patentably distinct from claims 1-19.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,089,830. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-20 of the current application and the invention of claims 1-14 of the patent lies in the fact that the invention of claims 1-14 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-14 is in effect a "species" of the "generic" invention of claims 1-20 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 1-20 are anticipated by claims 1-14, claims 1-20 are not patentably distinct from claims 1-14.
Claim Rejections - 35 USC § 112
Claims 2-6, 10, 11, 13, 14, and 16-18 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 13 recites the limitation "the first working instrument" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the second working instrument" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the first working instrument" in line 1. There is insufficient antecedent basis for this limitation in the claim.
There is an inconsistency in the body of 2 making the scope of the claim unclear. Claim 2 lines 1-2 recites …the outer member comprising a second lumen to receive a first working instrument …., indicating that the claim is directed to a subcombination, i.e. the system with an outer member including a second lumen. However, claim 2 lines 2-3 the applicant positively recites the first working instrument … the first working instrument extending through the second lumen, the first working instrument having a distal end movable within the altered space within the body lumen, indicating that the claim is directed to a combination, i.e. the system with an outer member including a second lumen and a first working instrument. Therefore, the claim is unclear regarding the applicant’s intent to claim the subcombination or combination. The applicant is hereby required to indicate to which invention the claims are direct towards, the combination or the subcombination, and amend the claims such that the language is consistent with this intent. For examination purposes claims 2-5 will be considered as being drawn to the combination.
There is an inconsistency in the body of 10 making the scope of the claim unclear. Claim 10 lines 1-2 recites …the outer member comprising a second lumen to receive a first working instrument …., indicating that the claim is directed to a subcombination, i.e. the system with an outer member including a second lumen. However, claim 10 lines 2-3 the applicant positively recites the first working instrument … the first working instrument extending through the second lumen, the first working instrument having a distal end movable within the altered space within the body lumen, indicating that the claim is directed to a combination, i.e. the system with an outer member including a second lumen and a first working instrument. Therefore, the claim is unclear regarding the applicant’s intent to claim the subcombination or combination. The applicant is hereby required to indicate to which invention the claims are direct towards, the combination or the subcombination, and amend the claims such that the language is consistent with this intent. For examination purposes claims 10-11 will be considered as being drawn to the combination.
There is an inconsistency in the body of 16 making the scope of the claim unclear. Claim 16 lines 1-2 recites …the outer member comprising a second lumen to receive a first working instrument …., indicating that the claim is directed to a subcombination, i.e. the system with an outer member including a second lumen. However, claim 16 lines 2-3 the applicant positively recites the first working instrument … the first working instrument extending through the second lumen, the first working instrument having a distal end movable within the altered space within the body lumen, indicating that the claim is directed to a combination, i.e. the system with an outer member including a second lumen and a first working instrument. Therefore, the claim is unclear regarding the applicant’s intent to claim the subcombination or combination. The applicant is hereby required to indicate to which invention the claims are direct towards, the combination or the subcombination, and amend the claims such that the language is consistent with this intent. For examination purposes claims 16-17 will be considered as being drawn to the combination.
Claim Rejections - 35 USC § 103
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.
Claims 1, 7-9, 15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (U.S. Publication 2012/0109178) in view of Hines (U.S. Patent 3,517,128).
Regarding claims 1, 7, and 8:
Edwards discloses a device (for example see Figure 8A) comprising:
(claim 1) an outer member (18) including
(claim 1) a first lumen configured to receive an endoscope (lumens 32 are capable of receiving optical wires as discussed in page 3 paragraph 48 and optical wires are known to be used as endoscopes such as the disclosed in U.S. Patent 4,718,406)
(claim 1) a first flexible element (a first upper element 24)
(claim 1) a second flexible element (a second upper element 24)
(claim 1) wherein the second flexible element is capable of moving laterally outward to atraumatically contact a side wall of a body lumen to alter a space within the body lumen (the flexible element moves laterally along a radius from a central longitudinal axis to create an expanded structure)
(claim 5) wherein the second flexible element is capable of expanding along one side of the longitudinal axis to form an asymmetric shape of an altered space within a body lumen (the flexible elements are disclosed as being capable of expanding independently and is therefore capable of performing this function; for example see page 3 paragraph 51)
(claim 8) wherein a distal portion of the first and second flexible elements are attached to a distal nexus and a proximal nexus, wherein the proximal nexus is distal to a distal end of the outer member (for example see paragraph 50)
(claim 7) a transverse bridge (46) connected to the second flexible element
Edwards fails to disclose the device further comprising an actuator. Edwards discloses the device comprising a plurality of flexible elements (24) capable of being moved together or independently by means such as material properties, i.e. shape memory material; see page 3 paragraph 51, in order to control the expansion and retraction of the flexible elements. Hines teaches a device comprising an outer member (42) and a plurality of flexible elements (18), wherein the device further comprises an actuator (16, 17, 42, etc.) positioned at a proximal region of the outer member and operable to effect movement of the plurality of flexible elements in order to control the expansion and retraction of the flexible elements. Because both the device of Edwards and the device of Hines disclose devices including an outer member, a plurality of flexible elements, and a means for controlling the expansion and retraction of the flexible elements, i.e. material properties and an actuator, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one means of controlling the expansion and retraction of the flexible elements with the other in order to achieve the predictable results of controlling the expansion and retraction of the flexible elements.
Regarding claim 9:
Edwards discloses a device (for example see Figure 8A) comprising:
(claim 9) an outer member (18) including
(claim 9) a first lumen (a first element 32)
(claim 9) a first flexible element (a first upper element 24)
(claim 9) a second flexible element (a second upper element 24)
(claim 9) wherein the second flexible element is capable of moving laterally outward to atraumatically contact a side wall of a body lumen to alter a space within the body lumen (the flexible element moves laterally along a radius from a central longitudinal axis to create an expanded structure)
(claim 9) wherein the first flexible element and the second flexible element extend longitudinally from a distal nexus to a proximal nexus (for example see paragraph 50)
Edwards fails to disclose the device further comprising an actuator. Edwards discloses the device comprising a plurality of flexible elements (24) capable of being moved together or independently by means such as material properties, i.e. shape memory material; see page 3 paragraph 51, in order to control the expansion and retraction of the flexible elements. Hines teaches a device comprising an outer member (42) and a plurality of flexible elements (18), wherein the device further comprises an actuator (16, 17, 42, etc.) positioned at a proximal region of the outer member and operable to effect movement of the plurality of flexible elements in order to control the expansion and retraction of the flexible elements. Because both the device of Edwards and the device of Hines disclose devices including an outer member, a plurality of flexible elements, and a means for controlling the expansion and retraction of the flexible elements, i.e. material properties and an actuator, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one means of controlling the expansion and retraction of the flexible elements with the other in order to achieve the predictable results of controlling the expansion and retraction of the flexible elements.
Regarding claims 15, 19, and 20:
Edwards discloses a device (for example see Figure 8A) comprising:
(claim 15) an outer member (18) including
(claim 15) a first lumen (a first element 32)
(claim 15) wherein the outer member is capable of being placed over an endoscope such that the endoscope extends through the first lumen (lumens 32 are capable of receiving optical wires as discussed in page 3 paragraph 48 and optical wires are known to be used as endoscopes such as the disclosed in U.S. Patent 4,718,406)
(claim 15) a first flexible element (a first upper element 24)
(claim 15) a second flexible element (a second upper element 24)
(claim 15) wherein the second flexible element is capable of moving laterally outward to atraumatically contact a side wall of a body lumen to alter a space within the body lumen (the flexible element moves laterally along a radius from a central longitudinal axis to create an expanded structure)
(claim 15) wherein the first flexible element and the second flexible element extend longitudinally from a distal nexus to a proximal nexus (for example see paragraph 50)
(claim 19) a third flexible element (third lower element 24)
(claim 19) wherein the third flexible element is capable of moving laterally outward to atraumatically contact a side wall of a body lumen to alter a space within the body lumen (the flexible element moves laterally along a radius from a central longitudinal axis to create an expanded structure)
(claim 19) wherein the third flexible element extend longitudinally from a distal nexus to a proximal nexus (for example see paragraph 50)
(claim 20) wherein the second flexible element and the third flexible element are movable together (page 3 paragraph 51)
Edwards fails to disclose the device further comprising an actuator. Edwards discloses the device comprising a plurality of flexible elements (24) capable of being moved together or independently by means such as material properties, i.e. shape memory material; see page 3 paragraph 51, in order to control the expansion and retraction of the flexible elements. Hines teaches a device comprising an outer member (42) and a plurality of flexible elements (18), wherein the device further comprises an actuator (16, 17, 42, etc.) positioned at a proximal region of the outer member and operable to effect movement of the plurality of flexible elements in order to control the expansion and retraction of the flexible elements. Because both the device of Edwards and the device of Hines disclose devices including an outer member, a plurality of flexible elements, and a means for controlling the expansion and retraction of the flexible elements, i.e. material properties and an actuator, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one means of controlling the expansion and retraction of the flexible elements with the other in order to achieve the predictable results of controlling the expansion and retraction of the flexible elements.
Claims 2-6, 10-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (U.S. Publication 2012/0109178) in view of Hines (U.S. Patent 3,517,128) further in view of Yoon (U.S. Patent 5,954,731).
The device of Edwards as modified by Hines discloses a device wherein the outer member includes a plurality of passages (32) configured to receive elements such as tools and optical wires (page 3 paragraph 48).
The device of Edwards as modified by Hines discloses the invention as claimed except for the outer member comprising a floating second lumen and a third lumen. Yoon teaches a device (for example see Figure 1) comprising an outer member (30) including a plurality of passages (for example 22a and 22b) configured to receive tools, wherein outer member further includes a floating second lumen (126a; elements 126a is configured to slide along the passage 22a and is therefore being interpreted as floating since it is not attached to the passage) that receives a first working instrument (18a) having a distal end movable to an angled position within an altered space of a body lumen and a third lumen (126b) that receives a second working instrument (18b) having a distal end movable to an angled position within an altered space of a body lumen (for example see Figures 7A-7C) in order to perform a procedure at a surgical site.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references 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