DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS document(s) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is invited to point out any particular references in the submitted IDS documents which they believe may be of particular relevance to the instant claimed invention in response to this Office action.
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 1-20 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 “wherein the partitioning section…generally obstructs flow of a fluid from the second compartment…to the first compartment…in the closed position” and later recites “wherein the fluid contained within the second compartment of the stomach may flow through the fluid passage into the first compartment of the stomach while…in the closed position”. As written, it is unclear how fluid may be both generally obstructed and flow from the second compartment to the first when the band is in the closed position.
Claim 11 recites “flow of fluid” in line 19 and later recites “a fluid” in lines 23-24. It is unclear whether the recitation of “a fluid” is intended to reference the same as that of line 19.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 2, 10, 11, and 19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent No. 4,558,699 (Bashour).
Regarding claim 1, Bashour teaches a method of installing a stomach band (10) onto a stomach of a body (abstract; col. 2, line 45; Figure 1), the method comprising:
providing the stomach band (10) that may be positioned in an open position or in a closed position (col. 4, lines 23-35; Figures 1-3);
inserting the stomach band into the body through an opening (in order to place the apparatus 10 around the stomach, the “band” 10 must first be inserted through an opening in the body, col. 4, lines 23-27; Figure 1);
positioning a first arm (12) of the stomach band on a first side of the stomach, and positioning a second arm (14) of the stomach band on a second side of the stomach while the stomach band is in the open position (Figure 1); and
closing and securing the stomach band into the closed position around the stomach to form a first compartment and a second compartment within the stomach with a partitioning section of the stomach band, and to form a fluid passage within the stomach with a passage-forming section of the stomach band such that, when the stomach band is secured on the stomach in the closed position, the first compartment of the stomach is in fluid communication with the second compartment of the stomach through the fluid passage of the stomach (Figure 1; col. 2, line 64-col. 3, line 8 and lines 26-30);
wherein the partitioning section of the stomach band generally obstructs flow of a fluid from the second compartment of the stomach to the first compartment of the stomach when the stomach band is installed in the closed position around the stomach (col. 3, lines 26-30; Figure 1),
wherein the fluid contained within the second compartment of the stomach may flow through the fluid passage into the first compartment of the stomach while the stomach band is installed in the closed position around the stomach (col. 3, lines 6-9 and lines 26-30; Figure 1), and
wherein the stomach band includes:
the partitioning section comprising the first arm (12) and the second arm (14); and
the passage-forming section comprising a first curved member (26) positioned adjacent an end of the first arm, and a second curved member (26) positioned adjacent an end of the second arm,
wherein, when the stomach band is secured to the stomach in the closed position, the first arm of the partitioning section is separated from the second arm of the partitioning section by a first distance,
wherein, when the stomach band is secured to the stomach in the closed position, an apex of a curve of the first curved member and an apex of a curve of the second curved member are separated by a second distance, and
wherein the second distance is greater than the first distance (Figures 1-3; see annotated Figure 2 below).
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Regarding claim 2, Bashour teaches closing and securing the stomach band into the closed position around the stomach includes coupling a second end of the first arm (12) and a second end of the second arm (14) (col. 4, lines 33-40; see Figures 1-2).
Regarding claim 10, Bashour teaches the first curved member is coupled to the second curved member (the “curved members” 26 are indirectly coupled via intervening components, see annotated Figure 2 above).
Regarding claim 11, Bashour teaches a method of partially partitioning a stomach of a body (abstract; col. 2, line 45; Figure 1), the method comprising:
providing a stomach band (10) that may be provided in an open position and in a closed position (col. 4, lines 23-35; Figures 1-3);
inserting the stomach band into the body through an opening (in order to place the apparatus 10 around the stomach, the “band” 10 must first be inserted through an opening in the body, col. 4, lines 23-27; Figure 1);
positioning a partitioning section of the stomach band on the stomach (col. 3, lines 26-30; col. 4, lines 23-35; Figures 1-2); and
closing and securing the stomach band in the closed position around the stomach to partition a portion of the stomach with the partitioning section of the stomach band (col. 4, lines 33-40),
wherein, when the stomach band is secured on the stomach in the closed position, the stomach is not fully partitioned (Figure 1);
wherein the stomach band when in the closed position includes:
a first arm (12) having a first end and a second end;
a second arm (14) having a first end and a second end; and
a bight having a hinge positionable between the open position and the closed position, the bight positioned adjacent the second end of the first arm and the second end of the second arm (“flexible hinge”, col. 2, lines 45-52; Figures 1-3),
wherein at least a portion of the first arm (12) and at least a portion of the second arm (14) comprise the partitioning section of the stomach band when the stomach band is secured in the closed position around the stomach (col. 3, lines 13-16 and lines 26-30; Figures 1-3),
wherein the partitioning section generally obstructs flow of fluid contained within the partitioned portion of the stomach when the stomach band is installed in the closed position around the stomach (col. 3, lines 26-30; Figure 1), and
wherein at least a portion of the bight comprises a passage-forming section (26), and the passage-forming section defines a fluid passage through which a fluid contained within the stomach may flow when the stomach band is installed in the closed position around the stomach (col. 2, line 64-col. 3, line 8; Figures 1-2).
Regarding claim 19, Bashour teaches a coupling configured to couple the first end of the first arm and the first end of the second arm (col. 4, lines 33-40; see Figures 1-2).
Claims 1, 2, 4, 5, 10, 11, 15, 16, 19, and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent No. 4,803,985 (Hill).
Regarding claim 1, Hill teaches a method of installing a stomach band (10) onto a stomach of a body (abstract; Figure 1), the method comprising:
providing the stomach band (14) that may be positioned in an open position or in a closed position (Figures 1-2);
inserting the stomach band into the body through an opening (in order to place the clamp 14 around the stomach, the “band” 14 must first be inserted through an opening in the body; Figure 1);
positioning a first arm (16) of the stomach band on a first side of the stomach, and positioning a second arm (18) of the stomach band on a second side of the stomach while the stomach band is in the open position (col. 3, lines 44-54; see annotated Figure 2 below); and
closing and securing the stomach band into the closed position around the stomach to form a first compartment and a second compartment within the stomach with a partitioning section of the stomach band, and to form a fluid passage within the stomach with a passage-forming section of the stomach band such that, when the stomach band is secured on the stomach in the closed position, the first compartment of the stomach is in fluid communication with the second compartment of the stomach through the fluid passage of the stomach (col. 3, lines 44-67; Figures 1-2);
wherein the partitioning section of the stomach band generally obstructs flow of a fluid from the second compartment of the stomach to the first compartment of the stomach when the stomach band is installed in the closed position around the stomach (col. 3, lines 57-61),
wherein the fluid contained within the second compartment of the stomach may flow through the fluid passage into the first compartment of the stomach while the stomach band is installed in the closed position around the stomach (col. 3, lines 61-67; Figures 1-2), and
wherein the stomach band includes:
the partitioning section comprising the first arm (16) and the second arm (18); and
the passage-forming section comprising a first curved member (26) positioned adjacent an end of the first arm, and a second curved member (28) positioned adjacent an end of the second arm (col. 3, lines 61-67; Figure 2),
wherein, when the stomach band is secured to the stomach in the closed position, the first arm of the partitioning section is separated from the second arm of the partitioning section by a first distance,
wherein, when the stomach band is secured to the stomach in the closed position, an apex of a curve of the first curved member and an apex of a curve of the second curved member are separated by a second distance, and
wherein the second distance is greater than the first distance (see annotated Figure 2 below).
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Regarding claim 2, Hill teaches closing and securing the stomach band into the closed position around the stomach includes coupling a second end of the first arm (16) and a second end of the second arm (18) (col. 3, lines 54-57; Figure 2).
Regarding claims 4 and 5, Hill teaches the stomach band (14) includes a silicone padding material (34) on at least a portion of the first arm (16) (silicone rubber balloon 34, col. 3, line 64-col. 4, line 18; Figure 3).
Regarding claim 10, Hill teaches the first curved member (26) is coupled to the second curved member (28) (“curved members” 26 and 28 are indirectly coupled via intervening structures, see Figure 2).
Regarding claim 11, Hill teaches a method of partially partitioning a stomach of a body (abstract; Figure 1), the method comprising:
providing a stomach band (14) that may be provided in an open position and in a closed position (Figures 1-2);
inserting the stomach band into the body through an opening (in order to place the clamp 14 around the stomach, the “band” 14 must first be inserted through an opening in the body; Figure 1);
positioning a partitioning section of the stomach band on the stomach (col. 3, lines 44-54); and
closing and securing the stomach band in the closed position around the stomach to partition a portion of the stomach with the partitioning section of the stomach band (col. 3, lines 54-61; Figure 1),
wherein, when the stomach band is secured on the stomach in the closed position, the stomach is not fully partitioned (Figure 1);
wherein the stomach band when in the closed position includes:
a first arm (16) having a first end and a second end;
a second arm (18) having a first end and a second end; and
a bight (20) having a hinge positionable between the open position and the closed position, the bight positioned adjacent the second end of the first arm and the second end of the second arm (col. 3, lines 50-54; Figure 2),
wherein at least a portion of the first arm (16) and at least a portion of the second arm (18) comprise the partitioning section of the stomach band when the stomach band is secured in the closed position around the stomach (col. 3, lines 44-61; Figures 1-2),
wherein the partitioning section generally obstructs flow of fluid contained within the partitioned portion of the stomach when the stomach band is installed in the closed position around the stomach (col. 3, lines 44-67), and
wherein at least a portion of the bight comprises a passage-forming section, and the passage-forming section defines a fluid passage through which a fluid contained within the stomach may flow when the stomach band is installed in the closed position around the stomach (col. 3, lines 61-67; Figures 1-2).
Regarding claims 15 and 16, Hill teaches the stomach band (14) includes a silicone padding material (34) on at least a portion of the first arm (16) (silicone rubber balloon 34, col. 3, line 64-col. 4, line 18; Figure 3).
Regarding claim 19, Hill teaches the stomach band further comprises a coupling configured to couple the first end of the first arm (16) and the first end of the second arm (18) (col. 3, lines 54-57; Figure 2).
Regarding claim 20, Hill teaches the stomach is not fully occluded at an antrum portion of the stomach when the stomach band is secured in the closed position around the stomach (since the band is shown as positioned on an upper region of the stomach away from the antrum, the antrum is “not fully occluded”, see Figure 2).
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 3 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,558,699 (Bashour).
Regarding claim 3, Bashour teaches all the limitations of claim 1. Bashour does not teach the fluid passage is formed at or adjacent an antrum portion of the stomach.
However, Bashour teaches “[p]referably the apparatus…is positioned relatively close to the upper end of the stomach…[i]t will be understood, however, that the precise positioning of the apparatus… is not critical to the practice of the invention” (col. 4, lines 28-32). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the placement of the stomach band such that the fluid passage is formed at or adjacent an antrum portion of the stomach in light of the teaching of Bashour in order to meet the treatment needs of the individual patient, as Bashour has noted “the precise positioning of the apparatus…is not critical to the practice of the invention” (col. 4, lines 28-32).
Regarding claim 14, Bashour teaches all the limitations of claim 11. Bashour does not teach the stomach band is positioned on the stomach in a substantially vertical position.
However, Bashour teaches “[p]referably the apparatus…is positioned relatively close to the upper end of the stomach…[i]t will be understood, however, that the precise positioning of the apparatus… is not critical to the practice of the invention” (col. 4, lines 28-32). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the placement of the stomach band such to be placed in a substantially vertical position in light of the teaching of Bashour in order to meet the treatment needs of the individual patient, as Bashour has noted “the precise positioning of the apparatus…is not critical to the practice of the invention” (col. 4, lines 28-32).
Claims 6 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,558,699 (Bashour) in view of U.S. Patent No. 4,458,681 (Hopkins).
Regarding claims 6 and 18, Bashour teaches all the limitations of claim 1. Bashour does not specify at least a portion of each of the first and second arms are curved to conform the first and second arms to a lesser curvature of the stomach.
However, Hopkins teaches a method of installing a stomach band onto a stomach of a body (abstract; Figures 2 and 8), comprising: first and second arms that are curved to conform the first and second arms to a lesser curvature of the stomach (“longitudinally curved”, col. 2, lines 39-44; Figure 4). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first and second arms of Bashour such that they are curved to conform the first and second arms to a lesser curvature of the stomach as taught by Hopkins, because Hopkins teaches curving the arms in such a manner makes the band “easier to apply” (col. 2, lines 42-44).
Claims 6 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,803,985 (Hill) in view of U.S. Patent No. 4,458,681 (Hopkins).
Regarding claims 6 and 18, Hill teaches all the limitations of claim 1. Hill does not specify at least a portion of each of the first and second arms are curved to conform the first and second arms to a lesser curvature of the stomach.
However, Hopkins teaches a method of installing a stomach band onto a stomach of a body (abstract; Figures 2 and 8), comprising: first and second arms that are curved to conform the first and second arms to a lesser curvature of the stomach (“longitudinally curved”, col. 2, lines 39-44; Figure 4). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first and second arms of Hill such that they are curved to conform the first and second arms to a lesser curvature of the stomach as taught by Hopkins, because Hopkins teaches curving the arms in such a manner makes the band “easier to apply” (col. 2, lines 42-44).
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,558,699 (Bashour) in view of U.S. Patent Application Publication No. 2005/0250980 (Swanstrom et al.).
Regarding claim 8, Bashour teaches all the limitations of claim 1. Bashour does not specify the stomach band is inserted via transgastric surgery, transvaginal surgery, transrectal surgery, and transcolonic surgery.
However, Swanstrom teaches a method of installing stomach restriction implant(s) (abstract), comprising: inserting the stomach restriction implant(s) transgastrically ([0032]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Bashour such that the stomach band is inserted via transgastric surgery as taught by Swanstrom, “in order to minimize invasiveness” (Swanstrom: [0032]).
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,803,985 (Hill) in view of U.S. Patent Application Publication No. 2005/0250980 (Swanstrom et al.).
Regarding claim 8, Hill teaches all the limitations of claim 1. Hill does not specify the stomach band is inserted via transgastric surgery, transvaginal surgery, transrectal surgery, and transcolonic surgery.
However, Swanstrom teaches a method of installing stomach restriction implant(s) (abstract), comprising: inserting the stomach restriction implant(s) transgastrically ([0032]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Hill such that the stomach band is inserted via transgastric surgery as taught by Swanstrom, “in order to minimize invasiveness” (Swanstrom: [0032]).
Claims 9 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,558,699 (Bashour) in view of U.S. Patent Application Publication No. 2005/0261712 (Balbierz et al.).
Regarding claims 9 and 13, Bashour teaches all the limitations of claims 1 and 11. Bashour does not teach the inserting the stomach band into the body through an opening includes placing an assistant trochar into an abdominal cavity of the body.
However, Balbierz teaches a method of installing a stomach band (12) (abstract; Figure 3), wherein the stomach band is inserted into the body through an opening by placing an assistant trochar into an abdominal cavity of the body ([0038]). It would have been obvious to one of ordinary skill in the art at the time of the invention to insert the stomach band of Bashour through an assistant trochar inserted into an opening in the abdominal cavity as taught by Balbierz in order to enable a less invasive surgical approach, wherein Balbierz recognizes either a laparoscopic or open surgical method ([0038]).
Claims 9 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,803,985 (Hill) in view of U.S. Patent Application Publication No. 2005/0261712 (Balbierz et al.).
Regarding claims 9 and 13, Hill teaches all the limitations of claims 1 and 11. Hill does not teach the inserting the stomach band into the body through an opening includes placing an assistant trochar into an abdominal cavity of the body.
However, Balbierz teaches a method of installing a stomach band (12) (abstract; Figure 3), wherein the stomach band is inserted into the body through an opening by placing an assistant trochar into an abdominal cavity of the body ([0038]). It would have been obvious to one of ordinary skill in the art at the time of the invention to insert the stomach band of Hill through an assistant trochar inserted into an opening in the abdominal cavity as taught by Balbierz in order to enable a less invasive surgical approach, wherein Balbierz recognizes either a laparoscopic or open surgical method ([0038]).
Claim 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,558,699 (Bashour) in view of U.S. Patent Application Publication No. 2007/0032807 (Ortiz et al.).
Regarding claim 17, Bashour teaches all the limitations of claim 11. Bashour does not expressly specify the hinge is biased such that the first arm is resiliently biased toward the second arm.
However, Ortiz teaches a method of installing a stomach band (810) (abstract), wherein the stomach band includes first and second arms (816, 818) joined at one end by a resiliently biased hinge (814) ([0054]-[0055]; Figures 25-26). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the bight hinge of Bashour such that it is resiliently biased as taught by Ortiz in order to assist in compression of the stomach walls to produce the partition.
Claim 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,803,985 (Hill) in view of U.S. Patent Application Publication No. 2007/0032807 (Ortiz et al.).
Regarding claim 17, Hill teaches all the limitations of claim 11. Hill does not expressly specify the hinge is biased such that the first arm is resiliently biased toward the second arm.
However, Ortiz teaches a method of installing a stomach band (810) (abstract), wherein the stomach band includes first and second arms (816, 818) joined at one end by a resiliently biased hinge (814) ([0054]-[0055]; Figures 25-26). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the bight hinge of Hill such that it is resiliently biased as taught by Ortiz in order to assist in compression of the stomach walls to produce the partition.
Conclusion
The examiner notes that, though no art has been applied against claims 7 and 12 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous clarity issues noted above.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2004/0147942 (Chao) teaches a gastric clip for partitioning the stomach (abstract)
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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