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 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 1-20 rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without the step of the pylorus-sparing antral myotomy medical procedure, which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The specification omits mentioning pylorus-sparing antral myotomy all together. It is unclear if the applicant equates pylorus-sparing antral myotomy with pylorus-sparing gastric myotomy.
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.
Regarding Claims 1, 11, & 20, the claim language “pylorus-sparing antral myotomy” is indefinite because the steps of this procedure are not explicitly claimed. Examiner recommends putting the steps for the procedure in the independent claim.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 5-7, 9, 11, 14-16, & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0182365 hereinafter Harris in view of US 2009/0018603 hereinafter Mitelberg in view of US 2010/0174295 hereinafter Kassab.
In regard to Claim 1: Harris teaches of a method of augmenting weight loss in a mammalian patient (Harris, Paragraph 77; “In morbidly obese patients, a functional volume reduction of 50% or more may be achieved in order to promote the desired excessive weight loss”), but does not teach creating a submucosal tunnel in a gastric antrum and/or gastric body of a patient, wherein the submucosal tunnel extends from a proximal gastric antrum or gastric body of the patient to a pre-pyloric area of the patient; performing a pylorus-sparing antral myotomy in the submucosal tunnel, wherein the pylorus-sparing antral myotomy extends from the pre-pyloric area to just distal of an opening of the submucosal tunnel.
Mitelberg pertains to a method of gastric surgery and teaches creating a submucosal tunnel in a gastric antrum and/or gastric body of a patient, and performing a pylorus-sparing antral myotomy (Mitelberg, Paragraph 87; Figure 24A item 230; “FIG. 24A illustrates a perspective view of region 220 in the digestive tract having a submucosal tunnel 230 formed by submucosal tunneling instrument 120”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the creation of a submucosal tunnel and performing a pylorus-sparing antral myotomy in the submucosal tunnel taught in Mitelberg to the method for reducing gastric volume taught in Harris, the motivation being to provide suitable access to the muscular wall or the placement of an implant device (Mitelberg, Paragraph 87).
Kassab pertains to methods for organ restriction with respect to restricting gastric capacity while avoiding nutritional deficiencies and other complications, and teaches performing surgical intervention on a stomach comprising creating the intervention extending from a proximal gastric antrum or gastric body of the patient to a pre-pyloric area of the patient (Kassab, Paragraph 21; “the gastric restriction device can be applied to the stomach in an axial or longitudinal fashion such that a gastric sleeve is formed extending from the gastro-esophageal junction to the pre-pyloric area without interfering with the pyloric sphincter”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the submucosal tunnel in the method of Harris as modified such that the submucosal tunnel extends from a proximal gastric antrum or gastric body to a pre-pyloric area of the patient as taught by Kassab, the motivation being to allow for sufficient reduction in the stomach.
A modified Harris teaches performing the pylorus-sparing antral myotomy extends from the pre-pyloric area to just distal of an opening of the submucosal tunnel (A modified Harris teaches performing a procedure for reducing the volume of the stomach by entering a submucosal tunnel).
In regard to Claim 2: A modified Harris teaches of the method as described in claim 1 further comprising performing a running suture along a greater curvature and posterior wall of a stomach of the patient (Harris, Figure 2D; Paragraph 82; Examiner interprets the sutures to be running sutures).
In regard to Claim 5: A modified Harris teaches of the method as described in claim 1 wherein two or more myotomies are performed (Harris, Paragraph 88; Figure 4a).
In regard to Claim 6: A modified Harris teaches of the method as described in claim 5 wherein at least a portion of the two or more myotomies are generally parallel to another myotomy (Harris, Paragraph 88, Figure 4A).
In regard to Claim 7: A modified Harris teaches of the method as described in claim 1, wherein the myotomy is performed endoscopically, laparoscopically, perorally, and/or robotically (Harris, Paragraph 73).
In regards to Claim 9: A modified Harris teaches of the method as described in claim 1, but does not teach wherein the pylorus-sparing antral myotomy is a partial thickness incision.
Mitelberg teaches wherein the pylorus-sparing antral myotomy is a partial thickness incision (Mitelberg, Paragraph 87; “The elevated mucosal layer 46 reduces the likelihood that the incision tool tip 226 will damage the underlying muscular layer 50”; Examiner interprets elevating the mucosal layer away from the muscle when making an incision would create a partial thickness incision).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the partial thickness incision taught in Mitelberg to the method of a modified Harris, the motivation being to prevent damage to the underlying muscular layer.
In regard to Claim 11: Harris teaches of a method of augmenting weight loss in a mammalian patient (Harris, Paragraph 77; “In morbidly obese patients, a functional volume reduction of 50% or more may be achieved in order to promote the desired excessive weight loss”) and performing a running suture along a greater curvature and posterior wall of a stomach of the patient (Harris Paragraph 88; Examiner Interprets the sutures to be running sutures; Figure 4A), but does not teach the method comprising: creating a submucosal tunnel in a gastric antrum and/or gastric body of a patient, wherein the submucosal tunnel extends from a proximal gastric antrum or gastric body of the patient to a pre-pyloric area of the patient; performing a pylorus-sparing antral/gastric myotomy in the submucosal tunnel, wherein the pylorus-sparing antral myotomy extends from the pre-pyloric area to just distal of an opening of the submucosal tunnel in the gastric antrum or gastric body; closing the submucosal tunnel.
Mitelberg pertains to a method of gastric surgery, and teaches creating a submucosal tunnel in a gastric antrum and/or gastric body of a patient; and performing a pylorus-sparing antral myotomy (Mitelberg, Paragraph 87; Figure 24A item 230; “FIG. 24A illustrates a perspective view of region 220 in the digestive tract having a submucosal tunnel 230 formed by submucosal tunneling instrument 120”) and closing the submucosal tunnel (Mitelberg, Paragraph 38; “the method also additionally includes the step of closing the mucosal opening”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the creation of a submucosal tunnel taught in Mitelberg to the method for reducing gastric volume taught in Harris, the motivation being to provide suitable access to the muscular wall or the placement of an implant device (Mitelberg, Paragraph 87).
Kassab pertains to a method of augmenting weight loss in a mammalian patient, and teaches performing a surgical intervention on a stomach comprising creating the intervention extending from a proximal gastric antrum or gastric body of the patient to a pre-pyloric area of the patient (Kassab, Paragraph 21; “the gastric restriction device can be applied to the stomach in an axial or longitudinal fashion such that a gastric sleeve is formed extending from the gastro-esophageal junction to the pre-pyloric area without interfering with the pyloric sphincter”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add length and placement of the submucosal tunnel taught in Kassab to the method for reducing gastric volume taught in a modified Harris, the motivation being to allow for sufficient reduction in the stomach.
A modified Harris teaches the pylorus-sparing antral myotomy extends from the pre-pyloric area to just distal of an opening of the submucosal tunnel in the gastric antrum or gastric body (A modified Harris teaches performing a procedure for reducing the volume of the stomach by entering a submucosal tunnel).
In regard to Claim 14: A modified Harris teaches of the method as described in claim 11 wherein two or more myotomies are performed in a common tunnel and/or in an adjacent tunnel (Harris, Paragraph 88; Figure 4a).
In regard to Claim 15: A modified Harris teaches of the method as described in claim 14 wherein at least a portion of the two or more myotomies are generally parallel to another myotomy (Harris, Paragraph 88, Figure 4A).
In regard to Claim 16: A modified Harris teaches of the method as described in claim 11, wherein the myotomy is performed endoscopically, laparoscopically, perorally, and/or robotically (Harris, Paragraph 73).
In regards to Claim 18: A modified Harris teaches of the method as described in claim 11, but does not teach wherein the pylorus-sparing antral myotomy is a partial thickness incision.
Mitelberg teaches wherein the pylorus-sparing antral myotomy is a partial thickness incision (Mitelberg, Paragraph 87; “The elevated mucosal layer 46 reduces the likelihood that the incision tool tip 226 will damage the underlying muscular layer 50”; Examiner interprets elevating the mucosal layer away from the muscle when making an incision would create a partial thickness incision).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the partial thickness incision taught in Mitelberg to the device of a modified Harris, the motivation being to prevent damage the underlying muscular layer.
Claim(s) 3-4, 12-13, & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0182365 hereinafter Harris in view of US 2009/0018603 hereinafter Mitelberg in view of US 2010/0174295 hereinafter Kassab in further view of US 2010/0256634 hereinafter Vogele.
In regards to Claim 3: A modified Harris teaches of the method as described in claim 1, but does not teach performing an endoscopic gastroplasty in the gastric body and/or fundus.
Vogele pertains to a method of gastric surgery, and teaches performing an endoscopic gastroplasty in the gastric body and/or fundus (Vogele, Paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add performing an endoscopic gastroplasty taught in Vogele to the method taught by a modified Harris, the motivation being to reduce the stomach’s volume.
In regards to Claim 4: A modified Harris teaches the method as described in claim 3 wherein a suture pattern of alternating U and interrupted sutures (Harris, Paragraph 115; Examiner interprets the U-shaped fasteners to be alternating U and interrupted sutures) is used.
In regards to Claim 12: A modified Harris teaches the method as described in claim 11 , but does not teach performing an endoscopic gastroplasty in the gastric body and/or fundus.
Vogele teaches performing an endoscopic gastroplasty in the gastric body and/or fundus (Vogele, Paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add performing an endoscopic gastroplasty taught in Vogele to the method taught by a modified Harris, the motivation being to reduce the stomach’s volume.
In regards to Claim 13: A modified Harris teaches the method as described in claim 12 wherein a suture pattern of alternating U and interrupted sutures is used, or other suturing or plication pattern (Harris, Paragraph 115; Examiner interprets the U-shaped fasteners to be alternating U and interrupted sutures).
In regard to Claim 20: Harris teaches a method of augmenting weight loss in a mammalian patient (Harris, Paragraph 77; “In morbidly obese patients, a functional volume reduction of 50% or more may be achieved in order to promote the desired excessive weight loss”) and suturing using a running, interrupted, or other pattern of sutures, clips, t-tags, or other closure devices (Harris Paragraph 88; Examiner Interprets the sutures to be running sutures; Figure 4A), but does not teach the method comprising: creating a submucosal tunnel in a gastric body of a patient, wherein the submucosal tunnel extends from a proximal gastric antrum and/or gastric body of the patient to a pre-pyloric area of the patient; performing a pylorus-sparing antral myotomy in the submucosal tunnel, wherein the pylorus-sparing antral myotomy extends from the pre-pyloric area to just distal of an opening of the submucosal tunnel; closing the submucosal tunnel; and performing an endoscopic gastroplasty in the gastric body and/or fundus.
Mitelberg pertains to a method of gastric surgery, and teaches creating a submucosal tunnel in a gastric antrum and/or gastric body of a patient; and performing a pylorus-sparing antral myotomy (Mitelberg, Paragraph 87; Figure 24A item 230; “FIG. 24A illustrates a perspective view of region 220 in the digestive tract having a submucosal tunnel 230 formed by submucosal tunneling instrument 120”) and closing the submucosal tunnel (Mitelberg, Paragraph 38; “the method also additionally includes the step of closing the mucosal opening”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the creation of submucosal tunnel and performing a pyorus -sparing antral myotomy in the submucosal tunnel taught in Mitelberg to the method for reducing gastric volume taught in Harris, the motivation being to provide suitable access to the muscular wall or the placement of an implant device (Mitelberg, Paragraph 87).
Kassab pertains to a method of augmenting weight loss in a mammalian patient, and teaches wherein the submucosal tunnel extends from a proximal gastric antrum or gastric body of the patient to a pre-pyloric area of the patient (Kassab, Paragraph 21; “the gastric restriction device can be applied to the stomach in an axial or longitudinal fashion such that a gastric sleeve is formed extending from the gastro-esophageal junction to the pre-pyloric area without interfering with the pyloric sphincter”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the submucosal tunnel in the method of Harris as modified such that the submucosal tunnel extends from a proximal gastric antrum or gastric body to a pre-pyloric area of the patient and add the length and placement of the submucosal tunnel taught in Kassab to the method for reducing gastric volume taught in a modified Harris, the motivation being to allow for sufficient reduction in the stomach.
A modified Harris teaches the pylorus-sparing antral myotomy extends from the pre-pyloric area to just distal of an opening of the submucosal tunnel in the gastric antrum or gastric body (A modified Harris teaches performing a procedure for reducing the volume of the stomach by entering a submucosal tunnel).
Vogele pertains to a method of gastric surgery, and teaches performing an endoscopic gastroplasty in the gastric body and/or fundus (Voegele, Paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add performing an endoscopic gastroplasty taught in Vogele to the method taught by a modified Harris, the motivation being to reduce the stomach’s volume.
Claim(s) 8 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0018603 hereinafter Mitelberg in view of US 2010/0174295 hereinafter Kassab in further view of US 2012/0029652 hereinafter Wagh.
In regards to Claim 8: A modified Harris teaches the method as described in claim 1, but does not teach wherein the pylorus-sparing antral myotomy is a full-thickness incision.
Wagh pertains to a method of performing gastric surgery, and teaches performing a full-thickness incision (Wagh, Paragraph 11; Figure 1C Item 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the full-thickness incision taught in Wagh to the method of a modified Harris, the motivation being to provide a greater structural support to the sutures.
In regards to Claim 17: A modified Harris teaches the method as described in claim 11, but does not teach wherein the pylorus-sparing antral myotomy is a full-thickness incision.
Wagh pertains to a method of performing gastric surgery, and teaches performing a full-thickness incision (Wagh, Paragraph 11; Figure 1C Item 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the full-thickness incision taught in Wagh to the device of a modified Harris, the motivation being to provide a greater structural support to the sutures.
Claim(s) 10 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0018603 hereinafter Mitelberg in view of US 2010/0174295 hereinafter Kassab in further view of US 2012/0004677 hereinafter Balbierz.
In regards to Claim 10: A modified Harris teaches the method as described in claim 1, but does not teach wherein the pylorus is left intact.
Balbierz is a method of gastric surgery, and teaches wherein the pylorus is left intact (Balbierz, Paragraph 88).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the pylorus being left intact taught in Balbierz to the device of a modified Harris, the motivation being to preserve the functions of the stomach.
In regards to Claim 19: A modified Harris teaches the method as described in claim 11, but does not teach wherein the pylorus is left intact.
Balbierz pertains to a method of gastric surgery, and teaches wherein the pylorus is left intact (Balbierz, Paragraph 88).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the pylorus being left intact taught in Balbierz to the device of a modified Harris, the motivation being to preserve the functions of the stomach.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./Patent Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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