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 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.
In relation to claims 1, 8, 17, 18, and 20, these claims recite "a tissue of the body lumen" without providing proper antecedent basis for "the body lumen"; the phrase "body lumen" has not been previously introduced in the claims. The first use of "body lumen" should be preceded by the indefinite article "a" rather than the definite article "the".
In relation to claims 2-7, 9-16, and 19, these claims are rejected as indefinite by virtue of their dependency on claims 1, 8, or 18, which contain the indefiniteness issue described above.
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.
Claims 1-7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 2008/0275445A1; hereinafter “Kelly”) in view of the publication by de Jonge et al. (Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes”; hereinafter “de Jonge”) and the publication by Sikaris (“The Correlation of Hemoglobin A1c to Blood Glucose”).
In relation to independent claim 1, Kelly discloses:
Method for treating diabetes.
[Abstract]: "cure or ameliorate metabolic pathophysiological conditions such as obesity,
insulin resistance, or type 2 diabetes mellitus".
Inserting a delivery catheter into the small intestine, duodenum, or jejunum.
Paragraph [0097]: "The ablative device is supported on the distal end of an elongated shaft 41 of an instrument, has been inserted into the alimentary tract by the oral route".
First treatment site in duodenum or jejunum.
Paragraph [0097]: "FIG. 2C shows an ablative device within the duodenum 10. FIG. 2D shows an ablative device within the jejunum 11".
Delivering energy to tissue.
Paragraph [0009]: "delivering radiofrequency energy from a non-penetrating electrode pattern on an ablation structure to the tissue surface within the target area".
Energy effective to injure/damage tissue.
Paragraph [0009]: "controlling delivery into the depth of tissue within the target area such that some volume portion of the tissue is ablated".
Second treatment site different from first.
Paragraph [0032]: FIG. 4 is a flow diagram depicting the method after the site of ablation of a portion of the gastrointestinal tract has been localized and a choice has been made regarding the preferred ablational device. The method includes an evaluation of the site, including particulars of location, stage, determination of the number of sites, and the dimensions.
Paragraph [0101]: "Variations of ablational energy emission may include ablating a single site as
well as moving the instrument to a second or to subsequent sites that were identified
during the evaluation step".
Reduction of HbA1c.
Paragraph [0108]: "Hemoglobin A1C (glycosylated hemoglobin) levels are used as an approach to evaluating blood glucose levels integrated over time...Any reduction in hemoglobin A1C
values after treatment that are statistically significant and reproducible would be considered an indication of therapeutic benefit".
Reduction of glucose level.
Paragraph [0106]: "A statistically significant and reproducible reduction in fasting glucose compared to levels prior to treatment...would be considered an indication of therapeutic benefit".
In relation to the use of different catheters to perform the method disclosed in claim 1 of this application, it is well-known in the art that the small intestine is composed of the duodenum, the jejunum and the ileum. These sections of the small intestine vary in diameter size; therefore, this heterogenous anatomy demands differentiated balloon catheter sizing to prioritize safety, and therefore, in some circumstances, will require the use of a different catheter of different size to complete the ablation process in a subsequent site. For this reason, Kelly in paragraph [0032] explicitly relates the choice regarding the preferred ablation device to the location, stage, determination of the number of sites, and the dimensions of the site being ablated.
In relation to the reduction of glucose levels and HbA1c, Kelly explicitly states in paragraph [0014] that the method is intended, inter alia, to decrease blood glucose levels [“decreasing blood glucose levels”]. Moreover, as indicated above, Kelly explicitly states in paragraph [0108] that “[a]ny reduction in hemoglobin A1C values [HbA1c] after treatment that are statistically significant and reproducible would be considered an indication of therapeutic benefit [from the application of the method].” Therefore, Kelly’s method is not only intended to reduce glucose levels, but is also capable of reducing hemoglobin A1C values [HbA1c].
In order to further demonstrate the relationship of glucose levels and HbA1c, two publications, de Jonge and Sikaris have been included to complement this rejection.
de Jonge discloses a clinical study on the effects of a duodenal-jejunal bypass liner on patients with type 2 diabetes. de Jonge teaches:
• HbA1c reduction:
"At 24 weeks after implantation...HbA1c had improved from 8.4 ± 0.2 to 7.0 ± 0.2 % (p < 0.01)" (see de Jonge, Abstract, page 1354, second column);
• Glucose reduction:
"Both fasting glucose levels and the postprandial glucose response were decreased at 1 week after implantation" (see de Jonge, Abstract, page 1354, second column).
The results of the study performed in the small intestine area clearly demonstrate that there is a direct relationship between glucose reduction and HbA1c reduction in the small intestine.
Sikaris further clarifies the relationship between glucose level and HbA1c by clarifying that hemoglobin A1c (HbA1c) simply represents the average blood glucose level of patients over the previous 120 days.
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In figure 1 above, Sikaris illustrates the direct relationship/correlation between hemoglobin A1c and non-fasting plasma glucose on 7365 episodes. Based on the teachings of de Jonge and Sikaris, a person of ordinary skill in the art would have concluded that a reduction in glucose levels in response to the application of the method disclosed by Kelly would have also resulted in an eventual reduction in hemoglobin A1c (HbA1c).
In relation to claim 2, Kelly further discloses:
Treating obesity.
[Abstract]: "cure or ameliorate metabolic pathophysiological conditions such as obesity, insulin resistance, or type 2 diabetes mellitus".
Reduction of body weight.
Paragraph [0105]: "A statistically significant and reproducible reduction in BMI compared to levels prior to treatment...would be considered an indication of therapeutic benefit".
Based on the above teachings, a person of ordinary skill in the art would have recognized that
Kelly’s method could have successfully treated obesity and reduce body weight in a patient.
In relation to claim 3, Kelly discloses treatment in the duodenum. Paragraph [0097] states: "FIG. 2C shows an ablative device within the duodenum 10." Based on the above teachings, a person of ordinary skill in the art would have recognized that Kelly’s method would have been capable of treating the duodenum.
In relation to claim 4, Kelly discloses treatment in both the duodenum and jejunum in paragraph [0097]: "FIG. 2C shows an ablative device within the duodenum 10. FIG. 2D shows an ablative device within the jejunum 11". Based on the above teachings, a person of ordinary skill in the art would have recognized that Kelly’s method would have been capable of treating both, the duodenum and the jejunum.
In relation to claim 5, Kelly discloses treatment in the jejunum in paragraph [0097]: "FIG. 2D shows an ablative device within the jejunum 11." Kelly further teaches treating multiple sites within the same region at [0101]. Based on the above teachings, since this step was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the process.
In relation to claim 6, Kelly discloses radiofrequency energy in paragraph [0009]: "delivering radiofrequency energy from a non-penetrating electrode pattern on an ablation structure to the tissue surface within the target area." Based on the above teachings, since this enhancement was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the process.
In relation to claim 7, Kelly explicitly discloses radiofrequency energy in paragraph [0009]: "delivering radiofrequency energy from a non-penetrating electrode pattern on an ablation structure to the tissue surface within the target area." Based on the above teachings, since this enhancement was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the process.
In relation to claim 17, as discussed above, the combination of Kelly/de Jonge/Sikaris teaches all limitations of claim 1. Kelly further teaches in paragraph [0101]: "Variations of ablational energy emission may include ablating a single site as well as moving the instrument to a second or to subsequent sites that were identified during the evaluation step." Based on the above teachings, the extension from two treatment sites to three treatment sites would have been an obvious modification of the method taught by Kelly. Kelly explicitly teaches treating "subsequent sites" beyond the second site, and one of ordinary skill in the art would have been motivated to treat additional sites to achieve a greater therapeutic effect.
Claims 8, 9-13, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2004/0089313A1) in view of the publication by de Jonge et al. (Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes”; hereinafter “de Jonge”) and the publication by Sikaris (“The Correlation of Hemoglobin A1c to Blood Glucose”), as discussed above, and in further view of Utley (US 2004/0089313A1) and Matthes et al. (“Concentration-dependent ablation of pancreatic tissue by EUS-guided ethanol injection”; hereinafter “Matthes”).
In relation to claim 8, the combination of Kelly/de Jonge/Sikaris does not explicitly teach the step of infusing a chemical formulation to the tissue. However, Utley teaches the step of treating obesity by "injection of a treatment agent that evokes a desired tissue tightening response" in paragraph [0025]. Utley further teaches that "[t]he treatment agent can comprise, e.g., at least one sub-type of a cytokine...and/or at least one sub-type of a vanilloid-containing compound" in paragraph [0025]. Based on the above teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the energy-based ablation method of Kelly to additionally include infusing a chemical formulation as taught by Utley. One of ordinary skill would have been motivated to make this combination because Utley teaches that chemical agents can enhance the tissue response and tightening effect, which would improve the therapeutic outcome of the ablation procedure.
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In relation to claim 9, the combination of Kelly/de Jonge/Sikaris does not explicitly teach a needle catheter. However, Utley shows in figure 6, a delivery catheter comprising a needle catheter. Accordingly, for an artisan skilled in the art, modifying any of the catheters disclose in the combination of Kelly/de Jonge/Sikaris with a needle catheter would have been considered obvious in view of the conventionality of this particular type of catheter. Moreover, the artisan would have been motivated to make the modification because the use of a needle catheter would have facilitated the delivery of a treatment agent to tissue with a high level of accuracy.
In relation to claim 10, Utley shows in figure 6 above, that the needle catheter is capable of infusing an agent into tissue; therefore, the catheter is an infusion catheter. Since this enhancement would have been considered well-known in the art at the time of filing, its application in the invention would have been considered an obvious alternative in the design of the catheter.
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In relation to claim 11, Utley shows in figure 8, a balloon infusion catheter. Since this enhancement would have been considered well-known in the art at the time of filing, its application in the invention would have been considered an obvious alternative in the design of the catheter.
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In relation to claim 12, Utley shows in figure 7, a balloon around a circumference of a shaft/catheter (70) with a formulation infusion lumen located within the shaft/catheter (70). Figure 5B shows distal end needles (76) infusing fluid that originates in the treatment agent delivery (80) [figure 3] and flows through the lumen within the shaft/catheter (70). Accordingly, since this enhancement would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the catheter.
In relation to claim 13, Utley explicitly discloses the step of deflating inflatable member (102) to facilitate the removal of the catheter (see Utley; paragraph [0114]). Accordingly, since this limitation would have been considered well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the catheter.
In relation to claims 14, 15, and 16, the combination of Kelly/de Jonge/Sikaris/Utley does not explicitly teach the use of the chemical formulations of ethanol or ethanol/water. However, Matthes discloses “EUS-guided injection of ethanol” [ethanol for tissue ablation] (Matthes, first page, Objective and Conclusions) and “40% to 100% ethanol” [diluted concentrations indicate water mixtures] (Matthes, first page, Results). Accordingly, since these enhancements were considered well-known in the art at the time of filing, their implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
Claims 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 2008/0275445A1; hereinafter “Kelly”) in view of the publication by de Jonge et al. (Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes”; hereinafter “de Jonge”) and the publication by Sikaris (“The Correlation of Hemoglobin A1c to Blood Glucose”).
In relation to independent claim 18, in summary, the claim recites similar limitations as in claim 1 plus a third treatment site [similar limitations as in claim 17] wherein the injury and/or damage to the tissue at the first treatment site, at the second treatment site, and at the third treatment site is effective to have a benefit of relieving symptoms comprising reduction of HbA1c(A1c) and glucose level.
Accordingly, as discussed above [claim 1], Kelly discloses:
Method for treating diabetes.
[Abstract]: "cure or ameliorate metabolic pathophysiological conditions such as obesity,
insulin resistance, or type 2 diabetes mellitus".
Inserting a delivery catheter into the small intestine, duodenum, or jejunum.
Paragraph [0097]: "The ablative device is supported on the distal end of an elongated shaft 41 of an instrument, has been inserted into the alimentary tract by the oral route".
First treatment site in duodenum or jejunum.
Paragraph [0097]: "FIG. 2C shows an ablative device within the duodenum 10. FIG. 2D shows an ablative
device within the jejunum 11".
Delivering energy to tissue.
Paragraph [0009]: "delivering radiofrequency energy from a non-penetrating electrode pattern on an ablation structure to the tissue surface within the target area".
Energy effective to injure/damage tissue.
Paragraph [0009]: "controlling delivery into the depth of tissue within the target area such that some volume portion of the tissue is ablated".
Second treatment site different from first.
Paragraph [0032]: FIG. 4 is a flow diagram depicting the method after the site of ablation of a portion of the gastrointestinal tract has been localized and a choice has been made regarding the preferred ablational device. The method includes an evaluation of the site, including particulars of location, stage, determination of the number of sites, and the dimensions.
Paragraph [0101]: "Variations of ablational energy emission may include ablating a single site as
well as moving the instrument to a second or to subsequent sites that were identified
during the evaluation step".
Reduction of HbA1c.
Paragraph [0108]: "Hemoglobin A1C (glycosylated hemoglobin) levels are used as an approach to evaluating blood glucose levels integrated over time...Any reduction in hemoglobin A1C
values after treatment that are statistically significant and reproducible would be considered an indication of therapeutic benefit".
Reduction of glucose level.
Paragraph [0106]: "A statistically significant and reproducible reduction in fasting glucose compared to levels prior to treatment...would be considered an indication of therapeutic benefit".
In relation to the use of different catheters [with different sizes] to perform the method in a second or a third treatment site, it is well-known in the art that the small intestine is composed of the duodenum, the jejunum and the ileum. These sections of the small intestine vary in diameter size; therefore, this heterogenous anatomy demands differentiated balloon catheter sizing to prioritize safety, and therefore, in some circumstances, will require the use of a different size catheter to complete the ablation process in a subsequent site (second or third site; refer to Kelly; paragraph [0101] … “moving the instrument to a second or to subsequent sites”). Moreover, Kelly in paragraph [0032] explicitly relates the choice regarding the preferred ablation device to the location, stage, determination of the number of sites, and the dimensions of the site being ablated.
In relation to the reduction of glucose levels and HbA1c, Kelly explicitly states in paragraph [0014] that the method is intended, inter alia, to decrease blood glucose levels [“decreasing blood glucose levels”]. Moreover, as indicated above, Kelly explicitly states in paragraph [0108] that “[a]ny reduction in hemoglobin A1C values [HbA1c] after treatment that are statistically significant and reproducible would be considered an indication of therapeutic benefit [from the application of the method].” Therefore, Kelly’s method is not only intended to reduce glucose levels, but is also capable of reducing hemoglobin A1C values [HbA1c].
In order to further demonstrate the relationship of glucose levels and HbA1c, two publications, de Jonge and Sikaris have been included to complement this rejection.
de Jonge discloses a clinical study on the effects of a duodenal-jejunal bypass liner on patients with type 2 diabetes. de Jonge teaches:
• HbA1c reduction:
"At 24 weeks after implantation...HbA1c had improved from 8.4 ± 0.2 to 7.0 ± 0.2 % (p < 0.01)" (see de Jonge, Abstract, page 1354, second column);
• Glucose reduction:
"Both fasting glucose levels and the postprandial glucose response were decreased at 1 week after implantation" (see de Jonge, Abstract, page 1354, second column).
The results of the study performed in the small intestine area clearly demonstrate that there is a direct relationship between glucose reduction and HbA1c reduction in the small intestine.
Sikaris further clarifies the relationship between glucose level and HbA1c by clarifying that hemoglobin A1c (HbA1c) simply represents the average blood glucose level of patients over the previous 120 days.
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In figure 1 above, Sikaris illustrates the direct relationship/correlation between hemoglobin A1c and non-fasting plasma glucose on 7365 episodes. Based on the teachings of de Jonge and Sikaris, a person of ordinary skill in the art would have concluded that a reduction in glucose levels in response to the application of the method disclosed by Kelly would have also resulted in an eventual reduction in hemoglobin A1c (HbA1c).
In relation to claim 19, as discussed above, the combination of Kelly/de Jonge/Sikaris discloses all the limitations of independent claim 18, plus the treatment of obesity and reduction of body weight as detailed in the rejection of claim 2.
As discussed above [claim 2], Kelly discloses:
Treating obesity.
[Abstract]: "cure or ameliorate metabolic pathophysiological conditions such as obesity, insulin resistance, or type 2 diabetes mellitus".
Reduction of body weight.
Paragraph [0105]: "A statistically significant and reproducible reduction in BMI compared to levels prior to treatment...would be considered an indication of therapeutic benefit".
Based on the above teachings, a person of ordinary skill in the art would have recognized that
Kelly’s method could have successfully treated obesity and reduce body weight in a patient, in addition to reducing obesity and Hb1c (A1c).
In relation to independent claim 20, the claim recites substantially the same limitations as the combination of claims 1 and 2. As demonstrated in the rejections of claims 1 and 2 above, the combination of Kelly/de Jonge/Sikaris discloses all of these limitations.
As discussed above [claim 1], Kelly discloses:
Method for treating diabetes.
[Abstract]: "cure or ameliorate metabolic pathophysiological conditions such as obesity,
insulin resistance, or type 2 diabetes mellitus".
Inserting a delivery catheter into the small intestine, duodenum, or jejunum.
Paragraph [0097]: "The ablative device is supported on the distal end of an elongated shaft 41 of an instrument, has been inserted into the alimentary tract by the oral route".
First treatment site in duodenum or jejunum.
Paragraph [0097]: "FIG. 2C shows an ablative device within the duodenum 10. FIG. 2D shows an ablative device within the jejunum 11".
Delivering energy to tissue.
Paragraph [0009]: "delivering radiofrequency energy from a non-penetrating electrode pattern on an ablation structure to the tissue surface within the target area".
Energy effective to injure/damage tissue.
Paragraph [0009]: "controlling delivery into the depth of tissue within the target area such that some volume portion of the tissue is ablated".
Second treatment site different from first.
Paragraph [0032]: FIG. 4 is a flow diagram depicting the method after the site of ablation of a portion of the gastrointestinal tract has been localized and a choice has been made regarding the preferred ablational device. The method includes an evaluation of the site, including particulars of location, stage, determination of the number of sites, and the dimensions.
Paragraph [0101]: "Variations of ablational energy emission may include ablating a single site as
well as moving the instrument to a second or to subsequent sites that were identified
during the evaluation step".
Reduction of HbA1c.
Paragraph [0108]: "Hemoglobin A1C (glycosylated hemoglobin) levels are used as an approach to evaluating blood glucose levels integrated over time...Any reduction in hemoglobin A1C
values after treatment that are statistically significant and reproducible would be considered an indication of therapeutic benefit".
Reduction of glucose level.
Paragraph [0106]: "A statistically significant and reproducible reduction in fasting glucose compared to levels prior to treatment...would be considered an indication of therapeutic benefit".
In relation to the use of different catheters to perform the method disclosed in claim 1 of this application, it is well-known in the art that the small intestine is composed of the duodenum, the jejunum and the ileum. These sections of the small intestine vary in diameter size; therefore, this heterogenous anatomy demands differentiated balloon catheter sizing to prioritize safety, and therefore, in some circumstances, will require the use of a different catheter of different size to complete the ablation process in a subsequent site. For this reason, Kelly in paragraph [0032] explicitly relates the choice regarding the preferred ablation device to the location, stage, determination of the number of sites, and the dimensions of the site being ablated.
In relation to the reduction of glucose levels and HbA1c, Kelly explicitly states in paragraph [0014] that the method is intended, inter alia, to decrease blood glucose levels [“decreasing blood glucose levels”]. Moreover, as indicated above, Kelly explicitly states in paragraph [0108] that “[a]ny reduction in hemoglobin A1C values [HbA1c] after treatment that are statistically significant and reproducible would be considered an indication of therapeutic benefit [from the application of the method].” Therefore, Kelly’s method is not only intended to reduce glucose levels, but is also capable of reducing hemoglobin A1C values [HbA1c].
In order to further demonstrate the relationship of glucose levels and HbA1c, two publications, de Jonge and Sikaris have been included to complement this rejection. de Jonge discloses a clinical study on the effects of a duodenal-jejunal bypass liner on patients with type 2 diabetes. de Jonge teaches:
HbA1c reduction:
"At 24 weeks after implantation...HbA1c had improved from 8.4 ± 0.2 to 7.0 ± 0.2 % (p < 0.01)" (see de Jonge, Abstract, page 1354, second column);
Glucose reduction:
"Both fasting glucose levels and the postprandial glucose response were decreased at 1 week after implantation" (see de Jonge, Abstract, page 1354, second column).
The results of the study performed in the small intestine area clearly demonstrate that there is a direct relationship between glucose reduction and HbA1c reduction in the small intestine.
Sikaris further clarifies the relationship between glucose level and HbA1c by clarifying that hemoglobin A1c (HbA1c) simply represents the average blood glucose level of patients over the previous 120 days.
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In figure 1 above, Sikaris illustrates the direct relationship/correlation between hemoglobin A1c and non-fasting plasma glucose on 7365 episodes. Based on the teachings of de Jonge and Sikaris, a person of ordinary skill in the art would have concluded that a reduction in glucose levels in response to the application of the method disclosed by Kelly would have also resulted in an eventual reduction in hemoglobin A1c (HbA1c).
In relation to the reduction of body weight, as discussed above [claim 2], Kelly further discloses:
Treating obesity.
[Abstract]: "cure or ameliorate metabolic pathophysiological conditions such as obesity, insulin resistance, or type 2 diabetes mellitus".
Reduction of body weight.
Paragraph [0105]: "A statistically significant and reproducible reduction in BMI compared to levels prior to treatment...would be considered an indication of therapeutic benefit".
Based on the above teachings, a person of ordinary skill in the art would have recognized that Kelly’s method could have successfully treated obesity and reduce body weight in a patient, in addition to, reducing glucose and Hb1c(A1c).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783