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 1-19 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.
Claims 1, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. § 112(b) as being indefinite because they recite the phrase "the body lumen" without providing proper antecedent basis. The first mention of "body lumen" in each of these claims is in the phrase "a tissue of the body lumen," but there is no preceding introduction of "a body lumen" to which "the" can refer. This renders the claims indefinite as it is unclear what specific body lumen is being referenced.
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, 2, 4-8, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Azamian et al. (US2013/0178910A1) in view of the publication Jonge et al. ("Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes"; hereinafter "de Jonge").
In relation to independent claim 1, Azamian discloses a method for treating diabetes by modulating nerves in the small intestine, including the duodenum. Specifically, Azamian teaches:
a method for treating diabetes:
"methods for therapeutically effecting neuromodulation...to treat metabolic diseases or conditions, such as diabetes mellitus" (paragraph [0002]).
inserting a delivery catheter into the duodenum:
"the neuromodulation system may be delivered transluminally either through the stomach, or through the duodenum" (paragraph [0013]).
treatment in small intestine/duodenum:
"sympathetic nerve fibers that innervate the small intestine (e.g., duodenum)" (paragraph [0008]).
Infusing a chemical formulation to injure/damage tissue:
"a delivery catheter system delivers drugs or chemical agents to nerve fibers to modulate the nerve
fibers (e.g., via chemoablation). Chemical agents used with chemoablation...may, for example, include phenol, alcohol, or any other chemical agents that cause chemoablation of nerve fibers" (paragraph [0010]).
multiple treatment sites:
"the neuromodulation system is used to modulate or disrupt sympathetic nerve fibers at one or more
locations or target sites...the ablation catheter system may perform ablation at a plurality of points linearly spaced apart" (paragraph [0017]).
Glucose reduction benefit:
"neuromodulation of targeted autonomic nerve fibers treats diabetes...by decreasing systemic glucose" (paragraph [0022]).
Azamian does not explicitly disclose (1) the sequential insertion and withdrawal of catheters at two different treatment sites as separate procedural steps, and (2) the benefit of HbA1c reduction. 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).
Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Azamian and de Jonge. Azamian teaches a method of treating diabetes by chemical ablation in the duodenum to achieve glucose reduction. de
Jonge teaches that intervention in the duodenum/jejunum for diabetes treatment [glucose reduction] results also in an associated reduction in HbA1c. A person of ordinary skill would have been motivated to apply the chemical ablation method of Azamian at multiple sites, as suggested by Azamian's disclosure of treating at a "plurality of points" (paragraph [0017]), to achieve a reduction in glucose levels and an associated improvement in HbA1c as demonstrated by de Jonge. The sequential treatment at two sites [sequential insertion and withdrawal of catheters at two different treatment sites as separate procedural steps] is an obvious variation of treating at a "plurality of points" to ensure adequate and effective treatment coverage. Therefore, the combination of Azamian and de Jonge renders Claim 1 obvious.
In relation to claim 2, Azamian discloses the treatment of diabetes and obesity. Concerning diabetes, as discussed above, Azamian discloses in paragraph [0002]: "methods for therapeutically effecting neuromodulation...to treat metabolic diseases or conditions, such as diabetes mellitus". Concerning obesity, in paragraph [0007], Azamian discloses “neuromodulation of targeted nerve fibers as described herein can be used for the treatment of...obesity". Concerning Bodyweight reduction, de Jonge discloses “[a]t 24 weeks after implantation, patients had lost 12.7±1.3 kg (p<0.01)” (see de Jonge, Abstract, pg. 1354, second column). Concerning HbA1c reduction, de Jonge explicitly discloses: "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). Finally, concerning Glucose reduction: de Jonge explicitly discloses: "Both fasting glucose levels and the postprandial glucose response were decreased at 1 week after implantation" (see de Jonge, Abstract, page 1354, second column).
Based on the above teachings, the combination of Azamian and de Jonge treats both diabetes and obesity, and contributes to the reduction of bodyweight, HbA1c, and glucose. Accordingly, for a person of ordinary skill in the art, the combination would have yield the predictable result of treating both conditions with the associated benefits.
In relation to claim 4, Azamian explicitly discloses "a delivery catheter system delivers drugs or chemical agents to nerve fibers" (paragraph [0010]). Accordingly, since this enhancement was 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 process.
In relation to claim 5, Azamian explicitly discloses a balloon infusion catheter in paragraph [0033]. The process of using the balloon catheter for the process of infusion is found in paragraphs [0175] and [0208]. Accordingly, since this enhancement was 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 process.
In relation to claims 6, 7, and 8, the combination of Azamian and de Jonge discloses the specific treatment sites disclosed in the claims in question.
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Accordingly, for a person of ordinary skill in the art, the selection of specific treatment sites within the duodenum and/or jejunum is an obvious design choice based on the clinical needs of the patient and the teachings of Azamian regarding treatment in the small intestine [it is well-known in the art that the small intestine includes the duodenum and the jejunum].
In relation to claim 15, Azamian explicitly discloses thermal neuromodulation: "thermal neuromodulation" (Title); "heating nerve tissue" (paragraph [0041]), and "RF energy to ablate sympathetic nerve fibers" (see paragraph [0010]). Azamian teaches the infusion of heat as a modality for tissue treatment. Accordingly, since this enhancement was 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 apparatus.
In relation to claim 16, as discussed above, Azamian teaches treating at a "plurality of points" [0017], which inherently includes treating at three or more sites. The sequential treatment at a third site is an obvious extension of the two-site treatment to ensure comprehensive coverage of the treatment
area.
In relation to independent claim 17, this independent claim is similar to claim 1 but recites three sequential treatment sites instead of two. The same rationale for the rejection of claim 1 applies here. Azamian teaches treating at a "plurality of points" (paragraph [0017]), which inherently includes treating at two, three, or more sites. Therefore, the sequential treatment at a third site is an obvious extension of the two-site treatment to ensure comprehensive coverage of the treatment area.
As discussed in the analysis of claim 1, Azamian discloses a method for treating diabetes by modulating nerves in the small intestine, including the duodenum. Specifically, Azamian teaches:
a method for treating diabetes:
"methods for therapeutically effecting neuromodulation...to treat metabolic diseases or conditions, such as diabetes mellitus" (paragraph [0002]).
inserting a delivery catheter into the duodenum:
"the neuromodulation system may be delivered transluminally either through the stomach, or through the duodenum" (paragraph [0013]).
treatment in small intestine/duodenum:
"sympathetic nerve fibers that innervate the small intestine (e.g., duodenum)" (paragraph [0008]).
Infusing a chemical formulation to injure/damage tissue:
"a delivery catheter system delivers drugs or chemical agents to nerve fibers to modulate the nerve
fibers (e.g., via chemoablation). Chemical agents used with chemoablation...may, for example, include phenol, alcohol, or any other chemical agents that cause chemoablation of nerve fibers" (paragraph [0010]).
multiple treatment sites:
"the neuromodulation system is used to modulate or disrupt sympathetic nerve fibers at one or more
locations or target sites...the ablation catheter system may perform ablation at a plurality of points linearly spaced apart" (paragraph [0017]).
Glucose reduction benefit:
"neuromodulation of targeted autonomic nerve fibers treats diabetes...by decreasing systemic glucose" (paragraph [0022]).
Azamian does not explicitly disclose (1) the sequential insertion and withdrawal of catheters at three different treatment sites as separate procedural steps, and (2) the benefit of HbA1c reduction. 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).
Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to combine the teachings of Azamian and de Jonge. Azamian teaches a method of treating diabetes by chemical ablation in the duodenum to achieve glucose reduction. de
Jonge teaches that intervention in the duodenum/jejunum for diabetes treatment [glucose reduction] results in an associated reduction in HbA1c. Accordingly, a person of ordinary skill would have been motivated to apply the chemical ablation method of Azamian at multiple sites, as suggested by Azamian's disclosure of treating at a "plurality of points" (paragraph [0017]), to achieve the known and desired clinical outcome of HbA1c reduction as demonstrated by de Jonge. The sequential treatment at three sites [sequential insertion and withdrawal of catheters at three or more different treatment sites as separate procedural steps] is an obvious variation of treating at a "plurality of points" to ensure adequate and effective treatment coverage. Therefore, the combination of Azamian and de Jonge renders Claim 17 obvious.
In relation to claim 18, this claim adds the treatment of obesity and body weight reduction to the three-site method of claim 17. The same rationale for the rejection of claim 2 applies here. Azamian
teaches treatment of obesity (paragraph [0007]), and de Jonge demonstrates body weight reduction from duodenal-jejunal intervention.
As discussed in the analysis of claim 2, Azamian discloses the treatment of diabetes and obesity. Concerning diabetes, as discussed above, Azamian discloses in paragraph [0002]: "methods for therapeutically effecting neuromodulation...to treat metabolic diseases or conditions, such as diabetes mellitus". Concerning obesity, in paragraph [0007], Azamian discloses “neuromodulation of targeted nerve fibers as described herein can be used for the treatment of...obesity". Concerning Bodyweight reduction, de Jonge discloses “[a]t 24 weeks after implantation, patients had lost 12.7±1.3 kg (p<0.01)” (see de Jonge, Abstract, pg. 1354, second column). Concerning HbA1c reduction, de Jonge explicitly discloses: "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). Finally, concerning Glucose reduction: de Jonge explicitly discloses: "Both fasting glucose levels and the postprandial glucose response were decreased at 1 week after implantation" (see de Jonge, Abstract, page 1354, second column).
Based on the above teachings, the combination of Azamian and de Jonge treats both diabetes and obesity, and contributes to the reduction of bodyweight, HbA1c, and glucose. Accordingly, for a person of ordinary skill in the art, the combination would have yield the predictable result of treating both conditions with the associated benefits.
In relation to independent claim 19, this independent claim is a combination of the subject matter of claims 1 and 2, reciting a method for treating both diabetes and obesity with two sequential treatment sites and the benefits of HbA1c, glucose, and body weight reduction. The combination of Azamian and de Jonge teaches all the elements of this claim.
As discussed in the analysis of claim 1, Azamian discloses a method for treating diabetes by modulating nerves in the small intestine, including the duodenum. Specifically, Azamian teaches:
a method for treating diabetes:
"methods for therapeutically effecting neuromodulation...to treat metabolic diseases or conditions, such as diabetes mellitus" (paragraph [0002]).
inserting a delivery catheter into the duodenum:
"the neuromodulation system may be delivered transluminally either through the stomach, or through the duodenum" (paragraph [0013]).
treatment in small intestine/duodenum:
"sympathetic nerve fibers that innervate the small intestine (e.g., duodenum)" (paragraph [0008]).
Infusing a chemical formulation to injure/damage tissue:
"a delivery catheter system delivers drugs or chemical agents to nerve fibers to modulate the nerve
fibers (e.g., via chemoablation). Chemical agents used with chemoablation...may, for example, include phenol, alcohol, or any other chemical agents that cause chemoablation of nerve fibers" (paragraph [0010]).
multiple treatment sites:
"the neuromodulation system is used to modulate or disrupt sympathetic nerve fibers at one or more
locations or target sites...the ablation catheter system may perform ablation at a plurality of points linearly spaced apart" (paragraph [0017]).
Glucose reduction benefit:
"neuromodulation of targeted autonomic nerve fibers treats diabetes...by decreasing systemic glucose" (paragraph [0022]).
Azamian does not explicitly disclose (1) the sequential insertion and withdrawal of catheters at two different treatment sites as separate procedural steps, and (2) the benefit of HbA1c reduction. 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).
Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Azamian and de Jonge. Azamian teaches a method of treating diabetes by chemical ablation in the duodenum to achieve glucose reduction. de
Jonge teaches that intervention in the duodenum/jejunum for diabetes treatment [glucose reduction] results also in an associated reduction in HbA1c. A person of ordinary skill would have been motivated to apply the chemical ablation method of Azamian at multiple sites, as suggested by Azamian's disclosure of treating at a "plurality of points" (paragraph [0017]), to achieve a reduction in glucose levels and an associated improvement in HbA1c as demonstrated by de Jonge. The sequential treatment at two sites [sequential insertion and withdrawal of catheters at two different treatment sites as separate procedural steps] is an obvious variation of treating at a "plurality of points" to ensure adequate and effective treatment coverage. Therefore, the combination of Azamian and de Jonge renders Claim 1 obvious.
As discussed in the analysis of claim 2, Azamian discloses the treatment of diabetes and obesity. Concerning diabetes, as discussed above, Azamian discloses in paragraph [0002]: "methods for therapeutically effecting neuromodulation...to treat metabolic diseases or conditions, such as diabetes mellitus". Concerning obesity, in paragraph [0007], Azamian discloses “neuromodulation of targeted nerve fibers as described herein can be used for the treatment of...obesity". Concerning Bodyweight reduction, de Jonge discloses “[a]t 24 weeks after implantation, patients had lost 12.7±1.3 kg (p<0.01)” (see de Jonge, Abstract, pg. 1354, second column). Concerning HbA1c reduction, de Jonge explicitly discloses: "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). Finally, concerning Glucose reduction: de Jonge explicitly discloses: "Both fasting glucose levels and the postprandial glucose response were decreased at 1 week after implantation" (see de Jonge, Abstract, page 1354, second column).
Based on the above teachings, the combination of Azamian and de Jonge treats both diabetes and obesity, and contributes to the reduction of bodyweight, HbA1c, and glucose. Accordingly, for a person of ordinary skill in the art, the combination would have yield the predictable result of treating both conditions with the associated benefits.
Claims 3, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Azamian et al. (US2013/0178910A1) in view of the publication Jonge et al. ("Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes"; hereinafter "de Jonge"), as discussed above, and in further view of Mitelberg et al. (US 8,128,592; hereinafter “Mitelberg”) and Ari et al. (US 4,684,363; hereinafter “Ari”).
In relation to claim 3, Azamian discloses the infusion of a chemical agent to cause ablation, which implies the use of a needle for injection. Mitelberg explicitly discloses: "Instruments include a safe access needle injection instrument...for performing submucosal medical procedures in a desired area of the digestive tract" (Abstract). Accordingly, for a person of ordinary skill in the art, it would have been obvious to use the needle injection catheter of Mitelberg to deliver the chemical agent of Azamian, as this is a simple substitution of a known and suitable delivery device for delivering agents into the digestive tract.
In relation to claim 9, as disclosed above, Azamian discloses a balloon catheter (paragraph [0033]). Azamian does not explicitly disclose a balloon catheter with an infusion lumen passing through the shaft in the region of the balloon.
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Ari shows in figure 5, a balloon catheter having a lumen (39, 37) that extends through the body of balloon (23) and ends at distal end (73, 79). Accordingly, since this enhancement was 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 apparatus.
In relation to claim 10, this claim recites the standard and inherent operation of a balloon catheter. Once it is obvious to use a balloon catheter as recited in claim 9, it is also obvious to operate it in the intended manner of inflating it at the treatment site and deflating it for withdrawal [see Ari; Abstract… “rapidly inflate” … “rapidly deflate”]. This is the normal and expected use of such a device. Accordingly, since this enhancement was 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 apparatus.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Azamian et al. (US2013/0178910A1) in view of the publication Jonge et al. ("Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes"; hereinafter "de Jonge"), as discussed above, and in further view of the publication by Matthes et al., (“Concentration-dependent ablation of pancreatic tissue by EUS-guided ethanol injection”; hereinafter “Matthes”.
In relation to claim 11, Azamian discloses chemical agents comprising phenol and alcohol (paragraph [0010]). Accordingly, since this enhancement was 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 apparatus.
In relation to claim 12, 13, and 14, 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 this enhancement was 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 apparatus.
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