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 .
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 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.
Status of the Claims
The current office action is made responsive to claims filed 10/14/2025.
Acknowledgement is made to the amendment of claims 2-5, 7-8, 11-16, and 18.
Acknowledgement is made to the cancellation of claim 1.
Acknowledgement is made to the newly added claims 20-29.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 2-29 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 2-4, 6-7, 9-13, 15-17, 20-22, 24-26, 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Stern (US 20040087936 A1) in view of Kelly (US 20080275445 A1).
Regarding claim 2, Stern teaches a method of treating a patient by ablating mucosal tissue (Abstract, [0023], [0101]), the method comprising:
introducing a distal portion of an elongate tube into a gastrointestinal tract of the patient, the distal portion comprising a fluid delivery element ([0024]- [0025], [0056]- [0057], [0070]);
circumferentially restricting a passage of the gastrointestinal tract by expanding a thickness of submucosal tissue of multiple segments of the gastrointestinal tract by delivering fluid into the submucosal tissue below a surface of the mucosal tissue via the multiple fluid delivery elements to generate thickened submucosal tissue ([0101]- [0105] discuss the method of separating the mucosal layers by injecting a fluid between the layers so as to create a separation barrier where the deeper layer may be separated from the more superficial layer by expanding one tissue layer); and
after generating the thickened submucosal tissue below the mucosal tissue ([0101]- [0102], [0105] discusses the separation layer as being provided to the tissue to be ablated), circumferentially ablating the mucosal tissue of the multiple segments of the gastrointestinal tract ([0071]) by applying a hot fluid to the surface of the mucosal tissue of the multiple segments of the gastrointestinal tract via the distal portion of the elongate tube ([0058], [0065] discusses the thermal energy of the heatable fluid as being used as the ablation energy source); and
wherein applying the hot fluid avoids adversely affecting non-target tissue ([0102], [0110]).
Stern fails to teach the method as being a method for treating insulin resistance and the location along the gastrointestinal tract as being the duodenum.
Kelly teaches a method for ablating tissue in the wall of various organs of the gastrointestinal tract of the patient in order to cure the patient of a variety of conditions such as insulin resistance (Abstract).
Kelly further teaches a variety of known locations which may be the ablation target area so as to treat this condition of insulin resistance, such as the duodenum ([0017]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the area which is being ablated within the gastrointestinal tract of the patient as being the duodenum, as is taught by Kelly, into the method for ablating a portion of the gastrointestinal tract as is taught by Stern, to produce the predictable result of treating insulin resistance, as is taught by Kelly, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Further, while Stern does not explicitly teach the a fluid delivery element as being multiple a fluid delivery elements, there is no evidence that more than one a fluid delivery element makes a meaningful difference to the function of the device compared to the currently taught a fluid delivery element and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 3, Kelly teaches the method according to claim 2, wherein ablation of the mucosal tissue causes the mucosal tissue to be replaced with new tissue ([0131], [0142] teaches cells as migrating into damaged areas and contributing to a functional recovery).
Regarding claim 4, Kelly teaches the method according to claim 3, wherein the new tissue displays different secretive properties than the ablated mucosal tissue ([0006], [0015], [0028]).
Regarding claim 6, Kelly teaches the method according to claim 3, wherein the new tissue comprises new mucosal cells that have migrated from at least one of a gastric mucosa or a jejunal mucosa ([0129] discusses the targeted area for ablating tissue [0131], [0142] display the manner of cell migration in response to damaged areas).
Regarding claim 7, Kelly teaches the method according to claim 2, wherein the target mucosal tissue comprises duodenal mucosal tissue within a portion of a gastrointestinal tract spanning from a pylorus to a ligament of Treitz of the patient ([0013], [0017]).
Regarding claim 9, Kelly teaches the method according to claim 2, wherein the non-target tissue is selected from the group consisting of tunica serosa of the intestine ([0013]); pancreas; tunica muscularis of the intestine; outermost partial layer of the submucosa of the intestine; bile duct; pylorus, Sphincter of Oddi, and combinations thereof.
Regarding claim 10, Stern teaches the method according to claim 2, wherein the elongate tube distal portion further comprises an expandable balloon constructed and arranged to receive the hot fluid ([0065]).
Regarding claim 11, Kelly teaches the method according to claim 2, wherein ablation of the target mucosal tissue treats diabetes ([0014]).
Regarding claim 12, Kelly teaches the method according to claim 2, wherein ablation of the target mucosal tissue treats a disease or disorder selected from the group consisting of: Diabetes ([0014]); Type-1 Diabetes; Type-2 Diabetes; hypercholesterolemia; a metabolic syndrome; celiac disease; obesity; cancer, bronchoalveolar carcinoma; cystitis, and combinations thereof.
Regarding claim 13, Kelly teaches the method according to claim 2, wherein ablation of the target mucosal tissue modifies a secretive property selected from the group consisting of: quantity of secretions ([0028]); material secreted; and combinations thereof.
Regarding claim 15, Kelly teaches the method according to claim 2, wherein the target mucosal tissue further comprises submucosal tissue of the duodenum ([0013], [0017]).
Regarding claim 16, Kelly teaches the method of claim 2, wherein ablation of the target mucosal tissue comprises causing at least one of: cell death; apoptosis; instant cell death; cell necrosis ([0147]); denaturing of cells; removal of cells ([0110]); and combinations thereof.
Regarding claim 17, Kelly teaches the method according to claim 2, wherein the method further includes visual interrogation of the mucosal tissue ([0089]- [0090]).
Regarding claim 20, Stern teaches the method of claim 1, wherein the thickened submucosal tissue is positioned as a thermal barrier for the circumferential ablation of the mucosal tissue ([0109]- [0110]).
Regarding claim 21, Stern teaches a method (Abstract, [0023], [0101]), comprising:
introducing a distal portion of an elongate tube into a gastrointestinal tract of a patient, the distal portion comprising fluid delivery element ([0024]- [0025], [0056]- [0057], [0070]);
circumferentially restricting a passage of the gastrointestinal tract by expanding a thickness of submucosal tissue of multiple segments of the gastrointestinal tract by delivering fluid into submucosal tissue below a surface of mucosal tissue of the gastrointestinal tract via the fluid delivery element to generate thickened submucosal tissue ([0101]- [0105] discuss the method of separating the mucosal layers by injecting a fluid between the layers so as to create a separation barrier where the deeper layer may be separated from the more superficial layer by expanding one tissue layer); and
after generating the thickened submucosal tissue below the mucosal tissue ([0101]- [0102], [0105] discusses the separation layer as being provided to the tissue to be ablated), circumferentially ablating the mucosal tissue of the multiple segments of the gastrointestinal tract ([0071]) by applying a hot fluid to the surface of the mucosal tissue of the multiple segments of the gastrointestinal tract via the distal portion of the elongate tube ([0058], [0065] discusses the thermal energy of the heatable fluid as being used as the ablation energy source);
wherein applying the hot fluid is positioned to avoid adversely affecting non-target tissue ([0102], [0110]).
Stern fails to teach the method as being a method for treating insulin resistance and the location along the gastrointestinal tract as being the duodenum.
Kelly teaches a method for ablating tissue in the wall of various organs of the gastrointestinal tract of the patient in order to cure the patient of a variety of conditions such as insulin resistance (Abstract).
Kelly further teaches a variety of known locations which may be the ablation target area so as to treat this condition of insulin resistance, such as the duodenum ([0017]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the area which is being ablated within the gastrointestinal tract of the patient as being the duodenum, as is taught by Kelly, into the method for ablating a portion of the gastrointestinal tract as is taught by Stern, to produce the predictable result of treating insulin resistance, as is taught by Kelly, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Further, while Stern does not explicitly teach the a fluid delivery element as being multiple a fluid delivery elements, there is no evidence that more than one a fluid delivery element makes a meaningful difference to the function of the device compared to the currently taught a fluid delivery element and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Regarding claim 22, Kelly teaches the method according to claim 21, wherein the mucosal tissue comprises duodenal mucosal tissue within a portion of a gastrointestinal tract spanning from a pylorus to a ligament of Treitz of the patient ([0013], [0017]).
Regarding claim 24, Kelly teaches the method according to claim 21, wherein the non-target tissue is selected from the group consisting of tunica serosa of the intestine ([0013]); pancreas; tunica muscularis of the intestine; outermost partial layer of the submucosa of the intestine; bile duct; pylorus, Sphincter of Oddi.
Regarding claim 25, Stern teaches the method according to claim 21, wherein the elongate tube distal portion further comprises an expandable balloon constructed and arranged to receive the hot fluid ([0065]).
Regarding claim 26, Kelly teaches the method according to claim 21, wherein ablation of the mucosal tissue modifies a secretive property selected from the group consisting of: quantity of secretions ([0028]); material secreted; and combinations thereof.
Regarding claim 28, Kelly teaches the method of claim 21, wherein ablation of the mucosal tissue comprises causing at least one of: cell death; apoptosis; instant cell death; cell necrosis; denaturing of cells; removal of cells ([0110]); and combinations thereof.
Regarding claim 29, Kelly teaches the method according to claim 21, wherein the method further includes visual interrogation of the mucosal tissue ([0089]- [0090]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stern (US 20040087936 A1) in view of Kelly (US 20080275445 A1) further in view of Vidyasagar (US 20120077748 A1).
Regarding claim 5, Stern as modified teaches the method according to claim 3.
However, Stern as modified fails to teach the method wherein the new tissue displays different absorptive properties than the ablated mucosal tissue.
Vidyasagar teaches the way in which epithelial tissue may be affected by disease and injury ([0003]- [0004]).
Vidyasagar further diseases such as diabetes as causing changes to the levels of absorptive capacity ([0098], [0104], [0116]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of changes to absorptive capacity to tissue due to diabetes, as is taught by Vidyasagar into the method of Stern as modified, as the new normal tissue will have different absorptive properties than the tissue affected by diabetes, as is taught by Vidyasagar.
Claim 8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Stern (US 20040087936 A1) in view of Kelly (US 20080275445 A1) further in view of Karpiel (US 6692484 B1).
Regarding claim 8, Stern as modified teaches the method according to claim 2.
However, Stern as modified fails to teach the method wherein ablation of the target mucosal tissue is directed to avoid adversely affecting non-target tissue comprising at least an ampulla of Vater of the patient.
Karpiel teaches a surgical device having a catheter for use within the gastrointestinal tract (Abstract).
Karpiel further teaches a desire to avoid damaging the papilla of vater as healing of the papilla of vater can be problematic (Col. 1, Line 42-Col. 2, Line 12).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date incorporate the teachings of avoiding damage to the ampulla of vater during gastrointestinal surgeries, as is taught by Karpiel, into the method of ablating the gastrointestinal tract, as is taught by Stern as modified, to avoid problematic healing from a surgical procedure.
Regarding claim 23, Stern as modified teaches the method according to claim 21.
However, Stern as modified fails to teach the method wherein ablation of the mucosal tissue is directed to avoid adversely affecting non-target tissue comprising at least an ampulla of Vater of the patient.
Karpiel teaches a surgical device having a catheter for use within the gastrointestinal tract (Abstract).
Karpiel further teaches a desire to avoid damaging the papilla of vater as healing of the papilla of vater can be problematic (Col. 1, Line 42-Col. 2, Line 12).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date incorporate the teachings of avoiding damage to the ampulla of vater during gastrointestinal surgeries, as is taught by Karpiel, into the method of ablating the gastrointestinal tract, as is taught by Stern as modified, to avoid problematic healing from a surgical procedure.
Claims 14 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Stern (US 20040087936 A1) in view of Kelly (US 20080275445 A1) further in view of Henning (US 20050256077 A1).
Regarding claim 14, Stern as modified teaches the method according to claim 2.
However, Stern as modified fails to teach the method wherein the target mucosal tissue further comprises stem cells at a base of crypts of the mucosal tissue.
Henning teaches a method of treating intestinal tissue of an individual in need of therapy due to insulin dependent diabetes ([0024]).
Henning further teaches this treatment as occurring by ablating the endogenous intestinal stem cells ([0031]) which are located in the crypts ([0016]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of ablating stem cells at a base of crypts of the mucosal tissue, as is taught by Henning, into the methods of mucosal tissue ablation of Stern as modified, to provide a method of treating diabetes.
Regarding claim 27, Stern as modified teaches the method according to claim 21.
However, Stern as modified fails to teach the method wherein the mucosal target tissue further comprises stem cells at a base of crypts of the mucosal tissue.
Henning teaches a method of treating intestinal tissue of an individual in need of therapy due to insulin dependent diabetes ([0024]).
Henning further teaches this treatment as occurring by ablating the endogenous intestinal stem cells ([0031]) which are located in the crypts ([0016]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of ablating stem cells at a base of crypts of the mucosal tissue, as is taught by Henning, into the methods of mucosal tissue ablation of Stern as modified, to provide a method of treating diabetes.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Stern (US 20040087936 A1) in view of Kelly (US 20080275445 A1) further in view of Satake (US 20030065371 A1).
Regarding claim 18, Stern as modified in the above provided claim 2 teaches the method according to claim 2, wherein circumferentially expanding a thickness of submucosal tissue comprises delivering fluid through the fluid delivery elements ([0058]).
However, Stern as modified fails to teach the fluid delivery elements as comprising one or more outlet ports for delivering the fluid.
Satake teaches an ablation balloon which provides heat uniformly to treat tissue (Abstract).
Satake further teaches the device as including nozzles to supply the balloon with liquid ([0023]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of utilizing nozzles to supply liquid into the balloon, as is taught by Satake, into the fluidly inflatable balloon of Stern as modified, to produce the predictable result of providing fluid into an ablation balloon.
Regarding claim 19, Satake further teaches the method according to claim 18, wherein the one or more outlet ports comprise one or more of a nozzle, a fluid jet nozzle, or a deliverable needle ([0023]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Starkebaum/Kellly reference are moot in view of the new rejections under Stern and Kelly.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794