DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3 Applicant’s arguments with respect to claim(s) 1-10 and 12-30 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
5. Claims 1, 5-9, 12-15, 18, 20, 23, and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadamus U.S. 2020/0305972 (herein referred to as “Kadamus”).
6. Regarding Claim 1, Kadamus teaches a method of ablating tissue (Fig. 7; para 0087, 0120), the method comprising:
a. inserting an endoscope into a duodenum of a patient (para 0087, “device 100 can be constructed and arranged for insertion into the body of a patient, such as through a channel of an endoscope (e.g., an endoscope inserted through the mouth of a patient and accessing a GI location such as the duodenum)…”);
b. inserting a catheter through a channel of the endoscope and into the duodenum of the patient (para 0087, “device 100 can be constructed and arranged for insertion into the body of a patient, such as through a channel of an endoscope (e.g., an endoscope inserted through the mouth of a patient and accessing a GI location such as the duodenum)…”);
c. expanding a structure to circumferentially surround an interior surface of the duodenum (para 0087, “submucosal tissue of the duodenum or other GI tract location can be expanded”; Fig. 7, ref num 130; para 0090), wherein the expanded structure defines a first treatment zone (Fig. 7, ref character “TT”; para 0147, “tissue expansion of a first portion of target tissue TT by device 100”);
d. directing a first amount of energy to a portion of the patient’s duodenum through the distal end of the catheter and into the expanded structure over a first period of time (Fig. 7, ref num 250 delivers energy to ref num 130; para 0189, “either both expandable assembly 130 or treatment assembly 160 can be used to ablate target tissue TT”; para 0169, 0181)
e. after directing the first amount of energy to the first treatment zone, compressing the structure (para 0167, “expandable assembly 130… can be resiliently biased, such as in a radially expanded or radially compacted state… by a control shaft….and manipulatable by an operator of the system 10 and/or by motion transfer assembly 260”), moving the catheter to a different portion of the patient’s duodenum (para 0154, “repositioning of… expandable assembly 130”), and expanding the structure to define a second treatment zone (para 0196, “configured to treat a first portion of the desired treatment area followed by a second portion of the desired treatment area”; para 0213);
f. directing a second amount of energy to said second treatment zone through the distal end of the catheter and into the expanded structure (para 0213, “Energy delivery can be varied from a first tissue location (e.g. a first portion of target tissue TT) to a second location (e.g. a second portion of target tissue TT)…”; understood that the second amount of energy would be delivered through expanded structure, ref num 130); and
g. after directing the second amount of energy to the second energy to the second treatment zone, repeatedly moving the catheter to different portions of the patient’s duodenum, forming different treatment zones, and applying amounts of energy until a contiguous circumferential ablation of 25% to 90% of the patient’s mucosa over a length of 2 cm to 25 cm of the duodenum is achieved (para 0213; para 0196, “treatment element 165 and/or other ablation elements of the present inventive concepts can be configured to treat a first portion of the desired treatment area followed by a second portion of the desired treatment area. The first and second treated tissue segments can be overlapping and they can have non-parallel central axes (e.g. tissue segments in a curved portion of the duodenum). Three or more target tissue segments can be treated, such as to cumulatively ablate at least 25% or at least 50% of the duodenal mucosa”; para 0140, “expand a submucosal layer of the duodenum comprising a cumulative axial length of at least 5 cm, at least 10 cm, or at least 15 cm”; para 0046).
7. Regarding Claim 5, Kadamus teaches a shape of the expanded structure is substantially cylindrical (para 0167, “Expandable assembly 130 and/or treatment assembly 160 can approximate a tubular shape when expanded”).
8. Regarding Claim 6, Kadamus directing the first amount of energy into the first treatment zone (Fig. 7, ref num 250 delivers energy to ref num 130; para 0189, “either both expandable assembly 130 or treatment assembly 160 can be used to ablate target tissue TT”; para 0169, 0181) causing a fluid to be delivered into the distal end of the catheter (Fig. 7, ref num 132; para 0168, “expandable assembly 130 and at least one fluid delivery element 132 are configured to expand or otherwise modify tissue, such as to expand one or more layers of tissue. One or more fluid delivery elements 132 can comprise a needle, water jet and/or iontophoretic fluid delivery element configured to deliver injectate 221 into target tissue”), heating the fluid within the distal end of the catheter to generate ablative vapor (para 0169, “thermal energy such as heat energy… provided by an ablative fluid”; para 0189 discusses ref num 130 releasing the ablative fluid), and releasing the ablative vapor through one or more ports positioned within an interior of the expanded structure (Fig. 7, ref num 109, 132; para 0189 and 0172, 0175).
9. Regarding Claim 7, Kadamus teaches the second treatment zone is proximally positioned in the duodenum relative to the first treatment zone (para 0196, “configured to treat a first portion of the desired treatment area followed by a second portion of the desired treatment area”; para 0140, “distal portion of device 100 can be repositioned (e.g., advanced, retracted and/or rotated)… repeated one or more additional times, such as to expand tissue in multiple locations… followed by an ablation of tissue”; it is understood that the second portion may be proximal compared to the first as desired by the treatment).
10. Regarding Claim 8, Kadamus wherein each different treatment zone is proximally positioned in the duodenum relative to the second treatment zone (para 0196, “configured to treat a first portion of the desired treatment area followed by a second portion of the desired treatment area”; para 0140, “distal portion of device 100 can be repositioned (e.g., advanced, retracted and/or rotated)… repeated one or more additional times, such as to expand tissue in multiple locations… followed by an ablation of tissue”; it is understood that an subsequent treatment zones may be proximal compared to the second as desired by the treatment).
11. Regarding Claim 9, Kadamus teaches the fluid is saline para 0151, “injectate 221 can comprise a fluid selected from the group consisting of: water; saline”).
12. Regarding Claim 12, Kadamus teaches the ablative vapor is released through the one or more ports positioned within the expanded structure for a duration of 1 to 10 seconds (para 0181, “cooling fluid is automatically and/or semi-automatically delivered to remove thermal energy from target tissue TT and/or other tissue, such as cooling fluid delivered for a time period of at least 2 seconds, at least 5 seconds, at least 10 seconds”; para 0168, “fluid delivery element 132”).
13. Regarding Claim 13, Kadamus teaches a length of the first treatment zone is between 2 cm and 25 cm in length (para 0140, “expand tissue in multiple locations of the gastrointestinal tract, such as to substantially expand a submucosal layer of the duodenum comprising a cumulative axial length of at least 5 cm, at least 10 cm, or at least 15 cm”).
14. Regarding Claim 14, Kadamus teaches the expanded structure comprises a plurality of openings to allow partial escape of the ablative vapor from the treatment zones (Fig. 7, ref nums 132).
15. Regarding Claim 15, Kadamus teaches measuring pressure in the treatment zones (para 0110, “functional element 109 can comprise a sensor… [such as a] pressure sensor”; para 0114).
16. Regarding Claim 18, Kadamus teaches inserting the catheter into the duodenum of the patient through a working channel of the endoscope (Fig. 7, ref num 50 = endoscope; catheter, ref num 100 inserted through ref num 50; para 0157, “flexible portion of device 100 is configured to pass through a working channel of an endoscope…. advanced to reach the… duodenum”).
17. Regarding Claim 20, Kadamus teaches the catheter comprises a temperature sensor adjacent to one or more ports (Fig. 7, ref num 109; para 0110, “functional element 109 can comprise a sensor…. Temperature sensor”).
18. Regarding Claim 23, Kadamus teaches the catheter comprises at least one lumen for delivery of the fluid (Fig. 7, ref num 54; para 0199, “second lumen 54 travels proximally and connects to a source of insufflation liquid”) and one lumen for electrode wiring (para 0155, “shafts 110a and 110b can include one or more lumens passing therethrough, and can comprise wires…. For transfer of data and/or energy such as RF energy to a functional element 109”).
19. Regarding Claim 28, Kadamus teaches inserting the endoscope into the duodenum of the patient such that a distal tip of the endoscope is positioned distal to the patient’s ampulla of Vater (para 0043, “the system is constructed and arranged to ablate tissue distal to the ampulla of Vater”).
20. Regarding Claim 29, Kadamus teaches said circumferential ablation of the patient’s mucosa is achieved without requiring any other device to be positioned int the patient’s duodenum outside said endoscope and catheter (see Fig. 7, ablation is achieved with the catheter, ref num 100, and the endoscope, ref num 50).
21. Regarding Claim 30, Kadamus teaches the circumferential ablation of the patient’s mucosa forms an ablated region, wherein said ablated region has an average thickness and a mean thickness, and wherein a thickness of ablated tissue at any specific point in the ablation region is within 25% of said average thickness or mean thickness (para 0197, “Target tissue TT can include at least a portion of safety-margin tissue comprising tissue whose ablation causes minimal or no adverse effect to the patient, such as sub-mucosal tissue of the GI tract. Target tissue TT can comprise one or more portions of tissue that are treated simultaneously or sequentially. In some embodiments, the target tissue TT comprises at least 25% or at least 50% of the duodenal mucosa”).
Claim Rejections - 35 USC § 103
22. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
23. Claims 2, 3, 22, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kadamus and in view of Rajagopalan U.S. 2017/0333122 (herein referred to as “Rajagopalan”).
24. Regarding Claim 2, Kadamus as modified teaches the method of Claim 1, but Kadamus fails to teach manipulating the sheath to expose the expandable structure.
Rajagopalan teaches a method of ablating tissue of analogous art (Fig. 6; para 0329) wherein the method comprises manipulating the sheath to expose the expandable structure (para 0341). This aids in navigating the catheter through the anatomy of the patient without prematurely expandable the expandable structure (para 0341). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to include that the sheath is manipulated to expose the expandable structure, as this provides the advantage of navigating through body lumens without prematurely deploying the structure.
25. Regarding Claim 3, Kadamus as modified teaches the method of Claim 2, but Kadamus alone fails to teach the expandable structure is self-expanding upon manipulating the sheath.
However, Rajagopalan teaches the expandable structure is self-expanding upon manipulating the sheath (para 0309). This allows for seamless, continual tissue treatment (para 0309). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to have the expandable structure self-expand when manipulating the sheath, as this provides the advantage of seamless tissue treatment.
26. Regarding Claim 22, Kadamus as modified teaches the method of claim 1, but Kadamus alone fails to teach the ablation of the portion of the surface of the gastrointestinal tract causes a structural change in at least one of a mucosal tissue layer or submucosal tissue layer of the surface of the gastrointestinal tract.
Rajagopalan teaches a method of ablating tissue of analogous art (Figs. 3 and 6; para 0329) wherein the method comprises ablation of the portion of a surface of the GI tract causes a structural change in at least one of a mucosal tissue layer or submucosal tissue layer (para 0330). Since Kadamus teaches treating the mucosal tissue/submucosal tissue (Kadamus, para 0182), and Rajagopalan discusses the treatment zone comprising duodenal tissue (Rajagopalan, para 0329), then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus with the teachings of Rajagopalan and had the mucosal or submucosal layer disrupted, as this produces the same expected result of treating tissue within that target area.
27. Regarding Claim 24, Kadamus teaches the method of claim 1, as well as the expanded structure extends longitudinally along a length of the patient’s duodenum, wherein the expanded structure has a first positioning element proximal to said length, and a second positioning element distal to said length (Fig. 7, ref nums 160 and 130 extend along duodenum).
Kadamus fails to teach a wire mesh extending from the first positioning element to the second positioning element.
Rajagopalan teaches a method of ablating tissue of analogous art (Figs. 5D and 6; para 0303, 0329) wherein the method comprises the expanded wire-mesh structure extends longitudinally along a length of the patients small intestine (Fig. 5D, ref num 100; para 0006, 0109, 0249), wherein the structure has a first position element proximal to said length (Fig. 5D, ref num 193b), a second position element distal to said length (Fig. 5D, ref num 193a), and a wire mesh extending from the first positioning element to the second positioning element (Fig. 5C, ref num 136”; para 0318, “such as two occluders 193 positioned at opposite ends of a segment of GI tract to be treated by agent dispensing element 136″…”; para 0316-0317). This prevents unwanted migration of the vapor outside of the treatment zone (para 0318). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to include a wire mesh extending between the two positioning elements in order to prevent undesired migration of the ablative vapor outside of the treatment zone.
28. Regarding Claim 25, Kadamus as modified teaches the method of claim 1, but fails to teach the expanded structure extends longitudinally along a length of the patient's small intestine, wherein the expanded wire-mesh structure has a first disc proximal to said length, a second disc distal to said length, and a wire mesh extending from the first disc to the second disc.
Rajagopalan teaches a method of ablating tissue of analogous art (Figs. 5D and 6; para 0303, 0329) wherein the method comprises the expanded wire-mesh structure extends longitudinally along a length of the patients small intestine (Fig. 5D, ref num 100; para 0006, 0109, 0249), wherein the structure has a first position element proximal to said length (Fig. 5D, ref num 193b), a second position element distal to said length (Fig. 5D, ref num 193a), and a wire mesh extending from the first positioning element to the second positioning element (Fig. 5C, ref num 136”; para 0318, “such as two occluders 193 positioned at opposite ends of a segment of GI tract to be treated by agent dispensing element 136″…”; para 0316-0317). This prevents unwanted migration of the vapor outside of the treatment zone (para 0318). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to include a first and second positioning elements in order to prevent undesired migration of the ablative vapor outside of the treatment zone.
While Kadamus as modified by Rajagopalan fails to explicitly teach that the first and second positioning elements are discs, it would have been an obvious matter of design choice to make the different portions of the positioning elements whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
29. Regarding Claim 26, Kadamus as modified teaches the method of claim 1, but fails to teach the expanded wire-mesh structure extends longitudinally along a length of the patient's small intestine, wherein the expanded structure has a first cone proximal to said length, a second cone distal to said length, and a wire mesh extending from the first cone to the second cone.
Rajagopalan teaches a method of ablating tissue of analogous art (Figs. 5D and 6; para 0303, 0329) wherein the method comprises the expanded wire-mesh structure extends longitudinally along a length of the patients small intestine (Fig. 5D, ref num 100; para 0006, 0109, 0249), wherein the structure has a first position element proximal to said length (Fig. 5D, ref num 193b), a second position element distal to said length (Fig. 5D, ref num 193a), and a wire mesh extending from the first positioning element to the second positioning element (Fig. 5C, ref num 136”; para 0318, “such as two occluders 193 positioned at opposite ends of a segment of GI tract to be treated by agent dispensing element 136″…”; para 0316-0317). This prevents unwanted migration of the vapor outside of the treatment zone (para 0318). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to include a first and second positioning elements in order to prevent undesired migration of the ablative vapor outside of the treatment zone.
While Kadamus as modified by Rajagopalan fails to explicitly teach that the first and second positioning elements are cones, it would have been an obvious matter of design choice to make the different portions of the positioning elements whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
30. Claims 4 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kadamus and Rajagopalan, and further in view of Beetel U.S. 2012/0101413 (herein referred to as “Beetel”).
31. Regarding Claim 4, Kadamus as modified teaches the method of Claim 2, but fails to teach the structure to expand into the stent-like shape by manipulating a wire attached to a distal end of the structure.
Beetel teaches a method of ablating tissue of analogous art (para 0070), wherein the method comprises an expanding structure that forms a stent-like shape (Figs. 6 and 7, ref num 22, 60 expands) by manipulating a wire attached to a distal end of the structure (Figs. 6 and 7, ref num 68; para 0078, “a control wire 68 that is fixed to the distal end 44 of the mesh structure… the control wire 68 facilitates the expansion and/or contraction of the mesh structure 22”). By manipulating a wire to expand the structure, this aids in maneuvering the structure to the desired area before expanding the structure, as well as being able to reposition the structure by compressing the before movement or removal (para 0078 and 0097). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to include a wire to manipulate the expansion of the structure in order to aid with proper placement of the structure through the compression and expansion thereof.
32. Regarding Claim 27, Kadamus as modified teaches the method of claim 1, but fails to teach compressing the expanded structure by manipulating a wire attached to a distal end of the structure and manipulating the sheath to cover the structure.
Beetel teaches a method of ablating tissue of analogous art (para 0070), wherein the method comprises an expanding structure that forms a stent-like shape (Fig. 12B, ref num 60) by manipulating a wire attached to a distal end of the structure (Fig. 12B, ref num 104; para 0101, “The self-expanding mesh structure 1222b may be compressed by retraction into the delivery sheath facilitated by pulling the wires 104. Wires 104 may further be beneficial by providing a flexible connection between the mesh structure 1222b and the distal end of the elongated shaft 16”) and manipulating the sheath to cover the structure (Fig. 12B, ref num 91; para 010 “the self-expanding mesh structure 1222b may be deployed by retracting a delivery sheath 91 to remove constraining forces”; para 0096, “delivery sheath 91 may be used in conjunction with a guide wire”). By manipulating a wire to expand the structure and manipulating the sheath to cover the structure, this aids in maneuvering the structure to the desired area before expanding the structure, as well as being able to reposition the structure by compressing the within the sheath before movement or removal (para 0078 and 0097). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to include a wire and sheath to manipulate and cover the expansion and compression of the structure in order to aid with proper placement of the structure thereof.
33. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kadamus and Rajagopalan, and further in view of Shadduck U.S. 2004/0068306 (herein referred to as “Shadduck”).
34. Regarding Claim 16, Kadamus as modified teaches the method of claim 1, but fails to teach heating the fluid within the distal end of the catheter generates a subtherapeutic dose of the ablative vapor and wherein said release of the ablative vapor through one or more ports positioned within the interior of the expanded structure causes said subtherapeutic dose to be delivered to the surface of the duodenum.
Shadduck teaches a method of analogous art, such as heating the fluid within the distal end of the catheter generates a subtherapeutic dose of the ablative vapor (para 0070, “electrodes 515A and 515B… for applying energy to inflowing liquid media M to cause it change in phase to vapor media M'”) and wherein said release of the ablative vapor through one or more ports positioned within the interior of the expanded structure causes said subtherapeutic dose to be delivered to the surface of the organ (Fig. 20A, ref nums 522 = ports within expandable structure, ref num 524; vapor “M'” released via the ports, para 0073-0074). This produces the same expected result of ablating the target tissue (para 0070, 0073-0074). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to heat the fluid to generate a subtherapeutic dose of ablative fluid and release said fluid through the ports of the expanded structure to deliver the subtherapeutic dose to be delivered to the surface of the duodenum in order to treat the target tissue area.
35. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kadamus, Rajagopalan, and Shadduck, and further in view of Hoey U.S. 2014/0276713 (herein referred to as “Hoey 2014”).
36. Regarding Claim 17, Kadamus as modified teaches the method of claim 16, but fails to teach following said delivery of the subtherapeutic dose and before moving the catheter, heating the fluid within the distal end of the catheter to generate a therapeutic dose of the ablative vapor and releasing the ablative vapor through one or more ports positioned within the interior of the expanded wire mesh structure to cause said therapeutic dose to be delivered to the surface of the gastrointestinal tract.
Hoey 2014 teaches a method of analogous art (Figs. 3, 4A, 4B, and 18), wherein the method comprises ablative vapor is released through one or more ports (Fig. 4B, ref num 125 ejects the ablative vapor; para 0102). Hoey 2014 also teaches generating a subtherapeutic dose and a therapeutic dose of vapor, such that both are released through one or more ports to be delivered to the surface of the organ (Fig. 18, ref nums 860A and 860B, ref num 892 and 896; para 0135). This promotes a more effective propagation of the vapor to the target tissue and allows for a greater energy delivery to the target tissue (para 0135). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to deliver a therapeutic dose of vapor after a subtherapeutic dose in order to achieve the desired effect of ablating the target tissue.
37. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kadamus and in view of Hoey U.S. 2011/0160648 (herein referred to as “Hoey 2011”).
38. Regarding Claim 19, Kadamus teaches the method of claim 1, but Kadamus alone fails to teach an amount of energy delivered by the released ablative vapor in the treatment zone is between 100 J and 500 J.
Hoey 2011 teaches a method of analogous art (para 0005, 0118), wherein the amount of energy delivered by a released ablative vapor in a treatment zone is between 100 J and 500 J (para 0034, “contacting the vapor media with the targeted tissue to thereby delivery energy ranging from 5 joules to 100,000 joules”). This produces the expected result of causing the therapeutic effect, i.e., ablating the target tissue (para 0034). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kadamus to delivery energy between 100 J and 500 J, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
39. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kadamus.
40. Regarding Claim 21, Kadamus as modified teaches the method of claim 1, but fails to teach the expanded wire mesh structure comprises a scalloped distal end and a scalloped proximal end. Kadamus does teach that the shape of the expandable structure could be a variety of shapes (para 0167). It would have been an obvious matter of design choice to make the different portions of the expanded structure whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Conclusion
41. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
42. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794