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 .
Acknowledgment
Claim 52 is amended and filed on 2/12/2026.
Claims 55-56 are newly added.
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.
Claim(s) 1-14, 16-17, 52-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US. 20190388133A1) in view of Rajagopalan et al. (US. 20170007310A1) (“Rajagopalan”) and Jones et al. (US 20170258855A1)(“Jones”) and further in view of Newberry et al. (US 20180228868 A1)(“ Newberry”).
Re Claim 1, Sharma discloses a method of treating a gastrointestinal tract dysbiosis (Fig. 1A-N, Fig. 11a-b ¶0012, ¶0347, improving the macrobiotic composition and other bacteria activities), the method comprising: delivering a condensable vapor to a targeted region of a lumen of a gastrointestinal tract (the system 100 in Fig. 1a can be used for ablating a tissue inside a gastrointestinal tract ¶0115, by vapor at condensable temperature see ¶0249, ¶0293, ¶0357) to ablate content of a luminal surface including a mucous layer of the gastrointestinal tract (¶0269, ¶0293, ¶0357, wherein the mucous layer can be treated) such that a microbiome of the luminal surface and the mucous layer is ablated (¶0255, ¶0344 wherein the temperature and the energy level can be controlled to treat the mucosa layer and the microbiome layer which is above the mucosa/ mucous layer, and the ablation, this include two steps of ablation ¶0249 to ensue complete ablation of the target tissue), but it is silent with regards that the ablation is done without ablating a submucosal layer of the gastrointestinal tract and the entire microbiome of the luminal surface and the mucous layer is ablated; and depositing a biodegradable material in the targeted region to release a restorative microbiota in the lumen of the gastrointestinal tract over a time interval, wherein the biodegradable material is contained in an implant affixed within the gastrointestinal tract.
However, Rajagopalan discloses a method of treating gastrointestinal tract (¶0145) has step of the ablation of a mucous layer without ablating a submucosal layer of the gastrointestinal tract (¶0145 such as mucosa layer alone) and the entire microbiome of the luminal surface and the mucous layer is ablated (abstract, ¶0144-¶0145, destroy local bacteria or alter the microbiota by the ablation, ¶0184).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that the ablating step is done without ablating a submucosal layer of the gastrointestinal tract and the entire microbiome of the luminal surface and the mucous layer is ablated as taught by Rajagopalan for the purpose of treating the digestive system related to the ineffective microbiota in desired target area (Rajagopalan, ¶0145).
The Sharma in view of Rajagopalan fail to disclose depositing a biodegradable material in the targeted region to release a restorative microbiota in the lumen of the gastrointestinal tract over a time interval, wherein the biodegradable material is contained in an implant affixed within the gastrointestinal tract.
However, Jones discloses a method of treating microbiota therapy (¶0005) and comprises the depositing a biodegradable material in the targeted region (¶0152) to release a restorative microbiota in the lumen of the gastrointestinal tract (abstract, ¶0075, ¶0076 by the orally, enema or suppository, ¶0092 inside a biodegradable carrier ¶0152).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma to include depositing a biodegradable material in the targeted region to release a restorative microbiota in the lumen of the gastrointestinal tract as taught by Jones for the purpose of treating the digestive system which disease related to the ineffective microbiota (Jones, ¶0076).
Sharma in view of Rajagopalan and Jones fails to disclose that the release the agent in the lumen of the gastrointestinal tract over a time interval, and wherein the biodegradable material is contained in an implant affixed within the gastrointestinal tract.
However, Newberry discloses a method of the gastrointestinal tract (method of administration ¶0121, control of the release in time ¶0122, location of the treatment is the gastrointestinal tract ¶0203) and comprises the depositing a biodegradable material in the targeted region (¶0143 such as polyglycolic acid similar to the material of the ¶0064 of the current application) to release an agent over a time interval (¶0143), and wherein the biodegradable material is contained in an implant (¶0143) affixed within the gastrointestinal tract (¶0121 just as released in rectal).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that to include release a restorative microbiota in the lumen of the gastrointestinal tract over a time interval, wherein the biodegradable material is contained in an implant affixed within the gastrointestinal tract as taught by Newberry for the purpose of controlling on releasing the agent over time (Newberry, ¶0143).
Re Claim 2, Sharma discloses delivering a catheter (¶0108, ¶0372) to the targeted region and expanding a first occlusion balloon and a second occlusion balloon to engage a wall of the gastrointestinal tract (Figs.1A-L, example balloons 168, 166..etc. ¶0108 and/or Fig. 11a-b, example Balloons 1147, 1148, ¶0373), where the first occlusion balloon is spaced apart from the second occlusion balloon (Figs.1A-L, example balloons 168, 166..etc. ¶0108 and/or Fig. 11a-b, example Balloons 1147, 1148, ¶0373), and delivering the condensable vapor through an inflow channel of the catheter to the targeted region between the first occlusion balloon and the second occlusion balloon (Figs.1A-L, example openings 167..etc. ¶0247and/or Fig. 11a-b, example openings 1149, ¶0373).
Re Claim 3, Sharma discloses wherein the condensable vapor undergoes a vapor-to- liquid phase change that applies ablative thermal energy to the luminal surface (¶0247, ¶0373).
Re Claim 4, Sharma discloses wherein a portion of a liquid condensate resulting from the vapor-to-liquid phase change flows outward from the targeted region through an outflow channel and an outlet in the catheter (channel within the catheter to the port such as 19, ¶0274, ¶0291).
Re Claim 5, Sharma discloses wherein the vapor-to-liquid phase change ablates an epithelium of the targeted region (the epithelium is surface of the mucosa, ¶0269).
Re Claim 6, Sharma discloses wherein the vapor-to-liquid phase change applies ablative thermal energy for 2 to 20 seconds (time can be in range of 1-60 seconds, ¶0344,¶0352).
Re Claim 7, Sharma discloses wherein the vapor-to-liquid phase change applies ablative thermal energy at a rate of 5 to 100 cal/second ( the range of energy rate around 5-2500 cal/sec, ¶0344, ¶0352).
Re Claim 8, Sharma discloses wherein the first occlusion balloon and the second occlusion balloon are spaced apart from 2 cm to 20 cm (the distance between the two position elements/balloons is around 1-20 cm base on the target tissue, ¶0248).
Re Claim 9, Sharma fails disclose ablating the mucous layer of the luminal surface sequentially in a plurality of locations by re-positioning the catheter, the first occlusion balloon and the second occlusion balloon.
However, Rajagopalan discloses a method of treating gastrointestinal tract (¶0145) has step of ablating the mucous layer of the luminal surface (¶0144) sequentially (¶0158) in a plurality of locations by re-positioning the catheter, the first occlusion balloon and the second occlusion balloon (143a, 143b, ¶0106, ¶0158).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that ablating the mucous layer of the luminal surface sequentially in a plurality of locations by re-positioning the catheter, the first occlusion balloon and the second occlusion balloon as taught by Rajagopalan for the purpose of treating the digestive system multiples target area (Rajagopalan, ¶0106, ¶0158).
Re Claim 10, Sharma discloses wherein ablating the mucous layer is provided over a continuous length of the gastrointestinal tract of at least 10 cm (¶0248, treatment area can be 1-20 cm or 1-10cm).
Re Claim 11, Sharma discloses wherein ablating the mucous layer is within a duodenum (¶0011, ¶0248 duodenal, ¶0249 duodenum).
Re Claim 12, Sharma discloses wherein ablating the mucous layer is within a jejunum (any location of the GI tract can be used for the ablation such jejunum which is part of small intestine ¶0012, ¶0292, see also, Fig. 23a to present that jejunum 2352 and duodenum 2350d).
Re Claim 13, Sharma discloses wherein ablating the mucous layer is within all four parts of a duodenum (any location of the GI tract can be used for the ablation, ¶0115 and specifically in ¶0012, ¶0247 to show that all tissue/parts of duodenum is treated with ablation ¶0249).
Re Claim 14, embodiment of Fig. 1, Fig. 11 of Sharma is silent with regards to the step of expanding either the first occlusion balloon or the second occlusion balloon to cover an ampulla of Vater when ablating the luminal surface on either side thereof.
However, Sharma discloses in embodiment of Fig. 23b expanding either the first occlusion balloon or the second occlusion balloon to cover an ampulla of Vater (2351) when ablating the luminal surface on either side thereof (¶0419).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention o have modified the method of embodiment of Fig. 1 , Fig. 11 of Sharma so that expanding either the first occlusion balloon or the second occlusion balloon to cover an ampulla of Vater when ablating the luminal surface on either side thereof as taught by embodiment of Fig. 23b of Sharma the purpose of treating specific area without damaging an ampulla of Vater (Sharma, ¶0419).
Re Claim 16, Sharma discloses using endoscopic vision during positioning of the catheter positioned and expanding the first occlusion balloon and the second occlusion balloon (¶0060, ¶0269).
Re Claim 17, Sharma discloses wherein at least one sensor of at least one occlusion balloon sends a signal of balloon contact with the luminal surface (17, sensor, Fig. 1a, can be optical or pressure or temperature, see the changes in the tissue area so it can detect that changes to the surface of the luminal so that it detect the effect of inflation the balloon when contacts the luminal surface, ¶0274).
Claim(s) 52-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Rajagopalan and Jones and further in view of Meade et al. (US 20050125075A1) (“Meade”).
Re Claim 52, Sharma discloses a method of treating a gastrointestinal tract dysbiosis (Fig. 1A-N, Fig. 11a-b ¶0012, ¶0347, improving the macrobiotic composition and other bacteria activities) the method comprising: delivering a condensable vapor to a targeted region of a lumen of a gastrointestinal tract (the system 100 in Fig. 1a can be used for ablating a tissue inside a gastrointestinal tract ¶0115, by vapor at condensable temperature see ¶0249, ¶0293, ¶0357) to ablate content of a luminal surface including a mucous layer of the gastrointestinal tract (¶0269, ¶0293, ¶0357, wherein the ablation device can also be specifically used for the treatment of focal or circumferential mucosal and moreover, the depth of the ablation is controllable to treat of mucosal, ) such that a microbiome of the luminal surface and the mucous layer is ablated (¶0255, ¶0344 wherein the temperature and the energy level can be controlled to treat the mucosa layer and the microbiome layer which is above the mucosa/ mucous layer, and the ablation, this include two steps of ablation ¶0249 to ensue complete ablation of the target tissue), but it fails to disclose that ablating step is done without ablating a submucosal layer of the gastrointestinal tract and the entire microbiome of the luminal surface is ablated and the mucous layer is ablated, affixing an implant device within the gastrointestinal tract, where the implant device is configured to deliver a restorative microbiota to the targeted region of the gastrointestinal tract over a selected time interval.
However, Rajagopalan discloses a method of treating gastrointestinal tract (¶0145) has step of the ablation of a mucous layer without ablating a submucosal layer of the gastrointestinal tract (¶0145 such as mucosa layer alone) and the entire microbiome of the luminal surface and the mucous layer is ablated (abstract, ¶0144-¶0145, destroy local bacteria or alter the microbiota by the ablation, ¶0184).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that the ablating step is done without ablating a submucosal layer of the gastrointestinal tract and the entire microbiome of the luminal surface is ablated and the mucous layer is ablated as taught by Rajagopalan for the purpose of treating the digestive system related to the ineffective microbiota in desired target area (Rajagopalan, ¶0145).
Sharma in view of Rajagopalan fails to disclose affixing an implant device within the gastrointestinal tract, where the implant device is configured to deliver a restorative microbiota to the targeted region of the gastrointestinal tract over a selected time interval
However, Jones discloses a method of treating gastrointestinal tract (¶0059) has step of placing an implant device within the gastrointestinal tract (delivery device such as implants, ¶0152 using endoscope ¶0149), where the implant device is configured to deliver a restorative microbiota (¶0092) to the targeted region of the gastrointestinal tract over a time (abstract, ¶0075, ¶0076, ¶0152, ¶0164).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma to include step of delivering an implant device within the gastrointestinal tract, where the implant device is configured to deliver a restorative microbiota to the targeted region of the gastrointestinal tract over a selected time interval as taught by Jones for the purpose of treating the digestive system related to the ineffective microbiota in controlled release formulation (Jones, ¶0076, ¶0152).
Sharma in view of Rajagopalan and Jones fails to disclose that the release the agent in over a selected time interval and the affixing the implant device is within the gastrointestinal tract.
However, Meade discloses a method of implanting an implant device within the gastrointestinal tract (Fig. 28-30) and wherein the implant device (2800) has a proximal end 2810 was affixed to the stomach (¶0152) and it is used to deliver an agent (¶0158) and control of the release in selected time interval ( time of implanting to releasing all drug ¶0013).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that affixing an implant device within the gastrointestinal tract and release the a restorative microbiota in the lumen of the gastrointestinal tract over a time interval, and as taught by Meade for the purpose of controlling on releasing the agent over predetermined time (Meade, ¶0013).
Re Claim 53, Sharma fails to disclose wherein the implant device is delivered through an endoscope.
However, Jones discloses a method of treating gastrointestinal tract (¶0059) has step of positioning an implant device within the gastrointestinal tract (¶0152), where the implant device is configured to deliver a restorative microbiota to the targeted region of the gastrointestinal tract over a selected time interval (abstract, ¶0075, ¶0076) and delivery can be through an endoscope. (¶0016, ¶0149, ¶0152).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that the implant device is delivered through an endoscope as taught by Jones for the purpose of treating the digestive system related to the ineffective microbiota in controlled release formulation (Jones, ¶0076, ¶0152).
Re Claim 54, Sharma fails to disclose the implant device is delivered outside of an endoscope.
However, Jones discloses a method of treating gastrointestinal tract (¶0059) has step of positioning an implant device within the gastrointestinal tract (¶0152), where the implant device is configured to deliver a restorative microbiota to the targeted region of the gastrointestinal tract over a selected time interval (abstract, ¶0075, ¶0076) and delivery can be outside of an endoscope (¶0149, ¶0152).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that the implant device is delivered through an endoscope as taught Jones for the purpose of treating the digestive system related to the ineffective microbiota in controlled release formulation (Jones, ¶0076, ¶0152).
Re Claim 55, Sharma fails to disclose wherein the implant comprises a proximal portion that does not release the biodegradable material.
However, Meade discloses a method of implanting an implant device within the gastrointestinal tract (Fig. 28-30) and wherein the implant device (2800) has a proximal end 2810 does not release the biodegradable material ¶0155, only the sleeve can be coated with agent).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that the implant comprises a proximal portion that does not release the biodegradable material as taught by Meade for the purpose of controlling on releasing the agent over predetermined time (Meade, ¶0013).
Re Claim 56, Sharma fails to disclose wherein the proximal portion is affixed in a stomach.
However, Meade discloses a method of implanting an implant device within the gastrointestinal tract (Fig. 28-30) and wherein the implant device (2800) has a proximal end 2810 is affixed in a stomach (¶0152).
Thus, it would have been prima facie obvious to one having ordinary skill in the art to have modified the method of Sharma so that the proximal portion is affixed in a stomach as taught by Meade for the purpose of anchoring the implanted device within a desired tissue to deliver the agent toward intestine (Meade, ¶0013, ¶0152).
Response to Arguments
Applicant's arguments filed 2/12/2026 with respect to claim have been fully considered but they are not persuasive.
The applicant argues that modifying Sharma to ablate submucosa and the entire microbiome contradicts the principle of Sharma as it is it is ablate from first level of bacteroidetes and the ablate to a second level of bacteroidetes …etc. this is found not persuasive as claimed “to ablate content of a luminal surface including a mucous layer ..such that an entirety of microbiome of the luminal surface is ablated” in view of ¶0052 of the current specification of the application, entire selected length of the GI lumen is ablated. Sharma has a similar device for performing similar method by ablating mucosal in affected area see ¶0269 but it is silent with regards ablating a mucous layer (only) of the gastrointestinal tract without ablating a submucosal layer such that an entirety of a microbiome of the luminal surface is ablated. The applicant’s argument seems to indicate that the first stage of treatment will leave some bacteria and the treatment is not for entire microbiome, this is not persuasive as device is removed from the ablated area so the microbiome is transport from other location. Therefore, the applicant introduces a secondary reference to show that the entire microbiome is ablated.
The applicant argues with regards to the term “affixing” that the art is used to position the implant in the GI tract without affixing. This is found not pervasive as placing the implant in GI tract such as in the rectal mean that the device is affixing within the GI tract. However, claim 56 further define the term leads to reject the claim in new reference ( only claim 52).
Applicant’s arguments, see remark, filed 2/12/2026, with respect to the rejection(s) of claim(s) 1 under 103 and with respected to claim 52 and in view of newly added claims 55-556 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sharma in view of Rajagopalan and Jones and Meade.
Conclusion
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.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783