DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Amendment filed 04/07/25 has been entered. Claims 1-12 have been cancelled, and new claims 13-28 have been entered. Claims 13-28 are addressed in the following action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 13, 15-21, and 25 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Utley et al. (US 2002/0115992).
Regarding claim 13, an invention relating to ablation devices, Utley discloses (Figs. 5, 8, 10-11) a device (26) for expanding tissue (Abstract) comprising: an elongate shaft (30); at least one fluid delivery tube (34 & 82) [Note, a tube would have to be between element 34 and element 66 in order for treatment agent to be delivered from the lumen of element 66, hence element 82 is interpreted as that tube since element 82 delivers the treatment agent] comprising a proximal end [i.e. proximal end of element 34], a distal end [i.e. distal end of element 82] and a lumen therebetween (Par. 0076, 0084, 0098), wherein the elongate shaft has a distal end (62) that surrounds at least part of the at least one fluid delivery tube (Par. 0081); at least two hollow fluid delivery needles (66) in fluid communication with the lumen of the at least one fluid delivery tube (Par. 0084 & 0098); and an expandable support (56 & 72) having a recess (84) constructed and arranged to slidingly receive a hollow fluid delivery needle of the at least two hollow fluid delivery needles (Par. 0086); wherein the at least two hollow fluid delivery needles-are constructed and arranged to deliver fluid into luminal wall tissue (Par. 0098).
Regarding claim 15, Utley discloses the device of claim 13. Utley further discloses wherein the at least one fluid delivery tube comprises a first fluid delivery tube and a second fluid delivery tube [i.e. each element 82 going into each spine body (58)], and wherein the at least two hollow fluid delivery needles comprise a first hollow fluid delivery needle fluidly connected to the first fluid delivery tube and a second hollow fluid delivery needle fluidly connected to the second fluid delivery tube [i.e. each element 66 going into each spine body (58) and connecting to a respective elements 82 and to element 34 to communicate treatment agent] (Par. 0083-0084 & 0098).
Regarding claim 16, Utley discloses the device of claim 13. Utley further discloses wherein the at least one fluid delivery tube comprises a first fluid delivery tube (34), and wherein the at least two hollow fluid delivery needles comprise a first hollow fluid delivery needle fluidly connected to the first fluid delivery tube and a second hollow fluid delivery needle fluidly connected to the first fluid delivery tube [i.e. each element 66 going into each spine body (58) and connecting to a respective elements 82 and to element 34 to communicate treatment agent] (Par. 0083-0084 & 0098).
Regarding claim 17, Utley discloses the device of claim 16. Utley discloses further comprising a fluid dispersion manifold [i.e. where the delivery apparatus (44) couples to needle lumens (136)] coupled between the at least one fluid delivery tube and the at least two hollow fluid delivery needles [i.e. each element 66 going into each spine body (58) and connecting to element 34 to communicate treatment agent] (Par. 0083-0084 & 0098).
Regarding claim 18, Utley discloses the device of claim 13. Utley discloses (Fig. 8) wherein the at least two hollow fluid delivery needles comprise a circumferential array of at least three fluid delivery elements (66; Par. 0081-0086).
Regarding claim 19, Utley discloses the device of claim 13. Utley discloses wherein the at least two hollow fluid delivery needles comprise at least three hollow fluid delivery needles equally spaced along a circumference (Fig. 8; Par. 0081-0086).
Regarding claim 20, Utley discloses the device of claim 13. Utley discloses (Fig. 8) wherein at least one said hollow fluid delivery needle of the at least two hollow fluid delivery needles comprises an advanceable fluid delivery element (66; Par. 0095).
Regarding claim 21, Utley discloses the device of claim 20. Utley discloses (Fig. 8) further comprising a surface (119) positioned to limit the advancement of the at least one hollow fluid delivery needle (Par. 0087).
Regarding claim 25, Utley discloses the device of claim 13. Utley discloses (Fig. 8) wherein the expandable support comprises an element selected from the group consisting of: at least one balloon (72); two or more support arms (58); a radially deployable structure (56); and combinations thereof (Par. 0086 & 0089-0090).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 14 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al. (US 2002/0115992) as applied to claim 13 above, and further in view of Edwards et al. (US 2010/0114087).
Regarding claim 14, Utley discloses the device of claim 13. Utley further discloses wherein the device is configured to expand tissue in the duodenum and the elongate shaft is configured to be inserted through a mouth (Par. 0071, 0073, 0092). However, Utley fails to explicitly disclose the elongate shaft has a working length greater than or equal to 100cm.
In the same field of endeavor, which is ablation devices, Edwards teaches (Fig. 3) an elongate shaft (18) has a working length greater than or equal to 100cm (Par. 0080).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Utley to have the elongate shaft has a working length greater than or equal to 100cm. Doing so would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (Par. 0080), as taught by Edwards.
Claims 22-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al. (US 2002/0115992) as applied to claim 13 above, and further in view of Utley et al. (US 2011/0257646) [Utley’646].
Regarding claims 22-23, Utley discloses the device of claim 13. Utley fails to disclose further comprising a spring-loaded hollow fluid delivery needle advancement assembly coupled to the at least two hollow fluid delivery needles [Claim 22]; and wherein the spring-loaded hollow fluid delivery needle advancement assembly is constructed and arranged to simultaneously advance multiple hollow fluid delivery needles [Claim 23].
In the same field of endeavor, which is ablation devices, Utley’646 teaches (Figs. 18-20) a spring-loaded hollow fluid delivery needle advancement assembly (204 & 228) coupled to the at least two hollow fluid delivery needles (216); and wherein the spring-loaded hollow fluid delivery needle advancement assembly is constructed and arranged to simultaneously advance multiple hollow fluid delivery needles (Par. 0131-0134).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Utley to have a spring-loaded hollow fluid delivery needle advancement assembly coupled to the at least two hollow fluid delivery needles [Claim 22]; and wherein the spring-loaded hollow fluid delivery needle advancement assembly is constructed and arranged to simultaneously advance multiple hollow fluid delivery needles [Claim 23]. Doing so would provide hand grips sized to be conveniently grasped in the hand of a physician, and provide spring-assisted return of the fluid delivery needles into their normally retracted position (Par. 0126 & 0136), as taught by Utley’646.
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al. (US 2002/0115992) as applied to claim 13 above, and further in view of Bek et al. (US 2006/0155261).
Regarding claim 24, Utley discloses the device of claim 13. Utley fails to disclose further comprising a pressure sensor, wherein the device is constructed and arranged to monitor pressure prior to, during and/or after the delivery of fluid into the luminal wall tissue.
In the same field of endeavor, which is ablation devices, Bek teaches a pressure sensor, wherein the device is constructed and arranged to monitor pressure prior to, during and/or after the delivery of fluid into the luminal wall tissue (Abstract & Par. 0049).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Utley to have a pressure sensor, wherein the device is constructed and arranged to monitor pressure prior to, during and/or after the delivery of fluid into the luminal wall tissue. Doing so would confirm the device is positioned at or near the targeted tissue region (Par. 0048-0049), as taught by Bek.
Claims 26-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Utley et al. (US 2002/0115992) as applied to claim 13 above, and further in view of Edwards et al. (US 2002/0013581).
Regarding claims 26-27, Utley discloses the device of claim 13. Utley fails to disclose wherein the expandable support is configured to apply a vacuum to each recess; and further comprising a vacuum source configured to bring the elongate shaft in contact with tissue.
In the same field of endeavor, which is ablation devices, Bek teaches (Figs. 70-71) wherein the expandable support is configured to apply a vacuum to each recess (300); and further comprising a vacuum source [i.e. source of negative pressure] configured to bring the elongate shaft in contact with tissue (Par. 0360 & 0367-0369).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Utley to have wherein the expandable support is configured to apply a vacuum to each recess; and further comprising a vacuum source configured to bring the elongate shaft in contact with tissue. Doing so would anchor surrounding tissue and mediate against the tenting of tissue during electrode penetration (Par. 0353), as taught by Edwards.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (US 2010/0114087) in view of Utley et al. (US 2002/0115992) and Starkebaum (US 2005/0246037).
Regarding claim 28, an invention relating to ablation devices, Edwards discloses (Figs. 1, 5B, 13, 16) a device (10) for expanding tissue (Par. 0079) comprising: an elongate shaft (18); at least one fluid delivery tube (58) comprising a proximal end, a distal end and a lumen therebetween, wherein the elongate shaft has a distal end that surrounds at least part of the at least one fluid delivery tube (Par. 0085); at least two hollow fluid delivery needles (90) in fluid communication with the lumen of the at least one fluid delivery tube (Par. 0026); and an expandable support (44 & 55) having a recess (64) constructed and arranged to slidingly receive a hollow fluid delivery needle of the at least two hollow fluid delivery needles (Par. 0094); wherein the at least two hollow fluid delivery needles-are constructed and arranged to deliver fluid into luminal wall tissue (Par. 0026). Note, Edwards further discloses the amount of clearance between the aperture inner diameter and the needle electrode outside diameter which can vary between 0.001'' and 0.1''. However, Edwards fails to disclose at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween, wherein the elongate shaft has a distal end that surrounds at least part of the at least one fluid delivery tube; at least two hollow fluid delivery needles in fluid communication with the lumen of the at least one fluid delivery tube; wherein the at least two hollow fluid delivery needles-are constructed and arranged to deliver fluid into luminal wall tissue [Claim 13]; and wherein the recess comprises an axial length up to 5mm and/or a width up to 2mm [Claim 28].
In the alternative and in the same field of endeavor, which is ablation devices, Utley teaches (Figs. 5, 8, 10-11) at least one fluid delivery tube (34 & 82) [Note, a tube would have to be between element 34 and element 66 in order for treatment agent to be delivered from the lumen of element 66, hence element 82 is interpreted as that tube since element 82 delivers the treatment agent] comprising a proximal end [i.e. proximal end of element 34], a distal end [i.e. distal end of element 82] and a lumen therebetween (Par. 0076, 0084, 0098), wherein the elongate shaft has a distal end (62) that surrounds at least part of the at least one fluid delivery tube (Par. 0081); at least two hollow fluid delivery needles (66) in fluid communication with the lumen of the at least one fluid delivery tube (Par. 0084 & 0098); wherein the at least two hollow fluid delivery needles-are constructed and arranged to deliver fluid into luminal wall tissue (Par. 0098).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Edwards to have at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween, wherein the elongate shaft has a distal end that surrounds at least part of the at least one fluid delivery tube; at least two hollow fluid delivery needles in fluid communication with the lumen of the at least one fluid delivery tube; wherein the at least two hollow fluid delivery needles-are constructed and arranged to deliver fluid into luminal wall tissue. Doing so would allow treatment agent to be injected into the sphincter (Par. 0098), as taught by Utley.
In the same field of endeavor, which is ablation devices, Starkebaum discloses (Fig. 3) a needle (36) with a diameter in the range of less than approximately 2 mm to 4 mm in inside diameter (Par. 0044), for delivering fluid into luminal wall tissue (Par. 0041). Hence, the needle diameter of less than approximately 2 mm to 4 mm plus the clearance of 0.001” to 0.1”, disclosed by Edwards, would provide the recess comprises an axial length up to 5mm and/or a width up to 2mm.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Edwards to have wherein the recess comprises an axial length up to 5mm and/or a width up to 2mm. Edwards discloses a hollow fluid delivery needles for delivering fluid into luminal wall tissue are desired (Abstract & Par. 0026), thus Starkebaum’s needle would have provided Osborne with a sufficiently sized hollow fluid delivery needles for delivering fluid into a luminal wall tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 10, 2026