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 .
Response to Arguments
Applicant’s arguments filed 1/14/2026 with respect to the 35 U.S.C. 112(b) rejection of Claim 2 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of 2 has been withdrawn.
Applicant's arguments filed 1/14/2026 with respect to the 35 U.S.C. 103 rejections have been fully considered but they are not persuasive. With respect to Claims 1 and 9, and the rejection of the claims as being unpatentable over Shaker in view of Houser, the Applicant argues the following:
The Applicant argues: “As amended, claim 1 [and claim 9] calls for a second fill volume of a second balloon that is independently controlled from a first balloon using a second infusion port to elicit a secondary peristalsis. That is, the second fill volume of the second balloon recited in claim 1 is independently controlled from the first balloon and elicits a secondary peristalsis. Such a baro-hydrometer device is neither taught nor contemplated by Shaker or Houser, whether taken alone or in combination.”
The Examiner disagrees and respectfully submits that Shaker discloses the independent controlled inflation/volume control of the first and second balloon using first and second infusion ports (see all of paragraph [0014] of Shaker for independent inflation schedules of each of balloons 28, 30 and 32).
The Applicant argues: “It was alleged in the Office Action that Shaker discloses a baro-hydrometer device including a first balloon (e.g., intrasphincteric balloon 30) and a second balloon (e.g., esophageal balloon 28 and/or gastric balloon 32). See Office Action, pp. 3, 4 . However, Shaker does not teach that the esophageal balloon (28) or the gastric balloon (32) elicit secondary peristalsis. In particular, Shaker expressly discloses that "the esophageal balloon 28 is inflated to trigger a motility response and relax the esophagus." Shaker [0038]. One of ordinary skill in the art would understand that a motility response and relaxation of the esophagus is not the same as secondary peristalsis. As such, the filling of the esophageal balloon (28) of Shaker does not elicit a secondary peristalsis, as recited in claim 1 [and claim 9].”
The Examiner disagrees and respectfully submits that the device of Shaker is capable of eliciting secondary peristalsis through independently controlled balloon fill volumes. The cited reference of Shaker discloses multiple balloons, independent inflation/deflation, controlled fill volumes and balloon distension to trigger a motility response. Balloon distension of the esophagus is known stimulus for secondary peristalsis, which is a distension-induced esophageal motility response The reference expressly teaches inflation to “trigger a motility response”. A device configured to distend the esophagus in a controlled manner is therefore capable of eliciting secondary peristalsis.
Second, the Applicant does not identify any structural limitations in Claims 1 and 9 that would distinguish “secondary peristalsis” from Shackler. The claim does not require a specific waveform, propagation speed, confirmation step, etc. The claims merely require that the interpedently controlled balloons be used to elicit secondary peristalsis. The cited structure is fully capable of doing so.
Third, the balloons having the same diameter, different fill volumes and independent control permit localized, controlled distension at separate esophageal regions, precisely the mechanism by which secondary peristalsis is physiologically induced. Applicant’s arguments address the intended purpose of the devices rather than structural incapability.
The Applicant argues: “Correspondingly, the gastric balloon (32) of Shaker merely provides a means for correctly positioning the apparatus (10). In particular, Shaker explicitly discloses that when the gastric balloon (32) is inflated, "the catheter [is allowed] to be gently pulled back from the stomach until the third balloon 32 contacts the stomach wall below the LES, thereby correctly positioning the first and second balloons 28, 30." Shaker, [0025]. As such, the filling of the gastric balloon (32) of Shaker does not elicit a secondary peristalsis, as recited in claim 1. Accordingly, Shaker fails to teach or suggest a second fill volume of a second balloon that is independently controlled from a first balloon using a second infusion port to elicit a secondary peristalsis, as recited in claim 1.”
The Examiner disagrees and respectfully submits the Claims 1 and 9 only require that the second balloon be independently control to elicit secondary peristalsis. The balloons of Shaker are independently inflatable. Inflation within the esophagus produces distension, and Shaker expressly teaches balloon inflation to “trigger a motility response.” Distention-induced motility response encompasses secondary peristalsis. Even if a balloon is used for positioning, this does not render it incapable of eliciting secondary peristalsis.
Furthermore, the Applicant’s arguments do not commensurate in scope with the claimed invention, because the claimed invention fails to set forth that the second ballon be dedicated solely to eliciting secondary peristalsis, the claim only requires that the second balloon be independently controlled to elicit secondary peristalsis.
The rejections are maintained
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20050027313 A1 to Shaker in view of WO 97/03604 to Houser.
Regarding Claims 1 and 6, Shaker discloses a baro-hydrometer device, comprising inter alia:
a catheter (catheter 12, FIG. 1) extending from a first end (at location of extending member 30) to a second end (at location of balloon 28 and/or 32) along a longitudinal axis;
a first balloon (balloon 30) arranged at the first end of the catheter and having a first fill volume (paragraph [0027] “The intrasphincteric balloon 30 … 4-6 cm long … balloon 32 … preferably 2-5 cm in diameter and 4-5 cm wide.”);
a second balloon (balloon 28 and/or 32) arranged at the second end of the catheter and having a second fill volume, wherein the second fill volume of the second balloon is smaller than the first fill volume of the first balloon (paragraph [0027] “The intrasphincteric balloon 30 … 4-6 cm long … balloon 32 … preferably 2-5 cm in diameter and 4-5 cm wide.”) (Examiner notes since Shaker already contemplates the diameter/width of balloon 32, the terms “long” and “wide” are each intended to suggest a length) (see FIG. 1, where balloon 30 appears significantly larger than balloons 28 and 32) (Shaker discloses a balloon 30 that is longer than but with the same common diameter as balloons 28 and/or 32, therefore, the fill volume of balloon 30 is larger than the fill volumes of balloons 28 and/32, because balloon 30 is longer (para [0027]));
a first infusion port fluidically coupling the first balloon to the catheter (paragraph [0026] “The compliance measurement catheter 12 of FIG. 1 is connectable to other instruments which both selectively inflate the series of balloons 28,30,32…”);
a second infusion port fluidically coupling the second balloon to the catheter (paragraph [0026] “The compliance measurement catheter 12 of FIG. 1 is connectable to other instruments which both selectively inflate the series of balloons 28,30,32…”);
where the second fill volume of the second balloon is independently controlled from the first balloon using the second infusion port to elicit a secondary peristalsis (see all of paragraph [0014] of Shaker for independent inflation schedules of each of balloons 28, 30 and 32) (Shaker: paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”) (Examiner notes the device of Shaker is capable of eliciting a secondary peristalsis, because the claims set forth that to elicit such a secondary peristalsis, the first and second fill volumes must be independently controlled through separate infusion ports, and Shaker describes such balloon volume control in paragraph [0014]);
a plurality of pressure sensors arranged with the first balloon (paragraph [0028] “A pressure meter (gauge) 16 is connected to the catheter 12 which communicates with a port 36 inside the intrasphincteric balloon 30 which is used to measure the pressure exerted on the balloon by the LES.”) and the second balloon (paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”).
Shaker discloses the claimed invention except for expressly disclosing where the plurality of pressure sensors are arranged on both the first balloon and the second balloon and where the plurality of pressure transducers comprises at least two pressure transducers coupled to the first balloon and at least one pressure transducer coupled to the second balloon.
However, Houser teaches a balloon catheter featuring on-balloon pressure sensing to read the pressure between the balloon’s exterior and tissue wall (page 4, line 29 to page 5, line 6), contemplates the use of two balloons on the same catheter (page 5, lines 28-29), and specifically states the device has generic application in body lumens of a patient (page 4, lines 4). Houser teaches a plurality of on-balloon pressure sensors mounted on the balloon’s exterior wall to measure pressure between the exterior surface of the balloon and tissue wall (page 4, lines 31-34 and page 4, line 34 to page 5, line 3). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pressure sensor arrangement of Shaker with the plurality of on-balloon pressure sensors of Houser, as Houser teaches that this would overcome the problem of overinflation, which occurs when pressure measurement is performed within the balloon (page 1, line 32 to page 2, line 9). A skilled artisan would have recognized that such modification would have increased patient safety and comfort, and would have provided more accurate and helpful pressure measurement readings.
Regarding Claim 2, Shaker in view of Houser teach the baro-hydrometer device of claim 1, wherein the first balloon and the second balloon have a same maximum diameter (Shaker: paragraph [0027] “… balloon 28 is generally spherical with a diameter of 2.0-2.5 cm.”, “… balloon 30 is typically 1-3 cm in diameter (more preferably 2-3 cm) …”) (“… balloon 32 … preferably 2-5 cm in diameter….”) (balloons 28, 30 and 32 are capable of achieving a common maximum diameter of 2 cm).
Regarding Claim 3, Shaker in view of Houser teach the baro-hydrometer device of claim 1, wherein the second balloon has a shorter length along the longitudinal axis than the first balloon (Shaker: paragraph [0027] “The intrasphincteric balloon 30 … 4-6 cm long … balloon 32 … preferably 2-5 cm in diameter and 4-5 cm wide.”) (Examiner notes since Shaker already contemplates the diameter/width of balloon 32, the terms “long” and “wide” are each intended to suggest a length) (see FIG. 1 of Shaker, where balloon 30 appears significantly larger than balloons 28 and 32).
Regarding Claim 4, Shaker in view of Houser teach the baro-hydrometer device of claim 1, wherein the catheter comprises a first channel providing fluid connection to the first infusion port, and a second channel providing fluid connection to the second infusion port (Shaker: paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”).
Regarding Claim 5, Shaker in view of Houser teach the baro-hydrometer device of claim 4, wherein the first channel is not in fluid communication with the second channel such that a fill volume of the first balloon can be adjusted independent from a fill volume of the second balloon (see all of paragraph [0014] of Shaker for independent inflation schedules of each of balloons 28, 30 and 32) (Shaker: paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”).
Regarding Claim 7, Shaker in view of Houser teach the baro-hydrometer device of any one of claim 1, wherein the first infusion port comprises a plurality of first infusion ports that fluidically couple the first balloon to the catheter (ports 36, 38 of Shaker).
Regarding Claim 8, Shaker in view of Houser teach where the first balloon is composed of polyurethane (Shaker: page 8, line 34 to page 9, line 1).
Regarding Claim 9, Shaker discloses a method for measuring esophageal function in a subject, the method comprising inter alia:
(a) positioning a catheter (catheter 12, FIG. 1) within an esophagus of a subject (paragraph [0024] “Disposed along the length of tubing 22 are a first extendable member 28, such as an inflatable balloon, with the first extendable member 28 being configured to expand and contact the walls of the esophagus, and a second extendable member 30, such as a non-elastic balloon or bag, that is placed in an intrasphincteric position for measuring the compliance of the LES.”), wherein the catheter includes a first balloon (balloon 30) having a pressure sensor (paragraph [0028] “A pressure meter (gauge) 16 is connected to the catheter 12 which communicates with a port 36 inside the intrasphincteric balloon 30 which is used to measure the pressure exerted on the balloon by the LES.”) and a second balloon (balloon 28 and/or 32) having a pressure sensor (paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”);
(b) measuring pressure data with the pressure sensors of balloon and the second balloon while independently controlling a first fill volume of the first balloon and a second fill volume of the second balloon using a second infusion port fluidically coupling the second balloon to the catheter (see all of paragraph [0014] for idependent inflation schedules of each of balloons 28, 30 and 32) (paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”) to elicit a secondary peristalsis (Examiner notes the device of Shaker is capable of eliciting a secondary peristalsis, because the claims set forth that to elicit such a secondary peristalsis, the first and second fill volumes must be independently controlled through separate infusion ports, and Shaker describes such balloon volume control in paragraph [0014]), where the second fill volume is smaller than the first fill volume (Shaker discloses a balloon 30 that is longer than but with the same common diameter as balloons 28 and/or 32, therefore, the fill volume of balloon 30 is larger than the fill volumes of balloons 28 and/32, because balloon 30 is longer (para [0027]));
(c) generating classified pressure data by inputting the pressure data to a classifier implemented with a computer system (paragraph [0028] “The pump 14 and the pressure meter 16 are electrically coupled to a processor/data acquisition unit computer 18, such as a standard desktop computer, for collecting and processing pressure and volume data as described below.”); and
(d) generating esophageal function data from the classified pressure data using the computer system (Claim 5 “… calculating a compliance curve by plotting the plurality of pressure readings taken at each of the progressive series of inflations and analyzing the compliance curve intraoperatively to assess the relative compliance of the lower esophageal sphincter.”).
Shaker discloses the claimed invention except for expressly disclosing where the plurality of pressure sensors are arranged on both the first balloon and the second balloon and where the plurality of pressure transducers comprises at least two pressure transducers coupled to the first balloon and at least one pressure transducer coupled to the second balloon.
However, Houser teaches a balloon catheter featuring on-balloon pressure sensing to read the pressure between the balloon’s exterior and tissue wall (page 4, line 29 to page 5, line 6), contemplates the use of two balloons on the same catheter (page 5, lines 28-29), and specifically states the device has generic application in body lumens of a patient (page 4, lines 4). Houser teaches a plurality of on-balloon pressure sensors mounted on the balloon’s exterior wall to measure pressure between the exterior surface of the balloon and tissue wall (page 4, lines 31-34 and page 4, line 34 to page 5, line 3). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pressure sensor arrangement of Shaker with the plurality of on-balloon pressure sensors of Houser, as Houser teaches that this would overcome the problem of overinflation, which occurs when pressure measurement is performed within the balloon (page 1, line 32 to page 2, line 9). A skilled artisan would have recognized that such modification would have increased patient safety and comfort, and would have provided more accurate and helpful pressure measurement readings.
Regarding Claim 10, Shaker in view of Houser teach the method of claim 9, wherein independently controlling the fill volume of the first balloon and the fill volume of the second balloon comprises adjusting the fill volume of the second balloon to elicit a secondary peristalsis in the esophagus of the subject (Shaker: paragraph [0010] “To measure compliance of the LES, a second extendable member, such as a non-elastic or non-distensible balloon (or bag), is inserted within the LES and filled at prescribed air volume increments via a catheter.”) (Shaker: paragraph [0014] “This balloon applies outward pressure on the esophagus at a suitable position above the LES, which causes the LES to relax through natural physiological functioning of the esophagus.”).
Regarding Claim 11, Shaker in view of Houser teach the method of claim 9, wherein the fill volume of the first balloon and the fill volume of the second balloon are independently adjusted by adjusting a first volume of fluid in the first balloon and a second volume of fluid in the second balloon (see all of paragraph [0014] of Shaker for independent inflation schedules of each of balloons 28, 30 and 32) (Shaker: paragraph [0030] “A suprasphincteric manometry port 40 is located between the esophageal balloon 28 and the intrasphincteric balloon 30 and a fourth port, the gastric manometry port 39, is located distal of the gastric balloon 32, each connected to a pressure transducer 33 or the pressure meter 16 via a separate lumen 24.”).
Regarding Claim 12, Shaker in view of Houser teach the method of claim 11, wherein the fluid is air (Shaker: paragraph [0010] “… prescribed air volume increments …”).
Regarding Claims 13-16, Shaker in view of Houser teach the method of claim 11 as set forth and cited above. Houser teaches wherein the first balloon is filled with saline and the second balloon is filled with air (Houser: page 4, lines 10-11; page 9, lines 30-32; page 11, lines 26-27). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to further modify Shaker to fill the first balloon with saline and the second balloon with air, as Houser teaches that the medium for filling each balloon is chosen independently (page 4, lines 10-11; page 9, lines 30-32; page 11, lines 26-27) because their catheter is designed for accurate pressure sensing and must be adaptable to different tissue properties to avoid overinflation (page 2, lines 30 to page 3, line 1). A skilled artisan would have recognized that such modification would have improved accuracy and adaptability to patient anatomy while avoiding overinflation.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaker and Houser as applied to claim 9 above, and further in view of US 20140343415 to Hoffman et al. (hereinafter, Hoffman).
Shaker and Houser teach the method of claim 9 as set forth and cited above except for expressly teaching wherein generating the classified pressure data comprises accessing a trained machine learning algorithm with the computer system and inputting the pressure data to the trained machine learning algorithm, generating output as the classified pressure data, wherein the trained machine learning algorithm is trained on training data comprising pressure profiles indicative of different contractile response patterns.
However, Hoffman teaches a system of using esophageal pressure profiles for diagnostic classification of esophageal function (paragraph 0007). Hoffman teaches wherein generating the classified pressure data comprises accessing a trained machine learning algorithm with the computer system ([0029] “The mapping performed by the program may use supervised machine learning based on a training set of clinically acquired swallow measurements each linked to a diagnostic value.”) and inputting the pressure data to the trained machine learning algorithm, generating output as the classified pressure data (paragraph [0056] “… supervised machine learning relies on the training of a supervised learning machine 76 using a training set 78 comprised of multiple data sets 80 of the type that need to be analyzed (e.g., the parameters described above associated with a swallow) tagged with the desired outputs 82 (e.g., the diagnoses outputs) to which each given data set 80 should be mapped. After training, an "undiagnosed" data set 80' may be provided to the supervised learning machine 76 to produce diagnostic outputs 82'.”), wherein the trained machine learning algorithm is trained on training data comprising pressure profiles indicative of different contractile response patterns (paragraph [0029] “The mapping performed by the program may use supervised machine learning based on a training set of clinically acquired swallow measurements each linked to a diagnostic value.”) (paragraph [0049] “… maximum pressure within the region, maximum rise time in pressure within the region, maximum fall time in pressure within the region, duration of pressure above the baseline, and maximum rise rate of pressure within the region.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the teachings of Shaker and Houser with the machine learning trained pressure profiles for diagnostic esophageal contractile response patterns of Hoffman, as Hoffman teaches at paragraph [0030] that machine-learning would have allowed for the mapping of complex data for diagnosis.
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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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791