DETAILED ACTION
1. This office action is in response to the communicated dated 18 March 2026 concerning application number 18/562,292 effectively filed on 18 November 2023.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
Information Disclosure Statement
3. The Information Disclosure Statement submitted on 18 March 2026 have been considered by the Examiner.
Claim Objections
4. Claim 23 is objected to because of the following informality.
Claim 23 contains a minor typographical error.
Claim 23, line 1: The Examiner suggests changing “The method of claim 12” to “The method of claim 11”.
Appropriate correction is required.
Response to Arguments
5. Applicant’s arguments dated 18 March 2026, referred to herein as “the Arguments”, have been fully considered. However, upon further consideration a new ground of rejection has been provided in the updated text below.
Claim Rejections - 35 USC § 102
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 11, 13-14, 16, 18, 20, 23-24, 27-31, 41, and 46-47 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Agha (US 2020/0246054 A1).
Regarding claim 11, Agha teaches a method of reducing visceral fat from a body of a patient (the cryoprobe is configured to reduce the intraperitoneal fat which is also referred to as “visceral fat” [abstract, 0005, 0032]) comprising thermally treating the visceral fat in the body of the patient sufficient to form a liquid-fat mixture or emulsion (the intraperitoneal fat (e.g., visceral fat) is thermally treated during the cryoablation treatment to form the liquified intraperitoneal fat [abstract, 0032, 0037-0038, claim 1]); and
aspirating the emulsion from the patient (the liquified intraperitoneal fat (e.g., visceral fat) is vacuumed or aspirated from the patient [abstract, 0032, 0037-0038, claim 1]).
Regarding claim 13, Agha teaches wherein the treating comprises cooling the visceral fat within the body of the patient to a low temperature sufficient to cause the visceral fat cells to freeze (the cryoprobe is configured to freeze the intraperitoneal fat cells (e.g., visceral fat) during the cryoablation treatment [abstract, 0032-0033, 0048, claim 1]).
Regarding claim 14, Agha teaches a warming liquid into the body of the patient at a warm temperature sufficient to thaw the fat cells, thereby releasing lipids into the warming liquid and forming the liquid-fat emulsion (the intraperitoneal fat (e.g., visceral fat) is thermally treated (e.g., heated) during the cryoablation treatment to form the liquified intraperitoneal fat [abstract, 0032, 0037-0038, claim 1]).
Regarding claim 16, Agha teaches making an incision in the skin of the patient to access the visceral fat (the cryoprobe is inserted through an incision and into the intraperitoneal fat (e.g., visceral fat) [0032, 0040-0043]).
Regarding claim 18, Agha teaches wherein the cooling step is performed with a cooling device comprising a handle (the cryoprobe includes a portion that is gripped by the surgeon [0024]), a shaft (the cryoprobe comprises an insulated shaft section 107 [0025, FIG. 1]), and a distal treatment section adapted to conduct heat from the visceral fat to cool the visceral fat to the low temperature (the cryoprobe includes an uninsulated distal treatment section 101 that freezes the intraperitoneal fat (e.g., visceral fat) [abstract, 0005, 0025-0026, claim 1, FIG. 1]).
Regarding claim 20, Agha teaches wherein the delivering a warming liquid is performed with a liquid delivery device (the cryoprobe includes a liquid delivery channel to provide a warm fluid (e.g., helium) to heat the intraperitoneal fat (e.g., visceral fat) [0032, 0037]).
Regarding claim 23, Agha teaches wherein the aspiration step is performed with an aspiration device (the aspiration device or vacuum sleeve is coupled to the cryoprobe to remove the intraperitoneal fat (e.g., visceral fat) [abstract, 0005, 0032, 0039, claim 1]). The Examiner respectfully submits that claim 23 further recites optional steps which are not required.
Regarding claim 24, Agha teaches measuring temperature with a cooling device (the cryoprobe includes a temperature sensor to measure the temperature [0036-0037, 0073, 0081]), and wherein the cooling device is adjusted or controlled based on the measured temperature (the surgeon may monitor and control the cryoprobe freezing based on the measurements from the temperature sensor [0036-0037, 0073, 0081]. Furthermore, a computer system may communicate with the temperature sensors to control the cooling of the cryoprobe [0036, 0073, 0081]).
Regarding claim 27, Agha teaches wherein the visceral fat is in the mesentery ([0032-0033]).
Regarding claim 28, Agha teaches comprising visualizing the treatment of the visceral fat ([0024, 0032-0033, 0038, 0052]).
Regarding claim 29, Agha teaches heating the liquid-fat mixture along a passageway out of the body to maintain the liquid-fat mixture in a low viscosity state (the cryoprobe may be warmed or heated using radiofrequency (RF) energy to thaw the frozen intraperitoneal fat (e.g., visceral fat) into a liquified-fat mixture [0032-0033, 0037, 0080, claim 1]. Furthermore, the RF warming helps prevent the liquified-fat mixture from sticking to the surface of the cryoprobe while the liquified-fat mixture is being vacuumed ([0032, 0037, 0052, 0080, claim 1]).
Regarding claim 30, Agha teaches advancing an introducer into the body of the patient to provide access to the visceral fat, and wherein the cooling device is advanced through the introducer (the cryoprobe is advanced through an outer cryoprobe sheath into the intraperitoneal fat (e.g., visceral fat) [abstract, 0025, 0032-0033]).
Regarding claim 31, Agha teaches avoiding mechanical disruption of the visceral fat and extracellular matrix while performing the cooling and aspiration steps (Agha avoids the use of mechanical processes (e.g., liposuction) that involve mechanical liquification of fat which would damage internal organs [0008, 0014]. Instead, during the cooling procedure, Agha teaches the use of a warm fluid or thermal energy (e.g., RF energy) to thaw the frozen intraperitoneal fat (e.g., visceral fat) into a liquified-fat mixture [0032-0033, 0037, 0080, claim 1]. Furthermore, the warm fluid or thermal energy (e.g., RF energy) helps prevent the liquified-fat mixture from sticking to the surface of the cryoprobe while the liquified-fat mixture is being vacuumed ([0032, 0037, 0052, 0080, claim 1]. Thus, the Examiner respectfully submits that Agha does not describe any mechanical treatment process that would cause mechanical disruption of the visceral fat and the extracellular matrix).
Regarding claim 41, Agha teaches a surgical method for reducing fat cells in the body of a patient ([abstract, 0032-0033, 0037-0038]) comprising:
accessing the fat cells through an incision in the body of the patient (the cryoprobe is inserted through an incision and into the intraperitoneal fat (e.g., visceral fat) [0032, 0040-0043]).;
gently forming, in situ, a liquid-fat mixture from the fat cells ([0040, 0051-0053, claim 1]);
wherein the forming step comprises cooling the fat cells with a cooling apparatus such that a cell membrane of the fat cells is disrupted, burst or ruptures (the cryoprobe can provide a temperature of -40° C to cause disruption or destruction of the cells of the intraperitoneal fat (e.g., visceral fat) [0032-0033, 0035, 0037, 0048]);
delivering a liquid to the fat cells, wherein components of the cells are taken up by the liquid, thereby forming the liquid-fat mixture (as stated previously above, the cryoprobe can provide a temperature of -40° C to cause disruption or destruction of the cells of the intraperitoneal fat (e.g., visceral fat) [0032-0033, 0035, 0037, 0048]. Furthermore, a liquid may be delivered to the frozen fat cells to form a liquified-fat mixture [0037, 0048, 0051-0052]); and
wherein the delivering step further comprises warming or thawing the cooled cells by delivering a warm liquid (a warm liquid may be used to thaw the frozen fat cells [0037, 0051-0052]); and
aspirating the liquid-fat mixture (the liquified intraperitoneal fat (e.g., visceral fat) is vacuumed or aspirated from the patient [abstract, 0032, 0037-0038, claim 1]).
Regarding claim 46, Agha teaches wherein the fat cells are visceral fat cells ([0032-0033, claim 1]).
Regarding claim 47, Agha teaches wherein the fat cells are mesentery fat cells ([0032-0033, claim 1]).
Claim Rejections - 35 USC § 103
8. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
9. Claims 19, 21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Agha.
Regarding claim 19, Agha teaches the method of claim 18. Agha teaches wherein the low temperature ranges from a minimum of -10 degrees C or lower to a maximum of -40 degrees C ([0035]).
Agha does not explicitly teach wherein the low temperature ranges from 0 to -40 degrees C. The Examiner respectfully submits that Agha teaches wherein the low temperature ranges from a minimum of -10 degrees C or lower to a maximum of -40 degrees C ([0035]). Thus, a person having ordinary skill in the art would have found it obvious to modify the cooling device (e.g., cryoprobe) to cool the visceral fat from a temperature of 0 to -40 degrees C. The advantage of such modification will provide a larger temperature range that can improve the process for freezing the cells of the visceral fat (see paragraphs [0032, 0035] by Agha). The Examiner further submits that the skilled artisan could arrive at the claimed range via routine experimentation (MPEP 2144.05).
Regarding claim 21, Agha teaches the method of claim 20. Agha teaches wherein the delivering a warming liquid is performed for a duration of 2 to 4 minutes from the cooling step ([0037]).
Agha does not explicitly teach wherein the delivering a warming liquid is performed for a duration ranging from 1 to 5 minutes within five (5) minutes from the cooling step, or optionally, within two (2) minutes. The Examiner respectfully submits that Agha teaches wherein the delivering a warming liquid is performed for a duration of 2 to 4 minutes from the cooling step ([0037]). Therefore, it would have been obvious to a person having ordinary skill in the art to modify the step of delivering the warm liquid to be performed for a duration of within 2 minutes. The advantage of such modification will improve the thawing of the frozen fat tissue (e.g., visceral fat) ([0032, 0037-0038]). The Examiner further submits that the skilled artisan could arrive at the claimed duration via routine experimentation (MPEP 2144.05).
Regarding claim 26, Agha suggests the method of claim 19, wherein the cooling is performed for a duration of a few minutes ([0028, 0032]).
Agha does not explicitly teach wherein the cooling is performed for a duration between 10 and 60 seconds. The Examiner respectfully submits that Applicant’s claimed duration of 10 to 60 second lies within Agha’s duration of a few minutes ([0028]). Therefore, a prima face case of obviousness exists. Based on the overlapping range, a person having ordinary skill in the art would have found it obvious to modify the cooling duration to range between 10 and 60 seconds (MPEP 2144.05). The advantage of such modification will provide cooling duration that allows for treating a precise region of the visceral fat without causing damage to the surrounding healthy tissue ([0028, 0032-0033]).
Conclusion
10. Due to the new grounds of rejection included in this office action, which were not necessitated by the Applicant’s amendments to the claims, this action has been made NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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