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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/28/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 8/28/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Gonzales, claim 9 was rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Babaev, claim 16 was rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rajagopalan, and claim 19 was rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Babaev. Now, claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan, claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Babaev, claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan, and claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Babaev. Regarding dependent claims 2-8, 10-15, 17-18, and 20, the arguments are also moot because the primary reference in the rejections is now Fan, rather than Rajagopalan.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the device shaft" in line 8. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the device shaft” will be considered “the cannulated device shaft” in line 7 of the claim.
Regarding dependent claims 2-8, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Claim 7 recites the limitation "the cannula device shaft" twice in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the cannula device shaft” will be considered “the cannulated device shaft” in line 2 of the claim.
Claim 9 recites the limitation "the cannulated device shaft" in line 10. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the cannulated device shaft” will be considered “the device shaft” in line 6 of the claim.
Regarding dependent claims 10-15, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Claim 16 recites the limitation "the device shaft" in line 8. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the device shaft” will be considered “the cannulated device shaft” in line 7 of the claim.
Regarding dependent claims 17-18, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 7-8, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan et al., US 20150066005, herein referred to as “Fan”.
Regarding claim 1, Fan discloses a tissue eradication method for at least partially eradicating a target tissue (Figure 1 and [0004]), comprising: reducing the temperature of a cold fluid to a target temperature or target temperature range ([0006]); obtaining a tissue eradication device having a cannulated device shaft (Figure 4: small diameter polymeric shaft 8) and an expanded basket cannula with a plurality of outwardly extending tissue separating members on the cannulated device shaft (Figure 5: spherical frame shape 14), the tissue separating members extending outwardly from and in fixed relationship to the device shaft ([0101]); inserting the cannulated device shaft of the tissue eradication device into the target tissue ([0007]), whereby the tissue separating members of the expanded basket cannula on the cannulated device shaft separate cells in the target tissue (Figure 5: as spherical frame shape 14 expands, it separates cells in the target tissue from each other); and inducing apoptosis in the target tissue by injecting and discharging the cold fluid from the cannulated device shaft of the tissue eradication device into the target tissue ([0090]: “When the liquid nitrogen reaches the distal end of catheter 128 it is sprayed out of cryogen delivery catheter 128 onto the target tissue.” And [0004]).
Regarding claim 5, Fan discloses the tissue eradication method of claim 1, wherein reducing the temperature of the cold fluid to the target temperature or target temperature range comprises reducing the temperature of the cold fluid to the target temperature or target temperature range of from about -21.12° C to about 0° C ([0006]: “The temperature range can be from negative 0.degree. C. to (-)195.degree. C.”; wherein “about -21.12° C to about 0° C is very broad).
Regarding claim 7, Fan discloses the tissue eradication method of claim 1, wherein inserting the cannulated device shaft (Figure 4: small diameter polymeric shaft 8) of the tissue eradication device into the target tissue comprises inserting the cannula device shaft having a cannula lumen in the cannula device shaft ([0093]) and the expanded basket cannula with the plurality of outwardly-extending tissue separating members (Figure 5: spherical frame shape 14) and a plurality of fluid flow spaces formed by and between the plurality of tissue separating members and communicating with the cannula lumen into the target tissue ([0101]: “The fenestrated hole pattern can vary with embodiments meant to target less or more longitudinal distance. The hole pattern can also be cut to target a quadrant or quadrants along a lumen ranging from 0 degrees to 360 depending on desired spray coverage.” And [0093]).
Regarding claim 8, Fan discloses the tissue eradication method of claim 1, further comprising providing a pump in fluid communication with the cannulated device shaft of the tissue eradication device ([0008]), providing a cold fluid container in fluid communication with the pump (Figure 1: reservoir 220) and providing a supply of the cold fluid in the cold fluid container ([0087]: “Cryosurgery system 100 comprises a pressurized cryogen storage tank 126 to store cryogen under pressure.”), and wherein injecting the cold fluid from the cannulated device shaft of the tissue eradication device into the target tissue comprises pumping the cold fluid from the cold fluid container through the cannulated device shaft into the target tissue ([0093]: “. After insertion of the cryogen delivery apparatus into the patient, cryogen is provided to cryogen delivery catheter 204 from a cryogen source. Tip 206 causes the cryogen to be sprayed on the target tissue via hole 214. ” and [0090]: “When the liquid nitrogen reaches the distal end of catheter 128 it is sprayed out of cryogen delivery catheter 128 onto the target tissue.”).
Regarding claim 16, Fan discloses a tissue eradication system for at least partially eradicating a target tissue (Figures 1-5), comprising :a tissue eradication device (Figures 4-5) including: a gripping portion (Figure 4: connector housing 3); a cannulated device shaft extending from the gripping portion (Figure 4: small diameter polymeric shaft 8); an expanded basket cannula (Figure 5: spherical frame shape 14) including a plurality of outwardly extending tissue separating members on the cannulated device shaft (Figure 5: spherical frame shape 14), the tissue separating members extending outwardly from and in fixed relationship to the device shaft ([0101]); and a cold temperature source ([0087]) including: a pump disposed in fluid communication with the cannulated device shaft ([0008]); a cold fluid container disposed in fluid communication with the pump ([0087]: “Cryosurgery system 100 comprises a pressurized cryogen storage tank 126 to store cryogen under pressure.”), the cold fluid container configured to contain a supply of liquid cold fluid ([0087]: “Cryosurgery system 100 comprises a pressurized cryogen storage tank 126 to store cryogen under pressure.”); and a fluid temperature control disposed in thermal communication with the cold fluid container ([0117]: “The precooling is either achieved by the console control or the user's input command (like via a foot pedal).”); and wherein the tissue eradication device is configured to facilitate flow of the liquid cold fluid from the cold fluid container through the cannulated device shaft and discharge the liquid cold fluid from the cannulated device shaft into the target tissue responsive to operation of the pump ([0090]: “When the liquid nitrogen reaches the distal end of catheter 128 it is sprayed out of cryogen delivery catheter 128 onto the target tissue.” And [0004]).
Regarding claim 18, Fan discloses the tissue eradication system of claim 16, wherein the cannulated device shaft comprises an elongated cannula wall (Figure 4: small diameter polymeric shaft 8), a cannula lumen formed by the cannula wall ([0093]) and a distal shaft end (Figure 5) having a shaft tip (Figure 5: machined piece 18), and wherein the plurality of tissue separating members extends outwardly from and in spanning relationship between the cannula wall and the distal shaft end (Figure 5: spherical frame shape 14)and a plurality of fluid flow spaces formed by and between the plurality of tissue separating members and communicating with the cannula lumen ([0101]: “The fenestrated hole pattern can vary with embodiments meant to target less or more longitudinal distance. The hole pattern can also be cut to target a quadrant or quadrants along a lumen ranging from 0 degrees to 360 depending on desired spray coverage.” And [0093]).
Claim Rejections - 35 USC § 103
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 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.
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.
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.
Claims 2-4, 9-15, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Babaev, US 20100076350, herein referred to as "Babaev".
Regarding claim 2, Fan discloses the tissue eradication method of claim 1, but does not explicitly disclose a tissue eradication method further comprising vibrating the cannulated device shaft of the tissue eradication device simultaneous with injecting the cold fluid from the cannulated device shaft of the tissue eradication device into the target tissue.
However, Babaev discloses a tissue eradication method ([0013]) comprising vibrating (Figure 1: ultrasound transducer 20 and [0021]) the cannulated device shaft (Figure 1: shaft 40) of the tissue eradication device (Figure 1) simultaneous with injecting the cold fluid from the cannulated device shaft of the tissue eradication device into the target tissue (Figure 3 and [0032] and [0040]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the shaft vibrates as taught by Babaev to create cavitations within the fluid or the tissue (Babaev [0032]), which provides therapeutic disinfecting properties to help patients resist infections (Babaev [0042]).
Regarding claim 3, Fan in view Babaev discloses the tissue eradication method of claim 2, and Babaev further discloses a method wherein vibrating the cannulated device shaft of the tissue eradication device comprises vibrating (Figure 1: ultrasound transducer 20 and [0021]) the cannulated device shaft (Figure 1: shaft 40) at a vibration or reciprocation frequency within a range of about 2,000-10,000 cycles/min ([0022]: about is interpreted broadly and hz = cpm/60).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the shaft vibrates within a frequency range of about 2,000-10,000 cycles/min as taught by Babaev to treat spider veins and other tissue or skin disorders (Babaev [0022]).
Regarding claim 4, Fan in view of Babaev discloses the tissue eradication method of claim 3, and Babaev further discloses a method wherein vibrating the cannulated device shaft at the vibration or reciprocation frequency within the range of about 2,000-10,000 cycles/min comprises vibrating (Figure 1: ultrasound transducer 20 and [0021]) the cannulated device shaft (Figure 1: shaft 40) at the vibration or reciprocation frequency of about 7,000 cycles/min ([0022]: about is interpreted broadly).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the shaft vibrates at a frequency of about 7,000 cycles/min as taught by Babaev to treat spider veins and other tissue or skin disorders (Babaev [0022]).
Regarding claim 9, Fan discloses a tissue eradication method for at least partially eradicating a target tissue (Figure 1 and [0004]), comprising: reducing the temperature of device shaft on a tissue eradication device to a target temperature or target temperature range ([0006]), the tissue eradication device having an expanded basket cannula (Figure 4: small diameter polymeric shaft 8) with a plurality of outwardly extending tissue separating members on the device shaft (Figure 5: spherical frame shape 14), the tissue separating members extending outwardly from and in fixed relationship to the device shaft ([0101]); inserting the device shaft of the tissue eradication device into the target tissue ([0007]), whereby the tissue separating members of the expanded basket cannula on the cannulated device shaft separate cells in the target tissue (Figure 5: as spherical frame shape 14 expands, it separates cells in the target tissue from each other); and inducing apoptosis in the target tissue by contacting the target tissue with the device shaft ([0090]: “When the liquid nitrogen reaches the distal end of catheter 128 it is sprayed out of cryogen delivery catheter 128 onto the target tissue.” And [0004]). Fan does not explicitly disclose a tissue eradication method comprising vibrating the device shaft.
However, Babaev discloses a tissue eradication method ([0013]) comprising vibrating (Figure 1: ultrasound transducer 20 and [0021]) the device shaft (Figure 1: shaft 40).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the shaft vibrates as taught by Babaev to create cavitations within the fluid or the tissue (Babaev [0032]), which provides therapeutic disinfecting properties to help patients resist infections (Babaev [0042]).
Regarding claim 10, Fan in view of Babaev discloses the tissue eradication method of claim 9, and Babaev further discloses a method wherein vibrating the device shaft comprises vibrating (Figure 1: ultrasound transducer 20 and [0021]) the device shaft (Figure 1: shaft 40) at a vibration or reciprocation frequency within a range of about 2,000-10,000 cycles/min ([0022]: about is interpreted broadly).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the shaft vibrates within a frequency range of about 2,000-10,000 cycles/min as taught by Babaev to treat spider veins and other tissue or skin disorders (Babaev [0022]).
Regarding claim 11, Fan in view of Babaev discloses the tissue eradication method of claim 10, and Babaev further discloses a method wherein vibrating the device shaft at the vibration or reciprocation frequency within the range of about 2,000-10,000 cycles/min comprises vibrating (Figure 1: ultrasound transducer 20 and [0021]) the device shaft (Figure 1: shaft 40) at the vibration or reciprocation frequency of about 7,000 cycles/min ([0022]: about is interpreted broadly).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the shaft vibrates at a frequency of about 7,000 cycles/min as taught by Babaev to treat spider veins and other tissue or skin disorders (Babaev [0022]).
Regarding claim 12, Fan in view of Babaev discloses the tissue eradication method of claim 9, and Fan further discloses a method wherein reducing the temperature of the device shaft on the tissue eradication device to the target temperature or target temperature range comprises reducing the temperature of the device shaft on the tissue eradication device to the target temperature or target temperature range of from about -21.12° C to about 0° C ([0006]: “The temperature range can be from negative 0.degree. C. to (-)195.degree. C.”; wherein “about -21.12° C to about 0° C is very broad).
Regarding claim 13, Fan in view of Babaev discloses the tissue eradication method of claim 9, and Fan further discloses a method wherein reducing the temperature of the device shaft on the tissue eradication device to the target temperature or target temperature range comprises placing at least one cold temperature source in thermal communication with the device shaft ([0087] and [0089-[0090]).
Regarding claim 14, Fan in view of Babaev discloses the tissue eradication method of claim 13, and Fan further discloses a method wherein placing at least one cold temperature source in thermal communication with the device shaft comprises placing a cold fluid in thermal communication with the device shaft ([0087] and [0089-[0090]).
Regarding claim 15, Fan in view of Babaev discloses the tissue eradication method of claim 9, and Fan further discloses a method wherein reducing the temperature of the device shaft on the tissue eradication device to the target temperature or target temperature range comprises reducing the temperature of the device shaft having a distal shaft end with a sharpened, pointed or tapered shaft tip (Figure 4: the shaft tip is tapered at polymeric junction 6) to the target temperature or target temperature range ([0087] and ([0006]: “The temperature range can be from negative 0.degree. C. to (-)195.degree. C.”).
Regarding claim 17, Fan discloses the tissue eradication system of claim 16, but does not explicitly disclose a system further comprising a vibratory motor disposed in contact with at least one of the gripping portion and the cannulated device shaft for vibration of the cannulated device shaft.
However, Babaev discloses a tissue eradication system ([0013]) comprising a vibratory motor (Figure 1: ultrasound transducer 20) disposed in contact with at least one of the gripping portion and the cannulated device shaft ([0021]) for vibration of the cannulated device shaft (Figure 1: shaft 40).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Fan so that the shaft vibrates as taught by Babaev to create cavitations within the fluid or the tissue (Babaev [0032]).
Regarding claim 19, Fan discloses a tissue eradication system for at least partially eradicating a target tissue (Figures 1-5), comprising: a tissue eradication device (Figures 4-5) including: a gripping portion (Figure 4: connector housing 3); a device shaft extending from the gripping portion (Figure 4: small diameter polymeric shaft 8), an expanded basket cannula including a plurality of outwardly extending tissue separating members on the device shaft (Figure 5: spherical frame shape 14), the tissue separating members extending outwardly from and in fixed relationship to the device shaft ([0101]); and a cold temperature source ([0087]) disposed in thermal contact with the device shaft ([0090]: “When the liquid nitrogen reaches the distal end of catheter 128 it is sprayed out of cryogen delivery catheter 128 onto the target tissue.” And [0004])., the cold temperature source configured reduce the temperature of the device shaft to a selected target temperature or target temperature range ([0087] and ([0006]: “The temperature range can be from negative 0.degree. C. to (-)195.degree. C.”). Fan does not explicitly disclose a tissue eradication system comprising a tissue eradication device including a vibratory motor disposed in contact with at least one of the gripping portion and the device shaft for vibration of the device shaft.
However, Babaev discloses a tissue eradication system ([0013]) comprising a vibratory motor (Figure 1: ultrasound transducer 20) disposed in contact with at least one of the gripping portion and the device shaft ([0021]) for vibration of the device shaft (Figure 1: shaft 40).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Fan so that the shaft vibrates as taught by Babaev to create cavitations within the fluid or the tissue (Babaev [0032]), which provides therapeutic disinfecting properties to help patients resist infections (Babaev [0042]).
Regarding claim 20, Fan in view of Babaev discloses the tissue eradication system of claim 19, and Fan further discloses a system wherein the cold temperature source comprises a cold fluid container configured to contain a supply of cold fluid ([0087])
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Buttar et al., US 10779886, herein referred to as "Buttar".
Regarding claim 6, Fan discloses the tissue eradication method of claim 1, including disclosing injecting the cold fluid from the cannulated device shaft of the tissue eradication device into the target tissue ([0090]: “When the liquid nitrogen reaches the distal end of catheter 128 it is sprayed out of cryogen delivery catheter 128 onto the target tissue. ”). Fan does not explicitly disclose a method that comprises injecting tumescent fluid, hypertonic saline solution, epinephrine solution, liposuction infiltration fluid or lactated ringer's solution from the cannulated device shaft into the target tissue.
However, Buttar teaches a method that comprises injecting tumescent fluid, hypertonic saline solution (Col. 5, lines 46-15), epinephrine solution, liposuction infiltration fluid or lactated ringer's solution from the cannulated device shaft into the target tissue (Figure 1: shaft 116 and Col. 5, lines 38-55).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Fan so that the fluid that is injected is hypertonic saline solution as taught by Buttar to facilitate enhanced delivery of energy to the target tissue area (Buttar Coo. 5, lines 46-51).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794