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 .
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.
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive.
First, the Applicant argues that Anand does not teach the use of a thermoelectric generator with an exposed surface and opposite concealed surface, but the Examiner does not agree. In Figure 4, the thermoelectric generator is identified as element 7, a thermoelectric element in Anand. The Examiner then cites surface 10 with 11 (an internal face of 10) as the exposed portion outside of the housing (see Fig. 4, where surface 10 is exposed) and concealed surface 12, which is a junction that is a concealed surface of the thermoelectric element 7. The structure of the claimed invention is taught under broadest reasonable interpretation. If the Applicant intends to claim a more advanced configuration that is seen in the specification, then the Applicant must do so explicitly in the claims. While the claims are read in light of the specification, limitations from the specification are not read into the claims. See in re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, the Applicant argues that Anand would not be capable of welding the blood vessels together, but the Examiner disagrees. The Examiner notes in the office action that Anand does not explicitly teach that the differential heat is applied weld the blood vessels together, but does cite pertinent disclosure from the art that thermoelectric element of Anand can create a temperature differential. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use (Anand’s structure does teach the claimed invention’s structure under broadest reasonable interpretation, and Anand’s system can create a temperature differential as cited in the Non-Final Office action and disclosure of Anand), then in meets the claim. The Examiner further went to cite Pate, a relevant and analogous piece of art that describes welding blood vessels together, to demonstrate that it is known in the art to use differential heating to denature proteins (what Anand accomplishes) to weld blood vessels together. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument to claims 8 and 12, the Examiner has fully considered the argument and does not find them to be persuasive. In MPEP 2144.04 VI B, it states that the mere duplication of parts does not provide any patentable significance unless there is a new or unexpected result to be achieved or produced. The Applicant has not provided any evidence of this in the filed Response.
Additionally, Applicant argues that the handheld energy generator of Ogata is not analogous to a thermoelectric generator. The Examiner relied upon Ogata as an example that it is known in the art to use handheld power sources for energy generation in surgical devices, as Ogata states. A power source is capable of producing power for radiofrequency, or thermoelectric generation, depending upon the parameters of the device in use. A source of power is a source of energy and is not limited to use for only one modality: for the purposes of example only, a battery is capable of supplying energy to a phone or a remote, it does not distinguish or prevent energy output based on the device being used. A recitation of the intended use (for use in a thermoelectric generator versus radiofrequency generator) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the Examiner’s position that the hand-held battery would be capable of providing power to the claimed invention, unless the handheld power source of the claimed invention has a different structure or feature that is not currently claimed. The Applicant argues that the thermoelectric control requirements of the claimed invention are not considered in the disclosure of Ogata, but the thermoelectric control requirements of the claimed invention are not positively recited: only a handheld energy device is. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Anand (WIPO Patent Publication WO 89/04137) in view of Pate (US Patent Publication US 2019/0133678).
Regarding claim 1, Anand teaches
“A system comprising a catheter (20 and 3) for forming a fistula between two blood vessels (the system is directed to the removal of deposits within a patient’s body via heat but is capable of being used according to the purpose of the claimed invention), the catheter comprising:”
“a housing (20);”
“a treatment portion (1, Figure 3) coupled to the housing, the treatment portion comprising:”
“a thermoelectric generator (7, Figure 4) comprising an exposed surface (10 with 11) exposed outside of the housing and a concealed surface (12) opposite and electrically connected to the exposed surface”,
“wherein: the thermoelectric generator is configured to produce a temperature differential between the exposed surface and the concealed surface when an electric current is applied to one of the exposed surface and the concealed surface thereby producing the temperature differential between the exposed surface and the concealed surface to weld the two blood vessels together (page 15, lines 27 – page 16, lines 12)”.
Anand does not explicitly teach that the differential heat applied is used to weld two blood vessels together, however, Pate does in an analogous device for welding blood vessels together. Pate teaches in p.[0031] that “The heat applied to the compressed vessel tissue (204, 210) may denature proteins in a manner to adhere the vessels together and may form a weld, which may increase the mechanical strength of the vessels. Upon completion of welding between the blood vessels (204, 210), the catheters (200, 206) may be removed.” The heat applied in Anand as described above would achieve the function of welding the blood vessels together, as recognized in Pate. It would have been obvious to one of ordinary skill in the art to use the thermoelectric generator configured to produce a temperature differential between the blood vessels in order to weld them together, as described in Pate, in view of Anand. The system of Anand is capable of producing the differential and one of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to do so in order to “increase the mechanical strength of the vessels” and produces predictable results.
Regarding claim 2, the limitations of claim 1 are taught as described above. Anand teaches “further comprising an energy source coupled to the thermoelectric generator (36, Figure 5)”.
Regarding claim 4, the limitations of claim 1 are taught as described above. Anand teaches “wherein the thermoelectric generator comprises at least one n-type semiconductor and at least one p-type semiconductor disposed between and electrically connected to the exposed surface and the concealed surface (page 4, lines 11-19; page 8, lines 12-30)”.
Regarding claim 5, the limitations of claim 1 are taught as described above. Anand teaches “wherein the thermoelectric generator comprises a thermoelectric material (page 4, lines 11-19; page 8, lines 12-30)”.
Regarding claim 6, the limitations of claim 1 are taught as described above. Anand nor Pate do not explicitly teach that there is location indicators configured to provide location information of the treatment portion of the catheter as it is advanced through a subject, however, Anand does teach a metal sleeve, 23 disposed on the treatment portion of the catheter (claim 6 of Anand). This metal sleeve, 23, has distinct visibility compared to native tissue in the subject through imaging methods, and would show the treatment portion of the catheter as it is advanced through the subject, therefore teaching the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recognize a metal sleeve as a visual indicator, as taught in Anand. As stated above, it is known in the art to use materials with different or varying attenuations to create distinct visibility compared to native tissue during use with imaging methods and the use of such materials (i.e., metal) produce predictable results.
Regarding claim 7, the limitations of claim 1 are taught as described above. Anand teaches “further comprising one or more biasing mechanisms configured contact a wall of a blood vessel to bias the treatment portion of the catheter into contact with the wall of a blood vessel (16, Figure 3)”. Anand teaches that balloon 16 can contact the wall of a blood vessel in Figure 3 and therefore teaches the claimed limitation as described. Note that this claim is interpreted in view of the claim interpretation described above, with the italicized portion reflecting the interpretation of the claim, and not the explicitly claimed limitation itself.
Regarding claim 8, Anand teaches
“A system comprising for forming a fistula between two blood vessels (the system is directed to the removal of deposits within a patient’s body via heat but is capable of being used according to the purpose of the claimed invention), the system comprising:”
“a first catheter (20 and 3) configured to be received in a first vessel (Figure 3), wherein the first catheter comprises:”
“a housing (20);”
“a treatment portion (1, Figure 3) coupled to the housing, the treatment portion comprising:”
“a thermoelectric generator (7, Figure 4) comprising an exposed surface (10 with 11) exposed outside of the housing and a concealed surface (12) opposite and electrically connected to the exposed surface”,
“wherein: the thermoelectric generator is configured to produce a temperature differential between the exposed surface and the concealed surface when an electric current is applied to one of the exposed surface and the concealed surface thereby producing the temperature differential between the exposed surface and the concealed surface to weld the two blood vessels together (page 15, lines 27 – page 16, lines 12)”.
Anand does not explicitly teach that the differential heat applied is used to weld two blood vessels together, however, Pate does in an analogous device for welding blood vessels together. Pate teaches in p.[0031] that “The heat applied to the compressed vessel tissue (204, 210) may denature proteins in a manner to adhere the vessels together and may form a weld, which may increase the mechanical strength of the vessels. Upon completion of welding between the blood vessels (204, 210), the catheters (200, 206) may be removed.” The heat applied in Anand as described above would achieve the function of welding the blood vessels together, as recognized in Pate. It would have been obvious to one of ordinary skill in the art to use the thermoelectric generator configured to produce a temperature differential between the blood vessels in order to weld them together, as described in Pate, in view of Anand. The system of Anand is capable of producing the differential and one of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to do so in order to “increase the mechanical strength of the vessels” and produces predictable results.
However, Anand does not teach “a second catheter configured to be received in a second vessel adjacent to the first vessel”. While Anand does not teach a second catheter, it is the Examiner's position that the presence of a second catheter is a mere duplication of parts. In MPEP 2144.04 VI. B. states that mere duplication of parts does not provide any patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 9, the limitations of claim 8 are taught as described above. Anand teaches “further comprising an energy source coupled to the thermoelectric generator (36, Figure 5)”.
Regarding claim 11, the limitations of claim 8 are taught as described above. Anand teaches “wherein the thermoelectric generator comprises at least one n-type semiconductor and at least one p-type semiconductor disposed between and electrically connected to the exposed surface and the concealed surface (page 4, lines 11-19; page 8, lines 12-30)”.
Regarding claim 12, the limitations of claim 8 are taught as described above. Anand does not teach “wherein the second catheter comprises a second housing and a second treatment portion coupled to the second housing, wherein the second treatment portion comprises a second thermoelectric generator” explicitly. While Anand does not teach a second catheter with a second housing with a second treatment portion and second thermoelectric generator, it is the Examiner's position that the presence of a second catheter (and housing, treatment portion, and thermoelectric generator) is a mere duplication of parts. In MPEP 2144.04 VI. B. states that mere duplication of parts does not provide any patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 13, the limitations of claim 8 are taught as described above. Anand does not explicitly teach that there is location indicators configured to provide location information of the treatment portion of the first or second catheter as it is advanced through a subject, however, Anand does teach a metal sleeve, 23 disposed on the treatment portion of the first catheter (claim 6 of Anand). This metal sleeve, 23, has distinct visibility compared to native tissue in the subject through imaging methods, and would show the treatment portion of the catheter as it is advanced through the subject, therefore teaching the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recognize a metal sleeve as a visual indicator, as taught in Anand. As stated above, it is known in the art to use materials with different or varying attenuations to create distinct visibility compared to native tissue during use with imaging methods and the use of such materials (i.e., metal) produce predictable results.
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Anand (WIPO Patent Publication WO 89/04137) in view of Pate (US Patent Publication US 2019/0133678) and Ogata (US Patent Publication US 20190298442).
Regarding claim 3, the limitations of claim 2 are taught as described above. Anand or Pate do not teach a handheld energy source coupled to the thermoelectric generator. A handheld energy source is generally considered to not be inventive, as the battery driven instruments are commonly used in the surgical field. However, for the sake of thorough examination, the Examiner cites Ogata, an analogous electrosurgical device. Ogata teaches in p.[0023] that "Optionally, in one example the energy generator 10 is a hand-held battery-operated device, although other types of RF generators may be utilized." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a handheld energy source such as a battery-operated device in the system of Anand/Pate. Doing so is known in the surgical arts and produces predictable results.
Regarding claim 10, the limitations of claim 8 are taught as described above. Anand/Pate does not teach a handheld energy source coupled to the thermoelectric generator. A handheld energy source is generally considered to not be inventive, as the battery driven instruments are commonly used in the surgical field. However, for the sake of thorough examination, the Examiner cites Ogata, an analogous electrosurgical device. Ogata teaches in p.[0023] that "Optionally, in one example the energy generator 10 is a hand-held battery-operated device, although other types of RF generators may be utilized." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a handheld energy source such as a battery-operated device in the system of Anand/Pate. Doing so is known in the surgical arts and produces predictable results.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 5712724764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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