DETAILED ACTION
The amendment filed August 20, 2025, has been entered and fully considered. Claims 1-20 are pending. Claims 1 and 17 are amended.
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 20, 2025, has been entered.
Claims 1-3, 5 6, 11-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fallat (hereinafter ‘Fallat,’ U.S. Pat. 7,250,046) in view of Marcol, W., et al., (2006). Prevention of painful neuromas by oblique transection of peripheral nerves. Journal of Neurosurgery, 104(2), 285-289, and Orosz, Jr. (hereinafter ‘Orosz,’ U.S. Pat. 6,716,192).
Regarding claim 1, Fallat discloses a cryotherapy probe configured to prevent neuroma formation in nerve tissue associated with a nerve during a medical intervention, the cryotherapy probe (22) comprising: a handle (not labeled) configured to be held by an operator of the cryotherapy probe (Fig. 2); a needle (24) extending distally from the handle (Fig. 2) and having a proximal end, a distal end, and a length therebetween (Figs. 2-3); and a controller (see col. 3, ll. 17-21, for controller controlling ice-ball size) configured to modulate coolant flow from a cooling fluid source to the needle according to a tissue treatment algorithm for degenerating a target nerve for a period of time so as to induce chronic denervation of the target nerve (see col. 3, ll. 3-20 for gas flowing from refrigerant engines (not shown) through probe tip 24 to generate cooling effect; also see col. 3, ll. 22-52 for freeze cycles; Fig. 4 for exemplary treatment algorithm diagram), wherein the chronic denervation of the target nerve (14) reduces a regenerative rate of the nerve and delays neuroma formation at a location of the target nerve (see col. 2, ll. 37-44, for destruction and death of nerve tissue; also see col. 2, ll. 49-64, for chronic denervation of the target nerve; and see col. 3, 3-35 for prevention of further neuroma formation); wherein the needle (24) is configured to produce a cooling therapy zone along the length of the needle (24) when the cryotherapy probe (22) is activated to administer a prophylactic cooling therapy to the target nerve to prevent or reduce neuroma formation in a residual limb of a patient that remains after amputation (col. 3, ll. 3-21; as broadly claimed, the cooling therapy may be administered to a target nerve for a variety of reasons, including to prevent or reduce neuroma formation in a residual limb of a patient that remains after amputation).
Although Fallat discloses the cryotherapy probe configured to prevent neuroma formation in nerve tissue, Fallat is silent regarding a location of the target nerve is associated with transection of a nerve during a medical intervention.
However, in the same field of endeavor, Marcol teaches that freezing has been reported to decrease the size of neuromas formed after injury (see p. 285). In addition to freezing, Marcol teaches that the oblique transection of peripheral nerves is rarely followed by classic neuroma development, and as such, neuropathic pain is significantly reduced (p. 285, Conclusions). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat to include wherein a location of the target nerve is associated with transection of a nerve during a medical intervention, as taught by Marcol, in order to decrease the likelihood of neuroma formation, thereby reducing pain and improving the overall success of treatment.
Fallat in view of Marcol are silent regarding wherein the needle includes at least one visible mark along the length of the needle indicative of the cooling therapy zone comprising the target nerve, wherein the at least one visible mark indicates at least one5 of a distal end, a proximal end, and a center of the cooling therapy zone so as to aid in alignment of the needle of the cryotherapy probe with the target nerve, wherein the cryotherapy probe is activated to administer the cooling therapy to the target nerve in response to aligning the needle of the cryotherapy probe with the target nerve.
However, in the same field of endeavor, Orosz (Fig. 4) teaches a similar medical needle (21) including at least one visible mark (22, 24) along the length of the needle (21) indicative of the therapy zone comprising the targeted treatment area. Orosz teaches wherein the at least one visible mark indicates at least one of a distal end (22), a proximal end, and a center (24) of the therapy zone so as to aid in alignment of the needle with the target area (Fig. 4). Further, “[a]s an extension of the concept of this embodiment, a series of marks can be provided as graduations along the length of the needle to indicate the degree to which it is inserted below the patient's skin surface.” (col. 3, ll. 26-29). This configuration is provided in order to aid in alignment and visualization of the needle within the targeted area, such that treatment may be effectuated at the intended location, thereby improving efficiency, accuracy and patient safety (see col. 1, ll. 29-54). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol to include wherein the needle includes at least one visible mark along the length of the needle indicative of the cooling therapy zone comprising the target nerve, wherein the at least one visible mark indicates at least one of a distal end, a proximal end, and a center of the cooling therapy zone so as to aid in alignment of the needle of the cryotherapy probe with the target nerve, wherein the cryotherapy probe is activated to administer the cooling therapy to the target nerve in response to aligning the needle of the cryotherapy probe with the target nerve, as taught by Orosz. Doing so aids in alignment and visualization of the needle within the targeted area, such that treatment may be effectuated (i.e., activated) at the intended location, thereby improving efficiency, accuracy and patient safety.
Regarding claim 2, Fallat in view of Marcol and Orosz teach all of the limitations of the device according to claim 1. In view of the prior modification of Fallat in view of Marcol and Orosz, Orosz teaches wherein the needle includes visible marks for each of the distal end (22) and the center (24) of the cooling therapy zone produced when the cryotherapy probe is activated to administer the cooling therapy.
Fallat in view of Marcol and Orosz are silent regarding wherein the needle includes a visible mark for the proximal end, however, Orosz teaches “[a]s an extension of the concept of this embodiment, a series of marks can be provided as graduations along the length of the needle to indicate the degree to which it is inserted below the patient's skin surface.” (col. 3, ll. 26-29). Thus, Orosz teaches a plurality of marks along the length of the needle. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol and Orosz to include wherein the needle includes a visible mark for the proximal end, as taught by Orosz, in order “to indicate the degree to which it is inserted below the patient's skin surface.” (col. 3, ll. 26-29), thereby improving efficiency, accuracy and patient safety. Further, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 3, Fallat in view of Marcol and Orosz teach all of the limitations of the device according to claim 1, but are silent regarding wherein the length of the needle is 10 cm or more. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol and Orosz such that the length of the needle is 10 cm or more, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 5, Fallat discloses wherein the distal end thereof has a sharp distal tip (24) that is configured for piercing tissue of a patient (Fig. 3).
Regarding claim 6, Fallat in view of Marcol and Orosz teach all of the limitations of the device according to claim 1. In view of the prior modification of Fallat in view of Marcol and Orosz, Orosz teaches wherein the needle further includes visible marks identifying a distance from the distal end of the needle. See rejection of claim 1 for obviousness rationale.
Regarding claim 11, Fallat discloses wherein the cooling therapy is configured to induce axonotmesis of the nerve such that connective tissue framework of the nerve is preserved (see col. 3, ll. 22-35 for preservation).
Regarding claim 12, Fallat discloses wherein the needle (24) is configured for insertion into a skin of a patient at a depth that is sufficient to prevent injury to the skin without requiring active heating of the skin (as broadly claimed, the needle is capable of insertion at any depth).
Regarding claim 13, Fallat discloses wherein the cryotherapy probe (22) is configured for repeated application of the cooling therapy to the target nerve (col. 4, ll. 48-67, “the probe may be operated to provide two sequential freeze cycles. Each freeze cycle may be about 3 minutes in duration. . . . Such repositioning may be a minor adjustment to increase the area of the neuroma targeted by cryoanalgesia. In one example, the probe is operated for no more than two freeze cycles in the same position.”).
Regarding claim 16, Fallat discloses wherein the cooling therapy is applied to the target nerve at a location proximal to a transection path so as to degenerate the target nerve across the transection path prior to a surgical transection along the transection path to transect the target nerve (see col. 4, ll. 48-67, the probe 22 may be positioned and repositioned proximal or distal to the site of treatment, such that treatment may be effectuated at a new location; as broadly claimed, this is capable of occurring prior to a surgical transection or other subsequent treatment).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fallat in view of Marcol and Orosz as applied to claim 1 above, and further in view of Brown et al., (hereinafter ‘Brown,’ U.S. PGPub. No. 2016/0235431).
Regarding claim 4, Fallat in view of Marcol and Orosz teach all of the limitation of the device according to claim 1, but are silent regarding wherein the distal end thereof has a blunt tip that is configured for blunt dissection of tissue of a patient.
However, in the same field of endeavor, Brown (Fig. 7) discloses a similar minimally invasive tissue incision system comprising various embodiments. In one embodiment, a cutting element (302) is provided with a rounded tip (304). This configuration provides the ability of cutting in either direction (i.e., laterally) without having to rotate the device 180 degrees. In another embodiment (Fig. 18), Brown teach a stylet having a stylet tip that may act as a blunt tissue dissector (blunt rounded stylet tip 710). In either embodiment, the distal end thereof has a blunt tip that is configured for blunt dissection of tissue of a patient. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol and Orosz to include wherein the distal end thereof has a blunt tip that is configured for blunt dissection of tissue of a patient, as taught by Brown in order to provide cutting in either direction, without having to rotate the device 180 degrees, thereby minimizing the need for repositioning the device and improving ease of use.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fallat in view of Marcol and Orosz as applied to claim 1 above, and further in view of Vriezema et al., (hereinafter 'Vriezema,' U.S. PGPub. No. 2014/0207000).
Regarding claim 7, Fallat in view of Marcol and Orosz teach all of the limitation of the device according to claim 1, but are silent regarding wherein the needle comprises a coating that enhances visibility of at least a portion of the needle in ultrasound imaging.
However, in the same field of endeavor, Vriezema teaches a similar coating for improving the ultrasound visibility of a device ([0022]). It is well known that ultrasound imaging is less harmful to humans than X-ray imaging. ([0003]), hence it would be advantageous to provide a device capable of being used with ultrasound imaging. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol and Orosz to include a coating that enhances visibility of at least a portion of the needle in ultrasound imaging, as taught by Vriezema. Doing so allows the user to take advantage of ultrasound imaging, over a more harmful imaging technique, such as X-ray, and allows the user to have improved visibility, thereby ensuring accuracy and safety.
Regarding claim 8, Fallat in view of Marcol and further in view of Orosz and Vriezema teach all of the limitation of the device according to claim 7. In view of the prior modification of Fallat in view of Marcol and further in view of Orosz and Vriezema, Vriezema teaches wherein the coating of the needle is provided to correspond with the at least one visible mark such that visibility of at least one of the distal end, the proximal end, and the center of the cooling therapy zone is enhanced in ultrasound imaging. See rejection of claim 7 above for obviousness rationale.
Regarding claim 9, Fallat in view of Marcol and further in view of Orosz and Vriezema teach all of the limitation of the device according to claim 7. In view of the prior modification of Fallat in view of Marcol and further in view of Orosz and Vriezema, Orosz teaches a plurality of visual markers along the entire length of the needle (Fig. 4; col. 3, ll. 26-29). Further, Vriezema teaches a coating for improving the ultrasound visibility of a device ([0022]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol and further in view of Orosz and Vriezema to provide wherein the coating of the needle is provided along the length of the needle except for at locations of the at least one visible mark, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 10, Fallat in view of Marcol and further in view of Orosz and Vriezema teach all of the limitation of the device according to claim 7. In view of the prior modification of Fallat in view of Marcol and further in view of Orosz and Vriezema, Vriezema teaches wherein the coating of the needle is provided from the proximal end of the needle to a position along the length of the needle indicative of the center of the cooling therapy zone. See rejection of claim 7 above for obviousness rationale.
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fallat in view of Marcol and Orosz as applied to claim 1 above, and further in view of Lueckge et al., (hereinafter ‘Lueckge,’ U.S. PGPub. No. 2013/0197496).
Regarding claims 14 and 15, Fallat in view of Marcol and Orosz teach all of the limitation of the device according to claim 1. Although Fallat discloses multiple freeze cycles (see col. 4, ll. 48-67), Fallat in view of Orosz are silent wherein a treatment interval of a second cooling therapy is administered based on a distance between the cooling therapy zone and a transection path of the target nerve, and wherein shorter treatment intervals are selected as the distance decreases and longer treatment intervals are selected as the distance increases.
However, in the same field of endeavor, Lueckge teaches “[w]hen using a cryoablation device such as a cryoprobe at sub-zero temperatures to ablate an area of tissue, the thermal effects on each cell vary depending on its distance from the cryoprobe (closer cells experiencing lower temperatures and faster freezing rates). Complete tissue destruction may occur at temperatures below approximately -40.degree. C., and temperatures at the edge of the iceball may be around -0.5.degree. C. Uneven cell death rates may occur between -40.degree. C. and -0.5.degree. C.” ([0008]). Therefore, it would have been obvious to one having ordinary skill in the art to have modified the cryotherapy as taught by Fallat in view of Marcol and Orosz to include wherein a treatment interval of a second cooling therapy is administered based on a distance between the cooling therapy zone and a transection path of the target nerve, and wherein shorter treatment intervals are selected as the distance decreases and longer treatment intervals are selected as the distance increases, as taught by Lueckge in order to maintain more uniform treatment results, thereby increasing control and safety.
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fallat in view of Marcol and further in view of Elkins (hereinafter ‘Elkins,’ U.S. Pat. 7,713,266) in view of Orosz.
Regarding claim 17, Fallat discloses a cryotherapy probe configured to prevent neuroma formation in nerve tissue associated with a nerve during a medical intervention, the cryotherapy probe (22) comprising: a handle (not labeled) configured to be held by an operator of the probe (Fig. 2); a first needle (24) extending distally from the handle and having a proximal end, a distal end, and a length therebetween (Fig. 2); wherein the first needle (24) is configured to produce a first cooling therapy zone along the length of the first needle when the cryotherapy probe is activated to administer a cooling therapy to a target nerve to prevent or reduce neuroma formation in a residual limb of a patient that remains after amputation (col. 3, ll. 3-21; as broadly claimed, the cooling therapy may be administered to a target nerve for a variety of reasons, including to prevent or reduce neuroma formation in a residual limb of a patient that remains after amputation). Fallat further disclose a controller (see col. 3, ll. 17-21, for controller controlling ice-ball size) configured to modulate coolant flow from a cooling fluid source to the needle according to a tissue treatment algorithm for degenerating a target nerve for a period of time so as to induce chronic denervation of the target nerve (see col. 3, ll. 3-20 for gas flowing from refrigerant engines (not shown) through probe tip 24 to generate cooling effect; also see col. 3, ll. 22-52 for freeze cycles; Fig. 4 for exemplary treatment algorithm diagram), wherein the chronic denervation of the target nerve (14) reduces a regenerative rate of the nerve and delays neuroma formation at a location of the target nerve (see col. 2, ll. 37-44, for destruction and death of nerve tissue; also see col. 2, ll. 49-64, for chronic denervation of the target nerve; and see col. 3, 3-35 for prevention of further neuroma formation).
Although Fallat discloses the cryotherapy probe configured to prevent neuroma formation in nerve tissue, Fallat is silent regarding a location of the target nerve is associated with transection of a nerve during a medical intervention.
However, in the same field of endeavor, Marcol teaches that freezing has been reported to decrease the size of neuromas formed after injury (see p. 285). In addition to freezing, Marcol teaches that the oblique transection of peripheral nerves is rarely followed by classic neuroma development, and as such, neuropathic pain is significantly reduced (p. 285, Conclusions). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat to include wherein a location of the target nerve is associated with transection of a nerve during a medical intervention, as taught by Marcol, in order to decrease the likelihood of neuroma formation, thereby reducing pain and improving the overall success of treatment.
Fallat in view of Marcol are silent regarding a second needle extending distally from the handle and having a proximal end, a distal end, and a length therebetween, wherein the second needle is configured to produce a second cooling therapy zone along the length of the second needle when the cryotherapy probe is activated to administer the cooling therapy to the target nerve to prevent or reduce neuroma formation in the residual limb of the patient that remains after amputation.
However, in the same field of endeavor, Elkins (Fig. 3B) teaches a similar probe (46) comprising a plurality of tissue-penetrating needle probes (54) wherein the needle probes are cooled by cryogenic cooling fluid from a fluid source (48) (col. 12, ll. 30-45). Elkins teaches devices comprising both a single needle probe (Fig. 1A) and a plurality of tissue-penetrating needle probes (Fig. 3B). By providing more needle probes, a greater surface area of tissue can be treated, thereby minimizing treatment duration and increasing efficiency. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the cryotherapy as taught by Fallat in view of Marcol to include a second needle as taught by Elkins in order to treat a greater surface area of tissue, thereby minimizing treatment duration and increasing efficiency
Further, Fallat in view of Marcol and Elkins are silent regarding wherein the first needle includes at least one visible mark along the length of the first needle to indicate at least one of a distal end, a proximal end, and a center of the first cooling therapy zone so as to aid in alignment of the first needle of the cryotherapy probe with the target nerve; and wherein the second needle includes at least one visible mark along the length of the second needle to indicate at least one of a distal end, a proximal end, and a center of the second cooling therapy zone so as to aid in alignment of the second needle of the cryotherapy probe with the target nerve, wherein the cryotherapy probe is activated to administer the cooling therapy to the target nerve in response to aligning the first needle and the second needle of the cryotherapy probe with the target nerve.
However, in the same field of endeavor, Orosz (Fig. 4) teaches a similar medical needle (21) including at least one visible mark (22, 24) along the length of the needle (21) indicative of the therapy zone comprising the targeted treatment area. Orosz teaches wherein the at least one visible mark indicates at least one of a distal end (22), a proximal end, and a center (24) of the therapy zone so as to aid in alignment of the needle with the target area (Fig. 4). Further, “[a]s an extension of the concept of this embodiment, a series of marks can be provided as graduations along the length of the needle to indicate the degree to which it is inserted below the patient's skin surface.” (col. 3, ll. 26-29). This configuration is provided in order to aid in alignment and visualization of the needle within the targeted area, such that treatment may be effectuated at the intended location, thereby improving efficiency, accuracy and patient safety (see col. 1, ll. 29-54). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cryotherapy probe as taught by Fallat in view of Marcol and Elkins to include wherein the first needle includes at least one visible mark along the length of the first needle to indicate at least one of a distal end, a proximal end, and a center of the first cooling therapy zone so as to aid in alignment of the first needle of the cryotherapy probe with the target nerve; and wherein the second needle includes at least one visible mark along the length of the second needle to indicate at least one of a distal end, a proximal end, and a center of the second cooling therapy zone so as to aid in alignment of the second needle of the cryotherapy probe with the target nerve, wherein the cryotherapy probe is activated to administer the cooling therapy to the target nerve in response to aligning the first needle and the second needle of the cryotherapy probe with the target nerve, as taught by Orosz. Doing so aids in alignment and visualization of the needle within the targeted area, such that treatment may be effectuated (i.e., activated) at the intended location, thereby improving efficiency, accuracy and patient safety.
Regarding claim 18, Fallat in view of Marcol and further in view of Elkins and Orosz teach all of the limitations of the device according to claim 17. In view of the prior modification of Fallat in view of Marcol and further in view of Elkins and Orosz, Elkins teaches wherein the second cooling therapy zone of the second needle is continuous with the first cooling therapy zone of the first needle (see Fig. 3B for all needle probes connected to one another; col. 13, ll. 50-59).
Regarding claim 19, Fallat in view of Marcol and further in view of Elkins and Orosz teach all of the limitations of the device according to claim 17. In view of the prior modification of Fallat in view of Marcol and further in view of Elkins and Orosz, Elkins teaches wherein the first needle and the second needle of the cryotherapy probe are configured to be positioned on opposite sides of the target nerve such that the first cooling therapy zone of the first needle and the second cooling therapy zone of the second needle are produced on opposite sides of the target nerve (see Fig. 3B; as broadly claimed, the cryoprobe is capable of being positioned at any location, including as claimed in claim 19).
Regarding claim 20, Fallat in view of Marcol and further in view of Elkins and Orosz teach all of the limitations of the device according to claim 17. In view of the prior modification of Fallat in view of Marcol and further in view of Elkins and Orosz, Elkins teaches wherein the first needle and the second needle are spaced apart by 2 millimeters or less (col. 15, ll. 27-31, “In general, the spacing between tissue-penetrating cooling treatment probes 54 may be between about ¼ mm and 2 mm, preferably having a needle-to-needle spacing of between about ½ mm and 1 mm, ideally being about ½ mm.”).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the amendment has necessitated a new ground of rejection.
Applicant has argued, “Fallat and Orosz Jr. do not disclose ‘a controller configured to modulate coolant flow from a cooling fluid source to the needle according to a tissue treatment algorithm for degenerating a target nerve for a period of time so as to induce chronic denervation of the target nerve, wherein the chronic denervation of the target nerve reduces a regenerative rate of the nerve and delays neuroma formation at a transaction location of the target nerve.’ Fallat discloses treating neuromas with cryotherapy, and it discloses administering cryotherapy to a nerve ‘prior to severing a ligament that may be rubbing against the nerve.’” This is not found persuasive.
As indicated above, it is the Examiner’s position Fallat further disclose a controller (see col. 3, ll. 17-21, for controller controlling ice-ball size) configured to modulate coolant flow from a cooling fluid source to the needle according to a tissue treatment algorithm for degenerating a target nerve for a period of time so as to induce chronic denervation of the target nerve (see col. 3, ll. 3-20 for gas flowing from refrigerant engines (not shown) through probe tip 24 to generate cooling effect; also see col. 3, ll. 22-52 for freeze cycles; Fig. 4 for exemplary treatment algorithm diagram), wherein the chronic denervation of the target nerve (14) reduces a regenerative rate of the nerve and delays neuroma formation at a transection location of the target nerve (see col. 2, ll. 37-44, for destruction and death of nerve tissue; also see col. 2, ll. 49-64, for chronic denervation of the target nerve; and see col. 3, 3-35 for prevention of further neuroma formation).
It is noted that the claims are drawn to a probe and not a method. It is the Examiner’s position that the structural components of Fallat meet the limitations of the claim and would be capable of use with any location, including at a transection.
Examiner has still provided a secondary reference Marcol to illustrate that freezing has been reported to decrease the size of neuromas formed after injury (see p. 285). In addition to freezing, Marcol teaches that the oblique transection of peripheral nerves is rarely followed by classic neuroma development, and as such, neuropathic pain is significantly reduced (p. 285, Conclusions). A person having ordinary skill in the art would have been motivated before the effective filing date to provide oblique transection at the targeted nerve to decrease the likelihood of neuroma formation, thereby reducing pain and improving the overall success of treatment.
Applicant argues option step 70 is directed to the cutting of a ligament and not a nerve. Marcol remedies any perceived deficiency.
The same arguments apply to claim 17. No further arguments have been set forth regarding the dependent claims.
Conclusion
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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794