DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 25, 2025 has been entered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551,32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed provisional applications, U.S. Provisional Application Nos. 61/800,478 and 61/801,268, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AlA35 U.S.C. 112, first paragraph for one or more claims of this application. More specifically, these applications both fail to disclose the limitations recited in claims 15-18.
The Examiner notes that support for claims 15-18 only goes back to U.S. Application 14/218,146. As such, for the purposes of examination these claims have been given a priority date of 3/18/14, while the remaining claims have been given a priority date of 3/15/13.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “wherein the controller is configured to operate the heater in response to the temperature information being above the threshold value”. However, there does not appear to be sufficient support for this specific claim language in Applicant’s disclosure. Appropriate correction is required.
Claim 4 recites “wherein the varying stiffness of the needle is additionally provided by material selection, metal tempering, or variation of wall thickness of the needle”. However, there does not appear to be sufficient support for this specific claim language (i.e., varying stiffness provided by multiple factors) in Applicant’s disclosure. Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 13-19 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 13 recites the limitation "a controller" in line 1. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 14 recites the limitation "a heating element" in lines 2 and 4. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “heater”. Appropriate correction is required.
Claim 14 recites the limitation "a processor" in lines 4 and 5 (also see claims 15 and 19). The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “controller”. Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 4-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,642,241. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patented claims. Here, the more specific patented claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1, 2, and 4-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,253,393. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patented claims. Here, the more specific patented claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 4-8, 12-15, 18, and 20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Elkins, U.S. 2008/0183164 (hereinafter Elkins).
Regarding claim 1, Elkins discloses (note fig. 1C, 10, and 11; as best understood by Examiner) a system comprising: a cryogenic cooling needle (26) having a proximal end, a distal end, and a lumen (see figs. 10-11) therebetween, the needle capable of insertion within a target tissue proximate to a motor nerve associated with the spasticity in the limb of the patient by bending the needle outside a body of the patient to access the nerve along a plane of the target tissue, wherein the needle necessarily has varying stiffness at a proximal portion and a distal portion (see enhanced support at proximal portion of needle in fig. 11 that would necessarily increase resistance to deflection; it should also be noted that a proximal portion of a standard needle would necessarily resist deflection more than a distal portion), wherein the motor nerve is capable of being disposed in the limb of the patient, wherein the needle comprises a ‘cladding’ (housing portion of ‘26A’ that surrounds proximal portion of needle ‘26’) of conductive material (note paragraph 108) conductively coupled (necessarily) to the proximal portion of the needle such that the proximal portion of the needle is necessarily configured to be stiffer than the distal portion of the needle, such that the distal portion necessarily deflects more easily than the proximal portion (see above); a cooling fluid supply lumen (236) extending distally within the needle lumen to a distal portion of the needle lumen; a cooling fluid source (18) coupled to the cooling fluid supply lumen to direct cooling fluid flow into the needle lumen so that the cooling fluid vaporizes within the lumen to provide cooling (note paragraph 90); a heater (note paragraph 76) thermally coupled to a ‘thermally responsive element’ (i.e., a temperature sensor) and a controller, wherein the controller is configured to receive temperature information of the thermally responsive element (note paragraphs 78 and 84-85), wherein the controller is necessarily configured to ‘initiate treatment’ in response to the temperature information being less than a threshold value (i.e., the controller necessarily activates the heater when the sensed temperature drops too low – note paragraphs 78 and 84-85), and wherein the controller is necessarily configured (as best understood by Examiner) to ‘operate’ (i.e., adjust) the heater in response to the temperature information being above the threshold value.
Regarding claim 2, Elkins discloses (see above) a system wherein the needle necessarily has a variable flexibility along its length and a different bending strength at the proximal portion and distal portion such that the proximal portion of the needle is more stiff than the distal portion of the needle so that the distal portion deflects more easily than the proximal portion.
Regarding claim 4, Elkins discloses (see above, as best understood by Examiner) a system wherein the varying stiffness of the needle is necessarily additionally provided by material selection (since any material would provide the above-described property), metal tempering, or variation of ‘wall’ thickness (see fig. 11) of the needle.
Regarding claim 5, Elkins discloses (see above) a system wherein the needle is capable of resiliently bending (slightly) at the distal portion by an angle up to 120 degrees.
Regarding claim 6, Elkins discloses (see above) a system wherein the nerve associated with the spasticity is capable of being located in an upper limb of the patient.
Regarding claim 7, Elkins discloses (see above) a system wherein the cryogenic cooling needle comprises a length of greater than 7 mm (note paragraph 62).
Regarding claim 8, Elkins discloses (see above) a system wherein a treatment cycle is controlled by a processor, the treatment cycle based at least in part on a treatment instruction from an operator (note paragraphs 61 and 114).
Regarding claim 12, Elkins discloses (see above) a system further comprising a supply valve for modulating a flow rate of the cooling fluid (note paragraphs 63 and 78).
Regarding claim 13, Elkins discloses (see above) a system further comprising a controller, wherein the supply valve is actuated by a control signal from the controller (note paragraphs 63 and 78).
Regarding claim 14, Elkins discloses (see above, as best understood by Examiner) a system further comprising: a heating element coupled with a proximal portion of the needle, the heating element configured to deliver heating phases to skin of the patient (note paragraph 76); and a processor configured to control the cooling fluid flow and the heating element in response to operator input (note paragraphs 78 and 84-85), the processor configured to provide a treatment cycle in response to a treatment instruction (note paragraph 81), the treatment cycle comprising at least one heating phase and at least one cooling phase (note paragraph 12).
Regarding claim 15, Elkins discloses (see above) a system wherein the processor is further configured to provide a degree of skin warming throughout the treatment cycle, wherein the degree of skin warming is between 28-42 °C (note paragraph 83).
Regarding claim 18, Elkins discloses (see above) a system wherein the at least one cooling phase has a duration of 5 seconds to 120 seconds (see Table 1).
Regarding claim 20, Elkins discloses (see above) a system further comprising: a body comprising a handpiece (16) having a size and shape suitable for supporting in a hand of an operator, the body supporting the needle, wherein the cooling fluid source (18) is disposed in the handpiece.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9-11 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Elkins in view of Aldridge, U.S. 2011/0087212 (hereinafter Aldridge).
Regarding claims 9-11 and 19, Elkins discloses (see above) a system comprising a processor that utilizes feedback to control the device, wherein the cryogenic cooling needle further comprises a temperature sensor, and wherein an out of normal condition comprises an indication of insufficient cooling based on a temperature measurement by the temperature sensor (note paragraphs 141-142). However, Elkins fails to explicitly disclose that this processor provides an audio/visual alert to the operator when there is an abnormal/error condition and at the completion of a treatment cycle. Aldridge teaches a similar device comprising a processor that provides an audio/visual alert to an operator when there is an abnormal/error condition (note paragraph 140) and at the completion of a treatment cycle (note paragraph 144). It is well known in the art that this processor/feedback configuration (which is easier for a user to monitor) results in increased safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have modified the apparatus of Elkins to comprise a processor that provides an audio/visual alert to the operator when there is an abnormal/error condition and at the completion of a treatment cycle, in order to increase safety and efficiency.
Claims 16, 17, and 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Elkins.
Regarding claim 16, Elkins discloses (see above) a system wherein the at least one heating phase comprises a pre- warm phase with the heating element before the at least one cooling phase (note paragraph 12; fig. 9). However, Elkins fails to explicitly disclose that this pre-warm phase has a duration less than 12 seconds. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system accordingly, 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 17, Elkins discloses (see above) a system wherein during the at least one cooling phase the cryogenic cooling needle generates a cryozone having a volume. However, Elkins fails to explicitly disclose the specific volume that is generated. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system accordingly, 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 21, Elkins discloses (note fig. 1C, 10, and 11) a system comprising: a cryogenic cooling needle (26) having a proximal end, a distal end, and a lumen (see figs. 10-11) therebetween, the needle capable of insertion within a target tissue proximate to a motor nerve associated with the spasticity in the limb of the patient by bending the needle outside a body of the patient to access the nerve along a plane of the target tissue, wherein the needle necessarily has varying stiffness at a proximal portion and a distal portion (see enhanced support at proximal portion of needle in fig. 11 that would necessarily increase resistance to deflection; it should also be noted that a proximal portion of a standard needle would necessarily resist deflection more than a distal portion), wherein the motor nerve is capable of being disposed in the limb of the patient, wherein the needle comprises a ‘cladding’ (housing portion of ‘26A’ that surrounds proximal portion of needle ‘26’) of conductive material (note paragraph 108) ‘applied’ to an exterior surface of the proximal portion of the needle and conductively coupled (necessarily) to the proximal portion of the needle such that the proximal portion of the needle is necessarily configured to be stiffer than the distal portion of the needle, such that the distal portion necessarily deflects more easily than the proximal portion (see above); a cooling fluid supply lumen (236) extending distally within the needle lumen to a distal portion of the needle lumen; a ‘needle probe’ (254) coupling the proximal portion of the needle to the cooling fluid supply lumen, the needle probe further comprising a ‘heater element’ (‘246’ – note paragraphs 107-108) and a ‘block’ (248) coupled to the cladding, wherein the cladding necessarily ‘extends from within’ (i.e., extends from within a space defined by) the needle probe, the heater element, and the conductive block and along the proximal portion of the needle forming an exposed length of the cladding (note fig. 11); and a cooling fluid source (18) coupled to the cooling fluid supply lumen to direct cooling fluid flow into the needle lumen so that the cooling fluid vaporizes within the lumen to provide cooling (note paragraph 90). While Elkins discloses a ‘needle probe’ further comprising a ‘block’ (see above), Elkins fails to explicitly disclose that this ‘block’ is made from a conductive material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified Elkins accordingly, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are either addressed below or rendered moot because they do not apply to the current rejections. Regarding Applicant’s arguments concerning Elkins and the new claim limitations, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have necessarily been met by Elkins as they are currently written (and as best understood), due to the breadth of limitations such as “treatment,” “operate,” “needle probe,” “heater element,” “conductive block,” and “extends from within” (see updated rejections above for new interpretation). Therefore, Examiner asserts that the claims are still met by the cited references, as can be seen above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794