DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 8/26/2025 have been fully considered but they are not persuasive. Applicant argues one or more of the prior-filed applications provides adequate support for the recited limitation “the horn and the needle are monolithic”; therefore, requests reconsideration of the priority granted to this application. Applicant points to U.S. App. No. 13/793,851 para. [0056]-[0057] and [0078]. However, this particular application is directed to an ink containing heterocyclic azo dye, and dye for use in said ink and is not in condition for receiving the benefit of an earlier filing date.
With the assumption that applicant intended to point to U.S. App. No. 13/493,851, para. [0056]-[0057] and [0078] are not found to provide sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time the priority application was filed. For example, para. [0056] recites that the “mounting member 152 is not a separate component of horn assembly 152, but rater is formed as a single, integral component of horn assembly”. The mounting member 152 is not equivalent to the claimed needle. Para. [0057] recites “In some embodiments, horn assembly 140 includes: (a) needle 136; and (b) horn 144”; however, it does not recite that the two are a single, monolithic structure and Fig. 5 points to the two parts 144, 136 being separate structures fixedly attached to one another. While para. [0078] states that the needle 136 can join together with horn 144 to form a single contiguous horn assembly, in order to achieve this structure, a brazing material is melted to cause the needle to join with the horn. The brazing material comprises “an alloy, nickel, silver, copper and/or a silver based alloy” ([0083]). Thus, the single contiguous horn assembly is not of a hardened stainless steel needle as claimed. Further to “braze” is generally understood to mean “to solder with a nonferrous alloy having a lower melting point than the metals being joined” (https://www.merriam-webster.com/dictionary/braze) which is contradictory to “monolithic” which is generally understood to mean “cast as a single piece” (https://www.merriam-webster.com/dictionary/monolithic). Accordingly, U.S. App. No. 13/493,851 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for “a hardened stainless steel needle; wherein the horn and the needle are monolithic”.
The previous objection of the drawings due to minor informalities has been withdrawn in light of applicant’s amendments made to the specification filed 8/26/2025.
Applicant's arguments filed 8/26/2025 with respect to Parham (US 2016/0331397 A1) have been fully considered but they are not persuasive. As discussed above, applicant’s arguments with respect to the priority of U.S. App. No. 13/493,851 are not found persuasive. Therefore, the effective filing date of the claimed invention is 11/21/2019 and Parham is valid prior art. Accordingly, rejections over Parham have been maintained.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
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 application, Application Nos. 13/493,851, 14/866,472, and 15/716,278, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, the prior-filed applications fail to provide support for “a hardened stainless steel needle; wherein the horn and the needle are monolithic”. Accordingly, the present application has been given an effective filing date of 11/21/2019.
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parham (US 2016/0331397 A1) in view of Shibata et al. (US 2002/0107538 A1).
Regarding claim 1, Parham discloses an ultrasonic energy delivery device (ultrasonic deliver device 100; Figs. 1-3) configured to deliver ultrasonic energy to a musculoskeletal tissue site (targets can include musculoskeletal tissues such as bone; [0063]), the device comprising: a horn (horn 350) configured to receive energy generated by a transducer (as the needle transmits ultrasonic energy via the horn and ultrasonic handpiece; [0018]); and a hardened stainless steel needle (needle 220 made of a work hardened stainless steel; [0009]).
Parham discloses wherein the needle (220) and the horn (350) are constructed as a unitary assembly ([0058]) but fails to disclose wherein the horn and the needle are monolithic.
However, Shibata teaches an ultrasonic energy delivery device (Figs. 17A-17D) comprising a horn (horn 213) and a needle (ultrasonic vibration transmission member 215) in which the horn and the needle can be made separately and fixedly connected to one another (Figs. 17A-17C) or, alternatively, where the horn and the needle can be formed of a single member (Fig. 17D; [0224]) i.e., are monolithic.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the horn and needle of Parham to be monolithic as taught by Shibata. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of achieving a unitary, integral, fixedly secured needle and horn assembly for an ultrasonic energy delivery device.
Regarding claim 3, Parham modified discloses the invention as claimed above, and Parham further discloses wherein the needle (220) comprises a work-hardened stainless steel needle ([0009]) which is found equivalent to the claimed “precipitation-hardened stainless steel” as both are heat treated.
Claim(s) 2, 4-5 and 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parham (US 2016/0331397 A1) in view of Shibata et al. (US 2002/0107538 A1) in view of Frankhouser et al. (US 2012/0209303 A1).
Regarding claim 2, modified Parham fails to disclose a processor configured to activate the transducer, wherein the processor includes stored instructions that when executed cause the device to deliver ultrasonic energy at a frequency selected to debride the musculoskeletal tissue.
However, Frankhouser teaches an ultrasonic energy device (202) comprising a processor to activate the transducer ([0204]), wherein the processor includes stored instructions that when executed cause the device to delivery ultrasonic energy at a frequency selected to debride the musculoskeletal tissue ([0196]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the stored instructions on the processor as taught by Frankhouser with the device of modified Parham because it allows the user to track whether the real time data matches the expected data stored on the processor and allows the device to automatically adjust the resonant frequency as needed (Frankhouser, [0196-0197]). The motivation for the modification is to automatically update the particular parameters of the device (Frankhouser, [0204]).
Regarding claim 4, Parham discloses a system configured to deliver ultrasonic energy to a musculoskeletal tissue site (targets can include musculoskeletal tissues such as bone; [0063]), the system comprising: a delivery device (ultrasonic delivery device 100; Figs. 1-3), the device comprising: a horn (horn 350); and a hardened stainless steel needle (needle 220 made of a work hardened stainless steel; [0009]).
Parham discloses wherein the needle (220) and the horn (350) are constructed as a unitary assembly ([0058]) but fails to disclose wherein the horn and the needle are monolithic; and a memory device containing instructions; a processor in communication with the memory device; wherein execution of the instructions by the processor causes a transducer to generate ultrasonic energy at a pre-determined frequency suitable for debriding musculoskeletal tissue.
However, Shibata teaches an ultrasonic energy delivery device (Figs. 17A-17D) comprising a horn (horn 213) and a needle (ultrasonic vibration transmission member 215) in which the horn and the needle can be made separately and fixedly connected to one another (Figs. 17A-17C) or, alternatively, where the horn and the needle can be formed of a single member (Fig. 17D; [0224]) i.e., are monolithic.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the horn and needle of Parham to be monolithic as taught by Shibata. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of achieving a unitary, integral, fixedly secured needle and horn assembly for an ultrasonic energy delivery device.
Modified Parham fails to disclose a memory device containing instructions; a processor in communication with the memory device; and wherein execution of the instructions by the processor causes a transducer to generate ultrasonic energy at a pre-determined frequency suitable for debriding musculoskeletal tissue.
However, Frankhouser discloses an ultrasonic energy device (202) comprising memory device containing instructions (stored values in a memory; [0196]); a processor in communication with the memory device ([0196]), wherein execution of the instructions by the pr4ocessor causes a transducer to generate ultrasonic energy ([0240]) at a pre-determined frequency suitable for debriding musculoskeletal tissue ([0196]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the stored instructions on the memory device of the processor as taught by Frankhouser with the device of modified Parham because it allows the user to track whether the real time data matches the expected data stored on the processor and allows the device to automatically adjust the resonant frequency as needed (Frankhouser, [0196-0197]). The motivation for the modification is to automatically update the particular parameters of the device (Frankhouser, [0204]).
Regarding claim 5, modified Parham discloses the invention as claimed above, and Parham further discloses a fluid source (as fluid is transported between needle 220 and sheath 230 either in or out of the needle; [0036]-[0037]), wherein the delivery device further comprises a fluid delivery conduit (conduit between needle 220 and sheath 230) for delivering fluid from the fluid source to the musculoskeletal tissue site ([0036]).
Regarding claim 8, Parham modified discloses the invention as claimed above, and Parham further discloses wherein the needle (220) comprises a work-hardened stainless steel needle ([0009]) which is found equivalent to the claimed “precipitation-hardened stainless steel” as both are heat treated.
Claim(s) 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parham (US 2016/0331397 A1) in view of Shibata et al. (US 2002/0107538 A1) in view of Frankhouser et al. (US 2012/0209303 A1), as applied to claim 4 above, and further in view of Wiksell (US 4,886,060).
Regarding claim 6, modified Parham fails to explicitly disclose wherein the delivery device further comprises an aspiration conduit configured to remove detritus from the musculoskeletal site.
However, Wiksell teaches an ultrasonic delivery device (abstract; Fig. 2) comprising a horn (at 7) and needle (distal end of 7; Fig. 2), wherein the needle and horn include an aspiration conduit (bore 6) configured to aspirate (column 3, lines 66-68).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the delivery device of modified Parham to include an aspiration conduit configured to remove detritus from the musculoskeletal site in light of the teachings of Wiksell in order to remove fluid and debris from the target treatment site.
Claim(s) 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parham (US 2016/0331397 A1) in view of Shibata et al. (US 2002/0107538 A1) in view of Frankhouser et al. (US 2012/0209303 A1), as applied to claim 4 above, and further in view of Desinger (US 2002/0007200).
Regarding claim 7, modified Parham fails to disclose wherein the delivery device includes a housing having a clear portion.
However, Desinger teaches an ultrasonic energy delivery system comprising a housing (14) having a clear portion ([0033]; “transparent”).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the housing comprising a clear portion as taught by Desinger with the system of modified Parham because it allows for an interior view of the housing (Desinger, [0033]). The motivation for the modification would have been to allow the user to see inside the housing to determine if the device needs cleaning or repair without having to open the housing.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771