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 .
Note: all citations with respect to the specification of present application are citing the paragraph numbers in the Pre-grant Publication US 2025/0262019 A1.
Claim Objections
Claim 12, 13, 15 – 17, 19 and 20 are objected to because of the following informalities:
Claim 12 line 2, limitation “a tissue” should read “the tissue”.
Claim 12 line 5, limitation “the maximum threshold” should read “the maximum threshold.”
Claim 13 line 2, limitation “a tissue” should read “the tissue”.
Claim 15 line 1, limitation “wherein detecting an axial force comprises” should read “wherein the step of detecting the axial force comprises”.
Claim 16 line 1, limitation “wherein detecting an axial force comprises” should read “wherein the step of detecting the axial force comprises”.
Claim 17 line 1, limitation “wherein detecting an axial force comprises” should read “wherein the step of detecting the axial force comprises”.
Claim 19 line 1, limitation “wherein alerting the user comprises a visual alert” should read “wherein the step of alerting the user comprises providing a visual alert”.
Claim 20 line 1, limitation “wherein alerting the user comprises” should read “wherein the step of alerting the user comprises”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Limitation “striking element” in claim 1 and 14.
Limitation “force indicator” in claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding limitation “striking element” in claim 1 and 14, the corresponding structural disclosure in the specification of present application is recited as: “wherein the stored energy of compressed compression spring 116 is periodically released causing driveshaft 115 to accelerate rapidly forwards and collide with transfer slug 162 which is then accelerated forward to collide with tip 110 thereby imparting an acoustic wave to the user” in [0021]. Thus, the above limitation is interpreted as a movable mass or reasonable equivalents.
Regarding limitation “force indicator” in claim 10, the corresponding structural disclosure in the specification of present application is recited as: “Colored LEDs are used in the preferred embodiment of the disclosure, but in other embodiments they may be other emissive devices or may be integrated into a display screen and displayed as a bar graph, pie-chart, or some other analog or representative symbol, or voice prompt or sound signal, or haptic signal such as a vibration felt by the user's hand communicate the tip force to the user by indicating which zone, as identified in the preceding paragraph, tip force corresponds to” in [0030]. Thus, the above limitation is interpreted as LEDs, display, emissive devices, sound device, haptic device or reasonable equivalents.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 2 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 11 of U.S. Patent No. 12,285,297 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because each and every limitation recited in the above claims of instant application 19/081,575 are being unpatentable over U.S. Patent No. 12,285,297 B2, which is detailed as following:
Instant application 19/081,575
Reference patent US 12,285,297 B2
[claim 2]
A treatment device comprising:
a housing having a longitudinal axis extending between a proximal end and a distal end;
a striking element disposed within the housing and moveable along the longitudinal axis;
a tip disposed adjacent the distal end and having a first end and a second end, the first end of the tip being capable of pressing against tissue of the user, and the second end of the tip being strikable by the striking element; and
a sensor disposed adjacent to, and configured to contact, a portion of the tip, the sensor comprising a force detector configured to detect an axial force of the tip pressing against the tissue of the user as the tip oscillates, the axial force being in line with the longitudinal axis.
[claim 1]
A treatment device comprising:
a housing having a longitudinal axis extending between a proximal end and a distal end;
a striking element disposed within the housing and moveable along the longitudinal axis;
a tip disposed adjacent the distal end and having a first end and a second end, the first end of the tip being capable of pressing against tissue of the user, and the second end of the tip being strikable by the striking element,
a sensor disposed adjacent to, and configured to contact, the flange of the tip, the sensor comprising a force detector configured to detect an axial force of the tip pressing against the tissue of the user as the tip oscillates between the first condition and the second condition, the axial force being in line with the longitudinal axis.
[claim 3]
The treatment device of claim 2, further comprising a printed circuit board and a signal wire coupling the printed circuit board to the sensor.
[claim 2]
The treatment device of claim 1, further comprising a printed circuit board and a signal wire coupling the printed circuit board to the sensor.
[claim 4]
The treatment device of claim 2, wherein the tip has a flange.
[claim 1]
the tip having a flange …
[claim 5]
The treatment device of claim 2, wherein the sensor is a piezoelectric load cell axially aligned with an axis of motion of the tip.
[claim 3]
The treatment device of claim 1, wherein the sensor is a piezoelectric load cell axially aligned with an axis of motion of the tip.
[claim 6]
The treatment device of claim 2, wherein the striking element is a slug.
[claim 4]
The treatment device of claim 1, wherein the striking element is a slug.
[claim 7]
The treatment device of claim 2, wherein the tip is axially moveable when struck by the striking element between a first condition in which the tip and the striking element are in contact with one another, and a second condition in which the tip and the striking element are not in contact with one another.
[claim 1]
and the tip being axially moveable when struck by the striking element between a first condition in which the tip and the striking element are in contact with one another, and a second condition in which the tip and the striking element are not in contact with one another;
[claim 8]
The treatment device of claim 2, further comprising:
a motor disposed within the housing;
a driveshaft operatively coupled to the motor;
a compression spring at least partially disposed about the driveshaft;
a helical cam disposed adjacent the compression spring, the helical cam having a first flat end and a second end having at least one discontinuity.
[claim 5]
The treatment device of claim 1, further comprising:
a motor disposed within the housing;
a driveshaft operatively coupled to the motor;
a compression spring at least partially disposed about the driveshaft;
a helical cam disposed adjacent the compression spring, the helical cam having a first flat end and a second end having at least one discontinuity.
[claim 9]
The treatment device of claim 8, wherein the striking element is the driveshaft.
[claim 6]
The treatment device of claim 5, wherein the striking element is the driveshaft.
[claim 10]
The treatment device of claim 2, further comprising a force indicator in communication with the sensor and configured to alert the user when the axial force is too high.
[claim 7]
The treatment device of claim 1, further comprising a force indicator in communication with the sensor and configured to alert the user when the axial force is too high.
[claim 11]
The treatment device of claim 2, wherein the force indicator includes a plurality of LED lights.
[claim 9]
The treatment device of claim 7, wherein the force indicator includes a plurality of LED lights.
[claim 12]
The treatment device of claim 11, wherein the plurality of LED lights includes a red light that illuminates when the axial force against a tissue is higher than a maximum threshold, a yellow light that illuminates when the axial force against the tissue is lower than a minimum threshold, and a green light that illuminates when the axial force against the tissue is between the minimum threshold and the maximum threshold
[claim 10]
The treatment device of claim 9, wherein the plurality of LED lights includes a red light that illuminates when the axial force against a tissue is higher than a maximum threshold, a yellow light that illuminates when the axial force against the tissue is lower than a minimum threshold, and a green light that illuminates when the axial force against the tissue is between the minimum threshold and the maximum threshold.
[claim 13]
The treatment device of claim 10, wherein the force indicator includes a graphical representation of the axial force of the tip against a tissue over time.
[claim 8]
The treatment device of claim 7, wherein the force indicator includes a graphical representation of the axial force of the tip against a tissue over time.
[claim 14]
A method of treatment comprising:
providing a housing having a longitudinal axis extending between a proximal end and a distal end,
a striking element disposed within the housing and moveable along the longitudinal axis, and
a tip disposed adjacent the distal end and having a first end and a second end, the first end of the tip being capable of pressing against tissue of the user, and the second end of the tip being strikable by the striking element; and
detecting an axial force of the tip pressing against the tissue of the user as the tip oscillates, the axial force being in line with the longitudinal axis.
[claim 1]
A treatment device comprising:
(although claim is related to apparatus, the functional limitations recited in the claim also teaches a method of using the apparatus)
a housing having a longitudinal axis extending between a proximal end and a distal end;
a striking element disposed within the housing and moveable along the longitudinal axis;
a tip disposed adjacent the distal end and having a first end and a second end, the first end of the tip being capable of pressing against tissue of the user, and the second end of the tip being strikable by the striking element,
the sensor comprising a force detector configured to detect an axial force of the tip pressing against the tissue of the user as the tip oscillates between the first condition and the second condition, the axial force being in line with the longitudinal axis.
[claim 15]
The method of claim 14, wherein detecting an axial force comprises providing a sensor disposed adjacent to, and configured to contact, a portion of the tip.
[claim 1]
a sensor disposed adjacent to, and configured to contact, the flange of the tip, the sensor comprising a force detector configured to detect an axial force of the tip …
[claim 16]
The method of claim 14, wherein detecting an axial force comprises detecting the axial force with a force detector.
[claim 1]
the sensor comprising a force detector configured to detect an axial force of the tip …
[claim 17]
The method of claim 14, wherein detecting an axial force comprises using a piezoelectric load cell axially aligned with an axis of motion of the tip.
[claim 3]
wherein the sensor is a piezoelectric load cell axially aligned with an axis of motion of the tip.
[claim 18]
The method of claim 14, further comprising alerting the user when the axial force is too high.
[claim 7]
a force indicator in communication with the sensor and configured to alert the user when the axial force is too high.
[claim 19]
The method of claim 18, wherein alerting the user comprises a visual alert.
[claim 8]
wherein the force indicator includes a graphical representation of the axial force of the tip against a tissue over time.
[claim 20]
The method of claim 18, wherein alerting the user comprises turning on at least one of a plurality of LED lights.
[claim 9]
wherein the force indicator includes a plurality of LED lights.
Therefore, claim 2 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 11 of U.S. Patent No. 12,285,297 B2.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Crunick et al. (US 2016/0151238 A1; published on 06/02/2016) (hereinafter “Crunick”) and Marlinghaus et al. (US 2009/0221940 A1; published on 09/03/2009) (hereinafter " Marlinghaus ") are cited as most relevant prior arts to the claimed invention.
Regarding independent claim 1, Crunick teaches a treatment device (“FIG. 22 is a side view of the facial stimulator instrument 106 in one aspect.” [0203]) comprising:
a housing having a longitudinal axis extending between a proximal end and a distal end (“… the impulse and sensing head 2202 may further include an elongated and generally cylindrical housing 2228 …” [0207]; see Fig.22);
a striking element disposed within the housing (“A solenoid assembly 2220 containing an armature 2212 inserted without attachment into an electromagnetic coil 2210 is also included in the impulse and sensing head 2202.” [0203]) and moveable along the longitudinal axis (“The probe 2204 of the facial stimulator instrument 106 may oscillate by repetitively accelerating the armature 2212 to impact the anvil 2208 …” [0213]);
a tip disposed adjacent the distal end and having a first end and a second end (“The impulse and sensing head 2202 includes a probe 2204 with one or more tips 2216 …” [0203]; see Fig.22), the first end of the tip being capable of pressing against tissue of the user (“… with one or more tips 2216 that contact the facial tissues of the patient.” [0203]), and the second end of the tip being strikable by the striking element (“… the armature 2212 is accelerated to impact the anvil 2208 and thereby produce a force impulse, which travels through the piezoelectric sensor 2206 and probe 2204 …” [0203]); and
a sensor disposed adjacent to, and configured to contact, a portion of the tip (“A piezoelectric sensor 2206 is firmly attached to the probe 2204, and an anvil 2208 is firmly attached to the piezoelectric sensor 2206.” [0203]), the sensor comprising a force detector configured to detect an axial force of the tip pressing against the tissue of the user (“The piezoelectric sensor 2206 may monitor the force impulses as they are applied to assess the response of the facial tissue of the patient to the application of the force impulses …” [0209]), the axial force being in line with the longitudinal axis (“… a force impulse which travels through the piezoelectric sensor 2206 in a direction essentially aligned with the movement of the armature 2212 just prior to impact.” [0219]).
Although Crunick teaches a piezoelectric sensor to monitor the force impulse applied axially to the skin, the tip/probe of the instrument is not oscillating, and the monitored force is not associated with the oscillating tip as claimed.
Further, Marlinghaus teaches a similar shockwave generator structure (see Fig.1) with a striking member (“A projectile 13 …” [0038]) and a tip (“… in contact with impact body 9 in FIG. 1.” [0038]). The impact body is supported by two O-rings (see 10 and 12 in Fig.22), but Marlinghaus does not imply that the impact body is capable of oscillating. There is neither teaching of force sensor.
Thus, the cited prior arts and other search results collectively neither teach nor fairly well suggest all limitations as claimed.
Claim 3 – 13 are dependent on claim 2 and inherently include the allowable features as discussed above.
Regarding independent claim 14, Crunick teaches a method of treatment (“Disclosed herein is a system and method for assessing and treating the facial tissues of a patient …” [0083]) comprising:
providing a housing having a longitudinal axis extending between a proximal end and a distal end (“… the impulse and sensing head 2202 may further include an elongated and generally cylindrical housing 2228 …” [0207]; see Fig.22), a striking element disposed within the housing (“A solenoid assembly 2220 containing an armature 2212 inserted without attachment into an electromagnetic coil 2210 is also included in the impulse and sensing head 2202.” [0203]) and moveable along the longitudinal axis (“The probe 2204 of the facial stimulator instrument 106 may oscillate by repetitively accelerating the armature 2212 to impact the anvil 2208 …” [0213]), and a tip disposed adjacent the distal end and having a first end and a second end (“The impulse and sensing head 2202 includes a probe 2204 with one or more tips 2216 …” [0203]; see Fig.22), the first end of the tip being capable of pressing against tissue of the user (“… with one or more tips 2216 that contact the facial tissues of the patient.” [0203]), and the second end of the tip being strikable by the striking element (“… the armature 2212 is accelerated to impact the anvil 2208 and thereby produce a force impulse, which travels through the piezoelectric sensor 2206 and probe 2204 …” [0203]); and
detecting an axial force of the tip pressing against the tissue of the user (“The piezoelectric sensor 2206 may monitor the force impulses as they are applied to assess the response of the facial tissue of the patient to the application of the force impulses …” [0209]), the axial force being in line with the longitudinal axis (“… a force impulse which travels through the piezoelectric sensor 2206 in a direction essentially aligned with the movement of the armature 2212 just prior to impact.” [0219]).
Although Crunick teaches using a piezoelectric sensor to monitor the force impulse applied axially to the skin, the tip/probe of the instrument is not oscillating, and the monitored force is not associated with the oscillating tip as claimed.
Further, Marlinghaus teaches using a similar shockwave generator for treatment (see Fig.1) with a striking member (“A projectile 13 …” [0038]) and a tip (“… in contact with impact body 9 in FIG. 1.” [0038]). The impact body is supported by two O-rings (see 10 and 12 in Fig.22), but Marlinghaus does not imply that the impact body is capable of oscillating. There is neither teaching of force sensor.
Thus, the cited prior arts and other search results collectively neither teach nor fairly well suggest all limitations as claimed.
Claim 15 – 20 are dependent on claim 14 and inherently include the allowable features as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Crunick et al. (US 2016/0113840 A1; published on 04/28/2016) teach an instrument and method for facial tissue therapy. The instrument includes a piezoelectric sensor to monitor the force impulses applied to tissue.
Donnet et al. (US 2011/0275965 A1; published on 11/10/2011) teach an instrument and method for treating tissue with shock wave. A projectile and impactor structure is taught to generate shock wave.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797