DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-20 are pending.
All claims stand rejected.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-4, 7-8, 10-11, 14, and 19 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Hynynen, K.H, US 20110319793.
Regarding claim 1, Hynynen teaches a method (see abstract for the “Apparatus and method for delivering increased amounts of energy to localized treatment zones in a target tissue volume”) comprising:
providing a plurality of sinusoidal acoustic waves (paragraph 27 states that “FIG. 2(a) shows the measured or calculated waveform 200 where the transducer is driven with 1.4 Watts ("W") of power and providing a sinusoidal signal providing a peak acoustic pressure 202 of about 0.7 mega Pascals (MPa)”. Also see fig. 2) having at least one frequency of at least 1 MHz (paragraph 21 states that “Embodiments hereof utilize a phased array applicator operating at some central response frequency, for example in the frequency range of 0.1-20 MHz”)
propagating at least a portion of the acoustic waves through a shockwave medium (paragraph 28 discloses that “FIG. 2(b) illustrates the waveform 210 that would result under similar circumstances when the transducer is driven at a power of 72 W, resulting in peak positive pressures 212 of about 12 MPa. Importantly, the waveform 210 is exhibiting the effects of nonlinear propagation and distortion of the wave front as discussed above, and the peaks 212 are no longer smooth as with the peaks 202 of FIG. 2(a), but rather, a "shocked" or steepened profile and non-symmetrical waveform 210 has developed. Propagation media such as water, agar, and living tissue contain significant water content and will form such shock wave fronts beyond some distance from the source of the acoustic waves.”) configured to exhibit nonlinear properties in the presence of the propagated acoustic waves to generate a plurality of shock waves (see paragraph 43 which states that “a propagation medium with substantial nonlinearity coefficient yet a modest or low absorption coefficient would allow development of shock waves in the advancing waveforms without attenuating the same too greatly. Therefore, in operation, the transducer is placed on one side of a layer of nonlinear propagation medium and the target tissue or patient is placed proximate to the other side of the layer of nonlinear propagation medium”);
delivering at least a portion of said plurality of shock waves to at least one cellular structure (see focal zone or target tissue in paragraphs 43-44) comprising at least one region of heterogeneity (Paragraph 45 describes that the tissue at or near the target region has different absorption coefficient so that shockwaves propagated through the tissue is maximally absorbed at the target site compared to the healthy tissue); and
rupturing the at least one cellular structure with the continued delivery of said plurality of shock waves (see paragraph 56 which states that “Collectively, and specifically through application of appropriate control and ultrasonic energy levels and frequencies, nonlinear acoustic wave steepening, shocking, or distortion takes place in and proximal to the focal areas described above. Moreover, the co-linear deposition of the ultrasound energy at said foci can lead to the creation of an elongated extended focal zone 820 within the diseased tissue location so as to thermally treat the diseased tissue, e.g. through necrosis or coagulation or other thermal mechanism as would be appreciated by those skilled in the art”).
Regarding claim 2, Hynynen further teaches wherein the at least one region of heterogeneity comprises an effective density greater than an effective density of the at least one cellular structure (Paragraph 45 describes that the tissue at or near the target region has different absorption coefficient so that the shockwaves propagated through the tissue are maximally absorbed at the target site compared to healthy tissue. This implies that the density of the tissue at the target region is greater than the tissue at the healthy tissue sites).
Regarding claim 3, Hynynen further teaches the step of varying the frequency of the acoustic waves (Paragraph 20 states that “Aspects of the present invention utilize nonlinear ultrasound propagation to enhance focused ultrasound treatments such that lower frequencies can be used and focal energy can be increased. This reduction in frequency may translate to fewer transducer elements when phased arrays are used, simplifying the design and lowering the cost of the therapy systems”).
Regarding claim 4, Hynynen further teaches the step of varying the amplitude of the acoustic waves (Paragraph 10 discloses “controlling an amplitude of said first and second driving signals so that the first ultrasonic dose of energy in said target volume experiences substantial nonlinear distortion on its way from said first acoustical source to said target volume”, and paragraph 27 states that “In comparing the effect of increasing the amplitude of the acoustic wave on the shape of the waveform in the propagation medium, FIG. 2(a) shows the measured or calculated waveform 200 where the transducer is driven with 1.4 Watts ("W") of power and providing a sinusoidal signal providing a peak acoustic pressure 202 of about 0.7 mega Pascals (MPa)”).
Regarding claim 7, Hynynen further teaches wherein the plurality of shock waves are generated in said shockwave medium (see paragraph 28 for the generated “a "shocked" or steepened profile and non-symmetrical waveform” as the sinusoidal waves propagates through the shockwave medium, that is, shockwaves form as they go through the medium) that exit a distal end (see fig. 6 for the propagation of the shockwaves from outside the tissue 606, having a boundary line, into the tissue, beyond the boundary line. While Hynynen does not show the transducer array 600 contained in a housing, Hynynen sufficiently teaches the limitation as the limitation does not provide any location, orientation or mechanical features of the housing with respect to the transducer and the tissue and Hynynen provides such illustrative relationship between the transducer and the tissue)
Regarding claim 8, Hynynen further teaches the step of actuating a first acoustic wave generator to provide the plurality of acoustic waves (paragraph 48 states that “the therapy beam can be generated using a two dimensional phased array either with a full or limited beam steering capacity. Each of the elements of the phased array is driven by a radio frequency (RF) driving signal generated by a wave generator and amplified by an amplifier. The array elements may share some, all, or none of the signal generator and amplifier circuits among them”).
Regarding claim 10, Hynynen further teaches identifying at least one target cellular structure be ruptured prior to delivering at least a portion of shock waves to the at least one target cellular structure (In paragraph 21, Hynynen discloses directing an ultrasound beam to a target tissue at a given location, whereby the target tissue is diseased tissue. Also see paragraph 49. Therefore, Hynynen at least suggests identifying the diseased target tissue at the given location (the target cellular structure of the instant application), prior to the delivery of the shock waves as explained in paragraph 28).
Regarding claim 11, Hynynen teaches an apparatus (see abstract for the “Apparatus and method for delivering increased amounts of energy to localized treatment zones in a target tissue volume”) comprising:
an acoustic-wave generator (wave generator of paragraph 48 of the phased array applicator of paragraph 21) configured to emit acoustic waves (paragraph 27 states that “FIG. 2(a) shows the measured or calculated waveform 200 where the transducer is driven with 1.4 Watts ("W") of power and providing a sinusoidal signal providing a peak acoustic pressure 202 of about 0.7 mega Pascals (MPa)”. Also see fig. 2) having at least one frequency between about 1 MHz and about 1000 MHz (paragraph 21 states that “Embodiments hereof utilize a phased array applicator operating at some central response frequency, for example in the frequency range of 0.1-20 MHz”);
a shockwave medium coupled to the acoustic-wave generator (propagation medium of paragraph 28 coupled to the phased array applicator); and
wherein the apparatus is configured to propagate at least a portion of the emitted acoustic waves through the shockwave medium (paragraph 28 discloses that “FIG. 2(b) illustrates the waveform 210 that would result under similar circumstances when the transducer is driven at a power of 72 W, resulting in peak positive pressures 212 of about 12 MPa. Importantly, the waveform 210 is exhibiting the effects of nonlinear propagation and distortion of the wave front as discussed above, and the peaks 212 are no longer smooth as with the peaks 202 of FIG. 2(a), but rather, a "shocked" or steepened profile and non-symmetrical waveform 210 has developed. Propagation media such as water, agar, and living tissue contain significant water content and will form such shock wave fronts beyond some distance from the source of the acoustic waves.”) to form shock waves (see paragraph 28 for the generated “a "shocked" or steepened profile and non-symmetrical waveform” as the sinusoidal waves propagates through the shockwave medium, that is, shockwaves form as they go through the medium) that exit a distal end (see fig. 6 for the propagation of the shockwaves from outside the tissue 606, having a boundary line, into the tissue, beyond the boundary line. While Hynynen does not show the transducer array 600 contained in a housing, Hynynen sufficiently teaches the limitation as the limitation does not provide any location, orientation or mechanical features of the housing with respect to the transducer and the tissue and Hynynen provides such illustrative relationship between the transducer and the tissue); and
wherein the formed shock waves are configured to rupture to at least one cellular structure (see paragraph 56 which states that “Collectively, and specifically through application of appropriate control and ultrasonic energy levels and frequencies, nonlinear acoustic wave steepening, shocking, or distortion takes place in and proximal to the focal areas described above. Moreover, the co-linear deposition of the ultrasound energy at said foci can lead to the creation of an elongated extended focal zone 820 within the diseased tissue location so as to thermally treat the diseased tissue, e.g. through necrosis or coagulation or other thermal mechanism as would be appreciated by those skilled in the art”) comprising at least one region of heterogeneity (Paragraph 45 describes that the tissue at or near the target region has different absorption coefficient so that shockwaves propagated through the tissue is maximally absorbed at the target site compared to the healthy tissue).
Regarding claim 14, Hynynen further teaches wherein the shockwave medium is configured to exhibit nonlinear properties in the presence of acoustic waves emitted from the acoustic-wave generator (see paragraph 43 which states that “a propagation medium with substantial nonlinearity coefficient yet a modest or low absorption coefficient would allow development of shock waves in the advancing waveforms without attenuating the same too greatly. Therefore, in operation, the transducer is placed on one side of a layer of nonlinear propagation medium and the target tissue or patient is placed proximate to the other side of the layer of nonlinear propagation medium”).
Regarding claim 19, Hynynen teaches all the limitations of claim 11 above.
Hynynen further teaches wherein the acoustic-wave generator comprises an ultrasound head. (See paragraph 48 which states that “the therapy beam can be generated using a two dimensional phased array”).
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 negatived by the manner in which the invention was made.
Claims 5-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hynynen, K.H, US 20110319793, hereafter referred to as “Hynynen”, in view of Babaev, E., US 20100076349 A1, hereafter referred to as “Babaev”.
Regarding claim 5, Hynynen teaches all the limitations of claim 1.
Hynynen fails to teach wherein the delivering step comprises delivering at least a portion of said plurality of shock waves to an epidermis layer of a patient.
However, within the same field of endeavor, Babaev teaches a medical ultrasound apparatus and associated methods of use is disclosed enabling a relatively non-invasive or minimally invasive method to treat skin or tissue. The apparatus is constructed from an ultrasound tip mechanically coupled to a shaft, according to the abstract. The abstract further goes on to state that “the disclosed method of treating spider, reticular or small varicose veins with the apparatus can be practiced by contacting the sheath with the patient's epidermal skin layers and delivering ultrasonic energy released from the various surfaces of the vibrating tip to the skin and/or tissue through direct contact and/or with a coupling fluid focused from a cavity”. And paragraph 6 states that “The method and apparatus may be used to treat vascular malformations and/or other vascular disorders in the dermis and/or subcutaneous layers of the skin.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Hynynen wherein the delivering step comprises delivering at least a portion of said plurality of shock waves to an epidermis layer of a patient, as taught by Babaev, to provide an effective way of reaching deeper tissues for treatment (paragraph 4).
Regarding claim 6, Hynynen in view of Babaev teaches all the limitations of claim 5 above.
Hynynen fails to teach Hynynen fails to teach wherein said delivering step further comprises the step of placing said shockwave medium near the epidermis layer.
However, Babaev further teaches wherein said delivering step further comprises the step of placing said shockwave medium near the epidermis layer (the abstract states that “The disclosed method of treating spider, reticular or small varicose veins with the apparatus can be practiced by contacting the sheath with the patient's epidermal skin layers and delivering ultrasonic energy released from the various surfaces of the vibrating tip to the skin and/or tissue through direct contact and/or with a coupling fluid focused from a cavity”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Hynynen wherein the delivering step comprises delivering at least a portion of said plurality of shock waves to an epidermis layer of a patient, as taught by Babaev, to provide an effective way of reaching deeper tissues for treatment (paragraph 4).
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hynynen, K.H, US 20110319793, hereafter referred to as “Hynynen”, in view of Del Giglio, A., US 20080009885 A1, hereafter referred to as “Del Giglio”.
Regarding claim 9, Hynynen teaches all the limitations of claim 8 above.
Hynynen fails to teach the step of actuating a second acoustic wave generator to provide the plurality of acoustic waves.
However, within the same field of endeavor, Del Giglio teaches a device for the destruction of adipose tissue comprising two or more ultrasound generators positioned on opposing sides of the treatment area each generating a non-focused wave that converge forming a interferential clash zone with the treatment area (see abstract). Paragraph 57 states that “The present invention overcomes the shortcomings of the prior art by providing a device for the destruction of adipose tissue comprising two or more ultrasound generators positioned on opposing sides of the treatment area each generating a non-focused wave that converge forming an interferential clash zone with the treatment area therein”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Hynynen to include the step of actuating a second acoustic wave generator to provide the plurality of acoustic waves, as taught by Del Giglio, hence making it possible to destroy cells inside a living subject's body by a non-invasive and extracorporeal and also extremely simple and efficient way, further permitting the treatment of metastases according to paragraph 27.
Claims 12-13 and 16-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hynynen, K.H, US 20110319793, hereafter referred to as “Hynynen”, in view of Granz, et al., US 5269292, hereafter referred to as “Granz”.
Regarding claim 12, Hynynen teaches all the limitations of claim 11 above.
Hynynen fails to teach wherein the apparatus further comprises a shockwave housing configured to contain the shockwave medium.
However, within the same field of endeavor, Granz teaches a system for the disintegration of a calculus by delivery of shockwaves to the calculus (see col. 4, lines 50-59) including a housing 1 of fig. 1, containing water as an acoustic propagation medium (see col. 4 lines 24-40) so that “pressure pulses gradually intensify over their propagation path to form shockwaves as a consequence of the non-linear compression properties of the propagation medium” (col. 4 lines 35-38).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to configure Hynynen wherein the apparatus further comprises a shockwave housing configured to contain the shockwave medium, as taught by Granz, as such modification would allow the safe focusing of the pulses on the calculi, with reduced damage to surrounding tissue (see col. 1, lines 36-50 of Granz), with a reasonable expectation of success, because Hynynen, in paragraph 43, also discusses ways to provide the nonlinear propagation medium proximate to the target tissue or patient, such that energy deposition to the target region is accurate and is accomplished safely without damage to surrounding tissue (see paragraph 47 of Hynynen).
Regarding claim 13, Hynynen teaches all the limitations of claim 12 above.
Hynynen does not teach wherein the shockwave housing is unitary with the shockwave medium.
However, within the same field of endeavor, Granz teaches a system for the disintegration of a calculus by delivery of shockwaves to the calculus (see col. 4, lines 50-59) including a housing 1 of fig. 1, containing water as an acoustic propagation medium (see col. 4 lines 24-40) so that “pressure pulses gradually intensify over their propagation path to form shockwaves as a consequence of the non-linear compression properties of the propagation medium” (col. 4 lines 35-38).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to configure Hynynen wherein the shockwave housing is unitary with the shockwave medium, as taught by Granz, as such modification would allow the safe focusing of the pulses on the calculi, with reduced damage to surrounding tissue (see col. 1, lines 36-50 of Granz), with a reasonable expectation of success, because Hynynen, in paragraph 43, also discusses ways to provide the nonlinear propagation medium proximate to the target tissue or patient, such that energy deposition to the target region is accurate and is accomplished safely without damage to surrounding tissue (see paragraph 47 of Hynynen).
Regarding claim 16, Hynynen in view of Granz teaches all the limitations of claim 11.
Hynynen does not teach wherein the shockwave housing defines a chamber having an input end coupled to the acoustic-wave generator and an output end extending from the acoustic-wave generator, and wherein the shockwave housing further comprises an end cap removably coupled to the output end of the chamber.
However, Granz further teaches wherein the shockwave housing (tubular housing 1 in reproduced fig. 1 below) defines a chamber (col. 4, lines 31-34 states that “The space surrounded by the shockwave generator 2, the housing 1 and the flexible sack 4 contains water as the acoustic propagation medium for the pressure pulses emanating from the shockwave source 2”) having an input end coupled to the acoustic-wave generator (shockwave generator 2 of reproduced fig. 2 below) the and an output end extending from the acoustic-wave generator (the distal end of the housing 1 is occupied by flexible sack 4), and wherein the shockwave housing further comprises an end cap removably coupled to the output end of the chamber (see col. 4, lines 50-59 which states that “The shockwave source can be pressed against a schematically-indicated body B of a patient by means of the flexible sack 4, for the purpose of acoustic coupling. The shockwave source is aligned such that a calculus C to be disintegrated, for example the stone of a kidney K in the body B of the patient, is situated in the focal zone. This is accomplished in known manner using a location system (not shown) which may be an x-ray system or an ultrasound system, such as an ultrasound system containing an ultrasound sector applicator”).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to configure Hynynen, wherein the shockwave housing defines a chamber having an input end coupled to the acoustic-wave generator and an output end extending from the acoustic-wave generator, and wherein the shockwave housing further comprises an end cap removably coupled to the output end of the chamber, as such as taught by Granz, as such modification would allow the safe focusing of the pulses on the calculi, with reduced damage to surrounding tissue (see col. 1, lines 36-50 of Granz), with a reasonable expectation of success, because Hynynen, in paragraph 43, also discusses ways to provide the nonlinear propagation medium proximate to the target tissue or patient, such that energy deposition to the target region is accurate and is accomplished safely without damage to surrounding tissue (see paragraph 47 of Hynynen).
Regarding claim 17, Hynynen in view of and Granz teaches all the limitations of claim 16 above.
Hynynen fails to teach wherein the end cap is configured to attenuate shock wave exiting the end cap to less than twenty percent.
However, Granz further teaches wherein the end cap is configured to attenuate a shock wave exiting the end cap by less than twenty percent (see col. 4, lines 50-59 which indicates that the flexible sack 4 is for acoustic coupling and so while Granz does not explicitly say that flexible sack attenuates the shockwaves by less than 20 percent, it is obvious that its use as an acoustic coupler achieves the attenuation threshold of less than 20 percent for use in propagating shockwaves into the tissue B).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to configure Hynynen wherein the end cap is configured to attenuate shock wave exiting the end cap to less than twenty percent, as such as taught by Granz, as such modification would allow the safe focusing of the pulses on the calculi, with reduced damage to surrounding tissue (see col. 1, lines 36-50 of Granz), with a reasonable expectation of success, because Hynynen, in paragraph 43, also discusses ways to provide the nonlinear propagation medium proximate to the target tissue or patient, such that energy deposition to the target region is accurate and is accomplished safely without damage to surrounding tissue (see paragraph 47 of Hynynen).
Claim 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hynynen in view in view of Coussios, et al, US 20120271169, hereafter referred to as “Coussios”.
Regarding claim 15, Hynynen teaches all the limitations of claim 11 above.
Hynynen fails to teach wherein the shockwave medium comprises one or more of: bubbles, solid particles, or a combination of bubbles and solid particles.
However, within the same field of endeavor, Coussios teaches A sensing system for sensing the condition of an object comprises a transducer arranged to generate pressure waves directed at the object and detection means, such as a pressure wave detector, arranged to detect cavitation or other processes in the object (see abstract) and the introduction of microbbubles into a medium to generate a nonlinear medium (see paragraph 86 which states that “If acoustic cavitation is involved, one possibility is that the cavitating microbubbles are acting as nonlinear scatterers due to changes in their cavitation dynamics, which are in turn caused by changes in the viscoelastic properties of the surrounding medium”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Hynynen, wherein the shockwave medium comprises one or more of: bubbles, solid particles, or a combination of bubbles and solid particles, as taught by Coussious to obtain the nonlinear properties of the medium for propagating the shockwave. See paragraph 86 of Coussios.
Claims 18 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hynynen in view of Fernando et al, “A Nonlinear Computational Method for the Propagation of Shock Waves in Aero-engine Inlets Towards a new Model for Buzz-saw Noise Prediction”, 15th AIA A/CEAS Aeroacoustics Conference (May 2009) pp. 1-18, hereafter referred to as “Fernando” (cited in the action dated 10/20/2016).
Regarding claim 18, Hynynen teaches all the limitations of claim 11 above.
Hynynen teaches wherein the length of shockwave medium through which the emitted acoustic waves propagate is greater than or equal to L for at least one wavelength of acoustic waves that the acoustic-wave generator is configured to emit, (see figs. 2 and 4 and paragraphs 27 and 35)
However, Hynynen in view of Granz does not indicate that length L of the propagating medium is determined by the following equation:
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where Є = nonlinear parameter of shockwave medium; ω = frequency of acoustic wave; ρo = density of the shockwave medium; λ = wavelength of acoustic wave; ϲo = velocity of sound in the shockwave medium; P0 = pressure amplitude in shockwave medium; and Mω = acoustic mach number = P0 + (c02 ρ0).
However, within the same field of endeavor, Fernando teaches the nonlinear propagation of finite amplitude acoustic waves in hard-walled guides (see abstract) and the determination of a length L of a wavelength of a sinusoidal acoustic wave propagated through a medium using equation 2 on page 2 (shown below).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to configure Hynynen wherein length L of the propagating medium is determined by the following equation:
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where Є = nonlinear parameter of shockwave medium; ω = frequency of acoustic wave; ρo = density of the shockwave medium; λ = wavelength of acoustic wave; ϲo = velocity of sound in the shockwave medium; P0 = pressure amplitude in shockwave medium; and Mω = acoustic mach number = P0 + (c02 ρ0), as taught by Fernando, to ensure that the shockwaves are effectively propagated through the fluid medium within the housing. See fourth paragraph of page 2 of Fernando.
Regarding claim 20, Hynynen in view of Granz and Fernando teaches all the limitations of claim 18 above.
Hynynen further teaches wherein the shockwave medium has a Goldberg number of greater than or equal to 1 wherein the Goldberg number is determined by dividing the length of the shockwave medium by an absorption length of the shockwave medium. (Hynynen teaches in paragraph 28 that the fluid medium is water, agar or living tissue. As indicated by the specification in paragraph 55 (see the PG Pub Version), the Goldberg number of water is greater than 1, therefore, Hynynen inherently teaches that the medium has a Goldberg number of greater than 1).
Double Patenting
The nonstatutory provisional 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 provisional 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11794040 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the copending application.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,865,371 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the copending application.
Conclusion
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/FAROUK A BRUCE/Examiner, Art Unit 3793
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797