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 .
Election/Restrictions
Claims 15-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation “said horn transmitting said acoustic vibrations from said transducer to said target site”, thus actively reciting transmission to said target site (i.e. a target site of a patient i.e. human) as a part of the claimed invention. Examiner recommends amending the claims in a manner that defines the configuration of the horn (e.g. said horn configured to transmit… or similar) in order to overcome the above 101 rejection.
Claim 12 recites the limitation “further comprising a polymer disposed continuously between said proximal end of said horn and a surface of the subject”. Examiner notes that the limitation positively recites the polymer with respect to a surface of the subject, thus positively recites a human organism in its broadest reasonable interpretation. Examiner recommends amending the claims in a manner that defines the configuration of the polymer (e.g. a polymer disposed at a proximal end of said horn and configured to be disposed between said proximal end of said horn and a surface of the subject or similar) in order to overcome the above 101 rejection.
Claim Rejections - 35 USC § 112
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 1-14 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 1 recites the limitation “for reducing injury response” and “generating acoustic vibrations sufficient to reduce the injury response in the subject at the target site when activated”. First the term “sufficient” is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear what the metes and bounds of the acoustic vibrations must be to be considered sufficient to reduce an injury response. In other words, it is unclear if the acoustic vibrations are at a certain power, frequency, duration, et which are considered sufficient to reduce an injury response. Furthermore, it is unclear what is and is not considered an injury/injury response (e.g. is the claim attempting to define that it is sufficient to reduce response of any injury such as cuts, scrapes, bruises, bullet wounds, etc?), thus further making unclear what the metes and bounds of the acoustic vibrations such that they are sufficient to reduce such an injury response.
Claim 12 recites the limitation “further comprising a polymer disposed continguously between said proximal end of said horn and a surface of the subject”. It is unclear what is meant by “continguously” and if the claim is attempting to recite “continuously” or “contiguously” or something else entirely. For examination purposes, it has been interpreted to mean either continuously or contiguously, however, clarification is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis et al. (US 20190269943 A1), hereinafter Lewis.
Lewis teaches an assembly (see at least fig. 4a (60) and corresponding disclosure in at least [0101]) for reducing injury response at a target site being at least a portion of injured tissue of a subject, said assembly (60) comprising:
a base (at least fig. 4a (10) and corresponding disclosure in at least [0091]) having a proximal end, an opposite distal end, a base aperture formed in said proximal end, and a channel formed in and extending along at least a portion of said base between said proximal and distal ends (see at least fig. 4a depicting proximal and opposite distal ends, an aperture formed in the proximal end, channel formed in an extending between the proximal and distal ends. See also fig. 1 depicting such ends, aperture, and channel), said base securable to the subject with said base aperture in proximity to the target site ([0123] which discloses an adhesive fabric 80 may be used to couple the ultrasound coupling adapter 10 to a location on the patient's body. After one or a predefined number of treatments, the adhesive properties of the adhesive fabric 80 substantially diminish to prevent further coupling of the ultrasound coupling adapter 10 to the patient, thus is securable to the subject with said base aperture in proximity to the target site)
a housing (see at least fig. 4a depicting a transducer enclosure and corresponding disclosure in at least [0066]) selectively secured to and variably adjustable relative to said base (10) (see at least fig. 4a), said housing having a proximal end, an opposite distal end, a housing aperture formed in said proximal end of said housing and aligned with said base aperture (see at least fig. 4a depicting housing 40 comprising a proximal end, an opposite distal end and a housing aperture aligned with said base aperture 10), and an alignment member (at least fig. 4A (25) and corresponding disclosure in at least [0093]) extending from said housing (see at least fig. 1) and slidably received within said channel of said base (10) (See at least fig. 4a in which the housing is slidably received within said channel of said base 10);
a transducer (at least fig. 4a (40) and corresponding disclosure in at least [0092]) retained within said housing (Examiner notes that a transducer is necessarily enclosed in the housing depicted as 40. See also [0066] which discloses an enclosure in which the transducer is affixed), said transducer capable of generating acoustic vibrations sufficient to reduce the injury response in the subject at the target site when activated ([0122] which discloses when the ultrasound transducer 40, or control module, is connected to, or brought in close proximity to, the ultrasound coupling adapter 10, respectively, a circuit senses the magnetic energy and allows activation of the ultrasound treatment. Examiner notes that an ultrasound transducer used for ultrasound treatment is thereby considered capable of generating acoustic vibrations sufficient to reduce injury response in a subject when activated);
and a horn (at least fig. 4a (33) and corresponding disclosure in at least [0109] where a lens is considered a horn in its broadest reasonable interpretation and also consistent with applicant’s specification in at least pg. 51 lines 16-18 which disclose the horn can be made from any material suitable for transmitting ultrasonic energy) retained within said housing (see at least fig. 4a), said horn having a distal end in contact with said transducer and a proximal end terminating at said housing aperture (see at least fig. 4a), said horn transmitting said acoustic vibrations from said transducer to said target site (Examiner notes that a lens would necessarily transmit the acoustic vibrations from said transducer to said target site).
Regarding claim 2,
Lewis further teaches wherein said housing is variably adjustable relative to said base along a longitudinal axis defined substantially perpendicular to said base aperture (Examiner notes that the housing is variably adjustable relative to said base in that a person could adjust the position along the longitudinal axis (e.g. up and down to either remove the housing from the base or insert the housing into the base)).
Regarding claim 3,
Lewis further teaches wherein said channel comprises a slope along its length (see at least fig. 4a depicting a slope in the base 10 along its length) , said alignment member of said housing slidable moveable along said channel to adjust said housing along said longitudinal axis relative to said base (see at least fig. 4a. Examiner notes that a person having ordinary skill in the art would have recognized that said alignment member is slidably moveable along said channel to adjust said housing along said longitudinal axis relative to said base (e.g. sliding the alignment member until it aligns with the space in the base housing for fixing it)).
Regarding claim 4,
Lewis further discloses said housing is selectively rotatable about said longitudinal axis to move said alignment member along said channel and adjust said housing along said longitudinal axis relative to said base (Examiner notes that a person having ordinary skill in the art would have recognized being able to rotate the housing to move said alignment member along said channel and adjust said housing along said longitudinal axis relative to said base (e.g. by rotating and moving the housing the alignment member would move along said channel and could adjust the housing along the longitudinal axis).
Regarding claim 5,
Lewis further discloses wherein said slope is an angle in the range of 1 to 10 degrees (examiner notes that the slope is in an angle in the range of 1 to 10 degrees with respect to the patient depending on how the base is placed. The slope is broadly recited and the angle is not defined with respect to any fixed element, thus a person having ordinary skill in the art would have recognized the slope being in any range including 1 to 10 degrees).
Regarding claim 6,
Lewis further discloses said base further comprising a base wall disposed about said longitudinal axis and having a thickness, and wherein said channel is formed in said base wall and either (i) is a portion of said thickness of said base wall, or (ii) extends through the entirety of said thickness of said base wall (see at least fig. 4a and 1 depicting the base wall, said channel is formed in said based all (e.g. when the base wall is the entire base, it is formed through it, and is a portion of said thickness of said base wall).
Regarding claim 7,
Lewis further discloses said base further comprising a top surface at said distal end of said base, and an opening defined in said top surface (see at least fig. 4a and fig. 1), said opening being continuous with said channel, said opening and channel being sized to receive and slidingly retain said alignment member therein (see at least fig. 4a).
Regarding claim 8,
Lewis further discloses said base further comprising a base ledge extending radially outwardly from said base aperture and said longitudinal axis (see at least fig. 1 depicting a base ledge extending radially outwardly from said base aperture), said base ledge sized and configured to receive and retain said proximal end of said housing (see at least fig. 4a depicting the base ledge configured to receive and retain said proximal end of said housing).
Regarding claim 9,
Lewis further discloses further comprising a locking mechanism comprising a receiver in said base (at least fig. 4a (23) and corresponding disclosure in at least [0093]) and a stem correspondingly configured to engage said receiver (at least fig. 4a (22) and corresponding disclosure in at least [0093]), said locking mechanism selectively actuated to secure said housing to said base and prevent further movement of said housing with respect to said base ([0093] which discloses the interface support region 14 comprises snap fit tabs 24 on the internal ring of the ultrasound coupling adapter 10. The snap fit tabs 24 may be designed for two-way or one-way operation, that is, removable or permanent connection to the ultrasound transducer 40, respectively. With a one-way connection of the ultrasound coupling adapter 10 to the ultrasound transducer 40, the ultrasound coupling adapter 10 includes a pull tab 22. The pull tab 22 may be any shape or size with pull direction tangential, radial, horizontal, or vertical, and provides leverage for a patient to break the ultrasound coupling adapter 10. In one embodiment, the pull tab 22 is curved with a thinned or perforated area 23 underneath the pull tab 22. The thinned or perforated area 23 may continue partially or completely around the circumference or perimeter of the ultrasound coupling adapter 10. Upon applying force to the pull tab 22, a shear force is generated in the thinned or perforated area 23 causing the material to separate and ultrasound coupling adapter 10 to dislodge the ultrasound transducer 40)
Regarding claim 10,
Lewis further discloses wherein said channel is continuous (see at least fig. 4a and fig. 1) and said locking mechanism is selectively actuated to secure said housing relative to said base at any point along said channel (See at least fig. 4a).
Regarding claim 11,
Lewis further discloses wherein said locking mechanism is actuated by one of biasing of said stem against said housing (See at least fig. 4a depicting the stem (i.e. tab 22) biased against said housing)
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Akramov et al. (US 20150297181 A1), hereinafter Akramov.
Regarding claim 12,
Lewis teaches the elements of claim 1 as previously stated. Lewis fails to explicitly teach further comprising a polymer disposed continuously between said proximal end of said horn and a surface of the subject at said base aperture when mounted thereon, said polymer transmitting said acoustic vibrations and being compressible with variable adjustment of said housing relative to said base without substantially altering properties of said acoustic vibrations transmitted therethrough.
Akramov, in a similar field of endeavor involving ultrasound transducer configurations, teaches a polymer (at least figs 1A and 1B (130) and corresponding disclosure in at least [0056]) disposed continuously between a proximal end of a horn (at least fig. 1a and 1b (120) and corresponding disclosure in at least [0053]) and a surface of a subject([0060] which discloses in the ultrasound probe 100 according to the present embodiment, an upper surface of the acoustic lens 120 that contacts the skin of a patient is coated with the lens coating layer 130) said polymer transmitting said acoustic vibrations and being compressible with variable adjustment without any substantially altering properties of said acoustic vibrations transmitted therethrough ([0058] which discloses the composite layer used for form the lens coating may have a thickness of about 1-20 microns and it may not affect the acoustic characteristics of the ultrasound probe 100, and at the same time the durability and resistance to wear of the ultrasound probe 100 that will be described later with reference to FIG. 7 may be increased).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Lewis to include a polymer as taught by Akramov in order to reduce surface abrasion of the acoustic lens 120 and increase the durability of the assembly (Akramov [0060]). Such a modification would further reduce the friction coefficient of the acoustic lens (Akramov [0109])
Regarding claim 13,
Lewis, as modified, further teaches wherein said polymer is biocompatible and is one of silicone (Akramov [0061] which discloses a silicon polymer).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis and Akramov, as applied to claim 13 above and further in view of NPL Avantor (MED4-4220), hereinafter Avantor.
Regarding claim 14,
Lewis, as modified, teaches the elements of claim 13 as previously stated. Lewis, as currently modified, fails to explicitly teach wherein said polymer comprises a durometer of 17A, a tensile strength of 660 psi and an elongation of 580%.
Nonetheless, Avantor teaches a polymer comprising a durometer of 17A, a tensile strength of 660 psi and an elongation of 580% which may be used as a coating in biomaterials.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the polymer of Lewis to be or include the Polymer as taught by Avantor. Such a modification amounts to merely a simple substitution of one known polymer for another yielding predictable results with respect to ultrasound transmission therefore rendering the claim obvious (MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Examiner, Art Unit 3797