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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/4/2025, 6/27/2025 and 10/7/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 37 and 45 are objected to because of the following informalities:
In claim 37, there is an instance of rough grammar in line 5 at “a control module electrically, which is connected to the driving module” (wherein a minor amendment such as “a control moduleelectrically connected to the driving module” will moot this minor objection); and
In claim 45, there is an instance of rough grammar in line 5 at “a control module electrically, which is connected to the driving module” (wherein a minor amendment such as “a control moduleelectrically connected to the driving module” will moot this minor objection).
Appropriate correction is required.
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.
Claim 38 is rejected under 35 U.S.C. 101 because 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.
Claim 38 is 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). In claim 38 is directed to or encompassing a human organism in line 3 at “the microbubble precursors penetrate into the thrombus from blood”. A minor amendment such as “the microbubble precursors are configured to penetrate into the thrombus from blood” will moot this 101 rejection.
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.
Claim(s) 31-33, 36-41, 44-48 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stigall et al. (US 2019/0053785).
Stigall discloses (see Figs. 1, 2B, 3B and 5) an ultrasound therapy system comprising the following claim limitations:
(claim 31) A thrombolysis promoting module, comprising: a driving module (130, Fig. 1; 124B/204B, Figs. 2B and 3B), which is an ultrasonic module for generating acoustic energy ([0027]-[0028]), the driving module being configured to (i.e., capable of) generate ultrasonic waves with a first frequency in a circumferential direction (as shown in Fig. 1; [0028]; circumferential array configuration expressly disclosed), and the ultrasonic waves with the first frequency being capable of driving microbubble precursors to penetrate into a thrombus (Applicant’s application (see claim 32) admits a frequency in the range of 20 kHz to 1 MHz is fully capable of driving microbubble precursor penetration, and Stigall (at [0006]; [0033]; [0058]) expressly discloses an embodiment of the driving module 130 generating a first frequency including the range of 20 KHz to 1 MHz); a cavitation module (120, Fig. 1; 124A/204A, Figs. 2B and 3B), which is an ultrasonic module for generating acoustic energy ([0027]-[0028]), the cavitation module being configured to (i.e., capable of) generate ultrasonic waves with a second frequency in the circumferential direction (as shown in Fig. 1; [0028]; circumferential array configuration expressly disclosed), the second frequency being greater than the first frequency, and the ultrasonic waves with the second frequency being capable of inducing cavitation in the microbubble precursors that penetrate into the thrombus or inducing cavitation on surfaces of the microbubble precursors to form microbubbles (Applicant’s application (see claim 32) admits a frequency in the range of 1 MHz to 20 MHz is fully capable of inducing cavitation in the microbubble precursors, and Stigall (at [0006]; [0031]; [0058]) expressly discloses an embodiment of the cavitation module 120 generating a second frequency greater than the first frequency and including the range of 10 MHz to 20 MHz);
(claims 32 and 41) wherein the microbubble precursors are micro/nano-droplets, the first frequency is 20 kHz to 1 MHz, and the second frequency is 1 MHz to 20 MHz; or the microbubble precursors are micro/nano-particles, the first frequency is 20 kHz to 1 MHz, and the second frequency is 1 MHz to 20 MHz (the system claims do not affirmatively claim microbubbles in any particular form, and Stigall (at [0032]) expressly discloses its system further using pharmacological/thrombolytic agents wherein agent uptake can advantageously improve as a result of the ultrasonic energy) (Stigall (at [0006]; [0033]; [0058]) expressly discloses an embodiment of the driving module 130 generating a first frequency including the range of 20 KHz to 1 MHz; and (at [0006]; [0031]; [0058]) expressly discloses an embodiment of the cavitation module 120 generating a second frequency greater than the first frequency and including the range of 10 MHz to 20 MHz);
(claims 33 and 50) wherein the driving module (130/124B/204B) comprises one or a plurality of first piezoelectric elements ([0029]; [0045]; [0060]), the cavitation module comprises one or a plurality of second piezoelectric elements ([0029]; [0045]; [0060]), and the first piezoelectric element and the second piezoelectric element are insulated from each other (as shown in Figs. 1, 2B, 3B and 5; [0052]; a portion of flexible substrate 214 is expressly shown disposed between and insulating the first and second piezoelectric elements from each other);
(claims 36 and 44) wherein the first piezoelectric element and the second piezoelectric element are coaxially arranged in an axial direction; or the first piezoelectric element and the second piezoelectric element are arranged in a staggered manner in the axial direction (i.e., axially staggered configuration expressly shown in 1, 2B, 3B and 5);
(claims 37 and 45) further comprising one of (emphasis added): an insulating sleeve, inside which the driving module and the cavitation module are disposed; and a control module (206, Fig. 2B) electrically, which is connected to the driving module (124B/204B, Fig. 2B) and the cavitation module (124A/204A, Fig. 2B) to provide excitation signals and energy inputs to the driving module and the cavitation module ([0058]-[0059]; [0064]; [0066]; [0072]; signals from control circuit 206 expressly disclosed);
(claims 38 and 46) wherein the thrombolysis promoting module is an interventional thrombolysis promoting module; and the microbubble precursors penetrate into the thrombus from blood ([0026]; [0032]; use of the Stigall system as a thrombolysis promoting module expressly disclosed);
(claims 39 and 47) wherein a stage in which the driving module operates is a driving stage, a stage in which the cavitation module operates is a cavitation stage, and the driving stage and the cavitation stage are alternately carried out ([0028]; drive and cavitation modules expressly disclosed as being fully capable of being independently controlled and activated);
(claim 40) A thrombolysis promoting module, comprising: a driving module (130, Fig. 1; 124B/204B, Figs. 2B and 3B), which is an ultrasonic module for generating acoustic energy ([0027]-[0028]), the driving module comprising one or a plurality of first piezoelectric elements ([0029]; [0045]; [0060]); a cavitation module (120, Fig. 1; 124A/204A, Figs. 2B and 3B), which is an ultrasonic module for generating acoustic energy ([0027]-[0028]), the cavitation module comprising one or a plurality of second piezoelectric elements ([0029]; [0045]; [0060]) insulated from the first piezoelectric element (as shown in Figs. 1, 2B, 3B and 5; [0052]; a portion of flexible substrate 214 is expressly shown disposed between and insulating the first and second piezoelectric elements from each other); wherein the driving module is configured to (i.e., capable of) generate ultrasonic waves with a first frequency in a circumferential direction (as shown in Fig. 1; [0028]; circumferential array configuration expressly disclosed), and the cavitation module is configured to (i.e., capable of) generate ultrasonic waves with a second frequency in the circumferential direction (as shown in Fig. 1; [0028]; circumferential array configuration expressly disclosed), and the second frequency is greater than the first frequency (Stigall (at [0006]; [0033]; [0058]) expressly discloses an embodiment of the driving module 130 generating a first frequency including the range of 20 KHz to 1 MHz, and (at [0006]; [0031]; [0058]) expressly discloses an embodiment of the cavitation module 120 generating a second frequency greater than the first frequency and including the range of 10 MHz to 20 MHz); and
(claim 48) An interventional thrombus removal device, comprising: at least one thrombolysis promoting module (200, Figs. 1, 2B and 3B); and a main catheter (116, Fig. 1) defining a lumen (i.e., lumen shown having guidewire 140 therein in Fig. 1; [0024]; and 236, Fig. 3B; [0071]) and comprising a distal part for accommodating the thrombolysis promoting module (as expressly shown in Figs. 1 and 3B), the distal part being configured to (i.e., capable of) release microbubble precursors in the lumen to the outside of the main catheter (116) (as shown in Figs. 1 and 3B, a guidewire lumen is fully capable of expelling a pharmacological/thrombolytic agent from the distal end of catheter 116); wherein the thrombolysis promoting module comprises (200): a driving module (130, Fig. 1; 124B/204B, Figs. 2B and 3B), which is an ultrasonic module for generating acoustic energy ([0027]-[0028]), the driving module being configured to (i.e., capable of) generate ultrasonic waves with a first frequency in a circumferential direction (as shown in Fig. 1; [0028]; circumferential array configuration expressly disclosed), and the ultrasonic waves with the first frequency being capable of driving microbubble precursors to penetrate into a thrombus (Applicant’s application (see claim 32) admits a frequency in the range of 20 kHz to 1 MHz is fully capable of driving microbubble precursor penetration, and Stigall (at [0006]; [0033]; [0058]) expressly discloses an embodiment of the driving module 130 generating a first frequency including the range of 20 KHz to 1 MHz); a cavitation module (120, Fig. 1; 124A/204A, Figs. 2B and 3B), which is an ultrasonic module for generating acoustic energy ([0027]-[0028]), the cavitation module being configured to (i.e., capable of) generate ultrasonic waves with a second frequency in the circumferential direction (as shown in Fig. 1; [0028]; circumferential array configuration expressly disclosed), the second frequency being greater than the first frequency, and the ultrasonic waves with the second frequency being capable of inducing cavitation in the microbubble precursors that penetrate into the thrombus or inducing cavitation on surfaces of the microbubble precursors to form microbubbles (Applicant’s application (see claim 32) admits a frequency in the range of 1 MHz to 20 MHz is fully capable of inducing cavitation in the microbubble precursors, and Stigall (at [0006]; [0031]; [0058]) expressly discloses an embodiment of the cavitation module 120 generating a second frequency greater than the first frequency and including the range of 10 MHz to 20 MHz).
Allowable Subject Matter
Claims 34-35, 42-43 and 49 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Jiang et al. (US 2021/0007759).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (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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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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