The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot in view of the new grounds of rejection.
Claim Interpretation
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.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
Claim 1
“A control system that generates a frequency waveform”
In paragraph 29 of PGPUB 2021/0393990 (representative of the specification of the instant application) it states “FIG. 1 includes an embodiment of an ultrasound transducer 100 including a transducer body 110… The transducer body 110 may include a combination of an ultrasound conducting component 114, which in one example may include… a piezoelectric component or layer 118… The piezoelectric component 118 may be used to generate ultrasound waves.” However, in paragraph 30 it states “The ultrasound transducer 100 may be connected to a transmitting unit which supplies a transmission ultrasound signal to the ultrasound transducer”. Since claim 1 also recites “one or more transducers”, it is not believed that “the transducer body 110” or its components reads on the claimed “control system”. Therefore, it is believed that “a transmitting unit which supplies a transmission ultrasound signal to the ultrasound transducer” does read on the claimed “a control system”. However, this term and its sole discussion in paragraph 30 does not teach sufficient structure for the purposes of invoking under 35 USC 112(f). Therefore, see the rejections that follow under 35 USC 112(a) and 112(b).
Claim Rejections - 35 USC § 112
35 USC § 112, First ParagraphThe following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim limitation “a control system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (see above). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. As stated above in the invoking of 35 USC 112(f), in paragraph 29 of PGPUB 2021/0393990 (representative of the specification of the instant application) it states “FIG. 1 includes an embodiment of an ultrasound transducer 100 including a transducer body 110… The transducer body 110 may include a combination of an ultrasound conducting component 114, which in one example may include… a piezoelectric component or layer 118… The piezoelectric component 118 may be used to generate ultrasound waves.” However, in paragraph 30 it states “The ultrasound transducer 100 may be connected to a transmitting unit which supplies a transmission ultrasound signal to the ultrasound transducer”. Since claim 1 also recites “one or more transducers”, it is not believed that “the transducer body 110” or its components reads on the claimed “control system”. Therefore, it is believed that “a transmitting unit which supplies a transmission ultrasound signal to the ultrasound transducer” does read on the claimed “a control system”. However, this term and its sole discussion in paragraph 30 does not teach sufficient structure for the purposes of invoking under 35 USC 112(f).
Therefore, the claimed term lacks written description and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
35 USC § 112, Second Paragraph
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 1-2 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 2 is rejected because “depending on the therapeutic target” is unclear and indefinite. The claims fails to recite that the system is configured to provide one or a plurality of energies, frequencies and duty cycles”, for instance, and instead recites that the ultrasound energy is positively tuned to one or a plurality of these, depending on the therapeutic target. Firstly, “the therapeutic target” lacks antecedent basis. Secondly, it is not clear what the therapeutic target is, nor what coverage such a recitation legally covers.
Claim 13 is rejected because it is unclear if this claim require that peripheral blood samples actually be taken in order to determine and adjust the ultrasound, or if “changes in the levels of target cells, cytokines, or the activity thereof” allows simply for changes in some indication of a change in activity that is unrelated to blood samples sufficiently reads on the claimed subject matter.
In claim 1, the limitation “a control system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (see above). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure and/or material to the function. See the description of the in the invoking of 35 USC 112(f) for clarity of the issues. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson (US Patent Pub. No. 2009/0177123).
Regarding claim 1, Peterson discloses a system (see Figure 6) using targeted ultrasound therapy to induce immunosuppression, comprising: a control system that generates a frequency waveform (see paragraph 129, which discusses generator 100), and one or more transducers (see element 501 in Fig. 6, discussed in paragraph 132) configured to deliver an ultrasound frequency waveform to a treatment area of a subject (see paragraph 41 – “The delivered ultrasonic energy decreases expression of said inflammatory cytokine in one or more of an effected joint, ligament, tendon, skin, or blood vessel of said patient”).
Regarding “wherein said treatment area comprises a lymphatic vessel” and “wherein delivery of the ultrasound frequency to the lymphatic vessel targets cytokines and white blood cells (WBCs) inducing immunosuppression”, it is noted that claim 1 is a system claim. The system itself, as claimed, is “a control system” and “one or more transducers”. These two wherein clauses are intended use (e.g., defining the treatment area as a lymphatic vessel, targeting of cytokines and WBCs and inducing immunosuppression). Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”, and also (with emphasis in the original) “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” As stated in paragraph 252, “one aspect of the invention provides methods for decreasing expression and/or activation of one or more pro-inflammatory cytokines.”
Regarding claim 2, see paragraphs 17-19 with regard to various different frequencies and/or energies that may be used. Additionally, see paragraphs 153-155 for different duty cycles.
Regarding claim 3, it is re-iterated that Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”, and also (with emphasis in the original) “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” Claims 1 and 3 are system claims. The location to which the ultrasound system is used (e.g., the left thoracic duct or the right thoracic duct, or both) does not change the system of claim 1. Peterson is capable of applying ultrasound energy to these areas of the body.
Regarding claim 4, it is noted that there are no other options besides delivering ultrasound energy continuously or over a plurality of duty cycles (i.e., pulsed). Therefore, any prior art reference applied to claim 1 automatically reads on claim 4. Specifically with regard to Peterson, see paragraph paragraphs 153-155.
Regarding claim 5, Peterson teaches that “in certain embodiments, the method comprises a single treatment (e.g., delivering ultrasonic energy once for a period of at least about 1 minute)” (see paragraph 155).
Regarding claim 6, it is again re-iterated that Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”, and also (with emphasis in the original) “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” Claim 1, as described above, is a system comprising “a control system…” and “one or more transducers…”, which the system of Peterson also comprises. Therefore, the system of Peterson is equally as capable of producing the same effective result that is claimed in claim 6 as the system which is claimed in claim 1 and 6.
Regarding claim 7, it is noted that Peterson states that “[w]hen activated, the transducer assembly 500 produces ultrasonic waves having a frequency and capable of delivering ultrasonic energy to patient tissue” (see paragraph 139). Externally applied ultrasound waves transmitted from an ultrasound probe of Peterson is capable of being positioned around the supraclavicular fossa.
Claims 1-4, 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tracey et al (WO 2018/081763).
Regarding claim 1, Tracey discloses a system (see Figure 2) using targeted ultrasound therapy to induce immunosuppression (see Abstract and Fig. 3 illustrating targeting a specific organ), comprising: a control system that generates a frequency waveform (see element 16 in Figure 2, noting that controller 16 includes a pulse generator 14); and one or more transducers configured to deliver an ultrasound frequency waveform to a treatment area of a subject (see paragraph 40: “The depicted system includes a pulse generator 14 coupled to an energy application device 12 (e.g., an ultrasound transducer… The energy application device 12 is configured to receive energy pulses, e.g., via leads, that in use are directed to a target tissue of the patient, which in turn results in a clinical effect at the site of energy focus”).
Regarding “wherein said treatment area comprises a lymphatic vessel” and “wherein delivery of the ultrasound frequency to the lymphatic vessel targets cytokines and white blood cells (WBCs) inducing immunosuppression”, it is noted that claim 1 is a system claim. The system itself, as claimed, is “a control system” and “one or more transducers”. These two wherein clauses are intended use (e.g., defining the treatment area as a lymphatic vessel, targeting of cytokines and WBCs and inducing immunosuppression). Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”, and also (with emphasis in the original) “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).”
Based on the above, Tracey reads on the claimed system of claim 1. Additionally, it is noted that according to claims 26, 30 and 31 of Tracey, the use of ultrasound energy via the system to lymph nodes in an amount to decrease serum levels of proinflammatory cytokines (see claim 26) is claimed as decreasing cytokines (see claim 30).
Regarding claim 2, it is noted that Tracey teaches operating parameters in paragraph 82, which includes at least one frequency, duty cycle, etc. Additionally, it is noted that Tracey teaches that “The treatment duration and frequency can be tailored to achieve the desired result” (see paragraph 43, last sentence).
Regarding claim 3, it is re-iterated that Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”, and also (with emphasis in the original) “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” Claims 1 and 3 are system claims. The location to which the ultrasound system is used (e.g., the left thoracic duct or the right thoracic duct, or both) does not change the system of claim 1. Tracey is capable of applying ultrasound energy to these areas of the body.
Regarding claim 4, it is noted that there are no other options besides delivering ultrasound energy continuously or over a plurality of duty cycles (i.e., pulsed). Therefore, any prior art reference applied to claim 1 automatically reads on claim 4. Specifically with regard to Tracey, paragraph 82 teaches burst cycles, periods and time of bursts. More importantly, Tracey is capable of either as taught in paragraph 43 (“The system 10 as provided herein may provide energy pulses according to various modulation parameters. For example, the modulation parameters may include various stimulation time patterns, ranging from continuous to intermittent”).
Regarding claim 6, it is again re-iterated that Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”, and also (with emphasis in the original) “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” Claim 1, as described above, is a system comprising “a control system…” and “one or more transducers…”, which the system of Tracey also comprises. Therefore, the system of Tracey is equally as capable of producing the same effective result that is claimed in claim 6 as the system which is claimed in claim 1 and 6.
Regarding claim 7, it is noted that Figure 3 of Tracey illustrates the energy application device 12 is placed at a location external to the patient and ultrasound waves transmit through the skin to the targeted internal organ. Additionally, paragraph 40 teaches that “the energy application device 12 may be a MEMS transducer”. Externally applied ultrasound waves transmitted from an ultrasound probe utilizing MEMS transducers are capable of being positioned around the supraclavicular fossa.
Claims 9, 11 and 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tracey.
Regarding claim 9, Tracey teaches a method of delivering ultrasound energy to a treatment area of the subject (see paragraph 76) to induce immunosuppression (see paragraph 76-78 – “applying ultrasound… to one or more of lymph nodes and/or spleen of the subject in an amount effective to… decrease serum levels of one or more proinflammatory cytokines in a subject”), wherein said ultrasound energy targets and inactivates the cytokines in the treatment area by disrupting the molecular structure of said cytokines in the treatment area or downstream thereof, resulting in immunosuppression. Note that in paragraph 76, Tracey states that the “method of treating… an inflammation of a subject compris[es] applying ultrasound… to one or more lymph nodes… in an amount effective to… decrease serum levels of one or more proinflammatory cytokines”. The mere application of ultrasound to a lymph node which then results in decrease of serum levels of proinflammatory cytokines would obviously, if not inherently, result from physical destruction and/or degradation of the cytokines such that they ultimately cannot perform their functions either within the lymph node or at some other location after leaving the lymph node.
Regarding claim 11, it is noted that the ultrasonic waves illustrated in the figures are not focused ultrasound, and therefore when the methods of Tracey are used to apply ultrasound to a lymph node, the proximate lymph vessels will obviously, if not inherently, also be ensonified by ultrasound, and therefore be included in “the treatment area”.
Regarding claim 13, it is noted that paragraph 42 of Tracey teaches that samples are used to determine the effects of the treatment and “[b]ased on the assessment, the modulation parameters of the controller 16 may be altered.” Additionally, paragraph 65 teaches that “The change in activity can comprise, for example, a change in a level of cytokine release in the internal tissue, a change in a level of a cytokine in the patient's blood”. And paragraph 89 teaches an example in which blood was collected and serum levels were determined, thereby determining the efficacy.
Claim Rejections - 35 USC § 103
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 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tracey.
Regarding claim 12, it is initially noted that Tracey was described above with respect to the limitations of claim 11. Furthermore, it would have been obvious to one of ordinary skill in the art at or before the effective filing date that if and when the methods of Tracey are used in lymph nodes proximate the thoracic duct, then the thoracic duct would be ensonified by the ultrasound, in the same manner as is described with regard to the rejection of claim 11.
Regarding claim 14, Tracey teaches a method of delivering ultrasound energy to a treatment area of the subject (see paragraph 76) to induce immunosuppression (see paragraph 76-78 – “applying ultrasound… to one or more of lymph nodes and/or spleen of the subject in an amount effective to… decrease serum levels of one or more proinflammatory cytokines in a subject”), wherein said ultrasound energy targets and inactivates the cytokines in the treatment area by disrupting the molecular structure of said cytokines in the treatment area or downstream thereof, resulting in immunosuppression. Note that in paragraph 76, Tracey states that the “method of treating… an inflammation of a subject compris[es] applying ultrasound… to one or more lymph nodes… in an amount effective to… decrease serum levels of one or more proinflammatory cytokines”. The mere application of ultrasound to a lymph node which then results in decrease of serum levels of proinflammatory cytokines would obviously, if not inherently, result from physical destruction and/or degradation of the cytokines such that they ultimately cannot perform their functions either within the lymph node or at some other location after leaving the lymph node. It is noted that the ultrasonic waves illustrated in the figures are not focused ultrasound, and therefore when the methods of Tracey are used to apply ultrasound to a lymph node, the proximate lymph vessels will obviously, if not inherently, also be ensonified by ultrasound, and therefore be included in “the treatment area”. As such, it would have been obvious to one of ordinary skill in the art at or before the effective filing date that if and when the methods of Tracey are used in lymph nodes proximate the thoracic duct, then the thoracic duct would be ensonified by the ultrasound in this same manner. And as explicitly taught by Tracey, this method results in the inactivation of proinflammatory cytokines to cause immunosuppression.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over either one of Peterson and Tracey as applied to claim 1 above, and further in view of Lewis (WO 2020046847).
Peterson and Tracey were each separately described above with respect to claim 1. However, neither reference discusses that the transducer(s) is/are waterproof.
Lewis teaches devices and methods for use in medical applications for humans and animals involving long duration ultrasound treatment (see Abstract). “In certain embodiments, the ultrasound transducer array includes a plurality of ultrasound transducers connected via flexible circuitry and laminated between two waterproof flexible sheets” (see paragraph 48). It would have been obvious to one of ordinary skill in the art before the effective filing date of the application to create the transducers to make them waterproof, as taught by Lewis, in either of the devices of Peterson or Tracey, thereby enabling long term use of the transducers for the immunosuppression uses, as such uses are not usually a single instance, but used for regularly over time.
Conclusion
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/JAMES M KISH/ Supervisory Patent Examiner, Art Unit 3792