DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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.
The following claim limitations
Surface features (claims 1, 11 and 20)
Wave generation system (claims 1 and 17)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Features (Surface features - claims 1, 11 and 20)
System (Wave generation system - claims 1 and 17)
coupled with functional language
configured to facilitate attachment of at least a portion of the plurality of particles to invasive agent cells within the living being (Surface features - claims 1, 11 and 20)
configured to provide a specific pattern of waves to the living being (Wave generation system - claims 1 and 17)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1, 11, 17 and 20 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
one or more citrate, lactate, glycol, or norbornene components, polymeric strings having a multiple of such components in a repeating pattern or one or more biological components, such as antibodies or other proteins (¶0012) or geometrical physical arrangements and biomolecules such as ligands, antibodies, and other proteins (¶0064)(Surface features - claims 1, 11 and 20)
generation system that can generate sound waves at infrasonic frequencies, ultrasonic frequencies, audible frequencies, non-audible frequencies (¶0065) or light waves, magnetic waves, or electromagnetic waves (¶00135)(Wave generation system - claims 1 and 17)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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, 9-12, 14-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190091350 A1 to Peyman.
Peyman discloses:
Regarding claim 1:
A system (figures 4 or 5) configured to treat invasive agent cells (66 or 75), the system comprising:
a plurality of particles (see nanoparticles mentioned in ¶0079) configured for introduction into a living being (within the patient as shown in figures 4 and 5), wherein the plurality of particles includes surface features configured to facilitate attachment of at least a portion of the plurality of particles to invasive agent cells within the living being (see the biomarker used to coat nanoparticles that can include proteins to aid in attaching to cancer cells consistent with the 35 USC 112(f) interpretation above; ¶0004, ¶0009, ¶0011); and
a wave generation system (48/52/68 or 82/68 ultrasound or anode/cathode that generates pulsed electrical current consistent with the 35 USC 112(f) interpretation) configured to provide a specific pattern of waves (ultrasound as indicated in ¶0079) to the living being, the specific wave pattern including waves at one or more frequencies (ultrasound as indicated in ¶0079), wherein the specific wave pattern is configured to actuate the plurality of particles to damage, destroy, or create an immune response to the invasive agent cells to which they are attached (“The focused ultrasound beam 84 passes through the skin and simultaneously heats up the tumor tissue and attached piezoelectric nanoparticles to a temperature of 39-40 degrees C. to damage the tumor cells of the tumor 75 with the thermal energy and to depolarize the tumor cell membranes by converting the sound waves to an electric pulse to depolarize the tumor cells exposed to the ultrasound, making the cells permeable to the medication/gene used to treat the tumor 75”; ¶0079).
Regarding claim 2:
The system of claim 1, wherein the living being is a human (as shown in figure 4 and 5) and the invasive agent cells are cancer cells (“cancer treatment system” in figures 4 and 5 as mentioned in ¶0020 and 0021) .
Regarding claim 3:
The system of claim 1, wherein the plurality of particles includes functionalized nanoparticles selected from the group consisting of gold (¶0028), silver, liposomes (¶0036), and dendrimers (¶0038-0039).
Regarding claim 4:
The system of claim 1, wherein the plurality of particles is contained within a fluid configured for injection into the bloodstream of the living being (¶0033 indicates the nanoparticles can be injected).
Regarding claim 5:
The system of claim 1, wherein actuating the plurality of particles includes inducing one or more movements, rotations, or changes in temperature (¶0034 or ¶0079), shape, confirmation, or chemical structure in at least a portion of the plurality of particles in response to the specific wave pattern.
Regarding claim 6:
The system of claim 1, wherein actuating the plurality of particles results in lysis of or immune response to invasive agent cells to which the at least a portion of the plurality of particles are attached (particles can include “immune stimulators, such as pluralities of antibody coated viral-like particles”).
Regarding claim 7:
The system of claim 1, wherein the specific wave pattern includes pulses of waves interspersed between pulses of no waves, and wherein durations of the pulses vary to form ratios between the pulses of waves and the pulses of no waves (¶0110 indicates the waves are maintained for 1-10 minutes until the tumor is damaged indicating the waves are pulsed on for periods of 1-10 minutes).
Regarding claim 9:
The system of claim 1, wherein the waves include sound waves (ultrasound as indicated in ¶0079 as shown in figure 5).
Regarding claim 10:
The system of claim 1, wherein the waves include light waves, magnetic waves, or electromagnetic waves or electromagnetic wave (electromagnetic waves form the anode or cathode 52/48 as shown in figure 4 and indicated in ¶0079).
Regarding claim 11:
A method (figures 4 or 5) of treating an invasive agent (66 or 75) within a living being (as shown in figures 4 and 5), the method comprising:
providing a plurality of particles (see nanoparticles mentioned in ¶0079), wherein the plurality of particles includes surface features configured to facilitate attachment of a significant amount of the plurality of particles to invasive agent cells within the living being (see the biomarker used to coat nanoparticles that can include proteins to aid in attaching to cancer cells consistent with the 35 USC 112(f) interpretation above; ¶0004, ¶0009, ¶0011);
introducing the plurality of particles into the living being (¶0033 indicates the nanoparticles can be injected);
facilitating attachment of a significant amount of the plurality of particles to invasive agent cells within the living being (attach to the cancer cells as indicated in ¶0030, ¶0049 and ¶0079); and
directing a specific wave pattern toward the living being (48/52/68 or 82/68 ultrasound or anode/cathode that generates pulsed electrical current consistent with the 35 USC 112(f) interpretation), the specific wave pattern including waves at one or more frequencies (ultrasound as indicated in ¶0079), wherein the specific wave pattern is configured to actuate the plurality of particles to damage, destroy, or create an immune response to the invasive agent cells to which they are attached (“The focused ultrasound beam 84 passes through the skin and simultaneously heats up the tumor tissue and attached piezoelectric nanoparticles to a temperature of 39-40 degrees C. to damage the tumor cells of the tumor 75 with the thermal energy and to depolarize the tumor cell membranes by converting the sound waves to an electric pulse to depolarize the tumor cells exposed to the ultrasound, making the cells permeable to the medication/gene used to treat the tumor 75”; ¶0079).
Regarding claim 12:
The method of claim 11, wherein the specific wave pattern includes pulses of waves interspersed between pulses of no waves, and wherein durations of the pulses vary to form ratios between the pulses of waves and the pulses of no waves (¶0110 indicates the waves are maintained for 1-10 minutes until the tumor is damaged indicating the waves are pulsed on for periods of 1-10 minutes).
Regarding claim 14:
The method of claim 11, further comprising the steps of: actuating the plurality of particles automatically with the specific wave pattern (vibrational force of ultrasonic waves as indicated in claim 1), wherein the actuating results in damaging, destroying, or provoking an immunological response to invasive agent cells to which any of the plurality of particles are attached (¶0079).
Regarding claim 15:
The method of claim 14, wherein actuating the plurality of particles involves rotational or translational movement of the particles due to the specific wave pattern (vibrational force of ultrasonic waves as indicated in claim 1).
Regarding claim 16:
The method of claim 11, wherein the waves include sound waves (ultrasound as indicated in ¶0079) and wherein the plurality of particles include functionalized nanoparticles (¶0079).
Regarding claim 17:
A system (figures 4 or 5) configured to treat invasive cells (66 or 75), the system comprising:
a wave generation system (48/52/68 or 82/68 ultrasound or anode/cathode that generates pulsed electrical current consistent with the 35 USC 112(f) interpretation) configured to project a specific wave pattern (ultrasound as indicated in ¶0079), the specific wave pattern including waves at one or more frequencies (ultrasound as indicated in ¶0079), wherein the specific wave pattern is configured to induce lysis of or immune response to a significant amount of invasive cells within a living being (“The focused ultrasound beam 84 passes through the skin and simultaneously heats up the tumor tissue and attached piezoelectric nanoparticles to a temperature of 39-40 degrees C. to damage the tumor cells of the tumor 75 with the thermal energy and to depolarize the tumor cell membranes by converting the sound waves to an electric pulse to depolarize the tumor cells exposed to the ultrasound, making the cells permeable to the medication/gene used to treat the tumor 75”; ¶0079).
Regarding claim 18:
The system of claim 17, wherein the specific wave pattern includes pulses of waves interspersed between pulses of no waves, wherein durations of the pulses vary to form ratios between the pulses of waves and the pulses of no waves (¶0110 indicates the waves are maintained for 1-10 minutes until the tumor is damaged indicating the waves are pulsed on for periods of 1-10 minutes), and wherein the relationship of the ratios of the pulses forms an arithmetic (on and off sequence for 1-10 minutes), geometric, or Fibonacci sequence.
Regarding claim 20:
The system of claim 17, further comprising:
a plurality of functionalized nanoparticles (see nanoparticles mentioned in ¶0079) configured for introduction into the living being (within the patient as shown in figures 4 and 5), wherein the plurality of functionalized nanoparticles includes surface features configured to facilitate attachment of the functionalized nanoparticles to the invasive cells within the living being without also facilitating attachment of the functionalized nanoparticles to a significant amount of healthy cells of the living being (see the biomarker used to coat nanoparticles that can include proteins to aid in attaching to cancer cells consistent with the 35 USC 112(f) interpretation above; ¶0004, ¶0009, ¶0011), and wherein the functionalized nanoparticles are configured to be actuated by the specific wave pattern (“The focused ultrasound beam 84 passes through the skin and simultaneously heats up the tumor tissue and attached piezoelectric nanoparticles to a temperature of 39-40 degrees C. to damage the tumor cells of the tumor 75 with the thermal energy and to depolarize the tumor cell membranes by converting the sound waves to an electric pulse to depolarize the tumor cells exposed to the ultrasound, making the cells permeable to the medication/gene used to treat the tumor 75”; ¶0079).
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.
Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190091350 A1 to Peyman as applied to claims 7, 12 or 18 above, and further in view of US 20120080305 A1 to Koruga.
Regarding claim 8:
Peyman fails to disclose:
The system of claim 7, wherein the relationship of the ratios forms an arithmetic, geometric, or Fibonacci sequence.
Koruga teaches:
A method of using a pulses of waves (¶0078) in accordance with a Fibonacci sequence (¶0078) for treatments of cancer. The reference teaches that these treatments can aid in treating cancer (¶0130).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman to make the ratios in a form of a Fibonacci sequence as taught by Koruga for improved cancer treatment (Koruga, ¶0130).
Regarding claim 13:
Peyman fails to disclose:
The method of claim 12, wherein the relationship of the ratios forms an arithmetic, geometric, or Fibonacci sequence.
Koruga teaches:
A method of using a pulses of waves (¶0078) in accordance with a Fibonacci sequence (¶0078) for treatments of cancer. The reference teaches that these treatments can aid in treating cancer (¶0130).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman to make the ratios in a form of a Fibonacci sequence as taught by Koruga for improved cancer treatment (Koruga, ¶0130).
Allowable Subject Matter
Claim 19 is 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. The following is pertinent prior art:
US-20030028071-A1
Handy
See the wave generator 102/104
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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