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 .
Claim Status
Claims 1-31 are currently pending and under examination.
Priority
Applicant claims priority for all claims based on the provision application 63/444,878, filed 10 February 2023.
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later- filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-Al A 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, 63/444,878 filed 10 February 2023, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more of the claims of this application.
The critical failure of the priority chain lies within independent claim 1, with which claims 2-31 directly or indirectly depend from. Instant claim 1 requires a high-density ultrasound coupling gel comprising:
90-99 wt% water-based ultrasound transmission gel material;
1-10 wt% sodium dopant; and
Density 1-2 g/mL
The provisional disclosure does support an aqueous ultrasound gel, a 2.5 wt% diclofenac sodium embodiment with a measured density of approximately 1.06 g/mL (p. 12). However, this is not the same disclosure as possession of 1-10 wt% genus of sodium dopants. In fact, the provisional disclosure does not even mention sodium dopant but instead, repeatedly characterizes this component as a pharmacotherapeutic agent/NSAID (p. 5). There is no general disclosure that NaCl, NaOH, NaBr, sodium bicarbonate, sodium sulfate, etc. can function as the invention’s currently claimed sodium dopant.
Also missing from the provision disclosure is the 90-99 wt% base gel range. A single 2.5 wt% diclofenac sodium example does not reasonably convey possession of the instantly claimed broad genus. Therefore, claim 1 is not entitled to the priority date of 63/444,878 and instead entitled to the date of the instantly filed application on 12 February 2024. Because each of claims 2-31 contains or incorporates the limitations of claim 1, claims 2-31 are also not entitled to the priority date of 63/444,878 and instead entitled to date of the instantly filed application on 12 February 2024.
Should Applicant disagree with examiner’s factual determination as to the disclosure of the various claim limitations, Applicant may identify, with particularity, where the subject matter in instant claims 1-31 is found in application 63/444,878.
Information Disclosure Statement (IDS)
There are no IDSs currently filed in this application.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.”
CLAIM INTERPRETATION
Claim 1 is directed to a high-density ultrasound coupling gel comprising:
About 90-99 wt% of a water-based ultrasound transmission gel material;
About 1-10 wt% of a sodium dopant effective to increase density; and
A resulting density of about 1-2 g/mL.
The phrases “effective to conduct acoustic energy,” “effective to increase density,” and similar functional statements are interpreted as requiring the recited compositions to possess the stated capability, but do not require any particular mechanism for producing that capability.
The term ‘about’ is given its ordinary reasonable scope consistent with the Specification.
Claim Rejections - 35 USC § 112(a)
The 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.
Claims 24 and 27-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some specific embodiments of high-density ultrasound coupling gel, does not reasonably provide enablement for the full breadth of the claimed functional genus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)).
These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims
as discussed below. The Wands factors support a finding of nonenablement.
(A)The breadth of the claims:
Claims 24 and 27-31 are method of treatment claims using the high-density ultrasound coupling gel recited in claim 1. The high-density ultrasound coupling gel of claim 1 encompasses ultrasound gels containing approximately 1-10 wt% of a broadly defined ‘sodium dopant,’ including numerous, chemically different sodium salts.
The genus encompasses, inter alia: sodium chloride; sodium sulfate; sodium bromide; sodium perchlorate; sodium fluoride; sodium iodide; sodium hypochlorite; sodium bicarbonate; sodium hydroxide; diclofenac-containing compositions; and numerous other NSAID-containing compositions.
The claims at issue then require this broad formulation genus to possess additional functional properties or therapeutic advantages including: “increased heat capacity effective to facilitate and maintain heat transfer from the ultrasound transducer to the subject’s tissue to improve long duration ultrasound therapy” (claim 24); “improve pain relief” (claim 27); “improve healing” (claim 28); “increase ultrasound coupling efficacy during treatment” (claim 29); “reduce excess heating or other pain sensations by the subject” (claim 30); and “increase length of time and quality of ultrasound coupling” (claim 31).
The functional scope is substantially broader than the particular formulation data disclosed.
(B)The nature of the invention:
The claimed invention concerns aqueous polymeric ultrasound coupling formulations whose acoustic, thermal, rheological, drug-delivery, and therapeutic properties depend upon multiple formulation and treatment variables.
The relevant variables include, at a minimum: 1) identity and concentration of the sodium dopant; 2) water content; 3) viscosity; 4) ionic strength; 5) pH; 6) acoustic impedance; 7) transducer frequency and power; 8) treatment duration; 9) anatomical treatment site; 10) tissue depth; 11) disease or injury treated; and 12) presence or absence of a pharmacologically active NSAID.
Thus, the relationship between increasing gel density and obtaining all the comparative biological and thermal results recited in claims 24 and 27-31 is not a simple, single-variable relationship.
(C) State of the Prior Art:
The prior art demonstrates that aqueous ultrasound gels, sodium-containing ultrasound media, wearable long-duration ultrasound systems, and diclofenac sonophoresis were known.1
However, the prior art does not establish a universal rule that every sodium-doped gel within the limitations of claim 1 necessarily encompasses every claimed property of claims 24 and 27-31.
The state of the art therefore does not supply the missing correlation across Applicant’s entire claimed genus.
(D) Level of Ordinary Skill:
A person of ordinary skill would have substantial knowledge of ultrasound coupling materials, pharmaceutical formulation, and/or therapeutic ultrasound treatment. A relatively high level of skill weighs somewhat in favor of enablement. However, such a high level of skill does not substitute for missing guidance where the claimed result depends upon specific formulation properties such as acoustic, thermal, and biological behavior.
(E) Predictability of the Art:
The art is reasonably predictable as to certain elementary physical effects, such as formulations containing dissolved salt to modify density or acoustic properties.2 The art is materially less predictable as to the broad therapeutic and comparative limitations recited in claims 24 and 27-31.
For example, an increase in solution density does not independently establish increased heat capacity, improved healing, improved analgesia, reduced painful heating, or improved long-term coupling performance as claimed for every claimed sodium compound and treatment method.
Different salts and drugs within the formulation can affect viscosity, ionic strength, polymer conformation, skin compatibility, acoustic impedance, thermal conductivity, specific heat, stability, and pharmacological activity differently.
(F) Amount of Direct or Guidance:
The Specification provides general embodiments where the high-density gel may be prepared by mixing a conventional water-based ultrasound gel with a sodium dopant using ordinary mixing techniques.
The Specification further provides a specific formulation comprising 3.047 g Aquasonic gel, 0.079 g diclofenac sodium, and 0.043 g hydroxyethyl cellulose ([0074]). Of note, Aquasonic is a brand of gel lines produced by Parker Labs Inc., which contains several types of gels such as Aquasonic 100 and Aquasonic Clear. This further supports a rejection of enablement because one-third of Applicant’s disclosed ingredients in their single, specific ultrasound gel embodiment names a product line, not the specific gel used.
Furthermore, the Specification does not provide a general formulation rule or parameter that would permit a skilled artisan to select any member of the claimed sodium dopant genus and reasonably expect the resulting composition would possess each of the functional results required by claims 24 and 27-31. Nor does the Specification provide formulation criteria identifying which sodium compounds, concentrations, viscosities, or acoustic properties would yield the claimed comparative results.
(G) Working Examples:
Example 1 pertains to a clinical treatment study using a 2.5% diclofenac ultrasound coupling patch. The exact composition of the patch is not disclosed ([0097], Examples pp. 1-10). Example 2 pertains to a study investigating long-duration ultrasound applied with high-density gel for 8-weeks of treatment. The exact composition of the patch is not disclosed ([0097], Examples pp. 10-14). Example 2 pertains to a long-duration, low-intensity ultrasound clinical treatment study using a 2.5% diclofenac ultrasound coupling patch. The exact composition of the patch is not disclosed ([0097], Examples pp. 14-16).
Therefore, the disclosure does not provide representative working examples across the breadth of the claimed sodium dopant genus. In particular, no representative working examples are provided demonstrating a particular formulation and its disclosed components apart from a 2.5% diclofenac patch. These examples do not provide the amount of water-based ultrasound gel, the amount and type of sodium dopant used, and the density of the material. Furthermore, no representative working examples are provided for demonstrating the claimed comparative results for gels containing the full scope of sodium dopant genus as claimed.
(H) Quantity of Experimentation Required:
To determine embodiments through the full scope of claims 24 and 27-31, a skilled artisan would need to: 1) prepare numerous formulations across the broadly claimed sodium dopant genus; 2) measure density and acoustic properties; 3) measure relevant thermal properties; 4) identify a lower-density comparative formulation; 5) conduct comparative heating studies; 6) conduct comparative pain or healing studies; and 7) repeat testing for materially different treatment conditions and formulations.
This constitutes substantially more than routine verification of a predictable property.
Considering the Wands factors as a whole, particularly the breadth of the claimed functional genus, relatively low predictability of the comparative therapeutic results, limited guidance for the claimed results, lack of representative examples across the genus, and substantial quantity of experimentation required, the specification does not enable the full scope of claims 24 and 27-31. A significant amount of undue experimentation would be required to use the composition in accordance with the rejected claims. Although the specification may enable a limited number of extremely small gel formulations containing diclofenac, the claims broadly encompass an extremely large and diverse genus of sodium dopants and materials. The specification does not provide sufficient representative examples, predictive guidance, or formulation rules commensurate with the broad scope of the claims.
Claim Rejections - 35 USC § 112(b)
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 1-31 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 initially recites, “a water-based ultrasound transmission gel material” but subsequently refers to “said water-soluble ultrasound transmission gel material.” It is unclear whether ‘water-soluble ultrasound transmission gel material’ refers to the previously recited ‘water-based ultrasound transmission gel material’ or constitutes a different limitation. A material may be water-based without necessarily being water-soluble.
Claims 2-31 are included in this rejection for their dependency on, including every limitation of, and failing to cure the defect of claim 1.
Claims 4 and 6 recite a viscosity of approximately 100,000-400,000 cP without specifying a measurement method or sufficient measurement conditions. Ultrasound coupling gels containing polymeric thickeners may exhibit shear-dependent/non-Newtonian viscosity. Therefore, the measured viscosity can be materially affected by parameters such as temperature, shear rate, spindle geometry, and instrument settings. The Specification provides no further guidance. The claims do not provide a measurement condition by which a person of ordinary skill can reasonably determine whether a particular gel falls within the recited range.
Claim 10 recites the sodium dopant comprises “a nonsteroidal anti-inflammatory drug (NSAID) and sodium.” It is unclear whether the claim requires: 1) an NSAID plus a separate sodium ingredient; 2) a sodium salt of an NSAID; 3) either of the foregoing; or 4) an NSAID composition containing some amount of sodium.
The ambiguity of claim 10 is enhanced by claim 11, which lists both sodium salts, such as diclofenac sodium and naproxen sodium, and compounds that do not themselves contain sodium such as diclofenac and naproxen.
Claim 23 requires the high density ultrasound coupling gel be “effective to increase ultrasound coupling between the ultrasound transducer and the subject’s tissue.” The claim does not identify the reference state against which the increase is determined (e.g., is the comparison to no coupling gel, an unspecified conventional gel, a lower-density gel, air, or some other reference condition). Therefore, the claim does not provide an objective boundary for reasonably determining the metes and bounds of the claim.
Claim 24 requires the high density ultrasound coupling gel have “an increased heat capacity effective to facilitate and maintain heat transfer from the ultrasound transducer to the subject’s tissue to improve long duration ultrasound therapy.” The claim does not identify the composition or condition relative to which the heat capacity is increased. Furthermore, heat capacity, thermal conductivity, heat transfer, and duration of treatment are distinct concepts. The claim does not identify an objective test or reference material from which the purported increase can be determined.
Claims 27-31 each require a comparison to treatment limitation employing “a lower density ultrasound coupling gel.” No composition, density, density range, or other objective definition of the lower density ultrasound coupling gel is recited or disclosed by Applicant. Without further guidance, virtually any gel having a density below that of the claimed gel could constitute a ‘lower density’ gel, the claims do not establish a reproducible comparison. The claims additionally recite indefinite comparative terminology including: “improve pain relief” (claim 27); “improve healing” (claim 28); “increase ultrasound coupling efficacy during treatment” (claim 29); “reduce excess heating or other pain sensations by the subject” (claim 30); and “increase length of time and quality of ultrasound coupling” (claim 31). The claims do not provide an object standard for determining, for instance, what would constitute an improvement in healing that would be sufficient to meet the claim limitations. Therefore, one of ordinary skill could not reasonably determine the metes and bounds of the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, 10-12, 15-16, 18-22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Treff (US PGPub No. 2019/0351078 A1, published 21 November 2019) in further view of Masterson (“Sustained acoustic medicine; sonophoresis for nonsteroidal anti-inflammatory drug delivery in arthritis,” published: 13 July 2020) and Ophir (US Pat. No. 4,286,455, date of patent 01 September 1981).
Treff teaches a conventional water-based ultrasound transmission gel for transmitting ultrasound waves between an ultrasound probe and tissue (abstract).
Regarding claim 1 –
Treff teaches formulations comprising approximately 90-95 wt% purified water together with Carbopol and other conventional ultrasound gel ingredients ([0007]).
While Treff does not expressly teach modifying its ultrasound gel by adding approximately 1-10 wt% of a sodium-containing pharmacotherapeutic dopant, this limitation is made obvious by Masterson.
Masterson teaches use of an ultrasound coupling gel in sustained acoustic medicine (SAM) and expressly states the ultrasound coupling reservoir was filled with 1 wt% diclofenac gel formulated using diclofenac sodium (p. 365). Masterson further reports the diclofenac gel provided effective ultrasound coupling into deep muscle tissue (p. 369).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Treff’s convention water-based ultrasound transmission gel by incorporating 1 wt% diclofenac sodium, as taught by Masterson, in order to provide a coupling gel capable of simultaneously transmitting therapeutic ultrasound and locally delivering the known NSAID diclofenac by sonophoresis.
Masterson expressly provides the reason for making such a modification: topical diclofenac has limited skin penetration, whereas sustained ultrasound enhances delivery of diclofenac through the skin (abstract). Masterson reports that a four-hour sonophoresis treatment increased diclofenac delivery approximately 3.8 times and increased penetration 32% relative to the control (abstract).
The resulting formulation from the combination of Treff and Masterson would comprise approximately 99 wt% of the conventional water-based ultrasound gel and 1 wt% of the diclofenac sodium additive, thereby falling within the ranges of claim 1.
As to the limitation that the sodium dopant is effective to increase density, neither Treff nor Masterson expressly state the diclofenac sodium was added for the purpose of increasing density. However, the claim does not require an increase in density to have motivated one of ordinary skill to modify Treff’s formulation with diclofenac sodium as disclosed by Masterson; it requires the material possess the capability.
Ophir teaches the addition of a dissolved sodium predictably alters the physical properties of an aqueous ultrasonic transmission medium (col. 2, lines 14-20). Specifically, Ophir teaches the addition of sodium chloride to an aqueous ultrasound medium to obtain ultrasonic propagation and reports that the resulting salt solution has a density of approximately 1.1 g/mL and an ultrasound velocity of approximately 1540 m/s (col. 4, lines 1-15).
Accordingly, one of ordinary skill would have understood that the addition of a sodium-containing solute to a highly aqueous ultrasound transmission medium predictably modifies its density and acoustic properties as taught by Ophir. The fact that Applicant characterizes this known physical consequence as the sodium dopant being effective to increase density does not render the otherwise obvious composition nonobvious.
Regarding claim 2 –
Ophir expressly teaches modifying an aqueous ultrasound transmission medium with sodium chloride such that ultrasound travels through the medium at approximately the velocity of ultrasound through human tissue or approximately 1540 m/s (col. 4, lines 3-9). The velocity disclosed by Ophir falls within the instantly claimed range. See MPEP 2144.05.
Regarding claim 3 –
Acoustic impedance is calculated as the product of density and speed of sound in that material. Since Ophir teaches an aqueous sodium salt ultrasonic medium having approximately 1.1 g/mL density and 1540 m/s sound velocity. The properties disclosed by Ophir correspond to an acoustic impedance within the numerical region recited by claim 3 under the conventional relationship between density, sound velocity, and acoustic impedance.
Regarding claim 7 –
Treff expressly teaches a water-rich ultrasound gel comprising 90-95 wt% purified water and Carbopol ([0007]). Carbopol is a polyacrylic acid-based polymer used to form the ultrasound gel.
Regarding claims 10, 11, and 12 –
Masterson expressly teaches an ultrasound coupling reservoir containing 1 wt% diclofenac gel formulated using diclofenac sodium (p. 365). Diclofenac is an NSAID and diclofenac sodium is expressly the sodium salt of diclofenac.
Regarding claim 15 –
Masterson expressly teaches a polypropylene containment reservoir designed to house the ultrasound coupling agent (p. 365). The reservoir holds approximately 3 mL of gel and was filled with the 1 wt% diclofenac gel formulated using diclofenac sodium.
Regarding claim 16 –
Masterson expressly describes the SAM device as a wearable ultrasound device (p. 368).
Regarding claim 18 –
Masterson teaches a sustained acoustic medicine system comprising an ultrasound transducer, a power-operated wearable ultrasound device, and the 1 wt% diclofenac ultrasound coupling gel positioned between the transducer and treatment surface (p. 364). The system operates at 3 MHz and provides continuous therapeutic ultrasound for four hours (p. 365).
Regarding claim 19 –
Masterson expressly provides using a SAM system to provide therapeutic ultrasound/sonophoresis for treatment of arthritis and painful inflammatory conditions in human subjects (p. 363).
Regarding claim 20 –
Masterson expressly provides a four-hour continuous ultrasound treatment (p. 364).
Regarding claim 21 –
Masterson expressly characterizes the therapy as ‘deep inside the tissue,’ thereby constituting deep tissue therapy (p. 365).
Regarding claim 22 –
Masterson expressly places thermocouples at 1, 2, and 5 cm below the tissue surface and demonstrated clinically relevant heating at all three depths (p. 366, Fig. 2(B)).
Regarding claim 25 –
Masterson expressly identifies sonophoresis for NSAID delivery and teaches 1 wt% diclofenac ultrasound gel formulated using diclofenac sodium (p. 365). Masterson further teaches active SAM treatment increased diclofenac delivery to deep tissue (p. 368).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Treff’s convention water-based ultrasound transmission gel by incorporating 1 wt% diclofenac sodium, as taught by Masterson, in order to provide a coupling gel capable of simultaneously transmitting therapeutic ultrasound and locally delivering the known NSAID diclofenac by sonophoresis.
Masterson expressly provides the reason for making such a modification: topical diclofenac has limited skin penetration, whereas sustained ultrasound enhances delivery of diclofenac through the skin (abstract). Masterson reports that a four-hour sonophoresis treatment increased diclofenac delivery approximately 3.8 times and increased penetration 32% relative to the control (abstract).
The resulting formulation from the combination of Treff and Masterson would comprise approximately 99 wt% of the conventional water-based ultrasound gel and 1 wt% of the diclofenac sodium additive, thereby falling within the ranges of claim 1.
As to the limitation that the sodium dopant is effective to increase density, neither Treff nor Masterson expressly state the diclofenac sodium was added for the purpose of increasing density. However, the claim does not require an increase in density to have motivated one of ordinary skill to modify Treff’s formulation with diclofenac sodium as disclosed by Masterson; it requires the material possess the capability.
Ophir teaches the addition of a dissolved sodium predictably alters the physical properties of an aqueous ultrasonic transmission medium (col. 2, lines 14-20). Specifically, Ophir teaches the addition of sodium chloride to an aqueous ultrasound medium to obtain ultrasonic propagation and reports that the resulting salt solution has a density of approximately 1.1 g/mL and an ultrasound velocity of approximately 1540 m/s (col. 4, lines 1-15).
Accordingly, one of ordinary skill would have understood that the addition of a sodium-containing solute to a highly aqueous ultrasound transmission medium predictably modifies its density and acoustic properties as taught by Ophir. The fact that Applicant characterizes this known physical consequence as the sodium dopant being effective to increase density does not render the otherwise obvious composition nonobvious.
Therefore, claims 1-3, 7, 10-12, 15-16, 18-22, and 25 are made obvious by the combination of Treff, Masterson, and Ophir.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Hsia (WO 2005/069916 A2, published 04 August 2005).
The teachings of Treff, Masterson, and Ophir are discussed above as rendering obvious the ultrasound gel composition of claim 1. While the combination of the references does not expressly teach the limitations of claims 4-6, these claims are made obvious in further view of Hsia.
Hsia describes commercially available ultrasound transmission gels, including Aquasonic® 100, Polysonic, EcoGel 100, and EcoGel 200 as the base gel with which to add additional ingredients (pp. 34-35). Of note, Applicant’s disclosure teaches Aquasonic or polysonic gels as the base ultrasound gel (See Specification, [0064]).
Regarding claim 4 –
Hsia teaches the Aquasonic and Polysonic gels have a pH of 6.5-7.0 (p. 34). See MPEP 2144.05.
Regarding claim 5 –
Hsia teaches the Aquasonic gel has a viscosity of 80,000 to 110,000 centipoise (p. 34). See MPEP 2144.05.
Regarding claim 6 –
Hsia teaches the Aquasonic gel has a viscosity of 80,000 to 110,000 centipoise (p. 34). Hsia further teaches the commercial base gels have a density of 1.034 g/cm3 and acoustic impedance of 1.60 (105 g/cm2 sec) (p. 35). As previously discussed, Ophir provides the speed of sound and acoustic impedance limitations as currently claimed.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate the modified Treff/Masterson/Ophir ultrasound gel at conventional pH and viscosity parameters as taught by Hsia. This is especially relevant because Hsia teaches the exact commercial base gel as currently disclosed in Applicant’s Specification. Addition of diclofenac sodium would not materially alter the pH or viscosity parameters of the commercial ultrasound gels. Therefore, one of ordinary skill would expect pH and viscosity parameters within the range of commercial base gels as taught by Hsia. Selection of a pH or viscosity within an overlapping known range would have amounted to routine optimization of a known result-effective variable absent evidence of criticality or unexpected results.
Accordingly, claims 4-6 are made obvious by Treff, Masterson, and Ophir in further view of Hsia.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Wiley (US PGPub No. 2012/0016236 A1, published 19 January 2012).
The teachings of Treff, Masterson, and Ophir are discussed above as rendering obvious the ultrasound gel composition of claim 1. While the combination of the references does not expressly teach the limitations of claims 8 and 9, these claims are made obvious in further view of Wiley.
Wiley expressly teaches ultrasound coupling gels containing sodium (abstract, [0037]).
Regarding claims 8 and 9 –
Wiley teaches the ultrasound gel sodium additives include sodium chloride ([0048]). Wiley teaches the concentration of the sodium additives range from 0.1 wt% to 3 wt%, preferably 0.5 wt% to 2 wt% ([0046]). Since sodium constitutes about 39.3 wt% of sodium chlorides, an ultrasound gel containing:
0.5 wt% NaCl contains about 0.20 wt% sodium;
1.0 wt% NaCl contains about 0.39 wt% sodium;
1.5 wt% NaCl contains about 0.59 wt% sodium; and
2.0 wt% NaCl contains about 0.79 wt% sodium.
These values overlap the claimed range of instant claim 8.
It would have been obvious to one of ordinary skill in the art to further modify the ultrasound coupling gel of Treff/Masterson/Ophir by selecting a sodium-containing additive and concentration as taught by Wiley. Wiley expressly teaches that sodium-containing materials, including sodium chloride, may be incorporated into ultrasound coupling gels and further teaches concentration ranges encompassing approximately 0.5 to 2 wt%.
A person of ordinary skill would have recognized the identity and amount of such ionic additives as ordinary formulation variables affecting the physical and acoustic behavior of an aqueous ultrasound coupling medium. Thus, once an aqueous ultrasound gel comprising a sodium-containing active ingredient was known from Masterson, Wiley would have provided additional guidance that sodium-containing compounds could be incorporated into ultrasound coupling gels at concentrations between 0.5 to 2 wt%. without destroying their ability to function as ultrasound couplants.
The skilled artisan would have had reason to select a sodium-containing compound and concentration from Wiley when formulating the known ultrasound coupling gel in order to adjust the formulation while retaining suitable ultrasound coupling characteristics. Such selection would have amounted to no more than the predictable use of a known ultrasound gel additive according to its established function and routine optimization of this amount.
Accordingly, claims 8 and 9 are made obvious by Treff, Masterson, and Ophir in further view of Wiley.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Guangdong (CN102580124A, published 18 July 2012).
The teachings of Treff, Masterson, and Ophir are discussed above as rendering obvious the ultrasound gel composition of claim 1. While the combination of the references does not expressly teach the limitations of claim 13, this claim is made obvious in further view of Guangdong.
Guangdong teaches a medical ultrasound composition containing a water-soluble polymer between 0.3 to 3 wt% (p. 2), which overlaps with the instantly claimed range. Guangdong further expressly identifies hydroxyethyl cellulose as one of the suitable water-soluble polymers (p. 2). Thus, the prior art teaches both the claimed thickener species, hydroxyethyl cellulose, at a concentration range overlapping the presently claimed range.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the ultrasound coupling gel of Treff/Masterson/Ophir by employing hydroxyethyl cellulose as a thickening polymer in an amount between 0.3 to 3 wt% as taught by Guangdong. Guangdong teaches hydroxyethyl cellulose specifically as a suitable water-soluble polymer for a medical ultrasound gel.
A person of ordinary skill would have reason to select hydroxyethyl cellulose as an alternative or additional gel-forming/thickening polymer in order to provide the viscosity, consistency, and structural characteristics necessary for the gel to remain at the transducer/tissue interface while effectively transmitting ultrasound energy. Such substitution represents the use of one known ultrasound gel thickening polymer for another according to its established function in the art.
Moreover, the amount of thickener would have been a result-effective formulation variable because the concentration of the polymer directly affects gel formation, viscosity, and consistency. Guangdong teaches a broad operative range of 0.3 to 3 wt%, which overlaps the claimed 0.1 to 1.5 wt% range. In the absence of evidence that the claimed range is critical, selection of a concentration within the overlapping range would have amounted to no more than routing optimization of a known ultrasound gel formulation.
Accordingly, claim 13 is made obvious by Treff, Masterson, and Ophir in further view of Guangdong.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Chew (US Pat. No. 8,273,024 B2, patent date 25 September 2012).
The teachings of Treff, Masterson, and Ophir are discussed above as rendering obvious the ultrasound gel composition of claim 1. While the combination of the references does not expressly teach the limitations of claim 14, this claim is made obvious in further view of Chew.
Chew expressly teaches a water-based ultrasound transmission gel (abstract). Chew further teaches a preservative may be added to the water-based ultrasound transmission gel to provide a longer shelf life and additional protection against microbial growth (col. 8, lines 4-21). Chew identifies suitable preservatives include those known to one of ordinary skill in the art such as methylparaben, sorbic acid, and propylparaben (col. 8, lines 11-14). Chew additionally identifies AquaSonic® 100 as an exemplary water-based ultrasound gel, whereby the commercial formulation of AquaSonic® 100 comprises diazolindinyl urea and methylparaben (col. 6, lines 1-9).
While Chew does not expressly teach the preservative at a concentration between approximately 0.01 to 1 wt%, this range is made obvious by Treff, who identifies a formulation comprising citric acid between 0.01 to 0.03 wt%. The range of preservative disclosed by Treff overlaps with the instantly claimed range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the specific species of preservative disclosed by Chew with the citric acid disclosed by Treff. Chew provides an express reason for doing so, namely that any preservative known in the art to increase shelf life and provide additional protection against microbial growth is suitable for use in a water-based ultrasound gel. A person of ordinary skill would have reasonably expected the same known preservatives to perform their conventional antimicrobial and preservative functions in the modified composition of Treff/Masterson/Ophir. The proposed modification therefore constitutes a substitution of known preservative additives in a closely analogous ultrasound gel for their established purpose.
Accordingly, claim 14 is made obvious by Treff, Masterson, and Ophir in further view of Chew.
Claims 17, 23, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Lewis (WO 2020/046847 A1, published 05 March 2020).
The teachings of Treff, Masterson, and Ophir are discussed above as rendering obvious the ultrasound gel composition of claim 1. While the combination of the references does not expressly teach the limitations of claims 17, 23, 29, and 31, these claims are made obvious in further view of Lewis.
Lewis teaches a device specifically for use in long duration ultrasound treatment (abstract).
Regarding claim 17 –
Lewis teaches the device is flexible ([0005], [0010]) and compatible for use with gel compositions containing therapeutic agents and coupling patches ([0080]-[0087]).
It would have been obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the wearable ultrasound device of Masterson with the teachings of Lewis to provide a flexible device capable of conforming to the patient’s anatomy, maintain contact with the treatment site, and permit long-duration treatment. One would be motivated to make such a modification because Lewis expressly teaches the flexibility allows the device to conform to the body and facilitates long-term wear.
Regarding claim 23 –
Lewis teaches placement of gel or hydrogel between the ultrasound transducer device and the patient’s treatment surface specifically to couple the transducer to the treatment area ([0111]). Lewis further teaches a hydrogel coupling patch that secures and couples the device to the body ([0138]).
It would have been obvious to employ the modified Treff/Masterson/Ophir gel in the method involving Lewis’ long-duration ultrasound transducer device because maintaining an acoustically coupled interface between transducer and tissue is the ordinary and intended function of an ultrasound coupling gel. To the extent “increase ultrasound coupling” means increased coupling relative to an air interface or an uncoupled transducer-to-skin interface, the result would have been inherent in and expected from use of the known ultrasound coupling gel.
Regarding claims 29 and 31 –
Lewis teaches long-duration ultrasound treatment and expressly recognizes the need for secure coupling to the skin during long duration treatment ([0108]). Lewis further teaches treatment duration up to 12 hours ([0118]).
One of ordinary skill in the art would have been motivated to combine the sodium-containing coupling gel of Treff/Masterson/Ophir with the long-duration wearable system of Lewis to maintain the acoustic interface over the treatment interval and reduce loss or migration of coupling gel. Maintaining the coupling material at the interface would predictably increase the duration and consistency of ultrasound coupling during extended treatment.
Accordingly, claims 17, 23, 29, and 31 are made obvious by Treff, Masterson, and Ophir in further view of Lewis.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Vaezy (US Pat. No. 7,070,565 B2, date of patent 04 July 2006).
The teachings of Treff, Masterson, and Ophir are discussed above as rendering obvious the ultrasound gel composition of claim 1. While the combination of the references does not expressly teach the limitations of claim 24, this claim is made obvious in further view of Vaezy.
Vaezy teaches hydrogels as acoustic couplings for clinical applications of ultrasound imaging and therapy (abstract). Vaezy explains that the coupling material must efficiently transmit ultrasound energy and must possess suitable thermal properties so that it does not undesirably overheat during application of therapeutic ultrasound (col. 13, lines 29-37). Vaezy specifically evaluates the thermal conductivity and specific heat capacity of its polyacrylamide ultrasound coupling hydrogel and reports an ultrasound coupling hydrogel having a heat capacity greater than that of water and having thermal properties suitable for use during therapeutic ultrasound (col. 17, lines 57-67 and col. 18, lines 1-66). Vaezy further explains that temperature rise within an ultrasound coupling medium depends upon the density and specific heat of the medium (Fourier’s Law at col. 18, lines 26-24). Therefore, Vaezy expressly recognizes specific heat capacity as a relevant design property of an ultrasound coupling gel used during therapeutic ultrasound.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further formulate or select the ultrasound coupling material of the Treff/Masterson/Ophir system so as to possess the increased heat capacity characteristics taught by Vaezy. The prior art references concern materials positioned between an ultrasound transducer and tissue for the express purpose of transmitting therapeutic ultrasound energy, and Vaezy expressly teaches the thermal properties of the coupling material are relevant to its ability to withstand and transmit ultrasound energy during therapy.
A person of ordinary skill seeking to employ the Treff/Masterson/Ophir coupling gel during extended therapeutic ultrasound would therefore have had reason to provide the coupling medium with a relatively high specific heat capacity, as taught by Vaezy, so that the coupling material could absorb and accommodate the thermal energy generated during prolonged ultrasound exposure while maintaining an effective acoustic interface between the transducer and treatment site. Such a modification would have been the predictable application of a known advantageous thermal property of an ultrasound coupling material to another known therapeutic ultrasound coupling formulation.
Moreover, Masterson teaches treatment for approximately 4 hours during which the ultrasound coupling gel remains between the transducer and tissue while deep-tissue temperature increases are produced at depths of 1, 2, and 5 cm as previously discussed. Thus, one of ordinary skill would have recognized the desirability of employing a coupling material having sufficient heat capacity and thermal stability for maintaining prolonged thermal and acoustic contact during such treatment.
Accordingly, claim 24 is made obvious by Treff, Masterson, and Ophir in further view of Vaezy.
Claims 26-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Treff, Masterson, and Ophir as applied to claims 1-3, 7, 10-12, 15-16, 18-22, and 25 above, and further in view of Jarit (“Long Duration Sonophoresis of Diclofenac to Augment Rehabilitation of Common Musculoskeletal Injuries,” published 20 January 2023).
The teachings of Treff, Masterson, and Ophir are discussed above. While the combination of the references does not expressly teach the limitations of claims 26-28 and 30, these claims are made obvious in further view of Jarit.
Jarit expressly teaches long-duration sonophoresis using a high-viscosity 2.5 wt% diclofenac ultrasound coupling gel in a wearable sustained acoustic medicine system (abstract).
Regarding claim 26 –
Jarit expressly teaches treatment of musculoskeletal conditions (p. 2).
Regarding claim 27 –
Jarit teaches daily long-duration sonophoresis using a wearable SAM device and 2.5 wt% diclofenac ultrasound coupling gel (abstract). The study involved 135 musculoskeletal injury treatments and reported a mean pain reduction of approximately 4.44 points, with significant pain relief across multiple musculoskeletal injury types (p. 4).
Regarding claim 28 –
Jarit expressly states that the intervention was responsible for enhanced and accelerated healing (pp. 7 and 8).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the ultrasound gel of the base references in Jarit’s known therapeutic method because the art teaches both: 1) the analgesic benefit of diclofenac sonophoresis; and 2) the importance of suitable gel properties for effective acoustic coupling. The combination would predictably preserve Jarit’s therapeutic pain-reduction benefits while providing the known coupling properties of the modified gel.
Regarding claim 30 –
Jarit reports 3,780 individual treatment sessions using 2.5 wt% diclofenac with no adverse events such as skin burn, skin irritation, or skin sensitization (p. 4). Therefore, it would have been obvious to use the known diclofenac-containing coupling gel of Treff/Masterson/Ophir during the long duration ultrasound treatment of Jarit with an expectation of maintaining therapeutic ultrasound without excessive heating or other pain sensations. One of ordinary skill would have a reasonable expectation of success in doing so because Jarit expressly teaches long duration ultrasound treatment with 2.5 wt% diclofenac ultrasound gel does not cause burning or pain sensations.
Accordingly, claims 26-28 and 30 are made obvious by Treff, Masterson, and Ophir in further view of Jarit.
Double Patenting
The nonstatutory 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 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
US Patent No. 12,714,884
Claims 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,714,884 (‘884).
Although the claims at issue are not identical, they are not patentably distinct from each other. The reference claims of ‘884 are drawn to an ultrasound coupling device comprising a gel component wherein the gel material is effective to conduct acoustic energy and a coupling compartment effective to hold the gel in place.
Regarding instant claim 15 –
‘884 claim 1 is drawn to a gel component comprising a gel material effective to conduct acoustic energy; and a coupling compartment effective for holding the gel component in place.
Regarding instant claim 16 –
‘884 claim 6 is drawn to a configuration, wherein the coupling device of claim 1 further comprises an adhesive fabric for interfacing the coupling device with a subject. This would constitute ‘wearable’ as instantly claimed.
Regarding instant claim 17 –
‘884 claim 1 further recites the device contains flexible material.
Therefore, claims 1 and 6 of ‘884 make obvious the currently claimed invention in claims 15-17.
Conclusion
Claims 1-31 are rejected. No claim is allowed.
Communication
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
1 See Madzia et al. “Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study.”
2 See US Pat. No. 4,286,455 (Ophir et al.), patented: 01 September 1981; see also Praharaj et al.”Study of Acoustical and Thermodynamic Properties of Aqueous Solution of NaCl at different Concentrations and Temperatures through Ultrasonic Technique.”
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