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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: ". Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 3, are objected to because of the following informalities:
In claim 1, line 4, “transmitting waves” should read “transmitting electromagnetic waves”
In claim 1, line 7, “the waves” should read “the electromagnetic waves”
In claim 3, line 2, “stiffness and” should read “stiffness, and”
In claim 6, line 2, “inflammatory rheumatism” should read “inflammatory rheumatism,”
In claim 7, line 1, “transmitting waves” should read “transmitting electromagnetic waves”
In claim 8, line 1, “the device” should read “the portable device”
In claim 8, line 9, “the device” should read “the portable device”
In claim 9, line 5, “twice or” should read “twice, or”
In claim 10, line 2, “thanks to a transmitter” should read “by a transmitter”
In claim 10, line 3, “said waves” should read “said electromagnetic waves”
In claim 10, line 5, “said waves” should read “said electromagnetic waves”
In claim 11, line 4, “the waves” should read “the electromagnetic waves”
In claim 12, line 7, “transmit waves” should read “transmit electromagnetic waves”
In claim 12, line 9, “the waves” should read “the electromagnetic waves”
In claim 12, line 11, “the waves” should read “the electromagnetic waves”
In claim 13, line 2, “the device” should read “the portable device”
In claim 13, line 9, “the device” should read “the portable device”
In claim 13, line 13, “the device” should read “the portable device”
In claim 14, line 4, “transmitting waves” should read “transmitting electromagnetic waves”
In claim 14, line 5, “the device” should read “the portable device”
In claim 14, line 6, “the waves” should read “the electromagnetic waves”
In claim 15, lines 3-4, “the device” should read “the portable device”
In claim 15, line 5, “thanks to regular” should read “by regular”
In claim 15, line 7, “to assessments” should read “to regular assessments”
In claim 15, line 12, “data which are” should read “data which is”
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“portable device” recited in claims 1, 11-14; equivalent structure found on page 2, lines 8-15. Therefore, in light of the specification, a “portable device” is best understood as an apparatus structurally equipped and configured to transmit electromagnetic waves, and equivalents thereof. Claim 12 is noted as reciting structure for performing the claimed function; therefore, “portable device” is not subjected to this interpretation.
“unit” in claims 11 and 13; equivalent structure is not recited in the specification. Per the specification, page 17, line 1, a “unit” determines the impedance of a human/animal’s skin.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim limitation “unit” in claims 11 & 13 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. The specification does not recite sufficient structure for the "transmitter" and the "unit" to perform the claimed functions. 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.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the application" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the application of a portable device” will be read as “an application of a portable device”.
Claim 1 further recites the limitation “such as” in line 4. Due to this claim language, it is unclear whether the claim requires a skin surface, as suggested by “such as” or it other surfaces, not recited by name, are practical alternatives. For examination purposes, additional surfaces not recited by name are being treated as suitable device-affixing sites.
Regarding claim 2, the term “preferably” renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for a type of osteoarthritis to be peripheral osteoarthritis or not. For examination purposes, the claim will be read as though the type of osteoarthritis may conceivably be peripheral osteoarthritis, but it’s not required to be.
Regarding claim 3, the phrase “chosen from (i) pain, (ii) stiffness and (iii) sleep impairments” renders the claim indefinite. It is unclear whether the claim requires only one of the options listed, as suggested by “chosen from” or all of the options, as suggested by the use of “and”. It is suggested to change “and” to “or”. For examination purposes, the claim is treated as requiring only one of the options listed. See MPEP § 2173.05(d).
Claim 4 recites the limitation “increasing the quality of life” in line 1. The term “increasing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not by reasonably apprised of the scope of the invention. Without first establishing a baseline or reference for comparison, “increasing the quality of life” cannot be meaningfully defined or measured.
Regarding claim 5, the term “preferably” renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for a symptom of osteoarthritis to be nociplastic pain or not. For examination purposes, the claim will be read as though a symptom of osteoarthritis may conceivably be nociplastic pain, but it’s not required to be.
Regarding claim 7, the term “preferably” renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the power flux density to be between 5 and 15 mW/cm^2 or not. For examination purposes, the claim will be read as if the power flux density is between 5-15 mW/cm^2. See MPEP § 2173.05(c).
Claim 8 recites the limitation "the back" in line 6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the back” will be read as “a back”.
Claim 8 further recites the limitation "the palm" in line 8. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the palm” will be read as “a palm”.
Regarding claim 8, the term “preferably” renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the portable device to be a wristband or a watch, or not. For examination purposes, the claim will be read as if the portable device is a wristband or watch. See MPEP § 2173.05(c).
Claim 9 recites the limitation "the transmission" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the transmission of electromagnetic waves” will be read as “a transmission of electromagnetic waves”.
Regarding claim 9, the term “preferably” in line 2 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the time period to be between 30-50 minutes or not. For examination purposes, the claim will be read as if the time period is between 30-50 minutes.
Regarding claim 9, the term “preferably” in line 3 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the time period to be between 35-45 minutes or not. For examination purposes, the claim will be read as if the time period is between 35-45 minutes.
Regarding claim 9, the term “preferably” in line 3 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the time period to be between 36-45 minutes or not. For examination purposes, the claim will be read as if the time period is between 36-45 minutes.
Regarding claim 9, the term “preferably” in line 4 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the time period to be between 37-40 minutes or not. For examination purposes, the claim will be read as if the time period is between 37-40 minutes.
Regarding claim 9, the term “preferably” in line 4 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the time period to be between 38-45 minutes or not. For examination purposes, the claim will be read as if the time period is between 38-45 minutes.
Regarding claim 9, the term “preferably” in line 4 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for said transmission to be performed once, twice, or thrice times a day, or not. For examination purposes, the claim will be read as if said transmission is performed once, twice, or three times a day.
Regarding claim 10, the term “preferably” in line 4 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the frequency to be between 50 to 100 GHz or not. For examination purposes, the claim will be read as if the frequency is between 50 to 100 GHz.
Regarding claim 10, the term “preferably” in line 4 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the frequency to be between 60 to 95 GHz or not. For examination purposes, the claim will be read as if the frequency is between 60 to 95 GHz.
Regarding claim 10, the term “preferably” in line 5 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the frequency to be between 61 to 61.5 GHz or not. For examination purposes, the claim will be read as if the frequency is between 61 to 61.5 GHz.
Regarding claim 12, the term “preferably” renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the power flux density to be between 5 and 15 mW/cm^2 or not. For examination purposes, the claim will be read as if the power flux density is between 5-15 mW/cm^2. See MPEP § 2173.05(c).
Regarding claim 13, the terms “preferably” and “about” in line 6 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the first session to last 40 minutes or not. For examination purposes, the claim will be read as if the first session lasts for 40 minutes.
Regarding claim 13, the term “typically” in line 7 renders the claim indefinite because it is unclear what this limitation imposes on the claim, and whether it’s required for the first time period to be 4 hours or not. For examination purposes, the claim will be read as if the first time period is 4 hours.
Regarding claim 13, the terms “preferably” and “about” in line 10 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the second session to last 40 minutes or not. For examination purposes, the claim will be read as if the second session lasts for 40 minutes.
Regarding claim 13, the term “typically” in line 11 renders the claim indefinite because it is unclear what this limitation imposes on the claim, and whether it’s required for the second time period to be 4 hours or not. For examination purposes, the claim will be read as if the second time period is 4 hours.
Regarding claim 13, the terms “preferably” and “about” in line 14 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the third session to last 40 minutes or not. For examination purposes, the claim will be read as if the third session lasts for 40 minutes.
Regarding claim 13, the term “preferably” in line 15 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for at least one session to occur around or at bedtime, or not. For examination purposes, the claim will be read as if at least one session occurs around or at bedtime.
Claim 15 recites the limitation “for example” in line 8. Due to this language, it is unclear whether the claim requires an assessment regarding a subject’s food or physical activity, as suggested by “for example” or if other assessments related to a subject’s health, adherence, or usability, are practical alternatives. For examination purposes, additional subject-related adherence, health, or usability assessments, not recited by name, are being treated as suitable assessments for determining the effectiveness of the portable device.
Claim 15 further recites the limitation “for example” in line 10. Due to this language, it is unclear whether the claim requires physical meetings or digital forum discussions, as suggested by “for example” or if other settings for discussion/meetings, are practical alternatives. For examination purposes, additional platforms or settings for meetings and discussions, not recited by name, are being treated as suitable means for discussing aliments between subjects.
Claim 15 further recites the limitation "the health practitioner" in line 12. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the health practitioner” will be read as “a health practitioner”.
Claim 16 recites the limitation "the coach" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the coach” will be read as “a coach”.
Regarding claim 16, the term “preferably” in line 3 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the coach to be a trained person or not. For examination purposes, the claim will be read as if the coach is a trained person.
Regarding claim 16, the term “preferably” in line 3 renders the claim indefinite because it is unclear what this limitation imposes on the claim , and whether it’s required for the coach to be a nurse or not. For examination purposes, the claim will be read as if the coach is a nurse.
The dependent claims not specifically addressed above are rejected under 35 U.S.C. 112(b) as indefinite due to their dependence from indefinite claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-5, and 7-12 as best understood in light of the rejections under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sibue et al. (US 2020/0253822).
Regarding claim 1, Sibue et al. teaches a method for treating osteoarthritis and/or one of its symptoms in a human or animal subject (Fig. 1, patient 1; para. 0002, “chronic pain”, wherein chronic pain is being construed as a symptom of osteoarthritis; paras. 0013, 0048, and 0104), which comprises the application of a portable device (Fig. 1, device 10) for transmitting electromagnetic waves to said human or animal subject (Claim 9; Abstract; paras. 0014 and 0104),
wherein said portable device is capable, when it is affixed at a surface such as skin, of transmitting waves having a power flux density of at least 0.5 mW/cm² of surface and a frequency value of between 3 and 120 gigaHertz (GHz) (para. 0014; Claim 9),
the device being further capable of simultaneously exposing at least 2.5 cm² of the surface to the waves (Claim 1; para. 0014).
Regarding claim 3, Sibue et al. teaches the method according to claim 1 as stated above which is for treating at least one symptom of osteoarthritis chosen from (i) pain (paras. 0002, 0013, 0065, and 0104), (ii) stiffness, or (iii) sleep impairments (paras. 0013 and 0140).
Regarding claim 4, Sibue et al. teaches the method according to claim 1 as stated above which is for increasing the quality of life (paras. 0013, 0015, 0067, and 0131, wherein decreasing a subject’s pain is being construed as improving a subject’s quality of life/well-being).
Regarding claim 5, Sibue et al. teaches the method according to claim 1 as stated above which is for treating at least one symptom of osteoarthritis that is pain (paras. 0002, 0013, 0048, and 0104) , preferably nociplastic pain.
Regarding claim 7, Sibue et al. teaches the method according to claim 1 as stated above wherein the transmitting waves have a power flux density of between 5 and 35 mW/cm2, preferably of between 5 and 15 mW/cm² (para. 0130; Claim 2).
Regarding claim 8, Sibue et al. teaches the method according to claim 1 as stated above wherein the device is worn at least in one of the following sites (para. 0024):
around a wrist (para. 0025);
on a leg (para. 0026);
on an ankle (para. 0027);
in the back (para. 0028);
on an ear (para. 0029); or
in the palm of a hand (para. 0030),
preferably the device is a wristband or a watch (paras. 0032 and 0104; Fig. 2).
Regarding claim 9, Sibue et al. teaches the method according to claim 1 as stated above wherein the transmission of electromagnetic waves to the human or animal subject is made during a period of 15 minutes to 50 minutes (paras. 0125 and 0130), preferably from 30 to 50 minutes, preferably from 35 to 45 minutes, preferably from 36 to 45 minutes, preferably from 37 to 40 minutes, preferably from 38 to 45 minutes, preferably said transmission is performed once, twice or three times a day (para. 0130).
Regarding claim 10, Sibue et al. teaches the method according to claim 1 as stated above which comprises a step of transmitting electromagnetic waves towards the human or animal subject’s skin, thanks to a transmitter worn by said subject, said waves having a power flux density of at least 0.5 mW/cm² of skin and a frequency between 3 and 120 GHz (para. 0048; Claim 9), preferably between 50 and 100 GHz, preferably between 60 and 95 GHz, more preferably said waves have a frequency of between 61 and 61.5 GHz (para. 0115).
Regarding claim 11, Sibue et al. teaches the method according to claim 1 as stated above which comprises the following steps (para. 0049):
a unit detects human or animal skin (para. 0050) , and
when the unit detects that the skin is located at three millimeters or less from the portable device comprising a transmitter, the transmitter transmits the waves (paras. 0046-0048 and 0051).
Regarding claim 12, Sibue et al. teaches the method according to claim 1 as stated above wherein the portable device (para. 0104) comprises:
a control module (Figs. 2-3, control module 20);
a transmission module (Figs. 2-3, transmission module 22; Figs. 7-8) comprising an application- specific integrated circuit (Fig. 7, ASIC 26) housed in a ball grid array-type housing (para. 0108), the circuit including a frequency oscillator (Fig. 8, oscillator 32) and a power amplifier (Fig. 8, power amplifier 34), the transmission module having a volume less than 3 cubic centimeters (para. 0115), the transmission module controlled by the control module (para. 0105) to, when placed at a surface, transmit waves having a power flux density between 5 and 35 mW/cm² (para. 0130), preferably between 5 and 15 mW/cm², of the surface and a frequency value of between 61 and 61.5 GHz, and simultaneously expose to the waves at least 2.5 cm² of the surface (paras. 0115), and the transmission module including a flexible sink (Fig. 7, heat sink 46; paras. 0035-0037, 0064-0065, 0074, and 0107) configured to maintain the surface exposed to the waves at a temperature below 43°C (para. 0041), the flexible heat sink comprising a thermal buffer (para. 0038).
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) 2 and 6 as best understood in light of the rejections under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibue et al. in view of Schwarz (US 2019/0030356).
Regarding claim 2, Sibue et al. teaches the method according to claim 1 as stated above. Sibue et al. fails to teach wherein osteoarthritis is peripheral osteoarthritis or osteoarthritis of the spine, preferably peripheral osteoarthritis.
Schwarz teaches an analogous method wherein osteoarthritis is peripheral osteoarthritis or osteoarthritis of the spine, preferably peripheral osteoarthritis (para. 0088).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Sibue et al. with the peripheral osteoarthritis teaching of Schwarz. A treatment intended to emit electromagnetic waves to alleviate pain in a patient may serve a dual purpose, specifically, patients diagnosed with peripheral osteoarthritis may also derive benefit from the treatment (Schwarz, paras. 0043 and 0087-0088).
Regarding claim 6, Sibue et al. teaches the method according to claim 1 as stated above. Sibue et al. fails to teach wherein osteoarthritis is osteoarthritis of the fingers, osteoarthritis of the lower limbs, an inflammatory rheumatism, or spondylarthritis.
Schwarz teaches an analogous method wherein osteoarthritis is osteoarthritis of the fingers (para. 0088), osteoarthritis of the lower limbs (para. 0088), an inflammatory rheumatism, or spondylarthritis.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Sibue et al. with the peripheral osteoarthritis teaching of Schwarz. A treatment intended to emit electromagnetic waves to alleviate pain in a patient may serve a dual purpose, specifically, patients diagnosed with peripheral osteoarthritis may also derive benefit from the treatment (Schwarz, paras. 0043 and 0087-0088).
Claim(s) 13 as best understood in light of the rejections under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibue et al. in view of Schwarz, further in view of Dissing et al. (US 2012/0101327) and Simon et al. (US 2014/0257438).
Regarding claim 13, Sibue et al. the method according to claim 1 as stated above which comprises the following steps:
a unit detects that the device has been attached to a human or animal subject (paras. 0042, 0049-0051 and 0081; Claim 10).
Sibue et al. fails to teach an osteoarthritic human or animal subject, i.e. osteoarthritic patient, or a human or animal subject afflicted with an inflammatory rheumatism or spondylarthritis; wherein a transmitter of the portable device transmits electromagnetic waves to the patient during a first session, preferably the first session lasts about 40 minutes; Then, the patient waits for a first time period, typically at least 4 hours, after the first session has ended; Then, the transmitter of the device transmits electromagnetic waves to the patient during a second session, preferably the second session lasts about 40 minutes; Then, the patient waits for a second time period, typically at least 4 hours, after the second session has ended; Then, the transmitter of the device transmits electromagnetic waves to the patient during a third session, preferably the third session lasts about 40 minutes; And preferably at least one of the sessions occurs around or at bedtime of the patient, and/or the sessions occur every day for at least 3 continuous months.
Schwarz teaches an analogous method further comprising an osteoarthritic human or animal subject (para. 0088).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Sibue et al. with the peripheral osteoarthritis teaching of Schwarz. A treatment intended to emit electromagnetic waves to alleviate pain in a patient may serve a dual purpose, specifically, patients diagnosed with peripheral osteoarthritis may also derive benefit from the treatment (Schwarz, paras. 0043 and 0087-0088).
While Schwarz teaches osteoarthritic human or subject, the combination of Sibue et al. and Schwarz fails to teach a transmitter of the portable device transmits electromagnetic waves to the patient during a first session, preferably the first session lasts about 40 minutes; Then, the patient waits for a first time period, typically at least 4 hours, after the first session has ended; Then, the transmitter of the device transmits electromagnetic waves to the patient during a second session, preferably the second session lasts about 40 minutes; Then, the patient waits for a second time period, typically at least 4 hours, after the second session has ended; Then, the transmitter of the device transmits electromagnetic waves to the patient during a third session, preferably the third session lasts about 40 minutes; And preferably at least one of the sessions occurs around or at bedtime of the patient, and/or the sessions occur every day for at least 3 continuous months.
In the same field of endeavor, Dissing et al. teaches wherein a transmitter of the portable device transmits electromagnetic waves to the patient (paras. 0040-0042; Fig. 7) during a first session, preferably the first session lasts about 40 minutes (para. 0131); Then, the transmitter of the device transmits electromagnetic waves to the patient during a second session, preferably the second session lasts about 40 minutes (para. 0131); Then, the transmitter of the device transmits electromagnetic waves to the patient during a third session, preferably the third session lasts about 40 minutes (para. 0131).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Sibue et al. in view of Schwarz with the treatment duration of Dissing et al. A 40-minute treatment sessions may generate an electromagnetic field strong enough to activate proteins in the targeted tissue (Dissing et al., Abstract; paras. 0141-0143).
While Dissing et al. teaches wherein the sessions last for 40 minutes, the combination of Sibue et al., Schwarz, and Dissing et al. fails to teach wherein the patient waits for a first time period, typically at least 4 hours, after the first session has ended; and then, the patient waits for a second time period, typically at least 4 hours, after the second session has ended; and preferably at least one of the sessions occurs around or at bedtime of the patient, and/or the sessions occur every day for at least 3 continuous months.
In the same field of endeavor, Simon et al. teaches wherein the patient waits for a first time period, typically at least 4 hours, after the first session has ended (para. 0076, “intervals between treatment sessions”); and then, the patient waits for a second time period, typically at least 4 hours (para. 0076, “intervals between treatment sessions”), after the second session has ended; and at least one of the sessions occurs around or at bedtime of the patient (para. 0075) and/or the sessions occur every day for at least 3 continuous months.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Sibue et al. in view of Schwarz, further in view of Dissing et al. with the break between sessions and the scheduled treatment session of Simon et al. Administering the treatment before bedtime could lead to a period of inactive stimulation while the patient sleeps. During this inactive phase, the concentration of inhibitory neurotransmitters in the brain may remain sufficiently elevated to reduce the likelihood of headaches and migraines (Simon et al., paras. 0073-0076).
Claim(s) 14-15 as best understood in light of the rejections under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibue et al. in view of Berman et al. (WO 2016/127183).
Regarding claim 14, Sibue et al. teaches the method according to claim 1 as stated above. Sibue et al. further teaches the application of a portable device (Fig. 1, device 10) for transmitting electromagnetic waves to said human or animal subject (Claim 9; Abstract; paras. 0014 and 0104), wherein said portable device is capable, when it is affixed at a surface such as skin, of transmitting waves having a power flux density of at least 0.5 mW/cm² of surface and a frequency value of between 3 and 120 gigaHertz (GHz) (para. 0014; Claim 9), the device being further capable of simultaneously exposing at least 2.5 cm² of the surface to the waves (Claim 1; para. 0014). Sibue et al. fails to teach before, during and/or after said application of a portable device, a coaching step.
In the same field of endeavor, Berman et al. teaches before, during and/or after said application of a portable device, a coaching step (Fig. 22, remote practitioner 224; Fig. 23; page 34, para. 3 and page 35, paras. 1-3; page 35, para. 2, “The portable controller 210 may also be capable of transmitting the data collected in near real time to a remote location over a data network such that a remote practitioner 224 monitoring the session remotely can adjust the directed energy therapy protocol while the treatment is occurring”; page 35, para. 3, “In response to various biometric feedback indicators that the practitioner 236 may observe, the practitioner may be able to alter the type or combination of energy, intensity, duration, and location of the directed energy treatment as it is being administered”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Sibue et al. with the coaching step of Berman et al. Doing so may enable a nurse located remotely to adjust the therapy protocol in real-time based on the user’s biometric feedback (Berman et al., Fig. 22, remote practitioner 224; page 34, para. 3 and page 35, paras. 1-3).
Regarding claim 15, Sibue et al. in view of Berman et al. teaches the method according to claim 14 as stated above wherein the coaching step includes at least one of the following components:
providing therapeutic education to the human or animal subject about the device or transmitter used;
improving compliance and effectiveness, notably thanks to regular assessments of subject’s usability, subject’s adherence, subject’s health benefits and dispensing personalized advice according to assessments, and for example, regarding food or physical activity;
discussing between subjects afflicted by osteoarthritis (i.e., peer support) or an inflammatory rheumatism or spondylarthritis, for example through physical meetings or digital forum discussions; and/or
collecting data which are to be used by the health practitioner (Berman et al., page 35, para. 2, “The portable controller 210 may also be capable of transmitting the data collected in near real time to a remote location over a data network such that a remote practitioner 224 monitoring the session remotely can adjust the directed energy therapy protocol while the treatment is occurring”; page 35, para. 3, “In response to various biometric feedback indicators that the practitioner 236 may observe, the practitioner may be able to alter the type or combination of energy, intensity, duration, and location of the directed energy treatment as it is being administered”).
Claim(s) 16 as best understood in light of the rejections under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibue et al. in view of Berman et al., further in view of Burnett (US 2003/0158585).
Regarding claim 16, Sibue et al. in view of Berman et al. teaches the method according to claim 14 as stated above. Sibue et al. in view of Berman et al. fails to specifically disclose wherein the coaching step comprises at least one discussion, by telephone, physical or through a digital platform, between the coach and the human or animal subject, and the coach is preferably a trained person, preferably a nurse.
In the same field of endeavor, Burnett teaches wherein the coaching step comprises at least one discussion, by telephone, physical or through a digital platform, between the coach and the human or animal subject (paras. 0049-0054), and the coach is preferably a trained person , preferably a nurse.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Sibue et al. in view of Berman et al. with the coaching step comprising at least one discussion between the patient and the medical personnel of Burnett. Following the physician’s provision of treatment and operation instructions to the patient, the patient may be capable of self-administering the treatment to the designated areas in an outpatient setting (Burnett, paras. 0049 and 0054).
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.
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Claims 1, 3, 7-8, and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8-9, 13, and 15-16 of copending Application No. 17/542,864 (reference application) in view of Sibue et al. (US 2020/0253822).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See table below for corresponding teachings of reference application 17/542,864.
Instant Application
17/542,864
Claim 1. Method for treating osteoarthritis and/or one of its symptoms in a human or animal subject,
Claim 1, line 3 “pain”
which comprises the application of a portable device for transmitting electromagnetic waves to said human or animal subject, wherein said portable device is capable, when it is affixed at a surface such as skin,
Claim 1, lines 7-9
of transmitting waves having a power flux density of at least 0.5 mW/cm² of surface
Not present
a frequency value of between 3 and 120 gigaHertz (GHz), the device being further capable of simultaneously exposing at least 2.5 cm² of the surface to the waves.
Claim 1, lines 11-13; Claim 8
Claim 3. Method according to claim 1, which is for treating at least one symptom of osteoarthritis chosen from (i) pain, (ii) stiffness and (iii) sleep impairments.
Claim 1; Claim 6
Claim 7. Method according to claim 1, wherein the transmitting waves have a power flux density of between 5 and 35 mW/cm2, preferably of between 5 and 15 mW/cm².
Claim 1
Claim 8. Method according to claim 1, wherein the device is worn at least in one of the following sites: around a wrist; on a leg; on an ankle; in the back; on an ear; or in the palm of a hand,
Not present
preferably the device is a wristband or a watch.
Claim 9
Claim 14. Method according to claim 1, which comprises the following steps: the application of a portable device for transmitting electromagnetic waves to said human or animal subject, wherein said portable device is capable, when it is affixed at a surface such as skin,
Claim 1
of transmitting waves having a power flux density of at least 0.5 mW/cm² of surface and
Not present
a frequency value of between 3 and 120 GHz, the device being further capable of simultaneously exposing at least 2.5 cm² of the surface to the waves, and
Claim 1
before, during and/or after said application of a portable device, a coaching step.
Claim 13
Claim 15. Method according to claim 14, wherein the coaching step includes at least one of the following components: (i) providing therapeutic education to the human or animal subject about the portable device or transmitter used; (ii) improving compliance and effectiveness, notably thanks to regular assessments of subject's usability, subject's adherence subject's health benefits and dispensing personalized advice according to the assessments, and, for example regarding food or physical activity; (iii) discussing between subject afflicted by osteoarthritis (i.e. peer support) or an inflammatory rheumatism or spondylarthritis, for example through physical meetings or digital forum discussions; and/or (iv) collecting data to be used by a health practitioner.
Claim 15
Claim 16. Method according to claim 14, wherein the coaching step comprises at least one discussion, by telephone, physical or through a digital platform, between the coach and the human or animal subject, and the coach is preferably a trained person, preferably a nurse.
Claim 16
Regarding claim 1, claim 1 of the reference application fails to explicitly disclose transmitting waves having a power flux density of at least 0.5 mW/cm² of surface.
In the same field of endeavor, Sibue et al. teaches transmitting waves having a power flux density of at least 0.5 mW/cm² of surface (para. 0014).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference application to include the power flux density of at least 0.5 mW/cm² of Sibue et al. A power flux density of at least 0.5 mW/cm² allows the treatment to effectively reduce pain in the subject (Sibue et al., para. 0015).
Regarding claim 8, claim 9 of the reference application fails to explicitly disclose wherein the device is worn at least in one of the following sites: around a wrist; on a leg; on an ankle; in the back; on an ear; or in the palm of a hand.
In the same field of endeavor, Sibue et al. teaches wherein the device is worn at least in one of the following sites: around a wrist; on a leg; on an ankle; in the back; on an ear; or in the palm of a hand (paras. 0024-0030).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference application to include the attachment sites of Sibue et al. Affixing the device at one of these sites, for example the wrist, like a watch, enables the device to be worn without particular inconvenience to the patient (Sibue et al., para. 0032).
Regarding claim 14, claim 1 of the reference application fails to explicitly disclose transmitting waves having a power flux density of at least 0.5 mW/cm² of surface.
In the same field of endeavor, Sibue et al. teaches transmitting waves having a power flux density of at least 0.5 mW/cm² of surface (para. 0014).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference application to include the power flux density of at least 0.5 mW/cm² of Sibue et al. A power flux density of at least 0.5 mW/cm² allows the treatment to effectively reduce pain in the subject (Sibue et al., para. 0015).
Claims 1, 7-8, and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8, and 11-12 of U.S. Patent No. 12,064,392 (reference application) in view of Sibue et al. (US 2020/0253822).
See table below for corresponding teachings of reference U.S. Patent No. 12,064,392.
Instant Application
12,064,392
Claim 1. Method for treating osteoarthritis and/or one of its symptoms in a human or animal subject,
Not present
which comprises the application of a portable device for transmitting electromagnetic waves to said human or animal subject, wherein said portable device is capable, when it is affixed at a surface such as skin,
Not present
of transmitting waves having a power flux density of at least 0.5 mW/cm² of surface
Not present
a frequency value of between 3 and 120 gigaHertz (GHz), the device being further capable of simultaneously exposing at least 2.5 cm² of the surface to the waves.
Claim 1
Claim 7. Method according to claim 1, wherein the transmitting waves have a power flux density of between 5 and 35 mW/cm2, preferably of between 5 and 15 mW/cm².
Claims 1 lines 50-53; Claim 11, lines 32-34
Claim 8. Method according to claim 1, wherein the device is worn at least in one of the following sites: around a wrist; on a leg; on an ankle; in the back; on an ear; or in the palm of a hand,
Claim 3
preferably the device is a wristband or a watch.
Claim 8
Claim 10. Method according to claim 1, which comprises a step of transmitting electromagnetic waves towards the human or animal subject’s skin, thanks to a transmitter worn by said subject,
Claim 11, lines 28-32
said waves having a power flux density of at least 0.5 mW/cm² of skin and
Not present
a frequency between 3 and 120 GHz, preferably between 50 and 100 GHz, preferably between 60 and 95 GHz, more preferably said waves have a frequency of between 61 and 61.5 GHz.
Claim 11, line 35
Claim 11. Method according to claim 1, which comprises the following steps: a unit detects human or animal skin, and when the unit detects that the skin is located at three millimeters or less from the portable device comprising a transmitter, the transmitter transmits the waves.
Claim 12
Claim 12. Method according to claim 1, wherein the portable device comprises: a control module; a transmission module comprising an application- specific integrated circuit housed in a ball grid array-type housing, the circuit including a frequency oscillator and a power amplifier, the transmission module having a volume less than 3 cubic centimeters, the transmission module controlled by the control module to, when placed at a surface, transmit waves having a power flux density between 5 and 35 mW/cm², preferably between 5 and 15 mW/cm², of the surface and a frequency value of between 61 and 61.5 GHz, and simultaneously expose to the waves at least 2.5 cm² of the surface, and the transmission module including a flexible sink configured to maintain the surface exposed to the waves at a temperature below 43°C, the flexible heat sink comprising a thermal buffer.
Claim 1
Regarding claim 1, claim 1 of the reference application fails to explicitly disclose a method for treating osteoarthritis and/or one of its symptoms in a human or animal subject, which comprises the application of a portable device for transmitting electromagnetic waves to said human or animal subject, wherein said portable device is capable, when it is affixed at a surface such as skin, of transmitting waves having a power flux density of at least 0.5 mW/cm².
In the same field of endeavor, Sibue et al. teaches a method for treating osteoarthritis and/or one of its symptoms in a human or animal subject (para. 0002, 0013, and 0104, “pain”), which comprises the application of a portable device for transmitting electromagnetic waves to said human or animal subject, wherein said portable device is capable, when it is affixed at a surface such as skin (Figs. 1-2), of transmitting waves having a power flux density of at least 0.5 mW/cm² (Abstract; paras. 0014 and 0048).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference application to include the method of treating osteoarthritis and/or one of its symptoms in a human subject, wherein the portable device is affixed to the skin of a human or animal subject, and the portable device is capable of transmitting electromagnetic waves with a power flux density of at least 0.5 mW/cm² as taught by Sibue et al. A portable device configured to transmit electromagnetic waves at a power flux density of at least 0.5 mW/cm² may produce an analgesic effect. Furthermore, a portable device capable of affixing to a human’s skin creates an accessible and easily usable form of treatment that can be worn without particular inconvenience for the patient (Sibue et al., paras. 0012-0013 and 0032).
Regarding claim 10, claim 11 of the reference application fails to explicitly disclose said [electromagnetic] waves having a power flux density of at least 0.5 mW/cm² of skin.
In the same field of endeavor, Sibue et al. teaches said [electromagnetic] waves having a power flux density of at least 0.5 mW/cm² of skin (Abstract, para. 0048).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference application to include the power flux density of at least 0.5 mW/cm² of Sibue et al. A power flux density of at least 0.5 mW/cm² allows the treatment to be effective and to reduce pain in the subject (Sibue et al., para. 0015).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Arendash (2022/0040492) teaches an electromagnetic wave generator configured to generate electromagnetic waves having a predetermined set of parameters wherein emitters emit the electromagnetic waves to a subject. Pilla et al. (US 2011/0207989) discloses a device and method for treating degenerative joint diseases with electromagnetic fields. The electromagnetic fields have an on time and off time. Johnson et al. (US 2014/0073836) discloses a system and method of applying a therapeutic electrical field to a bone region of a human being in order to promote healing and growth in a bone region. Brighton et al. (WO 03057312) discloses a device for treating osteoporosis, hip and spine fractures via induced electrical fields. Yakobson et al. (WO 2019/142196) discloses a method of treating a fractured bone side via an electronic patch covered by a cast. The cast is configured to wrap around a subject’s wrist to promote bone healing. Thomas et al. (2007) investigates the relationship between twice-daily PEMF and chronic pain. The aim of Thomas et al. (2007)’s study was to assess whether PEMF is more effective in patients with presumed central pain versus patient with more peripherally localized pain.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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