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 .
Status of the Claims
A preliminary amendment was received from Applicants on August 12, 2024. Claims 5-8, 10-11, 22, 24-28, 31-33, and 35 are amended and Claims 9, 12-21, and 34 are canceled. Thus, Claims 1-8, 10-11, 22, 24-28, 30-33, and 35 are pending and will be examined in this U.S. non-provisional application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the
one or more fastening means, one or more fastening means at least partially secured (Claims 1 and 30; it is not clear what the one or more fastening means actually is so that the one or more fastening means can then be partially secured as recited. It is also not ascertained from the drawings what structures shown in the drawings have a partial securement to another attaching structure such that this limitation is not shown in the drawings), and
curved profile of that at least one stimulator that corresponds to at least in part to a profile of at least a portion of a patient’s body (Claim 11; while mechanical stimulator 8 in Fig. 10 has a curved profile that is a convex curved profile it is not understood how this convex curved profile itself corresponds to a profile of at least a portion of a patient’s body as claimed),
at least one communication interface (Claim 22, lines 3 and 4) is not found in the drawings,
at least one sensor (Claim 24, line 2) is not found in the drawings, and
mobile device (Claim 25, line 4) is also not found in the drawings
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to because
Figs. 5, 6B, and 7 are objected to because according to the specification controllers 100 in each of these figures have different structures (compare the various descriptions in ¶s 0073, 0077, and 0079). Thus, they should be assigned with different reference numerals.
Fig. 5 illustrates backing layer 42, however, backing layer 42 is illegible.
Fig. 6C is objected to because there is no connection between the separated parts and the specification describes that “handles 54 may be secured to the pressure applicators 58” (¶ 0078).
Figs. 9a-10b are objected to because the arrows are confusing. In Figs. 9a and 9b the arrows represent the mechanical stimulator 8 which is confusing to understand. In Figs. 10a and 10b the mechanical stimulator 8 is shown as an oval structure that includes arrows that extend from this oval structure which is also confusing to understand. According to the specification it appears the mechanical stimulator can be secured between the handles (¶ 0083). Thus, arrows shouldn’t be used.
Fig. 10 shows a middle handle 4 and outer handles 4. The middle handle 4 has a different shape than the other handles 4. Thus, it should be assigned a different reference numeral.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72(b) and MPEP § 608.01(b, 1B). The abstract should be in narrative form and generally limited to a single paragraph preferably within the range of 50 to 150 words in length. The abstract should not exceed 15 lines of text. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should sufficiently describe the disclosure to assist readers in deciding whether there is a need for consulting the full patent text for details.
More particularly, the Abstract is objected to because it is written using legal phrases (“comprises” in line 2, “comprising” in line 3, and “means” in the next to last line of the Abstract).
Appropriate correction is required.
The disclosure is objected to because of the following informalities:
“secured adjacent bottom side” (¶ 0066, line 5) should be –secured adjacent the bottom side— to further clarify the readability of this sentence, and
“In Figure 8a,” (¶ 0083, third to last line) should be – In Figure 9a,-- to clarify that Fig. 9a is the figure that shows the back-and-forth mechanical movement which is not Fig. 8a as is currently described.
Appropriate correction is required.
Claim Objections
The following claims are objected to because of the following informalities:
“and/or or” (Claim 27, line 3); removing the duplicative word “or” improves the readability of this claim.
“a certain duration,.” (Claim 27, third to last line) should be –a certain duration.— removing the extraneous comma clarifies that the word “duration” is at the end of the sentence.
“the method comprising: (Claim 30, line 1) should be –the method comprising the steps of:-- in order to clearly define the actions in the body of the claim as method steps.
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 a claim limitation is: “one or more fastening means at least partially secured to the one or more fastening tapes” in claim 1, last two lines and claim 30, last four lines.
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.
A review of the specification shows that the following appears to be the corresponding structure under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
“at least one stimulator configured to apply a stimulating signal to the patient’s skin, wherein the stimulating signal is configured to cause a mechanical movement of the patient’s skin” (Claim 1, lines 11 and 12; Claim 30) – The specification describes the at least one stimulator configured to cause movement of a patient’s skin as being shown in the embodiments of Figs. 9a-14 (¶ 0083, and ¶ 0080…where the stimulator is a “mechanical stimulator 8”). The specification describes possible “mechanical movement” stimulators as vibrators, pressure applicators (¶ 0006), and mechanical devices for movement and rotation (¶ 0032, lines 1-5). The specification, while describing that the stimulator can also be a Transcutaneous Electrical Neuro Stimulator (TENS; ¶s 0032 and 0087), the specification does not explicitly call out/describe that a TENS device “causes mechanical movement of a patient’s skin”. The specification does describe that the fastening tape can comprise one vibration element (meets the requirements of Claim 1) and one TENS device (meets the requirements of Claim 7).
“one or more fastening means at least partially secured to the one or more fastening tapes” (Claim 1, last two lines; Claim 30) – The specification describes many elements/structures that can comprise the one or more fastening means as follows:
one or more fastening means are described as handles (54(s), Figs. 9a-10b) that are secured to the fastening tape via a fastener (adhesive)/detachable fastener (¶s 0012, 0089, and Claim 32). A detachable fastener is further described as a hook or a magnetic mechanism (¶ 0032),
one or more fastening means is described as being mechanical mechanisms, hooks, handles, or one or more stimulators (¶ 0034), and
one or more fastening means is described as being one or more fasteners to secure the stimulator to the fastening tape (bottom of ¶ 0081).
Claim Rejections – 35 USC § 112
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.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In Regard to Claim 5
Claim 5 recites the limitation “wherein the mechanical movement comprises a mechanical rotational movement”. This limitation is not enabling. The specification provides support for this limitation in ¶s 0014, 0093, and 0095 and Figs. 12 and 13 that show the mechanical rotational functionality of the stimulator in graphical representation.
Nowhere within the disclosure is there any description/direction as to specific physical structure(s)/elements that are needed to form a stimulator that is disposed within the therapy tape that can provide the mechanical rotational movement. As such, it is unclear how to make and use the invention because a person of ordinary skill in the art would not be able to know from the specification (i.e., because there is no direction in the specification of how to do so) how such a stimulator can be constructed and then disposed within the therapy tape to subsequently perform the mechanical rotational movement.
The breadth of the claim is large in that any structural arrangement of the stimulator disposed in a therapy tape that can perform the mechanical rotational movement would fall within the broad scope of the claim. In contrast and as previously described above, no particular structural arrangement for this kind of therapy tape stimulator is described within the specification that could otherwise provide the direction necessary for the person of ordinary skill in the art to make and use the invention without undue experimentation.
Additionally, the specification does not provide any supporting description that would explain/direct the person of ordinary skill in the art to begin to understand what kinds of structures/elements/materials/connection interfaces/components would be needed to begin to construct such a stimulator having a size that is easily disposed within the therapy tape to perform the claimed mechanical rotational movement.
Therefore, it is not understood how such a stimulator can be constructed and the used without undue experimentation.
Claim 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In Regard to Claim 35
The description in ¶ 0013 describes only that which is recited in Claim 35. The aspects of “artificial intelligence” and/or “statistical method” are only broadly recited and there is no corresponding adequate supporting written description that explains what makes up/comprises the recited “artificial intelligence” and/or “statistical method” aspects that can, in response, subsequently produce the recited parameters for individual treatments. Additionally, no specific parameters for individual treatments are described in ¶ 0013 or elsewhere in the specification.
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 1-8, 10-11, 22, 24-28, 30-33, and 35 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 pre-AIA the applicant regards as the invention.
In Regard to Claims 1 and 30 and claims dependent thereon
Claim limitation “one or more fastening means at least partially secured relative to the one or more fastening tapes” (Claim 1, last two lines and Claim 30) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The written description, however, 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. More specifically, it is not clear as to what part/portion of the one or more fastening means is actually partially secured to another structure of the tape (e.g., is this a specific structure of the fastening tape or is this a structure external to the fastening tape because if it being partially secured relative to the fastening tape?) for the scope of this phrase to be understood. 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.
The term “partially secured” recited in the phrase described above (recited in both Claims 1 and 30) is a relative term which renders the claim indefinite. The term “partially secured” 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 be reasonably apprised of the scope of the invention. It is further not understood how a structure such as the one or more fastening means can only be “partially secured” to an attaching structure in contrast to merely being secured to the attaching structure.
The term “one or more fastening means at least partially secured relative to the one or more fastening tapes “is unclear as to which structure the fastening means is being secured to.
In Regard to Claim 11
The term “(Canceled) The…..adhesive” (Claim 11, lines 4 and 5) makes the claim is confusing and indefinite and should not be included in the claim.
In Regard to Claim 27
The phrase “at least a portion of the stimulating signal is programmed to be maintained for a certain duration at given intervals, and/or for a number of durations” is confusing as what is meant by a “certain duration”, “a number of durations”, if the “certain duration” is associated with the number of durations, and what is meant by “given intervals” so that scope of the claim is understood as whole. Additionally, the limitation “a certain limitation” (third to last line in Claim 27) makes the claim indefinite in that it is not understood if this is a new duration being claimed.
In Regard to Claim 28
The term “one or more sensor…includes…one or more of a strain guage, an oedema sensor (Claim 28, lines 3 and 4)….” Is indefinite because one sensor cannot be multiple sensors and/or different types of sensors.
In Regard to Claim 32
The element “one or more handles” (Claim 32, line 5) in combination with a previously recited element “one or more handles” (Claim 32, line 2) makes the claim indefinite in that it is unclear if Applicants are trying to further limit a new element or are attempting to further limit an element previously recited.
In Regard to Claim 35
The term “one or more of artificial intelligence and a statistical method” (¶ 0035, line 3) makes the claim indefinite in that it is confusing if the claim is reciting that one or more of the artificial intelligence and a statistical method is claimed or if one or more of the artificial intelligence or a statistical method is being claimed. As recited, it appears neither one of the terms is actually selected such that the condition itself cannot be satisfied.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-8, 10-11, 22, and 30-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hietanen et al. (US2018/0104087).
In reference to Claim 1, Hietanen discloses:
A fastening tape system (title, Abstract, Figs. 1-7) comprising:
one or more fastening tapes (therapy tape(s) 41, 51, 61, ¶s 0057-0058, 0063, and 0065, Figs. 5-7), each of the one or more fastening tapes (41, 51, 61) comprising:
a backing layer (backing layer(s) 42, 52, ¶ 0058) configured to conform to a portion of a patient's body (¶ 0004, lines 1-5), wherein the flexible backing layer (52) defines a top side and a bottom side opposite the top side (¶ 0004, lines 3-5, as best seen in Fig. 6); and
an adhesive material (¶ 0032, first two lines) secured relative to the bottom side of the flexible backing layer (42, 52, ¶ 0058), wherein the adhesive material is configured to adhere the backing layer (42, 52, ¶ 0058) against the patient's skin (¶ 0032, lines 2-4);
wherein the adhesive material is configured to maintain adherence with the backing layer and the patient's skin (¶ 0032);
at least one stimulator (vibration elements 48, ¶ 0059, pressure applicators 58, ¶ 0063) configured to apply a stimulating signal to the patient's skin (¶s 0007, lines 1-3 and 0057), wherein the stimulating signal is configured to cause a mechanical movement of the patient’s skin in at least one dimension (a vibration element/pressure element inherently cause mechanical movement of a patient’s skin in at least one dimension); and
one or more fastening means (connecting portions 36 are the fastening means by which the handles can be connected and are secured to the backing layer, ¶ 0072; the handles 54 can be fastening means by which the stimulators are connected to, ¶ 0064, lines 6 and 7; yet another fastening means is one or more apertures extending through the therapy tape to which the stimulation elements are secured, ¶ 0058, last five lines) at least partially secured relative to the one or more fastening tapes (41, 51, 61).
In reference to Claim 2, Hietanen further discloses that the fastening tape system further comprises one or more handles (handles 4, 37, Figs. 1-7) secured relative to the top side of the flexible backing layer (backing layer 2, ), wherein the one or more handles (4, 37) are secured to the flexible backing layer via one or more fasteners (fasteners line sewn thread, adhesive, magnets, zippers, et cetera, see the full list of fasteners as described in ¶ 0040; also detachable fasteners like connecting portions 36, ¶ 0052; and attached via detachable fastener materials like hook-and-loop material, magnetic material, snaps, et cetera, ¶ 0049).
In reference to Claim 3, Hietanen also discloses that the mechanical movement is a back and forth movement (when mechanical vibration from vibration element 48 is applied to the skin, the skin will have movement in all directions that inherently includes a back-and-forth movement in a single direction along an axis in one dimension) and the horizontal/vertical direction of the back-and-forth movement can be attained with a proper positioning of the stimulator/fastener tape when placed on the skin.
In reference to Claim 4, Hietanen also discloses that wherein the mechanical movement is defined in two dimensions (when a mechanical vibration from vibration element 48 is applied to the skin, the skin will have movement in all directions that inherently includes mechanical movement defined in two dimensions).
In reference to Claim 6, Hietanen further discloses that the stimulating signal is configured to cause a vibration of the patient's skin (vibration element 48 causes a vibration to a patient’s skin, ¶ 0058).
In reference to Claim 7, Hietanen also discloses that the at least one stimulator comprises an electrical stimulator comprising a Transcutaneous Electrical Neuro Stimulator (TENS) (middle of ¶ 0065).
In reference to Claim 8, Hietanen further discloses that the at least one stimulator comprises a pressure applicator (pressure applicators 58, ¶ 0063) configured to cause a continuous pressure downwards (the pressure applicator 58 of the fastening tape is applied on top of the skin and when the pressure applicator 58 is activated at least a pressure force component of the pressure applied by the pressure applicator is inherently continuously applied to the skin beneath/a downward direction relative to pressure applicator 58).
In reference to Claim 10, Hietanen also discloses that the at least one stimulator is fastened to the one or more fastening tapes at one or more fastening points (handles/fastening points 54 and stimulators/pressure applicators 58 are fastened/connected together, ¶ 0064, lines 6 and 7).
In reference to Claim 11, Hietanen further discloses the fastening tape has a curved profile corresponding at least in part to a profile of at least a portion of a patient's body (the flexible therapy tape can be applied to limb body portions, ¶s 0003, last seven lines and 0004; and when circumferentially applied about at least a portion of a limb such as an arm or leg of a patient the applied flexible therapy tape would have a curved profile that follows the curve of the limb).
In reference to Claim 22, Hietanen also discloses that the fastening tape system further comprises a controller configured to generate one or more stimulator signals to selectively activate the at least one stimulator; wherein the controller comprises at least one communication interface configured to receive data transmitted from at least one external computing entity (¶ 0007, lines 5-12).
In reference to Claim 30, Hietanen discloses:
A method for manipulating a flexible material (the skin of a patient is the flexible material, ¶ 0008), the method comprising:
securing a fastening tape system against a surface of the flexible material (¶ 0008), wherein the fastening tape system comprises:
one or more fastening tapes, each of the one or more fastening tapes comprising:
a backing layer configured to conform to a portion of the surface of the flexible material, wherein the flexible backing layer defines a top side and a bottom side opposite the top side (¶ 0008);
an adhesive material secured relative to the bottom side of the flexible backing layer, wherein the adhesive material is configured to adhere the backing layer against the surface of the flexible material (¶ 0008);
at least one stimulator (stimulator elements 48, 58, ¶s 0059 and 0063) configured to apply a stimulating signal to a flexible material (¶s 0007, lines 1-3 and 0057), wherein the stimulating signal is configured to cause a mechanical movement of the flexible material (the patient’s skin) in a least one dimension (a vibration element/pressure element inherently cause mechanical movement of a patient’s skin in at least one dimension); and
one or more fastening means (the handles 54 can be fastening means by which the stimulators are connected to, ¶ 0064, lines 6 and 7) for securing the at least one stimulator to the one or more fastening tapes (41, 51, 61); and
applying a tensile force to the at least one of the fastening means to lift a portion of the backing layer and a secured portion of the surface of the flexible material (explicitly described in ¶ 0008, last three lines).
In reference to Claim 31, Hietanen further discloses that the flexible material is a patient's skin (¶ 0008).
In reference to Claim 32, Hietanen also discloses that the fastening means comprise one or more handles being detachably secured relative to the top side of the flexible backing layer (handle 37 secured to top side of backing layer via connecting portions 36, ¶ 0049, Figs. 4A-4D, especially Fig. 4D), and wherein the method further comprises steps for:
securing one or more handles relative to the top side of the flexible backing layer via one or more detachable fasteners (connecting portions 36 are formed from a variety of detachable fastener materials like hook-and-loop material, magnetic material, snap, et cetera, ¶ 0049).
In reference to Claim 33, Hietanen further discloses that the adhesive material is heat activated (¶ 0009, lines 6 and 7), and wherein securing the tape structure against a surface of the flexible material (¶ 0009, lines 7-9) comprises:
placing the adhesive material of the fastening tape system against the patient's skin (¶ 0009, lines 9 and 10); and
raising a temperature of the adhesive material based on the patient's body heat to securely adhere the adhesive material to the patient's skin (¶ 0009, lines 10-13).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al in view of Ji (CN208911280U) (an English Abstract of CN208911280U has been provided for Applicants’ convenience).
Hietanen discloses all of the limitations of Claims 1 and 4 including the at least one stimulator having a mechanical movement defined in two dimensions. Hietanen, however, lacks disclosure of the mechanical movement comprising a mechanical rotational movement. Ji teaches a therapy patch/tape (Abstract, line 1 and line 5 under the section header “Description” on p. 1, Figs. 1-3) that includes a stimulator/vibration assembly (5th full paragraph on p. 2, lines 2 and 3) that provides a mechanical rotational movement (Ji’s tape has two massaging modes: vibration massage and rotating massage, Abstract, line 10 and 2nd full paragraph on p. 6). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Heitanen’s tape by replacing the mechanical movement of the stimulator to be a mechanical rotational movement, as taught by Ji, to provide a massaging of the skin in the local area where the tape/vibration assembly is disposed on the skin to improve the health/healing recovery of the local skin area/muscle (bottom paragraph on p. 1 to the top of p. 2 of Ji).
Claims 24, 27-28, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen in view of Foster et al (WO2021/112922A1).
In reference to Claim 24, Hietanen discloses that the system further comprises a controller to generate one or more stimulating signals to selectively activate the at least one stimulator. Hietanen lacks where the system further includes at least one sensor configured for measurement of at least one property of the skin, wherein the at least one sensor is further configured to transmit measurements results to the controller, and wherein the controller is configured to adjust the one or more stimulator signals based at least in part on the measurements results. Foster teaches a vibration device for delivering a therapeutic vibration to the body (title, Abstract, Figs. 1-8) that further includes at least one sensor configured for measurement of at least one property of the skin (temperature sensor, claims 7 and 10), wherein the at least one sensor is further configured to transmit measurements results to the controller (¶ 0011), and wherein the controller is configured to adjust the one or more stimulator signals based at least in part on the measurements results (¶ 0011). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Hietanen’s device to further include at least one sensor configured for measurement of at least one property of the skin, wherein the at least one sensor is further configured to transmit measurements results to the controller, and wherein the controller is configured to adjust the one or more stimulator signals based at least in part on the measurements results, as taught by Foster, to provide information about an attribute of the user’s body that is used to further adjust the operation of the vibrational device to attain a useful therapy result for the patient/user (¶ 0011 of Foster).
In reference to Claim 27, Hietanen discloses the stimulating signal of the stimulator as described above. Hietanen lacks the stimulating signal being configured according to a selective adjustment as a response to a sensor measurement for a certain duration and that at least a portion of the stimulating signal is programmed to be maintained for a certain duration for a number of durations. Foster teaches a vibration device (title, Abstract, Figs. 1a-8d) for delivering a therapeutic vibration to a body that includes a selective adjustment as a response to a sensor measurement for a certain duration (Foster’s vibration device is used in conjunction with a sensor that is adjusted to achieve a predefined state/goal like lower heart rate and lower blood pressure for the user, ¶ 00011) and at least a portion of the stimulating signal is programmed to be maintained for a certain duration for a number of durations (the vibration device can, for example, generate a plurality of vibration pulses, ¶ 0024, and the vibration producing waveform is controlled by a motor controller that executes a sequence of commands (i.e., because of being previously programmed to do so) to make the stimulating signal applied to the user be regular, recurrent, or oscillatory, ¶ 0025). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the stimulating signal of Hietanen to have a selective adjustment in response to a sensor measurement for a certain duration wherein at least a portion of the stimulating signal is programmed to be maintained for a certain duration for a number of durations, as taught by Foster, to provide a stimulating signal waveform/output applied to the user which is effective to assist the user to reach a therapeutic goal (¶ 00024 of Foster).
In reference to Claim 28, Hietanen discloses the at least one stimulator configured to apply a stimulating signal to a patient’s skin which is configured to cause mechanical movement of the patient’s skin. Hietanen lacks having one or more sensor configured for measurement of at least one property of the skin, wherein the one or more sensor includes a temperature sensor. Foster teaches a vibration device for delivering a therapeutic vibration to the body (title, Abstract, Figs. 1-8) that utilizes a temperature sensor for measuring a temperature of the skin (sensor to measure “skin temperature”, ¶ 0011 and claims 7 and 10). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Hietanen’s device to have a temperature sensor for measurement of at least one property of the skin, as taught by Foster, to provide information about an attribute of the user’s skin to further adjust the operation of the vibrational device to attain a useful therapy for the patient/user (¶ 0011 of Foster).
In reference to Claim 35, Hietanen teaches all of the elements above including the at least one stimulator. Hietanen lacks collecting data comprising measurement results relating to a manipulation; and analyzing the data by artificial intelligence in order to define parameters for individual treatments based at least in part on the measurement results. Foster teaches a vibration device (title, Abstract, Figs. 1a-8d) for delivering a therapeutic vibration to a body that includes collecting data comprising measurement results relating to a manipulation (“using feedback from measured parameters to direct the vibration modes”, ¶ 00010, lines 1-3; measured parameters regarding the user’s status condition via sensors, bottom portion of ¶ 0051); and analyzing the data by artificial intelligence in order to define parameters for individual treatments based at least in part on the measurement results (“uses a learning algorithm with artificial intelligence to direct vibrational modes that adapt to the individual”, ¶ 00010, lines 4 and 5). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify HIETANEN’s therapy tape to collect data comprising measurement results relating to a manipulation and analyze the data by artificial intelligence in order to define parameters for individual treatments based at least in part on the measurement results, as taught by Foster, to provide an enhanced tailored therapeutic treatment for the body of a patient/user (Abstract, last two lines and ¶ 00010 of Foster).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen and Foster et al as applied to Claim 22 above, and further in view of Hwang et al (CN109069853A) (an English Machine translation has been provided for Applicants’ convenience and the citations in the rejection below is taken from this English Machine Translation).
In reference to Claim 25, Hietanen discloses that the system further comprises a controller to generate one or more stimulating signals to selectively activate the at least one stimulator. Hietanen lacks a system that further comprises at least one sensor configured for measurement of at least one property of the skin, wherein the at least one sensor is further configured to transmit the measurements results to a mobile device, and wherein the controller is configured to adjust the one or more stimulator signals based at least in part on the measurements results. Foster teaches a vibration device for delivering a therapeutic vibration to the body (title, Abstract, Figs. 1-8) that further includes at least one sensor configured for measurement of at least one property of the skin (temperature sensor, claims 7 and 10), wherein the at least one sensor is further configured to transmit measurements results to the controller (¶ 0011), and wherein the controller is configured to adjust the one or more stimulator signals based at least in part on the measurements results (¶ 0011). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Hietanen’s device to further include at least one sensor configured for measurement of at least one property of the skin, wherein the at least one sensor is further configured to transmit measurements results to the controller, and wherein the controller is configured to adjust the one or more stimulator signals based at least in part on the measurements results, as taught by Foster, to provide information about an attribute of the user’s body that is used to further adjust the operation of the vibrational device to attain a useful therapy result for the patient/user (¶ 0011 of Foster). The modified Hietanen, however, does not teach that wherein the at least one sensor is further configured to transmit the measurements results to a mobile device. Hwang teaches a skin attachment and storage device (title, Abstract, Figs. 1-11) that includes a vibration part (“vibrating part” is associated with attaching part 110, sixth full paragraph on p. 8) and a sensor (bottom paragraph on p. 5 and 3rd full paragraph on p. 6) where the device accumulates data from the sensor that is transmitted to a mobile device (bottom paragraph on p. 9 to the top of p. 10). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the modified Hietanen to have the at least one sensor be configured to transmit the measurements results to a mobile device, as taught by Hwang, to provide the user an easy way to check the measured conditions at the skin site where the skin device is disposed (bottom paragraph on p. 9 to the top of p. 10).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen in view of Paz et al (US2021/0138232).
In reference to Claim 26, Hietanen discloses the stimulator having the stimulating signal as described above. Hietanen lacks at least a portion of the stimulating signal being programmed to start and stop automatically in accordance with a measurement signal of a strain gauge. Paz teaches a wearable apparatus (stimulator device 31, title, Abstract, Figs. 3-7) that produces a stimulating signal (generated signal bursts 41 delivered by gated pulse generator 35, Figs. 3 and 4) delivered to the skin of a patient that is programmed to start and stop automatically in accordance with a measurement signal of a strain gauge (generated signal bursts 41 are controlled to activate/deactivate through connection 44 (Fig. 4) in response to data collected by the sensor output of sensor 32 that is analyzed, Abstract, “the device 31 is activated (or deactivated) in the case where the sensor output is produced that is below the minimum threshold or is above a maximum threshold”, bottom portion of ¶ 0328; the sensor 32 can be a strain gauge, ¶ 0305; also many other sensors are described that can be used in contrast to the strain sensor in ¶s 0274-0276). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the at least a portion of the stimulating signal of Hietanen’s device to have a portion of the stimulating signal being programmed to start and stop automatically in accordance with a measurement signal of a strain gauge, as taught by Paz, to provide improved operative control of the stimulating signal to produce an effective therapy treatment for a patient/user.
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.
Claim 1 of SN17/390507 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,096,817 in view of Rowen (US2014/0243589).
It is noted that Claim 1 of SN17/390507 is a broader recitation than claim 1 of US11,096,817, however, the elements of Claim 1 of SN17/390507 correspond to claim 1 of US11,096,817 as follows:
Instant Application (SN 17/390507)
U.S. Patent No. 11,096,817
A fastening tape system comprising: one or more fastening tapes, each of the one or more fastening tapes comprising: (see Claim 1, lines 1 and 2)
A formed roll of therapy tape comprising:
(the function of the roll of the therapy tape is for it to be secured to the skin of a patient’s body (col. 1, lines 45 and 46) via an adhesive material (col. 2, lines 9 and 10) which reads on a fastening tape system)
a backing layer configured to conform to a portion of a patient's body, wherein the flexible backing layer defines a top side and a bottom side opposite the top side; (see Claim 1, lines 3-5)
a continuous, elongated flexible backing layer having a top side and a bottom side opposite the top side; (see claim 1, lines 2 and 3)
an adhesive material secured relative to the bottom side of the flexible backing layer, wherein the adhesive material is configured to adhere the backing layer against the patient's skin; wherein the adhesive material is configured to maintain adherence with the backing layer and the patient's skin; (see Claim 1, lines 6-10)
a continuous adhesive layer comprising a first adhesive material secured to the bottom side of the elongated flexible backing layer and covering an entirety of the bottom side of the elongated flexible backing layer; (see claim 1, lines 4-7)
wherein the first adhesive material is configured to maintain adherence with the flexible backing layer and a patient’s skin (see claim 1, lines 34-36)
one or more fastening means at least partially secured relative to the one or more fastening tapes (Claim 1, last two lines)
a plurality of handles comprises an elongated material secured onto the top side of the flexible backing layer (see claim 1, lines 8-12)
US11,096,817 does not recite/disclose that the tape further comprises at least one stimulator configured to apply a stimulating signal to the patient's skin, wherein the stimulating signal is configured to cause a mechanical movement of the patient's skin in at least one dimension. Rowen, however, teaches a vibratory apparatus (apparatus 10 that contains patch 11, title, Abstract, ¶ 0015, Figs. 1-4) that includes at least one stimulator (vibratory element 14, ¶ 0015, Fig. 1) applied to the skin of a patient and configured to apply a stimulating signal to the patient's skin (Abstract and ¶ 0015), wherein the stimulating signal is configured to cause a mechanical movement of the patient's skin in at least one dimension (vibratory element 14 generates stimulation through mechanical vibratory motion, ¶ 0002, and when a mechanical vibration is applied to the skin via vibratory element 14, the skin will have mechanical movement in all directions that inherently includes mechanical movement defined in at least one dimension). Therefore, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the therapy tape as recited in claim 1 of US11,096,817 to include the at least one stimulator configured to apply a stimulating signal to the patient's skin, wherein the stimulating signal is configured to cause a mechanical movement of the patient's skin in at least one dimension, as taught by Rowen, to provide an effective vibratory sensation for therapeutic or pleasurable purposes for the patient (Abstract of Rowen).
Conclusion
Prior art of record not relied upon is considered pertinent to Applicants’ disclosure.
Goren (US20070073361) is cited to show a device for treatment of impairments relating to neuropathy.
Kannankeril (US4925453) is cited to show a medical sponge to absorb body fluids that includes a handle means (20, Fig. 1).
Kopanic (US7182739) is cited to show a therapy patch that delivers heat and vibration to the human skin.
Ghodsian (US4650705) is cited to show a sterile adhesive sheet used in surgical procedures.
Hunt (WO2021122701A1) is cited to show a therapy apparatus having a strain sensor.
A paper entitled “Transcutaneous Electrical Nerve Stimulation: Basic Science Mechanisms and Clinical Effectiveness” taken from the Journal of Pain, 2003, provides some base knowledge regarding the use of TENS devices in therapy treatments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W THIEDE whose telephone number is (313)446-4907. The examiner can normally be reached M-F 9:00 AM - 5:30 PM EST.
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/PAUL W THIEDE/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785
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