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 Claims
Claims 1-20 are currently pending and under investigation.
Drawings
The drawings are objected to because:
Fig. 7 does not accurately depict the electrode placement map upon reading the specification. It is unclear what exactly the visible markings 203 are supposed to encompass upon looking at Fig. 7. It is recommended that Fig. 7 is amended to contain more visual detail to better discern between the various elements shown in the Figure.
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.
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: “at least one orientation element that is configured to cooperate with a respective fiducial” in claim 10.
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.
Paragraph [0035] of the specification provides corresponding structure for “orientation element” that includes a protrusion extending into the interior, a marking, or a feature that alters the shape of the lower perimeter. Thus, the orientation element will be interpreted as a protrusion extending into the interior, a marking, or a feature that alters the shape of the lower perimeter.
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 6 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.
The term “substantially” in claim 6 is a relative term which renders the claim indefinite. The term “substantially” 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 unclear what the bounds of “substantially” are when it refers to the claim limitation of “substantially rigid”. Due to the fact that “substantially” is not defined, then “substantially rigid” could mean a material with no flexibility to a material with slight or even moderate flexibility. It is recommended that the Applicant either defines or removes the term “substantially”.
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.
Claims 1-3, 6-14, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dar et. al, (US 20150374971 A1, published 12/31/2015, hereinafter known as Dar).
Regarding claim 1, Dar discloses apparatus for applying at least one electrode array to a head of an individual (“apparatus and methods for applying electrical stimulation to the head region, to headsets having electrodes for treatment of medical conditions…to electrode arrangements for use with such headsets” [0002]), the apparatus comprising:
a head receiving structure configured to receive at least a portion of the head of the individual (“invented headset system, donned on head” [0096]),
wherein the head receiving structure defines an interior (shown below in annotated Fig. 2, [0097]), wherein the head receiving structure comprises an adhesive or hook or loop material within the interior (“electrode pad may include a “hook” (e.g., Velcro®) fastening layer” [0140]), and wherein the adhesive or hook or loop material is configured to retain the at least one electrode array within the interior of the head receiving structure (“the user may position electrode pad inside housing and thereby the hook layer of electrode pad and the loop layer may be reversibly attached” [0140]).
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Regarding claim 2, Dar discloses the apparatus as described in claim 1, wherein the head receiving structure comprises first and second portions, wherein the first and second portions are coupled together (“headset may be configured to include an elastic posterior member and elastic anterior member…posterior and anterior members may be configured to connect to middle bilateral members by size adjustment mechanisms configured to be located at both sides of the head”, Fig. 2, [0097]) to permit relative movement between the first portion and the second portion (“middle bilateral members may be configured to be flexible”, due to the flexibility of the middle coupling members, the posterior and anterior portions are capable of relative movement, [0098]).
Regarding claim 3, Dar discloses the apparatus as described in claim 2, wherein the head receiving structure comprises a hinge or linkage that couples the first and second portions (“anterior and posterior members may be configured to be coupled to bilateral members at connection points 8 and 16 as shown in Fig. 1”, the coupling point between the anterior/posterior members and bilateral members can be understood as a linkage, [0096]) to permit pivotal movement therebetween (“middle bilateral members may be configured to be flexible”, due to the flexibility of the middle coupling members, the posterior and anterior portions are capable of relative movement, [0098]).
Regarding claim 6, Dar discloses the apparatus as described in claim 2, wherein the first and second portions of the head receiving structure are substantially rigid (“the frame is adapted such that along at least 30%, at least 40%, at least 50%, or at least 60% of a length of the circumference, the frame is substantially non-elastic” [0027]).
Regarding claim 7, Dar discloses the apparatus as described in claim 2, wherein at least one of the first portion or the second portion of the head receiving structure is flexible (“circumferential frame (“headset body”) that may include a posterior elastic member and an anterior elastic member” [0096]).
Regarding claim 8, Dar discloses the apparatus as described in claim 2, wherein each of the first and second portions of the head receiving structure forms approximately half of the head receiving structure (“the front and rear mechanical elements span, in total, 45% to 75%, 50% to 75%, 55% to 75%, or 55% to 70%, of the circumference” [0016]).
Regarding claim 10, Dar discloses the apparatus as described in claim 1, further comprising at least one orientation element that is configured to cooperate with a respective fiducial to orient the apparatus relative to the head of the individual (“to ensure proper circumferential (rotational) and longitudinal placement of headset with respect to head without the need to use a mirror, the user may position his thumb on nose bridge and one of his fingers (of the same hand) on recess (i.e., a marking), to ensure that headset is accurately positioned” [0196]).
Regarding claim 11, Dar discloses the apparatus as described in claim 10, wherein the respective fiducial is a facial feature (“headset may be configured to include a recess at its anterior portion, configured to be aligned with the glabella midline and above a nose bridge” [0196]).
Regarding claim 12, Dar discloses the apparatus as described in claim 1, wherein the head receiving structure is flexible (“circumferential frame (“headset body”) that may include a posterior elastic member and an anterior elastic member…middle bilateral members may be configured to be flexible” [0096] & [0098]).
Regarding claim 13, Dar discloses the apparatus as described in claim 12, wherein the head receiving structure that is flexible is resiliently elastic (“elastic member may have a lower modulus of elasticity above electrode base housing”, it is well known in the art that a lower elastic modulus means that the material is less susceptible to deformation and can more easily return to its shape, [0119]).
Regarding claim 14, Dar discloses a system comprising: an apparatus (“apparatus and methods for applying electrical stimulation to the head region” [0002]) comprising: a head receiving structure configured to receive at least a portion of the head of the individual (“invented headset system, donned on head” [0096]), wherein the head receiving structure defines an interior (shown above in annotated Fig. 2, [0097]), wherein the head receiving structure comprises an adhesive or hook or loop material within the interior (“electrode pad may include a “hook” (e.g., Velcro®) fastening layer” [0140]), and wherein the adhesive or hook or loop material is configured to retain the at least one electrode array within the interior of the head receiving structure (“the user may position electrode pad inside housing and thereby the hook layer of electrode pad and the loop layer may be reversibly attached” [0140]); and an electrode placement map receivable within the interior of the head receiving structure of the apparatus (“mechanism for adjustment of the placement of electrode base housing” Fig. 12 and Fig. 13, [0125]), the electrode placement map comprising: a 2-dimensional substrate (“flexible connecting band” 84 in Fig. 13, [0126]); and visible markings associated with the 2-dimensional substrate (“flexible connecting band is configured to include holes” 98 in Fig. 13, [0126]), the visible markings being indicative of placement locations of a plurality of electrode arrays relative to each other in 2-dimensional space (“placement of electrode base housing may be adjusted by snapping protrusions and into other holes in flexible connecting band…electrode pad is disposed in electrode base” [0127] & [0128]) wherein the placement locations of the plurality of electrode arrays relative to each other in 2-dimensional space translates to optimized positions of the plurality of electrode arrays for delivering tumor-treating fields (“ensuring optimal conductivity between the electrodes and the scalp is essential for proper transfer of the electrical current to the target tissues, which is the basis for an effective treatment”, since the prior art discloses the claimed structure, the prior art is capable of the claimed function, which is treatment of tumor-treating fields [0094]) when the plurality of electrode arrays are placed on the individual in 3-dimensional space (“the position of electrode base housing may be adjusted to fit various morphological and anthropometric variables of certain users” [0124]).
Regarding claim 16, Dar discloses the apparatus as described in claim 14, wherein the visible markings of the electrode placement map comprise indications of at least a portion of a perimeter of each electrode array of the plurality of electrode arrays (“electrode base housing may be configured to be coupled to a “loop” (e.g., Velcro®) fastening layer, disposed in a groove in the internal perimeter of housing” markings 98 and perimeter of base 150, as shown below in annotated Fig. 13, [0141]).
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Regarding claim 17, Dar discloses the apparatus as described in claim 14, wherein the visible markings comprise indications of at least one fiducial that provides a reference location from which the plurality of electrode arrays can be positioned (“electrode base housing may be configured to include protrusions and arising from its bottom surface… placement of electrode base housing may be adjusted by snapping protrusions and into other holes in flexible connecting band”, protrusions 92a and 92b act as fiducial reference points allowing the electrodes to be positioned properly within holes 98, as shown above in annotated Fig. 13, [0127]).
Regarding claim 18, Dar discloses a method (“methods of donning and positioning the headset on the head of the user” [0007]) comprising: positioning within an interior of a head receiving structure at least one electrode array in a position (“elastic member (part of the headset) may enable stimulation and positioning of electrodes and sensors at higher locations on the head” [0113]) so that when the head receiving structure is positioned on a head of an individual, the at least one electrode array is in a predetermined position relative to the head of the individual (“Figs. 11A-11C provide three different pre-set positionings of the electrode base housings” [0123]), wherein the head receiving structure is configured to receive at least a portion of the head of the individual (“invented headset system, donned on head” [0096]), wherein the head receiving structure defines an interior (shown above in annotated Fig. 2, [0097]), wherein the head receiving structure comprises an adhesive or hook or loop material within the interior (“electrode pad may include a “hook” (e.g., Velcro®) fastening layer” [0140]), and wherein the adhesive or hook or loop material is configured to retain the at least one electrode array within the interior of the head receiving structure (“the user may position electrode pad inside housing and thereby the hook layer of electrode pad and the loop layer may be reversibly attached” [0140]).
Regarding claim 20, Dar discloses the method as described in claim 18, further comprising, positioning within the interior of the head receiving structure an electrode placement map receivable therein (“mechanism for adjustment of the placement of electrode base housing” Fig. 12 and Fig. 13, [0125]), the electrode placement map comprising:
a 2-dimensional substrate (“flexible connecting band” 84 in Fig. 13, [0126]); and visible markings associated with the 2-dimensional substrate, and
visible markings being indicative of placement locations of a plurality of electrode arrays relative to each other in 2-dimensional space (“placement of electrode base housing may be adjusted by snapping protrusions and into other holes in flexible connecting band…electrode pad is disposed in electrode base” [0127] & [0128]), wherein the placement locations of the plurality of electrode arrays relative to each other in 2-dimensional space translates to optimized positions of the plurality of electrode arrays for delivering tumor-treating fields (“ensuring optimal conductivity between the electrodes and the scalp is essential for proper transfer of the electrical current to the target tissues, which is the basis for an effective treatment”, since the prior art discloses the claimed structure, the prior art is capable of the claimed function, which is treatment of tumor-treating fields [0094]) when the plurality of electrode arrays are placed on the individual in 3-dimensional space (“the position of electrode base housing may be adjusted to fit various morphological and anthropometric variables of certain users” [0124]),
wherein positioning within the interior of the head receiving structure at least one electrode array comprises positioning a plurality of electrode arrays based on the visible markings of the electrode placement map (“electrode base arrangement in which the distance between adjacent electrode base housings, may be pre-set”, Figs. 11A-11C depict electrode base 60 containing multiple electrode base housings 150, which indicates that there could be multiple electrodes connected to the corresponding housings, [0123]).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dar in view of Gardin et. al, (US 20140142676 A1, published 05/22/2014, hereinafter known as Gardin).
Regarding claim 4, Dar discloses the apparatus as described in claim 3, wherein the hinge or linkage is a linkage that comprises a fastener that couples the first and second portions together (“anterior and posterior members may be configured to be coupled to bilateral members at connection points 8 and 16 as shown in Fig. 1”, the coupling point between the anterior/posterior members and bilateral members can be understood as a linkage, [0096]).
Dar does not disclose wherein the fastener is configured to permit selective decoupling between the first and second portions to thereby permit relative movement between the first portion and the second portion.
However, Gardin teaches headband for retaining electrodes in position on a patient's head (Abstract). To releasably lock the pin within the narrow portion of the keyhole…pin requires the application of force to enter the narrow portion and to be removed therefrom, as shown in Fig. 2 [0028]. The pin and keyhole setup of the headband allows for selective coupling and decoupling between the first and second portions of the headband.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the pin and keyhole setup of Gardin with the apparatus for applying at least one electrode array to a head of an individual of Dar because it allows for user control over fastening and unfastening the components of the headband.
Regarding claim 5, Dar discloses the apparatus as described in claim 4.
Dar does not disclose wherein the fastener comprises hook and loop material, a zipper, a button, or a snap.
However, Gardin teaches fastening means may consist of a…hook-and-loop fasteners…as are well known in the art [0028].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the fastening means of a hook and loop fastener of Gardin with the apparatus for applying at least one electrode array to a head of an individual of Dar because this type of fastener is known in the art for hats, hardhats, helmets and caps (Gardin, [0023]).
Regarding claim 19, Dar discloses the method as described in claim 18, wherein the head receiving structure comprises first and second portions (“headset may be configured to include an elastic posterior member and elastic anterior member”, Fig. 2, [0097]) and a hinge or linkage that couples the first and second portions (“anterior and posterior members may be configured to be coupled to bilateral members at connection points 8 and 16 as shown in Fig. 1”, the coupling point between the anterior/posterior members and bilateral members can be understood as a linkage, [0096]) to permit pivotal movement therebetween (“middle bilateral members may be configured to be flexible”, due to the flexibility of the middle coupling members, the posterior and anterior portions are capable of relative movement, [0098]).
Dar does not disclose the method further comprising removing the head receiving structure from the head of the individual by pivoting the first portion relative to the second portion about the hinge or linkage.
However, Gardin teaches in another embodiment, the strap may be pivotally affixed to the frame at a first end, and removably attached to the frame at a second end [0026].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the pivotal affixion and removable attachment of the frame of Gardin with the method of applying at least one electrode array to a head of an individual of Dar because it allows for the user to fully adjust and control the headband based on their particular treatment needs.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dar.
Regarding claim 9, Dar discloses the apparatus as described in claim 1, wherein the adhesive or hook or loop material is selected to have a first adhesion between the head receiving structure and the at least one electrode array (“electrode pad may be configured to include…a double adhesive layer, coupled to at least portion of the bottom perimeter of electrode pad which is configured to face conductive layer of housing” [0145]) and a second adhesion between an adhesive of the at least one electrode array and the head of the individual (“stimulation in the presence of hair, such as when attempting to non-invasively stimulate various areas of the head, presents a challenge, since the hair creates a high impedance layer between the superficial electrodes and the skin…solid adhesive hydrogel is the most common conductive medium used in electrical stimulation electrodes [0151]).
Dar does not disclose wherein the first adhesion of the adhesive or hook or loop material is less than the second adhesion.
However, the specification of the present invention provides no criticality or unexpected result for the claimed configuration. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the adhesive of the strength needed in order to secure the electrodes.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the adhesive portions of varying levels of adhesion, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dar in view of Munster (hereinafter known as modified Dar) as applied to claim 14 above, and further in view of Shambroom et. al, (US 20160325071 A1, published 11/10/2016, hereinafter known as Shambroom).
Regarding claim 15, modified Dar discloses the apparatus as described in claim 14.
Modified Dar does not disclose wherein the visible markings of the electrode placement map comprise ink or toner printed on the 2-dimensional substrate
However, Shambroom teaches a dream stimulator that may include a substrate and a plurality of electrodes positioned along a first side of the substrate (Abstract). The electrodes may be printed on the substrate…printing materials may include silver ink [0031].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the use of visible ink markings on the electrodes of Shambroom with the modified apparatus and electrode placement map of Dar because this allows for better visualization of the electrodes within the electrode placement map.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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