DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 use the word “means,” 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: “transmission improvement means for improving the transmission of EEG signals from the person’s brain” in claim 3.
The specification states the structure of the mean function recited as “the transmission improvement means comprise tines for shallow penetration in the person’s scalp, for example the stratum corneum of the person’s skin. The tines may be provided in a large number, arranged adjacent to each other in a grid-like manner, protruding from a common, central body. The tines may be made of a plastic material, for example made of Nylon, to obtain sufficient strength for shallow penetration of the person’s skin.” (Paragraph, 0023)
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 1-20 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 “typically” in claim 1 and 14 is a relative term which renders the claim indefinite. The term “typically” 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.
The term “substantially” in claim 1, 11,13,14 and 20 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.
Claim 2 recites the limitation " the crown" in line 4. There is insufficient antecedent basis for this limitation in the claim. The crown in line 2 should be “a crown”.
Claim 3 recites the limitation "the electrodes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “the plurality of electrodes”.
Claim 3 recites the limitation " the frontal electrode " in line 2. There is insufficient antecedent basis for this limitation in the claim.. The limitation should be “a frontal electrode”.
Claim 3 recites the limitation " the transmission " in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “transmission”.
Claim 3 recites the limitation " the person’s brain" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “a person’s brain”.
Claim 3 recites the limitation " the skin" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “skin”.
Claim 3 recites the limitation " the electrodes" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim. The electrodes in line 2 should be “the first and second electrode” and the electrode in line 4 should be “the frontal electrode”.
Claim 6 recites the limitation "the electrodes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “the plurality of electrodes”.
Claim 7 recites the limitation "the tines" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “the plurality of tines”.
Claim 7 recites the limitation "the flexible matrix" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “a flexible matrix”.
Claim 8 recites the limitation "the placement" in line 3. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “placement”.
The term “partially” in claim 8 and 18 is a relative term which renders the claim indefinite. The term “partially” 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.
Claim 9 recites the limitation "the respective electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “the first electrode and the second electrode”.
Regarding claim 14, the phrases, multiple "and/or" render the scope of the claim indefinite because it is unclear whether the claim phrase requires acute encephalopathy, delirium, both acute encephalopathy and delirium, or other combinations.
Claim 16 recites the limitation "the electrodes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “the plurality of electrodes”.
Claim 17 recites the limitation "the electrodes" in line 3. There is insufficient antecedent basis for this limitation in the claim. The limitation should be “the plurality of electrodes”.
The term “preferably” in claim 13 and 20 is a relative term which renders the claim indefinite. The term “preferably” 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.
The term “at least” in claim 8 and 18 is a relative term which renders the claim indefinite. The term “preferably” 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.
Regarding claim 5, 7, 11, 16, 17, 18, and 20 the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 3,14, and 16, the phrase, “i.e.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are parts of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 14 the phrase " Providing an electrode carrier according to any of
the preceding claims " renders the claim indefinite because it is unclear whether the claims intended the limitation(s) of “the first electrode for placement on a region of the person’s scalp that is free of hair” and “the second electrode for placement on a region of the person’s scalp that is with hair” as recited in claim 1 or the limitation(s) of “placing the second electrode on a region of the person’s scalp that is typically substantially free of hair” and “placing the first electrode on a region of the person’s scalp that is typically substantially covered with hair” as recited in claim 14. These limitations appear to be reversed relative to one another, thereby creating uncertainty as to the scope of the claimed invention. Therefore, "for the purposes of examination, we will treat it as if claim 14 is meant to be consistent with claim 1 where the first electrode is placed on a region substantially free of hair and the second electrode is placed on a region substantially covered with hair"
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1,3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over “Nahum” (US20150112153 A1) in view of “Shu” (CN 108670241 A)
Regarding claim 1, Nahum teaches an electrode carrier for electroencephalography (EEG) measurements (Paragraph, 0094: “EEG headset 100 includes a right lateral support assembly 120, a left lateral support assembly 130, two spring hinge assemblies 140, a headband assembly 150, an amplifier assembly 160, and an electrode/ lead assembly 110, 111.”), the carrier comprising:
a plurality of electrodes for electroencephalography measurements (Paragraph, 0094: “EEG headset 100 includes a right lateral support assembly 120, a left lateral support assembly 130, two spring hinge assemblies 140, a headband assembly 150, an amplifier assembly 160, and an electrode/ lead assembly 110, 111.”, and Paragraph, 0128: “FIG. 1 shows electrodes 116, and 117, 118 attached to external leads 112, 114, respectively. Electrodes 116, and 117, 118 mechanically and electrically connect to leads 112, 114, respectively”),
wherein the electrodes are arranged on the substrate, wherein the plurality of electrodes comprises (Paragraph, 0128: “FIG. 1 shows electrodes 116, and 117, 118 attached to external leads 112, 114, respectively. Electrodes 116, and 117, 118 mechanically and electrically connect to leads 112, 114, respectively” and Paragraph, 0129: “The positions of electrodes on leads 112, 114, along with the semi-flexible nature of the leads, facilitate alignment of electrodes 116, 117, and 118”):
a first electrode, for placement a region of the person’s scalp that is typically substantially free of hair (Paragraph, 00126: “Where used over relatively hair free regions”, and Paragraph, 0127: “electrodes, such as electrodes 116, 117, and 118, may be of a dry, noncontact (or capacitive), viscous gel, structurally durable hydrogel, adhesive gel, conductive paste, saline or other variety.”, and ” Electrodes may further be formulated without adhesive for use in pressure bearing electrode locations.”),
the first electrode comprising a non-adhesive conductive medium for contacting the person’s scalp (Paragraph, 00127: “electrodes, such as electrodes 116, 117, and 118, may be of a dry, noncontact (or capacitive), viscous gel, structurally durable hydrogel, adhesive gel, conductive paste, saline or other variety.”, and “Electrodes may further be formulated without adhesive for use in pressure bearing electrode locations.”), and
a second electrode, different from the first electrode, for placement on a region of the person’s scalp that is typically substantially covered with hair (Paragraph, 0127: “other electrode varieties may include protrusions, depressible or otherwise, to facilitate contact on the skin or through hair. In lieu of or in addition to electrodes 116, 117, 118 or electrode assemblies 110, 111”),
the second electrode comprising an adhesive conductive medium for contacting the person’s scalp (Paragraph, 0126: “Conductive medium 272 may be of any conductive, biologically compatible variety. Where used over the predominantly hair bearing region of the scalp, biocompatible adhesive 276 is formulated to optimize the properties of ease of removal from hair and system stabilization”, and Paragraph, 0127: “electrodes, such as electrodes 116, 117, and 118, may be of a dry, noncontact (or capacitive), viscous gel, structurally durable hydrogel, adhesive gel, conductive paste, saline or other variety.”).
Nahum does not teach a flexible substrate for placement on a person’s scalp.
Shu teaches a flexible substrate for placement on a person’s scalp (translated, page6, Paragraph 5, lines 20-21: “the present invention provides a kind of novel flexible printing veneer electrode array Row, electrode is bent, can preferably be bonded skin”, (translated, page 4, Paragraph 5, lines 30-33: “Three forehead EEG electrode signal acquisitions are (i.e. First electrode ontology 3, second electrode ontology 4 and third electrode body 5 “, “the scalp region being attached on the upside of face forehead eyes”),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with the flexible substrate of Shu because both Nahum and Shu are directed to EEG electrode systems for placement on a subject’s scalp, and incorporating Shu’s flexible substrate into Nahum would have improved conformity to the user’s scalp, thereby improving electrode contact and signal acquisition reliability while also enhancing user comfort and ease of use (Shu, English translated, page 6, lines 21-24 and page 7, lines 9-14).
Regarding claim 3, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Claim 3, Nahum teaches wherein at least one of the electrodes, for example the frontal electrode further comprises transmission improvement means for improving the transmission of EEG signals from the person’s brain, i.e. underneath the skin, towards the electrode (Paragraph, 0126: “Conductive medium 272 may be of any conductive, biologically compatible variety. Where used over the predominantly hair bearing region of the scalp, biocompatible adhesive 276 is formulated to optimize the properties of ease of removal from hair and system stabilization.”, and Paragraph, 0127: “Dry, non-contact, and other electrode varieties may include protrusions, depressible or otherwise, to facilitate contact on the skin or through hair”).
Regarding claim 5, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Claim 5, Nahum teaches wherein the non-adhesive conductive medium of the first electrode comprises a liquid, for example a liquid hydrogel (Paragraph, 0127: “electrodes, such as electrodes 116, 117, and 118, may be of a dry, noncontact (or capacitive), viscous gel, structurally durable hydrogel, adhesive gel, conductive paste, saline or other variety. Electrodes may further be formulated without adhesive for use in pressure bearing electrode location”).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, and “Cimenser” (US 20180188807 A1)
Regarding claim 2, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Claim 2, Nahum does not teach wherein the first electrode is a frontal electrode, for placement on the frontal region of the person’s scalp, and wherein the second electrode is a parietal electrode, for placement on the parietal region of the person’s scalp, for example on the crown.
Cimenser teaches “wherein the first electrode is a frontal electrode, for placement on the frontal region of the person’s scalp, and wherein the second electrode is a parietal electrode, for placement on the parietal region of the person’s scalp, for example on the crown (Paragraph, 0034: “EEG interfaces 228 may include frontal, central, and parietal EEG electrodes, among other suitable electrode locations.” and “The electrodes typically penetrate the hair of the human subject to contact the scalp or skin at respective locations relative to the head”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Cimenser because both Nahum and Shu are directed to EEG electrode systems for placement on a subject’s scalp, and Cimenser positions electrodes at frontal and parietal scalp regions for acquiring EEG signals at respective locations relative to head (Cimenser 0034), which would have enabled acquisition of EEG signals from spatially distinct brain regions while maintaining effective scalp contact and since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C)”.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, and “Hegde” (US 20110295100 A1)
Regarding claim 4, Nahum in view of Shu teaches the electrode carrier according to claim 3, (See rejection of claim 3 above),
Claim 4, Nahum teaches “wherein the transmission improvement means” (Paragraph, 0126: “Conductive medium 272 may be of any conductive, biologically compatible variety. Where used over the predominantly hair bearing region of the scalp, biocompatible adhesive 276 is formulated to optimize the properties of ease of removal from hair and system stabilization.”, and Paragraph, 0127: “Dry, non-contact, and other electrode varieties may include protrusions, depressible or otherwise, to facilitate contact on the skin or through hair”). However, Nahum is silent on “comprise tines for shallow penetration in the person’s scalp, for example the stratum corneum of the person’s skin.”.
Hegde teaches “comprise tines for shallow penetration in the person’s scalp, for example the stratum corneum of the person’s skin.” (Abstract: “Novelty-The method involves applying microneedle electrode (20) to subject's skin by placing microneedle electrode in direct contact with skin. The microneedles (28) of microneedle electrode are inserted into skin such that microneedles pierce stratum corneum of skin upto dermis of skin. An electrical signal is allowed to pass through microneedle electrode where impedance of microneedle is less than 10 ohms. method of enhancing physiological signal detection through subject skin using microelectrode needle.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Hegde to incorporate Hegde’s microneedles as the claimed tines for shallow penetration because both Nahum and Hegde are directed to EEG electrode systems for placement on a subject’s scalp, and Hegde teaches that microneedles piercing the stratum corneum provide good electrode-tissue contact, maintain good electrical contact, reduce impedance, and enhance conductivity of electrical signals and physiological signal detection through a subject’s skin (Hegde, Paragraph, 0007,0008, and 0010).
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu and Pal (JP 2016526447 A)
Regarding claim 6, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Nahum does not teach wherein at least one of the electrodes, for example the first electrode comprises a flexible matrix, such as a sponge, for holding the non-adhesive conductive medium.
Pal teaches wherein at least one of the electrodes, for example the first electrode comprises a flexible matrix (sponge), such as a sponge, for holding the non-adhesive conductive medium (sponge soaked in saline) (Paragraph, 0076: “this can be achieved by non-adhesive electrodes (e.g., sponges soaked in saline) that are held in low impedance contact with the subject's skin”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Pal to incorporate Pal’s sponge-based flexible matrix into Nahum electrode systems because Pal teaches a non-adhesive electrode comprising a sponge soaked in saline that is held in low impedance contact with the subject’s skin (Pal, Paragraph, 0076), thereby providing a flexible matrix for retaining the conductive medium while maintaining reliable electrical coupling between the electrode and the subject’s skin.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu and “Marro” (US20020019588 A1)
Regarding claim 7, Nahum in view of Shu teaches the electrode carrier according to claim 3, (See rejection of claim 3 above),
Nahum does not teach wherein the transmission improvement means, for example the tines, protrude through the flexible matrix.
Marro teaches wherein the transmission improvement means (Volcano tips 44), for example the tines, protrude through the flexible matrix (open-cell foam 42 with hydrogel 43) (Fig. 3A illustrates the transmission improvement means (Volcano tips 44) protrude flexible matrix (open-cell foam 42 with hydrogel 43), and Abstract: “acquiring EEG signals from a patient's head applied solely to the patient's forehead comprising a frontal array of hydrogel electrodes.”, “The electrodes further comprise a retaining mechanism and internal volcano tips”, and Paragraph, 0027: “Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to incorporate Marro’s transmission improvement means (volcano tips 44) in combination with Marro’s flexible matrix comprising open-cell foam 42 impregnated with conductive hydrogel 43, as illustrated in Fig. 3A, because Marro teaches that the volcano tips provide improved electrical contact and lower contact impedance (Abstract, lines 9-11). Such modification would have improved electrical coupling between the electrode and the subject’s scalp during physiological signal acquisition.
Regarding claim 8, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Nahum does not teach “further comprising an adhesive pad for the first electrode, at least partially surrounding the first electrode, for securing the placement of the first electrode on the person’s scalp.”. However, Marro teaches “further comprising an adhesive pad (resilient foam material 41) for the first electrode (Stiff volcano tips 44), at least partially surrounding the first electrode (Paragraph, 0027: “Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43.In the most preferred embodiment, this open cell foam element additionally comprises relatively stiff volcano tips 44”), for securing the placement of the first electrode on the person’s scalp (Paragraph, 0027: “a typical electrode 40 comprises an element of resilient foam material 41, adhesive on the side proximal to the patient, generally in the shape of an annulus.”)”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to incorporate Marro’s adhesive pad comprising resilient foam material 41 because Marro teaches that a resilient foam material that is adhesive on the side proximal to the patient and surround the electrode region (Marro, Paragraph, 0027). Such modification would have help maintain placement of the electrode assembly on the patient’s scalp and reduce unintended movement of the electrode during physiological signal monitoring.
Regarding claim 9, Nahum in view of Shu and Marro teaches the electrode carrier according to claim 8, (See rejection of claim 8 above),
Nahum does not teach wherein the adhesive pad is attached to the substrate and fully surrounds the respective electrode.
Marro teaches wherein the adhesive pad (resilient foam material 41) is attached to the substrate (flexible substrate 31) and fully surrounds the respective electrode (Stiff volcano tips 44) (Paragraph, 0027: ”a typical electrode 40 comprises an element of resilient foam material 41, adhesive on the side proximal to the patient, generally in the shape of an annulus.”, “ Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43.In the most preferred embodiment, this open cell foam element additionally comprises relatively stiff volcano tips 44”, and Fig. 3A illustrates Stiff volcano tips 44 (a part of typical electrode) surrounded by resilient foam material 41 and open cell form 42 integrated with conductive hydrogel 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to incorporate Marro’s adhesive pad comprising resilient foam material 41 because Marro teaches that a resilient foam material that is adhesive on the side proximal to the patient and surround the electrode region (Marro, Paragraph, 0027). Such modification would have help maintain placement of the electrode assembly on the patient’s scalp and reduce unintended movement of the electrode during physiological signal monitoring.
Regarding claim 10, Nahum in view of Shu and Marro teaches the electrode carrier according to claim 8, (See rejection of claim 8 above),
Nahum does not teach wherein the adhesive pad comprises an adhesive foam pad.
Marro teaches wherein the adhesive pad comprises an adhesive foam pad (Paragraph, 0027: “, as shown in FIG. 3A, a typical electrode 40 comprises an element of resilient foam material 41, adhesive on the side proximal to the patient, generally in the shape of an annulus. Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to incorporate Marro’s adhesive pad comprising resilient foam material 41 because Marro teaches that a resilient foam material that is adhesive on the side proximal to the patient and surround the electrode region (Marro, Paragraph, 0027). Such modification would have help maintain placement of the electrode assembly on the patient’s scalp and reduce unintended movement of the electrode during physiological signal monitoring.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, and “Porter” (US 20200030597 A1)
Regarding claim 11, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Nahum does not teach wherein the adhesive conductive medium comprises a substantially solid medium, for example a solid hydrogel.
Porter teaches wherein the adhesive conductive medium comprises a substantially solid medium, for example a solid hydrogel (Paragraph, 0020: “the approach discussed herein is equally applicable to many other areas that utilize electrodes 10, including functional electrical stimulation (FES), electrocardiography (ECG), electroencephalography (EEG) or electrical impedance tomography (EIT), among others.”, Paragraph, 0048: “Types of hydrogel that may be utilized with the invention”, Paragraph, 0049: “PROMEON Gel is a hi-tack gel”, Paragraph, 0008: “Electrode pads containing a hydrogel are easy to apply and remove. The hydrogel has adhesive properties that allows the pad to stick to the skin but be easily removed and replaced for multiple applications. Hydrogels are beneficial because they distribute the current from the TENS device well.”, and Paragraph, 0007: “Electrode pads are a required part of an electrode to have proper skin contact during periods of electrical stimulation. To enhance skin contact and comfort, carbon, silver or silver chloride electrodes may be used in combination with liquid or solid hydrogel as a medium between the skin and electrode.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Porter to incorporate Porter’s adhesive solid conductive medium consisting a solid hydrogel because Porter’s solid hydrogel teaches a hydrogel having adhesive properties that allow an electrode pad to adhere to a subject’s skin while remaining removable and replaceable (Porter, Paragraph, 0008), and further uses a solid hydrogel as a medium between the skin and the electrode (Porter, Paragraph, 0007), thereby maintaining proper skin contact while allowing convenient removal and replacement of the electrode pad (Porter, paragraph, 0008).
Regarding claim 12, Nahum in view of Shu and Porter teaches the electrode carrier according to claim 11, (See rejection of claim 11 above),
Nahum does not teach wherein the solid medium has an adhesive tack larger than 8.5 grams/mm to stainless steel, measured according to the PSTC- 5 test method.
Porter teaches wherein the solid medium has an adhesive tack larger than 8.5 grams/mm to stainless steel, measured according to the PSTC- 5 test method (Paragraph, 0020: “the approach discussed herein is equally applicable to many other areas that utilize electrodes 10, including functional electrical stimulation (FES), electrocardiography (ECG), electroencephalography (EEG)”, Paragraph, 0007 “Electrode pads are a required part of an electrode to have proper skin contact during periods of electrical stimulation. To enhance skin contact and comfort, carbon, silver or silver chloride electrodes may be used in combination with liquid or solid hydrogel as a medium between the skin and electrode”, Paragraph, 0049: “Types of hydrogels that may be utilized with the invention”, “PROMEON Gel is a hi-tack gel”. Its adhesion level is 220 grams/in minimum to stainless steel using the PSTC-5 Test method. It is typically non-sensitizing. Another PROMEON Gel has an adhesion strength of 240 grams/in minimum to Stainless steel as measured by PSTC-5 TEST method.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Porter to incorporate Porter’s solid medium consisting an adhesive tack having a specific adhesion level because Porter’s solid medium consisting adhesive tack (hi-tack hydrogel) exhibits an adhesion level of at least 220 grams/in (analogous to 8.6 grams/mm) to stainless steel as measured according to the PSTC-5 test method (Porter, Paragraph, 0049). Such modification would have provided enhanced adhesive retention and maintained secure attachment of the electrode assembly during physiological signal acquisition.
Regarding claim 13, Nahum in view of Shu teaches the electrode carrier according to claim 1, (See rejection of claim 1 above),
Nahum does not teach wherein the substrate comprises adhesive anchors for attaching the substrate to a side part of the person’s scalp, the adhesive anchors preferably comprising a substantially solid medium, for example a solid hydrogel.
Porter teaches wherein the substrate (the electrode substrate) comprises adhesive anchors (Paragraph, 0008:” Electrode pads containing a hydrogel are easy to apply and remove. The hydrogel has adhesive properties that allows the pad to stick to the skin but be easily removed and replaced for multiple applications. Hydrogels are beneficial because they distribute the current from the TENS device well.”) for attaching the substrate to a side part of the person’s scalp (Paragraph, 0007: “A skin-compatible adhesive is provided on the skin-side of the electrode substrate for adhering the device to the patient's skin.”, and Paragraph, 0002: “electrodes connected to or integrated within an EEG machine are placed along the scalp for detecting electricity produced by the brain”; Paragraphs 0042-0045),
the adhesive anchors preferably comprising a substantially solid medium, for example a solid hydrogel” (Paragraph, 0007: “Electrode pads are a required part of an electrode to have proper skin contact during periods of electrical stimulation. To enhance skin contact and comfort, carbon, silver or silver chloride electrodes may be used in combination with liquid or solid hydrogel as a medium between the skin and electrode”, Paragraph, 0008: “Electrode pads containing a hydrogel are easy to apply and remove. The hydrogel has adhesive properties that allows the pad to stick to the skin but be easily removed and replaced for multiple application”, and Paragraph, 0049: “PROMEON Gel is a hi-tack gel”, “Its adhesion level is 220 grams/in minimum to stainless steel using the PSTC-5 Test method.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Porter to incorporate Porter’s adhesive anchors comprising a solid medium (solid hydrogel) because hydrogel electrode pads have adhesive properties that allow the pad to stick to the skin while being removed easily and replaced (Porter, Paragraph, 0008), and further hydrogel may be used as a medium between the skin and electrode to provide proper skin contact (Porter, Paragraph, 00007). Such modification would have allowed the electrode substrate to adhere to the subject’s scalp with maintaining proper skin contact and permitting removal and replacement of the electrode pad (Porter, Paragraph, 0007-0008).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu and Souhoka (WO 2018115349 A1)
Regarding claim 14,
Nahum teaches A method of performing electroencephalography (EEG) measurements (Paragraph, 0002: “Electroencephalography (EEG) is a measure of the time varying electrical potentials of the brain as distributed over extracranial skin surfaces. EEG systems amplify, record, process, and display brain electrical potentials and, often in support of this, auricular (ear), ocular (eye), and muscle electrical potentials. The EEG interface to the subject typically consists of multiple discrete electrodes that assist in converting differential surface potentials into a signal of electrical form”; Paragraph 0039),
Providing an electrode carrier according to any of the preceding claims (SEE REJECTION OF CLAIM 1 ABOVE)
placing the second electrode on a region of the person’s scalp that is typically substantially covered with hair (To be consistent with rejection of claim 1 above, the claim limitation modified from “free of hair” into “with hair”, and see 112(b) rejection above) (Nahum, Paragraph, 0126: “Where used over the predominantly hair bearing region of the scalp, biocompatible adhesive 276 is formulated to optimize the properties of ease of removal from hair and system stabilization.”, Paragraph, 0127: “other electrode varieties may include protrusions, depressible or otherwise, to facilitate contact on the skin or through hair. In lieu of or in addition to electrodes 116, 117, 118 or electrode assemblies 110, 111”)
mechanically adhering and electrically contacting the person’s scalp with the second electrode, via the adhesive conductive medium (Nahum, Paragraph, 0126: “Conductive medium 272 may be of any conductive, biologically compatible variety”, “biocompatible adhesive 276 is formulated to optimize the properties of ease of removal from hair and system stabilization”),
placing the first electrode on a region of the person’s scalp that is typically substantially free of hair, (To be consistent with rejection of claim 1 above, the claim limitation modified from “with hair” into “free of hair”, and see 112(b) rejection above) (Nahum, Paragraph, 0126: “Where used over relatively hair free regions, biocompatible adhesive 276 may be of a different formulation, such as one that optimizes properties of skin adhesion and ease of removal from skin.”),
electrically contacting the person’s scalp with the first electrode, via the non-adhesive conductive medium (Nahum, Paragraph, 0127: “Electrodes may further be formulated without adhesive for use in pressure bearing electrode locations.”, “electrodes, such as electrodes 116, 117, and 118, may be of a dry, noncontact (or capacitive), viscous gel, structurally durable hydrogel,”) and
recording signals representative of brain activity from the first and second electrodes (Nahum, Paragraph, 0002: “Electroencephalography (EEG) is a measure of the time varying electrical potentials of the brain as distributed over extracranial skin surfaces. EEG systems amplify, record, process, and display brain electrical potentials and, often in support of this, auricular (ear), ocular (eye), and muscle electrical potentials. The EEG interface to the subject typically consists of multiple discrete electrodes that assist in converting differential surface potentials into a signal of electrical form”).
Nahum does not teach, i.e. for determining a parameter which is indicative for whether a person has acute encephalopathy and/or a delirium or not, or is at risk of becoming encephalopathic and/or delirious or not, or is at risk of becoming encephalopathic and/or delirious or not,
Souhoka teaches, i.e. for determining a parameter which is indicative for whether a person has acute encephalopathy and/or a delirium or not, or is at risk of becoming encephalopathic and/or delirious or not (Page 3, background, lines 14-15: “An example of EEG monitoring can be monitoring a subject for the occurrence of a delirium, epilepsy episode or similar deviation”, and Page 3, background, lines 25-26: “In delirium detection, for 25 example, three electrodes may suffice, e.g. two frontal electrodes attached to the forehead and one attached to the back of the head.”), the method comprising the steps of:
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Souhoka to employ EEG monitoring for evaluate delirium-related neurological conditions because Souhoka’s EEG monitoring can detect delirium or other abnormalities in brain activity and that EEG electrodes are placed on the subject’s skin/scalp to measure electrical activity of the brain (Page3, background, lines 14-15, 21-23, and 25-26). Such modification would have enabled detection of abnormal brain activity associated with delirium conditions.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, Souhoka, and Marro
Regarding claim 15, Nahum in view of Shu and Houhoka teaches the electrode carrier according to claim 14, (See rejection of claim 14 above),
Nahum teach “the first electrode on the person’s scalp” (Paragraph, 0127: “other electrode varieties may include protrusions, depressible or otherwise, to facilitate contact on the skin or through hair. In lieu of or in addition to electrodes 116, 117, 118 or electrode assemblies 110, 111”). However, Nahum is silent on both “further comprising the step of securing“ and “with the adhesive pad”.
Marro teaches “further comprising the step of securing” and “with the adhesive pad (resilient foam material 41) (Paragraph, 0027: “a typical electrode 40 comprises an element of resilient foam material 41, adhesive on the side proximal to the patient, generally in the shape of an annulus.”, “Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43.In the most preferred embodiment, this open cell foam element additionally comprises relatively stiff volcano tips 44”, Figure 3A illustrates Stiff volcano tips 44 (a part of typical electrode) surrounded by resilient foam material 41 and open cell form 42 integrated with conductive hydrogel 43, and Abstract: “A medical appliance for acquiring EEG signals from a patient's head applied solely to the patient's forehead comprising a frontal array of hydrogel electrodes.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to secure the first electrode on the person’s scalp using an adhesive pad because Marro’s adhesive foam element positioned on the patient-facing side of an EEG electrode assembly for adhering the electrode assembly to the patient (Marro, Paragraph, 0027). Such modification would have maintained the electrode in a desired position on the patient’s calp and reduce unintended electrode movement during EEG monitoring.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, Cimemser and Hegde.
Regarding claim 16, Nahum in view of Shu and Cimenser teaches the electrode carrier according to claim 2, (See rejection of claim 2 above),
Nahum teaches wherein at least one of the electrodes, for example the frontal electrode further comprises transmission improvement means for improving the transmission of EEG signals from the person’s brain, i.e. underneath the skin, towards the electrode (Paragraph, 0126: “Conductive medium 272 may be of any conductive, biologically compatible variety. Where used over the predominantly hair bearing region of the scalp, biocompatible adhesive 276 is formulated to optimize the properties of ease of removal from hair and system stabilization.”, and Paragraph, 0127: “Dry, non-contact, and other electrode varieties may include protrusions, depressible or otherwise, to facilitate contact on the skin or through hair”). However, Nahum is silent on wherein the transmission improvement means comprise tines for shallow penetration in the person’s scalp, for example the stratum corneum of the person’s skin.
Hegde teaches wherein the transmission improvement means comprise tines for shallow penetration in the person’s scalp, for example the stratum corneum of the person’s skin (Abstract: “Novelty-The method involves applying microneedle electrode (20) to subject's skin by placing microneedle electrode in direct contact with skin. The microneedles (28) of microneedle electrode are inserted into skin such that microneedles pierce stratum corneum of skin upto dermis of skin. An electrical signal is allowed to pass through microneedle electrode where impedance of microneedle is less than 10 ohms. method of enhancing physiological signal detection through subject skin using microelectrode needle.”, and Paragraph, 0074: “The microneedles may be inserted into the patient's skin such that one or more microneedles pierce or penetrate the stratum corneum of the skin up to or through the dermis of the skin.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Hegde to incorporate Hegde’s microneedles as the claimed tines for shallow penetration because both Nahum and Hegde are directed to EEG electrode systems for placement on a subject’s scalp, and Hegde teaches that microneedles piercing the stratum corneum provide good electrode-tissue contact, maintain good electrical contact, reduce impedance, and enhance conductivity of electrical signals and physiological signal detection through a subject’s skin (Hegde, Paragraph, 0007,0008, and 0010).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, Cimemser, Hegde., and Pal
Regarding claim 17, Nahum in view of Shu, Cimenser and Hegde teaches the electrode carrier according to claim 16, (See rejection of claim 16 above),
Nahum does not teach wherein the non-adhesive conductive medium of the first electrode comprises a liquid, for example a liquid hydrogel, and wherein at least one of the electrodes, for example the first electrode comprises a flexible matrix, such as a sponge, for holding the non-adhesive conductive medium.
Pal teaches wherein the non-adhesive conductive medium of the first electrode comprises a liquid, for example a liquid hydrogel and wherein at least one of the electrodes, for example the first electrode comprises a flexible matrix, such as a sponge, for holding the non-adhesive conductive medium. (Paragraph, 0076: “this can be achieved by non-adhesive electrodes (e.g., sponges soaked in saline) that are held in low impedance contact with the subject's skin by an adhesive (e.g., a sponge soaked in saline), or a combination of adhesive and non-adhesive electrodes,”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Pal to incorporate a non-adhesive conductive medium and a flexible matrix for holding the non-adhesive conductive medium because such incorporation of non-adhesive electrodes comprising sponge soaked in saline would provide low-impedance contact with the subject’s skin (Paragraph, 0076). Such modification would provide reliable electrical coupling between the electrode and the skin and maintain low-impedance skin contact for improved signal acquisition.
Claim 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, Cimenser, Hegde, Pal, and Marro.
Regarding claim 18, Nahum in view of Shu, Cimenser, Hegde, and Pal teaches the electrode carrier according to claim 17, (See rejection of claim 17 above),
Nahum does not teach wherein the transmission improvement means, for example the tines, protrude through the flexible matrix, and further comprising an adhesive pad for the first electrode, at least partially surrounding the first electrode, for securing the placement of the first electrode on the person’s scalp.
Marro teaches wherein the transmission improvement means (Volcano tips 44), for example the tines, protrude through the flexible matrix (open-cell foam 42 with hydrogel 43) (Fig. 3A illustrates the transmission improvement means (Volcano tips 44) protrude flexible matrix (open-cell foam 42 with hydrogel 43), and Abstract: “acquiring EEG signals from a patient's head applied solely to the patient's forehead comprising a frontal array of hydrogel electrodes.”, “The electrodes further comprise a retaining mechanism and internal volcano tips”, and Paragraph, 0027: “Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43.”).
Marro teaches “further comprising an adhesive pad (resilient foam material 41) for the first electrode (Stiff volcano tips 44), at least partially surrounding the first electrode (Paragraph, 0027: “Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43. In the most preferred embodiment, this open cell foam element additionally comprises relatively stiff volcano tips 44”), for securing the placement of the first electrode on the person’s scalp (Paragraph, 0027: “a typical electrode 40 comprises an element of resilient foam material 41, adhesive on the side proximal to the patient, generally in the shape of an annulus.”)”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to incorporate Marro’s transmission improvement means (volcano tips 44) in combination with Marro’s flexible matrix comprising open-cell foam 42 impregnated with conductive hydrogel 43, as illustrated in Fig. 3A, because Marro teaches that the volcano tips provide improved electrical contact and lower contact impedance (Abstract, lines 9-11). Such modification would have improved electrical coupling between the electrode and the subject’s scalp during physiological signal acquisition.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro to incorporate Marro’s adhesive pad comprising resilient foam material 41 because Marro teaches that a resilient foam material that is adhesive on the side proximal to the patient and surround the electrode region (Marro, Paragraph, 0027). Such modification would have help maintain placement of the electrode assembly on the patient’s scalp and reduce unintended movement of the electrode during physiological signal monitoring.
Regarding claim 19, Nahum in view of Shu, Cimenser, Pal and Hegde teach the electrode carrier according to claim 18, (See rejection of claim 18 above),
Nahum does not teach wherein the adhesive pad is attached to the substrate and fully surrounds the respective electrode, and wherein the adhesive pad comprises an adhesive foam pad.
Marrow teaches wherein the adhesive pad (resilient foam material 41) is attached to the substrate (flexible substrate 31) and fully surrounds the respective electrode (Paragraph, 0027: “a typical electrode 40 comprises an element of resilient foam material 41, adhesive on the side proximal to the patient, generally in the shape of an annulus. Inside the annular adhesive foam 41 is an element of open cell foam 42”, and Fig. 3A illustrates the resilient foam material 41 is attached to the flexible substrate 31), and wherein the adhesive pad comprises an adhesive foam pad (Paragraph, 0027: “Inside the annular adhesive foam 41 is an element of open cell foam 42 impregnated with conductive hydrogel 43” and Paragraph, 0029: “shown in FIG. 3B, the annular adhesive foam pad 41′”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Marro because Marro to incorporate an adhesive foam pad (resilient foam material) attached to the substrate and surrounding the electrode because Marrow teaches an annular adhesive foam surrounding the electrode structure (Marrow 0027; Fig. 3A) and further teaches an annular adhesive foam pad (Marrow, 0029). Such modification would have provided secure attachment of the electrode assembly to the patient while maintaining the conductive portion in contact with the patient, thereby helping maintain stable electrode positioning during physiological signal monitoring.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nahum in view of Shu, Cimenser, Hegde, Pal, Marro and in further view of Porter.
Regarding claim 20, Nahum in view of Shu, Cimenser, Hegde, Pal, and Marro teach the electrode carrier according to claim 19, (See rejection of claim 19 above),
Nahum does not teach wherein the adhesive conductive medium comprises a substantially solid medium, for example a solid hydrogel, wherein the solid medium has an adhesive tack larger than 8.5 grams/mm to stainless steel, measured according to the PSTC- 5 test method, and wherein the substrate comprises adhesive anchors for attaching the substrate to a side part of the person’s scalp, the adhesive anchors preferably comprising a substantially solid medium, for example a solid hydrogel.
Porter teaches wherein the adhesive conductive medium comprises a substantially solid medium, for example a solid hydrogel (Paragraph, 0048: “re known by the brand names PROMEON and COMFORT Hydrogels” and Paragraph, 0049: “PROMEON Gel is a hi-tack gel”, “Its adhesion level is 220 grams/in minimum”), “wherein the solid medium has an adhesive tack larger than 8.5 grams/mm to stainless steel, measured according to the PSTC- 5 test method” and “preferably comprising a substantially solid medium, for example a solid hydrogel.” (Paragraph, 0049: “PROMEON Gel is a hi-tack gel”, “Its adhesion level is 220 grams/in minimum to stainless steel using the PSTC-5 Test method. It is typically non-sensitizing. Another PROMEON Gel has an adhesion strength of 240 grams/in minimum to Stainless steel as measured by PSTC-5 TEST method.”) and
Porter teaches wherein the substrate (the electrode substrate) comprises adhesive anchors (Paragraph, 0008:” Electrode pads containing a hydrogel are easy to apply and remove. The hydrogel has adhesive properties that allows the pad to stick to the skin but be easily removed and replaced for multiple applications. Hydrogels are beneficial because they distribute the current from the TENS device well.”) for attaching the substrate to a side part of the person’s scalp (Paragraph, 0007: “A skin-compatible adhesive is provided on the skin-side of the electrode substrate for adhering the device to the patient's skin.”, and Paragraph, 0002: “electrodes connected to or integrated within an EEG machine are placed along the scalp for detecting electricity produced by the brain”; Paragraphs 0042-0045),
the adhesive anchors preferably comprising a substantially solid medium, for example a solid hydrogel” (Paragraph, 0007: “Electrode pads are a required part of an electrode to have proper skin contact during periods of electrical stimulation. To enhance skin contact and comfort, carbon, silver or silver chloride electrodes may be used in combination with liquid or solid hydrogel as a medium between the skin and electrode”, Paragraph, 0008: “Electrode pads containing a hydrogel are easy to apply and remove. The hydrogel has adhesive properties that allows the pad to stick to the skin but be easily removed and replaced for multiple application”, and Paragraph, 0049: “PROMEON Gel is a hi-tack gel”, “Its adhesion level is 220 grams/in minimum to stainless steel using the PSTC-5 Test method.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nahum with Porter to incorporate Porter’s adhesive anchors comprising a solid medium (solid hydrogel) because hydrogel electrode pads have adhesive properties that allow the pad to stick to the skin while being removed easily and replaced (Porter, Paragraph, 0008), and further hydrogel may be used as a medium between the skin and electrode to provide proper skin contact (Porter, Paragraph, 00007). Such modification would have allowed the electrode substrate to adhere to the subject’s scalp with maintaining proper skin contact and permitting removal and replacement of the electrode pad (Porter, Paragraph, 0007-0008).
Conclusion
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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