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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed provisional applications, Application No. 63/010,040 and 63/010,042, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 15 recites “when the change exceeds a threshold value, delivering a second type of therapy that is different from the first type of therapy; and if the change does not exceed the threshold value, continuing to deliver the first type of therapy” in lines 16-18. However, the provisional applications do not provide adequate support for the above limitation because they are completely silent regarding a threshold value for a change in ERP peaks. Claims 16-20 do not have adequate support by virtue of their dependence from claim 15. Therefore, the priority date of claims 15-20 are 04/13/2021.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20, line 3: –the– should be inserted in front of “images”.
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.
No limitations were interpreted under 35 U.S.C. 112(f).
The Examiner notes that “pleasantness aspect” in claim 16 and “affective pleasantness” in claim 18 are being interpreted to correspond to an affective valence, as indicated in ¶¶ [0054], [0057], [0065], [0111] of the specification.
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.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “intermediate-treatment” in line 13. There is no plain and ordinary meaning for the term, the specification and claim do not clearly define the term, and one of ordinary skill would not be able to ascertain the meaning of the term. Therefore, it is unclear what the term means and how it should be interpreted. For the purposes of examination, the recitation will be interpreted to be “mid-treatment”.
Claims 16-20 are rejected by virtue of their dependence from claim 15
Claim 16 recites “quantifying the extracted ERP peaks with affect-related measures having a pleasantness aspect and intensity aspect” in lines 4-5. It is unclear what it means to quantify ERP peaks with affect-related measures. The specification does not provide clarification.
Claim 17 recites “affective measures” in line 2. Claim 16 recites “affect-related measures” in line 4. It is unclear if these recitations are the same as, related to, or different from each other. If they are the same, consistent terminology should be used. If they are related or different from each other, the relationship should be made clear (e.g., using modifiers like “first” and “second”). For the purposes of examination, the recitation in claim 17 will be interpreted to be “the affect-related measures”.
Claim 17 recites “quantifying the extracted ERP peaks with affective measures comprises determining the extracted ERP peaks are above a first threshold or below a second threshold” in lines 1-3. It is unclear how ERP peaks are quantified using thresholds. Quantifying means determining, expressing, or measuring the quantity of something. However, comparison of a peak with threshold does not amount to measuring the quantity of the peak. The specification does not provide clarification. For the purposes of examination, the claim will be interpreted to recite “The method of claim 16, comprising determining whether the extracted ERP peaks are above a first threshold or below a second threshold”.
Claim 18 is rejected by virtue of its dependence from claim 17.
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 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0118618 A1 (John) in view of Electrophysiological indices of biased cognitive processing of substance-related cues: A meta-analysis (Littel) and US 2021/0110924 A1 (Tkach).
With regards to claim 15, John teaches a method of treating a user for an addictive or motivational salience disorder (¶ [0001] discloses using a system for evaluating and treating pathologies of the brain; ¶ [0004] and Fig. 3 disclose a method; ¶ [0040] discloses detecting warning signs of incipient problems or utilization of substances of abuse (e.g., marijuana or cocaine abuse in adolescence)), the method comprising: displaying to the user first visual stimuli (¶ [0004] and Fig. 3 disclose obtaining a baseline measurement; ¶ [0024] discloses providing visual stimuli for the determination of event related potential (ERP) data including P300 data); capturing from the user, with a portable electroencephalographic (EEG) headset and in a time-synchronized manner relative to displaying the first visual stimuli, a set of baseline event-related potential (ERP) peaks associated with the first visual stimuli (¶ [0004] and Fig. 3 disclose obtaining a baseline measurement; Fig. 1 and ¶ [0012] disclose a docking station 1 which may be portable or substantially stationary and is for performing baseline ERP measurements; ¶ [0024] discloses baseline measurements include extracted cognitive ERP; ¶¶ [0024]-[0026] discloses the ERP data comprising a series of about 100 numbers and being time-synchronized relative to the stimuli); delivering a first type of therapy to the user (Claim 13 discloses determining an effectiveness of one of a medical and a neurological treatment by comparing baseline and a second measurement, which indicates that a treatment is delivered after the baseline; ¶ [0040] discloses determining an administered dosage of psychoactive medicine or across multiple sessions for establishing a dose response curve for optimization of dosage); subsequent to delivering the first type of therapy for a period of time (There is necessarily a period of time during which the treatment is delivered), displaying to the user second visual stimuli (¶ [0025] discloses subsequent measurements of ERP using stimuli that is matched as closely as possible to the stimuli used to establish the baseline ERP data); capturing from the user, with the portable EEG headset and in a time-synchronized manner relative to displaying the second sequence of images, a set of intermediate-treatment ERP peaks associated with the second sequence of images (Fig. 3 and ¶¶ [0025], [0031] discloses determining subsequent measurements of ERP data; ¶ [0040] indicate that the subsequent measurements may be mid-treatment measurements); determining a change of the intermediate-treatment ERP peaks relative to the baseline ERP peaks (¶ [0032] discloses detecting differences between the baseline and subsequent data, wherein the differences in the amplitudes of the peaks of the data may be determined)
John is silent regarding whether the first visual stimuli is a first sequence of images, the second visual stimuli is a second sequence of images.
In a system relevant to the problem of providing stimuli for determining ERP peaks, Littel teaches providing a sequence of images for determining ERP responses (Paragraphs 2-6 of 1.4 Enhancement of late ERP components indicate motivated attention for substance cues in SUD populations depict presenting substance-related and neutral pictures for stimulating ERP (P300) responses). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first and second visual stimuli of John with the sequence of images of Littel. Because both stimuli are capable of stimulating ERP peaks, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding when the change exceeds a threshold value, delivering a second type of therapy that is different than the first type of therapy; and if the change does not exceed the threshold value, continuing to deliver the first type of therapy.
In a system relevant to the problem of treating a patient, Tkach teaches determining a change between baseline and subsequent data (Fig. 6 and ¶¶ [0105]-[0106] depict providing a baseline sample at step 600, receiving subsequent data at step 605, and determining a variance between the two at step 610), and when the change exceeds a threshold value, delivering a second type of therapy that is different than the first type of therapy (Fig. 6 and ¶ [0107] discloses these variances are checked against thresholds outlined from the collective database to note whether variances meet threshold level established indicating a change in treatment approach is recommended based on correlations with subsequent treatment events as common in the larger data population (Step 655); Fig. 6 and ¶ [0107] depict providing the treatment at 685); and if the change does not exceed the threshold value, continuing to deliver the first type of therapy (Fig. 6 and ¶ [0107] discloses that if these variances do not meet the threshold, then these variances are still documented in the personal and collective databases in order to reference against later in instances with subsequent treatment events (Step 660) with no suggestions made for adjustment to treatment made by this process; Fig. 6 and ¶ [0107] depict providing the treatment at 685). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that when the change exceeds a threshold value, delivering a second type of therapy that is different than the first type of therapy; and if the change does not exceed the threshold value, continuing to deliver the first type of therapy as taught by Tkach. The motivation would have been to improve the treatment provided to the user.
With regards to claim 16, the above combination teaches or suggests that capturing either the baseline ERP peaks or the intermediate-treatment ERP peaks comprises (a) receiving EEG signals from the portable EEG headset, (b) extracting ERP peaks form the received EEG signals (¶¶ [0012]-[0014] of John depict processing EEG data from the portable docking station to arrive at the ERP data), and (c) quantifying the extracted ERP peaks with affect-related measures having a pleasantness aspect and intensity aspect (¶ [0032] of John discloses determining amplitudes of the peaks of the data. The ERP peak amplitudes are necessarily affect-related measures having a pleasantness aspect and intensity aspect–see Paragraph 2 of 1.3 Late ERP components: P300 and Slow Potential (SP) of Littel discloses that the P300 amplitude of the ERP is enhanced in response to pleasant and arousing pictures, thereby indicating that the amplitude of P300 is a quantification of pleasantness and intensity).
With regards to claim 19, the above combination teaches or suggests the first type of therapy comprises at least one of a pharmaceutical treatment therapy, psychological or behavior modification therapy, or neuromodulation treatment (¶ [0040] of John discloses an administered dosage of psychoactive medicine).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0118618 A1 (John) in view of Electrophysiological indices of biased cognitive processing of substance-related cues: A meta-analysis (Littel) and US 2021/0110924 A1 (Tkach), as applied to claim 16 above, and further in view of US 2022/0262269 A1 (De Letter)
With regards to claim 17 and in view of the rejection under 35 U.S.C. §112(b) above, the claim is being interpreted to recite “The method of claim 16, comprising determining whether the extracted ERP peaks are above a first threshold or below a second threshold”.
The above combination is silent regarding determining whether the extracted ERP peaks are above a first threshold or below a second threshold.
In a system relevant to the problem of quantifying ERPs for diagnosing patients, De Letter teaches determining whether the extracted ERP peaks are above a first threshold or below a second threshold (¶ [0064] discloses receiving evoked event-related potential data and comparing one or more of amplitude, latency or source with predetermined criteria, e.g., normative values; ¶ [0069] discloses determining if the values are within the normative values, which indicates that they are above a first threshold and below a second threshold). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate determining whether the extracted ERP peaks are above a first threshold or below a second threshold as taught by De Letter. The motivation would have been to provide a more complete diagnostic analysis of the patient by determining if the ERP is indicative of normative values.
With regards to claim 18, the above combination teaches or suggests at least one of the first threshold or second threshold corresponds to a population-level expected value that is determined based on a normative rating of affective pleasantness and intensity for a corresponding image (¶ [0075] of De Letter discloses the normative data is based on population-level expected values; ¶ [0069] of De Letter discloses using P300). The Examiner notes that the P300 parameter is a rating of affective pleasantness and intensity as evidenced by Paragraph 2 of 1.3 Late ERP components: P300 and Slow Potential (SP) of Littel, which discloses that the P300 amplitude of the ERP is enhanced in response to pleasant and arousing pictures, thereby indicating that the amplitude of P300 is a quantification of pleasantness and intensity. The normative P300 responses of De Letter are therefore normative ratings of affective pleasantness and intensity for a corresponding stimulus.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0118618 A1 (John) in view of Electrophysiological indices of biased cognitive processing of substance-related cues: A meta-analysis (Littel) and US 2021/0110924 A1 (Tkach), as applied to claim 19 above, and further in view of US 2016/0350509 A1 (Sharma).
With regards to claim 20, the above combination teaches or suggests determining affect-related measures of the user's physiological response to images in the first sequence or the second sequence (¶ [0024] of John discloses providing visual stimuli for the determination of event related potential (ERP) data including P300 data; Paragraph 2 of 1.3 Late ERP components: P300 and Slow Potential (SP) of Littel discloses that the P300 amplitude of the ERP is enhanced in response to pleasant and arousing pictures, thereby indicating that the amplitude of P300 is a quantification of pleasantness and intensity).
The above combination is silent regarding whether the second type of therapy comprises displaying to the user a report, graph, or chart of historical change in the measures.
In a system relevant to the problem of providing treatment to a patient, Sharma teaches displaying to the user a report, graph, or chart of historical change in the measures (¶ [0097] discloses displaying tracked parameters in a tabular and/or graphical format). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second therapy of the above combination to incorporate, based on the teachings of Sharma, displaying to the user a report, graph, or chart of historical change in the affect-related measures of the user's physiological response to images in the first sequence or the second sequence. The motivation would have been to make the patient aware of their progression, thereby providing the patient with a more complete diagnostic analysis.
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.
Claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 of U.S. Patent No. 12,343,157 B2 (“the ‘157 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the species of claims 13-16 of the ‘157 patent anticipates the genus of claims 15-20 of the application. See MPEP 804 (II) (B) (2).
The instant application 19/246,161 was filed as a divisional of application 17/229,861 (“the 861 application), which corresponds to the ‘157 patent. The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. However, MPEP 804.01 includes examples (E) and (G) regarding situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply. The examples (E) and (G) apply to this case for the following reasons.
In the ‘861 application, the restriction requirement of 08/10/2023 was between Group I, which corresponds to the systems of claims 1-14, and Group II, which corresponds the method of claims 15-20. Group I, claims 1-14, was elected in the response filed 09/28/2023. Claims 15-20 were cancelled with the claim amendments filed 05/01/2024. The subject matter of claims 13-16 of the ‘157 patent were presented in the claim amendments filed 01/17/2025 (see claims 21-24). However, the method of the claims 21-24 of the ‘861 application required all the limitations of the claimed products of claims 1 and 3 and were directed to the process of using the claimed products. Therefore, pursuant to the procedures set forth in MPEP § 821.04(B) , the method claims were treated as rejoined, the restriction requirement was withdrawn, and all the claims were subsequently examined. See example G of MPEP 804.01. Because the restriction requirement was withdrawn, the need for a divisional application and the need for the double patenting prohibition disappears. See example E of MPEP 804.01. Therefore, the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply.
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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