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 .
Claims 1-26 are the current claims hereby under examination.
Claim Interpretation - 35 USC § 112(f)
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 preAIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 11. 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:
Claim 1: The claim limitation “data collection module……for storage of data on non-transitory computer readable media” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “module” coupled with functional language “for storage of data …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phase “module,” such as the phrase “data collection.”
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. A review of the specification at paragraph [00017] describes wherein the data collection module includes patient-associated devices including a mobile device (e.g. smartphone or table), wearable device (e.g. smartwatch etc.), sounds system, blood pressure monitor, and facilitator mobile device, such as an app, etc.
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.
Claims 5 and 8 recite the limitations “ePRO, eCOA, EMA, ClinRO, and HER/EMR” wherein it is unclear as to exactly what these abbreviations are or what exactly these limitations are. The specification appears to repeat said abbreviations, but does not appear to specify what exactly they mean. Therefore, said abbreviations are deemed as unclear and indefinite. For examination purposes, they will be interpreted to read on forms of electronic patient data recordings. Clarification via clearer claim wording is required.
Claim 8 recites the limitations “said blood pressure monitor" and “said facilitator mobile device” in line 4. There is insufficient antecedent basis for these limitations in the claim. It is unclear as to what blood pressure monitor the limitation is referring. For examination purposes claim 8 will be interpreted as depending from claim 5 and thereby giving proper antecedent basis. Clarification via clearer claim wording is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites “where said data collection module includes a facilitator mobile device,” but depends from claim 2, which recites “wherein said data collection module includes a patient mobile device, at least one wearable device, a sound system, and a blood pressure monitor.” The wording of claim 4 does not appear to provide a further limiting limitation, but an alternative limitation to said data collection module. As such, it appears claim 4 fails to further limit claim 2 from which it depends. It is suggested that claim 4 be amended to recite “wherein said data collection module further includes.” For examination purposes claim 4 is being interpreted as the module further includes a facilitator mobile device. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 9-10, 11-12, 14-16, 20-23, and 25-26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Raz et al. US P/N 20210183519.
With regards to claims 1 and 9: Raz et al. describe at paragraphs [0048], [0061], and [0140] the administration of a consciousness altering therapy, which reads on the preamble. Raz et al. teach a server for storing data at paragraph [0133] and fig. 1, discloses the use of smartphones and the sensors of a smart wearable device like a watch at paragraph and blood pressure measurements at paragraph [0103], which together reads on a data collection module in electronic communication with network servers for storage of data on non-transitory computer readable media for monitoring a patient’s well being during and after the treatment session.
With regards to claims 2-3: Raz et al. teach the use of smartphones and the sensors of a smart wearable device like a watch at paragraphs [0103] – [0104] and [0138], which reads on wherein said data collection module includes a patient mobile device chosen from the group consisting of a smartphone and tablet and at least one wearable device chosen from the group consisting of a smart watch and a fitness band. Raz et al. teaching the use of smartphones inherently discloses a sound system as smartphones come with speakers. Raz et al. teach at paragraph [0103] blood pressure measurements, which reads on a blood pressure monitor.
With regards to claim 4: Raz et al. teach at paragraphs [0005], [0076], and [0102] a third party in connection with the above components, which reads on a facilitator mobile device in electronic communication with said patient mobile device, said at least one wearable device, said sound system, and said blood pressure monitor.
Raz et al. teach claims 6 at paragraph [0057], [0085]. and [0126]-[0127].
Raz et al. teach claim 10 at paragraph [0157] (e.g. panic attacks).
Raz et al. teach the ongoing monitoring of patients for risk and following treatment at paragraphs [0002-0004], [0041], [0100 – 0108] and throughout, reads on claim 11 at paragraphs [0129-0130].
Raz et al. teach claim 12 at paragraph [0044], [0094], [0124] [0130, dose], and [0111, time], and [0108, duration].
Raz et al. teach claim 14 at paragraph [0057], [0085]. and [0126]-[0127].
Raz et al. teach claim 15 at paragraphs [0111], [0143], and [0147].
Raz et al. teach claim 16 at paragraph [0137] in combination with the other cited paragraphs above.
Raz et al. teach claims 20-21 at paragraphs [0041], [0103], [0123], [0162] and [0164].
Raz et al. teach claim 22 at paragraphs [0018], [0100], and [0103].
Raz et al. teach claim 23 at paragraph [0048].
Raz et al. teach claim 25 at the combination of the cited paragraphs above and at paragraph [0157].
Raz et al. teach claim 26 at paragraph [0104].
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.
Claim(s) 5, 13, and 17-19 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. US P/N 20210183519 as applied to claim 4 above, and further in view of additional rationale.
Raz et al. teach claims 4 and 12 as described above.
With regards to limitations of claim 5: Raz et al. do not explicitly list ePRO, eCOA, EMA, ClinRO, and HER/EMR as different forms of electronic patient data recordings. However, Raz et al. do teach at paragraphs [0127] and [0133]-[0139] describe the system architecture that envisions all variations of storing patient data, such as video, audio, text, etc. and sharing that between provider, patient, and third parties and may also be HIPPA compliant etc. As such it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have understood that the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art.
With regards to limitations of claim 13, Raz et al. describe checking baseline data, but do not explicitly teach recording a conversation. Raz et al. teach at paragraph [0041] wherein a clinician may conduct an interview and at paragraph [0071] wherein audio is recorded. As such it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have understood that the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art.
With regards to limitations of claim 17: Raz et al. teach recording a number of the listed limitations throughout and specifically at paragraphs [0093] and [0100] – [0121]. With regards to any differences between what’s taught and the claimed invention, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have understood that the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art.
With regards to limitations of claim 18: Raz et al. teach post-session assessment at paragraphs [0012-0013], [0028, rest/sleep] [0047], [0103, heart rate, blood pressure] [0148-0149], [0155 -0159, evaluate anxiety/panic, which is interpreted as stress], and in combination with the above cited paragraphs. With regards to any differences between what’s taught and the claimed invention, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have understood that the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art.
Raz et al. teach claim 19 at paragraph [0029].
With regards to limitations of claim 24: Raz et al. do not explicitly teach monitoring multiple patients at the same time. However Raz et al. at paragraph [0153] and throughout describe applying the screening and evaluation to a patient population and to patients. There is nothing taught by Raz et al. that would suggest infrastructure that would not enable simultaneous monitoring of multiple patients as it is described in the figs and paragraphs to be capable of such. Therefore the differences between what’s taught and the claimed invention, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have understood that the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. US P/N 20210183519 as applied to claim 1 above, and further in view of Bhatwadekar et al. (US P/N 10789553).
Raz et al. teach claim 1 as described above.
With regards to limitations of claim 7: Raz et al. at the description of the system architecture at paragraphs [0133-0139] describe using popular database software such as SQL and Oracle, which are most often used to design relational databases and additionally using system that have external storage, such as cloud based computing. Raz et al. do not explicitly teach a system having a backend with API.
Bhatwadekar et al. describe at Fig. 15 (and col. 39, line 51 through col. 40, line 12) and Fig 38 (col. 50, line 65 through col. 51 line 30), and col. 28 lines43-48 a SQL architecture that uses an API backend environment that is deployable in a variety of sectors including healthcare management. As such it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have understood that the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. US P/N 20210183519 as applied to claim 5 (interpreted as depending from claim 5 as described under 112(b) rejection above, and further in view of Roche (WO 2018050763).
Raz et al. teach claim 5 as described above.
With regards to limitations of claim 8: Raz et al. teach collecting audio [0071], music (paragraph [0107]), motion and actigraphy using accelerometers, gyroscope, heart rate sensor and blood pressure sensors at paragraph [0103]. Raz et al. do not explicitly teach using a magnetometer as a sensor for collecting data.
Roche is analogous art as its directed towards diagnostics and assessing a cognition and movement disorder in a patient population. Roche describe using sensors such as accelerometers, gyroscopes, and magnetometers etc. and that these are “typical sensors used as means for data acquisition.” Therefore, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have further incorporated the typical sensor of a magnetometer for acquiring data as taught by Roche into the system taught by Raz et al. This is because Raz et al. also teach a number of typical sensors used for data acquisition wherein the addition of another well known sensor (e.g. a magnetometer) would have been just applying another known data acquisition technique to the method of Raz et al. and the results would have been predictable. Furthermore, the differences between the claimed invention and the prior art were encompassed in known variation or in a principal known in the prior art.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390.
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the Central PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central PTO Fax Center number is (571)-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791