DETAILED ACTION
A response was received on 29 August 2025. By this response, Claim 1 has been amended. No claims have been added or canceled. Claims 14-20 were previously withdrawn from further consideration as drawn to a nonelected invention. Claims 1-12 and 21 are currently under examination in the present application.
Response to Arguments
Applicant’s arguments with respect to the rejection under 35 U.S.C. 103 have been considered but are moot in view of the new grounds of rejection set forth below.
Claim Rejections - 35 USC § 112
The rejection of Claims 1-12 and 21 under 35 U.S.C. 112(b) as indefinite is NOT withdrawn, because the amendments have raised new issues, as detailed below.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
A determination of a failure to comply with the enablement requirement is made considering the undue experimentation factors set forth in MPEP § 2164.01(a). In the present application, the factors which appear to weigh most heavily are the breadth of the claims (MPEP § 2164.08), the amount of direction provided by the inventor (MPEP § 2164.03), and the existence of working examples (MPEP § 2164.02). Claim 1 broadly recites modifying the de-identification solution based on the disclosure risk measurement. The claims do not recite any detail of how the de-identification solution is to be modified. The specification only broadly mentions modifying the solution in terms similar to those recited in the claims (see paragraph 0132). Although Applicant states that the specification discloses that how much data suppression or data generalization is included can be modified (see pages 9-10 of the present response, citing paragraph 0054 of the specification), this portion of the specification does not mention how such suppression or generalization would be modified. There are no details of how the de-identification solution is to be modified, nor is there a clear example in the specification of how this solution would be modified. The lack of details or examples in any detail beyond the claim language suggests that there is little direction provided by the inventor. Combined with the broad scope of the claims, this suggests that the enablement of the description is not commensurate in scope with the claims (MPEP § 2164.08) and that undue experimentation would be required to make or use the invention based on the disclosure (MPEP § 2164.06).
Claims not explicitly referred to above are rejected due to their dependence on a rejected base claim.
It is noted that reinstating the prior language of “selecting” a de-identification solution, along with further clarifying amendments relating to whether the same solution is selected and used for de-identification each time the selecting is repeated or a new, next, or updated solution is selected and used for de-identification each time the selecting is repeated, would likely overcome both the present rejection under 35 U.S.C. 112(a) for lack of enablement of “modifying” and the prior rejections under 35 U.S.C. 112(b) for lack of clarity in the repeated selecting step.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 21 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 1 recites “the unimodal population distribution centered about a global average of the at least one identified quasi-identifying field” in lines 10-12. It is not grammatically clear how this phrase is related to the remainder of the claim, although it appears that this may have been intended as a “wherein” clause or similar.
Claims not explicitly referred to above are rejected due to their dependence on a rejected base claim.
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.
Claims 1-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Scaiano et al, US Patent Application Publication 2018/0114037, in view of Town et al, US Patent 10924934, El Emam et al, US Patent 8316054, and LaFever et al, US Patent 9087216 (previously cited in the Office action mailed 23 June 2023).
In reference to Claim 1, Scaiano discloses a method that includes creating, for a dataset including patient data containing personally identifiable information, a list of quasi-identifying fields (paragraph 0006 and 0041; see also paragraph 0037, patient data); identifying one or more of the quasi-identifying fields from the list and classifying fields in the dataset (see paragraph 0041); selecting values from a population distribution that includes quasi-identifying values (paragraphs 0006 and 0042, retrieving population distribution); applying a de-identification solution to the dataset (paragraph 0098, performing de-identification on assessed risk); calculating a disclosure risk measurement of re-identification of the PII for individuals or entities represented in the dataset using the quasi-identifying fields including non-simulated values (paragraphs 0006 and 0048, calculating re-identification risk; see also paragraph 0097); and modifying a de-identification solution based on the disclosure risk measurement and de-identifying the dataset by applying the modified solution (paragraph 0098, performing de-identification based on assessed risk; see also paragraph 0079). However, Scaiano does not explicitly disclose identifying fields for both simulation and other fields, or calculating the disclosure risk measurement using both simulated and non-simulated values.
Town discloses a method that includes classifying and using simulated and non-simulated data in a data subject profile (column 7, lines 8-39; see also column 5, lines 42-55, and column 9, lines 24-42) and iterating calculation and assessment of risk until a threshold is reached (see Figure 4 and column 8, line 36-column 9, line 23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Scaiano to include the identification of fields for simulation and other fields and using both simulated and non-simulated values, in order to decrease the risk of disclosing genuine data (see Town, column 7, lines 32-39).
However, although Scaiano generally discloses repeating steps (paragraph 0079) and Town discloses iterating calculation and assessment of risk until a threshold is reached (see Figure 4 and column 8, line 36-column 9, line 23, cited above, where steps are repeated until a threshold is exceeded), neither Scaiano nor Town explicitly discloses repeating steps of performing de-identification and risk assessment until the risk is below a threshold. El Emam discloses a method that includes performing de-identification and risk assessment on de-identified data and repeating those steps until the risk threshold is not exceeded (see Figure 5 and column 6, lines 34-49). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Scaiano and Town to include repeating the de-identification until risk is below a threshold, in order to minimize data loss in relation to the overall value of the database (see El Emam, column 6, lines 35-40).
Further, although Scaiano generally discloses a population distribution (paragraphs 0006 and 0042), none of Scaiano, Town, or El Emam explicitly discloses a field characterized by a unimodal population distribution centered around an average value. LaFever discloses a method that includes de-identifying data including quasi-identifying fields characterized by a unimodal population distribution centered about a global average value of the field (see column 62, line 57-column 63, line 59, where height and weight are assigned dynamic de-identifiers, and height and weight are unimodal as described in the present specification). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Scaiano, Town, and El Emam to include a quasi-identifier characterized by a unimodal distribution, in order to deliver clinical data for analysis without divulging personally identifying information relating to weight or height (see LaFever, column 63, lines 47-57).
In reference to Claim 2, Scaiano, Town, El Emam, and LaFever further disclose using data from pre-existing external data sources (see Scaiano, paragraph 0061; see also Town, column 7, lines 8-39, and column 5, lines 42-55).
In reference to Claims 3-7 and 12, Scaiano, Town, El Emam, and LaFever further disclose assigning and aggregating information scores and calculating an anonymity value (Scaiano, paragraphs 0044-0045; see also LaFever, column 23, lines 7-14).
In reference to Claim 8, Scaiano, Town, El Emam, and LaFever further disclose mapping a value to a probability (Scaiano, paragraph 0042; see also LaFever, column 50, lines 59-62).
In reference to Claims 9-11, Scaiano, Town, El Emam, and LaFever further disclose selecting longitudinal quasi-identifying values and using counts thereof (Scaiano, paragraphs 0037-0038; see also LaFever, column 61, line 56-column 62, line 20, where blood pressure can be a longitudinal value).
In reference to Claim 21, Scaiano, Town, El Emam, and LaFever further disclose a clinical trial dataset (see Scaiano, paragraphs 0003 and 0037; see also El Emam, column 1, lines 20-36, and LaFever, column 76, lines 12-62).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zachary A Davis whose telephone number is (571)272-3870. The examiner can normally be reached Monday-Friday, 9:00am-5:30pm, Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rupal D Dharia can be reached at (571) 272-3880. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zachary A. Davis/Primary Examiner, Art Unit 2492