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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 1-3 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 calls for “measuring the expression of biomarkers hBD1, IL1RA, IL36g and S100A8/9” and then “comparing said expression to a determined standard”; there is no disclosure of measuring a single expression that is a measure of all four different biomarkers where that expression can be compared to a standard. At best, the specification calls for measuring the expression of each of these biomarkers individually and creating a statistical measure from each of these separate expressions (paragraph [0032] as filed), but not measuring a singular expression representative of all the biomarkers. Still further, the only disclosure of comparison of some value related to the plurality of biomarkers to a standard is the determination of Z-scores for each measured biomarker, where those scores are then combined to represent all four biomarkers with one value (paragraph [0071] as filed), though this still does not establish the source of data for providing the norm against which values are compared to determine each of the z scores (as required by paragraph [0065] as filed).
As such, the disclosure as filed does not reasonably convey possession of measuring a singular expression of a plurality of biomarkers and then comparing that singular expression to a standard at the time the invention was filed.
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 1-3 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 calls for “measuring the expression of biomarkers hBD1, IL1RA, IL36g and S100A8/9” and then “comparing said expression to a determined standard”; it is unclear how some singular expression can be measured that is representative of all of the plurality of biomarkers, or how a standard is to be determined that represents the combined expression. Per the disclosure, evaluation would require a first comparison of a singular biomarker’s expression to a standard, which is then combined with other comparisons and in turn compared to another standard. It is unclear which of these might be considered “a determined standard” against which some combined biomarker expression might be compared. Clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) using the result of a comparison to determine the propensity to develop a disease, which falls into the grouping of mental processes.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a process, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a method comprising comparing an expression of biomarkers on a skin area to a standard derived from observations of expression of the biomarkers in the absence of atopic dermatitis, and based on the comparison determining the propensity to develop atopic dermatitis
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely specify the location of observation.
The claim elements may be summarized as the idea of obtaining data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the evaluation of the expression of the biomarker
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because any additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The invention as claimed includes the additional nonspecific step of “measuring the expression” of the biomarkers, which does not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely acquire data in a nonspecific manner, apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The only potential additional element is the nonspecific step of “measuring the expression of biomarkers hBD1, IL1RA, IL36g and S100A8/9”, which is no more than the insignificant extrasolution activity of data gathering - see MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Response to Arguments
Applicant's arguments filed 18 May 2018 have been fully considered but they are not persuasive.
Regarding the rejections under 101, Applicant argues that the claims as presented are directed to significantly more than an abstract idea as a result of the inclusion of the nonspecific step of measuring an expression of biomarkers; as noted above, this “measuring” is presented at a high level of generality and is no more than the insignificant extrasolution of data gathering that is required for all uses of the recited abstract idea, such that this is unpersuasive.
Regarding the art rejections, Applicant’s remarks have been noted; as no art is currently applied against the claims these remarks will not be addressed at this time but will be revisited if still applicable upon resolution of the numerous other issues above.
The Examiner notes that Applicant’s remarks repeatedly refer to “IL36γ”, not IL36g as claimed. Applicant should ensure that the claims accurately reflect the intended claimed biomarker.
Conclusion
No art has been applied against the claims at this time; however, as the claims are all rejected under 112 and 101 above they are not presently allowable and the question of prior art will be revisited upon resolution of the other issues.
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.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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