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 .
Status of the Claims
Claims 1-20 are pending (claim set as filed on 07/10/2025).
Priority
This application is a divisional (DIV) of application no. 16/481,771 (now U.S. Patent no. 11,773,371 B2) filed on 07/29/2019, which is a 371 of PCT/GB2018/050120 filed on 01/17/2018, which has a foreign application UK 1701438.2 filed on 01/30/2017.
Maintained Rejections
Claim Rejections - 35 USC §101, Subject Matter Eligibility
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter (based on the 2019 Revised Patent Subject Matter Eligibility Guidance).
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a process of identifying a skin-softening compound.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
YES, the claims recite(s) at least one judicially recognized exception(s) of: a law of nature, natural phenomena, and/or an abstract idea.
a law of nature & natural phenomena: the recitation of “wherein an alteration in binding as compared to a control is an indicator that the test compound is a candidate skin-softening compound” describes a correlation or relationship between the test compound and its ability to bind/disrupt a LINC complex. This limitation sets forth a judicial exception, because it describes “A correlation that is the consequence of natural processes, e.g., how a certain compound is metabolized by the body – Mayo”.
(b) an abstract idea: the recitation of “identifying” and “detecting” under the broadest reasonable interpretation describes an abstract idea that falls within the mental processes groupings of abstract ideas which are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion). “Mental processes or basic critical thinking that can be performed in the human mind, such as: comparing information regarding a sample or test subject to a control or target data (Ambry); or diagnosing an abnormal condition by performing clinical tests and thinking about the results (Grams)”.
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the exception is not integrated into a practical application of the exception. The additional elements or a combination of elements in the claims does not impose a meaningful limit on the judicial exception. For example, the claims stop after the judicial exception and thus, it does not apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda Memo).
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to a law of nature, natural phenomena, and/or an abstract idea without significantly more. The claim(s) describes a correlation or relationship and the recitation of “identifying” and “detecting” if the test compound is a skin-softening compound. Moreover, under BRI, it also describes an abstract idea that falls within the mental processes groupings of abstract ideas which are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion). This judicial exception is not integrated into a practical application because the additional elements of contacting a candidate test agent in order to perform tests is well-understood, routine, and conventional activity for those in the field of diagnostics or drug evaluation. Further, the steps are recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., a mere data gathering step necessary to use the correlation and the determining, evaluating, and comparative steps are considered various common practices that are routine and conventional activities performed by visual observation, abstract mental analysis, and pathological side by side comparison. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. The claim here does not invoke any of the considerations that courts have identified as providing significantly more than the exception.
Additionally, the dependent claims are not deemed to qualify as significantly more because they do not add a specific limitation other than what is well-understood, routine, and conventional in the field. For example, “[0102] The skilled person would appreciate that the binding of a SUN domain to a KASH domain may be detected using a variety of techniques known in the art, which
include, but are not limited to, protein complex immunoprecipitation, Bimolecular Fluorescence complementation, Affinity electrophoresis, Immunoelectrophoresis, chemical cross linking, Proximity ligation assay and FRET” (e.g., claim 15). The other dependent claims describe the LINC complex which is “an intracellular network of multiple proteins found in eukaryotic cells. It spans the nuclear membrane and connects genetic material (and other nuclear components) to plasma membrane receptors via cytoskeletal structures (see FIGS. 1 and 2)” (see ¶ [0013] of the pre-grant publication).
Therefore, when the additional elements are viewed as an ordered combination, they are not deemed to add meaningful limits on the use of the exception.
Therefore, the claims, as a whole, are considered as processes directed to judicially recognized exceptions without amounting to significantly more from what naturally occurs and thus, are not eligible subject matter under 35 U.S.C. §101.
Examiner’s Response to Arguments
Applicant’s arguments filed on 12/22/2025 have been fully considered but they are not persuasive and deemed insufficient to overcome the subject matter eligibility rejection.
In response to Applicant’s argument (addressing page 2 of the remarks) that “the claim is not directed to an abstract idea, but is instead drawn to a method of identifying a skin-softening compound” and the Examiner “ignores the recited step of contacting in the presence of a test compound … this step cannot be performed in the mind”: this argument is not persuasive because note that the prior office action also identified another judicial exception which is a law of nature & natural phenomena where the claim’s recitation of “wherein an alteration in binding as compared to a control is an indicator that the test compound is a candidate skin-softening compound” describes a correlation or relationship between the test compound and its ability to bind/disrupt a LINC complex. This limitation sets forth a judicial exception, because it describes “A correlation that is the consequence of natural processes, e.g., how a certain compound is metabolized by the body – Mayo”. Furthermore, the Examiner did consider said step of contacting in the presence of a test compound (i.e., did not ignore the claim’s contacting step). The prior office action indicated that the additional elements of contacting a candidate test agent in order to perform tests is well-understood, routine, and conventional activity for those in the field of diagnostics or drug evaluation. Further, the steps are recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., a mere data gathering step necessary to use the correlation and the determining, evaluating, and comparative steps are considered various common practices that are routine and conventional activities performed by visual observation, abstract mental analysis, and pathological side by side comparison. The MPEP 2106.05(g) states:
2106.05(g) Insignificant Extra-Solution Activity
Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent.
In other words, in a basic sense, the claim’s initial contacting step in the presence of a test compound is a prequel step in order to use the correlating law of nature judicial exception.
In response to Applicant’s argument (addressing pages 3-4 of the remarks) that “Claim 1 is directed to a method of identifying a skin-softening compound, not the binding relationship between a test compound and the LINC complex. See Vanda Pharms … Example 43 provided by the USPTO’s Appendix 1 to the October 2019 Subject Matter Eligibility Update. The example explains that while Claim 1 "recites several nature-based product limitations including C11, C13, and the blood sample [...] review of this claim indicates that it is focused on a process of determining how much C11 and C13 is present in the blood sample and then treating a patient in accordance with that determination”: this argument is not persuasive because the instant claim differs from the Vanda example. Base claim 1 stops after the correlation step, in contrast to Vanda where there is a physical treatment step after the determination step (i.e., an additional physical step that integrates the law of nature into a practical application). For instance, the MPEP 2106.04(b)(I) states:
Even if a claim does recite a law of nature or natural phenomenon, it may still be eligible at any of Pathways A through C. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not "directed to" that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
Accordingly, for reasons stated herein, the claimed invention remains subject matter ineligible under 35 U.S.C. §101.
Conclusion
No claims were allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NGHI V NGUYEN/Primary Examiner, Art Unit 1653