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 4, 6-11, 13, and 31 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 4 now calls for actively “accommodating” both the first and second samples in a buffer in an atomic force microscope. The disclosure does not set forth both samples being within the microscope at the same time; the disclosure does provide for obtaining and analyzing a second sample, but all disclosures of preparing and accommodating a sample refer to only a sample in the singular (see pp. 5-6 as filed). The same issue is also found in claim 37. As such, the disclosure does not reasonably convey possession of accommodating both first and second samples in a buffer in an atomic force microscope at the time the invention was filed.
Claim 4 recites the use of a microprocessor circuit and a memory; claim 37 also recites “a non-transitory computer-readable medium encoded with a data structure”. At best, the disclosure generally recites “a computer” which is “configured to run a program” (see p. 13 as filed), but does not set forth a memory, circuit, computer-readable medium, etc. as recited in the claims for specific performance of various steps, such that the disclosure does not reasonably convey possession of use of a microprocessor circuit, memory, or non-transitory computer-readable medium at the time the invention was filed.
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.
Claim(s) 4, 6-11, and 13 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 4 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 4 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “analyse the stiffness distribution of the first sample and the stiffness distribution of the second sample”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements of “accommodating, in an atomic force microscope, a first and a second sample” and “measure under said physiological conditions with the atomic force microscope a stiffness value” are well-known, routine, and conventional measurements, recited only for the insignificant extrasolution activity of data gathering, as evidenced by US 2014/0007309 to Plodinec, previously cited, and 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 element of “providing a microprocessor circuitry and a memory” is not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. The step of generating a nonspecific output, the result of a comparison, is insignificant postsolution activity (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity) that also would not add anything significantly more to the abstract idea itself. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 4 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 6-11 and 13 fail to cure the deficiencies of independent claim 4 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Claims 6-11 are directed to the act of data gathering and claim 13 is directed to aspects of the abstract idea itself. Thus, claim(s) 4, 6-11, and 13 is/are rejected under 35 U.S.C. 101.
Claim(s) 31 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 31 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 31 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “analyse the stiffness distribution of the first sample and the stiffness distribution of the second sample”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements of “accommodating, in an atomic force microscope, a first and a second sample” and “measure under said physiological conditions with the atomic force microscope a stiffness value” are well-known, routine, and conventional measurements, recited only for the insignificant extrasolution activity of data gathering, as evidenced by US 2014/0007309 to Plodinec, previously cited, and 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 elements of “providing a microprocessor circuitry and a memory” with “the memory storing a non-transitory computer-readable medium encoded with a data structure” is not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. The step of generating a nonspecific output, the result of a comparison, is insignificant postsolution activity (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity) that also would not add anything significantly more to the abstract idea itself. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 31 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Thus, claim(s) 31 is/are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 9 February 2026 have been fully considered but they are not persuasive.
Regarding the 112 rejections, the Examiner notes that, though the previous rejections have been resolved by the amendments, the amendments have also raised new rejections.
Regarding the rejection under 101, Applicant initially argues that the invention as claimed cannot be practically performed in the human mind or using pen and paper because it would involve transforming force curves into stiffness distributions and determining modal peaks; it should be noted that the claims call for measuring these distributions such that this is part of the data gathering, not calculating them, and no step in any of the claims is directed to finding a modal peak, such that this argument is moot. If the claim does not accurately reflect the invention and the finding of stiffness distributions is, instead, a calculation rather than a measurement, the claim should be appropriately amended as such. The recited step of analyzing the distributions to find various maxima can certainly be performed by the human mind absent any particular algorithm or processing step that would preclude it.
Applicant next argues that the use of an atomic force microscope to produce a machine-generated result from real physical signals present a practical technological application; it is unclear whether the intent is to argue that this is an improvement to technology or the application of the judicial exception via a particular machine, as neither of these has been discussed by Applicant, or merely the assertion of a “practical technological application”, which is not persuasive as evaluation of the presence of a “practical technological application” is not a part of the Office’s 101 guidance. Further, the portion of the disclosure which Applicant cites to support this “practical technological application” is directed only to evaluation of a single sample and comparison of that sample’s stiffness to a particular threshold, whereas the invention calls for comparison between two samples, where the actual stiffness value of either sample is not involved in drawing any conclusions from the comparison but rather their relative values, such that this is entirely unpersuasive.
Applicant continues by asserting that the use of an AFM as recited “define[s] how the physical state of tissue is transformed into a technical representation from which the classification is derived”; this activity as defined by Applicant has long been held to be data gathering, for example performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) See MPEP 2106.05(g).
Applicant next asserts that no part of the claim “could be performed solely mentally”; as presented, the use of a computer program for analysing a stiffness distribution is merely providing a generic technological environment for execution of the abstract idea, using the computer as a tool to perform the abstract idea – see MPEP 2106.05(f), such that this is also unpersuasive.
Applicant continues by asserting that the identification of a particular stiffness peak in one sample as exhibiting similar characteristics to that of the other sample “provides a technological advantage over conventional staging based solely on histology”. It should be noted that an improvement to technology must be provided by an additional element, not the abstract idea itself. Further, as noted above, the passage Applicant relies upon to support this assertion is directed only to evaluation of the stiffness of one sample and comparison of that to a standard, not comparison of the samples to each other, where the disclosed significance is found in the value of the sample’s stiffness but the claimed significance is based only on the relative stiffness values, such that this is entirely unpersuasive.
The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all claims are rejected under 112 and 101 they are not presently allowable and the question of prior art will be revisited if applicable upon resolution of these 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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