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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on June 4th, 2026. Claims 1, 2, 6-9, 11-13, and 15-20 are pending. Claims 16-20 are withdrawn from consideration. Claims 3-5, 10, and 14 are canceled.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The recitation “in the context of high-throughput screening” lacks antecedent basis in the specification.
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, 2, 6-9, 11-13, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental step without significantly more.
The claim(s), both individually and as an ordered combination, recite(s) assessing “a change” that is occurring and it is being quantified/qualified by the recited “method of identifying” wherein such “measuring of a change” sets forth an evaluation that is drawn to a mental step (Step 2A, Prong 1).
This judicial exception is not integrated into a practical application because once the change is assessed nothing further is done by way of additional, active steps thereto and therefore an application is not provided, let alone a particular practical application that correlates therewith the abstract idea at-hand (Step 2A, Prong 2).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because providing of a composition comprising low molecular weight sickle hemoglobin (HbS) assemblies is drawn to insignificant extra-solution activity as this is drawn to mere sample provision in the base subject to be tested, and wherein such “providing” is recited at a high level of generality. Further, adding a test compound to the composition is further drawn to insignificant extra-solution activity in which such recitation is provided at a high level of generality and is seen as routine and conventional in a general and well-understood scientific method providing a stimulus to the sample (see, for example, prior art of Dufu et al. [cited in Applicant’s IDS of 05/24/24], and Corin et al. (USPN 6,184,228), and Petermans [previously or record] to likewise anti-sickling screening/testing.
Further, the recitation “measuring a change in the structure…” also implicitly provides a data gathering step therein in order to provide data to assess therefrom the recited “change,” (which necessitates a relative comparison) and wherein data gathering itself is drawn to insignificant extra-solution activity (Step 2B).
This remains to be seen within the dependent claims that do not provide to integrate the abstract idea into a practical application (Step 2A, Prong 2), nor do they provide significantly more than the abstract idea (Step 2B).
Dependent claims 2 and 6-9 provide further discussion to the sample itself and remain drawn to sample provision that is insignificant extra-solution activity and does not provide a particular application integrated to the abstract idea at-hand. Provision of such sample does not provide further, active steps subsequent to the assessed change that amount to a practical application in the art therewith. Further, claims 8-9, are also drawn to general discussion of well-understood comparisons of a control against a variable in an assessment, delineations of data gathering in that of FRET, in which data gathering is drawn to insignificant extra-solution activity.
Dependent claim 15 is drawn to characterizations/assessments that are further abstract ideas as they are drawn to evaluations/assessments.
Dependent claim 11 is drawn to recitation of a well-known and conventional measurement technique in the art, and recited at a high level of generality.
Dependent claims 12 and 13 are drawn to delineations in data gathering that are drawn to insignificant extra-solution activity.
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, 2, 6-9, 11-13, and 15 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.
The amended recitation of claim 1 to the composition comprising assemblies comprising a donor chromophore and acceptor chromophore, as recited therein, and measuring FRET or DLS of the composition is drawn to new matter in the claims.
As seen through the specification, DLS and FRET are orthogonal modalities (par.[0094], as well as through pars.[0049,0050 of Applicant’s pre-grant publication US 2023/0095509). This also aligns with what is known to the ordinary artisan that is conventionally known as DLS is based on Brownian motion and light scattering to give information about size/size distribution, and is accomplished with unlabeled particles. Whereas FRET is based on fluorescence energy transfer and provides molecular proximity and conformational state information, which is carried out with donor and acceptor chromophores.
The specification does not resolve this to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention that purports HbS assemblies comprising donor and acceptor chromophores to be measured for either of FRET and DLS (notably, DLS does not align with the present recitation).
Further, as in cl. 11, the recitation to “measuring is conducted in the context of high-throughput screening” is drawn to new matter in the claims.
Discussion to the descriptor “in the context of” is wholly absent, and further, High-throughput screening itself is only generally and prophetically discussed in par.[0012], and absent particular discussion to “in the context of” here or elsewhere in the specification..
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, 2, 6-9, 11-13, and 15 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.
As amended, the metes and bounds of the methodology are indefinite as the claim recites “…providing…under suitable conditions.”
The metes and bounds of what constitutes “suitable conditions” are indefinitely defined.
Initially, the ‘suitable conditions’ are not codified in an intended purpose/functionality that renders an indeterminate scope as the conditions themselves are provided in the broadest sense and without provision to their suitability.
Further, Applicant’s specification at par.[0019] speaks to conditions that are suitable and which is discussed at a high level of generality that does not particularly inform the claimed suitable conditions with respect to the recited assemblies.
Further, as in par.[0045], it is discussed that the composition includes suitable conditions for formation of, and/or maintaining the presence of, low molecular weight HbS assemblies. This discussion is generalized and prophetic and does not inform bounds to those conditions and being concordant to the noted functionalities.
This is further seen in the remaining portion of the paragraph, wherein the discussion of “for instance, low oxygen” both presents an exemplary, non-definitive definition, but also does not resolve or make clear what constitutes low oxygen. The remainder of the discussion is likewise in providing non-definitive, exemplary discussion to various embodiments that indefinitely define the “suitable conditions” as recited herein the claims.
With regard to claim 2, the recitation is indefinitely provided as the recitation is drawn to further limiting “the measuring” of claim 1, which is drawn to “measuring a change,” and the discussion of “…the donor chromophore, the acceptor chromophore, or the combination thereof…” is discordant with the prior recitation of claim 1.
Claim 1 sets forth measuring a change of 1) FRET or 2) DLS compared to the composition without the test compound.
Discussion herein to measuring the “…the donor chromophore, the acceptor chromophore, or the combination thereof…” indefinitely relates with claimed step of “measuring a change…” of claim 1.
This is also seen in claim 8 that is dependent upon claim 2. In claim 8, does Applicant intend to recite “wherein measuring the change comprises measuring the FRET” so as to impose a choosing of item 1) from the two items given in cl. 1.
Further to the above, it is noted that the constitution of claim 8 in view of claim 2 is indefinitely provided for similar reasons as discussed in terms of claims 1 and 2.
In claim 12, it appears Applicant intends to recite “comprises measuring the DLS” in order to avoid confusion as to a secondary, additional DLS measurement to be carried out beyond that of the choice of DLS in claim 1.
With regard to claim 6, the recitation to “the ratio of donor to acceptor,” which lack proper antecedent basis in the claims. It appears that Applicant intends to recite “a ratio of…”
Claim 11 is 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.
The recitation “…the measuring is conducted in the context of high-throughput screening” is indefinitely defined in setting forth clear metes and bounds as to the active step(s) that amount to “conducted in the context of high-throughput screening.”
The recitation “in the context of” is wholly indeterminate in the correlation or relationship to “high-throughput screening” and amounts to a generalized, vague prophetic discussion. Wherein it is also seen that the recitation to “high-throughput screening” itself is drawn to a categorical descriptor and does not delineate the active step(s) afforded to the methodology.
The specification does not remedy this with respect to “in the context of high-throughput screening” nor “high-throughput screening.”
High-throughput screening is generally and prophetically discussed in par.[0012], and the descriptor “in the context of” is wholly absent.
Examiner notes discussion to figs. 4A-C (pars.[0029,0096] and “lifetime FRET HTS,” however, this is both exemplary and non-definitive, incongruent with the present recitation and breadth thereof, and also does not clearly forth the active step(s) involved in such a “lifetime FRET HTS.”
Claim 13 is 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.
The recitation of claim 13 is indefinitely understood in its metes and bounds in what is being further defined or further added to the method.
Claim 1 provides a choice of measuring a change in 1) FRET or 2) DLS from that of the FRET or DLS in the same composition, but without the test compound.
Claim 12 provides necessitates a choice of item 2) from the prior, alternative choice listing in cl. 1.
The recitation “the DLS is reduced in the presence…” is not understood in its manner of relating to the prior method, whether it be the “measuring a change” step or the “providing” or “adding” steps. The recitation appears to present a presupposition of a computation of the measured change.
Clarification is required.
Response to Arguments
Applicant's arguments filed June 4th, 2026 have been fully considered but they are not persuasive.
With regards to claims 1-15 rejected under 35 USC 101, Applicant traverses the rejection.
Applicant asserts that claim 1 recites physical laboratory operations that cannot be performed in the human mind.
Applicant asserts that FRET and DLS measurements require analytical instrumentation capable of providing their detection functionalities.
Applicant asserts that claim 1 does not merely observe or evaluate information, but instead requires generating measurement data from a specifically recited assay system.
Initially, Examiner asserts the claim providing or inferring physical structure alone does not suffice to obviate the 35 USC 101 analysis as seen through MPEP 2106.04 and the above discussion in the body of the action to the Step analysis (Step 2A, Prong 1, Step 2A, Prong 2, and Step 2B).
It remains that the claims present an abstract idea of an assessing a change that is drawn to an abstract idea as this sets forth an evaluation that is drawn to a mental step.
Further, Applicant’s arguments are not commensurate in scope as Applicant purports FRET and DLS measurements require analytical instrumentation capable of providing their detection functionalities, however, the claims are absent any positive provision to any instrumentation and its application in setting forth a desired interrogation process and related measuring/detection process therewith such instrumentation.
Examiner refers Applicant to MPEP 2106.05(b) in “Particular Machines.”
“When determining whether a claim integrates a judicial exception, into a practical application in Step 2A Prong Two and whether a claim recites significantly more than a judicial exception in Step 2B, examiners should consider whether the judicial exception is applied with, or by use of, a particular machine. "The machine-or-transformation test is a useful and important clue, and investigative tool” for determining whether a claim is patent eligible under § 101. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010).
It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. Id.”
See further discussion therein MPEP 2106.05(b), as well as in sections I, II, III.
To this end, Applicant may amend the claims accordingly therewith to provide a particular machine as in MPEP 2106.05(b) with its implementation in various process steps that define the methodology.
Examiner notes, as discussed above, this is not a stand-alone test for eligibility.
Examiner further cautions Applicant from providing generalized or conventional infrastructure to such an optical system as this may very likely be drawn to routine and conventional structure as in section I. As above, Applicant is also made aware of the particular correlation/implementation of the particular machine to the steps of the method as in section II, and whether its involvement is extra-solution activity or a field-of-use as in section III.
Applicant further asserts that the claims provide a practical application as the claimed methodology describe a concrete experimental protocol for determining alterations in intermolecular contact between HbS molecules resulting from a presence of a test compound.
Examiner asserts that the experimental protocol alone does not set forth a practical application.
As discussed above, once the change is assessed nothing further is done by way of additional, active steps to the method and therefore an application is not provided, let alone a particular practical application that correlates therewith the abstract idea at-hand (Step 2A, Prong 2).
The claim(s) do not provide further steps that implement and utilize this assessment. See further as in MPEP 2106.04(d) and particular citations below.
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Applicant asserts that the claims recite significantly more than the abstract idea.
Applicant asserts that the donor- and acceptor-labeled HbS tetramers are not insignificant data-gathering tools, but they form the basis of the assay system through which intermolecular contacts are detected. Applicant further asserts that the recited FRET and DLS measurements are not ancillary to the claimed invention as they constitute the specific technological mechanism by which alterations in intermolecular contact are identified.
Examiner asserts that assemblies are drawn to insignificant extra-solution activity as this is drawn to mere sample provision in the base subject to be tested, and the discussion to “FRET and DLS” is within the abstract idea itself.
The step remains to be drawn to “measuring a change” as an abstract idea in that of mental step afforded by a judgment/assessment.
Further, there is no particular implementation of FRET and DLS optical assays that positively and particularly yield their respective measurements prior to being assessed. The methodology is provided at a high level of generality that does not amount to significantly more than the abstract idea.
Further, the step of “measuring a change in the structure…” also implicitly provides a data gathering step therein in order to provide data to assess therefrom the recited “change,” (which necessitates a relative comparison) and wherein data gathering itself is drawn to insignificant extra-solution activity.
By this, and for the reasons discussed above in the body of the action, Examiner maintains that the claims, individually and as an ordered combination, are properly rejected under 35 USC 101.
With regards to claims 1-15 rejected under 35 USC 112 b/2nd paragraph, Applicant traverses the rejection.
Examiner acknowledges Applicant’s remarks and asserts that in view of the amendments to the claims, claims 1, 2, 6-9, 11-13, and 15 are herein rejected under 35 USC 112 b/2nd paragraph in view of the amendments made to the claims.
Further, in view of the amendments to the claims, claims 1, 2, 6-9, 11-13, and 15 are rejected under 35 USC 112 a/1st for the reasons discussed above in the action.
Further, the specification is objected to for the reasons discussed above in the body of the action.
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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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