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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-15, in the reply filed on November 17th, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 16-20 are withdrawn from consideration.
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 1-15 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) 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 2-4 and 6-10 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 3-4, 8-10, 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 claims 5, 14, and 15 are themselves 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 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 1-15 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.
The metes and bounds of the methodology are indefinite as the preamble of the claims calls for a “method for identifying a compound that alters…”, however, the active steps provided in the body of the claim do not provide for such a premise.
It is noted that herein, the breadth of the claims to the “adding a test compound” and “measuring a change…” does not require any sort of correlation/causation therewith the added test compound, let alone provide for “identifying a compound that alters…”
Does Applicant intend to provide correlation/causation or additional active step(s)/thresholding comparisons to the method that utilize the prior aspects to identify if the added test compound constitutes “a compound that alters…”?
Examiner further notes the incongruent nature of the recitations to “alters intermolecular contact between proteins” in the preamble to that of “a change in the structure…” as in the “measuring” step.
Further, to the above, the recitation “the structure” in the last line of claim 1 lacks proper antecedent basis in the claims wherein it appears Applicant intends to recite “a structure.”
Claims 5 and 6 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.
The recitation in claim 5 to “the difference indicates…” and “the FRET” lacks proper antecedent basis in the claim; and further, claims 5 and 6 recite “the donor” and “the acceptor,” as well as “the ratio of donor to acceptor,” which lack proper antecedent basis in the claims; wherein Examiner notes that the FRET donor/acceptor is introduced in claim 2 in which it appears that Applicant intends claim 5 to depend from claim 2 and not claim 1.
Claims 2-4, 8-10, and 12-15 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.
Claims 2 and 12 both provide recitations to “wherein the measuring comprises [FRET…] or [DLS],” however, such recitations are indefinite in their metes and bounds as they relate to the independent claim and the step of “measuring a change in the structure….”
Discussion to measuring with FRET and DLS is drawn to optical signals (see e.g., Spec., Pg. 3, lines 1-15), but the claims do not particularly or clearly relate this to the recited step in claim 1 drawn to measuring a change in the structure.
What is the correlation/connection between these particular optical signals and the recited “measuring a change in the structure?”
It appears that Applicant intends a particular measuring of the cited optical signals, and determining/measuring a change in the structure therefrom as indicated/correlated with the FRET/DLS.
Herein, these recitations in claims 2 and 12 are incongruent to the base method step that they are attempting to particularly, further define.
Does Applicant intend to recite an initial active step to the methodology after the “providing a composition comprising…” that reads on the order of “irradiating the sample…” and “detecting the FRET/DLS” and then subsequently after the step of “adding a test compound…” provide a likewise active step to “irradiating the sample…” and “detecting the FRET/DLS” so as to provide a comparative before/after analysis to inform the “measuring a change in the structure…” as it relates to the difference in FRET/DLS?
Similarly, with respect to claims 3-4 and 13-15, wherein the present recitations to “a difference…” are drawn to narrative discussions without particular and clear connection to actively provided steps of the methodology. As discussed above, the claims are absent positive provisions to steps that provide these data points and the cited “differences” (i.e. optical assessment in the presence of test compound and optical assessment in the absence thereof) or a lack thereof such detection by actively recited steps thereto.
Clarification is required.
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.
With regard to claim 11 that sets forth that the “measuring” comprises high-throughput screening that is not particularly understood in the constitution of its linkage to claim 1.
Claim 1 recites a methodology carried out with singular (“a”) composition, singular (“a”) test compound, and measuring singular (“a”) change that does not suffice to and/or indefinitely provides for “high throughput screening”.
This is further understood on Pg. 3, lines 16-21 and Pg. 7, lines 10-23 of applicant’s specification filed November 7, 2022 which discloses a screened library of treated samples for FRET. To this end, it appears Applicant intends to introduce steps to this plurality of subjected compositions, plurality of treatments, and respective measurements therewith so as to set to provide “high throughput screening.”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, as best understood herein, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Dufu et al. (“GBT440 Improves Red Blood Cell Deformability…” Clin Hemorheol Microcirc., 2018, 70(1), 95-105, doi: 10.3233/CH-170340), hereafter Dufu.
With regard to claim 1, Dufu discloses providing a composition comprising low molecular weight sickle hemoglobin (HbS) assemblies (deoxygenated SS RBCs; see also 2.1 ‘Blood source’ as in sickle cell disease blood), adding a test compound to the composition (GBT440 as in voxelotor), and measuring a change in the structure of the low molecular weight HbS assemblies (assessing rheological and hemodynamic behavior; membrane shear elastic modulus, hyperviscosity, membrane deformability, movement ability as seen through their movement through a gel filtration column) (abstract, page 1; introduction, page 2; sections 2.3-2.7, 3.1 for example).
Claim(s) 1 and 11, as best understood herein, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Corin et al. (USPN 6,184,228), hereafter Corin.
Corin discloses anti-sickling agents selection methods and effective compounds that inhibit sickle hemoglobin polymerization (abstract). With regard to claim 1, Corin discloses providing a composition comprising low molecular weight sickle hemoglobin (HbS) assemblies (deoxygenated SS RBCs), adding a test compound to the composition (various gelation inhibitors/anti-sickling agents), and measuring a change in the structure of the low molecular weight HbS assemblies (visual assessment of morphology in presence or absence of the gelation inhibitors/anti-sickling agents, or microscopic evaluation of the morphology) (line 60, col. 17 – line 35, col. 19, for example). With regard to claim 11, as best understood herein, Corin provides measuring comprising high-throughput screening (lines 50-55, col. 5, lines 39-40, col. 20, for example).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11, as best understood herein, is/are rejected under 35 U.S.C. 103 as being unpatentable over Dufu in view of Corin.
Dufu has been discussed above.
Dufu does not specifically disclose measuring comprising high-throughput screening.
Corin has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Dufu to utilizing high-throughput screening such as suggested by Corin in order provide a means to screen large libraries rapidly for additional, beneficial agents beyond and/or similar to that of GBT440 (voxelotor) to expand drug discovery and options therewith treatment.
Claim(s) 12-15, as best understood herein, is/are rejected under 35 U.S.C. 103 as being unpatentable over Corin in view of Peetermans et al. (Proc. Natl. Acad. Sci. USA, Vol 83, pp. 352-356, Jan 1986, biophysics; “Light scattering study of depolymerization kinetics of sickle hemoglobin…”), hereafter Peetermans, and Gerber et al. (USPN 5,914,391), hereafter Gerber.
Corin has been discussed above.
Corin does not specifically disclose the measuring comprises measuring DLS as in cls. 12-15.
Notably, Corin discloses visual assessment of morphology in the presence or absence of the gelation inhibitors/anti-sickling agents, or microscopic evaluation of the morphology in the presence of absence thereof.
Peetermans discloses “a light-scattering study of depolymerization kinetics of sickle hemoglobin polymers inside single erythrocytes (abstract, for example).
Gerber discloses hemoglobin aggregates are detectable by methods such as visual inspection and light scattering methods such as dynamic light scattering (lines 15-27, col. 1, lines 49-55, col. 4, lines 49-59, col. 5, for example).
It would have been obvious to one of ordinary skill in the art to modify Corin to measure dynamic light scattering as recited in claims 12-15 such as suggested by the analogous prior art to Peetermans in assessing depolymerization kinetics of sickle hemoglobin and Gerber to the optical assessment of hemoglobin in which measuring light scattering as in by dynamic light scattering represents an obvious optical scattering analogue to that disclosed by Peetermans that would have a reasonable expectation of success therein and offer more particular and sensitive kinetic data to that of the visual/microscopic assessment in more specifically assessing the polymerization, and in which measuring a difference of DLS in the presence and absence of the test compound is akin to the above discussion in Corin and represents an observation to attribute the test compound’s effect to the DLS and a difference between the DLS in the presence of the test compound and in the absence thereof not being detected represents an obvious engineering choice so as to provide data purely to the DLS in the individual assessments with and without the test compound to provide quantitative data thereto as opposed to qualitative data in assessing a difference, and further wherein such difference as in cl. 15 “indicates…” in as much as claimed and recited herein wherein such recitation does not set forth any additional, active step(s) to the methodology.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dufu in view of Corin as applied above to claim 11 and in further view of Peetermans and Gerber.
Dufu/Corbin does not specifically disclose the measuring comprises measuring DLS as in cls. 12-15.
Peetermans and Gerber have been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Dufu/Corin to measure dynamic light scattering as recited in claims 12-15 such as suggested by the analogous prior art to Peetermans in assessing depolymerization kinetics of sickle hemoglobin and Gerber to the optical assessment of hemoglobin in which measuring light scattering as in by dynamic light scattering represents an obvious optical scattering analogue to that disclosed by Peetermans that would have a reasonable expectation of success therein and offer more particular and sensitive kinetic data to that of the visual/microscopic assessment in more specifically assessing the polymerization, and in which measuring a difference of DLS in the presence and absence of the test compound is akin to the above discussion in Dufu/Corin and represents an observation to attribute the test compound’s effect to the DLS and a difference between the DLS in the presence of the test compound and in the absence thereof not being detected represents an obvious engineering choice so as to provide data purely to the DLS in the individual assessments with and without the test compound to provide quantitative data thereto as opposed to qualitative data in assessing a difference, and further wherein such difference as in cl. 15 “indicates…” in as much as claimed and recited herein wherein such recitation does not set forth any additional, active step(s) to the methodology.
Conclusion
Presently, no prior art rejections are applied to claims 2-10 (and noting claims 5-6 appear intended to be dependent of claim 2); however, these claims are currently rejected under 35 USC 101 as discussed above and, in instances, under 35 USC 112 b/2nd.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mousa (US 2016/0222137) discloses compositions and methods for anti-sickling of red blood cells in sickle cell disease that is relevant to Applicant’s field of endeavor.
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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/NEIL N TURK/ Primary Examiner, Art Unit 1798