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 .
Priority
The application is a 371 of PCT/US2022/040732 08/18/2022 which claims benefit of 63/235,290 08/20/2021. Based on the filing receipt, the effective filing date of this application
is August 20 2021, which is the filing date of 63/235,290 from which the benefit of priority is
claimed.
Information Disclosure Statement
The information disclosure statement filed 09/16/2024 has been considered.
Status of Claims
Claims 4-8, 11-13, 17-22, 24-27, 29, 31, 33, 35-59, and 61-74 are cancelled.
Claims 1-3, 9-10, 14-16, 23, 28, 30, 32, 34, 60, and 75-76 are pending and examined herein.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 2 recites, “effect(s) of the complement factor deposition of on target effector cells”. The claim should recite, “effect(s) of the complement factor deposition
Claim 2 also recites, “the sample comprises a blood sample”. The claim would be clearer if it recited “the test sample comprises a blood sample”.
Appropriate correction is required.
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 2-3, 9-10, 15-16, 23, 30, and 32 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.
With respect to claim 2, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “blood cells”, and the claim also recites “red blood cells” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Throughout claims 3, 9-10, 15-16, and 23, limitations reciting baseline “positivity level[s]” are presented. It is unclear what measurements would meet the limitations of a baseline “positivity level”. The specification does not ameliorate the indefiniteness. Therefore, the metes and bounds of the claims cannot be ascertained. However, for the purpose of applying prior art, “positivity level” will be interpreted to mean a change in expression.
Claims 30 and 32 recite the limitation of a "third sample" in the body of the claims. There is insufficient antecedent basis for this limitation in the claim. The independent claim 1 does not recite a first sample and a second sample, therefore, it is unclear what sample would constitute a “third sample”. Therefore, the metes and bounds of the claims cannot be ascertained.
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, 9-10, 14-16, 23, 28, 30, 32, 34, 60, and 75-76 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Regarding claims 1-3, 9-10, 14-16, 23, 28, 30, 32, 34, 60, and 75-76, the independent claims recite a “method of identifying a test compound for treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT, the method comprising […] measuring a biological phenomenon” (claims 1, 14, and 28). All independent claims are directed at the relationship between a biological phenomenon and SCD, BT, or sickle cell BT. These judicial exceptions are not integrated into a practical application, such as constituting an improvement in the technological field, or including steps recited in addition to the judicial exception that integrates detection of the natural phenomena into a particular treatment/prophylaxis according to MPEP § 2106.04(d)(2). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the additional elements fail to provide either an inventive concept or impose meaningful limits upon the method such that the invention does not preempt every observance of the natural phenomenon itself.
Eligibility Step 1:
Claims 1-3, 9-10, 14-16, 23, 28, 30, 32, 34, 60, and 75-76 are directed to methods comprising measuring a biological phenomenon to assess the state of SCD, BT or sickle cell BT. Methods are one of the eligible statutory categories for invention (STEP 1: YES). However, eligibility of the claims is not self-evident, and therefore analysis must proceed to Step 2.
Eligibility Step 2A, Prong One:
The natural relationships to which the claims are directed (i.e. the relations between the measured biological phenomenon and SCD, BT, or sickle cell BT) are laws of nature. Similar concepts have been held by the courts to constitute law of nature/ natural phenomena, as in the identification of a correlation between the presence of in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017). In Mayo, the Supreme Court found that a claim was directed to a natural law, where the claim required administering a drug and determining the levels of a metabolite following administration, where the level of metabolite was indicative of a need to increase or decrease the dosage of the drug. See Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66, 74 (2012).
The instant claims are similar to those in Mayo as they involve a "relation itself [which] exists in principle apart from any human action" (id. at 77), namely the relationship between the biological phenomenon and SCD, BT, or sickle cell BT. Therefore, the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
The claims also recite the following limitations: “wherein an attenuation in the biological phenomenon in the test sample compared to the biological phenomena phenomenon in a reference standard is indicative that the test compound is effective in treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT” (claim 1), “measuring a biological phenomenon comprising (1) deposition of a complement factor on the cells in the test sample; or (2) effect(s) of the complement factor deposition of on target effector cells” (claim 1), “the signal for the biological phenomenon is: (i) a baseline C3 positivity level and/or a baseline C5b9 positivity level of about or greater than 20% in a population of endothelial cells; or (ii) a baseline Tissue Factor (TF) positivity level of about or greater than 10% in monocytes” (claim 3), “(i) the baseline C3 positivity level and/or a baseline C5b9 positivity level in the population of endothelial cells is greater than 30%; (ii) the baseline TF positivity level in monocytes is greater than 15%” (claim 9), “(a) the baseline C3 positivity level and/or a baseline C5b9 positivity level in the population of endothelial cells is greater than 50%; or (b) the baseline TF positivity level in monocytes is greater than 20%” (claim 10), “measuring a biological phenomenon comprising (1) deposition of a complement factor on the cells in said first and the second samples; or (2) effect(s) of the complement deposition in the cells of said first and second samples on target effector cells; wherein an attenuation in the biological phenomena phenomenon of (c) in the second sample compared to the biological phenomena phenomenon of (c) in the first sample is indicative that the test compound is effective in treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT” (claim 14), “(i) a baseline C3 positivity level and/or a baseline C5b9 positivity level of about or greater than 20% in a population of endothelial cells; or (ii) a baseline Tissue Factor {TF) positivity level of about or greater than 10% in monocytes” (claim 15), “(i) the baseline C3 positivity level and/or a baseline C5b9 positivity level in the population of endothelial cells is greater than 30%; or (ii) the baseline TF positivity level in monocytes is greater than 15%” (claim 16), “(i) the baseline C3 positivity level and/or a baseline C5b9 positivity level in the population of endothelial cells is greater than 50%; or (ii) the baseline TF positivity level in monocytes is greater than 20%” (claim 23), “measuring a biological phenomenon comprising (1) deposition of a complement factor on the cells in said first and the second samples; or (2) effect(s) of the complement deposition in the cells of the first and second samples on target effector cells comprising cells; wherein an attenuation in the biological phenomena phenomenon of (c) in the second sample compared to the biological phenomena phenomenon of (c) in the first sample is indicative that the test compound is effective in treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT” (claim 28), “the complement factor is complement factor C3 or a protein fragment of complement factor C3” (claim 32), “the effect(s) of complement deposition on target effector cells is mediated via a complement receptor (CR) in effector cells; (g) the effect(s) of complement deposition on target effector cells results in upregulation of tissue factor (TF)” (claim 30), and “the protein fragment of complement factor C3 is IC3b” (claim 34). These claim limitations are all directed at the natural relationship between the biological phenomenon and SCD, BT, or sickle cell BT. The claims are only further specifying the features of the natural relationship.
Furthermore, the claims are directed at another judicial exception, specifically abstract ideas. The claims are directed to methods of identifying a test compound for treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT. The “identifying” is an abstract idea, namely a mental process. The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, “methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’” 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) (“‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’” (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
Accordingly, the “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. Identifying is a species of judgement.
Eligibility Step 2A, Prong Two:
According to Step 2A, Prong Two, set forth in MPEP 2106.04 II A (2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. This analysis turns to the additional steps/elements recited within the claims. There are no additional/elements recited within the claims which are directed towards integrating the judicial exception into a practical application.
Regarding claims 2-3, 9, 14-16, 23, 30, 32, 34, 60, 75-76, providing samples/controls/references and measuring biological phenomenon using methods with different cell phenotypes and different test compounds are insufficient to integrate the judicial exception because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015). Furthermore, the steps of measuring biomarkers are recited at a high level of generality and are not tied, for example, to any particular machine or apparatus.
There are no additional elements that reflect an actual improvement within the technical field. For example, there are no additional elements that apply the natural correlation/phenomena judicial exception to a particular treatment or which utilize a particular machine; there are no additional elements that effect a transformation; and, there are no additional elements that apply the judicial exception in some other meaningful way beyond generally linking it to a field, namely, SCD, BT, or sickle cell BT. In this way the claims, as drafted, do not integrate the judicial exception into a practical application that would overcome monopolizing the exception. (STEP 2A, Prong Two: NO).
Eligibility Step 2B:
Lastly, there are no additional elements of claims 1-3, 9-10, 14-16, 23, 28, 30, 32, 34, 60, and 75-76.
Therefore, the steps/elements recited in addition to the judicial exception do not add significantly more (STEP 2B: NO).
The claimed steps/elements recited in addition to the judicial exception, alone or in combination, do not make an inventive contribution over the methods that were known in the art prior to filing, and they amount to mere observation of the natural phenomenon itself, by any means known, with the words “apply it” in order to append it to the field of SCD, BT, or sickle cell BT.
For all these reasons, the claimed subject matter is ineligible under 35 U.S.C. 101 because the claims are directed to a natural phenomenon judicial exception without significantly more.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 14-15, 28, 30, 32, 34, and 75-76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Merle (“Intravascular hemolysis activates complement via cell-free heme and heme-loaded microvesicles”, published 2018).
With respect to claim 1, Merle teaches a method of identifying a test compound for treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT, the method comprising, contacting a test sample comprising cells with heme, serum, and the test compound; and
measuring a biological phenomenon comprising:
(1) deposition of a complement factor on the cells in the test sample; or
(2) effect(s) of the complement factor deposition of on target effector cells;
wherein an attenuation in the biological phenomenon in the test sample compared to the biological phenomenon in a reference standard is indicative that the test compound is effective in treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “Primary HUVECs were cultured on 24-well plates as previously described (12, 54) and exposed to heme or RBC MVs at the indicated doses for 30 minutes at 37°C in serum-free M199 cell culture medium (Gibco) in presence or absence of Hx or HSA. For evaluation of complement activation, HUVECs were washed and further exposed to NHS diluted to 33% in M199 medium or serum was added to final dilution of 33% to the wells, already containing heme with and without Hx for 30 minutes at 37°C. HUVECs were used for experiments until passage 4. Cells were washed, detached, labeled, and fixed in 0.5% formaldehyde. Cells were analyzed by flow cytometry (BD LSR II) and further analyzed by FlowJo X”). It is understood that Hx (hemopexin) is equivalent to a test compound.
With respect to claim 2, Merle teaches wherein the test sample comprises endothelial cells (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “For evaluation of complement activation, [human umbilical vein endothelial cells (HUVECs)] were washed and further exposed to NHS diluted to 33% in M199 medium or serum was added to final dilution of 33% to the wells, already containing heme with and without Hx for 30 minutes at 37°C”).
With respect to claim 14, Merle teaches a method of identifying a test compound for treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT, the method comprising,
(a) contacting a first sample comprising cells with heme and serum;
(b) contacting a second sample comprising the cells with the test compound, heme and serum, and
(c) measuring a biological phenomenon comprising (1) deposition of a complement factor on the cells in said first and the second samples; or (2) effect(s) of the complement deposition in the cells of said first and second samples on target effector cells;
wherein an attenuation in the biological phenomena phenomenon of (c) in the second sample compared to the biological phenomenon of (c) in the first sample is indicative that the test compound is effective in treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “Primary HUVECs were cultured on 24-well plates as previously described (12, 54) and exposed to heme or RBC MVs at the indicated doses for 30 minutes at 37°C in serum-free M199 cell culture medium (Gibco) in presence or absence of Hx or HSA. For evaluation of complement activation, HUVECs were washed and further exposed to NHS diluted to 33% in M199 medium or serum was added to final dilution of 33% to the wells, already containing heme with and without Hx for 30 minutes at 37°C. HUVECs were used for experiments until passage 4. Cells were washed, detached, labeled, and fixed in 0.5% formaldehyde. Cells were analyzed by flow cytometry (BD LSR II) and further analyzed by FlowJo X”).
With respect to claim 15, Merle teaches wherein the first sample comprises endothelial cells (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “For evaluation of complement activation, [human umbilical vein endothelial cells (HUVECs)] were washed and further exposed to NHS diluted to 33% in M199 medium or serum was added to final dilution of 33% to the wells, already containing heme with and without Hx for 30 minutes at 37°C”).
With respect to claim 28, Merle teaches a method of identifying a test compound for treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT, the method comprising,
(a) contacting a first sample comprising cells with heme and serum;
(b) contacting a second sample comprising the cells with the test compound, heme, and
serum, and
(c) measuring a biological phenomenon comprising (1) deposition of a complement
factor on the cells in said first and the second samples; or (2) effect(s) of the complement deposition in the cells of the first and second samples on target effector cells comprising cells;
wherein an attenuation in the biological phenomena phenomenon of (c) in the second sample compared to the biological phenomenon of (c) in the first sample is indicative that the test compound is effective in treating sickle cell disease (SCD), β-thalassemia (BT), or sickle cell BT, and wherein the cells are endothelial cells or blood cells (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “Primary HUVECs were cultured on 24-well plates as previously described (12, 54) and exposed to heme or RBC MVs at the indicated doses for 30 minutes at 37°C in serum-free M199 cell culture medium (Gibco) in presence or absence of Hx or HSA. For evaluation of complement activation, HUVECs were washed and further exposed to NHS diluted to 33% in M199 medium or serum was added to final dilution of 33% to the wells, already containing heme with and without Hx for 30 minutes at 37°C. [human umbilical vein endothelial cells (HUVECs)] were used for experiments until passage 4. Cells were washed, detached, labeled, and fixed in 0.5% formaldehyde. Cells were analyzed by flow cytometry (BD LSR II) and further analyzed by FlowJo X”).
With respect to claim 30, Merle teaches wherein the measuring step comprises flow cytometry (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “Cells were analyzed by flow cytometry (BD LSR II) and further analyzed by FlowJo X”).
With respect to claim 32, Merle teaches the complement factor is a protein fragment of complement factor C3 (see, e.g., p. 7, under “Figure 3.”, under panel “D”).
With respect to claim 34, Merle teaches wherein the protein fragment of complement factor C3 is IC3b (see, e.g., p. 5, under “Figure 2.”, under panel “J”).
With respect to claim 75, Merle teaches the first sample and the second sample comprise RBCs (see, e.g., p. 14, para. 2: “Alternatively, RBCs from naive mice were purified and incubated at 1 × 106 cells/tube for 30 minutes with 50 μM heme, followed by addition of normal mouse serum for 30 minutes. Cells were washed and probed for C3 fragment deposits by flow cytometry (BD LSR II) and further analyzed by FlowJo X”).
With respect to claim 76, Merle teaches the cells are endothelial cells, and the method comprises contacting the first sample comprising endothelial cells with heme and serum for a period sufficient to induce complement deposition on endothelial cells (see, e.g., p. 14, under “Complement activation and complement receptors on ECs”, under “Flow cytometry”: “For evaluation of complement activation, HUVECs were washed and further exposed to NHS diluted to 33% in M199 medium or serum was added to final dilution of 33% to the wells, already containing heme with and without Hx for 30 minutes at 37°C”, and p. 7, under “Figure 3.”, under panel “D”).
Claim Rejections - 35 USC § 103
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.
Claims 3, 9-10, 16, 23, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Merle (cited above), as applied to claims 1-2, 14-15, 28, 30, 32, 34, and 75-76 above, and further in view of Thomas (“Complement Component C5 and TLR Molecule CD14 Mediate Heme-Induced Thromboinflammation in Human Blood”, published 2019).
Merle teaches as set forth above, but fails to teach the baseline Tissue Factor (TF) positivity level in monocytes is greater than 20%, as in claims 3, 9-10, 16, and 23. Merle also fails to teach the inhibitor is the anti-C5 antibody, eculizumab, as in claim 60.
However, Thomas teaches the baseline TF positivity level in monocytes is greater than 15%, as in claims 3, 9-10, 16, and 23 (see, e.g., p. 1571, under abstract: “In this study, we explored the effect of single and dual inhibition of complement component C5 and TLR coreceptor CD14 on heme-induced thromboinflammation in an ex vivo human whole blood model. Heme induced a dose-dependent activation of complement via the alternative pathway. […] Single inhibition of C5 by eculizumab attenuated the release of IL-6, IL-8, TNF, MCP-1, MIP-1a, IFN-g, LTB-4, MMP-8 and-9, and IL-1Ra with more than 60% (p < 0.05 for all) reduced the upregulation of CD11b on granulocytes and monocytes by 59 and 40%, respectively (p < 0.05), and attenuated monocytic tissue factor expression by 33%. […] Markers of thromboinflammation were also quantified in two patients admitted to the hospital with sickle cell disease (SCD) crisis”, emphasis added). Thomas also teaches measuring the inhibitor is the anti-C5 antibody, eculizumab, as in claim 60 (see, e.g., p. 1571, under abstract: “Single inhibition of C5 by eculizumab attenuated the release of IL-6, IL-8, TNF, MCP-1, MIP-1a, IFN-g, LTB-4, MMP-8 and-9, and IL-1Ra with more than 60% (p < 0.05 for all) reduced the upregulation of CD11b on granulocytes and monocytes by 59 and 40%, respectively (p < 0.05), and attenuated monocytic tissue factor expression by 33%”).
Merle and Thomas are analogous to the field of the claimed invention because they are both in the field of hemolytic disease. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the eculizumab to attenuate monocytic tissue factor expression as in Thomas into the method of Merle. An artisan would have been motivated to do so because Thomas discloses, “In conclusion, heme-induced thromboinflammation was largely attenuated by C5 inhibition alone, with a beneficial effect of adding a CD14 inhibitor to attenuate prothrombin activation. Targeting C5 has the potential to reduce thromboinflammation in SCD crisis patients” (see, p. 1571, under abstract). An artisan would have had a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
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/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 September 4, 2026
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