DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election of Group II in the reply filed on June 16, 2026 is acknowledged. Additionally Applicant’s election of the species (i) determining the fraction of PLC and IPF and (ii) PLCs characterized by CD41+CD61+SPARC+TREML1+ 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)).
After further consideration the restriction requirement between Groups I and II has been withdrawn.
Claims 1-20 are currently pending.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter (nonelected species), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2026.
Claim Rejections - 35 USC § 101
3. 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 1-5, 10-16, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite abstract ideas.
The claims recite the following limitation:
determining
(i) the fraction of platelet lineage cells (PLCs) among the total cells in the blood sample, wherein a reduced fraction of PLCs compared to a first reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment, and/or
(ii) the Immature Platelet Fraction (IPF) in the blood sample, wherein an increased IPF compared to a second reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment.
Neither the specification nor the claims set forth a limiting definition for “determining” and the claims do not set forth how this step is accomplished. The claims do not require performing any “wet” laboratory steps. The “determining” step broadly encompasses a mental processes. For example, one may “determine” the fraction of PLCs and IPF by reading this information in a laboratory report. Additionally the claims are considered to encompass “comparing”, even if this is not recited in the active tense. Comparing is also a mental process.
Additionally the claims recite the following limitation:
selecting a patient who has been diagnosed as not being at a heightened risk of developing secondary autoimmunity after a lymphocyte depleting therapy
The broadest reasonable interpretation of the “selecting” step is that it may be accomplished by a mental process. For example, one may “select” the patient by thinking about their risk level of developing secondary autoimmunity after a lymphocyte depleting therapy.
For the reasons discussed above, the “determining”, “comparing” and “selecting” could each be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).
The instant claims recite a law of nature.
The claims recite a correlation between the fraction of PLC’s and risk of developing secondary autoimmunity. Additionally the claims recite a correlation between IPF and risk of developing secondary autoimmunity. These correlations are a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses 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.
Claim 2 recites a step of “administering” a therapeutically effective amount of the lymphocyte depleting therapy to the patient. It is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. However the treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exceptions. Here the administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the judicial exceptions into a practical application.
In addition to the judicial exceptions the claims also recite a step of “providing” a blood sample. This step is not considered to integrate the judicial exception into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions the claims also recite a step of “providing” a blood sample. This step does not amount to significantly more because it simply appends a well understood, routine, and conventional activity previously known in the art, specified at a high level of generality, to the judicial exception.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Determining the level of a biomarker in blood 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);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For the reasons set forth above the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
4. 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 1-16 and 18-20 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.
Regarding Claim 1 it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites a method for assessing the risk of developing secondary autoimmunity in a patient with a primary autoimmune disease following lymphocyte depleting therapy, yet the method only requires steps of providing a blood sample and determining the fraction of PLCs and the IPC. Thus it is not clear if applicant intends to cover only a method of providing a blood sample and determining the fraction of PLCs and the IPC OR if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the later, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal set forth by the preamble of the claims. It is noted that the claims further recite “wherein a reduced fraction of PLCs compared to a first reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment” and “wherein an increased IPF compared to a second reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment”. However claim scope is not limited by claim language (such as wherein clauses) that suggests or makes optional but does not require steps to be performed.
Claims 1-14, 16, 18-20 are rejected over the recitation of the phrase “platelet lineage cells (PLC’s)”. This phrase in considered indefinite because “platelet lineage cells (PLC’s)” is not an art recognized term. While the specification (paras 0054-0056) teaches that PLC’s may be identified based on the expression of specific cell surface markers, a complete definition for this phrase is not provided. Because the phrase “platelet lineage cells (PLC’s)” has not been clearly defined in the specification and because there is no art recognized definition for this term, one of skill in the art cannot determine the metes and bounds of the claimed subject matter.
Claims 2-16 and 18-20 require selecting a patient who has been diagnosed as not being at a heightened risk of developing secondary autoimmunity after a lymphocyte depleting therapy. The claims state that the risk is diagnosed by determining (i) the fraction of platelet lineage cells (PLCs) among the total cells in a blood sample and (ii) the Immature Platelet Fraction (IPF) in a blood sample of the patient. However determining (i) and (ii) does not necessarily result in the diagnosis. Thus the claims are incomplete for omitting the essential step of “diagnosing”.
Claim Rejections - 35 USC § 112
5. 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 1-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for
A method for identifying a patient diagnosed with multiple sclerosis (MS) as having a decreased risk of developing a secondary autoimmune thyroid disease following treatment with alemtuzumab, comprising:
a) providing a blood sample from the patient;
b) assaying (i) the fraction of platelet lineage cells (PLCs) among the total cells in the blood sample, wherein PLSs are characterized by being CD41+CD61+SPARC+TREML1+ and (ii) the Immature Platelet Fraction (IPF) in the blood sample;
c) determining that (i) the fraction of PLC’s is reduced in comparison to the fraction of PLC’s from reference samples and (ii) the IPF is increased in comparison to the IPF from the reference samples, wherein the reference samples are from MS patients that developed a secondary autoimmune thyroid disease after treatment with alemtuzumab; and
identifying the patient as having a decreased risk of developing a secondary autoimmune thyroid disease following treatment with alemtuzumab.
does not reasonably provide enablement for the claims as broadly written. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Scope of the Claims/Nature of the Invention
The claims are drawn to (i) methods for assessing the risk of developing secondary autoimmunity in a patient with a primary autoimmune disease following lymphocyte depleting therapy and (ii) methods of treating a patient with a primary autoimmune disease that has been diagnosed as not being at a heightened risk of developing secondary autoimmunity in a patient with a primary autoimmune disease following lymphocyte depleting therapy. In view of the recitation of the phrase “primary autoimmune disease” the claims broadly encompass ANY type of primary autoimmune disease (i.e., Type 1 diabetes, lupus, multiple sclerosis, inflammatory bowel disease etc.). Only claims 4 and 20 are limited to specific primary autoimmune disease, namely MS. In view of the recitation of the phrase “secondary autoimmune disease” the claims broadly encompass ANY type of secondary autoimmune disease (i.e., Sjogren’s frequently accompanies lupus while Hashimoto’s and Graves frequently coexist with RA, Lupus, and MS). Only claim 19 is limited to specific secondary autoimmune diseases. In view of the recitation of the phrase “lymphocyte depleting therapy” the claims broadly encompass ANY type of therapy that depletes lymphocytes (i.e., radiation, chemotherapy, antigen therapy, etc.). Claim 5 is limited to a lymphocyte depleting antibody therapy. Claim 6 is limited to an anti-CD52 antibody or an antigen-binding portion thereof. Claim 7 is limited to an anti-CD52 antibody comprising the six CDRs of alemtuzumab. Claim 8 is limited to an anti-CD52 antibody comprising the heavy and light chain variable domains of alemtuzumab. Claim 9 is limited to alemtuzumab.
The claim requires determining the fraction of platelet lineage cells (PLCs) among the total cells in a blood sample. The claims do not define what a platelet lineage cell is. The claims broadly encompass determining the fraction of ANY cell (HSC, MEP, megakaryoblast, megakaryocyte, platelet) within the developmental pathway that originates from a hematopoietic stem cell and ultimately produces blood platelets. Only claim 15 states that the PLC’s are characterized by being CD41+CD61+SPARC+TREML1+. Additionally the claim requires determining the Immature Platelet Fraction (IPF) in a blood sample.
The claims recite that a reduced fraction of PLCs compared to a first reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment. The claims state that an increased IPF compared to a second reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment. The claims do not define what the first or second references are and therefore they broadly encompass ANY reference. Only claim 10 is limited to a method wherein the first and second references are obtained from a patient with the primary autoimmune disease who does not develop secondary autoimmunity after the lymphocyte depleting treatment, or from a healthy subject.
The nature of the invention requires a reliable correlation between the fraction of PLC’s and risk of developing secondary autoimmunity. The nature of the invention further requires a reliable correlation between IPF and risk of developing secondary autoimmunity.
Teachings in the Specification and Examples
The specification (para 0086) teaches that PBMC samples were obtained from patients diagnosed with relapsing-remitting multiple sclerosis (RR-MS) that were treated with alemtuzumab. This study analyzed samples from T0 and T24 time points for a total of 32 patients of which 11 developed secondary autoimmunity (sAI, defined by occurrence of thyroid events) following alemtuzumab treatment. 18 patients did not develop secondary autoimmunity (non-sAI) and 3 patients had laboratory abnormalities (LA). A thyroid event was defined as either having a laboratory finding (e.g., abnormal TSH) or a clinical adverse event (AE). If diagnosed, the clinical AE was classified as Grave's disease (i.e., hyperthyroidism), Hashimoto's disease (i.e., hypothyroidism), transient thyroiditis, Grave's disease switching to hypothyroidism, Hashimoto's disease switching to hyperthyroidism, or uncertain. The specification (paras 0089-90) teaches that 8000 cells were targeted per sample. Sequencing was carried out on a NOVAseq™ 6000 System (Illumina).
The specification (para 0095) teaches that since no difference in the relative abundance of known cell types or subtypes was observed between those with or without thyroid events, the abundance of cell types classified as unknown by the automated algorithm was analyzed. Surprisingly, this revealed a rare platelet-like cell-type (PLC) significantly lower in those with thyroid events compared to those without (FIG. 1, sAI 0.07%; non-sAI 0.52%). The PLC percentage was low (<0.1%), but the difference between sAI and non-sAI was highly significant and held both at the pre-treatment and post-treatment timepoint (FIG. 3). Based on marker expression (FIG. 4), PLCs strongly resembled platelets, but expressed two additional surface markers at high levels that are not ubiquitously associated with platelets: SPARC and TREML. Platelets are common contaminants in PBMC preparations, however they are small and not expected to contain RNA. Thus, this cell type was hypothesized to constitute platelet lineage cells (PLCs) with special physical characteristics (e.g., larger size and transcript content) amenable to sc-RNAseq capture.
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The specification (para 0106) teaches that an analysis of Immature Platelet Fraction (IPF) data available for the cohort was carried out and it was found that patients with thyroid events had a significantly increased IPF at TO compared to those without (FIG. 12A). Moreover, patients with thyroid events tracked higher in IPF in monthly measurements taken throughout the two-year period (FIG. 12B). High IPF at T0 is not specific to sAI. However low relative PLCs and high IPF together appear to be a more specific indicator than high IPF alone (FIG. 13).
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Unpredictability of the Art
The claims are drawn to a method for assessing the risk of developing secondary autoimmunity in a patient with a primary autoimmune disease following lymphocyte depleting therapy.
Autoimmunity is a condition where the body’s immune system mistakenly identifies its own health cells, tissues, or organs as foreign invaders and attacks them. It is noted that there are over 80 different autoimmune disease. The different primary autoimmune diseases encompassed by the claims have distinct etiologies, symptoms and outcomes. It is noted that the teachings in the specification are limited to patients diagnosed with MS as a primary autoimmunity. In the absence of evidence to the contrary it is highly unpredictable if the findings in the specification with regard to MS could be extrapolated to any of the other of the greater than 80 different autoimmune diseases.
A secondary autoimmunity disease is the development of a second distinct autoimmune condition in someone already diagnosed with one. Examples of this include Sjogren’s which frequently accompanies lupus and Hashimoto’s and Graves which frequently coexist with RA, Lupus, and MS. It is noted that the teachings in the specification are limited to MS patients that developed secondary autoimmune thyroid disease (Graves and Hashimoto’s). None of the patients developed any other types of secondary autoimmune diseases. In the absence of evidence to the contrary it is highly unpredictable if the findings in the specification with regard to secondary autoimmune thyroid disease (Graves and Hashimoto’s) could be extrapolated to any other secondary autoimmune disease (i.e., ITP, Goodpasture’s, myalgia, sarcoidosis, etc.).
The claims broadly encompass ANY type of therapy that depletes lymphocytes. Such therapies would include radiation, chemotherapy, antigen therapy. However the specification only provides evidence that the fraction of PLC and IPF are predictive of the occurrence of second autoimmunity in subject treated with a SINGLE type of lymphocyte depleting therapy, namely alemtuzumab. There are no examples in the specification where any other type of therapy was tested. It is highly unpredictable if the fraction of PLC and IPF are predictive of the occurrence of second autoimmunity in subjects treated with any other types of lymphocyte depleting therapy.
Additionally it is highly unpredictable if the claimed methods can be practiced using ANY reference. As discussed above the claims do not set forth what the reference is and broadly encompass any reference. However the teachings in the specification are limited to the analysis of PLC’s and IPF in (i) MS patients treated with alemtuzumab who developed secondary autoimmune thyroid disease (sAI) and (ii) MS patients treated with alemtuzumab who did not develop secondary autoimmune thyroid disease (non-sAI). It is highly unpredictable if patients that have increased risk of developing secondary autoimmunity will have reduced fraction of PLC and increased IPF when compared to ANY control encompassed by the claims.
The claims require assessing risk of developing secondary autoimmunity based on the fraction of PLC’s and/or IPF. However it is highly unpredictable if it is possible to assess risk of developing secondary autoimmunity based only on IPF. This is because the specification (para 0106) teaches that high IPF at T0 is not specific to sAI. However low relative PLCs and high IPF together appear to be a more specific indicator than high IPF alone (FIG. 13).
Quantity of Experimentation:
The quantity of experimentation necessary is great, on the order of many man-years, and then with little if any reasonable expectation of successfully enabling the full scope of the claims. In support of this position, it is noted that the claimed methods encompass being able to assess the risk of developing ANY type of secondary autoimmunity in a patient with ANY primary autoimmunity disease following ANY therapy that depletes lymphocytes.
In order to practice the breadth of the claimed invention one of skill in the art would first have to recruit a large number of patients having a representative number of different primary autoimmune disorders (i.e., Type 1 diabetes, lupus, multiple sclerosis, inflammatory bowel disease etc.). Then those patients would have to be treated with a representative number of different therapies that deplete lymphocytes (i.e., radiation, chemotherapy, antigen therapy, etc.) and followed several years to determine if they developed ANY type of secondary autoimmune disorders. All the patients would have to provide blood samples before, during, and after treatment so that the fraction of PLC’s and IPF could be determined. Then the patients would have to split into groups of those that did develop secondary autoimmunity and those that did not and the data on the fraction of PLC’s and IPF would have to be analyzed to see if it could be used to predict the outcome. The specification has merely provided an invitation for further experimentation. The results of such experimentation are highly unpredictable.
The amount of experimentation that would be required to practice the full scope of the claimed invention and the amount of time and cost this experimentation would take supports the position that such experimentation is undue. Attention is directed to Wyeth v. Abbott Laboratories 107 USPQ2d 1273, 1275, 1276 (Fed. Cir. June 2013):
Claims are not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380-81 [103 USPQ2d 1769] (Fed. Cir. 2012).
The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that it does. Undue experimentation is a matter of degree. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 [70 USPQ2d 1321] (Fed. Cir. 2004) (internal quotation omitted). Even “a considerable amount of experimentation is permissible,” as long as it is “merely routine” or the specification “provides a reasonable amount of guidance” regarding the direction of experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360-61 [47 USPQ2d 1705] (Fed. Cir. 1998) (internal quotation omitted). Yet, routine experimentation is “not without bounds.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013). (Emphasis added)
In Cephalon, although we ultimately reversed a finding of nonenablement, we noted that the defendant had not established that required experimentation “would be excessive, e.g., that it would involve testing for an unreasonable length of time.” 707 F.3d at 1339 (citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983)). Finally, in In re Vaeck, we affirmed the PTO's nonenablement rejection of claims reciting heterologous gene expression in as many as 150 genera of cyanobacteria. 947 F.2d 488, 495-96 [20 USPQ2d 1438] (Fed. Cir. 1991). The specification disclosed only nine genera, despite cyanobacteria being a “diverse and relatively poorly understood group of microorganisms,” with unpredictable heterologous gene expression. Id. at 496. (Emphasis added)
Additionally, attention is directed to Cephalon at 1823, citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 218 USPQ 961, that work that would require 18 months to 2 years so to enable the full scope of an invention, even if routine, would constitute undue experimentation. As stated therein:
Permissible experimentation is, nevertheless, not without bounds. This court has held that experimentation was unreasonable, for example, where it was found that eighteen months to two years’ work was required to practice the patented invention. See, e.g., White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] Fed. Cir.1983). (Emphasis added)
Attention is also directed to MPEP 2164.06(b) and In re Vaeck, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991).
Where, as here, a claimed genus represents a diverse and relatively poorly understood group of microorganisms, the required level of disclosure will be greater than, for example, the disclosure of an invention involving a “predictable” factor such as a mechanical or electrical element. See Fisher, 427 F.2d at 839, 166 USPQ at 24.
In view of such legal precedence, the aspect of having to work for so many years just to provide the starting materials for minute fraction of the scope of the claimed invention is deemed to constitute both an unreasonable length of time and undue experimentation.
Conclusions:
Herein, although the level of skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the invention as broadly claimed.
Claim Rejections - 35 USC § 102
6. 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuker (Blood Vol 118 No 24 12/8/2011 pages 6299-6305).
As noted in MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the present situation, the process steps are able to stand alone and the preamble limitation is not accorded patentable weight. Accordingly, the claim language of “A method for assessing the risk of developing secondary autoimmunity in a patient with a primary autoimmune disease following lymphocyte depleting therapy” merely sets forth the purpose of the process, but does not limit the scope of the claims.
Regarding Claim 1 Cuker discloses that in a phase 2 clinical trial of alemtuzumab for treatment of relapsing-remitting MS, 6 of the 216 patients (2.8%) developed immune thrombocytopenia (abstract), Cuker teaches that they compared characteristics between patients with and without ITP. Cuker teaches that to explore potential markers of ITP, immature platelet fraction was measured with Sysmex XE-2100 (page 6300). Cuker teaches that alterations in immature platelet fraction did not show a consistent temporal association with inception or resolution of ITP (page 6302). Thus Cuker teaches a method comprising a) providing a blood sample from a patient; and b) determining the Immature Platelet Fraction (IPF) in the blood sample. While Cuker teaches all of the claimed method steps, Cuker does not teach a correlation between an increased IPF and a heightened risk of developing secondary autoimmunity in the patient after treatment. However this art rejection is set forth because it teaches a broad interpretation of the claims which does not require such a correlation. In the instant case the preamble is considered to be an intended use of the claimed method and does not limit the scope of the claims. Further, regarding the recitation of “wherein an increased IPF compared to a second reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment”, Applicants are reminded that claim scope is not limited by claim language (such as wherein clauses) that suggests or makes optional but does not require steps to be performed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm 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, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
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