DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status and Formal Matters
This action is in response to filed 10/16/2025.
Claims 1-2, 4, 6-7, 9-10, 12, 16, 21, 24-28, 31, 33-36 are pending.
Claims 10, 12, 16, 21, 24-25, 31 have been amended.
Claims 33-36 have been added by amendment.
Applicant’s election without traverse of Group II, a. Subject suffers from cancer and said cancer is in remission; An increase is: b. as compared to a predetermined threshold; in the reply filed on 6/3/2025 is acknowledged.
Claims 1-4, 6-7, 9, 21, 25-26, 30-31 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/3/2025.
Claims 10, 12, 16, 21, 24, 27, 28, 31, 33-36 are being examined.
The previous objection to the claims have been withdrawn in view of the amendment.
The art and ODP rejection have been withdrawn in view of the amendment of claim 10 to recite, “diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks.”
Priority
The instant application was filed 06/02/2022 and is a national stage entry of PCT/IL2020/051244 with an international filing date: 12/02/2020 and claims priority from provisional application 62942276 , filed 12/02/2019.
Claim Objections
Claims 10, 12, 16, 21, 24, 27, 28, 31, 33-36 are objected to because of the following informalities:
The preamble of claim 1 has been amended to limit the claims to human. However steps (a), (c ) has been added by amendment and recites, “said subject.” Claims are clearer and more concise when same language is used throughout.
Appropriate correction is required.
Response to Arguments
This is a new ground of objection.
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 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.
New matter
MPEP 2163 IB New or amended claims section II
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04
Claim 10 has been amended to recite, “c) diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks; and d) administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse thereby diagnosing or predicting cancer relapse in said subject.” Thus the claims require administering an immunotherapy based on diagnosis.
The response provides no indication where support for the claimed amendment can be found. Review and searching of the specification revealed, “[073] In some embodiments, the method further comprises administering another therapy to the subject. In some embodiments, the another therapy is a different therapy. In some embodiments, the another therapy is a therapy that treats the cancer. In some embodiments, the method further comprises administering another therapy to a subject diagnosed with or predicted for a cancer relapse. In some embodiments, the method further comprises administering another therapy to a subject diagnosed with a cancer relapse. In some embodiments, the method further comprises administering another therapy to a subject predicted for a cancer relapse. In some embodiments, the method further comprises administering another therapy to a subject determined to be a non- responder. In some embodiments, the method further comprises administering another therapy to a subject determined to be a non-responder to the immunotherapy. In some embodiments, the other therapy is not the therapy that caused the remission. In some embodiments, the other therapy is a different therapy than the therapy initially used to treat the cancer. In some embodiments, the other therapy is not a PD-1/PD-L1 based immunotherapy. In some embodiments, the other therapy is not an immunotherapy. In some embodiments, the other therapy is not the therapy to which the subject is a non-responder.” However, the instant claims do not require the subject has cancer or a previously treated for cancer. Thus the amendment has introduced new matter.
Written description
As set forth in In re Alonso 88 USPQ2d 1849 (Fed. Cir. 2008), at 1851:
The written description requirement of 35 U.S.C. § 112, ¶ 1, is straightforward: “The specification shall contain a written description of the invention ….” To satisfy this requirement, the specification must describe the invention in sufficient detail so “that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997); see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 [76 USPQ2d 1724] (Fed. Cir. 2005); Eiselstein v. Frank, 52 F.3d 1035, 1039 [34 USPQ2d 1467] (Fed. Cir. 1995).
Alonso at 1852:
A genus can be described by disclosing: (1) a representative number of species in that genus; or (2) its “relevant identifying characteristics,” such as “complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Enzo, 323 F.3d at 964.
In applying the test as set forth in Alonso, it is noted that applicant is claiming a method of diagnosing or predicting cancer relapse in a human subject in need thereof, the method comprising a) receiving a sample obtained from said subject; b) measuring soluble CD28 (sCD28) levels in said sample, wherein an increase in sCD28 levels in said sample as compared to a sample from said human subject obtained while said human subject was cancer free or in remission indicates cancer relapse or an within the next 20 weeks from said measuring; [[,]] c) diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks; and d) administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse thereby diagnosing or predicting cancer relapse in said subject.
The claims encompass treating with any immunotherapy. However, the claim does not require the subject in which sCD28 was measured is the subject being treated in view of the indefinite article.
Further the claims are limited to, “diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks;”
The claims encompass replace of any cancer, although the claim does not require the human subject ever had cancer.
The specification teaches, “Cancer patients plasma samples of different indications, that received anti-PD 1 therapy, were diluted 1:10 and analyzed for soluble human CD28 by functional ELISA.” (090].
The specification teaches, “[092] To further understand the impact of sCD28 levels on cancer progression during immunotherapy, more than 100 serum samples from melanoma patients prior to initiation of anti- PD1 therapy (Nivolumab, NCT01176461) were tested for sCD28 levels by ELISA. Survival was monitored throughout therapy and a survival function was plotted comparing subjects with high and low levels of sCD28 before therapy (Fig. 1). It was found that subjects with low levels of sCD28 (below 2 ng/mL) had a longer median survival than those with high levels (659 days vs. 514 days).”
The specification in example 2 teaches, “[093] Serum from 166 individual patients (melanoma, renal cell carcinoma, lung squamous cell carcinoma and urothelial carcinoma patient) undergoing immunotherapy (anti-PD-1, for example Nivolumab and Pembrolizumab, anti-PD-L1, for example Atezolizumab and anti-CTLA-4, for example Ipilimumab) were examined for their sCD28 levels.”
The specification teaches, “Non-responders showed increasing sCD28 levels from baseline (before therapy) to week 7 and through to week 13 (Fig. 2B). In contrast, responders not only did not show increasing levels of sCD28, but in fact the average sCD28 levels decreased from baseline to week 7 and through to week 13 (Fig. 2C). When the absolute change in sCD28 expression is quantified at weeks 7 and 13 the increases seen in the non-responder population were statistically significant (Fig. 2D).” [094]
Example 3 of the specification teaches, “Both patients were, on average, negative for sCD28 during their response to the therapy, that is during the periods of remission (Fig. 3). However, both patients showed a marked increase in sCD28 levels just before or at the initiation of cancer relapse. The patient that had a complete response entered a phase of progressive disease (PD) and sCD28 levels began increasing from week 46 and on (Fig. 3, upper panel). The patient that had a partial response entered a phase of stable disease (SD) and sCD28 levels began increasing at week 35 (Fig. 3, lower panel). This demonstrates that increased and/or increasing sCD28 levels can act as a marker for cancer relapse after immunotherapy, and that this increase can be a predictive marker for imminent relapse.”
The teachings of the specification are limited to humans subjects at least . 36 weeks post immunotherapy treatment.
The teachings with respect to relapse are limited to subjects following complete or partial response, but did not occur until 25 or 46 week.
The teachings of the specification are limited to blood sample, however the claim in view of claim 21 encompass any sample.
Nolan (Am J Respir Crit Care Med Vol 177. pp 301–308, 2008) teaches. “Whereas the levels of sCD28 and sCD154 were no different in septic subjects compared with healthy control subjects, the plasma concentrations of both were higher in nonsurvivors compared with either survivors or healthy control subjects (Figure 7).”
Wang (Journal of Neuroimmunology 243 (2012) 52–55) teaches, “Plasma sCD28 levels were higher in NMO and MS.” (page 54. 1st column). Wang teaches, “Plasma sCD28 and sCTLA-4 had been investigated in many autoimmune diseases and infectious diseases (Cao et al., 2011), but less studied in NMO and MS. The functions of soluble T cell costimulatory molecules like sCD28 and sCTLA-4 are still controversial
(Ip et al., 2006). sCD28 could enhance T cell response.” (page 54. 1st column).
Thus this does not provide adequate written description for the breadth of the claims as submitted.
Response to Arguments
The response traverses the rejection in view of the amendment. The amendment has introduced new matter and has not addressed all of the issues.
Claims 10, 12, 16, 21, 24, 27, 28, 31, 33-36 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 comprising: obtaining a sample from a human subject and detecting sCD28 in the sample from the subject.
, does not reasonably provide enablement for determining relapse in any species based on sCD28 expression. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use There are many factors to be considered when determining whether there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors have been described by the court in re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in the Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The nature of the invention and the breadth of the claims:
Instant claim 10 is drawn to method of diagnosing or predicting cancer relapse in a human subject in need thereof, the method comprising a) receiving a sample obtained from said subject; b)measuring soluble CD28 (sCD28) levels in said sample, wherein an increase in sCD28 levels in said subject, wherein an increase in sCD28 levels in said subject sample as compared to a sample from said human subject obtained while said human subject was cancer free or in remission indicates cancer relapse or an imminent cancer relapse within the next 20 weeks from said measuring; [[,]] c) diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks; andd) administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse thereby diagnosing or predicting cancer relapse in said subject..
Thus the claims encompass any subject of any species is treated, however diagnosis is limited to a human subject.
The claims encompass treating with any immunotherapy. However, the claim does not require the subject in which sCD28 was measured is the subject being treated in view of the indefinite article.
Claim 12 depends from claim 10 and draws the invention to herein said subject:immunotherapy is PD-1, PD-L1 and/or CD80 based immunotherapy
Claim 16 depends from claim 10 and draws the invention to wherein said increase is:
Claim 21 depends from claim 10 and draws the invention to , wherein said sample is a blood sample..
Thus the independent claim encompasses in vivo or without obtaining a sample.
Claim 24 depends from claim 10 and draws the invention to wherein remission comprises a partial response and a complete response to a therapy.. The claim encompasses any complete response to any therapy for any disease.
Claim 27 depends from claim 10 and draws the invention to wherein said cancer is selected from skin cancer, urothelial cancer, lung cancer, and renal cancer.
Claim 31 depends from claim 10 and draws the invention to wherein said immunotherapy is selected from: a. a checkpoint inhibitor, optionally wherein said checkpoint inhibitor is a PD-1 and/or PD-L1 based immunotherapy; b. a chimeric antigen receptor (CAR) based therapy; and c. a cancer vaccine.
Claim 33 depends from claim 10 and draws the invention to wherein said human subject is at least 36 weeks post treatment. The claim encompasses any human subject that is 36 weeks post treatment for any disease or condition.
Claim 34 depends from claim 33 and draws the invention to wherein said subject has undergone or is undergoing immunotherapy. The claim encompasses any immunotherapy for any disease.
Claim 35 depends from claim 34 and draws the invention to wherein said immunotherapy is a PD-1/PD-L1 based immunotherapy.
Claim 36 depends from claim 12 and draws the invention to wherein said immunotherapy is a PD-1/PD-L1 based immunotherapy.
The amount of direction or guidance and the Presence and absence of working examples.
The specification provides no limiting definition of subject. However the claim has been amended to require diagnosis of the human subject, however treatment is “a subject” and thus is not limited to humans. The specification does teach, “[047] In some embodiments, the CD28 is mammalian CD28.” Thus subject broadly encompasses any mammal.
The specification teaches, “Cancer patients plasma samples of different indications, that received anti-PD 1 therapy, were diluted 1:10 and analyzed for soluble human CD28 by functional ELISA.” (090].
The specification teaches, “[092] To further understand the impact of sCD28 levels on cancer progression during immunotherapy, more than 100 serum samples from melanoma patients prior to initiation of anti- PD1 therapy (Nivolumab, NCT01176461) were tested for sCD28 levels by ELISA. Survival was monitored throughout therapy and a survival function was plotted comparing subjects with high and low levels of sCD28 before therapy (Fig. 1). It was found that subjects with low levels of sCD28 (below 2 ng/mL) had a longer median survival than those with high levels (659 days vs. 514 days).”
The specification in example 2 teaches, “[093] Serum from 166 individual patients (melanoma, renal cell carcinoma, lung squamous cell carcinoma and urothelial carcinoma patient) undergoing immunotherapy (anti-PD-1, for example Nivolumab and Pembrolizumab, anti-PD-L1, for example Atezolizumab and anti-CTLA-4, for example Ipilimumab) were examined for their sCD28 levels.”
The specification teaches, “Non-responders showed increasing sCD28 levels from baseline (before therapy) to week 7 and through to week 13 (Fig. 2B). In contrast, responders not only did not show increasing levels of sCD28, but in fact the average sCD28 levels decreased from baseline to week 7 and through to week 13 (Fig. 2C). When the absolute change in sCD28 expression is quantified at weeks 7 and 13 the increases seen in the non-responder population were statistically significant (Fig. 2D).” [094]
Example 3 of the specification teaches, “Both patients were, on average, negative for sCD28 during their response to the therapy, that is during the periods of remission (Fig. 3). However, both patients showed a marked increase in sCD28 levels just before or at the initiation of cancer relapse. The patient that had a complete response entered a phase of progressive disease (PD) and sCD28 levels began increasing from week 46 and on (Fig. 3, upper panel). The patient that had a partial response entered a phase of stable disease (SD) and sCD28 levels began increasing at week 35 (Fig. 3, lower panel). This demonstrates that increased and/or increasing sCD28 levels can act as a marker for cancer relapse after immunotherapy, and that this increase can be a predictive marker for imminent relapse.”
Presence and absence of working examples
The teachings of the specification are limited to humans subjects. The specification does not provide any teachings to any other mammals.
The teachings with respect to relapse are limited to subjects following complete or partial response, but did not occur until 25 or 46 week.
The state of prior art and the predictability or unpredictability of the art:
MPEP2164.03 teaches, " The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.”
Nolan (Am J Respir Crit Care Med Vol 177. pp 301–308, 2008) teaches. “Whereas the levels of sCD28 and sCD154 were no different in septic subjects compared with healthy control subjects, the plasma concentrations of both were higher in nonsurvivors compared with either survivors or healthy control subjects (Figure 7).”
Wang (Journal of Neuroimmunology 243 (2012) 52–55) teaches, “Plasma sCD28 levels were higher in NMO and MS.” (page 54. 1st column). Wang teaches, “Plasma sCD28 and sCTLA-4 had been investigated in many autoimmune diseases and infectious diseases (Cao et al., 2011), but less studied in NMO and MS. The functions of soluble T cell costimulatory molecules like sCD28 and sCTLA-4 are still controversial
(Ip et al., 2006). sCD28 could enhance T cell response.” (page 54. 1st column).
Arikan (Turk J Biochem 2017; 42(5): 551–558) teaches, “Similarly, the expression of CD28 is increased in patients with colorectal carcinoma, myeloma and melanoma [17, 34, 35]. Conversely, there are studies reporting decreased sCTLA-4 and sCD28 levels in clear cell renal cell carcinoma and breast cancer.”
Hebbar (Clin Exp Immunol 2004; 136:388–392) teaches, “Concentrations of soluble CD28 were significantly higher in patients with SLE, primary SS and SSc than in healthy subjects. Soluble CD28 concentrations were higher in patients with systemic primary SS than in patients with glandular-limited primary SS. PCR analysis sug gested that soluble CD28 resulted from the shedding of the membrane form.”
Sun (Centr Eur J Immunol 2014; 39 (2): 216-222) teaches, “{Our results suggested that mean concentrations of soluble CD28 in plasma of patients with Graves’ disease were 1.79 ±1.52 ng/ml, and levels of soluble CD28 in healthy subjects were only 0.83 ±1.35 ng/ml.”
The level of skill in the art:
The level of skill in the art is deemed to be high
Quantity of experimentation necessary:
The skilled artisan would have to determine how would have to determine if sCD28 is predictable of cancer relapse in any subject at any time. This would be unpredictable as the teachings of the specification are limited to subjects 36 or 46 post treatment, while the claims encompass anyone in need thereof. Further the claims do not require the subject has ever had cancer. Further the art teaches subjects with sepsis, systemic lupus, erythematosus, primary Sjögren’s syndrome and systemic sclerosis Graves, MS and NMO also had increased sCD28. Thus it would be unpredictable to extrapolate the findings to any increase is sCD28 realtive to a cnacer free sample.
Further it would be unpredictable to extrapolate the findings to any subject of any species as the specification is limited to humans, however the prior art demonstrates there are nearly 6,500 known mammals. Further the art also demonstrates homologs of the same gene in different species have different functions due to different evolutionary pressures.
Finaly the teachings of specification with respect to relapse are limited to 2 out of 166 patients at 36 or 45 weeks post treatment.. Thus it would be unpredictable to extrapolate the findings to any human subject at any time relative to any treatment.
Due to the scope of the claims, one of skill in the art would be required to further undertake extensive trial and error experimentation to determine if any increase at any time in any subject is indicative of cancer relapse, including subjects that do not have or have not had cancer.
Therefore, in light of the breadth of the claims, the lack of guidance in the specification, the high level of unpredictability in the associated technology, the nature of the invention, the negative teachings in the art, and the quantity of unpredictable experimentation necessary to practice the claimed invention, it would require undue experimentation to practice the invention as claimed.
Response to Arguments
The response traverses the rejection in view of the amendment. The amendment has introduced new matter and has not addressed all of the issues.
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 10, 12, 16, 21, 24, 27, 28, 31, 33-36 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.
Claim 10 is indefinite because it lacks a positive active step relating back to the preamble. The preamble recites a method of diagnosing or predicting cancer relapse in a subject in need thereof, however the last positive active step is drawn to administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse. Therefore it is unclear as to whether the method is drawn to diagnosing or predicting cancer relapse in a subject in need thereof or administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse.
Further claim 10 has been amended to recite, “measuring soluble CD28 (sCD28) levels in said sample, wherein an increase in sCD28 levels in said sample as compared to a sample from said human subject obtained while said human subject was cancer free or in remission indicates cancer relapse or an cancer relapse within the next 20 weeks from said measuring.” The claim is confusing and unclear how the wherein clause limits the measuring the level. Further the claim is confusing, vague and unclear as the claim recites, “while said human subject was cancer free or in remission indicates cancer relapse or an cancer relapse within the next 20 weeks from said measuring” However, the claim does not previously require the subject has cancer. Thus it is unclear how a human subject which has never had cancer can have relapses within the next 20 weeks.
Further the claim is confusing as it recites, “d) administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse thereby diagnosing or predicting cancer relapse in said subject.” This is confusing and unclear as the indefinite article prior to subject encompasses subjects other than those in which soluble CD28 where detected. Further it is unclear how the administering provides for diagnosing or predicting cancer relapse.
Claim 16 recites, “wherein said increase is:” and “a) an increase of at least 50%.” The recitation of increase is a relative term and specification provide no standard to differentiate an increase from unchanged or decrease.
Response to Arguments
The response traverses the rejection in view of the amendment. This argument is not persuasive as the amendment has raised new issues.
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 10, 12, 16, 21, 24, 27, 28, 31, 33-36 , are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation and mental step without significantly. The claim(s) recite(s) the abstract idea or mental step and/or natural correlation of diagnosing or predicting relapse and determining increase. The claims recite diagnosing which is a mental step and/or natural correlation This judicial exception is not integrated into a practical application because no treatment is required if expression is not increased. Further the treating with an immunotherapy is set forth with a high level of generality. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims provide no active steps with require a specific reagent.
Claim analysis
The instant claim 10 is directed towards method of diagnosing or predicting cancer relapse in a human subject in need thereof, the method comprising a) receiving a sample obtained from said subject; b)measuring soluble CD28 (sCD28) levels in said sample, wherein an increase in sCD28 levels in said subject, wherein an increase in sCD28 levels in said subject sample as compared to a sample from said human subject obtained while said human subject was cancer free or in remission indicates cancer relapse or an imminent cancer relapse within the next 20 weeks from said measuring; [[,]] c) diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks; and d) administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse thereby diagnosing or predicting cancer relapse in said subject. The correlation in the thereby clause is a natural correlation or phenomena. The wherein clause requires an increase is determined which is a mental step.
The measuring soluble CD28 is considered an active step requiring the analysis of a sample.
Dependent claims set forth further limitations to about the subject, tyiming of sample, the cancer the subject has or had, etc.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract idea and law of nature or natural phenomena.
With regards to claim 10, the claim recites, “wherein an increase in sCD28 levels in said subject sample as compared to a sample from said human subject obtained while said human subject was cancer free or in remission indicates cancer relapse or an imminent cancer relapse within the next 20 weeks from said measuring; [[,]] c) diagnosing said subject with said increase as having cancer relapse or as predicted for cancer relapse within the next 20 weeks; and.” The wherein clause is a mental step to determine an increase. Further the wherein clause is a natural correlation. The thereby clause is a mental step and/or natural correlation with respect to diagnosing or predicting relapse.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as in the rejected claims provide no steps which integrate the judicial exception in the absence of an increase in sCD28 or alternatively the administering step is set forth with a high degree of generality and is not limited to the human subject in which the sCD28 is measured in view of the indefinite article prior to subject in step d).
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, as the claims require no specific reagents.
With regards to claim 10 the claim requires a single active step of measuring sCD28. The specification provides no specific teaching on how sCD28 is determined,
However the prior art of Wang (Journal of Neuroimmunology 243 (2012) 52–55), Arikan (Turk J Biochem 2017; 42(5): 551–558), Nolan (Am J Respir Crit Care Med Vol 177. pp 301–308, 2008) demonstrate detecting sCD28 is routine and conventional.
Thus the claim does not provide additional steps which are significantly more.
Response to Arguments
The response traverses the rejection in view of the amendment to amend the independent claim to recite, “administering an immunotherapy to a subject diagnosed with or predicted for cancer relapse.” This argument has been thoroughly reviewed but is not considered persuasive as this does not require the human subject in which sCD28 is measured to be treated thus it does not integrate the judicial exception.
Summary
No claims are allowed.
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 STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Steven Pohnert/Primary Examiner, Art Unit 1683
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