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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Withdrawn Objections/Rejections
The objections of the claims are withdrawn in response to the amendments.
The 112b rejections are withdrawn in response to the amendments.
The 102, 103 and double patenting rejections are withdrawn in response to the amendments.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT /EP2021/060724, filed 04/23/2021. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. EP20305403.6, filed on 04/24/2020 in Europe.
Status of the Claims
Claims 16-20, 22-30 and 35-36 are pending; claims 16 and 22-23 are amended, claims 1-15, 21 and 31-34 are canceled; claims 28-29 and 35-36 are withdrawn. Claims 16-20, 22-27 and 30 are examined below
Maintained Rejections
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 16-20, 22-27 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to at least one judicial exception without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement." See MPEP 2106.04 (II)(A)(1).
The claims recite “predicting the return to functional autonomy in a subject suffering from an acute event comprising the following steps: i) determining neopterin level in a biological sample obtained from said subject;… iii) predicting that the subject will have a long time to return to functional autonomy when the level of neopterin is higher than the predetermined reference neopterin level or predicting that the subject will have a short time to return to functional autonomy when the level of neopterin is lower than the predetermined reference neopterin level” (claim 1).
The natural relationship to which the claims are directed (i.e., the relation between neopterin levels and recovery) is a law 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 myeloperoxidase 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 naturally occurring levels of neopterin in a sample obtained from said patient and the time to return to functional autonomy.
The correlation between neopterin levels and recovery is a judicial exception as it exists in principle apart from any human action; the correlation itself therefore cannot form the basis for eligibility. Furthermore, the limitation “wherein the short time to return to functional autonomy is comprised between five days to three months, and the long time to return to functional autonomy is comprised between three months to a year; and wherein the acute event is selected from the group consisting of hip fracture, pelvic fracture, tibia fracture, fibula fracture, foot fracture, wrist fracture, clavicle fracture, and hand fracture” merely narrows the natural correlation, i.e. the recovery time and the type of recovery. Therefore this limitation is also directed to at least one judicial exception.
Additionally, the claims also recite steps of “comparing said level with a predetermined reference neopterin level” which is considered a mental step – abstract idea.
Furthermore, the claimed step of predicting the time to return to functional autonomy by comparing neopterin levels to a predetermined reference may also be categorized as abstract ideas, namely mental processes/concepts performed in the human mind (such as a doctor simply thinking about the measured level of neopterin in relation to a predetermined reference value and making an evaluation, judgment, or opinion). The claims, under their broadest reasonable interpretation, cover performance of identifying risk solely within the human mind, or by a human using pen and paper. Comparing information regarding a sample to a control or target data represents abstract ideas.
Similar concepts involving comparing information regarding a sample or test subject to a control or target data have been held to be an "abstract mental process", as in University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014) which involved "comparing BRCA sequences and determining the existence of alterations", the collecting and comparing of known information in Classen, the comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC, as well as Mayo (which also involved specific numerical cutoff levels).
The limitation “wherein said predetermined reference neopterin level is 15 nmol/L” also constitutes abstract ideas (a cutoff value being itself a mathematical concept). The recitation of the specific numerical value of 15 nmol/L merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own. Claims 17-20 merely limit the subject population used in the natural correlation, therefore these claims are also directed to the judicial exception(s).
Claim 22 merely limits the acute event used in the natural correlation between the recovery of the acute event and the level of neopterin, therefore these claims are also directed to the judicial exception(s).
Claims 23-25 merely limit the sample used in the natural correlation, therefore these claims are also directed to the judicial exception(s).
Step 2A, Prong 2
The above-discussed steps of “predicting the return to functional autonomy in a subject suffering from an acute event” and “comparing” the neopterin concentration to a predetermined reference level are insufficient to integrate the judicial exception(s) into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application. In this case, predicting disease recovery and comparing numerical values, represent judicial exceptions and not a practical application thereof.
Claim 30 recites “wherein step i) is performed by ELISA”. Such steps of measuring the concentration of neopterin therein using an antibody are insufficient to integrate the judicial exception(s) 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 neopterin are recited at a high level of generality and are not tied, for example, to any particular machine or apparatus.
Claim 26 recites “wherein the biological sample is obtained…between the acute event and a surgery operation aimed to treat the acute event”. Claim 27 recites “wherein the biological sample is obtained at hospital arrival”.
Claims 26-27 limit the obtaining of the biological sample used in the natural correlation, therefore, these claims are drawn to insignificant presolution activity. Claims 26-27 are mere data gathering steps that do not use, rely on or apply the judicial exception(s) such to amount to a practical application thereof.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
The additional elements of the claims, including the steps drawn to the obtaining of the biological sample and the measuring of the concentration of neopterin therein, do not add significantly more to the judicial exception(s). The step of measuring neopterin is recited at a high level of generality and is not limited, for example, to any specific technique.
Although measurement of neopterin is performed using ELISA, no particular or specific antibody is set forth. Furthermore, the specification indicates that antibody-based methods were known in the art (see page 10 lines 6-9, “Methods for determining a neopterin level in a biological sample are well known in the art. Examples of such methods include, but are not limited to, immunohistochemistry, multiplex methods (Luminex), enzyme-linked immunosorbent assay (ELISA), sandwich ELISA,…”). Given that antibody-based measurements were predominant in the clinical assay art and were also in routine use for determination of neopterin, the requirement that neopterin is measured by ELISA does not go beyond routine/ conventional activity and fails to impose meaningful limits on the claim scope.
In this case, it was well-understood, routine and conventional to determine the concentration of neopterin in samples. See for example Zeng et al. Mol Neurobiol. 2016 Aug;53(6):3939-3947. doi: 10.1007/s12035-015-9310-3. Epub 2015 Jul 15. (Cite No. 1 of IDS filed 1/27/2023) (“Zeng”). Zeng teaches i) determining neopterin level in a biological sample obtained from said subject; ii) comparing said level with a predetermined reference neopterin level; and iii) predicting that the subject will have a long time to return to functional autonomy when the level of neopterin is higher than its predetermined reference neopterin level or predicting that the subject will have a short time to return to functional autonomy when the level of neopterin is lower than its predetermined reference neopterin level (Abstract). Zeng further teaches that “neopterin levels were measured using a human ELISA kit” (page 3941 col. 1 para. 2).
In view of the above evidence, the claimed steps of determining the concentration of neopterin using an antibody do not add any feature that is more than well-understood, purely conventional, or routine in the field of diagnostics and biochemical assay methodologies.
Furthermore, every application of the judicial exception would require determination of the level of neopterin in a sample. Limitations that are necessary for all practical applications of a judicial exception, such that everyone practicing the judicial exception would be required to perform those steps or every product embodying that judicial exception would be required to include those features, would not be sufficient to confer patent eligibility. In this case, everyone practicing the judicial exception would need to determine the concentration of neopterin.
When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. See also MPEP 2106.05(g).
Also, obtaining the biological sample at hospital arrival is well-understood routine and conventional. Zeng teaches that “blood samples of patients who were admitted to hospital were drawn from the antecubital vein at the first morning after admission (within 0–6 [n=75],…h[ours] from symptom onset)” (page 3941 col. 1 para. 2).
Furthermore, obtaining the biological sample between the acute event and a surgery operation aimed to treat the acute event is well-understood, routine and conventional. Sauce-Larsen et al. (WO 2018/046522 Al) (Cite No. 1 of IDS filed 1/27/2023) (“Sauce-Larsen”) teaches “a method for predicting the survival time in a subject suffering from an acute event comprising the following steps: i) determining neopterin level in a biological sample obtained from said subject; ii) comparing said level with its predetermined reference value and iii) concluding that the subject will have a short survival time when the level of neopterin is higher than its predetermined reference value or concluding that the subject will have a long survival time when the level of neopterin is lower than its predetermined reference value” (Abstract). Sauce-Larsen further teaches that “survival time” encompasses functional autonomy (“"predicting the survival time" refers to whether the subject will have or not any complications after a post-acute-event… Typically, complications can be:…loss of independence” page 2 lines 28-32). Sauce-Larsen further teaches obtaining the biological sample between the acute event and a surgery operation aimed to treat the acute event (“The concentration measured in the patients at their arrival to hospital is the best predictive marker observed in our experiments and correlated negatively with the time of survival after hip fracture surgery” page 17 lines 14-16). Note that the teachings of Larsen also address obtaining the biological sample at hospital arrival.
Also, Larsen et al. Volume 26, December 2017, Pages 157-164 https://doi.org/10.1016/j.ebiom.2017.11.003 (Cite No. 2 of IDS filed 1/27/2023) (“Larsen”) teaches that “neopterin measured at arrival to the hospital correlated negatively with the time of survival after HFS” [hip fracture surgery] (Abstract).
For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
New Rejections
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 16-20, 22-27 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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 the invention commensurate in scope with these claims. The specification does not reasonably provide enablement for iii) predicting that the subject will have a long time to return to functional autonomy when the level of neopterin is higher than the predetermined reference neopterin level, or predicting that the subject will have a short time to return to functional autonomy when the level of neopterin is lower than the predetermined reference neopterin level, wherein the short time to return to functional autonomy is comprised between five days to three months, and the long time to return to functional autonomy is comprised between three months to a year; and wherein the acute event is selected from the group consisting of hip fracture, pelvic fracture, tibia fracture, fibula fracture, foot fracture, wrist fracture, clavicle fracture, and hand fracture.
The specification does not provide sufficient evidence that the claimed method of using the 15 nmol/L neopterin reference level is effective for predicting return to functional autonomy within 5 days to three months, or within 3 months to a year from a hip fracture, pelvic fracture, tibia fracture, fibula fracture, foot fracture, wrist fracture, clavicle fracture, or hand fracture. The evidence provided merely shows an ROC analysis related to the ability to walk at 30 days post- hip fracture surgery based on a cutoff neopterin value of 15 nmol/L (“A cutoff value between a population of functionally autonomous subjects and a population of dependent subjects was determined at 15 nmol/L (75% sensitivity; 100% specificity; AUC=0.91) based on Receiver Operating Characteristic analysis related to ability to walk at D30 post surgery (Figure 4)” page 19 lines 15-18). Notably this evidence does not address the predicting that the subject will take 3 months to a year to to return to functional autonomy from a hip fracture when the level of neopterin is higher than 15 nmol/L. Furthermore, there is no data regarding pelvic fracture, tibia fracture, fibula fracture, foot fracture, wrist fracture, clavicle fracture, or hand fracture in the disclosure. Therefore, 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 use the invention.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S.261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied.
In re Wands, 858F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In regard to Wands factors (A) and (B), the breadth of the claims needed to enable the invention is determined by whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought in the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The nature of the invention is a biological/medical case, where there is natural unpredictability in performance of certain species other than those specifically enumerated; see MPEP § 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the claimed method(s), with a reasonable expectation of success, because it would not have been predictable from the disclosure that the claimed reference neopterin level would function as claimed with respect to predicting 3 months to a year of time to return to functional autonomy from a hip fracture, or pelvic fracture, tibia fracture, fibula fracture, foot fracture, wrist fracture, clavicle fracture, or hand fracture (see MPEP § 2164.03). The specification discloses that “HF are devastating with 50% of patients becoming dependent and 30% dying within one-year post surgery. Indeed, HF patients belong to a vulnerable group of old people with comorbid diseases and a high risk of postoperative morbidity and mortality.” (page 1 lines 16-17). Thus, the specification teaches that hip fractures are a special type of fracture, with a 30% 1-year mortality rate. Because of this, it is not expected that the time to return to functional autonomy would be at most a year for all hip fracture patients that have a neopterin level higher than 15 nmol/L, or that the method would be effective for any one of the other types of fractures claimed.
In regard to Wands factors (C), (D) and (E), the state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains and provides evidence for the degree of predictability in the art; see MPEP § 2164.05(a).
Accordingly, Larsen et al. EBioMedicine 26 (2017) 157–164 https://doi.org/10.1016/j.ebiom.2017.11.003 (Cite No. 2 of IDS filed 1/27/2023) (“Larsen”) teaches that “HF [hip fracture] is a common condition associated with a 20–30% one-year mortality in the elderly” (page 157 col. 1 para. 2). Larsen further teaches that “Other clinical and biological factors have been associated with mortality (Laulund et al., 2012), including gender, comorbidities (Roche et al., 2005), post-operative complications (Beloosesky et al., 2007), low albumin (Pimlott et al., 2011), high creatinine (Seyedi et al., 2015), increased post-operative troponin (Chong et al., 2009), elevated procalcitonin post-surgery (Vallet et al., 2017)” (page 157 col. 2 para. 2)” (page 157 col. 2 para. 2). Larsen further teaches that “statistical differences were observed when comparing hip-fracture patients who died within the first year post-fracture with either control individuals (p = 0.0009) or survivors (p = 0.0004). A cut-off value was set at 18.7 nmol/L… According to the level of neopterin measured in each patient at their arrival to hospital (high level > 18.7 nmol/L vs low level < 18.7 nmol/L), the probability of survival (within the year of follow-up) was statistically significant” (page 160 col. 2 para. 2 and page 161 col. 1 para. 1).
Also, Sauce-Larsen (WO 2018046522 A1)-Cite No. 1 of IDS 1/27/2023) (“Sauce-Larsen”) teaches that “[h]ip fracture is a common condition associated with a poor outcome of 20-30% one-year mortality in the elderly. Factors causing the high morbidity burden in surgery for hip fractures commonly include older age and cardiorespiratory comorbidities as shown in the ESCORTE study analyzing the outcomes after hip fracture surgery in a large cohort of French patients [l]” (page 1 lines 15-19). Sauce-Larsen further teaches that “According to the level of neopterin measured in each patient at their arrival to hospital (high level > 20 nmol/1 vs low level< 20 nmol/1), the probability of survival (within the year of followup) was statistically significant (Figure 3A; p =0.0005)” (page 17 lines 6-9). See figure 3A showing that high level > 20 nmol/L neopterin predicts death within a year.
Given the cited teachings of the prior art that a neopterin level higher than 15 nmol/L predicts death within the year in hip fracture patients, the cited references demonstrate that the use of a 15 nmol/L as a reference level for predicting return to functional autonomy within a year from a list of different types of fractures is unpredictable.
While the level of skill in the art is high, the amount of guidance provided regarding how to use the claimed neopterin reference level in the claimed methods is scant. Accordingly, the amount of experimentation required to determine how to use the recited neopterin reference level to predict return to functional autonomy quite extensive.
Due to the large quantity of experimentation necessary to determine how to use the recited 15 nmol/L neopterin reference level to predict return to functional autonomy from any one of a hip fracture, pelvic fracture, tibia fracture, fibula fracture, foot fracture, wrist fracture, clavicle fracture, or hand fracture; the lack of direction/guidance presented in the specification regarding the same; the absence of working examples directed to the same; the complex nature of the invention; the limited state of the prior art; the unpredictability of the effects of injury on different physiological systems, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. §112 first paragraph.
Response to Arguments
Applicant's arguments filed 2/19/2026 have been fully considered but they are not persuasive.
Regarding the 101 rejections,
Applicant argues that “Specifically, amended claim 16 further features 1) specific value of the "predetermined reference neopterin level", 2) specific definition of the "short/long time to return to functional autonomy", and 3) specific "acute event" (the feature from previously presented claim 21, which is now canceled without prejudice or disclaimer)… therefore recites significantly more than any alleged judicial exception” (page 9 para. 4 and page 10 para. 2).
However, the limitations specifying the reference neopterin level, the short/long time to return to functional autonomy, and the acute event fail to add significantly more because these limitations are drawn to at least one judicial exception (see rejection above).
Applicant further argues that “Zeng does not disclose, teach, or suggest a similar method in a comparable technical field” (page 10 para. 5).
However, the claims are rejected because they are directed to at least one judicial exception without significantly more. Zeng is relied upon to show that determining the concentration of neopterin using an antibody does not add any feature that is more than well-understood, purely conventional, or routine in the field of diagnostics and biochemical assay methodologies.
Applicant further argues that “Applicant respectfully submits that the added feature, namely, that the predetermined reference level of neopterin is 15 nmol/L, is not well-understood, purely conventional, or routine in the field of diagnostics and biochemical assay methodologies” (page 11 para. 1).
However, the predetermined reference level to 15 nmol/L is a limitation directed to at least one judicial exception (see rejection above).
Applicant further argues that “More particularly, NONE of the cited documents discloses or suggests to use the level of 15 nmol/L of neopterin as a biomarker to predict if the subject will need a short or a long time to return to a functional autonomy, such as the ability to walk 5 m at day 30 post surgery…This feature amounts to significant technical
improvements in the field of diagnostics and biochemical assay methodologies” (page 11 para. 6 and page 12 para 4).
However, to use the level of 15 nmol/L of neopterin as a biomarker to predict if the subject will need a short or a long time to return to a functional autonomy, such as the ability to walk 5 m at day 30 post surgery describes at least one judicial exception, e.g. a correlation between neopterin and recovery, which is not patent eligible (see rejection above for the 101 analysis).
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.
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678