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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/12/2026 has been entered.
Withdrawn Rejection
The 112a enablement rejection of claims 16-20, 23-27 and 30 is withdrawn in response to the amendments.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, 23-30 and 35-42 are pending; claim 16 is amended, claims 1-15, 21-22 and 31-34 are canceled; claims 28-29 and 35-36 are withdrawn. Claims 16-20, 23-27, 30 and 37-42 are examined below.
Maintained Rejection
This rejection was modified in response to the amendments.
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 40-42 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 the short-term prediction, does not reasonably provide enablement for the long-term prediction. This is a scope of enablement rejection.
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 predicting that the subject will have a long time to return to functional autonomy when the level of neopterin is higher than 15 nmol/L, wherein the long time is comprised between thirty days to a year; and wherein the acute event is a hip 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 thirty days to a year from a hip 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 thirty days to a year to return to functional autonomy when the level of neopterin is higher than 15 nmol/L. 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 15 nmol/L neopterin level would function as claimed with respect to predicting 30 days to a year of time to return to functional autonomy from a hip 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.
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.
See also Thomas et al. Physical Therapy Volume 91 Number 10 October 2011 DOI: 10.2522/ptj.20100310 (“Thomas”). Thomas teaches that “[h]ip fracture has serious implications for the older population: 25% to 35% of patients die in the first year postfracture, approximately 60% do not regain their prefracture level of mobility, fewer than 50% of survivors can walk unaided at 12 months, and only 40% can perform activities of daily living independently ” (page 1491 col. 1 para. 1).
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, and that from the survivors only 40% can perform activities of daily living independently, 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 of a hip fracture 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 level to predict return to functional autonomy from a hip 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.
New Rejections
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 37-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “…wherein: when the neopterin level is higher than 15 nmol/L, the treatment comprises assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician; and when the neopterin level is lower than 15 nmol/L, the treatment comprises subjecting the subject to a standard level of care…” (emphasis added).
Dependent claim 37 recites “wherein when the neopterin level is higher than 15 nmol/L, the treatment consists of assigning the subject to a specialized care unit” (emphasis added).
Dependent claim 38 recites “wherein when the neopterin level is higher than 15 nmol/L, the treatment consists of subjecting the subject to an adapted regimen of physical exercises under supervision of a physician” (emphasis added).
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim (MPEP 2111.03). In the present instance, dependent claims 37-38 encompass the broad recitation “the treatment comprising” (recited in independent claim 16), and the claims also recites “the treatment consisting of”. Therefore, the language “consisting of” appears to be contradicting the language “comprising” recited in claim 16. Claims 37-38 require both treatments (assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician), but the claims attempt to limit the treatment to just one of the two, which is not clear. The claims are considered indefinite because there is a question regarding the metes and bounds of the claim.
Maintained Rejection
This rejection was modified in response to the amendments.
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, 23-27, 30 and 37-42 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 “A method for treating a subject suffering from an acute event comprising: i) determining a neopterin level in a biological sample obtained from said subject; ii) comparing said level with a predetermined reference neopterin level of 15 nmol/L; and iii) administering a treatment to the subject based on the neopterin level, wherein: - when the neopterin level is higher than 15 nmol/L, the treatment comprises assigning the subject to a specialized care unit…and when the neopterin level is lower than 15 nmol/L, the treatment comprises…”.
Therefore, the claims to a method for treating the subject based on a comparison between a determined neopterin level and a predetermined reference neopterin level of 15 nmol/L are considered to be directed to mental steps – abstract ideas.
First, the “determining” step i) reads on a mental step because the determining can be performed entirely in the human mind, such as by comparing a value to a calibration curve.
Second, the “comparing” step ii) is a mental step because comparing a determined level to a reference can be performed in the human mind (such as a doctor simply thinking about the level of neopterin in relation to the predetermined reference value and making an evaluation, judgment, or opinion). The claims, under their broadest reasonable interpretation, cover performance of treating the subject 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 limitations “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.
Furthermore, the limitation “wherein: - when the neopterin level is higher than 15 nmol/L, the treatment comprises assigning the subject to a specialized care unit” also describes an abstract idea, i.e. a mental step of assigning the subject based on a comparison. Therefore, this limitation can be performed in the human mind or using pen and paper. The limitation “a specialized care unit” merely narrows the type of assignment. Similarly, claim 37 merely narrows the abstract idea, that is a judicial exception.
Claim 16 further recites “wherein the acute event is a hip fracture”. This limitation merely narrows the acute event to which the comparisons and abstract ideas are directed to. Therefore, this limitation is also directed to the judicial exception.
Claims 17-20 merely limit the subject population used in the mental steps, therefore these claims are also directed to the judicial exception, i.e. abstract ideas.
Claims 23-27 and 39 merely limit the sample used in the mental steps, therefore these claims are also directed to the judicial exception, i.e. abstract ideas.
Claims 40-42 recite “predicting that the subject will have a long time to return to functional autonomy when the neopterin level is higher than 15 nmol/L, or a short time when the neopterin level is lower than 15 nmol/L wherein the short time is comprised between five days to thirty days and the long time is comprised between thirty days to a year”.
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 comprised between five days to thirty days, and the long is comprised between three months to a year” merely narrows the natural correlation, i.e. the recovery time. Therefore this limitation is also directed to at least one judicial exception.
Claims 41-42 merely narrow the degree of recovery. Therefore this limitation is also directed to at least one judicial exception.
Step 2A, Prong 2
Claim 16 further recites “subjecting the subject to an adapted regimen of physical exercises under supervision of a physician… subjecting the subject to a standard level of care”. Claim 38 also recites “the treatment consists of subjecting the subject to an adapted regimen of physical exercises under supervision of a physician”.
These “treating” steps are insufficient to integrate the judicial exception as they are not limited to a particular treatment.
The recited treatments of “physical exercises under supervision of a physician” and “a standard level of care” are recited at a high level of generality and are not limited to a particular treatment. Such highly generalized treatment limitations – which do not require any specific treatment for hip fracture – do not amount to sufficient practical application to provide patentability. Although a claim limitation can integrate a judicial exception by applying or using the judicial exception(s) to effect a particular treatment or prophylaxis for a disease or medical condition, in this case no specific or particular treatment is set forth.
The level of generality in the instant claims stands in contrast to the treatment claims found patent-eligible in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) and Natural Alternatives Int’l v. Creative Compounds LLC, 2017 WL 1216226 (Fed. Cir. Mar. 15, 2019). The claims at issue in Vanda recited administering a specific drug (iloperidone) at specific dosage ranges based on a patient’s genotype. Vanda, 887 F.3d at 1135. Accordingly, the court found that although the inventors recognized the relationships between iloperidone, a patient’s genotype, and QTc prolongation, what they claimed is “an application of that relationship,” i.e., “‘a new way of using an existing drug’ that is safer for patients because it reduces the risk of QTc prolongation.” Id. (quoting Mayo, 566 U.S. at 87). The Federal Circuit characterized the Vanda claims as being directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Id. at 1136. Similarly, the Federal Circuit found that the claims in Natural Alternatives “contain specific elements that clearly establish they are doing more than simply reciting a natural law,” such as specifying a patient population, particular results to be obtained, specific compounds to be administered to achieve the claimed results, and dosages via an “effective” limitation. Natural Alternatives, 4-5.
In contrast to the claims in Vanda and Natural Alternatives, the present claims do not specify a particular result to be obtained, a compound or exercise to be administered to achieve a claimed result, or any specific dosage of a specific compound.
Rather, “physical exercises” and “standard level of care” read on treatment limitations “simply to tell doctors to apply the law somehow when treating their patients.” Mayo, 566 U.S. at 81-82.
Here, the claimed treatment step is instead merely an instruction to “apply” the exception in a generic way. Thus, the treatment step does not integrate the abstract idea(s) into a practical application.
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…”. 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 mental steps, 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).
See also Marcos-Pérez et al./ JAMDA xxx (2017) 1e9 http://dx.doi.org/10.1016/j.jamda.2017.06.021 ("Marcos-Pérez").
Marcos-Pérez teaches i) determining by ELISA a neopterin level in a fresh frozen or frozen blood sample obtained from said subject following medical management (“Serum neopterin levels were determined by using a commercially available ELISA kit (BRAHMS GmbH, Hennigsdorf, Germany),” page 4 col. 1 para. 2, “Participants were recruited from several associations of retired or older people, nursing homes, and daycare centers located in Galicia, North-western Spain… A clinical evaluation was carried out by trained interviewers to unify criteria, and participants completed a questionnaire to collect medical, lifestyle, and demographic information. In addition, whole blood samples were collected into vacutainer tubes without anticoagulant or containing sodium heparin between 9:30 AM and 12:30 PM, and were transported to the laboratory immediately. Serum and plasma samples were obtained by centrifugation at 2300 rpm for 10 minutes, aliquoted, and stored at -80C until analysis” page 3 col. 1 para. 1).
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).
Furthermore, “subjecting the subject to an adapted regimen of physical exercises under supervision of a physician” and “subjecting the subject to a standard level of care” are both well-understood, routine and conventional treatments for hip fracture.
See for example, Naylor et al. BMC Musculoskeletal Disorders (2019) 20:214 https://doi.org/10.1186/s12891-019-2570-8 ("Naylor").
Naylor teaches administering a treatment to the subject based on patient need for healthcare support wherein: when the patient has most need for healthcare support, the treatment comprises assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician; and when the patient does not need healthcare support, the treatment comprises subjecting the subject to a standard level of care, and wherein the acute event is a hip fracture (“High-level evidence consistently indicates that resource-intensive facility-based rehabilitation does not provide better recovery compared to home programs for uncomplicated knee or hip arthroplasty patients and, therefore, could be reserved for those most impaired” Abstract, “the more intensely supervised facility-based programs i.e., inpatient or clinic-based programs, do not provide superior recovery to that seen in domiciliary or other forms of home program after unilateral TKA [30–40] or THA [39, 41–45] for uncomplicated patients” page 2 col. 1 para. 4, “The absence of an evidence-based guideline can result in widespread practice variation, with many people not receiving the most appropriate care and limited healthcare resources being used sub-optimally. If the rehabilitation pathway provided following hip or knee arthroplasty was aligned with current evidence, patients would participate predominantly in a home-based therapy program, with intensely supervised facility-based programs reserved for people who require more assistance and support throughout the rehabilitation process” page 2 col. 2 para. 2).
Furthermore, Larsen suggests that hip-fracture surgery is the standard level of care for hip fracture (“management of the health… hip-fracture surgery” Abstract).
See also Baehl et al. Gerontology Published online: January 27, 2016 DOI: 10.1159/000443142 ("Baehl").
Baehl also suggests that surgery is the standard level of care for hip fracture (“HF patients have a high incidence (43–48% of cases) of opportunistic bacterial infections that follow surgery [7]” page 2 col. 1 para. 1).
See also Strasser et al. Aging Clinical and Experimental Research (2020) 32:2419–2423 https://doi.org/10.1007/s40520-019-01461-7 (“Strasser”).
Strasser teaches “Role of dietary protein and exercise on biomarkers of immune activation in older patients during hospitalization” (Title). Strasser further teaches a method for treating a subject suffering from a hip fracture (“hip fracture recovery” page 2419 col. 2 para. 1, “the postoperative course in older patients with hip fracture [6].” Page 2420 col. 1 para. 1) comprising: i) determining a neopterin level in a biological sample obtained from said subject (“neopterin levels were measured by enzyme-linked immunosorbent assay (BRAHMS Diagnostica GmbH, Germany)” page 2420 col.1 para. 1); ii) comparing said level with a predetermined reference neopterin level (“Older patients with hip fracture exhibited higher degrees of immune activation, as indicated by biomarker concentrations compared with reference values obtained from a healthy non-frail older population” page 2420 col. 2 para. 2); and iii) administering a treatment to the subject, wherein the treatment comprises assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician and a standard level of care (“During hospitalization (mean length of stay: 16.4 days), members of the intervention group received… Muscle-strengthening exercises for the hip, thigh and the upper arm and shoulder muscles were performed in addition to standard therapy on 3 days of the week (30 min per session) under the supervision of a physiotherapist. The control group received standard care with regular non protein-enriched food. Nutritional” page 2420 col. 1 para. 1).
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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-20, 23-26, 30 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Naylor et al. BMC Musculoskeletal Disorders (2019) 20:214 https://doi.org/10.1186/s12891-019-2570-8 ("Naylor") in view of Marcos-Pérez et al./ JAMDA xxx (2017) 1e9 http://dx.doi.org/10.1016/j.jamda.2017.06.021 ("Marcos-Pérez") and Rautenberg et al. (US 5439799 A) ("Rautenberg")-Cite No. A of PTO 892 11/19/2025.
Regarding claims 16-17, 20, 23-26, 30 and 39, Naylor teaches a method for treating a subject suffering from an acute event, wherein the subject is a human subject (“Variation in rehabilitation setting after uncomplicated total knee or hip arthroplasty: a call for evidence-based guidelines” Title, “In Australia…one in eight women and one in ten men will have a THA [total hip arthroplasty]” page 2 col. 1 para. 1). Note that although Naylor fails to use the language “a method for treating a subject suffering from an acute event” the teaching of hip arthroplasty inherently provides the method for treating a subject suffering from an acute event because a hip arthroplasty is a total hip replacement surgery which is a treatment for a fractured hip, i.e. an acute event. Naylor further teaches administering a treatment to the subject based on patient need for healthcare support wherein: when the patient has most need for healthcare support, the treatment comprises assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician; and when the patient does not need healthcare support, the treatment comprises subjecting the subject to a standard level of care, and wherein the acute event is a hip fracture (“High-level evidence consistently indicates that resource-intensive facility-based rehabilitation does not provide better recovery compared to home programs for uncomplicated knee or hip arthroplasty patients and, therefore, could be reserved for those most impaired” Abstract, “the more intensely supervised facility-based programs i.e., inpatient or clinic-based programs, do not provide superior recovery to that seen in domiciliary or other forms of home program after unilateral TKA [30–40] or THA [39, 41–45] for uncomplicated patients” page 2 col. 1 para. 4, “The absence of an evidence-based guideline can result in widespread practice variation, with many people not receiving the most appropriate care and limited healthcare resources being used sub-optimally. If the rehabilitation pathway provided following hip or knee arthroplasty was aligned with current evidence, patients would participate predominantly in a home-based therapy program, with intensely supervised facility-based programs reserved for people who require more assistance and support throughout the rehabilitation process” page 2 col. 2 para. 2). Naylor further suggests that there is a need of a biomarker that can inform whether the patient is in most need of healthcare support (“there is not yet a clear, unified evidence-based clinical practice guideline for rehabilitation following TKA or THA” page 2 col. 2 para. 1) because there is evidence that uncomplicated patients do not benefit from “the more intensely supervised facility-based programs i.e., inpatient or clinic-based programs… and may not be cost-effective” (page 2 col. 1 para. 4). Furthermore, Naylor suggests that such biomarker would improve the efficiency of the treatment (“As the number of arthroplasty surgeries grows, along with the associated costs, the alignment of rehabilitation setting with the evidence – particularly if led by a shift away from inpatient rehabilitation programs - offers an opportunity to improve the efficiency of TKA and THA surgeries. With this goal in mind, the development of evidence-based guidelines would be a reasonable place to start though” page 7 col. 1 para. 1).
Naylor fails to teach i) determining a neopterin level in a biological sample obtained from said subject; ii) comparing said level with a predetermined reference neopterin level of 15 nmol/L; and administering a treatment to the subject based on the neopterin level, wherein: when the neopterin level is higher than 15 nmol/L, the treatment comprises assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician; and when the neopterin level is lower than 15 nmol/L, the treatment comprises subjecting the subject to a standard level of care, wherein the subject is 75 years old, wherein the biological sample is a fresh, fresh frozen or frozen sample, wherein the biological sample is obtained at a time chosen from the group comprising (a)-(f) (claim 26), wherein the sample is a blood sample, wherein step i) is performed by ELISA, mass spectrometry, high-performance liquid chromatography or Lateral Flow Immunoassay.
Marcos-Pérez teaches that “Frailty Status in Older Adults Is Related to Alterations in Indoleamine 2,3-Dioxygenase 1 and Guanosine Triphosphate Cyclohydrolase I Enzymatic Pathways” (Title). Marcos-Pérez further teaches that the “[a]verage age of populations around the world is rapidly increasing… This aging situation leads to an increase in future healthcare expenditure” (page 1 col. 2 para. 1) and suggests that biomarkers of frailty, may help reduce “sanitary and socioeconomic costs in the future” (page 1 col. 2 para. 1). Marcos-Pérez further teaches that neopterin is a biomarker of frailty (“neopterin, tryptophan, kynurenine, phenylalanine, tyrosine, and nitrite) were analyzed in a population of Spanish older adults aged 65 years and above, and their relationships with frailty status were evaluated… Significant increases in neopterin levels…in frail individuals compared with nonfrail persons were obtained” Abstract). Marcos-Pérez further teaches i) determining by ELISA a neopterin level in a fresh frozen or frozen blood sample obtained from said subject following medical management (“Serum neopterin levels were determined by using a commercially available ELISA kit (BRAHMS GmbH, Hennigsdorf, Germany),” page 4 col. 1 para. 2, “Participants were recruited from several associations of retired or older people, nursing homes, and daycare centers located in Galicia, North-western Spain… A clinical evaluation was carried out by trained interviewers to unify criteria, and participants completed a questionnaire to collect medical, lifestyle, and demographic information. In addition, whole blood samples were collected into vacutainer tubes without anticoagulant or containing sodium heparin between 9:30 AM and 12:30 PM, and were transported to the laboratory immediately. Serum and plasma samples were obtained by centrifugation at 2300 rpm for 10 minutes, aliquoted, and stored at -80C until analysis” page 3 col. 1 para. 1) and ii) comparing said level with a predetermined reference neopterin level (“Reference ranges were calculated for the immune biomarkers on the basis of values from nonfrail and prefrail individual” page 4 col. 2 para. 2, see Table 2 in page 4). Marcos-Pérez further suggests iii) administering a treatment to the subject based on the neopterin level, wherein the subject is older than 75 years old (“These findings provide a basis for further investigations on the underlying immune mechanisms that contribute to frailty status in the elderly to determine the orientation and feasibility of future interventional strategies focused on prevention and treatment of frailty” page 7 col. 2 para. 4, “Age (y)…85.8” Table 1 page 3). Marcos-Pérez further teaches that neopterin levels are related to cellular immune activation and pathology (“In conditions of immune activation, neopterin is released by activated human monocytic cells at the expense of the formation of BH4.22 Thus, neopterin concentration in body fluids, including serum, urine, and cerebrospinal fluid, is considered a sensitive marker of immune system activation” page 2 col. 2 para. 1).
Rautenberg teaches “an agent and process for treating body fluids in the immunological determination of neopterin using a specific antibody against neopterin and a detection system” (Abstract). Rautenberg further teaches that “[r]aised concentrations of neopterin in body fluids directly reflect the degree of activation of the cellular immune system. Thus, determination of the concentration of neopterin in body fluids is very suitable indeed for monitoring the cellular immune status” (para. 6). Rautenberg further suggests wherein the predetermined reference neopterin level is 15 nmol/L (“The average concentration of neopterin in the serum of healthy persons is about 5 nmol/l ; values above 10 to 15 nmol/l are considered to be pathological” para. 9). Rautenberg suggests this reference level is a serum biomarker of cellular immune activation and pathology (paras. 6 and 9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Naylor to include the determining by ELISA a neopterin level in a fresh frozen or frozen blood sample obtained from the patient following medical management, the comparing said level with a predetermined reference neopterin level, and administering a treatment to the subject based on the neopterin level, wherein the subject is older than 75 years old taught by Marcos-Pérez because Marcos-Pérez teaches that neopterin is a biomarker of frailty and suggests that neopterin levels can aide in the decision making process regarding healthcare for the elderly and Naylor is interested in biomarkers that inform the level of rehabilitation needed in hip fracture patients, such as those that inform the patients that are most frail. One would have been motivated to make such a modification because there is a socioeconomic need for evidence-based decision making regarding the level of healthcare that is appropriate in the elderly population as taught by both Naylor (page 2 col. 1 para. 4) and Marcos-Pérez (page 1 col. 2 para. 1). Furthermore, Naylor suggests that such evidence-based decision making would improve the efficiency of hip replacement surgery (page 7 col. 1 para. 1). A person having ordinary skill in the art would have had a reasonable expectation of success because both Naylor and Marcos-Pérez are concerned with the high cost of healthcare in the growing elderly population. Furthermore, Marcos-Pérez provides the company name of the commercially available ELISA kit used to determine the neopterin level.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Naylor in view of Marcos-Pérez to rely on the 15 nmol/L reference neopterin level taught by Rautenberg because Rautenberg suggests this reference level is a biomarker of cellular immune activation and pathology and Naylor in view of Marcos-Pérez are interested in biomarkers related to cellular immune activation and pathology. One would have been motivated to make such a modification because there is a need for evidence-based decision making regarding the level of healthcare that is appropriate in the elderly population as taught by both Naylor (page 2 col. 1 para. 4) and Marcos-Pérez (page 1 col. 2 para. 1); therefore, one would have been motivated to use the 15 nmol/L threshold in order to better decide what treatment to administer given that this threshold can determine healthy from pathological patients as taught by Rautenberg. A person having ordinary skill in the art would have had a reasonable expectation of success because both Naylor in view of Marcos-Pérez and Rautenberg teach measuring neopterin levels in the blood using an antibody.
Regarding claim 18, Naylor in view of Marcos-Pérez and Rautenberg address the method of claim 16 as discussed above.
Naylor in view of Marcos-Pérez and Rautenberg further suggest wherein the subject is an elderly subject (“the aging population” page 2 col. 1 para. 1 of Naylor).
Regarding claim 19, Naylor in view of Marcos-Pérez and Rautenberg address the method of claim 16 as discussed above.
Naylor in view of Marcos-Pérez and Rautenberg further suggest wherein the subject is older than 65 years old (“Hip: n = 692, mean age 65.5 (10.4) yr.” Abstract of Naylor).
Regarding claim 37-38, although the claims are indefinite (see 112b rejection above), in the interest of compact prosecution, the claims are interpreted as reciting “the treatment comprises” (emphasis added).
Naylor in view of Marcos-Pérez and Rautenberg address the method of claim 16 as discussed above.
Naylor in view of Marcos-Pérez and Rautenberg further suggest wherein when the neopterin level is higher than 15 nmol/L, the treatment comprises of assigning the subject to a specialized care unit and subjecting the subject to an adapted regimen of physical exercises under supervision of a physician (Abstract of Naylor, “the more intensely supervised facility-based programs i.e., inpatient or clinic-based programs” page 2 col. 1 para. 4 of Naylor and page 7 col. 2 para. 4 of Marcos-Pérez).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Naylor in view of Marcos-Pérez and Rautenberg as applied to claim 26 above, and further in view of Baehl et al. Gerontology Published online: January 27, 2016 DOI: 10.1159/000443142 ("Baehl").
Regarding claim 27, Naylor in view of Marcos-Pérez and Rautenberg address the method of claim 26 as discussed above.
Marcos-Pérez further teaches that “[i]n conditions of immune activation, neopterin is released by activated human monocytic cells” (page 2 col. 2 para. 1).
Naylor in view of Marcos-Pérez and Rautenberg fail to teach wherein the biological sample is obtained at hospital arrival.
Baehl teaches “Alterations in Monocyte Phenotypes and Functions after a Hip Fracture in Elderly Individuals: A 6-Month Longitudinal Study” (Title). Baehl teaches a method for treating a subject older than 65 years old suffering from an acute event wherein the acute event is a hip fracture (“Here, we have investigated changes in monocyte subset (cM, iM and ncM) properties prior to surgery and 6 weeks and 6 months after surgery. We found that the trauma of HF [hip fracture] differently affected migrating properties, phagocytosis and superoxide production” page 3 col. 1 para. 3, “aged 65 years and older” page 3 col. 2 para. 1). Baehl further teaches determining the level of monocytes in a blood sample obtained from the subject at hospital arrival (“Heparinized blood samples were collected from healthy subjects and, in the case of HF patients, samples were collected before surgery (0 week)” page 3 col. 2 para. 3). Note that although Baehl fails to use the language “at hospital arrival” the teaching of obtaining the blood sample of the elderly hip fracture patient before surgery inherently provides the obtaining the biological sample at hospital arrival because the elderly hip fracture patient is expected to undergo surgery at a hospital arrival. Baehl further teaches that hip fractures cause immune activation as shown by the elevated intermediate monocyte levels in blood (“iM transiently increased before surgery” Abstract, see Figure 1b page 5). Baehl further suggests that the immune activation may impact in recovery from hip fracture (“These changes may impact clinical outcomes of HF with respect to inflammation, opportunistic infections and physical recovery” Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Naylor in view of Marcos-Pérez and Rautenberg to rely on the obtaining the biological sample at hospital arrival taught by Baehl because Baehl teaches that this enables the assessment of immune activation prior to hip surgery which can impact physical recovery and Naylor in view of Marcos-Pérez and Rautenberg are interested in biomarkers of immune activation and physical recovery from hip fracture surgery. A person having ordinary skill in the art would have had a reasonable expectation of success because both Naylor in view of Marcos-Pérez and Rautenberg and Baehl teach a method for treating an elderly subject that is 65 years or older for hip fracture, that is surgery.
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive.
Regarding the 101 rejections,
Applicant argues that “Applicant submits that amended claim 16 is now directed to a method of treating a subject, wherein: • the neopterin level is measured in a biological sample from the subject; and • the treatment administered to the subject is specifically adapted depending on whether the neopterin level is above or below 15 nmol/L (referral to a specialized care unit and adaptation of the rehabilitation protocol, or application of a standard level of care). Therefore, the subject matter recited in claim 16 is not a mere biological correlation. To the contrary, the present invention is directed to a concrete therapeutic application” (page 9 para. 2).
However, even though claim 16 no longer recites a natural correlation, claim 16 still recites abstract ideas, which is a judicial exception. Furthermore, contrary to Applicant’s remark, the claim recites “determining”, not measuring neopterin, which is reasonably interpreted as an abstract idea; also, the referral is another abstract idea. Regarding the additional limitations, the rehabilitation protocol and standard level of care are not considered to be particular treatments; here, the claimed treatment step is instead merely an instruction to “apply” the exception in a generic way. Finally, the treatments and additional limitation are all considered to be well-understood, routine and conventional in the art. Therefore, the claims are directed to at least one judicial exception without significantly more (see the rejection above for the complete analysis). Applicant’s arguments are not persuasive and the claims remain rejected under 101.
Regarding the 112a enablement rejection,
Applicant argues that “These time ranges correspond to the clinical results disclosed in the Application, particularly with respect to the assessment of functional autonomy following hip fracture. One of ordinary skill in the art would readily understand that these data reasonably support a distinction between shorter and longer recovery periods around the clinically relevant threshold of 30 days…Such categorization is also consistent with standard medical practice, in which patient outcomes are generally classified using approximate time ranges rather than exact durations” (page 11 para. 3).
However, new grounds of rejection are set forth above, namely the rejection has been modified to a scope of enablement rejection. In this case, the specification fails to disclose data regarding the longer recovery period of 30 days to a year. The specification and the art teach that 30% of hip fracture patients die within a year. Therefore, the patients that did not recover within 30 days are not necessarily expected to recover within a year. Indeed, many are expected to die and most of the survivors are expected to not be functionally autonomous (see rejection above). Therefore, Applicant’s arguments are not persuasive.
Conclusion
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
