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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/06/2025 has been entered.
Response to Arguments
Applicant’s arguments, see page 11, filed 05/06/2025, with respect to claim objections and 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The previously-held claim objections and 35 U.S.C. 112(b) rejections have been obviated by amendments to the claims. The previously-held claim objections and 35 U.S.C. 112(b) rejections have been withdrawn. However, there are new 35 U.S.C. 112(b) rejections necessitated below.
Applicant’s arguments, see pages 11-14, filed 05/06/2025, with respect to 35 U.S.C. 101 rejections have been fully considered but they are not persuasive. The Applicant argues (page 11) that the monitoring and determining steps of the rejected claims are not mental processes. The Applicant argues that in claim 1, the recited “monitoring” step (I) comprises monitoring in the pregnant patient at least each of the parameters of (a) fetal heart rate (FHR), (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity to determine whether each parameter exhibits at least one non-reassuring characteristic from a plurality of pre-defined non-reassuring characteristics. The Applicant argues that this comprehends the acts of receiving the underlying input signals and determining the recited parameters. The Applicant argues that all of these acts are well understood by those skilled in the art to be, at least according to conventional practices, the task of apparatus and not the province of mental activity. The Applicant also argues that the recited “determining” step (II), similarly, comprises determining a present level of risk for neurological injury to the child which takes into account the monitored parameters of at least (a) through (e) that exhibit at least one of the non-reassuring characteristics at a given point in time during labor that is just prior to delivery of the child and the total number present of (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors which elevate the level of fetal risk during labor. The Applicant further argues that this is necessarily an act which is consigned to a machine and beyond performance as a mere mental act. The Applicant argues that this is made even more explicit in claim 15, wherein the involvement of at least one computer is recited.
This is not found persuasive. Firstly, claim 1 does not recite any apparatus or machine that is performing the recited method steps. An apparatus or machine that is not recited in the claims can’t be read into the claims. Regardless, a broadest reasonable interpretation of the method claims would include interpreting the method steps as being carried out in the human mind. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could monitor (i.e., observe/evaluate) and make determinations (i.e., judgements). For example, a person could receive (e.g., be told or read) fetal heart rate measurements and mentally make a determination about whether the fetal heart rate exhibits a non-reassuring characteristic. Regarding claim 15, the computer is considered insignificant extra-solution activity in that it amounts to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. Claims can still recite a mental process even if they are claimed as being performed on a computer.
The Applicant further argues that it is the Office’s burden to establish that the claimed invention is the mere province of mental activity and that there is no factual demonstration of this.
This is not found persuasive. It is held that a proper eligibility analysis under 35 U.S.C. 101 has been carried out below. It is also held that Applicant’s arguments are sufficiently responded to herein. Please see 35 U.S.C. 101 rejections below.
The Applicant also argues that in regards to Step 2A of the Section 101 analysis, that the Vanda Memo makes clear that so-called “method of treatment claims” “which apply natural relationships as opposed to being ‘directed to’ them” are appropriately patent-eligible under Step 2A of the 2019 Revised Guidance. The Applicant argues that claim 1’s step of performing one or more measures for treating the child for neurological injury or its onset following delivery of the child is not ancillary to the determination of a present level of risk that corresponds to one of a plurality of predetermined levels of predicted risk for neurological injury to the child as a neonate. The Applicant argues that it is rather the practical application of the identified correlation between the level of risk to the fetus and the risk for neurological injury to the neonate. The Applicant argues that the claimed invention is not an attempt to patent an abstract idea, but rather the novel utilization of various diagnostic inputs, via an apparatus, to improve labor outcomes. The Applicant argues that such an application is patentable subject matter under Section 101.
This is not found persuasive. Firstly, the Examiner notes that the “performing one or more measures for treating the child for neurological injury or its onset following delivery of the child” is part of an “and/or” limitation. In other words, this part of the claim is not even required, as the step of “commencing monitoring the child for one or more postnatal parameters indicative of neurological injury or its onset within the first 5 minutes following delivery of the child” may be carried out and not require the performing step to satisfy the method. Additionally, the Vanda Memo referenced by the Applicant shows that applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition has been found as a limitation that is indicative of integration into a practical application. Claim 1 does not use the mental process to effect a particular treatment or prophylaxis for a disease or medical condition, but instead generally recites “performing one or more measures for treating the child for neurological injury”. The Applicant’s specification also lists general therapeutic measures that are known to those skilled in the art that may be enacted based on a determination that a risk of neurological injury is significant enough to warrant intervention based on conventional criteria (Applicant’s specification, Page 38, 2nd Par.). Therefore, there is no evidence of the mental process of claim 1 being applied or used to effect a particular treatment or prophylaxis. This limitation does not integrate the abstract idea into a practical application and therefore does not overcome 35 U.S.C. 101. Instead, this “performing/treating” step is an example of generally linking the use of a judicial exception to a particular field of use, which is an example of a limitation that the courts have found to not integrate a judicial exception into a practical application [MPEP 2106.04(d)(I) and 2106.05(h)].
With reference to claim 15, the Applicant further argues that the invention as recited goes well beyond “mere post-solution activity of displaying the solution” by at least the inclusion of at least one output through which can be indicated, by no later than the first 5 minutes following delivery of the child, the determined level of risk and/or the corresponding one of the plurality of predetermined levels of predicted risk for neurological injury to the child as a neonate, and information representing the received input signals corresponding to the one or more postnatal parameters. The Applicant argues that these outputs provide the clinician with information for effecting the timely treatment of neurological injury or its onset, thereby implementing a very practical application of the realized correlation between the level of risk to the fetus and the risk for neurological injury to the neonate.
This is not found persuasive. Claim 15 recites at least one output that is connected to the computer and helps the computer indicate the determined level of risk for neurological injury and information representing the received input signals corresponding to the postnatal parameters. It is noted that the at least one output is recited with a high level of generality, as the Applicant’s specification explains that the at least one output may comprise, for example, a video display and/or a printer, warning lights, an audible alarm, etc. (2nd Par. of page 43 and 1st Par. of page 45 of Applicant’s specification). The involvement of the “computer” and the “at least one output” continues to be considered insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. The involvement of “at least one output” additionally does amount to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)].
Therefore, the 35 U.S.C. 101 rejections are maintained. Please see 35 U.S.C. 101 rejections below.
Applicant’s arguments, see pages 14-16, filed 05/06/2025, with respect to 35 U.S.C. 103 rejections have been fully considered and are persuasive. In particular, in addition to Applicant’s arguments as a whole, the Examiner is persuaded by the Applicant’s argument that Higgins, while disclosing determination of the metabolic condition of the neonate, including Base Excess, does not disclose a correspondence between the fetal parameters of the present invention and a predicted Base Excess. The Examiner conducted further search and consideration, and ultimately determined that no single or combination of prior art references could be found to fairly teach or suggest all the limitations of the instant independent claims. The 35 U.S.C. 103 rejections have been withdrawn. Please see reasons for indicating allowable subject matter below.
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 1-6, 8-9, 11-12, and 14 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 discloses a method for determining the present level of risk for neurological injury to the child during based on at least first set of parameters. However, no specific structure is claimed for collecting or evaluating these parameters. Applicant’s disclosure cites a computer and sensors for performing these processes in Pages 41-43 of the specification, but this is not reflected in claim 1. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated (MPEP 2163.03). In the instant case the method is enabled by a wide variety of medical technology, while the disclosure only identifies a computer. Dependent claims 2-6, 8-9, 11-12, and 14 are rejected by virtue of their dependency on claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8-9, 11-12, 14-18, 21-22, and 24-25 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 1 recites the limitation "the total number present of (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors" in lines 24-25. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the total number of the monitored parameters of at least (a) through (e)" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the step (IV)" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the total number present of (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors" in lines 38-39. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the number of the parameters (a) through (e)" in line 5. There is insufficient antecedent basis for this limitation in the claim.
*All other claims are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8-9, 11-12, 14-18, 21-22, and 24-25 are rejected under 35 USC 101 because the claimed invention is directed to a judicial exception, specifically abstract idea (mental process of predicting level of risk for neurological injury to a neonatal human child), without significantly more.
Step 1
Independent claims 1 and 15 are directed to statutory subject matter as the claims recite a method and apparatus for reducing the risk of neurological injury to a neonatal human child.
Step 2A, Prong 1
Regarding claims 1 and 15, the following steps recite an abstract idea:
“monitoring in a pregnant patient during labor at least a first set of parameters indicative of a present level of risk for neurological injury to the child as a fetus” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could monitor (i.e., observe/evaluate) parameters indicative of a present level of risk for neurological injury to the child as a fetus in a pregnant patient during labor.
“determining a present level of risk for neurological injury to the child based on the at least first set of parameters at a given point in time during labor that is just prior to delivery of the child” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a determination (i.e., judgement) of a present level of risk for neurological injury to the child based on the monitored parameters.
“commencing monitoring the child for one or more postnatal parameters indicative of neurological injury or its onset within the first 5 minutes following delivery of the child” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could monitor (i.e., observe/evaluate) a child for postnatal parameters indicative of neurological injury.
“monitoring in the pregnant patient at least each of the parameters of (a) fetal heart rate (FHR), (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity to determine whether each parameter exhibits at least one non-reassuring characteristic from a plurality of pre-defined non-reassuring characteristics” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could monitor (i.e., observe/evaluate) such parameters to determine (i.e., judge) whether each parameter exhibits a non-reassuring characteristic. For instance, a human could monitor such parameters that are told to them or shown via fetal heart rate measuring equipment.
“determining a present level of risk for neurological injury to the child which takes into account the monitored parameters of at least (a) through (e) that exhibit at least one of the non-reassuring characteristics at a given point in time during labor that is just prior to delivery of the child and the total number present of (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors which elevate the level of fetal risk during labor” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could determine (i.e., judge) a present level of risk for neurological injury to the child based on the monitored parameters of (a) through (e) and (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors. For instance, a human could consider each of these parameters in order to make a determination of a present level of risk for neurological injury to the child.
Step 2A, Prong 2
Regarding claims 1 and 15, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
“a computer” and “at least one output” is recited with a high level of generality. The computer is not described to be anything more than a general computer in the Applicant’s specification. The at least one output is recited with a high level of generality, as the Applicant’s specification explains that the at least one output may comprise, for example, a video display and/or a printer, warning lights, an audible alarm, etc. (2nd Par. of page 43 and 1st Par. of page 45 of Applicant’s specification). The involvement of the “computer” and the “at least one output” is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
The involvement of “and/or performing one or more measures for treating the child for neurological injury or its onset following delivery of the child” does not integrate the judicial exception into a practical application. According to pg. 38, par. 2 of the specification, Applicant discloses the following: determination of the risk of neurological injury may be based on conventional criteria, the interventions can merely be therapeutic measures known to those skilled in the art, and the improvement over the prior art is to sooner apply the generic intervention than the prior art does. Therefore, this is not an example of applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Instead, this “performing/treating” step is an example of generally linking the use of a judicial exception to a particular field of use, which is an example of a limitation that the courts have found to not integrate a judicial exception into a practical application [MPEP 2106.04(d)(I) and 2106.05(h)].
The involvement of “receiv[ing] from a monitored patient during labor input signals corresponding to at least a first set of parameters indicative of a present level of risk for neurological injury to the child as a fetus”, “receiv[ing] from the neonatal child input signals corresponding to one or more postnatal parameters indicative of neurological injury or its onset”, and “receiv[ing] user-inputs indicative of the presence in the patient of one or more (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors which elevate the level of fetal risk during labor” (in claim 15) is considered insignificant extra-solution activity in that it is merely involved with gathering and collecting data [MPEP 2106.05(g)].
Step 2B
The additional elements of claims 1 and 15, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “computer” and at least one “output”, along with their associated functions and components are recited with a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)]. Guha (U.S. Patent No. 5,808,609) discusses and evidences that computer systems, processors, and displays are conventional and well-known (Col. 1, lines 12-23; Col. 2, lines 8-25; Col. 10, line 64-Col. 11, line 3). In this case, well-known elements of a general computer system are used to implement the abstract idea of monitoring and receiving inputs from the pregnant patient and the child, as well as determining a level of neurological injury of the child. Also, generally linking the use of the judicial exception to the field of neurology for neonates/newborns is not indicative of an inventive concept [MPEP 2106.05(h)].
Dependent claims
Regarding dependent claims 3-6, 8-9, 11-12, 14, 16, 18, 22, and 24-25 the limitations only further define the abstract idea.
Regarding dependent claim 2, the limitations only further generally link the use of a judicial exception to a particular field of use.
Regarding dependent claims 17, 21, the limitations only further define insignificant extra-solution activity of generic computer implementation of the abstract idea.
Therefore, claims 1-6, 8-9, 11-12, 14-18, 21-22, and 24-25 are unpatentable under 35 U.S.C. 101.
Allowable Subject Matter
Claims 1-6, 8-9, 11-12, 14-18, 21-22, and 24-25 contain potentially allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record (namely Walker, Watzlawik, Ater, and Higgins) does not disclose or fairly suggest either singly or in combination the claimed invention of independent claims 1 and 15 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the monitoring step (I) comprises monitoring in the pregnant patient at least each of the parameters of (a) fetal heart rate (FHR), (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity to determine whether each parameter exhibits at least one non-reassuring characteristic from a plurality of pre-defined non-reassuring characteristics;
wherein the determining step (II) comprises determining a present level of risk for neurological injury to the child which takes into account the monitored parameters of at least (a) through (e) that exhibit at least one of the non-reassuring characteristics at a given point in time during labor that is just prior to delivery of the child and the total number present of (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors which elevate the level of fetal risk during labor; and
wherein the predetermined levels of predicted risk for neurological injury to the child as a neonate comprises predicted Base Excess and/or pH values for 30 minutes post-delivery.
The Examiner notes that Ater does disclose wherein: the monitoring step (I) comprises monitoring in the pregnant patient at least each of the parameters of (a) fetal heart rate (FHR) (Par. [0051] – the system monitors fetal heart rate), (b) baseline FHR variability (Par. [0051] – the system monitors fetal heart rate abnormalities, including baseline rate), (c) FHR accelerations (Par. [0051] – the system monitors fetal heart abnormalities, which would include heart rate accelerations), (d) FHR decelerations (Par. [0051] – monitors heart rate abnormalities including variable and prolonged decelerations), and (e) maternal uterine activity (Par. [0051] – uterine contraction monitoring system). However, Ater does not disclose or render obvious wherein these monitored parameters are used to determine whether each parameter exhibits at least one non-reassuring characteristic from a plurality of pre-defined non-reassuring characteristics. Ater further does not disclose or render obvious wherein the determining step (II) comprises determining a present level of risk for neurological injury to the child which takes into account the monitored parameters of at least (a) through (e) that exhibit at least one of the non-reassuring characteristics at a given point in time during labor that is just prior to delivery of the child. In other words, although Ater discloses a device that is capable of fetal heart monitoring, it does not disclose characteristics that would assure of a neurological condition at any point during labor. Additionally, the cited references above fail to disclose wherein the plurality of predetermined levels of predicted risk comprises predicted Base Excess values for 30 minutes post-delivery. While Higgins does disclose umbilical-cord blood gas analysis following birth for neonates with abnormal fetal heart rate tracing (see Pages 6-7), Higgins does not teach or render obvious wherein predetermined levels of predicted risk comprise predicted Base Excess values for 30 minutes post-delivery. Therefore, the indicated limitations of instant claims 1 and 15, in view of the claims as a whole, are not found to be taught or suggested by the cited references herein. Additionally, no other prior art reference could be found that teaches or renders obvious the limitations of instant claims 1 and 15. Due to their dependency on independent claims 1 and 15, instant claims 2-6, 8-9, 11-12, 14, 16-18, 21-22, and 24-25 are also considered to contain allowable subject matter.
Therefore, in view of the prior art and its deficiencies, the claimed invention as a whole is rendered novel and non-obvious, and thus, is considered to contain allowable subject matter as claimed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Specifically, the 35 U.S.C. 101 and 112(b) rejections hereinabove must be overcome.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Roberts, et al. (U.S. Patent No. 11,045,148)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796