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 .
Applicant's amendment and reply filed July 10, 2026 have been received and entered into the case. Claim 16 is canceled; claims 21 - 26 are added; claims 10 - 14, 18, 21 - 22 are withdrawn; claims 5 - 7, 9, 15, 17, 19 - 20, 23 - 26 have been considered on the merits insofar as they read on the elected spices or viral or bacterial infection. All arguments have been fully considered.
Claim Objections
Previous objections are withdrawn due to the amendment changing the dependency of claim 20 to claim 15.
Claim 5 is objected to because 5 should first spell out mps, then abbreviation in lines 1 and 3.
Appropriate correction is required.
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 5 - 7, 9, 15, 17, 19 - 20, 23 – 26 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 5 recites diagnosing the subject as having a severe, non-MPS condition when the subject has at least two standard deviations above the mean, however the specification as originally filed does not appear to support this finding. Table 1 discloses multiple conditions having at least two standard deviations above the mean and are not diagnosed as "severe." Examples include but are not limited to jaundice, hypothermia, hypoglycemia, secondary carnitine deficiency, influenza or acute encephalopathy, CPT2 deficiency, vomiting, West syndrome, hypoxic ischemic encephalopathy and periventricular leukomalacia. While the specification shows some non-mps conditions are severe with the at least two standard deviations above the mean" the specification fails to disclose the claimed measure as diagnosing any non-mps condition as severe, including bacterial or viral infections (e.g., viral infections or influenza encephalopathy). Table 1 only serves to infer the claimed measure might suggest some conditions are severe but fails to support the scope of the phrase as originally filed.
This is a new matter rejection.
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 5 - 7, 9, 15, 17, 19 - 20, 23 - 26 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.
Previous rejections are withdrawn due to the amendment clarifying the method is diagnosing severity of a non-MPS condition; spelling out full names followed by appropriate abbreviations; deleting "normal range" in favor of an age-matched pool of controls samples; deleting "patient" in favor of subject; and correlating a particular result to a diagnosis of "severe."
Claim 5 and its dependents are drawn to a method for diagnosing severity of a non-mps condition, however are rendered indefinite because claim 5, step d) requires comparing the level of a disaccharide of the patient to "one or more biological samples" but step e) requires the diagnosis is made as it relates to "the mean of the aged-matched pool" of control. It is unclear if the comparison and diagnosis is based on the same control or if multiple controls are "compared" to the subject sample. Moreover, it is unclear what must occur at step d) other than a mental observation made of the subject sample and any other aged matched sample.
Claim 23 is drawn to a method for diagnosing severity of a non-mps condition, however is rendered indefinite because it is unclear whether "elevated" is intended to mean "more than" or if the phrase continues to require "at least two standard deviations above the mean" of the control as required in claim 5. Since the claim changes the scope of the claim on which it depends from diagnosing a condition as severe to diagnosing a subject to have a condition; and also recites "elevated" compared one or more samples rather than "at least two standard deviations above the mean of the age matched pool," the scope of the claim has not been clearly set forth.
Claims 24 and 25 are rendered indefinite for reciting "using" one or more enzymes because the term using appears to require steps that are not recited in the claim. As such, the scope of the claim cannot be clearly ascertained.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 23 is more broad than the claim on which it depends. Claims 5 and 17 require diagnosing a subject with a severe condition, whereas claim 23 only requires diagnosing that a subject has a condition. Since "having a bacterial infection" encompasses any severity thereof, to include asymptomatic, the claim is more broad then the claims on which it depends.
The claim appears to further broaden the claim on which it depends by reciting a subject is diagnosed with a bacterial infection when the level of disaccharide is "elevated" compared to biological samples from the control. It is unclear whether "elevated" is intended to mean "more than" or if the phrase continues to require "at least two standard deviations above the mean" of the control as required in claim 5.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 5 - 7, 9, 15, 17, 19 - 20, 23 - 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1: Yes, the claims are drawn to process, specifically method of diagnosing severity of a condition in a subject.
Step 2A, Prong 1: Yes, the claims are drawn to method of measuring the level of a glycosaminoglycan (GAG) in a subject and diagnosing severity of a condition, which is interpreted as a both a natural phenomenon and an abstract idea. Specifically, the claims include naturally occurring relations between the level of GAG in a biological sample and severity of diseases, which is identified as an example of natural phenomenon (2106.04(b)(I)(v); the claims further require mental steps performed in the human mind (abstract idea). The step of diagnosing severity of a disease is merely a claim to collecting and comparing information, observations, evaluation and judgement or opinions (MPEP 2106.04(a)(2)(III)(A)).
Step 2A, Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application. Although the claims newly recite obtaining a sample and enzymatically digesting GAGs in the sample to obtain disaccharides, these steps of preparing biological sample for testing were standard practice in the art and does not integrate the judicial exception itself into a practical application. Moreover, the concept of enzymatically digesting GAG in biological samples to measure GAG levels via disaccharides was known in the art as admitted by applicant (specification 0072, US 9982288). Dependent claims only further define the biological sample, the condition, a control for mental comparison or the particular GAG measured.
Step 2B: No, the claims do not recite any additional elements that amount to significantly more than the judicial exception. Although the claims newly recite obtaining a sample and enzymatically digesting GAGs in the sample to obtain disaccharides, as admitted by applicant (specification 0072, US 9982288), these steps are routinely carried out when measuring GAG levels in a biological sample. An inventive concept "cannot be furnished by the unpatentable law of nature" but must be furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself (MPEP 2106.05(I). Dependent claims only further define the biological sample, the condition, a control for mental comparison or the particular GAG measured.
Response to Arguments
Applicant argues that the method requires physical manipulation of a biological sample and comparison to a control, as well as correlating GAG disaccharide levels to disease severity, thereby integrating the judicial exception into a practical application (Step 2A, Prong 2); that the method can be used to determine disease severity which can be later appropriately treated; and that the invention is the discovery that subjects with non-MPS conditions also have elevated GAGs.
However, the claims do not recite treating a subject that is diagnosed as having a severe non-MPS condition. Preparing a biological sample for testing is standard practice in the art and does not integrate the judicial exception itself into a practical application. Moreover, the concept of enzymatically digesting GAG in biological samples to measure GAG levels via disaccharides was known in the art as admitted by applicant (specification 0072, US 9982288).
Regarding the argument that the judicial exception is integrated into a practical application of treating a subject, the claims fail to recite treating a subject based on the correlation of elevated disaccharides to severe disease. In this regard, applicant is merely asserting an argument to an intended use of the claimed invention or a field of use limitation, which does not integrate the judicial exception into a practical application (MPEP 2106.04(d)(2)). With respect to claim 7, the claim is highly generic and fails to recite "a particular treatment." This administration step is not particular and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application (MPEP 2106.04(d)(2)(a)). Moreover, any recited additional elements must "transform the nature of the claim" into a patent eligible application of the judicial exception 2106.04(II)(A)(2).
Regarding applicant's argument that the invention is the "unexpected discovery" that subjects with non-MPS conditions also have elevated GAGs, confirms the "invention" is specifically drawn to the judicial exception itself.
Applicant argues that the claims recite additional elements that amount to significantly more than the judicial exception, that is enzymatically digesting GAG to disaccharides in a biological sample, which are not routine or conventional in the art for diagnosing non-MPS conditions (Step 2B).
However, as admitted by applicant (specification 0072, US 9982288), these steps are routinely carried out when measuring GAG levels in a biological sample. An inventive concept "cannot be furnished by the unpatentable law of nature" but must be furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself (MPEP 2106.05(I). The claims simply add well-understood, routine, conventional activities previously known to the industry (enzymatically digesting GAG in a subject sample to measure disaccharide levels), specified at a high level of generality (of subjects without MPS conditions), to the judicial exception (MPEP 2106.05 (I)(A)(ii)). Therefore, the claims do not recite additional elements that amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 and 102a2 as being anticipated by Shimada et al. (US 9982288) are withdrawn due to the amendment limiting the subject population to those having a non-MPS condition. The prior art teaches methods for assessing severity of MPS conditions in a patient, wherein the methods measure samples comprising GAG by digesting into disaccharides. However, the prior art does not teach or suggest performing the method to diagnose non-MPS conditions.
Previous rejections under 35 U.S.C. 102a1 as being anticipated by Schmidt et al. (2016) are withdrawn due to the amendment limiting the subject population to those having a non-MPS condition and digesting GAG into disaccharides prior to measuring.
The prior art teaches methods for predicting outcomes in patients diagnosed with septic shock and Acute Respiratory Distress Syndrome by measuring intact GAG, however the prior art does not teach or suggest measuring digested GAG for determining severity of disease.
Double Patenting
Previous rejections on the ground of nonstatutory double patenting are withdrawn in light of the amendments requiring the subject population to those having a non-MPS condition and measuring digested disaccharide to measure GAG in biological samples.
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
