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 .
Election/Restrictions
Applicant’s election of Group II, claims 5 – 7, newly amended claims 9 – 20, and the species of “bacterial or viral infection” in the reply filed on November 26, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s request for rejoinder of non-elected species upon an allowable genus is acknowledged.
Claims 5 – 7 and 9 – 20 are pending; claims 10 – 14 and 18 are withdrawn as being drawn to non-elected species; claims 5 – 7, 9, 15 – 17 and 19 – 20 have been considered insofar as they read on the elected species of a viral or bacterial infection.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 2 and August 28, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 and 19 – 20 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 5 and its dependents are drawn to a method of diagnosing “severity of a condition severity” however are indefinite for reciting “severity of a condition severity” because it is unclear what the phrase intends to encompass. It is unclear if the phrase is merely a grammatical error or if either of “severity” or “condition severity” intends to encompass a specific set of conditions whereby one term modifies the other. Clarification is required.
Claim 5 is indefinite for reciting “GAG” without first spelling out the term followed by the abbreviation.
In claim 5, the phrase “normal range” renders the claim and its dependents indefinite as the phrase is not adequately defined by the claim language or specification. Since a “normal range” can vary depending on a governing body, advisory committee and/or updates within the field, what a skilled artisan understands to be “normal” may change over time. In this regard, absent a clear definition of “normal range,” the claims fail to clearly delineate the scope of the invention.
Claim 5 is indefinite for reciting “mean of a control patient” since it is unclear how a mean, or the average number of data set, is calculated by “a” patient.
In claim 5, line 5, the recitation of “a patient” appears to lack proper antecedent basis. For purposes of examination, “a patient” is interpreted to refer to the “subject in need thereof.”
Claim 5 and its dependents are further indefinite because the preamble intends to diagnose a severity of a condition, which indicates a scale of relativity is required to ascertain and assign the relative “severity,” e.g., mild, moderate or severe, but fails to recite or assign any measured outcome with a particular degree of severity. Although the claim recites “diagnosing condition severity” as a subject having a GAG level two standard deviations above a control, this step fails to correlate any degree of severity of condition.
Claims 15 and 19 are indefinite for reciting ΔDiHS-0S, ΔDi-4S, KS and ΔDiHS-NS without first spelling out the name followed by the abbreviation.
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 – 6, 9, 15 – 17 and 19 – 20 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); and the claims do not require any active steps, but only 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. 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. Dependent claims only further define the biological sample, the condition, a control for mental comparison or the particular GAG measured.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 5 – 7, 9, 15 – 16 and 20 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Shimada et al. (US 9982288).
Regarding claim 5, Shimada teaches methods for assessing severity of a conditions in a patient with mucopolysaccharidosis (MPS) (a subject in need thereof), the method comprising a) measuring ΔDi-6S (glycosaminoglycans or GAG) in a biological sample that is elevated over a control (e.g., normal range); and b) identifying subjects having 2 SD (two standard deviations) above a control (diagnosing the severity) (col.3, 7, example).
Regarding claims 6 and 20, the biological sample may be blood, plasma, serum or urine (col. 45 – 50).
Regarding claim 7, the methods include treating for the condition (col.4 line 49 – 55).
Regarding claim 9, the disorder is mucopolysaccharidosis, or a developmental disorder (abstract, col.3).
Regarding claim 15, the elevated GAG may be keratan sulfate (KS) (col.8 line 5 – 10, example).
Regarding claim 16, the control includes an age matched controls (col.3 line 60 – 61, example).
The reference anticipates the claimed subject matter.
Claims 5 – 6, 9, 17 and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Schmidt et al. (2016).
Regarding claims 5, 6, 9, 17 and 20, Schmidt teaches methods for predicting outcomes in septic shock and Acute Respiratory Distress Syndrome (viral and/or bacterial infections, respiratory condition) wherein measuring elevated levels (outside normal range) of hyaluronic acid (HA) and chondroitin sulfate (CS) (GAG) in urine (biological sample) are associated with severity of illness (Figure 2) and predict renal dysfunction (disorder) and mortality (or diagnoses condition severity) (p.445 – 446, Discussion).
The reference anticipates the claimed subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5 – 6, 15 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 7951545. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued patent claims a method comprising a) measuring the level of keratan sulfate (GAG) in a blood sample from a subject suspected of having mucopolysaccharidosis (a subject in need) with at least two times higher level of keratan sulfate compared to a control/health subject; and b) correlating the subject with a higher risk mucopolysaccharidosis (or diagnoses condition severity). Although the method is not claimed as a method to diagnose condition severity, the method steps are the same.
Claims 5 – 6 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8569001. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued patent claims a method comprising a) measuring the level of heparan sulfate (GAG) in a blood sample from a subject suspected of having lysosomal storage disease (a subject in need) with at elevated levels compared to a health subject; and b) correlating the subject with a higher risk of disease (or diagnoses condition severity). Although the method is not claimed as a method to diagnose condition severity or where the elevated level is 2 times standard deviation, it would have been well within the purview of one of ordinary skill in the art to correlate elevated levels of heparan sulfate with higher risk (or severity) of disease since it is a disclosed and claimed biomarker for disease.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699