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 .
Detailed Action
Summary
This is the Final Office Action based on application 18/026088 filed 12/15/2025.
Claims 1-2, 4-7, 9-10 & 17-23 are pending and have been fully considered.
Claims 3, 8, 11-16, & 24-27 are cancelled.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 reads in lines 1-2, “treating a subject with having Glycogen Storage Disease Type Ia.” This is improper English.
Appropriate correction is required.
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 ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title.
The claimed invention of Claims 1-2, 4-7, 9-10 & 17-23 are directed to non-statutory subject matter.
The invention of instant claims for independent claim 1 is drawn towards a method for treating a subject with glycogen storage disease type Ia (GSD Ia).
However, as instantly considered as a whole the independent claim is drawn towards the judicial exceptions which are a combination of a natural correlation and an abstract idea.
Through 101, inquiry:
Inquiry: Are the claims directed to a statutory category of invention?
Yes, independent Claim 1 is drawn towards a statutory category (a method).
Step 2A, Prong 1: Do the claims involve a Judicial Exception?
Yes, independent Claim 1 involves judicial exceptions.
Independent Claim 1 requires, “treating,” a subject with GDS Ia, based on “determining,” the level of 1,5-AG. Though the diagnosis part and the word diagnosis is no longer used in Claim 1, the correlation of the level of 1,5-AG = GSD Ia and the need to treat (so diagnosis or disease remaining) is a natural correlation. Though the word “diagnose,” is no longer used in the claim and the natural correlation is not explicitly in the claim, it is still implicitly there. Claim 1 also include an abstract idea/ math of the correlation which is another judicial exception.
Step 2A, Prong 2: Has the natural correlation or abstract idea been integrated into a particular practical application?
In Claim 1 there is no integration of the claimed judicial exceptions into a practical application.
In addition to the judicial exception parts of the claim, Claim 1 contains the additional steps of:
Obtaining a bio-sample from subject
This is considered extra-solution activity performed to accomplish the judicial exceptions. See MPEP 2106.05(g). Further, nothing is done to after the “determining,” and “diagnosing,” judicial exceptions are accomplished, to practically apply the judicial exceptions. Therefore, there is no practical application.
“Treating,” the subject with a therapeutic amount of “one or more inhibitors that target renal sodium glucose co-transporter 2 (SGLT2) function, and or administering cornstarch,” “when,” the level of 1,5-AG is higher than a reference. If the level measured is lower or the same as the reference, nothing further is done and there is no application. Since the claim is left open to no treatment occurring, there is not practical application as nothing is done after the claimed measuring. Further—a “therapeutic amount,” can be broadly interpreted as any amount, and is not the same as claiming “therapeutically effective amount.” Therefore, even if the claim were limited to a treatment always occurring, it is unclear on the moment if the claimed treatments would be considered to or not to practically apply with the current wording of “therapeutic amount.”
With respect to particular treatment, See MPEP 2106.04 (d)(2) & Vanda memorandum.
Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea?
For Claim 1 the additional steps, outlined above are not considered to be significantly more than the claimed judicial exceptions.
Obtaining samples, whether it be pre or post treatment is well understood, routine and conventional (WURC) in the art. This is done for almost any medical diagnostic procedure. Further, treating a patient with a general treatment and then monitoring to see the effect is also WURC. This is the case especially at the level of generality claimed.
Therefore, as claimed all these steps are WURC and standard laboratory technique and are not sufficient to show an improvement in technology or add significantly more. See MPEP 2106.05 (d) & (a).
For the claimed treating step, again the claim is left open to no treatment occurring, so the treatments are not significantly more in these instances. Further—a “therapeutic amount,” can be broadly interpreted and is not the same as claiming “therapeutically effective amount.” Therefore, even if the claim were limited to a treatment always occurring, it is unclear on the moment if the claimed treatments would be considered to add significantly more with the wording of “therapeutic amount.”
The dependent claims are reviewed for additional limitations dependent on the independent claim above.
Claim 2 claims an association with a Z score. Z scores are a mathematical concept, and this is an abstract idea so part of the judicial exception itself.
Claim 4 specifies that the bio-sample is from a subject which does not have GSD. Whether the sample has or does not have the disease (or diagnosis of), is part of the natural correlation judicial exception itself.
Claims 5 specifies that a reference sample is used and that the bio-sample is blood, serum, or plasma. All of these types of samples are used to obtain data to accomplish the judicial exceptions at step 2A/2 and also are WURC in the art at step 2B—therefore do not change the analysis above.
Claims 6 specifies that the bio-sample is from a subject which does have GSD. Whether the sample has or does not have the disease (or diagnosis of), is part of the natural correlation judicial exception itself.
Claims 7 & 23 specify that the level of 1,5-AG is determined by one of mass spectrometry, HPLC, or other generally claimed detection device/technique. Especially at the level of generality claimed, this detection is not claimed in a way which turns the claimed natural correlation into specific detection claims (so that they read different than diagnostic claim or abstract idea claims), nor is it claimed in a way which practically applies or adds significantly more to the judicial exceptions.
Claim 9-10 specify that cellular metabolites are analyzed and compared to a reference. This is the claiming of a judicial exception itself (both natural correlation and abstract idea) and therefore does not change the matters above.
Claim 17 specifies that the treatment can be cornstarch uncooked or modified or a cornstarch alternative, which can be considered to be anything. This is not considered to be particular or specific treatment, nor does it practically apply a judicial exception as the treatment is performed before the judicial exceptions in the claim body, so there is no practical application.
Claim 18 & 20 specify conditions for determinations on if the treatment is effective. These conditions though as claimed are mental process/ abstract ideas, and are also just statement of the natural correlation. Therefore, does not practically apply nor does it add significantly more.
Claim 19 specifies that only in some instances, the treatment is repeated. Therefore- this does not limit the claim to always practically applying the judicial exception. Also, the claimed treatment is not particular and specific.
Claim 21-22 specify that only in some instances, the subject’s diet is modified (with cornstarch or carbohydrates). People modify their diet on a regular basis. Therefore, the claimed treatment is not particular and specific. So, this does not limit the claim to always practically applying the judicial exception
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 18-22 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.
The term “effective” is not defined by the claim in Claims 19 & 21, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further what one person would consider effectiveness or level of effectiveness would be different from person to person. Therefore, this is unclear in the claims.
With respect to Claims 18 & 20, “the reference range,” fails to have proper antecedent basis and “reference range,” was not used priorly to this in the claims. Only “reference level,” was used and it is unclear if applicant means the same thing by both terms. Further, it is unclear if “the reference level,” is referring back to the reference biosample or not as this is not specified and this term fails to have proper antecedent basis as well. Therefore, this is unclear in the claim language.
Claim 22 is rejected by virtue of being dependent on a claim rejected under 112.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-7, 9-10, 18-20 & 23 are rejected under 35 U.S.C. 103 as being unpatentable by UNIVERSITE CATHOLIQUE in WO 2019202149 (as cited on IDS dated 03/13/2023) in view of VEIGA DA CUNHA in, Failure to eliminate a phosphorylated glucose analog leads to neutropenia in patients with G6PT and G6PC3 deficiency (also as cited on IDS dated 03/13/2023).
With respect to Claim 1, UNIVERSITE CATHOLIQUE teaches a method of diagnosing a subject with a Glycogen Storage Disease (GSD) (methods for determining the level of 1,5-AG in a biological sample,
preferably in a blood sample, more preferably in a plasma or serum sample, Pg. 42, Lns. 3-5; the subject is a human patient who is... monitored for the development... of a neutropenia, Pg. 8, Lns. 22-24;
a subject suffering from neutropenia is a responder or responds to a treatment with a SGLT2 inhibitor... if the administration of said SGLT2 inhibitor to the subject results in a decrease of the blood level of 1,5-AG of the subject, preferably a decrease of the serum or plasma level of 1,5 -AG of the subject, Pg. 33, Lns. 21-24;
the intracellular 1,5-AG-6-P results from the phosphorylation of 1,5-AG in animal cells.... measuring the level of 1,5-AG in a biological sample obtained from a subject suffering from neutropenia associated with an intracellular accumulation of 1,5-AG-6-P allows the monitoring of said neutropenia in the subject, Pg. 38, Lns. 5-9; subject suffers from neutropenia linked... to a deficiency of the glucose-6-phosphate transporter encoded by G6PT, Pg. 3, Lns. 21-23; the neutropenia linked to a deficiency of the giucose-6-phosphate transporter encoded by G6PT, also known as SLC37A4, is one of the symptoms of the congenital glycogen storage disease type Ib, Pg. 3, Lns. 26-29).
The method comprises: obtaining a biosample from a subject suspected of having GSD and determining the level of 1,5-anhydroglucitol (1,5-AG) in the biosample (a method for monitoring neutropenia associated with an intracellular accumulation of 1,5-anhydroglucitol-6-phosphate in a subject, said method comprising measuring the level of 1,5-anhydroglucitol in a biological sample obtained from the subject, Pg. 38, Lns. 1-4; monitoring neutropenia associated with an intracellular accumulation of 1,5-anhydroglucitol-6-phosphate in a subject, said method comprising measuring the level of 1,5-anhydroglucitol in a biological sample, Pg. 38, Lns. 1-3;
comparing the level of 1,5-AG in a plasma or serum sample obtained from the subject to a reference level of 1,5-AG, Pg. 40, Lns. 22-23).
UNIVERSITE CATHOLIQUE further teaches of treating the patient with an SGLT2 inhibitor (abstract), when they have an elevated level of 1, 5- anhydroglucitol-6-phosphate in comparison to a control (Page 3, Lines 18-20). Administration of any amount can be considered a “therapeutic amount,” through broadest reasonable interpretation.
UNIVERSITE CATHOLIQUE fails to explicitly teach when the level of 1,5-AG in the biosample of the subject suspected of having a GSD is higher than that of a reference biosample, then diagnosing the subject with a GSD la/that the subject is diagnosed with GDS Ia.
VEIGA DA CUNHA is in the field of neutropenia caused by failure to eliminate a phosphorylated glucose analog (Title) and teaches when a level of 1,5-AG in a biosample of a subject is higher than that of a reference, then diagnosing the subject with a GSD la or Ib (deficiency in G6PT leads to glycogen storage disease type Ib... GSD lb... which associates all of the metabolic symptoms of G6PC1 deficiency with neutropenia and neutrophil dysfunction, Pg. 1241, right hand column, first full paragraph from bottom; metabolomic analysis by LC-MS showed that the presence of 1,5AG resulted in a time-dependent increase in 1,5AG6P, which reached ~3 mM after 22 h, Pg. 1245, left hand column, first partial paragraph from top; physiological concentrations of 1,5AG lead to the accumulation of 1,5AG6P in G6PC3- deficient neutrophils to concentrations that are sufficient to inhibit phosphorylation of glucose and reduce cell viability, Pg. 1245, left hand column, first full paragraph from top).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of UNIVERSITE CATHOLIQUE to be diagnostic for a specific condition/disease (GSD 1b) as taught by VEIGA DA CUNHA due to the advantage this offers for the purpose of targeting the cause of the decrease in neutrophil numbers and of their impaired function in glycogen storage disease type Ib (VEIGA DA CUNHA, Pg. 1241, right hand column, first full paragraph from bottom).
With respect to Claim 4, UNIVERSITE CATHOLIQUE the method of Claim 1. They further disclose wherein the reference biosample comprises a biosample from a subject not having a GSD (the reference level is derived from the measure of the blood level of 1,5-AG in one or more subjects who are substantially healthy, Pg. 40, Lns. 6-7).
With respect to Claim 5, UNIVERSITE CATHOLIQUE teaches the method of Claim 1. They further teach obtaining a reference biosample (the reference level is derived from the measure of the blood level of 1,5-AG | in one or more subjects who are substantially healthy/which reads on the sample not having GSD Ia, Pg. 40, Lns. 6-7). They further teach that the sample is preferably a blood sample, more preferably in a plasma or serum sample, Pg. 42, Lns. 3-5.
With respect to Claim 6, UNIVERSITE CATHOLIQUE teaches the method of Claim 5. UNIVERSITE CATHOLIQUE further teaches wherein obtaining a reference biosample comprises obtaining a biosample from a subject not having a GSD and determining the level of 1,5-AG in the biosample (the reference level is derived from the measure of the blood level of 1,5-AG in one or more subjects who are substantially healthy, Pg. 40, Lns. 6-7).
With respect to Claim 7, modified UNIVERSITE CATHOLIQUE teaches, the method of Claim 1. UNIVERSITE CATHOLIQUE further teaches wherein determining the level of 1,5-AG in the biosample comprises using mass spectrometry, ultra-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), mass spectrometery in conjunction with UPLC, LC/MS/MS, ELISA, Western blots, or any combination thereof (the level of 1,5-AG of a subject can be determined by performing LC-MS analysis... liquid chromatography-mass spectrometry... on a plasma sample or a serum sample obtained from the subject, Pg. 39, Lns. 6-8).
With respect to Claim 9, modified UNIVERSITE CATHOLIQUE teaches the method of Claim 1. UNIVERSITE CATHOLIQUE further teaches determining the level of one or more cellular metabolites and comparing the level of the one or more cellular metabolites to that of the reference biosample to identify one or more differentially present cellular metabolites (incubation of neutrophil precursors derived from G6PC3-deficient mice with 1,5-anhydroglucitol induced... the accumulation of 1,5-anhydroglucitol-6-phosphate... a decreased rate of glucose metabolism, Pg. 61, Lns. 22-24; Fig. 4).
With respect to Claim 10, modified UNIVERSITE CATHOLIQUE teaches the method of Claim 9. UNIVERSITE CATHOLIQUE further teaches wherein the one or more differentially present cellular metabolites comprise glucose, uric acid, lactate, triglycerides, and any combination thereof (incubation of neutrophil precursors derived from G6PC3-deficient mice with 1,5-anhydroglucitol induced... the accumulation of 1,5-anhydroglucitol-6-phosphate... a decreased rate of glucose metabolism, Pg. 61, Lns. 22-24; Fig. 4).
With respect to Claim 18, UNIVERSITE CATHOLIQUE teaches the method of Claim 1, wherein the treatment is effective when the post-treatment level of 1,5-AG is lower than the pre-treatment level of 1,5- AG, or when the post-treatment level of 1,5-AG is within an acceptable range of the reference level of 1,5-AG (a subject suffering from neutropenia is a responder or responds to a treatment with a SGLT2 inhibitor as described hereinabove if the administration of said SGLT2 inhibitor to the subject results in a decrease of the blood level of 1,5-AG of the subject, preferably a decrease of the serum or plasma level of 1,5 -AG of the subject, Pg. 33, Lns. 21-24).
With respect to Claim 19, UNIVERSITE CATHOLIQUE teaches the method of Claim 1, wherein when the treatment is effective, further comprising repeating the treatment (said SGLT2 inhibitor is to be administrated at a dose ranging from about 0.015 mg per kilo body weight per day... to about 4.5 mg/kg/day, preferably at a dose ranging from about 0.035 mg/kg/day to about 1.5 mg/kg/day.... said SGLT2 inhibitor is to be administrated once a day for at least 4 days and subsequently once a week, pg. 4, Lns. 11-15; experiment was repeated with a larger cohort of G6PC3-deficient mice... and the effect of the treatment... was assessed... on the blood 1,5-anhydroglucitol, Pg. 47, Lns. 9-14; Fig. 71).
With respect to Claim 20, UNIVERSITE CATHOLIQUE teaches method of Claim 13, wherein the treatment is not effective when the post-treatment level of 1,5-AG is higher than the pre-treatment level of 1,5- AG, or when the post-treatment level of 1,5-AG is not within an acceptable range of the reference level of 1,5-AG (after receiving a therapeutic amount of a SGLT2 inhibitor according to the present invention, the subject shows... a decrease of the blood level of 1,5-AG, preferably a decrease of the serum or plasma level of 1,5-AG, Pg. 9, Lns. 28-31; rapid decrease in blood 1,5-anhydroglucitol, as a result of empagliflozin administration.... these effects were not observed after the administration of saline, Pg. 66, Lns. 13-17; Fig. 71).
With respect to Claim 23, UNIVERSITE CATHOLIQUE teaches the method of claim 13, wherein determining the level of 1,5-AG in a biosample comprises using mass spectrometry, ultra-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), mass spectrometry in conjunction with UPLC, LC/MS/MS, ELISA, Western blots, or any combination thereof (the level of 1,5-AG of a subject can be determined by performing LC-MS analysis... liquid chromatography-mass spectrometry... on a plasma sample or a serum sample obtained from the subject, Pg. 39, Lns. 6-8).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable by UNIVERSITE CATHOLIQUE in WO 2019202149 (as cited on IDS dated 03/13/2023) in view of VEIGA DA CUNHA in, Failure to eliminate a phosphorylated glucose analog leads to neutropenia in patients with G6PT and G6PC3 deficiency, (also as cited on IDS dated 03/13/2023) and further in view of SECK in 1,5-anhydrogucitol as a useful marker for assessing short term glycemic excursions in Type I Diabetes (as cited on IDS dated 03/13/20203).
With respect to Claim 2, modified UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA teaches the above for Claim 1, but fails to explicitly teach wherein the level of 1,5-AG in the subject suspected of having a GSD is associated with a Z-score of at least +1.5, at least +2, or more than +2.
SEOK is in the field of 1,5-Anhydroglucitol as a useful marker for hypoglycemia (Title; Abstract) and teaches a level of 1,5-AG in a subject is associated with a Z-score of at least +1.5, at least +2, or more than +2 (subjects showed severe glycemic excursions, including hypoglycemia.... [the change in 1,5-AG level was significantly correlated with changes in the glycemic excursion indices of the standard deviation, Abstract; results showed the change in 1,5-AG... A1,5-AG... level was significantly correlated with changes in most of the variability indices of CGMS.... [t]he A1,5- AG was correlated with changes in SD, Pg. 167, left hand column, first partial paragraph from top; Table 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA by a threshold as taught by SEOK due to the advantage this offers for assessing short-term changes in glycemic variability (Seok, Abstract).
Claim 17, 21, & 22 is rejected under 35 U.S.C. 103 as being unpatentable by UNIVERSITE CATHOLIQUE in WO 2019202149 (as cited on IDS dated 03/13/2023) in view of VEIGA DA CUNHA in, Failure to eliminate a phosphorylated glucose analog leads to neutropenia in patients with G6PT and G6PC3 deficiency, (also as cited on IDS dated 03/13/2023) and further in view of WORTMANN in Treating neutropenia a neutrophil dysfunction in glycogen storage disease type 1b with an SGLT2 inhibitor.
With respect to Claim 17, UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA teaches of the method of Claim 1. UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA fails to explicitly teach wherein the treatment comprises administering to the subject uncooked cornstarch, modified cornstarch, a cornstarch derivative, a cornstarch alternative, or a combination thereof.
WORTMANN is in the field of treating neutropenia and neutrophil dysfunction in glycogen storage disease type Ib (Title) and teaches administering to a subject uncooked cornstarch (continuous gastric drip feeding was replaced by frequent meals with small doses of uncooked cornstarch.... [as determined by CGM, hypoglycemic episodes quickly became less frequent.... [daily glucose urinary excretion on empagliflozin at 0.4 and 0.5 mg/kg per day corresponded to a weight percentage of 4% and 7%, respectively, of the daily dose of uncooked cornstarch, Pg. 1037, left hand column, first partial paragraph from bottom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA by a treatment as taught by Wortmann for the purpose of treating neutropenia and neutrophil dysfunction in glycogen storage disease type Ib due to the advantage the treatments in WORTMANN have for treating the claimed diseases (WORTMANN, Title, abstract).
With respect to Claim 21, UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA teaches the method of Claim 20. UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA fails to explicitly teach wherein when the treatment is not effective, then implementing a change in the subject's dietary intake of carbohydrates. WORTMANN is in the field of treating neutropenia and neutrophil dysfunction in glycogen storage disease type ib (Title) and teaches implementing a change in a subject's dietary intake of carbohydrates (continuous gastric drip feeding was replaced by frequent meals with small doses of uncooked cornstarch.... [as determined by CGM, hypoglycemic episodes quickly became less frequent... [daily glucose urinary excretion on empagliflozin at 0.4 and 0.5 mg/kg per day corresponded to a weight percentage of 4% and 7%, respectively, of the daily dose of uncooked cornstarch, Pg. 1037, left hand column, first partial paragraph from bottom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA by a treatment as taught by WORTMANN for the purpose of treating neutropenia and neutrophil dysfunction in glycogen storage disease type Ib due to the advantage the treatments in WORTMANN have for treating the claimed diseases (WORTMANN, Title, abstract).
With respect to Claim 22, modified UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA teaches the method of Claim 21. UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA does not teach wherein implementing a change in the subject's dietary intake of carbohydrates comprises administering more cornstarch and/or carbohydrates to the subject, more frequently administering cornstarch and/or carbohydrates to the subject, or both. WORTMANN is in the field of treating neutropenia and neutrophil dysfunction in glycogen storage disease type Ib (Title) and teaches implementing a change in a subject's dietary intake of carbohydrates comprises administering cornstarch (continuous gastric drip feeding was replaced by frequent meals with small doses of uncooked cornstarch.... [as determined by CGM, hypoglycemic episodes quickly became less frequent... [daily glucose urinary excretion on empagliflozin at 0.4 and 0.5 mg/kg per day corresponded to a weight percentage of 4% and 7%, respectively, of the daily dose of uncooked cornstarch, Pg. 1037, left hand column, first partial paragraph from bottom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of UNIVERSITE CATHOLIQUE and VEIGA DA CUNHA by a treatment as taught by Wortmann for the purpose of treating neutropenia and neutrophil dysfunction in glycogen storage disease type Ib due to the advantage the treatments in WORTMANN have for treating the claimed diseases (WORTMANN, Title, abstract).
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
Most of the prior 112 rejections have been overcome by amendments made 12/15/2025. Some remain as shown above. Further, an objection is made as shown above.
The 101 rejections are maintained for the claims which were significantly amended 12/15/20225. The claim amendments and the examiners reasoning are addressed in the rejection above instead of in the response to arguments, due to the significant amount of amendments made 12/15/2025.
The prior 102 rejection was overcome due to amendments made, which included the cancelling of some of the claims rejected under 102. However, all pending claims remain rejected under 103.
With respect to the 103 rejections, and specifically Claim 1, applicant argues that neither Universite Catholique nor Veiga teach of GSD Ia. The examiner disagrees. Veiga teaches of GDS Ia.
VEIGA DA CUNHA is in the field of neutropenia caused by failure to eliminate a phosphorylated glucose analog (Title) and teaches when a level of 1,5-AG in a biosample of a subject is higher than that of a reference, then diagnosing the subject with a GSD la or Ib (Page 1241, column 2, paragraph 1). Specifically, VEIGA DA CHUNHA teaches that G6PC1 is associated with glycogen storage disease type Ia, and that G6PC1 is associated with the 1,5 AG6 P levels (Page 1243, column 1).
Therefore, the instant claims are made obvious by the prior art.
Applicant argues about Claim 2 and Claims 17, 21 7 22 rejections which all use an additional piece of prior art to the rejection of Claim 1. Applicant only argues that they do not think the prior art teaches of the same thing they argued for Claim 1. The examiner has already responded to this above.
All claims remain rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758