DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The instant application is a 371 of PCT/JP2022/017237 filed on 04/07/2022 and claims foreign priority to application no. JP2021-174365 filed on 10/26/2021, JP2021-076579 filed on 04/28/2021, and JP2021-065938 filed on 04/08/2021. The certified copies of the foreign priority applications filed on 10/06/2023 are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/26/2023, 11/27/2023, 03/11/2024, 10/10/2025, and 12/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 10/10/2023 is acknowledged. Claims 3-5 and 7-8 are amended. Claim 9 is newly added.
Accordingly, claims 1-9 are pending and being examined on the merits herein.
Drawings
The drawings are objected to because the data and text in FIG. 1, FIG. 3A-3C, FIG. 5A-5C, FIG. 6A-6B, FIG. 8, FIG. 9A-9B, and FIG. 19 have poor resolution. The text labels for the data points in FIG. 4B are overlapping and are not readable.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The hyperlinks are found in paragraph 0072, 0074, 0108, 0208, 0222 (two hyperlinks), paragraph 0225 page 120 (third to last line), paragraph 0227 (references 1-3, 5-19 have all hyperlinks), and paragraph 0229 (reference D12 on page 127 and D18 on page 128).
The disclosure is objected to because of the following informalities: Tables 2-1 through 2-21 (paragraph 0073) and Tables 3-1 through 3-3 (paragraph 0079) all have poor text resolution.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “…for prophylactic, ameliorating and/or curative treatment … Parkinson’s disease (PD) and/or epilepsy.”. A common is need before both of the recited “and/or”.
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 of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more.
Claim 1 recites “A composition for improving gut microbiota, comprising a beta-glucan produced by Aureobasidium pullulans APO-202 (FERM BP-l9327).”. Claims 2-6 recite additional intended uses of the composition such as wherein the improvement of gut microbiota comprises a decrease of Akkermansia muciniphila with an increase of beneficial bacteria including Roseburia in a gut (claim 2), wherein the composition is for prophylactic, ameliorating and/or curative treatment of autism spectrum disorders (ASD), multiple sclerosis (MS), Alzheimer's disease (AD), Parkinson's disease (PD) and/or epilepsy (claim 3), wherein the composition is for improving behavioural pattern and alpha-synuclein levels (claim 4), wherein the composition is for improving sleep pattern and serum melatonin (claim 5), and wherein the improvement is in a child with autism spectrum disorder (claim 6). Claims 7-8 recite specific compositions of instant claim 1 such as pharmaceutical (claim 7) and food (claim 8).
Subject matter that is not patent eligible is determined by evaluating a claim for patentability based on the eligibility test set forth below:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter?
For the instant claims, the answer is “Yes” because the claims are to a composition of matter.
(2a) Prong 1: Does the claim recite or involve a judicial exception?
The answer is “Yes” because the composition includes beta-glucan that are naturally produced by Aureobasidium pullulans APO-202 as disclosed in paragraphs 0035-0039 on page 10 of the instant specification.
(2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The answer is “No”.
MPEP 2106.04(b) section II recites “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”, and MPEP 2160.4(c) sets forth the markedly different characteristic analysis consisting of A. selecting the appropriate counterpart, B. identifying appropriate characteristics for analysis, and C. evaluating characteristics to determine whether they are “markedly different”.
The claims are drawn to a composition comprising a beta-glucan produced by Aureobasidium pullulans APO-202. The closest natural counterpart in nature for the claimed composition is beta-glucans that are naturally produced by the APO-202 strain.
Here, the recited composition does not amount to a markedly different characteristic because the simple isolation of the beta-glucan from APO-202, in the absence of additional components recited in the claims, does not change the structure or function of the beta-glucan in its natural state. Furthermore, the recitation of the intended uses described above in instant claims 1-6 as well as a pharmaceutical or food composition recited in instant claims 7-8 also do not amount to a markedly different characteristic because the recited intended uses and composition forms also do not change the structure or function of the recited beta glucan derived from the APO 202 strain.
Therefore, since no markedly different characteristics are found for the claimed composition, the claims do not recite additional elements that integrate the judicial exception into a practical application.
(2b) Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)?
The answer is “No.”
As described above, MPEP 2160.4(c) sets forth the markedly different characteristic analysis consisting of A. selecting the appropriate counterpart, B. identifying appropriate characteristics for analysis, and C. evaluating characteristics to determine whether they are “markedly different”.
The claims are drawn to a composition comprising a beta-glucan produced by Aureobasidium pullulans APO-202. The closest natural counterpart in nature for the claimed composition is beta-glucans that are naturally produced by the APO-202 strain.
Here, the recited composition does not amount to a markedly different characteristic because the simple isolation of the beta-glucan from APO-202, in the absence of additional components recited in the claims, does not change the structure or function of the beta-glucan in its natural state. Furthermore, the recitation of the intended uses described above in instant claims 1-6 as well as a pharmaceutical or food composition recited in instant claims 7-8 also do not amount to a “markedly different” characteristic because the recited intended uses and composition forms also do not change the structure or function of the recited beta glucan derived from the APO 202 strain.
Therefore, since no markedly different characteristics are found for the claimed composition, the claims do not recite additional elements that amount something more than the judicial exception.
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.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for ameliorating of autism spectrum disorders (ASD), multiple sclerosis (MS), Alzheimer’s disease (AD), Parkinson’s disease (PD), and/or epilepsy, does not reasonably provide enablement for prophylactic and/or curative treatment of autism spectrum disorders (ASD), multiple sclerosis (MS), Alzheimer’s disease (AD), Parkinson’s disease (PD), and/or epilepsy. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) The breadth of the claims,
2) The nature of the invention,
3) The state of the prior art,
4) The level of one of ordinary skill,
5) The level of predictability in the art,
6) The amount of direction provided by the inventor,
7) The existence of working examples, and
8) The quantity of experimentation necessary
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, the breadth of the claims, and relative skill level
The invention relates to a composition according to claim 1, wherein the composition is for prophylactic, ameliorating, and/or curative treatment of autism spectrum disorders (ASD), multiple sclerosis (MS), Alzheimer’s disease (AD), Parkinson’s disease (PD), and/or epilepsy
The claims are broad in that they encompass prophylactic and/or curative treatment of the recited diseases.
In the absence of an explicit definition in Applicant’s specification, the claims are given their broadest reasonable interpretation. See MPEP 2111. Merriam-Webster (reference included with PTO-892) defines " prophylactic" as meaning, " guarding from or preventing the spread or occurrence of disease or infection." Thus, the broadest reasonable interpretation of “prophylactic” includes “prevention”, and in the absence of a limiting definition by Applicant, “prevention” is interpreted as defined according to Institute for International Medical Education (IIME, reference included with PTO-892), which defines “prevention” as promoting health, preserving health, and to restore health when it is impaired, and to minimize suffering and distress (see page 16, “Prevention”. IIME further states that “Primary prevention refers to the protection of health by personal and community wide effects, such as preserving good nutritional status, physical fitness, and emotional well-being, immunizing against infectious diseases, and making the environment safe. Secondary prevention can be defined as the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health. Tertiary prevention consists of the measures available to reduce or eliminate long-term”
Furthermore, NCI Dictionary (in PTO-892) defines “curative therapy” as meaning “Treatment that is meant to cure an illness or disease with the goal of a full recovery that includes an acceptable quality of life”. Thus, the broadest reasonable interpretation of “curative treatment” includes a “cure” and is being interpreted as defined in Taber’s Medical Dictionary (in PTO-892), which defines “cure” as a restoration to heath.
Therefore, in order to give the broadest reasonable interpretation to the claims, “prophylactic" is thus interpreted to mean that the onset of a condition never occurs and the patient’s health is protected and preserved, and the term “curative treatment” is interpreted as the full restoration to health from a condition.
The relative skill of those in the art is high, that of an MD or PHD, someone with experience in the recited diseases.
The amount of direction or guidance provided and the presence or absence of working examples
Applicant demonstrates in Example 1 that subjects who underwent conventional treatment and were additionally supplemented with beta glucan AFO-202 had a decrease in the abundance of Enterobacter (see Fig. 10-13 as well as paragraph 0103). Applicant states Enterobacter produce functional amyloid proteins termed curli which promotes human amyloid alpha-synuclein pathology, and the aggregation of curli and alpha-synuclein stimulated pathological and immunological processes that lead to neurodevelopmental and neurodegenerative diseases such as ASD, MS, PD, and AD (paragraph 0104). Therefore, Applicant states that consumption of the recited AFO-202 beta glucan may alleviate the pathological processes behind such diseases involving amyloid accumulations (paragraph 0104).
However, the instant disclosure does not identify a method that could be used by one of ordinary skill in the art to determine that a subject would have predictably developed a recited disease without the claimed methods in order to establish that such recited diseases was prevented and/or cured.
The described example suggests that the recited beta glucan was potentially effective in alleviating the pathological processes behind such neurodevelopmental and neurodegenerative diseases involving amyloid accumulations by reducing Enterobacter. However, the example does not demonstrate prevention and/or cure of the recited diseases or a predictable method to identify patients who would have developed the recited diseases.
The state and predictability of the art
There are no art recognized methods that could be used to establish that the recited diseases were prevented and/or cured using therapeutic treatment or to identify patients who would predictably develop the recited diseases in order to predictably identify that prevention and/or cure was achieved using therapeutic approaches. Rather, the art indicates that the recited diseases were not predictable.
Gialloreti (in PTO-892) discloses that autism spectrum disorder (ASD) is a complex condition with early childhood onset, and the etiology of ASD is not yet fully understood (see Abstract). Gialloreti further discloses that there is no treatment for the core features of ASD, and that symptoms can only be reduced by early behavioral interventions and some pharmacology therapies (see second paragraph page 2). Gialloreti teaches that genetics is a well-established risk factor, however several environmental factors may also contribute and interact with genetics (see Abstract).
The teachings of Gialloreti demonstrate that ASD is complex condition with the cause not being fully understood. Furthermore, Gialloreti teaches that there is no treatment for the core features of ASD. Therefore, these teachings demonstrate that there was no specific known cause of ASD and/or preventative treatment, and therefore, suggest that there would be no method to predictably determine that ASD would have developed in order to establish that it was prevented and/or cured.
Winquist (in PTO-892) discloses the complex etiology of multiple sclerosis. Winquist discloses that the pathogenesis of MS has proven to be quite complex as observations exist which question the role of autoreactive lymphocytes in the etiology of MS (Abstract). Furthermore, Winquist discloses that the current immunomodulatory therapeutics do not prevent most patients from progressing into more serious forms of the disease and that the development of truly transformational therapeutics for MS will likely require a broad assault that expands beyond the concept of MS being an autoimmune disease (see Abstract).
The teachings of Winquist demonstrate that MS is complex condition with the pathogenesis not being fully understood. Furthermore, Winquist teaches that current therapeutic do not prevent most patients from progressing into more serious forms of the disease. Therefore, these teachings demonstrate that there was no specific known cause of MS and/or preventative treatment, and therefore, suggest that there would be no method to predictably determine that MS would have developed in order to establish that it was prevented and/or cured.
Castellani (in PTO-892) discloses that the diagnosis of Alzheimer’s disease (AD) requires clinical evidence of memory loss and impairment of at least one other cognitive domain, with evidence of disturbance in social or occupational function (see first paragraph under section II page 2). Castellani discloses that while attempts to identify early AD is strategic, it is important to point out that mild cognitive impairment (MCI) is not a distinct entity. Rather MCI lacks a pathological substrate, genetic predispositions, and discernible treatment benefits, whereas a given patient with this diagnosis may progress to neurodegenerative disease, remain clinically stable for many years, and even improve over time (see second paragraph under section II page 2). Castellani discloses that a given MCI is therefore a case of early AD or not a case of early AD, such that a pool of subjects will, with mathematical certainty, be comprised of a mixture of subjects with genuine AD, subjects with neurodegenerative conditions, and subjects who would not develop neurodegeneration for many years, if ever (see second paragraph section II page 2). Castellani discloses that genuine AD, unfortunately, is relentlessly progressive, in spite of all available therapy. Initial insidious memory impairment converts, over months and years, to disorientation, personality and judgment dysfunction, speech abnormalities, and apraxias, among other signs (see third paragraph section II page 2). Castellani also discloses that the distinction between the pathology of AD and the pathology of aging is problematic, particularly in the elderly (see second paragraph page 4).
The teachings of Castellani demonstrate that the diagnosis of AD is difficult with potential false positives in the early stages of AD, and that the pathology of AD can overlap with the pathology of aging. Therefore, these teachings suggest that there would be no method to predictably determine that AD would have developed in order to establish that it was prevented and/or cured.
Gazewood (in PTO-892) discloses that there are a number of neurologic conditions that mimic Parkinson disease (PD), making it difficult to diagnose in its early stages (see Abstract). Gazewood discloses that diagnosis of PD relies of the presence of the cardinal features of bradykinesia, rigidity, tremor, and postural instability, coupled with gradual symptom progression and a sustained response to therapy with levodopa (see second paragraph left column first page). Gazewood discloses that these features are shared among other neurologic conditions, and commonly misdiagnosed symptoms include nonparkinsonian tremors such as essential tremor, and diseases with parkinsonian features such as vascular parkinsonism, progressive supranuclear palsy, and drug-induced parkinsonism (see second paragraph left column through first paragraph right column first page). Gazewood discloses that the diagnosis of PD in the early stage is particularly difficult and diagnostic error is common (see third paragraph right column first page).
The teachings of Gaze demonstrate that the diagnosis of PD, particular in the early stage, is difficult and is often misdiagnosed. Therefore, these teachings suggest that there would be no method to predictably determine that PD would have developed in order to establish that it was prevented and/or cured.
Benbadis (in PTO-892) discloses that the wrong diagnosis of epilepsy is common (Abstract). Benbadis discloses that the common conditions often misdiagnosed as epilepsy include psychogenic non-epileptic attacks as well as hypoglycemia, panic attacks, paroxysmal movement disorders, paroxysmal sleep disorders, TIAs, migraines, and TGA (see Abstract). Benbadis discloses that due to the common misdiagnosis of epilepsy, diagnosis can be delayed for 7 to 10 years (see first paragraph right column first page). Benbadis discloses that neurologists may not have a high enough index of suspicion to question the diagnosis of ‘‘seizures” when drugs fail (see first paragraph right column first page).
The teachings of Benbadis demonstrate that the diagnosis of epilepsy is frequently misdiagnosed, resulting in a delay for diagnosis as long as 7 to 10 years. Therefore, these teachings suggest that there would be no method to predictably determine that epilepsy would have developed in order to establish that it was prevented and/or cured.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of a predictable method to identify patients who would develop a recited disease without treatment, one of ordinary skilled in the art would not be able to predictably use the claimed agent to prevent and/or cure the recited diseases. Furthermore, the quantity of experimentation to develop a method that could be used to prevent and/or cure a recited disease would be undue because a method to predictably identify a patient who would get the recited diseases does not exist and as described above, one of ordinary skill would have to further develop this method such that the recited method could then be used as a preventative and/or curative measure against the recited diseases. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claims 1-9 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that beta glucans derived from Aureobasidium pullulans strain FO-68 (also known as AFO 202) is required to practice the claimed invention. As such the AFO-202 biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the AFO 202.
Applicant has disclosed that the AFO 202 strain was deposited at the International Patent Organism Depositary on April 21st, 2021 with the accession number: FERM BP-19327 (paragraph 0036 in specification). However, there is no indication in the specification as to the public availability or if restrictions on availability will be lifted.
If a deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP2013170162 (in IDS filed 10/26/2023, an English translation is provided in PTO-892 and used as the basis for this rejection).
JP’162 discloses a serotonin biosynthesis promoter that is characterized by containing beta-1,3-1,6 glucan as an active ingredient and is preferably derived from Aureobasidium pullulans (paragraphs 0011-0012). JP’162 discloses the use of a beta-1,3-1,6 glucan produced by the FO-68 strain belonging to Aureobasidium pullulans which has the preferred molecular weight and side chain branching ratio (paragraph 0022). Here, as evidenced by the instant specification, the FO-68 strain is also referred to as strain AFO 202 (paragraph 0035 page 10 in instant specification). JP’162 further discloses that the beta-1,3-1,6 glucan can be added into cooked rice (paragraph 0029) as well as to semi-solid food or fluid diet given to elderly person or patient who has difficult ingesting solid food (paragraph 0034), which meets the limitation of a food and pharmaceutical composition.
JP’162 does not disclose the recited intended uses in instant claims 1-6, such as for improving gut microbiota (claim 1), wherein the improvement of gut microbiota comprises a decrease of Akkermansia muciniphila with an increase of beneficial bacteria including Roseburia in a gut (claim 2), wherein the composition is for prophylactic, ameliorating and/or curative treatment of autism spectrum disorders (ASD), multiple sclerosis (MS), Alzheimer's disease (AD), Parkinson's disease (PD) and/or epilepsy (claim 3), wherein the composition is for improving behavioral pattern and alpha-synuclein levels (claim 4), wherein the composition is for improving sleep pattern and serum melatonin (claim 5), and wherein the improvement is in a child with autism spectrum disorder (claim 6). However, MPEP 2111.02 II states that “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim”.
Here, the compositions of JP’162, which comprises the recited beta glucan, would be able capable of performing any of the intended uses recited in instant claims 1-6, and therefore instant claims 1-8 are anticipated.
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 nonobviousness.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over CN110917207 (in IDS filed 10/26/2023) in view of JP2013170162 (in IDS filed 10/26/2023, an English translation is provided in PTO-892 and used as the basis for this rejection).
CN’207 discloses preparing a composition comprising beta-glucans for improving gut microbiota diversity and/or abundance (claim 1 on page 2). CN’207 discloses that their compositions can be safely and effectively administered to a mammal such as a human in need of treatment, wherein the dose is preferably 20-1000mg for a 60kg human (paragraph 0234).
The difference between CN’207 and the claimed invention is that CN’207 does not disclose the recited beta glucan produced by Aureobasidium pullulans AFO-202.
The teachings of JP’162 are as described above. Furthermore, JP’162 discloses that serotonin plays various roles in vivo including both inhibiting and promoting effects on gastrointestinal motility based on activation of its diverse sub-type receptors, and that abnormality of serotonin can cause abnormalities in the digestive tract function (paragraph 0005). JP’162 discloses that their beta glucan composition can significantly increase the biosynthesis amount of serotonin in vivo, particular in the intestinal tract (paragraphs 0009 and 0015).
It would have been prima face obvious before the effective filing date of the claimed invention to have substituted the beta-glucan of CN’207 with the beta glucan produced by Aureobasidium pullulans FO-68 disclosed in JP’162 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make this substitution because JP’162 discloses an advantage that their beta glucans can significantly increase the biosynthesis amount of serotonin in vivo, particularly in the intestinal tract which can improve its function. One of ordinary skill in the art would have a reasonable expectation of success because both CN’207 and JP’162 teach administering beta-glucans for improving the health or function of the gastrointestinal tract.
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 1-6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/569,553 (‘553).
Claim 6 of ‘553 recites a composition for improving gut microbiota, comprising a beta-glucan produced by Aureobasidium pullulans N-163, and claim 7 of ‘553 recites further comprising a beta-glucan produced by Aureobasidium pullulans AFO-202. Claim 8 of ‘553 recites wherein the improvement of gut microbiota comprises a decrease of Akkermansia with an increase of beneficial bacteria including Lactobacillus in a gut.
Instant claim 1 is anticipated.
In regards to instant claims 2-6, the claims of ‘553 do not recite the intended uses in instant claims 2-6 such as wherein the improvement of gut microbiota comprises a decrease of Akkermansia muciniphila with an increase of beneficial bacteria including Roseburia in a gut (claim 2), wherein the composition is for prophylactic, ameliorating and/or curative treatment of autism spectrum disorders (ASD), multiple sclerosis (MS), Alzheimer's disease (AD), Parkinson's disease (PD) and/or epilepsy (claim 3), wherein the composition is for improving behavioral pattern and alpha-synuclein levels (claim 4), wherein the composition is for improving sleep pattern and serum melatonin (claim 5), and wherein the improvement is in a child with autism spectrum disorder (claim 6). However, MPEP 2111.02 II states that “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim”.
Here, the composition recited in the claims of ’553, which comprises the recited beta glucan, would be able capable of performing any of the intended uses recited in instant claims 2-6, and therefore instant claims 2-6 are anticipated.
In regards to instant claim 9, it would have been prima facie obvious before the effective filing date of the claimed invention to have administered the composition recited in claim 7 of ‘553 to a subject for improving gut microbiota. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because claims 6-7 of ‘554 recite the composition is intended for improving gut microbiota.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/569,553 (‘553) in view of JP2013170162 (in IDS filed 10/26/2023, an English translation is provided in PTO-892 and used as the basis for this rejection).
The claims of ‘553 are as recited above.
The claims of ‘553 do not recite the composition is a pharmaceutical or food composition.
The teachings of JP’162 is as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the claims of ‘553 to be a food and pharmaceutical composition as disclosed in JP’162 to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because JP’162 provides guidance that the recited AO202 beta-glucan can be added into cooked rice as well as in semi-solid food or fluid diet given to elderly person or patient who has difficult ingesting solid food, which also meets the limitation of a pharmaceutical composition.
Furthermore, even though the combination of the claims of ‘553 and JP’162 do not recite the intended uses in instant claims 2-6 as described above, MPEP 2111.02 II states that “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim”.
Here, the composition recited in the combination of the claims of ‘553 and JP’162, which recites the beta glucan, would be able capable of performing any of the intended uses recited in instant claims 2-6.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693