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 .
Priority
This Application is a 371 National Stage Entry of PCT/US2023/020036, filed on April 26, 2023, and claims benefit to domestic Provisional Application No. 63/336,945 filed on April 29, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 29, 2024, is acknowledged and has been considered.
Claim Objections
Claim 23 is objected to because of the following informalities:
Claim 23 appears twice on the “Amendments to Claims” record submitted on 08/11/2025. The claim is entered as a pending claim and also recorded as a canceled claim - “23-27 (Canceled)” – (emphasis added). Examiner notes the “Remarks” submitted by Applicant on 08/11/2025, recorded claim 23 as pending and claims 24-27 as cancelled. Applicant needs submit an amended set of claims that correctly reflects the status of pending and canceled claims.
Appropriate correction is required.
Status of the Claims
Acknowledgement is made of the claims in the filed Application 18/861,309.
Claims 1 and 23 are original. Claims 28, 30, 33-37 and 39-49 are amended, and claims 2-22, 24-27, 29, 31-32 and 38 are canceled by Applicant. No new matter was introduced.
Claims 1, 23, 28, 30, 33-37 and 39-49 are currently under consideration.
Claim Rejections - 35 USC § 112a
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 47 and 48 are 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 a method of treating the diseases and conditions recited in the claims, does not reasonably provide enablement for a method for preventing the diseases and conditions recited. 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 application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
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 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). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not experimentation".
The factors that may be considered in determining whether a disclosure would
require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the relative skill of those in the art,
6- the amount of direction or guidance provided,
7- the presence or absence of working examples and
8- the quantity of experimentation necessary to make or use the invention.
.
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). Undue experimentation is required by one skilled in the art to determine enablement of the instant disclosure as claimed due to the following:
Regarding the nature of the invention and breath of the claims, the said claims (47 and 48), are drawn to an intended use of the compounds in the instant invention.
The claims are drawn to methods of preventing or treating the disease and conditions recited. However, it should be noted that the Wands Factors are only directed to the part of the claims drawn to prevention.
As such, instant claim 47 is drawn to a method of preventing a neurodegeneration comprising administering to a subject in need thereof an effective amount of the claimed compound. Instant claim 48 is drawn to method of preventing a neurodegenerative disease or disorder selected from Alzheimer’s disease, Parkison’s disease, amyotrophic lateral sclerosis, epilepsy, astrocytoma, glioblastoma and Huntington’s chorea comprising an effective amount of the claimed compound.
The specification provides a definition of the term “prevent” or “prevention” as used in this invention; “prevent” or “prevention” means no infection, disorder or pathological development if none had occurred or no further disorder or pathological development if there had already been development of the disorder or infection – ([0133] – Specification page 16).
Regarding the state of the art, examiner picked Alzheimer’s disease and Epilepsy as examples on the discussion pertaining to the state of the art. A review by Tang et al., 2022, (Tang et al., A mechanistic survey of Alzheimer’s disease, Biophysical Chemistry, Vol. 281, Issue 1, Feb 2022, 106735, pages 1-11; Published 30 November 2021), hereon after Tang, teaches Alzheimer’s disease (AD), is the most common age-dependent neurodegenerative disorder, that has been intensively studied from different aspects. Tang states there is no effective cure for Alzheimer’s disease due to a lack of clear mechanistic understanding of the disease. Tang teaches different mechanisms illustrate different molecular and cellular pathways in AD pathogenesis (abstract). Examples of different pathogenic mechanisms accounting for the cause of AD include-B aggregation, Tau hyperphosphorylation and aggregation, neurotransmitter imbalance, genetic defects, microbial infection and neuroinflammation, amyloid cross-seeding, vascular dysfunction, mitochondria dysfunction and metal ion dysregulation (Scheme 1 -page 2). Tangs notes that, for the age-dependent AD, ‘time is everything’. Further, there are currently only two categories of FDA-approved drugs of cholinesterase enzyme inhibitors and N-methyl d-aspartate (NMDA) antagonists for improving the symptoms of AD, but they do not cure or prevent AD (page 1).
Balestrini et al., 2021, (Balestrini et al., The aetiologies of Epilepsy, Seminar of Epileptology, Epileptic Disorders, Vol. 23, Issue 1, Feb 2021, pages 1-16; Published 30 March 2021), lists the major aetiologies for epilepsy which include, (i) structural aetiologies e.g. hippocampal sclerosis, tumors, malformations, vascular lesions, traumatic brain injury; (ii), genetic aetiologies, (iii) infectious causes including geographical impacts e.g. bacteria, fungal, viral, parasites; (iv) metabolic causes, e.g. inborn errors of metabolism, glucose transport defects, pyridoxine dependent seizures among others; (v) immune causes e.g. Rasmussen encephalitis, LG11 antibodies, NMDA antibodies, etc., and (vi) neurodegenerative causes such as Alzheimer’s disease, Down syndrome, progressive myoclonic epilepsies (page 1). In addition, Balestrini’s Fig 1 illustrates epidemiological studies done in Europe that show about 36% of epilepsy cases are attributed to unknown causes (page 2).
Notably, prior art teaches neurodegeneration and neurodegenerative diseases or disorders as exemplified by Alzheimer’s disease and Epilepsy are multifactorial in nature and in some of them, there are genetic complexities, a host of environmental risk factors as well as other unknown causes. In addition, the mechanisms of most of these diseases, as relates to disease onset and progression are not fully understood.
Regarding predictability in the art, prior art reveals prevention is unpredictability of neurodegeneration / neurodegenerative diseases or disorders selected from Alzheimer’s disease, Parkison’s disease, amyotrophic lateral sclerosis, epilepsy, astrocytoma, glioblastoma and Huntington’s chorea, in view of the complex and multifactorial nature of these diseases and conditions. There are multiple causes for these diseases/ conditions, different genes are implicated, a variety of environmental factors, and some of the diseases like Huntington’s are predominantly hereditary. Prior art reveals that neurodegeneration often begins years before first symptoms of the disease and the underlying causes for most of the diseases remain largely unknown. Thus, it is difficult to propose prevention for a disease without established pathogenesis and successful treatments.
Regarding relative skill level, while the relative skill is high, that of an MD or PhD, that factor is outweighed by the unpredictable nature of the art as illustrated in the prior art discussed above. There is no absolute predictability even in view of the seemingly high level of skill in the art. That a compound ameliorates the condition / disease, or treats a disease as recited, for example Alzheimer’s disease, does not establish that one or ordinary skill could predict that the compound would prevent Alzheimer’s from occurring in the first place.
Regarding the amount of direction provided, presence or absence of working examples: The Specification states, “the compounds described are believed to be effective to reduce plasma levels of fatty acids” ([0157]). Further recites, that the compounds, formulations, therapeutic compositions, dietary supplements and food substances comprising the claimed compounds can be used to reduce the level of free fatty acids circulating in the plasma of a subject, human or non-human. As such can be used to treat a condition that is exacerbated by or associated with elevated plasma levels ([0157]). The disclosure goes on to name the conditions caused by, exacerbated by or associated with elevated plasma levels of free fatty acids, “including but not limited to, neurodegenerative diseases or disorders for instant Alzheimer’s disease, Parkinson’s disease, Huntington’s chorea” - ([0158].
The specification further recites; “the compounds are believed to prevent neurodegeneration caused by a neurodegenerative disease or disorders” are recited in [0167 to [0169] with no specific example for prevention. It states in certain embodiments the subject is one that exhibits biomarker positivity of Aβ in a clinically normal subject. ([0169], line 25); in certain embodiments, “the subject exhibits cerebral amyloidosis, or clinical dementia rating above zero or below about 1.5 ([0167]). The specification also discloses that in certain embodiments administration produces a reduction of CSF levels or one or more components selected from Aβ42, and others as recited in para [00169]. It is understood the examples provided in the disclosure are enabled for treatment not prevention.
Applicant discloses the claimed compounds can be used to reduce the level of free fatty acids circulating in plasma and as such can be used to treat a condition exacerbated by or associated with elevated plasma levels.
That the claimed compounds produce a reduction of CSF levels or one or more components recited the level of free fatty acids circulating in plasma, would not be an indication that this stops the onset or prevents the neurodegenerative conditions or diseases from occurring. Prior art reveals that the neurodegenerative diseases or conditions in consideration are caused by multiple causes and mechanisms. For example, in Alzheimer’s, Aβ aggregation mentioned in the instant specification is 1 of 10 mechanisms discussed by Tang. In epilepsy, traumatic brain injury (TBI) is one of the known causes – one would wonder if administering claimed compounds would prevent epilepsy that is due to TBI.
Moreover, the specification does not disclose any model or data demonstrating that administration of claimed compounds or their pharmaceutical composition, prior to the occurrence of the disease in a subject would prevent the occurrence of the disease. Thus, there are no examples that support “prevention” as defined by Applicant – “no infection, disorder or pathological development if none had occurred or no further disorder or pathological development if there had already been development of the disorder or infection”.
Regarding quantity of experimentation necessary, Because of the unpredictability in the art, one skilled in the art would need to determine whether the compounds in the claimed invention are effective in preventing the onset of neurodegeneration and the recited diseases across all the possible causes of these diseases. The recited diseases have diverse pathogenesis, affected by different genetic complexities, environmental factors and other risk factors.
Determining if compounds of claimed invention would be therapeutic for prevention of numerous neurodegenerative diseases, with multifactorial causes would require careful analysis and replicability of composition of the claimed compounds, or formulation into a suitable dosage form, relevant assay testing to correlate clinical efficacy, identify off-targets, subjecting to animal trials and subjecting to clinical trials. All this is undue experimentation given the limited guidance and direction provided by applicant. As such the full scope of the claim, insofar as it encompasses preventing neurodegeneration and neurodegenerative diseases recited in the invention is not enabled.
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.
Claim 23 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by prior art as follows: Compound of Formula IV is anticipated by Tabata and Abe, 2014, (Tabata Y. and Abe H, Synthesis and Properties of alternating copolymers of 3-hydrobutyrate and lactate units with different stereo compositions, Macromolecules, 2014, 47, page 7354-7361; Published, October 27, 2014), hereon after, Tabata.
Regarding instant claim 23 compound of formula IV, Tabata discloses the two stereoisomers of (R)-3-hydroxylbutyrate-2-hydroxypropionate ((R)-3HB-2HP) as shown below (Scheme 1, page 7356).
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Thus, Tabata anticipates instant claim 23 compound of formula IV.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1, 28, 30, 33-37 and 39-49 are rejected under 35 U.S.C. 103 as being unpatentable over Verdin et al., 2017, (Verdin et al., WO 2017/213999 A1, Medium chain fatty acid esters of beta-hydroxybutyrate and butanediol and compositions and methods for using same; Published 14 December 2017), hereon after, Verdin in view Ulrich S.M., 2019, (Urich S.M., WO 2019/147503 A1, Synthesis of 3-hydroxybutyryl 3-hydroxybutyrate and related compounds; Published 01 August 2019), hereon after Ulrich.
Regarding instant claim 1, Verdin teaches on fatty acid esters of β-hydroxybutyrate and fatty acid esters of butanediol, their pharmaceutically acceptable salts and the uses thereof (abstract). Verdin reveals different embodiments that include a compound of formula (IIa) – shown below, wherein R4 is selected from H, alkyl and substituted alkyl, R5 and R6 are independently unsubstituted or substituted alkyl C4 -C30, and salts, solvates or hydrates thereof. Verdin further states in certain instances, R4 is methyl – [0095-00100 page 23-24]).
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Formula (IIa)
Because Verdin’s compound of formula (IIa) is broad, wherein R5 and R6 are independently unsubstituted or substituted alkyl C4 -C30, it encompasses the instant claimed compound of Formula (I), where R1 is a fatty acid and R2 is encompassed under a substituted R5 in Verdin’s compound. While Verdin reference does not teach an embodiment that reads on the instant embodiments, it teaches preparation methods of as follows. Using R-ethyl β-hydroxybutyrate Verdin teaches a method of preparing a β-hydroxyester compound with one substituent as in Example 1 (scheme 3 – page 48) or two substituents (Example 2 - page 49).
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Example 1 - Scheme 3 (page 48)
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Example 2 (page 49)
In some instances, Verdin presents a method of preparation of butanediol esters, starting from 1,3-butandiol (Schemes 5-7). Verdin explains to artisans that a stepwise deprotonation of each hydroxy group in 1,3-butanediol with weak base followed by stepwise addition of one equivalent of substituted acyl chloride provides a hetero- substituted 1,3-butanediol ester (Example BDE2 – page 51).
How prior art differs from instant claim 1: Verdin teaches methods of preparation of hydroxyesters or butanediol esters starting from hydroxybutyrate or from butanediol respectively. Verdin teaches a broad genus that reads on the instant application compound of formula (I) but does not show examples that map on the embodiments of the instant application.
Ulrich teaches a synthetic method of preparing (R) 3-hydroxybutyryl (R) 3-hydroxy butyrate of formula (I) as discussed in para [0008] –[0010] (page 2-3).
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Formula (I) (claim 1 – page 72).
Notably, Ulrich’s compound, (R) 3-hydroxybutyryl (R) 3-hydroxy butyrate contains two hydroxy groups and reads on the instant compound of formula (I), where both R1 and R2 are OH. Instant formula (I) recites a compound wherein R1 is OH or C(4-14) saturated fatty acid; R2 is OH or C(4-14); at least one of the R1 or R2 is said saturated fatty acid.
Instant Application
Ulrich, 2017
Veldin, 2019
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Para [0191] (Pg. 30)
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(R) 3-hydroxybutyryl (R) 3-hydroxy butyrate
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Scheme 4 (Pg. 49)
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Para[0192](Pg.30)
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Scheme 4 (Pg. 49)
Per MPEP § 2143 (I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. Thus, it would have been obvious to one of ordinary skill in art to combine Verdin’s teaching of making fatty acids of β-hydroxybutyrate and of butanediol reacted with a substituted acyl chloride i.e. using Ulrich’s disclosure (R) 3-hydroxy butyryl (R) 3-hydroxy butyrate to arrive at the instant claimed invention compound of formula (I) where at least one of the R1 or R2 is the said saturated fatty acid, with reasonable expectation of success.
One would have been motivated to do so because (i) prior art teaches similar compounds, for the same purpose (ii) both Verdin and Ulrich discloses efficient methods of preparing esters of butanediol or esters of β-hydrobutyrate and Ulrich teaches a novel method of preparing (R) 3-hydroxybutyryl (R) 3-hydroxy butyrate (iv) Verdin’s prior art reveals results from tests performed on mice, plasma concentration, among others, after mice injection of C6 and C8 esters of butanediol or esters of β-hydrobutyrate. Therefore, a skilled artisan would be motivated to use (R) 3-hydroxybutyryl (R) 3-hydroxy butyrate convert it to an ester using known art and known methods to obtain predictable results in a known field.
Regarding instant claims 28, Verdin teaches pharmaceutical formulations (para [00107]-[000108], pg. 26 and claim 51).
Regarding instant claim 30, Verdin teaches claimed compounds in food composition to be ingested by mice (pg. 61-62)
Regarding instant claim 33, Verdin teaches a food supplement comprising disclosed compounds (claims 25-26 and 57).
Regarding instant claim 34, Verdin teaches a compound comprising a food supplement and one or more components of a ketogenic diet (claim 58).
Regarding instant claim 35, Verdin’s reference teaches the disclosed compounds in a method of treating heart failure (claim 54).
Regarding instant claim 36, Verdin teaches a method for treating Alzheimer’s disease, epilepsy, and Parkison’s disease, among others (claim 54).
Regarding instant claim 39, Verdin teaches a method of reducing epileptiform activity in the brain with disclosed compounds (claims 53 and 56 and Fig. 7a-7h).
Regarding instant claim 40, Verdin teaches a method of treating all the conditions recited in the instant claim. (claim 54 -page 71).
How Prior art differs from Instant claim: Verdine does not teach conditions as recited in instant claims 41-49.
Ulrich teaches on pharmaceutical compositions of having one or more fatty acid β-hydroxyester compounds or one or more fatty acids of butanediol and method of treating a subject by administering one or more esters.
Regarding instant claims 28, 30, 33, 34-40, Ulrich teaches a pharmaceutical formulation comprising the claimed compound including the (S,S) enantiomer formulations ([0280-0282] – page 61).
Regarding an ingestible composition, Ulrich teaches ingestible composition of the claimed compounds and dietetically or pharmaceutically acceptable carrier (claim 54).
Ulrich also teaches a composition comprising a food supplement and one or more components of a ketogenic diet (claim 58).
Ulrich teaches a method of treating dementia or other neurocognitive disorders (page 86). Further, teaches a method of treating conditions recited including heart failure, among others (para [0116 – page 20).
Ulrich teaches a method of treating mild cognitive impairment, ameliorating one or more pre-Alzheimer’s condition or cognitive dysfunction (Claims 66-67 and 69).
Regarding instant claim 41, Ulrich teaches a method treating a condition caused by exacerbated by or associated with elevated plasma levels of free fatty acid in a human or animal subject ([0207] and claim 90).
Regarding instant claim 42, Ulrich teaches a method of treating a condition where weight loss or weight gain is implicated using disclosed compounds. ([0209] and claim 91).
Regarding instant claim 43, Ulrich teaches a method of suppressing appetite, treating obesity, promoting weight loss, maintaining a healthy weight or decreasing the ration of fat to lean muscle ([0242] and claim 92).
Regarding instant claim 44, Ulrich discloses a method of preventing or treating a condition selected from cognitive dysfunction, a neurodegenerative disease or disorder, muscle impairment, fatigue and muscle fatigue ([0217] and claim 93).
Regarding instant claim 45, Ulrich teaches a method of treating diabetes, hyperthyroidism, metabolic syndrome X, or for treating a geriatric patient (page 45 and claim 94).
Regarding instant claim 46, Ulrich teaches a method of treating, or reducing the effects of neurodegeneration, free radical toxicity, hypoxic conditions or hyperglycemia (page 44 and claim 95).
Regarding instant claim 47, Ulrich teaches a method of treating the effects of neurodegeneration (Page 44 and claim 96).
Regarding instant 48, Ulrich teaches methods of treating similar conditions as recited in instant application ([0216] and claim 98).
Regarding instant 49, Ulrich teaches a method of promoting alertness or improving cognitive function in a subject ([0213 - 0214] and claim 99).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to take Verdin’s teachings and combine with Ulrich’s teachings to arrive at the instant claimed invention with reasonable expectation of succession.
Per MPEP § 2144.05(I), a prima facie case of obviousness exists when the claimed invention overlaps with, or is close to prior art. Additionally, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of known material based on its suitability for its intended use.
A skilled artisan would have been motivated to arrive at the instant invention because the results from similar compounds as shown by Ulrich to increase BHB levels, with no side effects. For example, Ulrich discloses the novel compounds in his prior art have the expected biological function of increasing blood BHB in some cases to the similar extent as an overnight fast and lasting several hours. Ulrichs teaches examples that show suppression of epileptiform spikes in mice and cognitive improvements in mice. One would therefore be motivated to combined prior art as disclosed by Verdin and Ulrich to arrive at instant invention to yield predictable results.
Claims 1, 28, 30, 33-37 and 39-49 are rejected under 35 U.S.C. 103 as being unpatentable over Verdin et al., 2017, in view Ulrich S.M., 2019 and further in view of Hirakura et al., 2006, (Hirakura et al.,, Excipient hydrolysis and ester formation increases pH in a parenteral solution over aging, International Journal of Pharmaceuticals, 325, page 26-38; Published 9 June 2006), hereon after, Hirakura and Li et al., 1998, (Li et al., NMR Spectroscopic Studies on Complex Formation between (R)-3-Hydrobutanoic Acid and B-Cyclodextrin, Bull. Chem. Soc. Jpn, (1998), page 1953-1957), hereon after Li.
Regarding claims 1, 28, 30, 33-37 and 39-49, all the teachings of Verdin and Ulrich as discussed above are incorporated herein.
Regarding instant claim I compound of formula II, Hirakura discloses 1,2-propanediol-2-lactate (Fig 2 page 29), which reads on compound of formula II,
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where R3 is H, and where j=0 and n = 0.
In addition, Li teaches the compound shown below (page 1953), which reads on instant claim 1, compound of formula (II) as follows.
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where R is O, a is a double bond, n is 1 and j is 1.
Hinakura and Li do not disclose other variables of claim 1 compound of formula (II) neither do they disclose claim 1 compound of formula I.
Hinakura and Li disclose variables of instant claim 1, where R3 is H, and where j=0 and n = 0 and where R is O, a is a double bond, n is 1 and j is 1, respectively. As such it would have been obvious to one of ordinary skill in the art before the effective filing date to arrive at the instant claimed invention with reasonable expectation of success because the claimed compounds are simple structurally and different isomeric variations of known compounds.
Claims 1, 23, 28, 30, 33-37 and 39-49 are rejected under 35 U.S.C. 103 as being unpatentable over Verdin et al., 2017, in view Ulrich S.M., 2019 and further in view of Hirakura et al., 2006, and Li et al., 1998, and further in view of Tabata and Abe, 2014, (Tabata Y. and Abe H, Synthesis and Properties of alternating copolymers of 3-hydrobutyrate and lactate units with different stereo compositions, Macromolecules, 2014, 47, page 7354-7361; Published, October 27, 2014), hereon after, Tabata.
Regarding claims 1, 23, 28, 30, 33-37 and 39-49, all the teachings of Tabata, Verdin and Ulrich, Hirakura and Li as discussed above are incorporated herein.
Regarding claim 1, compound of formula II, enantiomeric compounds 8 and 9 as disclosed by Tabata read on compound of formula II as follows.
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where R=O, a is a double bond, j is 1 and n is 0.
Tabata does not teach other variables of claim 1 compound of formula (II) neither does the reference teach claim 1 compound of formula I.
Tabata teaches, compound of formula II, where R=O, a is a double bond , j is 1 and n is 0. As such it would have been obvious to one of ordinary skill in the art before the effective filing date to arrive at the instant claimed invention with reasonable expectation of success because the claimed compound is a different isomeric variation of known compounds.
Conclusion
No claim is allowed. Claims 1, 23, 28, 30, 33-37 and 39-49 are rejected.
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/P.O./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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