DETAILED ACTION
All rejection and objections not mentioned below have been withdrawn.
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
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 63/078,195, filed on 9/14/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/28/2023 and 11/10/2025 are being considered by the examiner.
Claim Interpretation
The claims 65-81 stand rejected as incomplete claims due to their dependence on canceled claim 1 but for the purposes of examination they were interpreted as being dependent on claim 43.
Claim Rejections - 35 USC § 112- New Rejection Based on Amendments
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 65-81 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.
Claims 65-81 are rejected because they depends improperly on canceled claim 1. Thus the scope of the claim is indefinite because it is unclear what the method of claim 1 is because there is no claim 1. "If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete". MPEP 608.01(n) (V).
The term “about” in claims 78-79 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, 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. No range is given in the specification for the degree to which the term 'about' covers thus the range of amounts and concentrations are indefinite.
Claim Rejections - 35 USC § 103- Updated due to Amendments
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.
Claim(s) 43, 44, 63, 65-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over GANT (GANT, THOMAS, SUBSTITUTED XANTHINE COMPOUNDS, US20100087455A1, 2010-04-08, previously provided) in view of Benchekroun (Benchekroun et al., Isotopic effects on retention times of caffeine and its metabolites 1,3,7-trimethyluric acid, theophylline, theobromine and paraxanthine, Volume 688, Issue 2, 24 January 1997, Pages 245-254, previously provided)).
The reference Gant teaches the following compounds (page 1):
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The reference Gant teaches “Caffeine, theobromine, theophylline, and paraxanthine are substituted xanthine-based agents that exert a wide range of biological effects by targeting and modulating the activity of various receptors, channels, and enzymes. The carbon-hydrogen bonds of caffeine, theobromine, theophylline, and paraxanthine contain a naturally occurring distribution of hydrogen isotopes, namely 1 H or protium (about 99.9844%), 2 H or deuterium (about 0.0156%), and 3 H or tritium (in the range between about 0.5 and 67 tritium atoms per 1018 protium atoms). Increased levels of deuterium incorporation may produce a detectable Kinetic Isotope Effect (KIE) that could affect the pharmacokinetic, pharmacologic and/or toxicologic profiles of caffeine, theobromine, theophylline, and paraxanthine in comparison with caffeine, theobromine, theophylline, and paraxanthine having naturally occurring levels of deuterium”[0017] and “A pharmaceutical composition comprising a pharmaceutically acceptable carrier together with a compound having structural Formula I:
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or a pharmaceutically acceptable salt thereof, wherein:
R1 -R 3 are independently selected from the group consisting of hydrogen, deuterium, CD 3 , CD 2 H, CH 2 D, and CH 3 ;
R4 is selected from the group consisting of hydrogen and deuterium; and
at least one of R 1 -R 4 is deuterium or contains deuterium” (reference claim 11). This helps to teach claims 1, 9, 14, 20, 21, 63.
The reference Gant teaches “The compositions include those suitable for oral, parenteral (including subcutaneous, intradermal, intramuscular, intravenous, intraarticular, and intramedullary), intraperitoneal, transmucosal, transdermal, rectal and topical (including dermal, buccal, sublingual and intraocular) administration. The most suitable route for administration depends on a variety of factors, including interpatient variation or disorder type, and therefore the invention is not limited to just one form of administration. The compositions may conveniently be presented in unit dosage form and may be prepared by any of the methods well known in the art of pharmacy. Typically, these methods include the step of bringing into association a compound of the subject invention or a pharmaceutically salt, prodrug, or solvate thereof (“active ingredient”) with the carrier which constitutes one or more accessory ingredients. In general, the compositions are prepared by uniformly and intimately bringing into association the active ingredient with liquid carriers or finely divided solid carriers or both and then, if necessary, shaping the product into the desired formulation”[0066]. This helps to teach claims 76.
The reference Gant teaches “Since deuterium (D) has twice the mass of protium (1 H), a C-D bond is stronger than the corresponding C—1 H bond. If a C—1 H bond is broken during a rate-determining step in a chemical reaction (i.e. the step with the highest transition state energy), then substituting a deuterium for that protium will cause a decrease in the reaction rate. This phenomenon is known as the Deuterium Kinetic Isotope Effect (DKIE)” [0013] and “Based on discoveries made in our laboratory, as well as considering the KIE literature, caffeine, is likely metabolized in humans at one of the three methyl groups to generate either theobromine, theophylline, or paraxanthine. Theobromine, theophyline, paraxanthine are likely metabolized at one of the two remaining methyl groups to form a methylxanthine, or oxidized at the imidazole carbon atom located adjacent to the nitrogen atoms to form a methyluric acid. The current approach has the potential to prevent or retard metabolism at these sites. Other sites on the molecule may also undergo transformations leading to metabolites with as-yet-unknown pharmacology/toxicology. Limiting the production of such metabolites has the potential to decrease the danger of the administration of such drugs and may even allow increased dosage and concomitant increased efficacy. All of these transformations, among other potential transformations, can occur through polymorphically-expressed enzymes, leading to interpatient variatability. Further, it is quite typical for disorders ameliorated by the present invention, such as asthma, to produce symptoms that are best medicated around the clock for extended periods of time. Additionally, continued intake of caffeine leads to a tolerance adaptation, whereby individuals become much more sensitive to adenosine, resulting in unwelcome withdrawal symptoms in tolerant users upon discontinuation of caffeine intake, such as headache, irritability, drowsiness, a feeling of fatigue, an inability to concentrate, and stomach aches. For all of the foregoing reasons, a medicine with a longer half-life may result in greater efficacy and cost savings. Various deuteration patterns can be used to (a) reduce or eliminate unwanted metabolites, (b) increase the half-life of the parent drug, (c) decrease the number of doses needed to achieve a desired effect, (d) decrease the amount of a dose needed to achieve a desired effect, (e) increase the formation of active metabolites, if any are formed, (f) decrease the production of deleterious metabolites in specific tissues, and/or (g) create a more effective drug and/or a safer drug for polypharmacy, whether the polypharmacy be intentional or not. The deuteration approach has the potential to slow the metabolism of caffeine, theobromine, theophylline and paraxanthine”[0018]. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.) This helps to teach all claims especially 68, 69, 70, 71, 72, 73, 74, 75, 79.
The reference Gant teaches “The method as recited in claim 12 further comprising the administration of an additional therapeutic agent” (reference claim 15). This helps to teach claim 26.
The reference Gant teaches “The method as recited in claim 15 wherein said additional therapeutic agent is selected from the group consisting of adrenergic agonists, anti-cholinergics, mast cell stabilizers, xanthines, leukotriene antagonists, glucocorticoids treatments, decongestants, anti-tussives, mucolytics, expectorant treatments, anti-histamines, NSAIDs, antibacterial agents, antifungal agents, sepsis treatments, steroidals, local or general anesthetics, NRIs, DARIs, SNRIs, sedatives, NDRIs, SNDRIs, monoamine oxidase inhibitors, hypothalamic phospholipids, ECE inhibitors, opioids, thromboxane receptor antagonists, potassium channel openers, thrombin inhibitors, hypothalamic phospholipids, growth factor inhibitors, anti-platelet agents, P2Y(AC) antagonists, anticoagulants, low molecular weight heparins, Factor VIIa Inhibitors and Factor Xa Inhibitors, renin inhibitors, NEP inhibitors, vasopepsidase inhibitors, squalene synthetase inhibitors, anti-atherosclerotic agents, MTP Inhibitors, calcium channel blockers, potassium channel activators, alpha-muscarinic agents, beta-muscarinic agents, antiarrhythmic agents, diuretics, thrombolytic agents, anti-diabetic agents, mineralocorticoid receptor antagonists, growth hormone secretagogues, aP2 inhibitors, phosphodiesterase inhibitors, protein tyrosine kinase inhibitors, antiinflammatories, antiproliferatives, chemotherapeutic agents, immunosuppressants, anticancer agents and cytotoxic agents, antimetabolites, antibiotics, farnesyl-protein transferase inhibitors, hormonal agents, microtubule-disruptor agents, microtubule-stablizing agents, plant-derived products, epipodophyllotoxins, taxanes, topoisomerase inhibitors, prenyl-protein transferase inhibitors, cyclosporins, cytotoxic drugs, TNF-alpha inhibitors, anti-TNF antibodies and soluble TNF receptors, cyclooxygenase-2 (COX-2) inhibitors, and miscellaneous agents”(reference claim 16). This helps to teach claim 27.
The reference Gant teaches “Compounds may be administered orally or via injection at a dose of from 0.1 to 500 mg/kg per day. The dose range for adult humans is generally from 5 mg to 5 g/day. Tablets or other forms of presentation provided in discrete units may conveniently contain an amount of one or more compounds which is effective at such dosage or as a multiple of the same, for instance, units containing 1 mg to 1000 mg, usually around 10 mg to 200 mg”[0078]. This helps to teach claim 67 and 78.
The reference Gant teaches “Formulations of the compounds disclosed herein suitable for oral administration may be presented as discrete units such as capsules, cachets or tablets each containing a predetermined amount of the active ingredient; as a powder or granules; as a solution or a suspension in an aqueous liquid or a non-aqueous liquid; or as an oil-in-water liquid emulsion or a water-in-oil liquid emulsion. The active ingredient may also be presented as a bolus, electuary or paste” [0067] and “The amount of active ingredient that may be combined with the carrier materials to produce a single dosage form will vary depending upon the host treated and the particular mode of administration” [0079]. The reference also teaches “The compounds can be administered in various modes, e.g. orally, topically, or by injection. The precise amount of compound administered to a patient will be the responsibility of the attendant physician. The specific dose level for any particular patient will depend upon a variety of factors including the activity of the specific compound employed, the age, body weight, general health, sex, diets, time of administration, route of administration, rate of excretion, drug combination, the precise disorder being treated, and the severity of the disorder being treated. Also, the route of administration may vary depending on the disorder and its severity”[0080]. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.) This helps to teach claim 80-81.
The reference Gant teaches “The method as recited in claim 12 wherein the biochemical-mediated disorder is selected from the group consisting of obesity, drowsiness, apnea of prematurity, bronchopulmonary dysplasia, Parkinson's disease, asthma, cephalagia, Alzheimer's disease, ADHD, brain injury, diabetes, COPD, bradyarrhythmias, cancer, nephrotoxicity induced by intravenously administered contrast medium, erythrocytosis, angina pectoris, coronary ischemia, arteriosclerosis, peripheral vascular diseases, hypertension, disorders associated with dopaminergic cell death, disorders associated with breathing difficulties, conditions benefited by administering an ergogenic aid, disorders prevented by administering a neuroprotective agent, and disorders benefited by administering an adenosine receptor antagonist” (reference claim 14) and
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This helps to teach claims 42, 43, 44, 48, 57.
The reference Gant teaches “Additionally, the compounds disclosed herein can exist in unsolvated as well as solvated forms with pharmaceutically acceptable solvents such as water, ethanol, and the like. In general, the solvated forms are considered equivalent to the unsolvated forms” [ 0042] and “The compounds can be administered in various modes, e.g. orally, topically, or by injection. The precise amount of compound administered to a patient will be the responsibility of the attendant physician. The specific dose level for any particular patient will depend upon a variety of factors including the activity of the specific compound employed, the age, body weight, general health, sex, diets, time of administration, route of administration, rate of excretion, drug combination, the precise disorder being treated, and the severity of the disorder being treated. Also, the route of administration may vary depending on the disorder and its severity”[0080]. The reference also teaches “For buccal or sublingual administration, the compositions may take the form of tablets, lozenges, pastilles, or gels formulated in conventional manner. Such compositions may comprise the active ingredient in a flavored basis such as sucrose and acacia or tragacanth”[0072] This helps to teach claims 45, 48.
The reference Gant teaches “Caffeine, a plant alkaloid, is commonly consumed by humans in infusions extracted from the beans of the coffee plant and leaves of the tea bush, as well as from various foods and drinks containing products derived from the kola nut or from cacao”[0007] This helps to teach claims 56 and 57.
The reference Gant does not specifically teach a composition of deuterated paraxanthine (all claims), the specific deuterated paraxanthine (claims 14, 20-21), the specific concentrations (claim 39, 55), a specific beverage (claims 45, 48, 52, 55) or a specific food product (claims 56, 57).
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The reference Benchekroun teaches the following deuterium paraxanthine derivatives (Table 1, page 247). This helps to teach claim 77.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Gant with Benchekroun because Gant teaches generic deuterium paraxanthine derivatives and Benchekroun teaches specific lead compounds that are deuterium paraxanthine derivatives. Thus one would have a reasonable expectation of success to produce the pharmaceutical composition of deuterium paraxanthine derivatives because they are taught generically by Gant and one would then have a reasonable expectation of success of achieving the specific paraxanthine derivative because they are taught by Benchekroun. One would be motivated to do so to treat the diseases suggested by Gant. Additionally, one would have a reasonable expectation of modifying the lead compounds using the generic formula of Gant to achieve a compound in which all the Y=D since this may slow the rate of reaction and thus one would be motivated to do so for the long list of KIE benefits suggest by Gant [0018] including: (a) reduce or eliminate unwanted metabolites, (b) increase the half-life of the parent drug, (c) decrease the number of doses needed to achieve a desired effect, (d) decrease the amount of a dose needed to achieve a desired effect, (e) increase the formation of active metabolites, if any are formed, (f) decrease the production of deleterious metabolites in specific tissues, and/or (g) create a more effective drug and/or a safer drug for polypharmacy. Additionally, for the same reasoning it would have been obvious with a reasonable expectation of success to have the majority or all (100%) of the paraxanthine deuterated. One would be motivated to do so to achieve the same list of KIE benefits.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have varies the concentration of the compound depending the aforementioned factors. As such, the concentration recited in the claim is merely obvious variant of the prior art. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the compositions of Gant to achieve a beverage or food product because Gant teaches that caffeine is consumed in various foods and drinks containing products and that the compositions of the invention can be taken orally as both solid and liquid. Additionally, it is suggested for treating drowsiness (energy enhancing/performance enhancing) and can be combined with other ingredients in a flavored basis such as sucrose. For these reasons one would have a reasonable expectation of success at including these compositions in food (including food supplements) or drink and one would be motivated to do so to improve taste while treating the taught conditions.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
The applicant argues that amending in three alternative administration schedules for claim 43 makes claim 43 allowable. This not a persuasive argument both because the first option is once daily and Gant teaches doses per day as well [0078] and because it is well known to one of ordinary skill in the art that dosages will be dependent on a variety of factors that one of ordinary skill in the art would need to determine on a case by case basis[0080]. It would be obvious to administer a drug on a daily basis to one of ordinary skill of the art. Additionally, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
The applicant argues that the suggested lead compounds of Benchekroun are not lead compounds because they don’t fit the description of a lead compound. This argument is not found persuasive because one of the descriptors of a lead compound given by the applicant is “a natural choice for further development efforts” this does describe the lead compounds of Benchekroun because they are examples of deuterium paraxanthine derivatives that are taught generically by the formula in Gant (reference claim 12) and thus one would naturally choose compound of a generic formula that are already known in the literature to further develop because methods of synthesis are likely are already available.
The applicant argues that there was no reasonable expectation of success or motivation to arrive at the claimed invention. This argument is not found persuasive because one would have a reasonable expectation of success to produce the pharmaceutical composition of deuterium paraxanthine derivatives because they are taught generically by Gant and one would then have a reasonable expectation of success of achieving the specific paraxanthine derivative because they are taught by Benchekroun. One would be motivated to do so to treat the diseases suggested by Gant. Additionally, one would have a reasonable expectation of modifying the lead compounds using the generic formula of Gant to achieve a compound in which all the Y=D since this may slow the rate of reaction and thus one would be motivated to do so for the long list of KIE benefits suggest by Gant [0018] including: (a) reduce or eliminate unwanted metabolites, (b) increase the half-life of the parent drug, (c) decrease the number of doses needed to achieve a desired effect, (d) decrease the amount of a dose needed to achieve a desired effect, (e) increase the formation of active metabolites, if any are formed, (f) decrease the production of deleterious metabolites in specific tissues, and/or (g) create a more effective drug and/or a safer drug for polypharmacy. Additionally, for the same reasoning it would have been obvious with a reasonable expectation of success to have the majority or all (100%) of the paraxanthine deuterated. One would be motivated to do so to achieve the same list of KIE benefits.
The applicant argues that one would not arrive from this broad genus to the specific compounds in the instant claims. This is not persuasives because instant claims 43-44 and 65-81 are also generic formula and so are obviously taught by the compounds of Benchekroun. Benchekroun specifically teaches instant claim 63’s compound.
The applicant argues that most of the reference is about non-isotopically enriched caffeine and to push caffeine toward theophylline instead of the paraxanthine pathway. This argument is not considered persuasive because it is clear from reference claim 12 and 21 to one of ordinary skill in the art that deuterated paraxanthine is also included as one of the few major xanthine compounds that are the subject of the reference publication.
The applicant argues that the reference list 25 undifferentiated disorders and there is no specific reason to treat just the disorders of the instant application. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Thus it would have been obvious to treat any of the 25 disorders.
The applicant argues unexpected results of deuterated paraxanthines. However, the unexpected results are not commensurate in scope with the claims. The unexpected results discussed administer d9-caffeine to a subject which is not the same as administering deuterated paraxanthine to the subject. Even if this was commensurate in scope the argument is still not persuasive because having a longer half-life for a deuterated compound compared to the non-deuterated compound is expected. The reference Gant teaches “The deuteration approach has the potential to slow the metabolism of caffeine, theobromine, theophylline and paraxanthine”[0018]. Additionally, the data of table 2 is not commensurate in scope with the claims because the claims require many paraxanthine derivatives not just d6, any concentration not just those listed, and the administration of paraxanthine not caffeine. Thus these results are neither unexpected nor commensurate in scope with the claims and are thus not persuasive. Additionally, no error bars or statistical analysis was provided and thus the results are not persuasives for this reason as well. “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).”MPEP 716.02(b).
Conclusory statements that results were "unexpected," unsupported by objective factual evidence, were considered but were not found to be of substantial evidentiary value. Although an affidavit or declaration which states only conclusions may have some probative value, such an affidavit or declaration may have little weight when considered in light of all the evidence of record in the application. In re Brandstadter, 484 F.2d 1395, 179 USPQ 286 (CCPA 1973). The objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988). In the instant case, Applicants have not provided any evidence the unexpected results would be achieved in the same manner at any concentrations/amounts administered. The argument that it would also work in other amounts is a conclusory statement not supported by objective factual evidence.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F .2d 731,741,218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
MPEP 716.02(d) states “The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979) (Claims directed to mixtures of an herbicide known as "FENAC" with a diphenyl ether herbicide in certain relative proportions were rejected as prima facie obvious. Applicant presented evidence alleging unexpected results testing three species of diphenyl ether herbicides over limited relative proportion ranges. The court held that the limited number of species exemplified did not provide an adequate basis for concluding that similar results would be obtained for the other diphenyl ether herbicides within the scope of the generic claims. Claims 6-8 recited a FENAC:diphenyl ether ratio of 1:1 to 4:1 for the three specific ethers tested. For two of the claimed ethers, unexpected results were demonstrated over a ratio of 16:1 to 2:1, and the effectiveness increased as the ratio approached the untested region of the claimed range. The court held these tests were commensurate in scope with the claims and supported the nonobviousness thereof. However, for a third ether, data was only provided over the range of 1:1 to 2:1 where the effectiveness decreased to the "expected level" as it approached the untested region. This evidence was not sufficient to overcome the obviousness rejection.); In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972) (Evidence of nonobviousness consisted of comparing a single composition within the broad scope of the claims with the prior art. The court did not find the evidence sufficient to rebut the prima facie case of obviousness because there was "no adequate basis for reasonably concluding that the great number and variety of compositions included in the claims would behave in the same manner as the tested composition.").”
The “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support”. The evidence of unexpected results use specific amounts where the claims encompass any thus absent any evidence that any amounts would behave in the same manner, the claims are not commensurate with the showing of unexpected results.
Conclusion
Claims 43, 44, 63, 65-81 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.A.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627