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 .
Claims 1-4 are pending and have been considered on the merits.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1 discloses “the incubating cells” in step (iv). It appears to be “the incubated cells” instead.
In step (iv) of claim 1, the term “or” in between “labeled antibodies” and “phalloidin-rhodamine” appears to be “with” instead.
Claim 1 discloses “spinophylline” in step (iv). There is a typographical error for the term. It should be “spinophilin” instead.
Claim 4 discloses “glass support”. There would be an article “a” in front of the “glass support”.
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The instant specification does not provide proper antecedent basis for the terms disclosed in the instant claims. For example, “spinophylline” in step (iv) of claim 1 is not disclosed in the instant specification. The term “spikes” in step (vi) of claim 1 is not supported while the specification only discloses “microspikes” (p.11, line 20).
Claim 1 also discloses the term “neuronal cell” whereas the instant specification discloses “neuronal precursors”, as the scope of “neuronal cell” and “neuronal precursor” is different, and the specification does not provide antecedent basis of the “neuronal cell”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 discloses that the claimed method would determine the optimal and personalized concentration of melatonin and ketamine. However, the claim discloses the concentration of ketamine is fixed at 10-7 M whereas the concentration of melatonin is increased. Based on the limitation of step (iii), the concentration of ketamine appears not to be determined as it is used at a fixed concentration. Clarification is required.
Claim 1 discloses “increasing concentrations of melatonin” in step (iii). It is not clear what subject matter this phrase intends to point out. Does this mean that the concentration of melatonin being increased during the incubation or the different concentration of melatonin is utilized in different set of incubation to obtain the effect of the ketamine and melatonin on the neuronal cells in the method. Clarification is required.
Claim 1 discloses “the appearance of spikes” in step (vi). It is not clear if the spikes being physically formed on the cells or the spikes are meant to be electrophysiological signal (i.e. action potential). Clarification is required.
Claim 4 discloses the series of solution used in the step ii). It is not clear how these solutions are used in the step ii) of claim 1. The wherein clause of claim 4 does not particularly disclose how these solutions are utilized and there are no active steps how to use these solutions. Thus, the metes and bounds of the limitations are not clear. Furthermore, even if all of the solutions are used in step (ii) of claim 1, it is not clear how cryopreservation solution, fixing solution, differentiation solution, and/or staining or detection solution (immunocytochemical solutions; i.e. solutions 7-8) would be all included in step (ii) of claim 1. It is not clear the solutions of claim 4 require any steps to be carried out including dissociation/dispersion, cryopreservation, fixation, differentiation, immunostaining during the culturing step. Clarification is required.
Claim 4 discloses that the solution 5 of cryopreservation comprising one or more cryoprotective agents from cells of neuronal origin. It is not clear what the phrase “from cells of neuronal origin”. Is this meant to the cryoprotective agents are derived from neuronal cells or the term “from” is a typographical error of “for”. Clarification is required.
Claim 4 discloses “whose function is to wet the cells that will be propagated later” in item (b) of the solution 2. It is not clear what subject matter this phrase intends to point out. It is not clear what the term “wet” means here. The cells are maintained in a culture solution (solution 1). If so, what does this solution to “wet” the cell mean?
Claim 4 discloses “protein molecule identifiers” specific to neuronal structure is in the solution 7. First, it is not clear what the “protein molecule identifiers” are. Are they the specific protein expressed in the cells when there is any structural change (e.g. appearance of spines) in the neuronal cells? If so, it is not clear how the solution comprises these proteins, and how such solution would be used in the method of claim 1. Clarification is required.
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 1-4 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 discloses a method of determining the optimal concentration of melatonin and ketamine for the treatment of a “neuropsychiatric disease”, and the method steps utilize “neuronal cells” from the subject’s nasal cavity.
Scope of the neuropsychiatric diseases
The scope of the neuropsychiatric disease is broad to encompass attention and cognitive deficit disorders (ADHD and CDDs), anxiety, depression, addiction, migraine headaches, seizures, eating disorders and uncontrolled anger, etc.
The instant specification and the claims (claims 2-3) disclose only a single example of the psychiatric disorder, which is depression. There is no additional disclosure with regard to the method treating any other psychiatric disorders than depression. Depression is one of many psychiatric disorders known in the art. Yet the disclosure of the instant specification limited to depression would not necessarily provide sufficient written description to the entire genus of the psychiatric disorder as claimed. As the claimed method appears to rely on the synergistic effect of ketamine and melatonin, and the limited showing of the instant specification fails to provide that the claimed method would be effective in determining the optimal dosage of ketamine and melatonin in any other psychiatric disorder.
Scope of the neuronal cell
The instant claims utilize the neuronal cells obtained by exfoliation of the subject’s nasal cavity. The scope of the “neural cells” as claimed would be neuronal cells present in olfactory neuroepithelium. The instant specification, however, discloses that neuronal precursors are prepared from the olfactory epithelium. There is no disclosure in the specification to support the neuronal cells from the olfactory epithelium, or the neuronal precursors differentiated into neuronal cells for the claimed method. It is noted that the specification and claim 4 disclose “solution 6 of differentiation”, which is understood as “differentiation solution”, however, there is no detailed disclosure such that this refers to the differentiation of neuronal precursors into neuronal cells, particularly claim 4 discloses the “neuronal” cells being treated with the series of solutions.
M.P.E.P. §2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
Determining the optimal concentration of ketamine and melatonin
It is noted that the claimed method is based on culturing neuronal cells in vitro and determining the concentration of melatonin for the treatment of the neuropsychiatric disease. The claims do not disclose how the optimal concentration is determined from the cell culture in the presence of ketamine and melatonin. The instant specification discloses examples showing that ketamine at the concentration of 10-7 M would cause the formation of spines which is increased upon longer incubation time (Table 1), and cell cluster formation in the presence of ketamine and/or melatonin at different concentration of melatonin (Table 2). However, there is no disclosure in the instant specification, which concentration would be considered to meet the requirement of the optimal concentration that “must be achieved at the plasma level after administration of the such optimal and personalized concentration of ketamine and melatonin to the patient for the treatment of the neuropsychiatric disease, and wherein said optimal and personalized concentrations of ketamine and melatonin prevent or reduce psychotomimetic and dissociative adverse effects to the patient.”
In other words, the specification fails to provide sufficient written description how to determine the claimed optimal concentrations from the in vitro cell culture method and how such concentrations would be converted to the in vivo treatment to produce therapeutic efficacy as claimed.
Still further, claim 1 requires that the determined optimal and personalized concentrations of ketamine and melatonin “prevent” or “reduce” psychotomimetic and dissociated adverse effects to the patient. There is no showing in the instant specification that the in vitro determined concentration is somehow “prevent” or “reduce” the claimed effects. The instant specification fails to provide detailed description such that the in vitro assay in determining the optimal concentration of ketamine and melatonin, using the concentrations to treat in vivo patients, or prevents or reduces the psychotomimetic and dissociated adverse effects in the patients.
Protein molecule identifier
Claim 4 discloses one of solutions being used in step (ii) of claim 1 including “solution 7” which comprises one or more protein molecule identifiers specific to neuronal structure such that neuronal cells from patients with neuropsychiatric diseases can be distinguished from healthy subjects. The scope of the “protein molecule identifiers” as claimed to distinguish from the patient with a neuropsychiatric disease and the healthy subject appears to be broad, and yet the instant specification does not disclose any example or working embodiment for any neuropsychiatric diseases and their markers.
It is noted that spinophilin, doublecortin, actin and Ki67 are disclosed in claim 1, step (iv), and even if these proteins are qualified as the protein molecule identifier as claimed, however, they do not represent the genus of the protein molecule identifiers for each and every neuropsychiatric diseases as claimed. Rather, they appear to be related to depression according to the instant specification.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
M.P.E.P. § 2163 also recites, “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention… one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.” and further, “The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.< Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims >present in the application when originally filed,< even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) ("One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant's disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out."). In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a method to determine the optimal and personalized concentration of melatonin and ketamine for the treatment of a neuropsychiatric disease, and the method comprises “observing” the induced cellular response of the stained cells, and “determining” the optimal and personalized concentration of ketamine and melatonin. The step of “observing” and “determining” can be carried out mentally by looking at the data obtained from the steps of culturing the olfactory neuronal cells. MPEP2106.04(a)(2)(III) states that if a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. Thus, the instant claims recite a judicial exception (STEP 2A, Prong One: YES).
The claim then requires further analysis in Step 2A Prong Two, to determine whether any additional elements in the claim integrate the abstract idea into a practical application. This judicial exception is not integrated into a practical application because the additional element, i.e. step of culturing, incubating and staining the cells (i.e. steps (i)-(iv) do not provide any improvement to a technology or technical field, or applying or using the judicial exception as they are well known in the art. The isolating and culturing neuronal cells obtained by exfoliation of a subject’s nasal cavity for psychiatry and neuroscience research is well known in the art (Borgmann-Winter et al. 2015, Transl. Psychiatry; Benitez-King et al. 2011, J. Neurosci. Meth.), the use of ketamine and melatonin for depression (Mantovani et al. 2003, Neurosci. Letters), and the detection (staining) of spinophilin, doublecortin, filamentous actin, or Ki67 in neuronal cells is also well known in the art, and they are also known to be linked to neural plasticity mechanism implicated in depression (see Feng et al. 2000, PNAS; Maheu et al. 2013, J. Psych. Res.). The additional elements do not apply or use the judicial except to effect a particular treatment or prophylaxis for a disease or medical condition (STEP 2A, Prong Two: NO). It is noted that the claims disclose that the optimal concentrations of ketamine and melatonin must be achieved at the plasma level after administration to the patient and the concentrations of ketamine and melatonin prevent or reduce psychotomimetic and dissociative adverse effects to the patient. However, this is merely directed to an desired or intended purpose without any particular active step to be carried out for the claimed method. The claimed method is directed to “determining” the concentration. It is noted that claim 4 discloses solutions utilized in the step (ii) of claim 1. The solutions listed in claim 4 are generically disclosed and they are well known solutions utilized for cell culture method, harvesting, cryopreserving, differentiating, and staining and detecting any known protein expressed in the cells, and they are parts of extra-solution activity as discussed above. Thus, the limitation of claim 4 does not integrate the judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements as discussed above do not significantly add more to the judicial exception. The additional element disclosed in the claims is directed to a merely extra-solution activity to obtain the data to carry out the judicial exception of comparing the data (see MPEP2106.05(g)) rather than adding significantly more to the judicial exception.
Based on the above discussion, it is the Examiner’s position that the instant claims are directed to a judicial exception and thus, the claims are not directed to eligible subject matter under 35 U.S.C. 101.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benitez-King et al. (2011, J. Neurosci. Methods) in view of Borgmann-Winter et al. (2015, Translational Psychiatry), Penzes et al. (2011, Nature Neuroscience), Qiao et al. (2016, Neural Plasticity), Law et al. (2004, Am. J. Psychiatry) and Mantovani et al. (2003, Neuroscience Letters).
The instant claims are interpreted as a method comprising i) obtaining neuronal cells from a subject’s nasal cavity by exfoliation; ii) culturing the neuronal cells using a series of solutions for culture of clonal or primary neuronal cells; iii) incubating the cells in the presence of ketamine at 10-7M and melatonin at 10-5 to 10-7M; and iv) staining the cells to detect spinophilin.
The steps of (v)-(vi) directed to observing and determining are not considered as active steps to be carried out as they are directed to mental steps.
The wherein clauses disclosed in step (vi) are directed to the results of the determined concentration and/or intended outcome of the concentration utilized for the in vivo treatment. Thus, they do not limit the method of determining the optimal concentration as claimed in claim 1.
Benitez-King et al. teach a method of obtaining neuronal cells from the nasal epithelium by exfoliation from a patient suffering from schizophrenic and bipolar diseases (entire document). Benitez-King et al. teach that the neuronal cells exfoliated from the nasal cavity are cultured, passaged, frozen, thawed and subcultured (p.37, 2.3. Nasal epithelium cell isolation and culture). Benitez-King et al. teach a solution for rinsing (cytoskeletal buffer) comprising EGTA (calcium chelating agent) and the buffer is a pH regulator (p.37, 2.4). Benitez-King et al. teach the medium for harvesting cells and dissociating, the step for fixing on the glass plate and immunofluorescence staining for various markers (p.37, 2.4-2.5). Benitez-King et al. teach the step for differentiating the neuronal cells and there is no growth factors listed (p.37, 2.6). Benitez-King et al. teach an enriched culture media to propitiate neural lineage maintenance and proliferation, and differentiated with Db-cAMP (p.36, 2.3; 1st col.). These teachings would meet the series of solutions of claim 4 being utilized for culturing the neuronal cells obtained from the nasal cavity of the subject. While Benitez-King et al. do not particularly teach passage 5 at a temperature 37°C and 5% CO2, however, this limitation does not provide any structure to the solution 8, and this limitation does not require any active step to be carried out. Thus, it does not provide any weight in determining patentability of the instant method.
Benitez-King et al. do not teach that the cells are incubated with ketamine and melatonin for the concentration as claimed.
It would have been obvious to a person skilled in the art to use the neuronal cells obtained by exfoliation taught by Benitez-King et al. for other psychiatric disorders or mood disorder including depression because Benitez-King et al. teach that the neural precursors obtained from the nasal epithelia may be a plausible option to evaluate neural structural and functional alterations originated during the neurodevelopment (p.42, 2nd col.). Furthermore, Borgmann-Winter et al. that neuronal cells derived from olfactory mucosa (OM) can be used for ex vivo or in vitro studies for psychiatric illness (Abstract). They teach that studies have been performed investigating the effects of pharmacological agents on intracellular signaling, molecular expression and cell function in OM-derived cells derived from schizophrenia, bipolar disorder and major depressive disorder patients (p.7, 1st col.). Thus, it would have been obvious to a person skilled in the art to use the neuronal cells obtained by the method of Benitez-King et al. for studying psychiatric illness including depression and such study includes drug action on neuronal cells or OM-derived cell culture.
Regarding the staining for spinophilin, Benitez-King et al. do not teach the staining the cells for spinophilin.
However, it is known in the art that the quantity and morphology of dendritic spines of neuronal cells are associated with psychiatric disorders according Penzes et al. Penzes et al. teach that at the cellular level, spine structural plasticity is tightly coordinated with synaptic function and plasticity; for example, spine enlargement parallels long-term potentiation, whereas long-term depression is associated with spine shrinkage and disease-specific disruptions in dendritic spine shape, size or number accompany a large number of brain disorders, suggesting that dendritic spines may serve as a common substrate for many neuropsychiatric disorders (p.285, 1st col.).
Qiao et al. teach that depression is closely associated with alterations in dendritic spine morphology and spine density (Abstract) and many synaptic proteins including spinophilin play an important role in the regulation of the spine formation and/or synaptic plasticity (p.16, 1st col.). Qiao et al. teach that expression of these synaptic proteins in the brain is altered by chronic stress, and these proteins may play a key role in chronic stress-induced both depression-like behaviors and spine alterations (p.16, 1st col.), and the use of spinophilin as a marker for stress induced animal models of depression (see Table 1, #16, #22; Table 3, #18).
Law et al. teach that reduced spinophilin in the patients with major depression and bipolar disorder (p.1848, Method).
Mantovani et al. teach that melatonin and ketamine produce a synergistic effect on treating depression (Abstract).
Based on the teachings of the cited references above, it would have been obvious to a person skilled in the art to detect the expression of spinophilin as an indicative of the changes in dendritic spine morphology and density in the presence of ketamine and melatonin with a reasonable expectation of success. One skilled in the art would recognize that by assaying the effect of ketamine and melatonin the effective concentrations of these drugs can be determined based on the morphology and density of dendritic density of the neuronal cells obtained from the nasal cavity of the patients.
Regarding the concentration of ketamine and melatonin as claimed, the cited references do not teach the limitation. However, the concentrations of ketamine and melatonin are considered as result-effective parameters as the outcome would be determined by the concentration, and thus, one skilled in the art would readily modify the concentration to determine the desired outcome of dendritic spine morphology and density of the neuronal cells used in the method with a reasonable expectation of success. It is well settled that routine optimization is not patentable, even if it results in significant improvements over the prior art. In support of this position, attention is directed to the decision in In re Aller, Lacey, and Haft, 105 USPQ 233 (CCPA 1955): Normally, it is to be expected that a change in temperature, or in concentration, or in both, would be an unpatentable modification. Under some circumstances, however, changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art. In re Dreyfus, 22 C.C.P.A. (Patents) 830, 73 F.2d 931,24 USPQ 52; In re Waite et al., 35 C.C.P.A. (Patents) 1117, 168 F.2d 104, 77 USPQ 586. Such ranges are termed "critical" ranges, and the applicant has the burden of proving such criticality. In re Swenson et al., 30 C.C.P.A. (Patents) 809, 132 F.2d 1020, 56 USPQ 372; In re Scherl, 33 C.C.P.A. (Patents) 1193, 156 F.2d 72, 70 USPQ 204. However, even though applicant's modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art. In re Sola, 22 C.C.P.A. (Patents) 1313, 77 F.2d 627, 25 USPQ 433; In re Normann et al., 32 C.C.P.A. (Patents) 1248, 150 F.2d 708, 66 USPQ 308; In re Irmscher, 32 C.C.P.A. (Patents) 1259, 150 F.2d 705, 66 USPQ 314. More particularly, where 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 Swain et al., 33 C.C.P.A. (Patents) 1250, 156 F.2d 239, 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 69 App. D.C. 217, 99 F.2d 986, 38 USPQ 213; Allen et al. v. Coe, 77 App. D. C. 324, 135 F.2d 11,57 USPQ 136. (Emphasis added). With regards to determining experimental parameters, such as time in culture, the court has held that "[d]iscovery of optimum value of result effective variable in known process is ordinarily within skill of art (In re Boesch and Slaney, 205 USPQ 215 (CCPA 1980)).
The adjustment of particular conventional working conditions (e.g., concentration) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan having the cited reference before him/her.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631