Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-3,10-11 and 13 of H. Ito, et al., US 17/996,070 (10/12/2022) are pending. Claims 2-3,10-11 and 13 are withdrawn as directed to unelected Groups; claim 1 under examination on merits and is rejected.
Election/Restrictions
Pursuant to the restriction requirement, Applicant confirmed the election of Group I (claim 1) made on 04/18/2025 over the phone without traverse in the reply filed on 10/31/2025. Claims 2-3,10-11 and 13 drawn to non-elected Groups (I)-(IV) are withdrawn from consideration pursuant to 37 CFR 1.142(b). The Restriction requirement is maintained as FINAL.
Withdrawal Claim Rejections - 35 USC § 102
Rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by R. Takahashi, et al, 12 Nature Communications, 12(1), 6691 (Published on 11/18/2021)(“Takahashi”) is withdrawn in view of Applicant filling a certified English translation of the foreign application, from which the priority is being claimed, together with a statement that the translation of the certified copy is accurate. Thus, the effective filling date of the instant claim is 03/19/2021, and Takahashi is disqualified as a prior art, therefore, the rejection made in the previous Office action is withdrawn.
Rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by R. Takahashi, et al, solventless mechanochemical synthesis of magnesium-based carbon nucleophiles and their application to organic synthesis, Proceedings of the 101st CSJ Annual Meeting (03/04/2021)(“Takahashi-1”) withdrawn in view of the Declaration of inventor Hajime Ito and Koji Kubota under 37 CFR § 1.130 (10/31/2025).
Applicant submits the Declaration of Hajime Ito under 37 CFR § 1.130 (10/31/2025) (the “Declaration”). The Declaration states that:
We, Hajime ITO and Koji KUBOTA, the joint inventors of the above-identified : application, do hereby declare as follows:
. . .
2. I understand that the article by R. Takahashi, et al, “Solvent-less mechanochemical synthesis of magnesium-based carbon nucleophiles and their application to organic synthesis”, Proceedings of the 101st CSJ Annual Meeting (03/04/2021), that is cited against claim 1 in the Office action dated 05/02/2025, was published less than one year before the effective filing date (03/19/2021) of the claimed invention. The Examiner asserts that paragraph 2 and the following reaction scheme disclosed in the article are relevant to the claimed invention.
3. The article indicates Rina Takahashi, Anqi Hu, Yadong Pang, and Tamae Seo as co-authors in addition to us. However, Orina Takahashi, Angi Hu, Yadong Pang, and Tamae Seo were lab technicians working under our direction and supervision who did not contribute to the conception of the claimed invention.
The Declaration at 2-3.
The Declaration shows sufficient facts, in weight and character, to establish that (1) the Takahashi-1 disclosure was made by the inventor or a joint inventor, or (2) the Takahashi-1 subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor of the instant application. MPEP § 717.01(a)(1).1 The Declaration otherwise meets the formal requirements. MPEP § 717.01(c). Takahashi-1 is therefore exemptible prior art pursuant to 35 U.S.C. 102(b)(1). See MPEP 2153. Therefore, the rejection made in the previous Office action is withdrawn.
Claim Interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See, MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III).
Interpretation of the term “mechanochemical process”
Independent claim 1 recites the term “mechanochemical process” in the following context.
1. A method for producing an organometallic nucleophile, comprising reacting an organohalide and a metal or metal compound with each other by a mechanochemical process in the presence of an ether compound in an amount of 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide.
The specification provides the following discussion with respect to the claimed “mechanochemical process”:
<Mechanochemical process>
The mechanochemical process is a processing method in which mechanical energy is applied to a reactant (particularly, a solid reactant) by means of, for example, shearing, compression, stretching, grinding, rubbing, kneading, mixing, dispersion, disintegration, or shaking to thereby activate the reactant and provide structural change, phase transition, reactivity, adsorbability, catalytic activity, etc. This is expected to lead to surface activation, an increase in surface area, an increase in lattice defect, a decrease in crystal grain size, amorphization, etc.
The device for the mechanochemical process is not particularly limited as long as it is a device capable of applying mechanical energy by the above means.
Specification at page 32, [0031] (emphasis added).
In working Examples 1-60, the specification teaches reactions of various organic halides with magnesium according to the following general equation.
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Specification at pages 77-84.
The portion of specification working Example 1 that corresponds to claim 1 is summarized by the Examiner below.
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Example 1 thus employs 123 μL of tetrahydrofuran as a solvent. Consistent with the specification, the claim 1 step of:
“reacting an organohalide and a metal or metal compound with each other by a mechanochemical process”
term “mechanochemical process”, within the context of the claim 1 method, is broadly and reasonably interpreted as any physical force applied to a reaction mixture comprising the claimed organohalide, the claimed metal or metal compound, and the claimed ether compound.
Interpretation of “metal compound”, “ether compound”, and “organohalide”
Independent claim 1 recites the term “mechanochemical process” in the following context.
1. A method for producing an organometallic nucleophile, comprising reacting an organohalide and a metal or metal compound with each other by a mechanochemical process in the presence of an ether compound in an amount of 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide.
The specification provides the following definition with respect to the claimed “organohalide”:
The organohalide used in the method for producing an organometallic nucleophile according to the present invention is a compound (I) represented by formula (I) below.
A1-Xm (I)
In the formula,
A1 represents an optionally substituted m-valent aromatic hydrocarbon group, an optionally substituted m-valent aromatic heterocyclic group, an optionally substituted m-valent aliphatic hydrocarbon group, or an optionally substituted m-valent unsaturated aliphatic hydrocarbon group.
Each occurrence of X represents F (fluorine), Cl (chlorine), Br (bromine), or I (iodine).
m is the number of X and represents an integer of 1 or greater.
Specification at page 17, [0017].
Therefore, “organohalide” is interpreted as the definition provided by the specification.
The specification provides the following discussion with respect to the claimed “metal compound”:
The metal or metal compound is not particularly limited as long as it can react with the organohalide to form an organometallic nucleophile. Examples of the metal include one or more selected from the group consisting of alkaline-earth metals, alkali metals, transition metals, zinc, aluminum, indium, tin, bismuth, boron, silicon, gallium, germanium, antimony, lead, and rare-earth metals. Examples of the metal compound include one or more selected from the group consisting of salts of these metals (e.g., chlorides, bromides, iodides, nitrates, sulfates, and carbonates), oxides of these metals, and the like.
Specification at page 29,[0026].
Based on its plain meaning and consistent with the specification, the term “metal compound” is broadly and reasonably interpreted as any compound comprising a metal.
The specification provides the following discussion with respect to the claimed “ether compound”:
The ether compound is a compound having one or more ether bonds (-O-) in a molecule, and is not particularly limited as long as it is a compound inactive in the reaction between the organohalide and the metal or metal compound.
Specification at page 30,[0028]. Therefore, consistent with the specification, the term “ether compound” is broadly and reasonably interpreted as any compound comprising a one or more “C-O-C“.
Interpretation of “in an amount of 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide”
Independent claim 1 recites the term “in an amount of 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide” in the following context.
1. A method for producing an organometallic nucleophile, comprising reacting an organohalide and a metal or metal compound with each other by a mechanochemical process in the presence of an ether compound in an amount of 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide.
The specification has the follows discussion:
[0030] The amount of ether compound used is 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide. The amount of ether compound is preferably 0.7 equivalents or more, more preferably 1.0 equivalents or more, still more preferably 1.2 equivalents or more, yet still more preferably 1.5 equivalents or more, and preferably 7.0 equivalents or less, more preferably 5.0 equivalents or less. If the amount of ether compound is less than 0.5 equivalents, the organometallic nucleophile, particularly a Grignard reagent, cannot be efficiently synthesized, and when the organometallic nucleophile is subjected to a subsequent reaction, the reaction may not proceed sufficiently. If the amount of ether compound is more than 10.0 equivalents, since the ether compound functions substantially as a solvent to make it difficult to apply a mechanochemical action to reaction components, the organometallic nucleophile, particularly a Grignard reagent, cannot be efficiently synthesized, and when the organometallic nucleophile is subjected to a subsequent reaction, the reaction may not proceed sufficiently.
Specification at page 31, [0030], emphasis added.
According to the specification, the claim 1 context is interpreted as the amount of an ether compound is 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide
Claim Rejections - 35 USC § 112(a) (Scope of Enablement)
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.
Claim 1 is rejected under 35 U.S.C. 112(a) because the specification, while enabling one of skill in the art to make and use (where proposed amendments to claim 1 are indicated by underlined text):
Claim 1 A method for producing an organometallic nucleophile, comprising:
reacting an organohalide and a metal or metal compound with each other by a mechanochemical process in the presence of an ether compound in an amount of 0.5 to 10.0 equivalents relative to 1 equivalent of the organohalide, wherein, the metal is magnesium element (Mg);
does not reasonably enable one of skill in the art to make and use the full scope of
the metal or metal compound listed in claim 1 in combination with any organohalide within the context of claim 1.
Note: The rejection is modified according to claim amendment.
Factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
MPEP. § 2164.01(a); In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993).
Breadth of the Claims
The claims are directed to the art of a method for producing an organometallic nucleophile, comprising reacting an organohalide and the listed metal or a metal compound comprising the listed metal with each other by a mechanochemical process in the presence of an ether compound. The claim is super broad because:
(i). the scope of organohalide is essentially uncountable;
(ii). most the listed metals have different oxidation states, therefore, the number of possible metal compound is virtually infinite;
(iii). ether also has millions of species.
State of the Prior Art/Level of Predictability in the Art
The art evidences unpredictability with respect to use of metals other than magnesium in formation of nucleophiles. For example, Koch teaches that:
However, the application of the Grignard reaction to heavier alkaline earth metals has inherent challenges, and diverse reasons account for the lack of an early straightforward development of organocalcium compounds of the type R-Ca-X. On the one hand, these organometallics are very sensitive toward moisture (hydrolysis) and air (oxidation) because of highly polar Ca-C bonds based on the electronegativity difference between calcium and carbon. On the other hand, the reduction of organic halides with calcium is accompanied by side reactions such as ether degradation (formation of RH), . . . , which often lead to irreproducible results from the direct synthesis using calcium.
See A. Koch, et al, 24 Chemistry–A European Journal, 16840-16850 (2018)(“Koch”) at page 16841, left col. paragraph 2, line 1-15, emphasis added.
Koch teaches that:
The direct synthesis of organocalcium compounds (heavy Grignard reagents) by the reduction of organyl halides with activated calcium powder succeeded in a straight forward manner for organic bromides and iodides that are bound at sp2 -hybridized carbon atoms. Extension of this strategy to alkyl halides was very limited.
Koch at Abstract line 1-6, emphasis added.
Thus, Koch teaches one ordinary skill that synthesis R-Ca-X directly by reaction of calcium with organic halides has inherent challenges and the results are irreproducible.
Claim 1 encompasses rare, exotic and radioactive metals. For example, francium is a alkali metals and Orozco teaches that there is much less than an ounce of francium at any given time in the whole Earth and it is the most unstable element of the first 103 in the periodic table, and its longest lived isotope lasts a mere 20 minutes. See L. A. Orozco, Francium, (2003). paragraph 2, emphasis added. Therefore, there is also a challenge to make metals such as francium to react with an organohalide in the presence of an ether to form a an organometallic nucleophile.
Supporting Disclosure in the Specification
Most of working examples in the specification utilize metal Mg as the metal. Specification at pages 77-109, Example 1-113 and Tables 2-3. While working Examples 117-118 and 120-135 utilize metal Ca as the metal and Examples 136-150 utilize metal Mn as the metal; however, these Examples all use aromatic halides (compound 101a-101i, 201a-202e) as the organohalide. See Table 120-121, [0151]-[0152]; and page 124-125, [0158]-[[0160]. The specification does not provide any evidence that calcium based Grignard reagents and /or manganese based Grignard reagents compounds can be prepared from a reaction of Ca/Mn with alkyl halides.
The Quantity of Experimentation Needed Is Undue
In the current case, claim 1 is properly rejected under 35 U.S.C. § 112(a), for lack of enablement because upon balancing the above-discussed factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full claim scope without undue experimentation.
The primary issue with respect to the § 112 rejection is as follows. The specification working examples are limited to 3 species of the metals. This lack of guidance is balanced with the lack of supplemental disclosure in the prior art and the art’s unpredictability.
The amount of experimentation required to properly select each of the claim 1 reagents (from among the large genera claimed) as well as reaction conditions (e.g., time, temperature, concentrations) is necessarily undue on view of the vast breadth of the recited genera of:
i) an organohalide,
ii) the listed metal or a compound comprising the listed metal,
iii) an ether
and in view of the lack of guidance in the specification (i.e., only 3 species of the metal of the above in the working examples and general guidance in the specification body) in further view of the unpredictability in the art; for example, Koch teaches one ordinary skill that synthesis R-Ca-X directly by reaction of calcium with organic halides has inherent challenges and the results are irreproducible.
Applicant’s Argument
Applicant first argues on the ground that in addition to Mg, the specification also teaches working examples associated with Ca and Mn; and the Japanese application 38-9142 states that R1-Ca-X can be obtained from metallic calcium and hydrocarbon halides. Remarks at page 4-6, Response to the Rejection of Claim 1 Under 35 U.S.C.
These arguments have been fully considered but not persuasive, as mentioned in the rejection above that Koch teaches that while calcium based Grignard reagents can be obtained through a reaction of activated calcium powder with organic bromides and iodides that are bound at sp2 -hybridized carbon atoms, extension of this strategy to alkyl halides was very limited. Koch at Abstract line 1-6. While working Examples 117-118 and 120-135 utilize metal Ca as the metal; however, these Examples all use aromatic halides (compound 101a-101i, 201a-202e) as the organohalide. See Table 120-121, [0151]-[0152]; and page 124-125, [0158]-[[0160]. The specification does not provide any evidence that calcium based Grignard reagents can be formed from a reaction of Ca with alkyl halides that is a subgenus of the claimed organohalide in claim 1. Examiner conducted reaction searching and do not find a method of preparing of Mn based Grignard reagents by reaction of Mn with alkyl halides. With regards the four references mentioned by Applicant for further arguments (Remarks at page 5, last paragraph), theses references all are published after 03/19/2021 which is the effective filling date of the instant application, therefore, none of these references evidences the level of skill as of the effective filed.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Rejection of Claim 1 under 35 U.S.C. 103 as being unpatentable over C. Hofmann, et al, US20190161505A1(2019)(“Hofmann”) is maintained for the same reason as given in the previous Office action and is repeated as below.
C. Hofmann, et al, US20190161505A1 (2019)(“Hofmann”).
Hofmann teaches a method for the production of Grignard adducts, in which the magnesium chips are activated mechanically in situ. Hofmann at page 1, [0001].
Hofmann teaches that:
The mechanical activation of the magnesium chips is achieved, in one method variant, by friction of the magnesium chips against each other, preferably by friction triggered by vibrations, grinding movements, particularly preferably by friction triggered by vibrations with a frequency of 20 to 200 Hz.
Hofmann at page 1, [0015]. Hofmann teaches that:
The water-free solvent consists preferably of an ether, particularly preferably diethyl ether, 2-methyl-tetrahydrofuran, tetrahydrofuran, the mixtures thereof or mixtures thereof with other organic solvents, in particular toluene.
Hofmann at page 1, [0017], emphasis added. Hofmann teaches that:
The high concentrations contribute to expenditure being able to be reduced. Less solvent than in comparable methods from the state of the art is required.
Hofmann at page 2, [0021], emphasis added. Hofmann also teaches the follows working example:
[0037] In a 3D sintered reactor, 15 g of fresh, untreated magnesium chips are introduced. Subsequently, the supply lines and a thermostat are connected to the reactor. Furthermore, a vibration motor is fitted to the reactor. By switching on the vibration motor, the magnesium chips in the interior of the reactor are firstly compacted. The reactor is in addition pre-temperature-controlled to a temperature of 55° C. by the thermostat in order to enable rapid starting of the Grignard adduct formation. Then a water-free solution of phenyl bromide in tetrahydrofuran with a concentration of 1 mol/l is introduced into the reactor. For conveyance of the solution, an injection pump is used and the flow rate is adjusted to 2 ml/min.
[0038] At intervals of a few minutes, inline, infrared spectra are recorded in order to be able to observe the reaction course. Even the first spectrum shows a peak which is attributed to the Grignard compound. The reaction has therefore started immediately. Complete conversion is achieved after 15 min running time.
Hofmann at page 2, [0037]-[0038], emphasis added.
The Hofmann working example can be schematic summarized as below:
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Hofmann at Figure 1.
The Hofmann method comprise:
(i). a step of reaction of phenyl bromide with Mg by vibration which is a mechanochemical process in the presence of THF which is an ether;
(ii). the concentration of phenyl bromide in tetrahydrofuran 1 mol/l, therefore, the ratio between tetrahydrofuran and phenyl bromide is 12.2 (1000 ml× 0.88 g/ml ÷ 72 g/mol =12.2) to 1.
Difference between Hofmann and the Claim
The Hofmann method differs from the instant claim 1 only in that the ratio between tetrahydrofuran and phenyl bromide is not the claimed ranges.
Obviousness Rationale
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05 and see Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Herein, the claimed an ether compound in an amount of 10.0 equivalents relative to 1 equivalent of the organohalide is close to the Hofmann prior art 12.2 equivalents of the tetrahydrofuran to 1 equivalent of the phenyl bromide, therefore, a prima facie case of obviousness exists and claim 1 is obvious.
Further, one ordinary skill is further motivated optimize the Hofmann method by adjusting the ratio between the tetrahydrofuran and the phenyl bromide to the claimed ranges by use higher concentration phenyl bromide in tetrahydrofuran because Hofmann teaches that:
The high concentrations contribute to expenditure being able to be reduced. Less solvent than in comparable methods from the state of the art is required.
Hofmann at page 2, [0021]. It is a well-settled tenet that one of ordinary skill in the art to develop workable or optimum ranges for result-effective parameters, where Applicant can rebut a prima facie case of obviousness by showing the criticality (unexpected result) of the range. MPEP § 2144.05; see also, In re Boesch, 617 F.2d 272,276 (CCPA 1980); In re Aller, 220 F.2d 454, 456 (CCPA 1955) (generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical); In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (explaining that, in cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims, "the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range").2
Applicant’s argument
Applicant first argues on the ground that:
The invention of Hotmann simply involves polishing magnesium chips to a surface (removing the passivation layer) by friction in the presence of a large amount of solvent (e.g., [0016]). In other words, the friction in Hotmann appears to function solely to polish the magnesium chips to a surface, and cannot be said to involve a mechanochemical reaction between an organohalide and a metal or metal compound in the presence of a specific amount of an ether compound, as recited in claim 1. The present invention involves a mechanochemical reaction, and the reaction itself is carried out under the application of shear force. Therefore, the present invention is a fundamentally different technology from the invention of Hotmann.
Remarks at page 7, last paragraph to line 2 of page 8.
This argument has been fully considered but not persuasive because Hotmann clearly teaches that vibration is mechanical method to activate the magnesium chips (see Hofmann at page 1, [0015] and Claim Interpretation), which matches the discussion with respect to the claimed “mechanochemical process” in the specification:
The mechanochemical process is a processing method in which mechanical energy is applied to a reactant (particularly, a solid reactant) by means of, for example, shearing, compression, stretching, grinding, rubbing, kneading, mixing, dispersion, disintegration, or shaking to thereby activate the reactant and provide structural change, phase transition, reactivity, adsorbability, catalytic activity, etc. This is expected to lead to surface activation, an increase in surface area, an increase in lattice defect, a decrease in crystal grain size, amorphization, etc.
Specification at page 32, [0031], line 1-11, emphasis added.
Thus, the Hotmann method comprises reacting an organohalide and a metal/metal compound with each other by a mechanochemical process in the presence of an ether compound; with regards the argued “shear force”, applicant argues something not being claimed.
Applicant further on the ground that:
Hotmann is directed to a reaction carried out in the presence of an ether compound in an amount far exceeding 10.0 equivalents relative to 1 equivalent of the organohalide. As described in para [0030] of the specification as filed, if the amount of the ether compound used exceeds 10.0 equivalents relative to 1 equivalent of the organohalide, "the ether compound functions substantially as a solvent to make it difficult to apply a mechanochemical action to reaction components," which may make it impossible to efficiently synthesize organometallic nucleophiles, particularly Grignard reagents. Accordingly, upon reading Hotmann, a skilled artisan would not have been motivated to experiment with an ether compound at an amount insufficient for polishing the surface of magnesium chips to arrive at the claimed invention with a reasonable expectation of success. Thus, claim 1 would not have been obvious over Hotmann. Applicant respectfully requests withdrawal of the rejection.
Remarks at page 8, last paragraph 2.
First of all, Applicant is not arguing on unexpected result. As discussed in the 103 rejection above that one ordinary skilled artisan has a motivation to optimize the Hotmann method by reducing the amount of THF into the claimed ranges given Hotmann teaches that:
The high concentrations contribute to expenditure being able to be reduced. Less solvent than in comparable methods from the state of the art is required.
Hofmann at page 2, [0021]
Generally, with respect to optimization of result-effective variables, changes to the prior art involving degree is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. MPEP § 2144.05(II)(A) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). Herein, clearly, Hofmann teaches the amount of solvent (THF) is a result-effective variables for his method of preparing of Grignard adducts, therefore, one ordinary skilled of artisan has a motivation to optimize the amount of the result-effective variables with a reasonable expectation of success.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). Herein, Applicant does not provide any convincible data to show the claimed range is critical, rather Hofmann teaches that the amount of THF is not critical and it can be optimized.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FRANK S. HOU/Examiner, Art Unit 1692
/ALEXANDER R PAGANO/Primary Examiner, Art Unit 1692
1 An "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. MPEP § 717.01(a)(1) (citing In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982)).
2 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. MPEP § 716.02(d) (citing In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960)).