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 .
This is the first action on the merits.
The lack of unity was revised below to address any deficiencies and clarification.
Election/Restrictions
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group (I), claim(s) 1-14, drawn to a mass production of sodium taurodeoxycholate.
Group (II), claim(s) 15, drawn to the compound sodium taurodeoxycholate.
The claims herein lack unity of invention under PCT rule 13.1 and 13.2 since, under 37 CFR 1.475(a) Group I -Group II lack unity of invention since under 37 CFR 1.475:
Where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features…those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: The special technical feature of Group (II) is the compound sodium taurodeoxycholate, which can be found in US 5182258, see claim 2, column 22. The special technical feature of Group (I) is the process of making sodium taurodeoxycholate. Therefore, the above claims are not so linked as to form a single general inventive concept and there is a lack of unity of invention because they lack a common technical feature. Accordingly, unity of invention is considered to be lacking and restriction of the invention in accordance with the rules of unity of invention is considered to be proper.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
WHEN CLAIMS ARE DIRECTED TO MULTIPLE CATEGORIES OF INVENTIONS
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Rejoinder Advisory
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the Examiner before the patent issues. See MPEP § 804.01.
Election/Restrictions
Applicant's election without traverse of Group (I) in the reply filed on December 11, 2026 is acknowledged. Group (I), drawn to a mass production of sodium taurodeoxycholate, embraced by claims 1-14 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 3-5 is blurry. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities: the term “to” should be replaced with “or” in line 3. Appropriate correction is required.
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.
Claim 2 is 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 pre-AIA the applicant regards as the invention.
In claim 2, the phrase, “stirring the solution while adjusting a temperature” is vague. What determines the temperature adjustment? The specification does define the adjustment.
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 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-14 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Xu et al. (WO 2020182228) in view of Lack et al. (Journal of Lipid Research, 1973, 14, 367-370), Tserng et al. (Journal of Lipid Research, 1977, 18, 404-407, cited on the IDS), Hardwood et al. ((Experimental Organic Chemistry, Standard and Microscale, 2nd Edition, 1998, pp. 131-143) and Perrin et al. (Purification of Laboratory Chemicals, 3rd Edition, 1988, pp. 12-41).
The present application is drawn to the mass production method of sodium taurodeoxycholate comprising 1) synthesizing crude sodium taurodeoxycholate; 2) washing the crude sodium taurodeoxycholate with an organic solvent; and 3) purifying sodium taurodeoxycholate with a solution containing isopropyl alcohol further comprising heating, cooling and filtering the recrystallized solid.
Xu et al. teach a method of purifying a similar compound, sodium taurocholate, comprising dissolving a crude sodium taurocholate in an alcohol solvent, heating, filtering after cooling, and drying under reduced pressure to obtain sodium taurocholate, see abstract of original document.
The Xu reference does not teach isopropyl alcohol as the organic solvent or the isopropyl alcohol in step 3; and deoxycholic acid as the bile acid in the sodium taurodeoxycholate.
Xu teaches the alcohol solvents methanol, ethanol, propanol, or butanol, at the bottom of page 1/8 of the translated document. These alcohol solvents are homologues of isopropyl alcohol and are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Furthermore, Lack et al. teaches the equivalency of deoxycholic acid and cholic acid, among other bile acids, in a mixture coupled with taurine as the sodium salt in the presence of EEDQ as a coupling agent, see page 367, left-hand column, third paragraph. The M.P.E.P. states (2144.09): A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
The Lack reference further teaches washing a crude solid taurochenodeoxycholate with ethanol, see page 367, left-hand column, first paragraph.
The Xu reference teaches dissolving the taurine conjugate cholic acid in methanol, adding acetone, and cooling to crystallize, see the translated document at the top of page 3/8.
Tserng et al. teaches sodium salts of taurine conjugates can be recrystallized from ethanol, see page 405, right-hand column, third paragraph.
Claims 3-13 are drawn to different solvents for the washings and crystallization step, repeating the crystallization step, temperatures for heating and cooling, and ratios of different solvents. These are conventional and routine in an organic chemistry lab for purifying products by filtration and crystallization, unless there is evidence to the contrary. More specifically, claims 3-13 can also be addressed by crystallization or recrystallization references.
Crystallization or recrystallization is a commonly used technique in organic chemistry to purify solid compounds. “The simplest and most effective technique for the purification of solid organic compounds is crystallization. Crystalline compounds are easy to handle, their purity is readily assessed… and they are often easier to identify than liquids or oils. Crystals can be obtained in one of three ways: from the melted
solid on cooling, by sublimation… or from a supersaturated solution. The last method is by far the most common in the organic laboratory,” see the Crystallization paragraph on page 131 of the Hardwood reference.
Hardwood goes on to state, “The process involves five stages: dissolution[,]
Filtration[,] crystallization[,] collection of the crystals[,] and drying the crystal,” see the last two lines on page 131. On page 132, the reference states, “The technique involves dissolving the impure solid in the minimum volume of a hot solvent and filtering to remove insoluble impurities. The resulting hot saturated solution of the compound, together with any soluble impurities, is set aside to cool slowly, whereupon crystals of pure compound will separate from solution,” see the bottom paragraph on page 132.
The Perrin reference teaches solvents commonly used for crystallizations, see page 40, Table 5, which teaches ethanol and acetone. The Perrin reference goes on to state, “Where a substance is too soluble in one solvent and too insoluble in another, for either to be used for recrystallisation, it is often possible (provided they are miscible) to use them as a mixed solvent. (In general, however, it is preferable to use a single solvent if this is practicable.) Table 6 comprises many of the common pairs of miscible solvents,” see page 15, first paragraph and page 41. Thus, purification of the same general approach used for single-solvent dissolution is followed when mixed solvents (solvents and anti-solvents) are employed.
The solution is allowed to cool to allow for crystal formation (crystallization will be better if this step takes place slowly). After the system reaches room temperature, cooling it in an ice bath may improve the yield. Then the solid product is isolated by filtration. The crystals normally are washed with a small amount of cold solvent during the filtration step. The solid may be heated at reduced pressure to remove solvents with higher boiling points.
The choice of solvent is perhaps the most critical step in the process of crystallization since the correct solvent must be selected to form a product of high purity and in good recovery or yield. This is considered routine optimization unless there is evidence to the contrary. 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. "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 Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Thus, the claims are rendered obvious.
Conclusion
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624