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
This action is FINAL.
Status of Claims
Claims 1-4, 6,9-11, 13, 17-19, 21-22, 24-25, 27, and 30-32 are pending.
Priority
Instant application 18010033, filed 12/13/2022 claims benefit as follows:
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The priority documents are not in English, so the 01/13/2022 effective filing date is given in this action.
Restriction Requirement
In the response received 09/22/2025, Applicant affirmed the restriction requirement.
Information Disclosure Statements
No additional IDS(s) submissions have been submitted since the last notification.
Response to Applicant Amendment/Argument
In view of Applicant amendment, the objection of record is withdrawn.
In view of Applicant amendment, the 112(b) rejection is withdrawn.
With respect to the 103 rejection, Applicant argument has been considered but is not persuasive for at least the following reasons. First, Applicant argues that high purity and high yield of 3HP are achieved by “concentrating a 3HP fermentation broth in the presence of a specific metal salt”. However, the claims do not require a fermentation broth, or an active step of concentrating from such a broth, but instead require “…crystals of [3HP] in a concentrate…”. This could be purely chemical, any form of concentrating or reaction could get the crystals to this point given the claim language as it stands. Thus, Applicant is not considering the BRI as the claims currently stand. Thus, Applicant is arguing from limitations that are not required by the instant claims. Thus, this argument has been considered but is not found to be persuasive.
With respect to the Urbanus reference, the rejection is to be taken as a whole. The Examiner pointed out the failures of Urbanus alone, but the additional references cure the deficiencies of the individual reference. Thus, this argument has been considered but is not found to be persuasive.
With respect to McDonald and Ramachandran and Mersmann, these argument has been considered but is not found to be persuasive. As mentioned above, all that is required by the claim in step 1 is “forming crystals of [3HP] in a concentrate”. The concentrate can be the addition of salts to make a precipitation occur. There is nothing in the claim that requires a concentrating step in gerund form. Thus, this argument has been considered but is not found to be persuasive.
The combination of references teach that precipitation is a result effective variable and that it would be obvious to one having ordinary skill in the art to optimize routine experimental conditions to precipitate a salt from a solution.
Applicant argues that the process suggested by the combination of art is different from the instant claims because the combination would lead a person of ordinary skill in the art to a process where large quantities of calcium salt are added to a 3HP broth, which is contrasted by crystalizing by concentrating the 3HP solution itself to a specific high level of 3HP, which minimizes the required amount of metal salt. First, the claims as they stand do not require the specific interpretation as argued by Applicant. For example, no base concentration is found in the claim such that any excess is allowed by the claim. Even so, it is well within the skill of a chemist to calculate the amount of acid and the amount of base in molar quantities and add the specific amount of base needed to neutralize the acid. There is even motivation to do so – reduce cost of the base one needs to purchase. Further, with respect to the specific concentration in the claim, there is nothing argued as to criticality of this concentration. The burden has shifted to Applicant to establish the criticality of the concentration of 300 g/L. No arguments have been made to the criticality of this concentration and absent such a showing and/or argument the routine optimization argument holds. Thus, Applicant arguments have been considered but are not found to be persuasive.
With respect to the provisional obviousness-type double patenting rejections, Applicant argues the dates. However, since the 103 rejection is maintained the provisional ODP rejections are also maintained. Thus, Applicant arguments have been considered but are not found to be persuasive.
Claim Rejection – 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.
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, 3-4, 6, 9-11, 13, and 17-19 are is/are rejected under 35 U.S.C. 103 as being unpatentable over the article to Urbanus in view of McDonald in view of Ramachandran (made of record on the IDS) and as evidenced by and/or in view of Mersmann (Mersmann, A. “Crystallization and precipitation”, Volume 38, Issues 4-6, 1999, 345-353).
Urbanus teaches reactive crystallization as a method for recovering 3-hydroxypropionic acid (abstract, page 22 and tables).
With respect to claim 1, Urbanus fails to teach an alkali metal salt being used as a base, a crystal being formed at a concentration of 300 g/L or 350-900 g/L (claim 4), and the crystal being separated and then being converted into the free acid from the salt.
With respect to the alkali metal, McDonald teaches using calcium hydroxide in reactive crystallization for crystallizing carboxylic acids (3-hydroxy propionic acid is a carboxylic acid). See for example pages 12-13.
With respect to concentration differences, it would have been prima facie obvious to one having ordinary skill in the art to optimize concentrations since concentrations impact the rate of crystal formation, Thus, concentration is a result effective variable and optimizing concentrations of solutions for crystallization is routine experimentation. See MPEP 2144.05 incorporated by reference herein. Evidence for this assertion can be found in the evidentiary reference (Mersmann, for example: “…the main objective in crystallization and precipitation is to choose and to maintain the optimal supersaturation…”, abstract and throughout) which shows that supersaturation a concentration is “optimized” to the optimal concentration).
With respect to generating the free acid, Ramachandran in the same field of endeavor of recovering a free acid, teaches a method for recovering gluconic acid (salts), discloses a gluconic acid calcium salt by adding the base, calcium hydroxide, with heating and stirring, concentrating and cooling, followed by crystallization. Further, Ramachandran teaches recovering the acid through acid treatment of the salt (see for example page 192).
Given that all 3 references relate to the recovery of carboxylic acids through reactive crystallization, it would have been prima facie obvious combine the teachings of the references to arrive at instant claim 1. Applying for example KSR prong A, would arrive at the instant process of claim 1.
With respect to claim 3, McDonald and Ramachandran teach calcium hydroxide.
With respect to claim 4, concentration optimization is viewed as routine experimentation (see argument above incorporated by reference herein).
With respect to claim 6, the 3 references fail to explicitly teach particle sizes and distributions.
However, Mersmann teaches that particle sizes and therefore distributions can be optimized (see for example 340-353, for example: “6. How to influence the median crystal size” at page 352). Thus, it would have been prima facie obvious absent a showing of criticality to one having ordinary skill in the art to arrive at different particle sizes and distributions because there are routine variables that can be optimized (see MPEP 2144.05 incorporated by reference herein).
With respect to claim 9, the Karl Fischer technique relates to concentration as well since the it measures the water content in the crystals. The references fail to explicitly teach this concentration of moisture. Applying the same logic above, it would have been facie obvious to dry the crystals in order to have better handling properties. Optimizing water content is routine experimentation since removing water would allow for improved handling as a motivation, but such optimization is also routine experimentation absent criticality.
With respect to claim 10-11, and 13 the references fail to teach these limitations explicitly.
However, with respect to claim 10, Urbanus for example teaches integrating fermentation products which would be expected to have overlapping radioactive levels. Thus, absent a showing of criticality it would have been prima facie obvious and/or inherent to meet these levels of radioactivity.
With respect to claims 11 and 13, the resulting crystals from the combination would be expected to have these properties. It should be noted that no X-ray diffraction peaks are present in these claims.
With respect to claims 17-19, at least Urbanus and Ramachandran teach isolating from fermentation. Since the crystals are isolated there is necessarily a cell removal step and crystallization itself is a purifying step. Isolation of crystals would require them to be filtered from solution. Further, as taught in for example Mersmann, one would concentrate in order to supersaturate and expect crystallization. Still further, Urbanus teaches overlapping windows of fermentation and crystallization.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4, 6, 9-11, 13, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18569334 (’334 application) as evidenced by Mersmann. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘334 application recite a process for recovering 3-hydroxypropoinic acid including forming crystals, adding an alkali metal sat, overlapping concentrations, overlapping hydroxides of calcium and magnesium, overlapping structural formulas (claim 8), particle sizes (claim 10), fermenting a bacterium strain (claim 12), slurry and precipitate (claim 14). The claims of the ‘334 application also recite an additional step of adding ammonia, which is not required by the instant claims and/or the “ammonia” contains ammonium cations which can form the acid. Further, the ‘334 application recites fermenting, and the background radiation would be expected to have similar properties, and the crystal properties would also be expected to overlap with the instant crystals.
With respect to particle sizes and concentrations of water, the claims of the ‘334 application fail to explicitly recite particle sizes or Karl Fischer numbers.
However, Mersmann provides evidence that such limitations fall under routine experimentation. Further, the Karl Fischer numbers relate to the amount of solvent concentration remain in the crystals which is a concentration issue. Thus, it would have been prima facie obvious to on having ordinary skill in the art to arrive at particle sizes and distributions because these are routine experimentation to the chemist.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-4, 6, 9-11, 13, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18570184 (’184 application) as evidenced by Mersmann. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘184 application recite a process for recovering 3-hydroxypropoinic acid including forming crystals, adding an alkali metal salt, overlapping concentrations, overlapping hydroxides of calcium and magnesium, fermenting a bacterium strain (claim 11), calcium and magnesium (claim 18), particle sizes (claim 19). Further, the ‘184 application recites fermenting, and the background radiation would be expected to have similar properties, and the crystal properties would also be expected to overlap with the instant crystals.
With respect to particle sizes and concentrations of water, the ‘184 application fail to explicitly recite particle sizes or Karl Fischer numbers.
However, Mersmann provides evidence that such limitations fall under routine experimentation. Further, the Karl Fischer numbers relate to the amount of solvent concentration remain in the crystals which is a concentration issue. Thus, it would have been prima facie obvious to on having ordinary skill in the art to arrive at particle sizes and distributions because these are routine experimentation to the chemist.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1. 3-4, 6, 9-11, 13, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-18 of copending Application No. 18571995 (’995 application) as evidenced by Mersmann. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘995 application recite a process for recovering 3-hydroxypropoinic acid including forming crystals, adding an alkali metal salt, concentrations, overlapping hydroxides of calcium and magnesium, fermenting a bacterium strain (claim 17), calcium and magnesium (claim 14). It should be noted that the instant claims do not require a specific solvent so a “non-solvent” or organic solvent also reads on the instant claims. Further, claim 18 of the ‘995 application recites that the crystals are converted to the free acid. Further, the ‘995 application recites fermenting, the background radiation would be expected to have similar properties, and the crystal properties would also be expected to overlap with the instant crystals.
With respect to particle sizes and concentrations of water, the claims of the ‘995 application fail to explicitly recite particle sizes or Karl Fischer numbers.
However, Mersmann provides evidence that such limitations fall under routine experimentation. Further, the Karl Fischer numbers relate to the amount of solvent concentration remain in the crystals which is a concentration issue. Thus, it would have been prima facie obvious to on having ordinary skill in the art to arrive at particle sizes and distributions because these are routine experimentation to the chemist.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-4, 6, 9-11, 13, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18571983 (’983 application) as evidenced by Mersmann. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘983 application teach a process for recovering 3-hydroxypropoinic acid including forming crystals, adding an alkali metal salt, concentrations, overlapping hydroxides of calcium and magnesium, fermenting a bacterium strain, reducing moisture content (overlapping water content, claim 14 for example), particle sizes and isotope content (claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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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/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621