Office Action Predictor
Application No. 17/281,732

Amorphous Form of Chelating Agents and Process for Preparing them

Final Rejection §102§103
Filed
Mar 31, 2021
Examiner
MURESAN, ANA Z
Art Unit
1692
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hovione Scientia Limited
OA Round
4 (Final)
76%
Grant Probability
Favorable
5-6
OA Rounds
2y 4m
To Grant
99%
With Interview

Examiner Intelligence

76%
Career Allow Rate
527 granted / 698 resolved
Without
With
+43.6%
Interview Lift
avg trend
2y 4m
Avg Prosecution
42 pending
740
Total Applications
career history

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
39.6%
-0.4% vs TC avg
§102
20.1%
-19.9% vs TC avg
§112
26.3%
-13.7% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§102 §103
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 Office action is responsive to Applicant's Remarks and Amendment after Non-Final Rejection, filed August 04, 2025. As filed, Claims 1, 7, 12-17, 19-26, 29-32 are pending are pending of which claims 1 and 17 are amended; claims 22-25 are new. Claims 7, 12-20 were withdrawn from consideration. Claims 2-6, 8-11, 18, 27, 28 are cancelled. New claims 29-32 read on the elected species. Claims 7, 12-20, 23-25 are withdrawn from further consideration. Response to Remarks Applicant’s amendments have been fully considered and are entered. The status for each rejection and/or objection in the previous Office Action is set out below. The rejection of claim 1 under 35 U.S.C. § 102(a)(1) and 102(a)(2) over US 4636336 is maintained. Applicant's arguments filed 8/04/2025 have been fully considered but they are not persuasive. Applicant's arguments on page 8 and further that PNG media_image1.png 200 400 media_image1.png Greyscale ”(Remarks page 9) have been carefully considered but these were not found persuasive. As noted before and reiterated herein, the prior art by the ‘336 patent specifically teach ethylenediamine sodium salt which corresponds to same compound sodium edetate (Na-EDTA), as required by instant claims. The compound Na-EDTA indexed in the CAS Registry data base. Products of identical chemical composition cannot have mutually exclusive properties. Given that the ‘336 patent teach that : a) sodium edetate which is same sodium ethylenediamine compound indexed as CAS RN 139-33-3 in the Registry Data base - same compound as instantly claimed and b) said compound is free of any additional compounds or a support matrix- therefore the prior art meets the limitation of instant claims. The missing descriptive matter -amorphous form- would be recognized by one of ordinary skill in the art as inherent property derived from the chemical makeup of instantly claimed compound. The prior art is silent as to some characteristics such as amorphous form of compound but the absence of such data does not necessarily mean that the prior art compound were of different physical form and characteristics. In the end, the instant application and the prior art are directed to compound Na-EDTA and one skilled in the art may assume that since the compounds are the same one would expect them to have the same properties. Note: the compound CAS RN 139-33-3 is cited in additional in 38K references. The compound of the prior art has the same structure and chemical formula as compound of instant claims. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the compound of the prior art does not possess the same material, structural and functional characteristics of the claimed compound Na-EDTA. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed compound Na-ETDA is of different form compared to the compound taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).The rejection is still deemed proper and is thus maintained. The rejection of claim 1 under 35 U.S.C. § 103 as being unpatentable over US 4636336 by Gay et al, May 14, 2010 is maintained. Regarding Applicant’s arguments that claimed amorphous form has improved solubility, which supports patentability (Remarks page 11-12) these were carefully considered, but not found persuasive. In response it is noted that per MPEP 716.02 guidance:” Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).” In the instant case, increase in solubility of amorphous form compared to crystalline form is a known and expected/predictable property as demonstrated by the prior art. In this regards, preparation of both crystalline and amorphous forms of a compound and assessing the stability, formulation, solubility, bioavailability, hygroscopicity of crystallin and/or amorphous forms of a compound are known in the chemical art as evidenced by the article by Yu, Advanced Drug Delivery Reviews 48 (2001) 27–42 (cite din PROP-892 attached herewith). The ‘article by Yu teach that amorphous solids have higher solubility solubility, higher dissolution rate corresponding than the corresponding crystalline forms (excerpt below, see the entire article): PNG media_image2.png 200 400 media_image2.png Greyscale Therefore, contrary to Applicants assertion, the higher solubility property of amorphous compounds is predictable and expected to be higher compared to the corresponding crystalline forms. The Applicant has not shown evidence of substantially improved and unexpected results or properties between the instantly claimed amorphous forms of chelating agent EDTA and the prior art teaching the same compound(s) to establish patentability differences. Please note that if Applicant intends to rely on unexpected or unforeseen results, attention is invited to MPEP 716.02. Absent clear, convincing, side-by-side data demonstrating unobviousness vis-a-vis the prior art commensurate with the scope of protection sought and showing that the claimed amorphous forms of a known in the prior art chelating agent EDAT and its corresponding salt are distinct, the claims are considered prima facie obvious. This rejection is still deemed proper, and is therefore maintained. 3.The rejection of claims 1, 21, 26 under 35 U.S.C. § 103 as being unpatentable over US 7,629,333 by Stogniew et al. Dec. 8, 2009 (“the ‘333 patent”; cited in PTO-892 mailed 10/23/2024) in view of US 7,271,177 B2 is maintained/modified to incorporate newly added claims 29-30 for the same reasoned regarding predictability of amorphous forms compared to polymorphs as discussed above. Moreover, the ‘177 patent, specifically teach solubility studies of pharmaceutical compositions comprising crystalline versus amorphous forms of a compound, and shows improvement of 3 folds in solubility of amorphous forms compared to crystalline forms of an active compound ( col 2 lines 40-53; col 10 line 55; examples, Table 3). Therefore, the prior art relied upon, and knowledge generally available in the art before the effective filing date provide some suggestion that would have motivated the skilled artisan to prepared amorphous forms of EDTA and have expectation of success in increased solubility. Per MPEP 716.02 guidance:” Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).” In the instant case, increase in solubility of amorphous form compared to crystalline form is a known and expected/predictable property as demonstrated by the prior art. The rejection is still deemed proper and is thus maintained. The following are modified or new grounds of rejections necessitated by Applicants’ amendment, filed on 8/04/2025, wherein claim 1 has been amended, and new claims 29-32 are added. Claim Objections 1.Claim 1 is objected to for reciting “ a salt of any of one of the above" . The recitation should be deleted or changed to clarify what is intended by said limitation and what additional slats besides those already recited in the claims are claimed to avoid potential indefiniteness issues. 2. Claim 29 is objected to for reciting “European Pharmacopeia”. Appropriate correction is required. Claim Rejections - 35 USC § 102 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. (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 1.Claim 1 is rejected under 35 U.S.C. 102 (a)(1) and 102(a)(2) as being anticipated by US 4636336 by Gay et al, May 14, 2010 ( “the ‘336 patent”; cited by Applicants in IDS). The ‘336 patent teaches the anticipatory compound disodium ethylenediaminetetraacetic acid powder on col 3 lines 51-52 (see also claims 1, 3 and 7 of the cited reference). Reproduced below is the anticipatory compound - CAS RN 139-33-3 as disclosed in the CAS Registry data base: PNG media_image3.png 454 479 media_image3.png Greyscale Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See also MPEP § 2112.01. In the instant case, the prior art by the ‘336 patent specifically teach ethylenediamine disodium salt which corresponds to same compound sodium edetate (Na-EDTA), as required by instant claims. Given that the ‘336 patent teach: a) sodium edetate which is same ethylenediamine compound indexed as RN 139-33-3 in the Registry Data base - as instantly claimed and b) said compound is free of any additional compounds or a support matrix which limitations read; the prior art meets the limitation of instant claims. Regarding the missing descriptive matter - amorphous form- would be recognized by one of ordinary skill in the art as inherent property derived from the chemical makeup of instantly claimed compound, as such the prior art anticipates the limitations of instant claims. Because the solid sodium EDTA disclosed in the ‘336 patent must necessarily be crystalline or amorphous, one of ordinary skill in the art may reasonably infer that the inherent properties of amorphous sodium EDTA recited in the instant claims are also inherent in the solid sodium EDTA disclosed in the ‘336 patent. See also MPEP 2112:” Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The compound of the prior art has the same structure and chemical formula as compound of instant claims, and is disclosed as powder. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the compound of the prior art does not possess the same material, structural and functional characteristics of the claimed compound Na-EDTA. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed compound is of different form compared to the compound taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). Therefore, the prior art teach the limitations of instant claims. 2.Claims 29, 31, 32 are rejected under 35 U.S.C. 102 (a)(1) and 102(a)(2) as being anticipated by US 7,629,333 by Stogniew et al. Dec. 8, 2009 ( “the ‘333 patent”; cited in PTO-892 attached herewith). Claim interpretation: The recitation of instant claims "amorphous form", in absence of specific characterization data is merely understood, as the compound being in solid form. The ‘333 patent teaches composition comprising an amorphous aminoalkyl dihydrogen phosphorothioate, and of amifostine which corresponds to the active pharmaceutical ingredient of claim 29 and 32 in composition with the claimed compound ethylenediaminetetraacetic acid (EDTA) as excipient on col 5 line 1. Shown below is the compound as disclosed in Registry data base: RN 60-00-4 CAPLUS CN Glycine, N,N'-1,2-ethanediylbis[N-(carboxymethyl)- (CA INDEX NAME) PNG media_image4.png 304 314 media_image4.png Greyscale The EDTA compound of the prior art has the same structure and chemical formula as compound of instant claims, as part of amorph composition containing pharmaceutical ingredients. Regarding the solubility limitation of instant claim 29, it is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the solubility properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See also MPEP § 2112.01. Given that the ‘333 patent teach a) EDTA compound which is the same as the compound claimed indexed as RN 60-00-4 in the Registry Data base - as instantly claimed and b) said compound is free of any additional compounds or a support matrix (instant claim 31) which limitations read; as such the prior art meets the limitation of instant claims. Regarding the amorphous form limitation, the compound of the prior art has the same structure and chemical formula as compound of instant claims, and is disclosed as powder. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the compound of the prior art does not possess the same material, structural and functional characteristics of the claimed compound Na-EDTA. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed compound is of different form compared to the compound taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). 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 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 of this title, 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 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 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. 1. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over US 4636336 by Gay et al, May 14, 2010 ( “the ‘336 patent”; cited by Applicants in IDS). The ‘336 patent teaches the compound disodium ethylenediaminetetraacetic acid as chelating agent (same utility as instant application) on col 3 lines 51-52 (see also claim 3 and 7 of the cited reference). Example 1 on col 5-6 of the ‘336 patent teach drying a saline solution of EDTA to a solid product characterized as flowable powder which read on claimed amorphous EDTA and salt thereof. The compound of the prior art has the same structure and chemical formula as compound of instant claims, and is disclosed as flowable powder. Therefore, the prior art teaches the limitations of instant claims. per MPEP 716.02 guidance:” Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).” In the instant case, the prior art by the ‘336 patent specifically teach ethylenediamine salt which corresponds to same compound sodium edetate (2Na-EDTA), as required by instant claims, of high purity suitable for therapeutic applications. Shown below is the compound CAS RN 139-33-3 as disclosed by the ‘336 patent and indexed in the CAS Registry data base ( note RN 139-33-3 is cited in 38K references: PNG media_image3.png 454 479 media_image3.png Greyscale Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See also MPEP § 2112.01. Given that the ‘336 patent teach a) sodium edetate which is same ethylenediamine compound indexed as RN 139-33-3 in the Registry Data base - as instantly claimed and b) said compound is free of any additional compounds or a support matrix which limitations read; as such the prior art meets the limitation of instant claims. Furthermore, the missing descriptive matter -amorphous form- would be recognized by one of ordinary skill in the art as inherent property derived from the chemical makeup of instantly claimed compound, as such the prior art anticipates the limitations of instant claims. The difference between that taught by the ‘336 patent and that instantly claimed is that the prior art is silent regarding the amorphous form of EDTA disodium salt. While the prior art is silent as to some characteristics such as amorphous form of compound but the absence of such data does not necessarily mean that the prior art compound were of different physical form and characteristics. Regarding the amorphous form of a compound, it is noted that a novel or unobvious chemical product is identified first by its "chemical nature, i.e. elemental content and their ratios, i.e. the chemical identity. Because the solid sodium EDTA disclosed in the ‘336 patent must necessarily be crystalline or amorphous, one of ordinary skill in the art may reasonably infer that the inherent properties of crystalline or amorphous sodium EDTA recited in the instant claims are also inherent in the solid sodium EDTA disclosed in the ‘336 patent. Additionally, for a known compound with defined chemical structure to be patentable for a new form, it must have a patentability basis of an advantage in terms of stability, formulation, solubility, bioavailability, hydroscopicity, etc. Even if the product of the instant application and the prior art differ in “amorphous” form the mere difference in physical parameter does not offer any unexpected advantage of prior art product with the same chemical property and biological property i.e. a mere variation in physical property which flows naturally with the changing form. MPEP 2112.V states that, “once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference." In the instant case, given that the prior art teach the compound with the same structure and chemical formula as compound of instant claims, namely 2 ethylenediaminetetraacetic acid sodium salt (Na-EDTA) as chelating agent, one of ordinary skills in the art can conclude that the compound disclosed in the prior art and the instantly claimed compound appear to be identical and therefore the compound of prior art would have identical inherent properties. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the compound of the prior art does not possess the same material, structural and functional characteristics of the claimed compound Na-EDTA. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed compound sedum salt of ethylenediaminetetraacetic acid (Na-EDTA) is of different form compared to compound taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). In the end, the instant application and the prior art are directed to compound ethylenediaminetetraacetic acid sodium salt (Na-EDTA) and one skilled in the art may assume that since the compounds are the same one would expect them to have the same properties. Thus, the instant claims are prima facie obvious over the teachings of the prior art. 2. Claims 1 and 21, 26, 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 7,629,333 by Stogniew et al. Dec. 8, 2009 (“the ‘333 patent”; cited in PTO-892 mailed 10/23/2024) in view of US 7,271,177 B2, sept 2007, by Benjamin et al (the ‘177 patent; cited in PTO-892 attached herewith). The ‘333 patent teaches composition comprising an amorphous aminoalkyl dihydrogen phosphorothioate, and of amifostine which corresponds to the active pharmaceutical ingredient of claims 21, 26, 32 in composition with the claimed compound ethylenediaminetetraacetic acid (EDTA) as excipient on col 5 line 1. Shown below is the compound as disclosed in Registry data base: RN 60-00-4 CAPLUS CN Glycine, N,N'-1,2-ethanediylbis[N-(carboxymethyl)- (CA INDEX NAME) PNG media_image4.png 304 314 media_image4.png Greyscale Regarding instant claims 29—30, it is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See also MPEP § 2112.01. Given that the ‘333 patent teach a) EDTA compound which is the same as the compound claimed indexed as RN 60-00-4 in the Registry Data base - as instantly claimed and b) said compound is free of any additional compounds or a support matrix which limitations read; as such the prior art meets the limitation of instant claims. Furthermore, the missing descriptive matter -amorphous form and solubility properties- would be recognized by one of ordinary skill in the art as inherent property derived from the chemical makeup of instantly claimed compound, as such the prior art anticipates the limitations of instant claims. However, there is no reason to construe the silence as evidence of patentable distinctness. The Applicant has not shown evidence of substantially improved and unexpected results or properties between the instantly claimed compound EDTA and the prior art ETDA . Furthermore, the it is noted that a novel or unobvious chemical product is identified first by its "chemical nature, i.e. elemental content and their ratios, i.e. the chemical identity. Additionally, for a known compound with defined chemical structure to be patentable for a new form, it must have a patentability basis of an advantage in terms of stability, formulation, solubility, bioavailability, hydroscopicity, etc. In the instant case, preparation of both crystalline and amorphous forms of a compound and assessing the stability, formulation, solubility, bioavailability, hygroscopicity of crystallin and/or amorphous forms of a compound are known in the chemical art as shown by the ‘177 patent. The ‘177 patent, analogous prior art drawn to compositions containing EDTA as chelating agent shows aspects of solubility studies of pharmaceutical compositions comprising crystalline versus amorphous forms of a compound, and shows improvement of 3 folds in solubility of amorphous forms compared to crystalline forms of an active compound (col 2 lines 40-53; col 10 line 55; examples, Table 3). Therefore, the prior art relied upon, and knowledge generally available in the art before the effective filing date provide the suggestion that would have motivated the skilled artisan to prepared amorphous forms of EDTA and have expectation of success in increased solubility. Even if the product of the instant application and the prior art differ in X-ray diffraction or " amorphous form" the mere difference in physical parameter such as X-ray diffraction pattern does not offer any unexpected advantage of prior art product with the same chemical property and biological property i.e. a mere variation in physical property which flows naturally with the changing form. MPEP 2112.V states that, “once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference." See also Ex parte Anderson, 21 USPQ 2nd 1241 and 1251 "There is ample precedent for shifting burden to an Applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture.” Because the solid EDTA disclosed in the ‘333 patent must necessarily be crystalline or amorphous, one of ordinary skill in the art may reasonably infer that the inherent properties of crystalline or amorphous EDTA recited in the instant claims are also inherent in the solid sodium EDTA disclosed in the ‘333 patent. Given that the prior art teach the compound with the same structure and chemical formula as compound of instant claims, namely EDTA as chelating agent, as part of amorph composition containing pharmaceutical ingredients, therefore one of ordinary skills in the art can conclude that the compound disclosed in the prior art and the instantly claimed compound and compositions appear to be identical and therefore the compound of prior art would have identical inherent properties. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the compound of the prior art does not possess the same material, structural and functional characteristics of the claimed compound EDTA. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed compound ethylenediaminetetraacetic acid (EDTA) is of different form compared to EDTA taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). The prior art is silent as to some characteristics such as amorphous form of compound EDTA and X-ray diffraction pattern but the absence of such data does not necessarily mean that the prior art compound were of different physical form and characteristics. Nevertheless, the instant application and the prior art are directed to the same compound ethylenediaminetetraacetic acid (EDTA) and one skilled in the art may assume that since the compounds are the same one would expect them to have the same properties. Thus, the instant claims are prima facie obvious over the teachings of the prior art. Conclusion Claims 1, 21, 22, 26, 29-32 rejected. Claims 7, 12-20, 23-25 are withdrawn from further consideration. Conclusion In view of the rejections to the pending claims set forth above, no claim is 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 extension fee 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 date of this final action. Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to: Ana Muresan (571) 270-7587 (phone) (571)270-8587 (fax) Ana.Muresan@uspto.gov The examiner can normally be reached Monday - Friday (9:00AM - 5:30PM). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANA Z MURESAN/Primary Examiner, Art Unit 1692
Read full office action

Prosecution Timeline

Mar 31, 2021
Application Filed
Jul 11, 2024
Non-Final Rejection — §102, §103
Sep 11, 2024
Examiner Interview Summary
Sep 11, 2024
Applicant Interview (Telephonic)
Oct 16, 2024
Response Filed
Nov 09, 2024
Final Rejection — §102, §103
Feb 13, 2025
Request for Continued Examination
Feb 16, 2025
Response after Non-Final Action
Feb 27, 2025
Non-Final Rejection — §102, §103
Apr 08, 2025
Applicant Interview (Telephonic)
May 03, 2025
Examiner Interview Summary
Aug 04, 2025
Response Filed
Sep 12, 2025
Final Rejection — §102, §103
Apr 09, 2026
Response after Non-Final Action

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5-6
Expected OA Rounds
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Grant Probability
99%
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2y 4m
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