Prosecution Insights
Last updated: October 04, 2026
Application No. 18/023,086

METHODS OF PREPARING IRON COMPLEXES

Non-Final OA §103§112
Filed
Feb 24, 2023
Priority
Sep 29, 2020 — CN 202011055787.3 +2 more
Examiner
SAEED, ALI S
Art Unit
1616
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
LG Bionano LLC
OA Round
2 (Non-Final)
31%
Grant Probability
At Risk
2-3
OA Rounds
5m
Est. Remaining
67%
With Interview

Examiner Intelligence

Grants only 31% of cases
31%
Career Allowance Rate
41 granted / 131 resolved
-28.7% vs TC avg
Strong +36% interview lift
Without
With
+35.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
64 currently pending
Career history
205
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
45.6%
+5.6% vs TC avg
§102
7.7%
-32.3% vs TC avg
§112
23.4%
-16.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 131 resolved cases

Office Action

§103 §112
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 . Priority Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN 202011055787.3 and CN202011055789.2, filed on 2020-09-29. Information Disclosure Statement The IDS filed on 7/20/2026 has been fully considered with all the references. See the attached PTO 1449 forms. IDS filed on 09/02/2025 has been considered, however NPL reference cited “Setkina et al.,” was not considered because copy of the reference was not provided. Applicant in the remarks stated the reference was submitted on 9/2/2025 and a copy of the reference is submitted again. In response, the reference submitted does not have an English translation. The examiner requests the applicant provide an English translation for consideration of the reference. Status of Action/Claims Receipt of Remarks/Amendments filed on 4/30/2026 is acknowledged. Claims 1, 4-31 are currently pending in this application. Claims 22-27, 30-31 have been withdrawn. Accordingly, claims 1, 4-21, 28-29 are presented for examination on the merits for patentability. Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application. Note: This is a second non-final office action that is prompted by further consideration of the instant claims and the prior art. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 28 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 28 recites “or a mixture thereof” in line 3. It is unclear mixture of which components is this mixture referring to. It is unclear if it is referring to a mixture of iron hydroxide suspension and a carboxylated carbohydrate, carboxylated carbohydrate mixed with another component, or a mixture of some other components. The claims do not clarify mixture of which components is the limitation “or a mixture thereof” in line 3 referring to. Claim 29 is rejected because it depends on claims that are indefinite as discussed above, and does not clarify the issues, and thus is also rejected under 35 U.S.C. 112(b). Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claims 1, 5-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/094202 A2 (Newton, published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024). Regarding Claim 1 Newton, throughout the reference, teaches making ferric hydroxide complex. (e.g. Abstract). Newton teaches preparation of ferric hydroxide (reads as iron hydroxide of instant claim 1) including steps of: dissolving ferric salt in aqueous medium (e.g. pg. 14, line 9-10+), adding first base (e.g. Pg.14, line 4-10+) to obtain pH 2-2.5 (Pg.14, line 26-27+). In general, given the ordinary and customary meaning of the term “about” in this art, it would be roughly ± 10% which would make the end point of pH 2.5 to pH 2.7. therefore, pH 2.75 reads on the claimed genus of range 2.7-2.8 of the instant claim 1. Newton also teaches adding second base to form a suspension (Pg. 14, lines 15-16+; Pg.15, lines 9-13+) to obtain pH 3.5-9 (Pg.15, line 10-11+). Here, the amount of second base added until pH 3.5 according to Newton, reads on second base of instant claim 1 and the additional amount of second base added above pH 3.5 according to Newton, reads on addition of third base of instant claim 1. The pH 3.5 reached by addition of second base taught by Newton reads on the claimed genus of pH 2.8-3.8 in instant claim 1. Similarly, the end point pH 9 reached by adding additional second base above pH 3.5, reads on the claimed genus of pH 5-9 in the instant claim 1. (See MPEP § 2131.03) Newton also teaches the resultant ferric hydroxide precipitate (reads as polynuclear iron hydroxide of instant claim 1) is filtered and washed (reads as purified) (Pg.15, lines 20-25+). Newton teaches all the bases were added while maintaining temperature from about 20 ̊ to 30 ̊C (pg.15, line 1) which reads as all the bases were added at temperature from about 20 ̊ to 30 ̊C. The temperature range taught by Newton reads on the claimed temperature range of between 15 °C and 50 °C in the instant claims. (See MPEP § 2131.03). Regarding Claim 5 Newton teaches sodium carbonate as first and second base (Pg.14, lines 4-8; exemplary preparation on pg.23, lines 5, 12-15). Second base taught by Newton also reads on third base of instant claim 5, as explained supra. Regarding Claim 6 Newton teaches first and second bases are (30% W/V solution) sodium carbonate (Pg.14, lines 4-8+; exemplary preparation on pg.23, lines 5, 12-15+) and further in the exemplary preparation, teaches first base can be aqueous solution of 25% W/V Na2CO3 (Pg.26, lines 20-23+). The mass percent of 25% W/V Na2CO3 reads on the claimed range of 1 % to 25% Na2CO3 of instant claim 6. (See MPEP § 2131.03). Regarding Claim 7 Newton teaches ferric salt is selected from Fe (NO3)3 and FeCl3. (Pg.14, lines 1-3). Regarding Claim 8 Newton teaches solution of 5 g of ferric chloride hexahydrate (reads as ferric salt) dissolved in 20 mL water which is calculated as 25% W/V (Pg.34, lines 25-26). The mass percentage of 25% W/V taught by Newton reads on claimed genus of mass percentage of 5% to 60% in the instant claim 8. (See MPEP § 2131.03). Regarding claim 9 Newton teaches mixing purified ferric hydroxide (reads as iron hydroxide) and sucrose (reads as carbohydrate, pg.16, lines1-2+). Newton teaches that pH of mixture of ferric hydroxide and sucrose can be adjusted to between 6.5-13 (Pg.47, claim 42). The pH range of 6.5-13 taught by Newton reads on the claimed range of pH 7.5-13. Newton also teaches heating the mixture at 100-105°C (exemplary preparation on pg.23, lines 25-26+). The temperature range of 100-105°C reads on the claimed genus of temperature range of 60°C - 125°C in the instant claim 9. Newton teaches the process of mixing ferric hydroxide and sucrose at pH and temperature taught by Newton as above, produces iron sucrose complex containing 1 to 60% ferric ion by Wt. (Pg.49-50, claims 54-57) which is calculated as 1:99 to 60:40. The ratio of 60:40 translates to 1.5 of Ferric ion to Sucrose which is same as 150:100. Thus, calculated mass ratio of 150:100 reads on the claimed mass ratio between iron and carbohydrate of (1-1100): 100 in the instant claim 9(See MPEP § 2131.03 I). Regarding Claim 10 Newton further teaches use of sucrose which is monosaccharides (Pg.16, lines 1-2) Regarding Claim 11 Newton teaches 20% W/V of NaOH solution is added to carbohydrate mixture (exemplary preparation on pg.23, lines 26-27+). The 20% concentration of NaOH taught by Newton reads on the claimed genus of 10% to 25% and 5% to 50% NaOH in the instant claim 11. (See MPEP § 2131.03) Regarding Claim 12 Newton teaches pH of the carbohydrate mixture is adjusted with 20% W/V sodium hydroxide (exemplary preparation on pg. 23, lines 26-27), in range of pH 6.5-13 (claim 42), the mixture is heated at 100-105°C for 2 hours (exemplary preparation onpg.23, lines 25-26). The higher point of pH 13 taught by Newton reads on the claimed genus of pH 10-13.5 in the instant claim 12. The temperature range of 100-105°C as taught by Newton reads on the claimed temperature range 80°C - 125°C in the instant claim 12. The heating time of 1-50 hours of the claimed invention overlaps the heating time of 2 hours taught by Newton. (See MPEP § 2131.03) Regarding Claim 13 Newton teaches molar ratio of sucrose to ferric hydroxide is 1:2 to 1:50 (claim 28). Molar ratio of 1:50 is calculated as 1:15.6 by mass which reads on the claimed ratio of 1: (13-17) in instant claim 13. (See MPEP § 2131.03) Regarding Claim 14 Newton teaches mixing purified ferric hydroxide (same as iron hydroxide) and sucrose (carbohydrate) (Pg.16, lines1-2), adjusting pH with 20% W/V sodium hydroxide (exemplary preparation on pg.23, lines 26-27), in range of 6.5-13 (Pg. 46, claim 42). The lower end-point of pH 6.5 as taught by Newton reads on the claimed genus of pH range of 5.5-11 in the instant claim 14. (See MPEP § 2131.03) Regarding Claim 15 Newton teaches pH modifier used for adjusting pH of ferric hydroxide-sucrose complex is NaOH (exemplary preparation on pg. 23, lines 26-27). Regarding Claim 16 Newton teaches drying of purified iron sucrose complex suspension at 25-140°C temperature (pg. 18, lines 8-12). Regarding Claim 17 Newton teaches preparation of iron sucrose complex where the average molecular weight is about 55,000 Daltons and does not explicitly teach presence of free ferric ions which reads on absence of free ferric ions (exemplary preparation on pg. 23-24, lines 2-4). Newton also teaches weight average molecular weight of the sucrose complex is in range of 30,000 to about 60,000 Daltons (pg. 4, lines 10-13). T75 reaction rate is intrinsic chemical property of complex dependent on it size or molecular weight, therefore, complex prepared by newton method in molecular weight range of 30k to 60 k would exhibit predictable T75 rates of 35 min or less. Regarding Claim 18 Newton teaches that pH of carbohydrate mixture is adjusted with 20% W/V sodium hydroxide (exemplary preparation on pg. 23, lines 26-27), where in the pH value is in range of 6.5-13 (claim 42), heating the mixture at 100-105°C for 2 hours (exemplary preparation on pg.23, lines 25-26). The range of pH 6.5-13 taught by Newton reads on the claimed pH 7.5-13 in the instant claim 18. The heating time of the mixture of the claimed invention overlaps the heating time of 2 hours as taught by Newton. (See MPEP § 2131.03) Regarding Claim 21 Newton teaches that pharmaceutical composition of invention may be formulated as tablet, capsule, powder (pg. 19, lines 10-11). Newton also teaches exemplary injectable parenteral formulation of iron sucrose complex (pg. 19, lines 1-5). Regarding Claim 19 Newton teaches that pH of carbohydrate mixture is adjusted with 20% W/V sodium hydroxide (exemplary preparation on pg.23, lines 26-27) to 6.5-13 (claim 42) and the mixture is heated at 100-105°C for 2 hours (exemplary preparation on pg.23, lines 25-26). The higher end point of pH 13 taught by newton is prima facie obvious over the claimed pH range 9-12.5 in the instant claim 19. (See MPEP § 2144.05 I) The temperature range of 100-105°C and heating time of 2 hours taught by Newton reads ib the claimed temperature range of 65°C - 121 °C and the heating time of 0.2 hours to 30 hours respectively, in the instant claim 19. (See MPEP § 2131.03). Newton teaches molar ratio of sucrose to ferric hydroxide is 1:2 to 1:50 (claim 28) which is calculated as 1.59:1 to 1:15.6 by mass. The calculated ratio of sucrose to ferric hydroxide (1:15.6) in the prior art is prima facie obvious over the mass ratio (1:24) of the claimed invention. (See MPEP § 2144.05 II(A)). Regarding Claim 20 Newton teaches exemplary parenteral formulation of iron sucrose complex dissolved in 20% aqueous solution (pg. 19, lines 25-30). Newton also teaches iron concentration in the iron-carbohydrate complex is 1-50% (claim 55) which overlaps with the claimed range of 10% - 47% in the instant claim 20. Prima facie obviousness exists for the range taught by Newton over the claimed range (See MPEP § 2144.05 (I)). Newton further teaches the sodium salts such as sodium chloride less than 10% wt/wt (Pg.18, lines 15-17) which is prima facie obvious over chloride ion less than 1% and 0.1% as claimed in the instant claim 20. (See MPEP § 2144.05) "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Newton teaches a process of making ferric hydroxide product as discussed supra. Newton teaches that the reaction mixture was allowed to equilibrated for about 10 minutes before adding the second base and also for about 5-60 minutes after addition of second base (see e.g. Pg.14-15). Equilibration time of 10 minutes and 5-60 minutes taught by Newton reads on claimed genus of equilibration time 1 minute to 15 minutes and 2-60 minutes of instant claim 1. Newton does not explicitly state adding a third base solution to adjust the pH of the iron hydroxide suspension after equilibration of the suspension to which second base has been added. As discussed supra, the amount of second base added until pH 3.5 according to Newton reads on second base of instant claim 1 and the amount of base added above pH 3.5 according to Newton reads on addition of third base of instant claim 1. Newton also teaches that the second base is added at suitable addition rates from about 0.02 to 0.2 equivalents of base per minute (Pg.15, lines 5-8+). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the instant application to add a third base solution to adjust the pH of the iron hydroxide suspension after equilibration of the suspension to which second base has been added. Newton explicitly teaches the steps of adding first and second base solution and equilibrating the mixture after each base solution is added and Newton teaches the desired pH after the bases have been added is selected from a pH ranging from 3.5 to 9. It would have been obvious to one skilled in the art to simply perform another step of adding a base solution (e.g. third base solution) to achieved a pH which ranges from 3.5 to 9. Absence any evidence of unexpected effect of adding base solution three times (as claimed) versus two times (as disclosed in Newton), a prima face case of obviousness exists to replicate another step of adding a base solution (e.g. third base solution) to get to a pH which is desired. See MPEP: 2144. Claims 1, 4, 5-21 are rejected under 35 U.S.C. 103 as being unpatentable by WO 2005/094202 A2 (Newton, published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024) as evidenced by lab procedures in University of Richmond lab manual (Vacuum Filtration/Organic Chemistry I Lab, CHEM-205, Spring 2023). The teachings of Newton regarding claims 1 and 5-21 have been set forth above. Newton teaches a process of making ferric hydroxide product as discussed supra. Regarding claim 4, Newton teaches ferric hydroxide suspension was washed with water using vacuum filtration system e.g., for example through a Buchner funnel. (Pg.15, line 20-25+). The removal of water is resultant action of vacuum filtration process. Therefore the purification steps taught by Newton inherently teaches removing water and concentrating ferric hydroxide suspension. It is evidenced by chemistry lab procedures in University of Richmond lab manual (Vacuum Filtration/Organic Chemistry I Lab, Spring 2023; hereinafter referred to as CHEM205), that when using vacuum filtration system with Buchner funnel to purify the chemical reaction product, the product is washed and subsequently dried (concentrated) by allowing to sit on the filter while vacuum is on. (CHEM205, page 2, paragraph 3). It would have been obvious for a person of ordinary skills in the art before the effective filing date of the instant application to concentrate the iron hydroxide suspension after washing by removing water to determine the concentration. Newton does not explicitly teach the concentration of iron hydroxide of 3 wt% to 16 wt%. However, the resulting concentration of iron hydroxide produced from a reaction is dependent on the amount of the reactant used. It would be obvious to a person of ordinary skills in the art to carry out routine experiments and reach to the instantly claimed concentrations. Newton does not disclose formation of any residual chlorine when iron hydroxide is prepared. Therefore, it reads on “less than 1% or 0.1%” in instant claim 4. Claims 1, 4-21 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/094202 A2 (Newton et. al., published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024) as applied to claims 1 and 4-21 above, and further in view of US 2003/0216566 A1 (Durga et.al) published 11/20/2003. Newton, throughout the reference, teaches making ferric oxide complexed with carbohydrate, as discussed supra. Newton teaches mixing purified ferric hydroxide (reads as iron hydroxide) and sucrose (carbohydrate) (Pg.16, lines1-2) and heating the mixture at 100-105°C (which reads on temperature range of 65°C - 125°C of instant claim 28) for 2 hours which reads on heating time of 5 minutes to 10 hours in instant claim 28 (exemplary preparation on pg.23, lines 25-33). Newton further teaches molar ratio between iron and sucrose (reads as carbohydrates) is from 1: 2 to about 1: 50 (Pg.44, claim 28). The molar ratio between iron and sucrose of 1:2 taught by Newton reads on the ratio of 1:(0.3-5) in the instant claim 28. Newton does not explicitly teach mixing carboxylated carbohydrate with iron hydroxide claimed in instant claim 28. Newton also does not teach gluconate as claimed in instant claim 29. Durga teaches preparation of sodium ferric gluconate by mixing ferric oxyhydroxide with sodium gluconate and heating up to about 70-80°C for 2 hours (pg. 2, [0044], lines 7-13). Durga also teaches the ratio of ferric oxyhydroxide to sodium gluconate is 2:1 (Pg. 2, [0044], lines 11-13). Durga discloses in the background of invention that ferric gluconate complex is known for 40 years and been used as an injectable for treating iron deficiencies in humans. Durga also discloses that ferric gluconate complex has several advantages over other iron complexes including low toxicity, low adverse reaction, and satisfactory rate of absorption ([0002]). Newton discloses in the background of invention iron complexes such as iron dextran complex has been associated with significant side effects. (pg.1, lines 29-31) and proposed iron sucrose complex comprising narrower molecular weight distribution to achieve safe and efficient therapy. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the instant application to substitute carbohydrate in the iron carbohydrate complex preparation of Newton et.al., with the carboxylated carbohydrate specifically gluconate used in the iron carbohydrate complex preparation by Durga et.al. to obtain the iron gluconate complex of invention claimed in the instant application, because both Newton and Durga teach complexing different carbohydrates with ferric oxide or ferric hydroxide are routine and known in the art. In addition, Durga teaches the advantage of using gluconate (a carboxylated carbohydrate) to complex with the ferric oxyhydroxide such as provide low toxicity low adverse reaction, and satisfactory rate of absorption. Thus, one of skilled in the art would be motivated to using gluconate to complex with ferric hydroxide for the desired pharmaceutical application. A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Newton have demonstrated making ferric hydroxide complex with carbohydrate is routine and known in the art. Response to Arguments Applicant argued that Newton teaches addition of the second base to the reaction mixture is continued until pH of the reaction is in the range from about 3.5 to about 9. The second base addition in Newton is not divided into two separate base additions. Claim 1 also requires an equilibration time of 1 minutes to 15 minutes before adding the second base and an equilibration time of 2 minutes to 60 minutes before adding the third base. Newton does not teach such limitations. In response, as discussed supra, Newton teaches that the reaction mixture was allowed to equilibrated for about 10 minutes before adding the second base and also for about 5-60 minutes after addition of second base (see e.g. Pg.14-15). Equilibration time of 10 minutes and 5-60 minutes taught by Newton reads on claimed genus of equilibration time 1 minute to 15 minutes and 2-60 minutes of instant claim 1. Newton does not explicitly state adding a third base solution to adjust the pH of the iron hydroxide suspension after equilibration of the suspension to which second base has been added. However, as discussed supra, the amount of second base added until pH 3.5 according to Newton reads on second base of instant claim 1 and the amount of base added above pH 3.5 according to Newton reads on addition of third base of instant claim 1. It would have been obvious for a person of ordinary skill in the art to add a third base solution to adjust the pH of the iron hydroxide suspension after equilibration of the suspension to which second base has been added. Newton explicitly teaches the steps of adding first and second base solution and equilibrating the mixture after each base solution is added and Newton teaches the desired pH after the bases have been added is selected from a pH ranging from 3.5 to 9. It would have been obvious to one skilled in the art to simply perform another step of adding a base solution (e.g. third base solution) to achieved a pH which ranges from 3.5 to 9. Absence any evidence of unexpected effect of adding base solution three times (as claimed) versus two times (as disclosed in Newton), a prima face case of obviousness exists to replicate another step of adding a base solution (e.g. third base solution) to get to a pH which is desired. See MPEP: 2144. Applicant argued that to optimize safety and efficacy, iron sucrose complex nanoparticles each should have an appropriate particle size, and it has been found that useful iron hydroxide sucrose complex nanoparticles each have a weight molecular weight in the range of 32,000 to 60,000 daltons, and this range is required for certification of injectable iron nanoparticles products by US pharmacopeia (USP). It was argued that Newton teaches polynuclear iron sucrose complexes prepared from the iron hydroxide suspension had weigh average molecular weights of 55,000 Da (example 1 with pH of 4), 65,000 Da (example 3 with pH of 7) and 90,000 Da (example 4 with pH of 8.3). Thus, Newton clearly teaches polynuclear iron sucrose complexes prepared from the iron hydroxide suspension made with a pH endpoint greater than 4 are above the upper limit of 60,000 Da. It was argued that iron oxide product of claim 1, with a final pH of 5-9, can be used to make polynuclear iron sucrose complexes falling within the recommended weight average molecular weight range. Applicant pointed to specification examples 1-3 to argue that an iron hydroxide suspension produced by the three step base addition method with a final pH of 5 had a weight average molecular weight of 46,700 Da. In response, the examiner argues that in example 1 of Newton, the ferric salt used is ferric chloride. In example 2 of Newton, ferric salt used was ferric nitrate which gave weight average molecular weight of 45,000 Daltons. In example 9 of Newton, second base addition was continued until the pH reached 7, which gave the weight average molecular weight of about 60,000 Daltons. These results in Newton suggest that the type of ferric salt used affects the weight average molecule weight achieved and example 9 of Newton, where second base addition was continued until the pH reached 7, suggests that even a pH greater than 4 (i.e. pH of 7) gave weight average molecular weight of about 60,000 Daltons, which is within the claimed weight. Thus, it cannot be concluded from Newtons examples that simply a pH greater than 4 after addition of second base leads to weight average molecular weight of greater than 60,000 Da because Newtons results suggest that the type of salt used or the type of base solution used affects the weight average molecular weight and example 9 of Newton suggests even a pH endpoint of 7 after second base solution yielded weight average molecular weight of 60,000 Da. The examples disclosed in the instant specification do not provide any single comparative data which compares the three step base addition with two step base addition, with all other variable being the same. Thus, applicant’s argument that the three base addition method step provides the claimed weight average molecular weight and this is an unexpected effect is not persuasive at this time. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI SAEED whose telephone number is (571)272-2371. The examiner can normally be reached M-F 8-5 EST. 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, SUE X LIU can be reached at 5712725539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ALI S SAEED/ Examiner, Art Unit 1616
Read full office action

Prosecution Timeline

Feb 24, 2023
Application Filed
Feb 05, 2026
Non-Final Rejection mailed — §103, §112
Apr 30, 2026
Response Filed
Aug 27, 2026
Non-Final Rejection mailed — §103, §112 (current)

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