Prosecution Insights
Last updated: September 17, 2026
Application No. 18/557,294

PHOSPHOLIPID PROCESSING AID AND APPLICATION THEREOF

Non-Final OA §112
Filed
Mar 22, 2024
Priority
Apr 27, 2021 — CN 202110462040.8 +1 more
Examiner
RHOADES, DEREK JAMES
Art Unit
Tech Center
Assignee
Shanghai Taiwei Pharmaceutical Corp. Ltd.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
1y 1m
Est. Remaining
87%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allowance Rate
56 granted / 78 resolved
+11.8% vs TC avg
Strong +15% interview lift
Without
With
+15.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
25 currently pending
Career history
90
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
43.0%
+3.0% vs TC avg
§102
14.3%
-25.7% vs TC avg
§112
23.0%
-17.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 78 resolved cases

Office Action

§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 . Claim Status Claims 1-12 are pending. Claims 1-10 have been amended. No claims have been cancelled. Claims 11-12 have been newly added. Thus, claims 1-12 represent all claims currently under consideration. Priority Domestic Priority data as claimed by Applicant: This application is a 371 of PCT/CN2021/100554 (06/17/2021) Foreign Applications: CHINA 202110462040.8 (04/27/2021) Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Specification The disclosure is objected to because of the following informalities: On page 1, line 13 (0002), “The iron iron content” should read “The iron content”. On page 10, line 19 (0047), “2nm-1” should read “2nm-1”. Appropriate correction is required. Claim Objections Claim 6 is objected to because of the following informalities: In line 2, “the active phospholipids” should read “active phospholipids”. Claim 10 is objected to because of the following informalities: In line 6, “0.5-2nm-1” should read “0.5-2nm-1”. 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. Claims 7-8, 10, and 12 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “wherein sodium hydroxide or potassium hydroxide is added to the soybean oil sediments or the raw water”, and the claim also recites “preferably, the weight of the sodium hydroxide or potassium hydroxide is 0.01%-0.5% of the weight of the soybean oil sediments” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “wherein the settling is natural settling or centrifugal settling”, and the claim also recites “preferably, the separation factor of the centrifugal settling is 1000-4000g” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. Claim 10 recites the phrase “oil-like polarized texture” in line 4. However, this phrase is vague and subjective and it is unclear as written as to what constitutes an “oil-like polarized texture”. The specification (page 10, 0046 and page 12, 0053) and Fig. 2 do not adequately define this term, and this ambiguity renders the instant claim indefinite. Claim 10 recites the phrase “sensory index” in line 5. However, it is unclear how this term is defined and how the “sensory index” is determined. The specification (page 11, 0050) does adequately remedy this deficiency, and this ambiguity renders the instant claim indefinite. Claim 10 recites the phrase “obvious Bragg scattering peak” in lines 6-7. However, it is unclear as written as to what constitutes an “obvious Bragg scattering peak”. The specification (page 10, 0047 and page 12, 0054) and Fig. 3 do not adequately define this term, and this ambiguity renders the instant claim indefinite. Claim 12 recites the phrase “oil-like polarized texture” in line 4. However, this phrase is vague and subjective and it is unclear as written as to what constitutes an “oil-like polarized texture”. The specification (page 10, 0046 and page 12, 0053) and Fig. 2 do not adequately define this term, and this ambiguity renders the instant claim indefinite. Claim 12 recites the phrase “sensory index” in line 5. However, it is unclear how this term is defined and how the “sensory index” is determined. The specification (page 11, 0050) does adequately remedy this deficiency, and this ambiguity renders the instant claim indefinite. Claim 12 recites the phrase “obvious Bragg scattering peak” in line 6. However, it is unclear as written as to what constitutes an “obvious Bragg scattering peak”. The specification (page 10, 0047 and page 12, 0054) and Fig. 3 do not adequately define this term, and this ambiguity renders the instant claim indefinite. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 recites “A process of preparation of active phospholipid lamellar liquid crystal or active phospholipids, using the phospholipid processing aid prepared by the preparation method as claimed in claim 3 in the preparation of active phospholipid lamellar liquid crystals or active phospholipids.” The instant claim requires the active step of using the phospholipid processing aid, a product of base method claim 3. However, since claim 3 recites a method of making a specified product (i.e., a phospholipid processing aid), a claim to the product set forth in claim 3 would not be a proper dependent claim if the product can be made by a method other than that recited in the base method claim, and thus, does not include the limitations of the base claim. See MPEP § 608.01(n)(III). Therefore, the instant claim fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements. Subject Matter Free From the Prior Art Claims 1-5 and 7-8 appear to be free from the prior art. Claims 6 and 9-12 appear to be free from the prior art and could be allowable if rewritten or amended to overcome the objections to claims 6 and 10, the rejections of claims 7-8, 10, and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and the rejection of claim 11 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, set forth in this Office Action. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or suggest a phospholipid processing aid as recited in instant claim 1. Exemplary prior art includes: Guan et al. (CN107325125A; IDS of 03-22-2024; published 11-07-2017; English language machine translation obtained from Espacenet on 09-03-2026), who teaches a method for preparing hydrated phospholipid from soybean oil sediment and hydrated phospholipids prepared with the method. The method is characterized by taking soybean oil residue, adding softened water and mixing evenly, then allowing it to stand for chromatography. After chromatography, controlling the temperature at 85-95 ºC, and centrifuging to obtain hydrated phospholipids. Before chromatography, the mixture of soybean oil residue and softened water was heated to 60-95 ºC at a rate of 2-5 ºC/min (Title; Abstract; claims 1 and 3; 0008-0009, 0013; English language machine translation). Example 2 of Guan teaches a hydrated phospholipid prepared from soybean oil residue obtained by the following method. Step (1) comprises taking soybean oil residue and adding softened water and sodium hydroxide and mix evenly in a reaction tank. The mass ratio of softened water to soybean oil residue is 0.59:1. The weight ratio of sodium hydroxide to soybean oil residue is 0.5%. The mixture was heated to 75 ºC, kept at this temperature and allowed to stand for 4 hours for chromatography. After chromatography, the material temperature was kept at 75 ºC and centrifuged at 3000r/min. The resulting hydrated phospholipids were then placed in a storage tank. Step (2) add 3% hydrogen peroxide and 0.1% potassium sorbate by mass of hydrated phospholipids to the storage tank and stir evenly. Then concentrate the solution using a thin-film evaporator at 85 ºC and a vacuum of -0.1 to -0.07 MPa to control the moisture content at around 20%. Step (3) After sealing the concentrated hydrated phospholipids in a sealed package, sterilize them with hot water at 90 ºC for 30 minutes (0035-0041; Example 1; English language machine translation). Guan does not teach a phospholipid processing aid comprising a hydrolysate of impurity components that is ionized in water, as recited in instant claim 1. Although the method of Guan has overlapping features with that of the claimed invention, including heating soybean oil sediments in water, allowing the reaction to stand without stirring, and settling the reaction by centrifugation, Guan does not teach the separation of a middle layer contained aqueous phase and drying the aqueous phase to obtain the phospholipid processing aid as recited in the present application (Specification; pages 13-17, (0063-0077); Examples 1-3). Instead, Guan teaches several additional method steps that teach away from the method of the claimed invention, such as chemical treatment of the hydrated phospholipids with hydrogen peroxide. Guan also fails to teach the application of a phospholipid processing aid for the preparation of active phospholipid lamellar liquid crystals or active phospholipids, as recited in the present application (Specification; pages 17-21, (0078-0092); Examples 4-6). Furthermore, Guan does not provide any teachings or suggestions that would motivate the skilled artisan to modify the method of Guan to arrive at the phospholipid processing aid recited in instant claim 1. Therefore, the claims are free from the prior art for the reasons of record and the reasons set forth above. Conclusion The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Derek Rhoades whose telephone number is (703)-756-5321. The Examiner can normally be reached Monday–Thursday, 7:30 am–5:00 pm EST; Friday, 7:30 am–4:00 pm 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, Scarlett Goon can be reached on 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 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. /D.R./Examiner, Art Unit 1692 /AMY C BONAPARTE/Primary Examiner, Art Unit 1692
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Prosecution Timeline

Mar 22, 2024
Application Filed
Sep 09, 2026
Non-Final Rejection mailed — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
87%
With Interview (+15.3%)
3y 7m (~1y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 78 resolved cases by this examiner. Grant probability derived from career allowance rate.

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