Prosecution Insights
Last updated: October 04, 2026
Application No. 18/557,371

A SPECIFIC COMBINATION OF LIPIDS AND METHODS AND USES RELATED THERETO

Non-Final OA §103§112§DOUBLEPATENT
Filed
Oct 26, 2023
Priority
Apr 30, 2021 — FI 20215505 +1 more
Examiner
ANDERSON, REBECCA L
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Helsingin Yliopisto
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
766 granted / 1044 resolved
+13.4% vs TC avg
Strong +24% interview lift
Without
With
+23.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 4m
Avg Prosecution
49 currently pending
Career history
1095
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
18.8%
-21.2% vs TC avg
§102
24.1%
-15.9% vs TC avg
§112
32.8%
-7.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1044 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
DETAILED ACTION Claims 1, 3, 4, 8, 9, 11, 12, 14, 16-20, 23, 25-27, 30, and 32-35 are currently pending in the instant application. Claims 8, 19, 26, 30, and 32-35 are withdrawn from consideration as being for non-elected subject matter. Claims 1, 3, 4, 9, 11, 12, 14, 16-18, 20, 23, 25, and 27 are rejected. 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 . Election/Restrictions Applicant’s election without traverse of Group I and the species 18-(oleoyloxy)stearic acid as the fatty acid ester of a hydroxy fatty acid and behenyl oleate as the wax ester in the reply filed on 18 May 2026 is acknowledged. According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species does not appear allowable. However, in order to expedite prosecution, the search and examination has been extended to a composition of the structural analogue of 18-(oleoyloxy)stearic acid which is PNG media_image1.png 124 384 media_image1.png Greyscale and the structural analogue of behenyl oleate which is palmityl oleate which are not allowable. Claims 1, 3, 4, 9, 11, 12, 14, 16-18, 20, 23, 25, and 27 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned composition. Abstract The abstract of the disclosure is objected to because the abstract has legal phraseology such as “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Specification The disclosure is objected to because of the following informalities: The Preliminary Amendment filed 26 October 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “the entirety of each of which is incorporated herein by reference.” MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications: MPEP 211.02, in-part For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p). When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b). MPEP 201.06(c)(IV), in-part 201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015] IV. INCORPORATION BY REFERENCE An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). 20.6 Confirmation of Incorporation by Reference of Elements and Parts (a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7 , a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18 , accompanied by: (i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned; (ii) where the applicant has not already complied with Rule 17.1(a) , (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed; (iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a) , a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and (iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii). (b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office. (c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i) , 20.5(b) , 20.5(c) , 20.5bis(b) or 20.5bis(c) , as the case may be. 20.7 Time Limit (a) The applicable time limit referred to in Rules 20.3(a) and (b) , 20.4 , 20.5(a) , (b) and (c) , 20.5bis(a) , (b) and (c) , and 20.6(a) shall be: (i) where an invitation under Rule 20.3(a) , 20.5(a) or 20.5bis(a) , as applicable, was sent to the applicant, two months from the date of the invitation; (ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office. (b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit. 4.18 Statement of Incorporation by Reference Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) , or a part of the description, claims or drawings referred to in Rule 20.5(a) , or an element or part of the description, claims or drawings referred to in Rule 20.5bis(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6 , incorporated by reference in the international application for the purposes of Rule 20.6 . Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date. The instant application is a 371 application which has an International filing date of 29 April 2022. The incorporation by reference statement is being added by way of a Preliminary Amendment filed 26 October 2023, which is after the instant application's International filing date of 29 April 2022. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter. Applicant is required to cancel the new matter in the reply to this Office Action. 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. Claim 1, 3, 4, 8, 9, 11, 12, 14, 16, 17, 18, 20, 23, 25, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 6-7, 11, 12, 14, 16, 17-27 of copending Application No. 19/124,080 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims claim a pharmaceutical composition comprising such as (ii) a combination of a fatty acid ester of a hydroxy fatty acid of formula I: PNG media_image2.png 226 668 media_image2.png Greyscale and a wax ester of formula II: PNG media_image3.png 90 110 media_image3.png Greyscale PNG media_image4.png 152 658 media_image4.png Greyscale (conflicting claim 1). Conflicting claims 11 and 12 provide wherein the fatty acid ester of a hydroxy fatty acid of formula I is: PNG media_image5.png 102 480 media_image5.png Greyscale which corresponds to the instantly claimed elected species of 18-(oleoyloxy)stearic acid. Conflicting claims 14 provide wax esters such as behenyl oleate: PNG media_image6.png 80 644 media_image6.png Greyscale . Conflicting claim 17 provides a molar ratio of about 1:1 with a combination of 18-(oleoyloxy)octadecanoic acid and behenyl oleate. Conflicting claim 25 provides a pharmaceutical composition. Conflicting claims 26-28 provide amounts in w/v percentage. In regards to the evaporation resistance of the composition, it is noted that this limitation is a property of the composition itself and a composition and its properties are inseparable. Therefore, if the conflicting claims claim the identical composition, the properties applicant claims are necessarily present, see MPEP 2112.01. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1, 3, 4, 9, 11, 12, 14, 16-18, 20, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the claims are drawn: PNG media_image7.png 94 674 media_image7.png Greyscale the only definition of “structural analogue” is found on page 35 where "a structural analogue" refers to a compound having a structure similar to a compound described in the present disclosure but differing from it in respect to a certain component such as one or more atoms, functional groups, or substructures, which are replaced with other atoms, groups, or substructures. In one embodiment structural analogs are isoelectronic analogues and/or functional analogues. While pages 15-19 provide specific examples of “structural analogues” of FAHFA, there are no specific examples of “structural analogues” of wax esters provided. The definition provided for “structural analogue” is non-limiting. Besides this non-limiting definition there is no written description for how to make or use any “structural analogue” of FAHFA or a wax ester as there is no written description other than the definition on page 35 and some specific examples of FAHFA structural analogues. There is no direction or written description on how to determine a particular reaction scheme to produce a structural analogue, how much it can be derivatized, how to determine if pharmaceutically active. There is no written description on how far from the original starting product, the structural analogue can be in regards to structure, i.e. what is required in the moiety that is the resulting product. Please see Wermuth et al. which provides 3 classes of analogs, with the second class made of “structural analogs” possessing only chemical similarities. Section 4.2 of Wermuth et al. provides that structural analogs, despite their similar chemical structure exhibit different pharmacological profiles and provide a diverse amount of changes such as change of a group of atoms, schaffold change, homolog, bioisoesters, etc. It is suggested that all instances or variations of “or a structural analogue thereof” be deleted from the claims as the specification does not provide how to use any structural analogue” as structural analogues can have different pharmacological profiles and does not provide how to make as the definition in the specification states that the analogues vary by one or more atoms, functional groups, or substructures, which are replaced with other atoms, groups, or substructures and does not provide any processes of preparing these structural analogues. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 20 and 25 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. Regarding claims 20 and 25, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 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 27 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. Specifically, claim 27 provides wherein the molar ration of the O-Aceyl-w-hydroxy fatty acid: wax ester is about 1:1, however, claim 25, from which claim 27 depends provides that the molar ration of O-aceyl-w-hydroxy fatty acid to wax ester is 1:1 or less. About 1:1 could include more than 1:1 or less. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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. 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, 9, 11, 12, 14, 16-18, 20, 23, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/091020 (IDS filed 3/19/2024, Reference B2) in view of Rantamaki et al (IDS filed 3/19/2024, Reference C26) and/or in view of US 2011/0130457. Determining the scope and contents of the prior art. WO 2013/091020 discloses ophthalmic formulation comprising a compound of formula (I) on page 9: PNG media_image8.png 162 256 media_image8.png Greyscale wherein R1 can be linear C9-C33 alkyl, such as linear C15,C16 and C17, page 10, such as palmityl (C16:0) and stearyl (C18:0) and wherein R2 can be linear C16-C19 alkenyl with 1 double bond (page 10), such as R2 a linear C17 alkyl with 1 double bond, with the specific compound of formula (I): PNG media_image1.png 124 384 media_image1.png Greyscale on page 10. Page 11 provides the the compounds of formula (I) may be present in amounts from about 0.001wt% to about 20wt%. Page 4 provides that the ophthalmic formulation is an oil-in-water emulsion. Figure 1 provides pressure/area curves for films of three wax esters and three compound of formula (I). Figure 3 shows pressure/area curves of PNG media_image9.png 42 340 media_image9.png Greyscale . Page 8 provides that the compounds of formula (I) can be used to prepare ophthalmic formulations that mimic the physical properties of tear lipids. Page 14 provides the formulations in the form of oil-in-water emulsions are effective in reducing tear evaporation, and thus useful in the management of evaporative dry eye. Rantamaki et al. discloses behenyl oleate as a wax ester which retarded evaporation, page 5211. Rantamaki et al. examined in vitro the evaporation-retarding effect of wax esters, page 5211. Behenyl oleate was shown to retard evaporation see Figure 1, page 5214. Page 5216 provides that wax esters should be accompanied by more efficient surfactants. US 2011/0130457 discloses wax-based emulsion for treatment of dry eye conditions. Page 3 provides that the invention relates to the eye lubricants which reduce the evaporation rate of the tear film and include a wax based emulsion. Paragraph [0015] provides a list of wax esters including palmityloleate. Determining the scope and contents of the prior art and Resolving the level of ordinary skill in the pertinent art. The difference between the prior art and the instant claims is the prior art does not provide a combination containing 18-(oleoyloxy)stearic acid as the fatty acid ester of a hydroxy fatty acid and behenyl oleate or does not provide a combination of structural analogue of 18-(oleoyloxy)stearic acid which is PNG media_image1.png 124 384 media_image1.png Greyscale with the structural analogue of behenyl oleate which is palmityl oleate. However, WO 2013/091020 does disclose ophthalmic formulation comprising a compound of formula (I) on page 9: PNG media_image8.png 162 256 media_image8.png Greyscale wherein R1 can be linear C9-C33 alkyl, such as linear C15,C16 and C17, page 10, such as palmityl (C16:0) and stearyl (C18:0) and wherein R2 can be linear C16-C19 alkenyl with 1 double bond (page 10), such as R2 a linear C17 alkyl with 1 double bond, with the specific compound of formula (I): PNG media_image1.png 124 384 media_image1.png Greyscale on page 10 useful in the management of evaporative dry eye. Whereas Rantamaki et al. or US 2011/0130457 provide wax-esters such as behenyl oleate and palmityloleate for the retarded evaporation and treatment of dry eye conditions. It would have been prima facie obvious for a person having ordinary skill in the art to administer a combination 18-(oleoyloxy)stearic acid and behenyl oleate or (0-oleoyl)-16-hydroxypalmitic acid and palmityl oleate as all were known in the art to be efficacious in treating dry eye. Per MPEP 2144.06, I. “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”. In regards to the evaporation resistance, it is noted that this limitation is a property of the composition itself and a composition and its properties are inseparable. Therefore, if the conflicting claims claim the identical composition, the properties applicant claims are necessarily present, see MPEP 2112.01. In regards to the molar ratio, instant claim 14 provides molar ratios or 1:1 or less or more, which covers all molar ratios. Instant claims 19 and 20, while discussing molar ratio, it is not required but is optional. In regards to claim 23, while weight percent is discussed, it is and or or, and the claim also provides for the composition to be in various forms, such as an oil-in-water emulsion. In regards to the molar ratios of instant claims 16, 17, 25 and 27, discovering the optimum or workable ranges of a parameter disclosed in the prior art is generally not considered inventive unless the parameter is shown to be critical or result effective, see MPEP 2144.05. As seen in instant claim 14, any molar ratio is considered as claim 14 provides ratios of 1:1, less than 1:1 or more than 1:1 which covers all molar ratios. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm. 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, Andrew Kosar can be reached at 571-272-0913. 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. /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 6 August 2026 Rebecca Anderson Primary Examiner Art Unit 1626, Group 1620 Technology Center 1600
Read full office action

Prosecution Timeline

Oct 26, 2023
Application Filed
Aug 10, 2026
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12735385
ALKYLSULFENYL THIOCARBONATES: PRECURSORS TO HYDROPERSULFIDES POTENTLY ATTENUATE OXIDATIVE STRESS
2y 10m to grant Granted Sep 15, 2026
Patent 12729196
N-(2-(4-CYANOTHIAZOLIDIN-3-YL)-2-OXOETHYL)-QUINOLINE-4-CARBOXAMIDES
3y 2m to grant Granted Sep 08, 2026
Patent 12715864
PROCESS FOR THE SYNTHESIS OF N-BUTYLOXYCARBONYL-3-(4-IMIDAZOL-1- YLMETHYLPHENYL)-5-ISO-BUTYLTHIOPHENE-2-SULFONAMIDE
3y 9m to grant Granted Aug 25, 2026
Patent 12703706
ANTHELMINTIC COMPOUNDS COMPRISING A THIENOPYRIDINE STRUCTURE
3y 2m to grant Granted Aug 11, 2026
Patent 12692233
ANTHELMINTIC COMPOUNDS COMPRISING A PYRIDINE STRUCTURE
3y 1m to grant Granted Jul 28, 2026
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
73%
Grant Probability
97%
With Interview (+23.6%)
2y 4m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1044 resolved cases by this examiner. Grant probability derived from career allowance rate.

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