1DETAILED 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 .
Applicants’ response of 9/3/2026 has been received and entered into the application file. Claims 27-46 are pending, all of which have been considered on the merits.
Priority
Acknowledgement is made of Applicants’ claim for benefit as a continuation of prior-filed US application 17/083045 (filed 10/28/2020, now US Patent 11959120), which is a continuation of prior-filed US application 15/178,890 (filed 6/10/2016, now US Patent 10851395).
It is required that the later-filed application be an application for an invention which is also disclosed in the prior application(s) (the parent of original non-provisional application or provisional application). The disclosure of the invention in the parent application(s) and in the later-filed application must be sufficient to comply with the requirements of 35 USC 112(a), except for best mode requirement. See Transco Products, Inc.. V. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Circ. 1994)
The disclosure of prior-filed applications 17/083045 and 15/178890 fail to provide adequate support or enablement in the manner provided by 35 USC 112(a) for one or more claims of this application. Specifically, the details of claims 37-39 do not have support in the prior-filed applications. Claims 37-39 recite ranges (5-100% DPA, 7-11% palmitoleic acid, and 6-11% cis-vaccenic acid, respectively) which are not taught in the prior-filed applications. Values within these ranges are taught (e.g. Table 3), but the ranges are not.
The effective filing date of claims 27-36 and 40-46 is considered to be the filing date of the ‘890 application (6/10/2016).
The effective filing date of claims 37-39 is considered to be the filing date of the instant application: 4/21/2023. It is noted that the limitations of claims 37-39 were present in original claims 19-21, and claims 37-39 were added in a preliminary amendment filed on the date of filing, making them part of the original application.
Claim Interpretation
The claims recite an oil composition.
An “oil” is being given its standard definition in accordance with the state of the art, which is “any non-polar, water-insoluble chemical substance that is liquid at room temperature” (See Encyclopaedia Britannica, accessed 6/19/2026). Thus an oil composition is distinguished from a solid, e.g. wax composition.
Describing the oil as “microbial” is a product-by-process limitation. In this case, the source of the oil does not impart specific physical or biochemical properties to the oil. Any oil composition comprising the fatty acids as recited in the claims will be considered to meet the claims.
Claim 35 recites product-by-process limitations. The generic production limitations do not clearly impart specific biochemical limitations. Thus any oil composition having the fatty acid composition required by claim 27 will be considered to meet the claim.
Response to Arguments/Status of Rejections
RE: Priority
Response at Pg 7-8 argues that claims 37-39 find support in the examples of the specification (the specification being the same specification in the instant application, and prior-filed applications 17/083045 and 15/178890). This is not found persuasive. The examples disclose values within the claimed ranges, but do not provide basis for the end points of the ranges as claimed.
RE: Rejection of claims 27-46 under 35 USC 101:
Applicants have traversed the rejection on several grounds. The following ground is found persuasive to overturn the rejection:
Applicants assert that the claimed composition has properties which are distinct than each of the individual fatty acid (provided separately). Specifically, Applicants assert the separate oils would be waxy and solidified, not flowable oil at ambient temperature (See Response at pg 6).
It is noted that at least instant claim 27 does not recite the limitation that the oil is flowable at ambient temperature; however, all claims are to an oil, which, by definition, must be liquid at room temperature. Therefore, the claimed composition must be liquid (flowable) at room temperature. This different physical property of the combined fatty acids does make the claimed composition markedly different than a combination of the individual ingredients, based on Applicants’ statements. The rejection is withdrawn.
RE: Rejection of claims 37-39 under 35 USC 102(a)(1) over Sun et al:
Applicants have traversed on the grounds that the claims should be given the effective filing date of 6/10/2016, which would make Sun et al ineligible as prior art.
For the reasons discussed under “Priority”, this is not found persuasive. The effective filing date of claims 37-39 is 4/21/2023. The rejection is maintained.
RE: Rejection of claims 27-46 under 35 USC 102/103 over Burja et al: Applicants have traversed stating that the oil of Fig. 4 “has a much greater amount of saturated fatty acids less DHA and less omega-7 fatty acids than the oils described and claimed” (Response at Pg 8). However, the Applicants have not specifically pointed out errors in the Examiner’s reading of the left hand column of Fig. 4. The rejection of record sets forth reasonable interpretations for each of the fatty acids, and explains why they anticipate, or at least render obvious, the oil currently claimed.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
The rejection is maintained.
RE: Rejection based on NSDP over claims of US Patents 10385370, 10851395 and 11959120:
Applicants filed terminal disclaimers over these three patents. The terminal disclaimers have been approved and recorded. The rejections are withdrawn.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 37-39 recite ranges (5-100% DPA, 7-11% palmitoleic acid, and 6-11% cis-vaccenic acid, respectively) which do not have antecedent basis in the specification. Values within these ranges are taught (e.g. Table 3), but the ranges are not.
Claim Rejections - 35 USC § 112
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 44 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 27 has been amended to require the saturated fatty acids to be 20-35%. Claim 44 recites the same range, and thus does not further limit. 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 37-39 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al (US 2018/0208954).
Regarding claims 37-39: Example 3 of Sun et al discloses culturing Thraustochystrium strain ONC-T18 to yield an oil comprising the fatty acid profile of Table 3. Batch #1 contains saturated fatty acids at a concentration of 25.03% (totally of myristic acid and palmitic acid), omega-7 fatty acids at a concentration of 17.69% (total of palmitoleic acid and vaccenic acid), and DHA at a concentration of 43.45%.
Regarding claim 37: Batch #1 contains 7.32% DHA which is within the claimed range.
Regarding claim 38: Batch #1 contains 7.36% palmitoleic acid, which is within the claimed range.
Regarding claim 39: Batch #1 contains 10.33% vaccenic acid, which is within the claimed range.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
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 27-46 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by, or in the alternative, under 35 U.S.C. 103 as being unpatentable over Burja et al (Appl Microbiol Biotechnol, 2006).
Burja et al disclose isolation of Thraustochytrium ONC-T18, the same microorganism as used in the instant specification. Burja et al disclose culturing the Thraustochytrium ONC-T18 under various culture conditions and characterizing the fatty acids thereby produced (See abstract). Burja et al describe the microorganisms as producing an oil (see Pg 1168, col. 2). The embodiment wherein the ONC-T18 was cultured on agar plate for 27 days is being relied upon (See Fig. 4). The fatty acid profile produced by the ONC-T18 when cultured on agar plates for 27 days is shown in the left hand column of Fig. 4:
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Regarding claims 27-32, 35-40, 44-46: Burja et al describe the ONC-T18 as producing an oil. The fatty acid product produced is comparable to the claims as follows: It contains saturated fatty acids 14:0 (myristic acid; at approximately 10%), 16:0 (palmitic acid, at approximately 20%) and 18:0 (stearic acid, amount negligible, e.g. less than 2%). The total saturated fatty acid content appears to be approximately 35%.
It contains DHA. The total DHA content appears to be approximately 37%.
It contains DPA (n-6) at approximately 10%.
It contains C16:1 (at approximately 10%-15%) and C18:1 (at approximately 10%). The sum of C16:1 and C18:1 appears to be approximately 20-25%.
Though Burja et al do not specify if the C16:1 is C16:1 (n-7) palmitoleic acid, and the C18:1 is C18:1 (n-7) cis-vaccenic acid, given that Burja et al use the same microorganism as taught in the instant application (ONC-T18), there is a reasonable basis to conclude that the C16:1 and C18:1 fatty acids are, in fact, omega-7 fatty acids C16:1 (n-7) palmitoleic acid and C18:1 (n-7) cis-vaccenic acid. "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). See MPEP 2112.01(I).
Regarding the % of each of the above fatty acids: Burja et al do not provide clear numerical values, thus the % can only be guesstimated from the figure. The % disclosed in the figure appear to meet the limitations of the claim, and thus there is anticipation. However, even if the true % are slightly different, and there is in fact, no anticipation, there is at least a prima facie case of obviousness due to the prior art amounts being extremely close to the claimed ranges. See MPEP 2144.05.
Regarding claims 33-34, and 41-43: Burja et al does not report on the melting point, cloud point or pour point. However for the reasons set forth above, a prima facie case of anticipation, or at least obviousness, has been made. Products of identical chemical composition cannot have mutually exclusive properties. Therefore, given that Burja et al teaches the same fatty acid composition, the properties applicant claims are necessarily present. See MPEP 2112.01(II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
