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 .
The preliminary amendment received on 4/21/2023 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.
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 27-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (specifically a natural phenomenon) without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Regarding claim 27: The claim is directed to an oil composition.
The claim is directed to a composition, which is a statutory category of invention (Step 1: YES).
The oil composition is defined by its fatty acid content. The various fatty acids required by the claim (e.g. saturated fatty acids, omega-7 fatty acids, and DHA) are each nature-based products. When a claimed composition includes nature-based products, further analysis is taken to determine if the claimed composition recites a nature-based product judicial exception by comparing the claimed composition to the closest naturally occurring counterpart to determine if the claimed composition has markedly different characteristics than the counterpart. In the instant case, it is not clear that the composition as a whole (i.e. in combination), exists in nature. The specification teaches the claimed composition is created by culturing the naturally occurring microorganism Thraustochytrium ONC-T18 under artificial conditions (See Example 3 of instant application). The fatty acid profile of the microorganism Thraustochytrium ONC-T18 will change based on culture conditions (See, e.g. Burja et al (Appl Microbiol Biotechnol, 2006), Fig 4). The exact concentrations of the fatty acids secreted in naturally occurring conditions is not known to the Examiner. As such, there is no known naturally occurring counterpart to the composition as a whole. However, simply because a combination of nature-based products does not exist in nature does not mean the claim is not directed to a product of nature judicial exception. When a claim is to a combination of multiple nature-based products and the composition as a whole (i.e. in combination) does not exist in nature, comparison is made between each of the individual nature-based products in the composition and their respective naturally occurring counterparts. In the instant case, the claimed composition can consist of the saturated fatty acids, omega-7 fatty acids including palmitoleic acid and cis-vaccenic acid, and DHA. Each of saturated fatty acids, omega-7 fatty acids palmitoleic acid and cis-vaccenic acid and DHA are naturally occurring lipids that exist in nature. There is no indication or evidence in the specification or prior art that combining these individual natural products together results in any structural, chemical or functional change to any one or more of the individual fatty acids; thus, even in combination none of the individually recited components are markedly different from their respective naturally occurring counterparts. When multiple nature-based products are provided in combination, but the combination does not impart any change to the individual components (i.e. the individual components are not incorporated into a higher ordered structure, or physically or chemically changed due to the combination), then the nature-based products must be considered independently from one another. Therefore, while the composition as a whole does not exist in nature, the composition includes several nature-based product which are not markedly different from their individual respective naturally occurring counterparts (each type of fatty acid). Each of the nature-based products are thus considered to be products of nature, and thus the claim is considered directed to at least one product of nature judicial exception (Step 2A, prong 1: YES).
The claim does not integrate the product into a practical application because the claim is to the composition, per se, not a method of use. (Step 2A, Prong 2: NO).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is provided for that will elevate the claim to amount to significantly more than the at least one judicial exception. Because the combination of products of nature do not occur together in nature and are not markedly changed by their combination into a mixture, each is considered as an additional element to the other. This consideration provides an opportunity to explore whether this combination of “products of nature” amounts to significantly more than the products themselves. As discussed above, there is no evidence that providing the combination of products together markedly changes the characteristics of any one product, because each product continues to have the same properties in the mixture as it had alone. There are no additional components beyond the three products of nature discussed above. Therefore the claims do not include any additional features that add significantly more to the judicial exceptions (Step 2B: NO).
The claim is patent ineligible.
Regarding claims 28-32, 36-40 and 44-46: These dependent claims further require the presence of additional naturally occurring fatty acids or further specify the concentration of one or more fatty acid. For the same reasons as discussed above, these additional fatty acids do not make the claim patent eligible.
Regarding claims 33-35, 41-43: These claims recite physical properties that appear to flow naturally from the recited combination of fatty acids, and are not newly developed or gained by the specific combination. These claims are not considered patent eligible.
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 are 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 are 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).
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.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10385370.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
The patented claims are to a narrower species of oil than the instant claims. The patented claims recite all limitations regarding the content of saturated fatty acids, omega-7 fatty acids, including palmitoleic and cis-vaccenic acid, and DHA as required by the instant claims.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10851395.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method that will necessarily produce the oil currently claimed. The patented claims define the oil produced as having the same saturated fatty acid content and omega-7 fatty acid content as the instant claims (See patented claims 1, 15-21). The patented claims do not specify the oil produced contains DHA, wherein greater than 37% of the fatty acids are DHA. However, the patented method comprises culturing the same microorganism (Thraustochytrium microorganism having ATCC Accession No. PTA-6245) in the same culture conditions (in the presence of an anti-foaming agent and with controlled carbon consumption rate) as used to generate the currently claimed oil composition in the instant application (See Example 3). Therefore, based on principles of inherency, if the patented method involves the same steps as used to create the instantly claimed oil, then the oil produced by the patented method will necessarily have the same composition as the instantly claimed oil.
Where the claimed and prior art (in this case, patented) products … are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art (in this case, patent) 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.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11959120.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method that will necessarily produce the oil currently claimed. The patented claims define the oil produced as having the same saturated fatty acid content and omega-7 fatty acid content as the instant claims (See patented claims 1, 12-18). The patented claims further specify the oil contains DHA, wherein greater than 35% of the fatty acids are DHA. “Greater than 35%” is slightly lower than the greater than 37% required by the current claims. However, the patented method comprises culturing the same microorganism (Thraustochytrium microorganism having ATCC Accession No. PTA-6245 (see patented claim 22)) in the same culture conditions (in the presence of an anti-foaming agent and with controlled carbon consumption rate) as used to generate the currently claimed oil composition in the instant application (See Example 3). Therefore, based on principles of inherency, if the patented method involves the same steps as used to create the instantly claimed oil, then the oil produced by the patented method will necessarily have the same composition as the instantly claimed oil.
Where the claimed and prior art (in this case, patented) products … are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art (in this case, patent) 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.
Conclusion
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
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