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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on April 16, 2026 is acknowledged. The traversal is on the grounds that there is no serious burden in in examining claim 15 as it has been amended to depend from claim 1. This was found persuasive. Therefore, the restriction requirement has been withdrawn and claims 1-9 and 15-17 are pending and addressed below.
Specification
The disclosure is objected to because of the following informalities: The specification is missing information pertaining to the depository made under the terms of the Budapest Treaty. It appears as though the statement “All restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent” is missing and should be added per MPEP 2410.01. 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 1-9 and 15-17 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 1 recites “A method for preparing a food product comprising….”, however, the steps never make clear how the food product is prepared as the active steps do not require a food product. The only active steps are “expressing a lipase” and “using the lipase”. The method does not make clear how to make the food product as there is no mixing or combining the lipase with a food product or any additional ingredients.
Claim 7 recites the limitation "the Yarrowia strain" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-6, 8-9 and 15-17 are included as they depend from rejected claims.
Claim Rejections - 35 USC § 102
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 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 1-5 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Damude et al. (US 2008/0254191 A1; Oct. 16, 2008).
Regarding claim 1, Damude discloses a method for preparing a food product comprising expressing a lipase from Yarrowia in a Yarrowia cell and using the lipase from step a) for preparing the food product ([0262], [0418]-[0437], See Examples and Tables).
Damude teaches that the expressing step is carried out in the absence of olive oil as Damude does not disclose the use of olive oil ([0407]).
Damude further teaches that the lipase comprises an amino acid sequence having 100% identity with one of the claimed SEQ ID Nos. (See Sequence Search Results).
With respect to the lipase having a higher specificity towards the release of C4-fatty acids from a dairy composition comprising milk fat and/or other fat, the examiner notes that as Damude teaches that the lipase has 100% match to an amino acid with the claimed SEQ ID No, the lipase of Damude would necessarily have the same higher specificity properties as the lipase of Damude is the same as claimed.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 2, as stated above, Damude teaches that the expressing step is carried out in the absence of olive oil as Damude does not disclose the use of olive oil ([0407]).
Regarding claim 3, as stated above with respect to claim 1, Damude teaches that the lipase comprises an amino acid sequence having 100% identity with one of the claimed SEQ ID Nos. (See Sequence Search Results).
Regarding claim 4, Damude teaches that the food product can be a dairy product selected from cheese ([0422], butter, yogurt, or cream ([0433]).
Regarding claim 5, Damude additionally teaches that the food product can be a non-dairy product ([0424]-[0426]).
Regarding claim 15, Damude discloses a method for preparing a food product comprising expressing a lipase from Yarrowia lipolytica in a Yarrowia lipolytica cell and using the lipase from step a) for preparing the food product ([0262], [0418]-[0437], See Examples and Tables).
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.
Claims 6-9 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Damude et al. (US 2008/0254191 A1; Oct. 16, 2008) as applied above.
Regarding claim 6, Damude teaches that the Yarrowia cell is modified to result in high-level production of various PUFAs ([0004] [0262], [0418]-[0437], See Examples and Tables). It would have been obvious to one of ordinary skill in the art to use a non-genetically modified Yarrowia cell if a high-level production was not desired.
Regarding claims 7-9, as stated above, Damude discloses a method for preparing a food product comprising expressing a lipase from Yarrowia lipolytica in a Yarrowia lipolytica strain and using the lipase from step a) for preparing the food product ([0262], [0418]-[0437], See Examples and Tables).
Damude, however, fails to specifically disclose that the Yarrowia lipolytica strain is one of the claimed strains.
However, it would have been obvious to one of ordinary skill in the art to perform the method of claim 1 on any Yarrowia lipolytica strain that has a lipase with an amino acid having the claimed SEQ ID No. As the lipase would be the same, since it has the same SEQ ID, the specific strain from which it is expressed is not expected to result in a different lipase and therefore it would have been obvious to use any Yarrowia lipolytica strain.
Regarding claim 16, Damude teaches that the media comprises carbon sources that can include glucose, but can also be glycerol and/or fatty acids ([0407]). Therefore, it would have been obvious to one of ordinary skill in the art to use one of the other media sources disclosed by Damude instead of glucose.
Regarding claim 17, as stated above, Damude teaches that the food product can be a dairy product selected from cheese ([0422], butter, yogurt, or cream ([0433]).
Damude, however, it silent with respect to the cheese being selected from one of the claimed cheeses. As the claimed list includes a wide variety of different cheeses, and Damude teaches a generic cheese product, it would have been obvious to one of ordinary skill in the art to have the cheese product be any desired type of cheese as claimed.
Claims 1-9 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Fickers et al. (“Identification and characterization of LIP7 and LIP8 genes encoding two extracellular triacylglycerol lipases in the yeast Yarrowia lipolytica”, Fungal Genetics and Biology 42, 2005, pages 264-274).
Regarding claim 1, Fickers discloses a method for expressing a lipase from Yarrowia (Abstract, pages 265-266).
Fickers fails to specifically teach that the lipase is used in preparing a food product, but teaches that lipases are used in the development of characteristic flavors in food processing (page 264) and therefore it would have been obvious to have the lipase expressed from Yarrowia be used in a food product in order to develop flavors.
Fickers teaches that the expressing step is carried out in the absence of glucose and olive oil as Fickers does not disclose the use of either (page 266 col 1).
Fickers further teaches that the lipase comprises an amino acid sequence having 100% identity with one of the claimed SEQ ID Nos. (See Sequence Search Results).
With respect to the lipase having a higher specificity towards the release of C4-fatty acids from a dairy composition comprising milk fat and/or other fat, the examiner notes that as Fickers teaches that the lipase has 100% match to an amino acid with the claimed SEQ ID No, the lipase of Fickers would necessarily have the same higher specificity properties as the lipase of Fickers is the same as claimed.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 2, as stated above, Fickers teaches that the expressing step is carried out in the absence of glucose and olive oil as Fickers does not disclose the use of either (page 266 col 1).
Regarding claim 3, as stated above with respect to claim 1, Fickers teaches that the lipase comprises an amino acid sequence having 100% identity with one of the claimed SEQ ID Nos. (See Sequence Search Results).
Regarding claims 4-5 and 17, as stated above, it would have been obvious to use the expressed lipase in a food product. It would have been obvious to use it in any food product desired for the development of flavor.
Regarding claim 6, Fickers teaches that the Yarrowia cell is a non-genetically modified Yarrowia lipolytica cell (pages 264-266).
Regarding claims 7-9, as stated above, Fickers discloses expressing a lipase from Yarrowia lipolytica in a Yarrowia lipolytica strain (pages 264-266).
Fickers, however, fails to specifically disclose that the Yarrowia lipolytica strain is one of the claimed strains.
It would have been obvious to one of ordinary skill in the art to perform the method of claim 1 on any Yarrowia lipolytica strain that has a lipase with an amino acid having the claimed SEQ ID No. As the lipase would be the same, since it has the same SEQ ID, the specific strain from which it is expressed is not expected to result in a different lipase and therefore it would have been obvious to use any Yarrowia lipolytica strain.
Regarding claim 15, Fickers discloses expressing a lipase from Yarrowia lipolytica in a Yarrowia lipolytica cell (pages 264-266).
Regarding claim 16, as stated above, Fickers teaches that the expressing step is carried out in the absence of added glucose to a growth medium (page 266 col 1).
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 1-4, 6 and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,495,812. Although the claims at issue are not identical, they are not patentably distinct from each other because both make claim to a method for preparing a food product comprising expressing a lipase from Yarrowia liplytica, using the lipase for preparing a food product, wherein the expressing step is carried out in the absence of sugars, olive oil, or tributyrin; wherein the lipase comprises an amino acid having at least 90% identity with the claimed SEQ ID Nos., and wherein the lipase has a higher specificity towards release of C4 fatty acids. Both make claim to the food product being a dairy product, even specifically cheese.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art contains lipases from Yarrowia with amino acids comprising matching SEQ ID Nos.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Nikki Dees can be reached at (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791
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