The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 9, 2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 1-14, 16-17, 20-87 are canceled. Claims 15, 18-19, 88 are under consideration.
Priority: This application is a 371 of PCT/US20/16672, filed February 4, 2020, which claims benefit of provisional applications 62/800708, filed February 4, 2019, and 62/810435, filed February 26, 2019.
Objections and Rejections
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 15, 18 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The instant claims are product claims reciting plant lipocalins that are not markedly different from naturally occurring plant lipocalins.
Claims 15, 18 recite a composition comprising an isolated carrier protein comprising an amino acid sequence selected from the group consisting of SEQ ID NOS: 1-46 or a carrier protein having an amino acid sequence with at least 95% or more sequence identity with any of SEQ ID NOS: 1-46. Claim 15 recites the composition is a “solubilized cannabinoid” composition, which is an intended use or property of the composition. The claims recite lipocalin proteins comprising amino acid sequences that are the same as naturally occurring plant lipocalin proteins. The claims are directed to a statutory category, i.e. a composition of matter (step 1: YES).
Since the claims recite a nature-based product, i.e. plant lipocalin(s), the claims are analyzed to determine whether it is directed to any judicial exception. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. The recited lipocalin proteins are compared to its closest naturally occurring counterpart(s) to determine if it has markedly different characteristics. Here, the closest natural counterpart is naturally occurring plant lipocalin. When the claimed lipocalin is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Plant lipocalins are naturally occurring and found nature. There is no indication that the claimed lipocalin has any structural and/or functional characteristics that are different from the naturally occurring plant lipocalin in its natural state. Therefore, the lipocalin does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to an exception (step 2A: YES). Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception(s). Claim 15 recites the lipocalin is in a composition and has the property of binding THC or CBD. The composition does not comprise any additional components besides the lipocalin. The incorporation of a protein into a composition is not only well-understood, routine and conventional activity already engaged in by the scientific community, it is also required for using the protein. The claim recites the composition at such a high level of generality that it merely tells a scientist to use whatever general buffer or excipient to form a composition comprising the protein. The claims do not recite anything significantly different than the natural product, i.e. the claims do not recite elements or features that demonstrate that the claimed lipocalin is markedly different from what exists in nature. Therefore, the claims as a whole add nothing significantly more to the "product of nature" itself (Step 2B: NO), and thus, the claim does not qualify as eligible subject matter.
See also Funk Brothers Seed Co., V. Kalo Inoculant Co., 333 U.S. 127, (1948) and Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ 2d. 1972 (2013).
Reply: In view of Applicants’ amendments, claims 15, 18 are rejected under 35 U.S.C. 101 for the reasons noted above.
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 15, 18-19, 88 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 15 recites the limitation "the cannabinoid carrier protein" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Further, claim 15 is directed to a “solubilized cannabinoid” composition; however, the claim does not appear to recite that there is an actual cannabinoid compound present or in the composition. The limitations in the wherein clause appear to be a property or characteristic of the recited protein. Further clarification and/or correction is requested.
Claims 18-19, 88 are included in this rejection because they are dependent on the above claim and fail to cure its defects.
Reply: In view of Applicants’ amendments, the claims remain rejected under 35 U.S.C. 112(b) for the reasons noted above.
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 15, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skatrud et al. (US 20150337294). For prior art purposes, instant claim 15 is interpreted as a composition comprising an isolated carrier protein comprising an amino acid sequence selected from the group consisting of SEQ ID NOS: 1-46 or a carrier protein having an amino acid sequence with at least 95% or more sequence identity with any of SEQ ID NOS: 1-46. The recited limitation “solubilized cannabinoid” composition is an intended use or property of the composition.
Skatrud et al. teach compositions for binding a target molecule, the compositions comprising recombinant plant lipocalins (at least abstract, paragraphs 0004-0007, 0046), where the plant lipocalin is selected from a polypeptide comprising SEQ ID NO: 15 (at least paragraph 0042), where SEQ ID NO: 15 of Skatrud et al. has 100% sequence identity with instant SEQ ID NO: 2 (instant claim 15).
Regarding the limitations recited in the wherein clause (instant claim 15), it is noted that the wherein clause recites a property of the recited protein. In this instance, since the plant lipocalin comprising the polypeptide comprising SEQ ID NO: 15 of Skatrud et al. comprises the same structural features as the recited carrier protein comprising instant SEQ ID NO: 2, it would follow that the plant lipocalin comprising the polypeptide comprising SEQ ID NO: 15 of Skatrud et al. binds THC or CBD. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
Regarding instant claim 18, Skatrud et al. teach the lipocalin proteins are secreted (at least paragraphs 0007). Skatrud et al. teach adding a DNA sequence encoding a transit or signal peptide to the coding sequence of the particular gene (at least paragraphs 0081-0083).
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 15, 18, 88 are rejected under 35 U.S.C. 103 as being unpatentable over Skatrud et al. (US 20150337294). The teachings of Skatrud et al. over at least instant claims 15, 18 are noted above.
Regarding instant claim 88, Skatrud et al. disclose mutating the plant lipocalins by random mutagenesis for enhanced specificity or binding of a target molecule (at least paragraph 0023). Skatrud et al. disclose the lipocalin structure comprises a beta-barrel structure and a binding pocket (at least paragraph 0051). Skatrud et al. disclose introducing amino acid substitutions based on hydrophilicity, hydrophobicity, and relative similarity (at least paragraphs 0059-0063). Therefore, Skatrud et al. can reasonably be deemed to disclose substitutions at the compound binding pocket. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at an engineered plant lipocalin comprising the polypeptide comprising SEQ ID NO: 15 of Skatrud et al., where the lipocalin is mutated at the binding pocket of the target protein with a similar amino acid residue.
Claims 15, 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Skatrud et al. (US 20150337294) in view of Sallman (US 20090136968; IDS 08.04.21, previously cited) and Ohgiya et al. (US 20070248967, also published as WO 2006132350; previously cited). The teachings of Skatrud et al. over at least instant claims 15, 18 are noted above.
Regarding instant claim 19, as noted above, Skatrud et al. disclose compositions for binding a target molecule, the compositions comprising recombinant plant lipocalins (at least abstract, paragraphs 0004-0007, 0046). Skatrud et al. disclose the lipocalin proteins are secreted (at least paragraphs 0007). Skatrud et al. disclose adding a DNA sequence encoding a transit or signal peptide to the coding sequence of the particular gene (at least paragraphs 0081-0083). Sallman also discloses expressing recombinant lipocalin proteins (at least paragraph 0054), where cells include yeast cells (at least paragraph 0067). Sallman discloses that the lipocalin protein can be modified to alter its secretion (at least paragraph 0051). Ohgiya et al. disclose a secretory signal peptide comprising the amino acid sequence of SEQ ID NO: 12 has been known to contribute to high secretion efficiency in yeast (at least paragraph 0086), where SEQ ID NO: 12 of Ohgiya et al. has 100% sequence identity with instant SEQ ID NO: 47.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further incorporate the secretion signal peptide of Ohgiya et al. noted above to the recombinant plant lipocalin comprising the polypeptide comprising SEQ ID NO: 15 of Skatrud et al. (instant claim 19). One of ordinary skill would be motivated to do so to increase the amount of lipocalin protein purified. One of ordinary skill would have a reasonable expectation of success because the prior art discloses modifying proteins of interest with a secretion signal peptide to increase secretion efficiency.
Reply: In view of Applicants’ amendments/remarks, the previous 103 rejection has been withdrawn. However, the claims are rejected under new 102 and 103 rejections for the reasons noted above.
Applicants assert that as amended, the claims are directed to a specific subset of (non-Cannabis) plant-based protein sequences that bind to a cannabinoid, such as THC or CBC.
Applicants’ remarks are not persuasive. As currently amended, claim 15 recites the lipocalin is in a composition and has the property of binding THC or CBD. The composition does not comprise any additional components besides the recited lipocalin. As noted above, Skatrud et al. teach compositions for binding a target molecule, the compositions comprising recombinant plant lipocalins (at least abstract, paragraphs 0004-0007, 0046), where the plant lipocalin is selected from a polypeptide comprising SEQ ID NO: 15 (at least paragraph 0042), where SEQ ID NO: 15 of Skatrud et al. has 100% sequence identity with instant SEQ ID NO: 2 (instant claim 15).
Applicants assert that a skilled artisan would not have expected non-cannabinoid-derived plant proteins to bind cannabinoids at all.
Applicants’ remarks are not persuasive. As currently amended, the composition of claim 15 only comprises the noted lipocalin protein. The composition does not comprise any additional components besides the recited lipocalin. The limitations recited in the wherein clause appear to be a property of the recited protein. In this instance, since the plant lipocalin comprising the polypeptide comprising SEQ ID NO: 15 of Skatrud et al. comprises the same structural features as the recited carrier protein comprising instant SEQ ID NO: 2, it would follow that the plant lipocalin comprising the polypeptide comprising SEQ ID NO: 15 of Skatrud et al. binds THC or CBD. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
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, Manjunath N. Rao can be reached on 571-272-0939. 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.
/Marsha Tsay/Primary Examiner, Art Unit 1656
Prosecution Insights