DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are not of sufficient quality to permit examination. Particularly, Fig. 4, 9-11, 14, 17-28. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the text characters in the figures characters not sufficiently legible, due to font sizes and low resolution. The applicant may correct this defect by submitting higher-resolution drawings (minimum 300 DPI) with clear, machine-printed text, ensuring all text labels comply with 37 CFR § 1.84 (e.g., font size ≥ 0.32 cm (1/8 inch) for characters). Failure to correct the figure may result in expungement of non-compliant drawings. The applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings.
Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The applicant is given a shortened statutory period of two (2) months to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of six months set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in abandonment of the application.
Status of the Claims
The listing of claims filed 23 August 2024, have been examined. Claims 1-9 are pending.
Claim Objections
Claims 1, 2, 4, and 6 are objected to because of the following informalities:
Claim 1 is objected to because the term "curcuminiod" lacks proper spelling and appears inconsistent with terminology used throughout the specification. The specification consistently uses the term "curcuminoid." Appropriate correction is required.
Claim 2 is objected to for grammar, wherein “to increase a solubility” should use the definite article (i.e., “to increase the solubility”). Appropriate correction is advised.
Claim 4 is objected to for the use of “a clay minerals”, wherein the indefinite article "a" requires singular noun (i.e., a clay mineral) or the “a” should be removed to recite “clay minerals”.
Claim 6 is objected to for the chemical name “(1E,6E)-1,7-Bis(4(hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione)”, which should be “(1E,6E)-1,7-Bis(4-(hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione)”.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claims 2, 3 and 7 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, regards as the invention.
Claims 2 and 3 are indefinite because the phrases “subjecting the curcuminoid substance to a solubility process” and “subjecting the curcuminoid substance to a flocculant distribution process”. The phrase "solubility process" lacks clear boundaries because the claim does not define what process parameters are required or what degree of increased solubility is necessary. The phrase "a flocculant distribution process" does not include sufficient objective boundaries regarding what constitutes such a process. The specification describes multiple, sometimes overlapping, methods for enhancing solubility (e.g., mixing with deionized water, ozonated seawater, ethanol, heating to 40° C. for 1 hour), but the claims do not recite any particular process parameters. A person of ordinary skill would not know which steps constitute “a solubility process” or “a flocculant distribution process” as those terms are not defined in the art with sufficient clarity. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention.
Claim 7 is rejected as indefinite because “hydrogenated form of Curcuma longa” is not a recognized chemical or biological term. Hydrogenation is a chemical process applied to specific molecules (e.g., converting curcumin to tetrahydrocurcumin), not to an entire plant species. A person of ordinary skill would not understand what product is claimed.
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 1-9 are rejected under 35 U.S.C. § 103 as being unpatentable over John and Tsengam (US-20220132858-A1; published 05 May 2022, hereinafter referred to as “John”), in view of Chen et al. (Brevetoxin-2, is a unique inhibitor of the C-terminal redox center of mammalian thioredoxin reductase-1. Toxicol Appl Pharmacol. 2017 Aug 15;329:58-66. Epub 2017 May 25, hereinafter referred to as “Chen”), and in further view of Colon et al. (The Marine Neurotoxin Brevetoxin (PbTx-2) Inhibits Karenia brevis and Mammalian Thioredoxin Reductases by Targeting Different Residues. Journal of Natural Products. 2021 Nov;84(11):2961-2970), Pokrzywinski et al. (Cell cycle arrest and biochemical changes accompanying cell death in harmful dinoflagellates following exposure to bacterial algicide IRI-160AA. Sci Rep. 2017 Mar 23;7:45102, hereinafter referred to as “Pokrzywinski”), Coyne et al. (Algicidal Bacteria: A Review of Current Knowledge and Applications to Control Harmful Algal Blooms. Front Microbiol. 2022 Apr 7;13:871177, hereinafter referred to as “Coyne”), and Yuan et al. (Inhibition of Diarrheal Shellfish Toxins Accumulation in the Mussel Perna viridis by Curcumin and Underlying Mechanisms. Toxins (Basel). 2021 Aug 20;13(8):578, hereinafter referred to as “Yuan”).
John teaches clay flocculation for Karenia brevis mitigation. John teaches a method for treating harmful algal blooms (HABs) using a composition comprising water, a metal-phenolic network film including a polyphenol and a multivalent metal ion, and a secondary flocculant comprising clay particles (Abstract, claim 1). John explicitly names dinoflagellate Karenia brevis algal cells as the target, which release brevetoxins resulting in fish deaths (¶[0004] and ¶[0010]). John teaches that the composition induces flocculation and sedimentation of algae, eventually killing the algae due to lack of sunlight (¶[0038] and ¶[0039]).
John also teaches the method, wherein preparing the mitigation substance comprises a process to increase solubility (¶[0043], ¶[0044], and ¶[0057]), and mixing the polyphenol containing substance with a clay slurry flocculant (¶[0069]). John explicitly teaches the composition components suitable for spraying application onto the target algae (¶[0054]) and applying the composition according to any of its variously disclosed embodiments (¶[0019]). However, John uses the polyphenol tannic acid, rather than the diarylheptanoid polyphenol curcumin, (1E,6E)-1,7-Bis(4-(hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione), or any curcuminoid substance from turmeric extract powder, zedoary root, or a hydrogenated form of Curcuma longa.
Chen teaches that curcumin binds to the same thioredoxin reductase active site as the brevetoxin, PbTx-2, reciting, “PbTx-2 blocks the inhibition of TrxR [thioredoxin reductase] by the inhibitor curcumin. Whereas curcumin blocks PbTx- 2 activation of TrxR.” (page 1, Abstract; see also page 24, Figure 4D). The proposed mechanism of curcumin is Michael addition of selenocysteine residues of thioredoxin reductase (Abstract), suggesting the ability of curcumin to disrupt redox homeostasis and oxidative stress of the cell by modifying thioredoxin reductase (page 3, ¶2, last 6 lines of the Introduction). Thus, Chen shows that curcumin directly inhibits mammalian thioredoxin reductase, which has the potential to compromise the oxidative status of the cell and redox signaling.
Colon teaches that PbTx-2, known to inhibit mammalian thioredoxin reductase, is also an inhibitor of Karenia brevis thioredoxin reductase (stated to be a “critical enzyme” for Karenia brevis) by forming covalent adducts (page 2961, Abstract), which can disrupt cellular redox homeostasis (page 2962, ¶1)- principally, the cellular balance essential for survival. Colon as also recites “Many TrxR inhibitors act by reacting with Sec and inactivating the C-terminal redox center. Some are α,β-unsaturated carbonyls such as quinones, curcumin, manumycin A, and acrolein, which can function as electrophiles in a 1,4-conjugate addition, forming a covalent adduct, resulting in the inhibition of Sec containing TrxR.” (page 2962, ¶2).
Pokrzywiński teaches that oxidative stress can induce biochemical changes associated with non-necrotic or programmed cell death responses in phytoplankton (page 1, ¶2, lines 1-3), wherein oxidative stress (reactive oxygen species accumulation) induced by the exudate (IRI-160AA) is effective as an algicide against dinoflagellates (via cell cycle arrest and cell death; page 1, ¶1, Abstract). Thus, linking algicidal activity to oxidative stress pathways, wherein thioredoxin reductase is a principal reactive oxygen species detoxification component. In addition, Coyne also teaches that build up of reactive oxygen species is a key mechanism for algicidal activity (page 7, last ¶ and page 8, ¶1 and 2). Coyne suggest that in addition to HAB mitigation strategies aimed at reducing algal cell abundance, preventing or mitigating toxin release should be addressed (page 16, ¶1).
Further, Yuan teaches that curcumin inhibits the accumulation of diarrheal shellfish toxins (produced by algal species; page 1, Introduction, ¶1 and 2) in the digestive gland of a bivalve mollusk (Perna viridis) after exposure to the dinoflagellate Prorocentrum Lima by downregulating toxin uptake genes (page 1, Abstract), demonstrating curcumin’s ability to interfere with algal toxin pathways.
Evidentiary reference, Safavy (US-20100316631-A1; published 16 December 2010) teaches that it was known in the art at the time of the invention that curcumin’s chemical structure is (1E,6E)-1,7-Bis(4-(hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione) ant that curcumin is found in significant amounts in turmeric, a spice derived from the perennial herb Curcuma longa L., which can be extracted with organic solvents (¶[0003] and ¶[0047]). Safavy also teaches that it is well-established that curcumin has poor water solubility, limiting its bioavailability and efficacy in aqueous environments (¶[0004]-[0007]). A person of ordinary skill in the art would recognize that for application to HABs in seawater, solubility enhancement is necessary.
The additional evidentiary reference, Minami and Kushi (US-20120177758-A1; published 12 July 2012), teaches turmeric is a medicinal plant of the genus Curcuma belonging to the family Zingiberaceae, wherein turmeric plants include Curcuma longa (autumn turmeric) and Curcuma zedoaria (purple turmeric, referred to as “zedoary”) (¶[0002]) and that a turmeric rhizome comprises 3% to 5% curcumin (¶[0003]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the use of curcumin to the invention of John, because Chen and Colon explicitly identify thioredoxin reductase as a validated molecular target for inhibiting brevetoxin PbTx-2 binding to mammalian cells and for disrupting Karenia brevis cellular redox homeostasis that is essential for survival. Both references expressly teach curcumin as a known thioredoxin reductase inhibitor. Further, Pokrzywinski and Coyne establish that targeting oxidative stress pathways (where thioredoxin reductase is central) is an effective algicidal strategy and Yuan demonstrates curcumin’s ability to reduce algal toxin accumulation. Thus, adding curcumin to the invention of John would be expected to supplement the physical entrapment/flocculation mechanism causing cell death from sedimentation-based sunlight depravation of John with an additional mechanism direct biochemical inhibition of thioredoxin reductase disrupting Karenia brevis redox homeostasis and competitive inhibition of brevetoxin released from Karenia brevis, along with possible reduced accumulation in the digestive system of aquatic animals, as taught by Yuan, wherein curcumin reduces algal toxin accumulation in vivo.
A person of skill in the art would have had a reasonable expectation that curcumin would effectively destroy Karenia brevis cells and inhibit toxin release because Colon teaches that Karenia brevis thioredoxin reductase is a “critical enzyme” and that curcumin‑class compounds inhibit thioredoxin reductase via covalent modification. Chen shows curcumin competes with PbTx‑2 at the thioredoxin reductase active site, which is the same toxin the alga uses for its own regulation. Pokrzywinski validates that thioredoxin reductase disruption leads to dinoflagellate cell death.
Evidentiary reference Safavy shows that it was known in the art at the time of the instant invention that curcumin has poor solubility, thus one of skill in the art would recognize solubility enhancement is necessary for aqueous applications. John provides generic solubility processing methods of HAB mitigation substances. A person of ordinary skill in the art would be motivated to apply John’s solubility techniques to curcumin to render it effective in seawater HAB applications. John’s solubility processes (heating, solvent addition, deionized water suspension) are routine and would have been expected to improve curcumin dispersion.
A person of skill in the art would be motivated by the teachings of John to distribute curcumin throughout a flocculant to enhance its dispersal and contact with target algae. John demonstrates that his flocculant distribution process works for polyphenolic compounds, curcumin is a known polyphenol, and no structural feature would preclude similar distribution. Clay minerals and modified clays (kaolinite, halloysite) as secondary flocculants are directly taught by John. Adding curcumin or substitution of curcumin for tannic acid in John’s clay‑based formulation would be straightforward with reasonable expectation of success, as curcumin’s phenolic groups can hydrogen‑bond to clay silanol surfaces similarly to tannic acid.
Curcumin is the prototypical and most studied curcuminoid and the chemical structure is known (as evidence by Safavy), a person of ordinary skill in the art would have expected it to function as taught in Chen and Colon. A person of ordinary skill in the art would also understand that turmeric extract, zedoary root, or Curcuma longa are routine sources of curcumin, with predictable properties (as evidence by Safavy and Minami & Kushi). John explicitly names Karenia brevis as the target HAB organism, applying the composition, wherein the composition is formulated for spraying. Thus, these limitations are directly taught and thus are obvious.
Under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the combination of prior art elements is obvious when a person of ordinary skill in the art has a reason to combine them and a reasonable expectation of success. Here, the combination is a predictable solution to a known problem wherein John addresses HAB mitigation. Chen and Colon identify thioredoxin reductase as a target and Colon lists curcumin is a known thioredoxin reductase inhibitor, which would be expected to have predictable algicidal effects, wherein Pokrzywinski and Coyne teach that thioredoxin reductase disruption (via oxidative stress) induces dinoflagellate cell death. Yuan shows curcumin reduces algal toxin accumulation in vivo by separate mechanisms, further encouraging the selection of curcumin. Safavy and Minami teach curcumin sources and solubility issues. John’s solubility processing and flocculant distribution are routine techniques applied to curcumin to overcome its known solubility limitations for seawater application.
Claim Rejections – Nonstatutory 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).
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 20, 24, 25, 29, 34, and 89 of co-pending US Application No. 19/381,801 (hereinafter referred to as "'801"; published as US-20260068888-A1). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The method of instant claims 1 and 8 is taught by claim 89 of '801, teaching a "method for mitigating, inhibiting, and/or eliminating phytoplankton growth in a waterbody" by applying a foam composition to a "waterbody" containing phytoplankton (which includes HAB-forming algae, such as dinoflagellates Karenia brevis). The preparing a HAB mitigation substance comprising a curcuminoid substance of instant claims 1, and 5-7 is taught by claim 20 of '801, teaching that "the algicide comprises a polyphenol, curcumin, a tannin... or a combination thereof." Claim 5 broadly recites "an algicide." The limitation of instant claim 7, wherein the curcuminoid substance comprises turmeric extract powder, zedoary root, or hydrogenated Curcuma longa, would be obvious to one of skill in the art from '801 claim 20 reciting "curcumin", because these sources are well-known commercial sources of curcumin.
The “prevent or inhibit release of toxins” limitation of instant claim 1 is not explicitly recited, the '801 application contemplates algicide activity that inherently reduces toxin presence by destroying algal cells. See '801 specification ¶[0056], wherein an algicide kills or controls the growth of algae). Instant claim 2 (solubility process) and instant claims 3 and 4 (flocculant distribution with clay) are not explicitly recited, though '801 allows for optional flocculants (claims 24, 25, 29, and 34) and optional water (claims 3 and 4).
A person of ordinary skill in the art would have found the claimed method of instant claim 1 obvious over the '801 application because both the instant application and the '801 application are directed to HAB mitigation using compositions containing algicides. The '801 application explicitly lists curcumin as an algicide in claim 20. The '801 application teaches a broad genus of algicides including curcumin. The instant application merely selects curcumin from that genus. Selecting a single known compound from a disclosed genus is a predictable, routine optimization, not a patentable distinction.
The '801 application teaches a foam-based delivery system for an algicide (including curcumin) to a waterbody containing phytoplankton. The instant application applies a curcumin-containing substance to a HAB to destroy algal cells. These are the same core steps of applying curcumin to water containing algae. The addition of the word "preparing" in the instant claim does not render it patentably distinct, as any application necessarily requires some preparation of the composition. In addition, it is well-understood in the art that destroying algal cells inherently prevents or inhibits the release of toxins because the cells are no longer viable to produce or release new toxins (see Coyne, cited above, which teaches that "ideally, a mitigation agent should kill target cells without causing toxin release.") A person of ordinary skill in the art would have expected that applying an algicide to kill algal cells would, at a minimum, inhibit further toxin release from the killed cells. Thus, the "prevent or inhibit release of toxins" limitation is inherent in any algicidal method that destroys cells and is a predictable result of algicidal activity.
The '801 application teaches a composition comprising water (claims 3 and 4) and an algicide (curcumin), wherein “The foam can be loaded with multiple algicides that are either soluble in water or exist as particulates dispersed throughout the foam volume either in the microaqueous phase or at the bubble-water interface.” (¶[0190]). Thus, subjecting a curcuminoid to solubility process to increase solubility is not explicitly recited in the '801 claims. However, A person of ordinary skill in the art would understand that to be effective in an aqueous foam, curcumin must be solubilized or dispersed and the '801 application specification contemplates a soluble or dispersible form of curcumin. Further, the '801 application teaches applying curcumin to a waterbody. A person of skill in the art would recognize that curcumin is hydrophobic and requires solubility enhancement for aqueous application. The recited "solubility process" is a routine, well-known step (e.g., using surfactants, co-solvents, or nanosuspensions) that would have been obvious to a person of skill in the art.
Claims 24, 25, 29, and 34 of '801 the explicitly teach that the composition may "further comprise a flocculant," including a "monomeric or polymeric aluminum salt" (claim 29) or a "metal phenolic network (MPN)" (claim 34). Claim 34 teaches an "MPN" flocculant, which the specification of the '801 application explicitly discloses as being used with or as a substitute for clay. While "clay minerals" are not explicitly recited in the claims, the '801 specification teaches that MPN films can be applied with secondary flocculants including "clay particles." A person of skill in the art would recognize clay as a standard flocculant. The '801 application teaches a foam composition containing an algicide (curcumin) and optionally a flocculant. The instant claims 3-4 merely specify that the flocculant is mixed with the curcuminoid and that the flocculant comprises clay. This is a predictable selection of a known flocculant (clay) for use with a known algicide (curcumin) in a known delivery system (aqueous composition). Thus, instant claims 3-4 are obvious over the '801 application.
The '801 application teaches applying a foam to a waterbody (claim 89). Foam application inherently involves spraying or dispensing the foam from a vessel or aircraft. Additionally, it is common general knowledge in HAB mitigation that surface vessel spraying, airborne spraying, and submerged spraying are standard application methods. A person of skill in the art would have used these routine methods to apply the '801 foam composition. Furthermore, the application methods recited in instant claim 9 are conventional, well-known, and routine in HAB mitigation. A person of ordinary skill in the art would have applied the '801 foam composition using these standard techniques without any inventive effort. Therefore, instant claim 9 is not patentably distinct from the '801 application.
To overcome the provisional non-statutory double patenting rejection, the applicant may file a terminal disclaimer under 37 C.F.R. § 1.321(c) disclaiming any term of the patent granted on this application that would extend beyond the expiration date of the patent granted on any commonly owned patent or application that claims the same invention or an obvious variation thereof. Alternatively, the applicant may amend the claims to be patentably distinct from the co-pending references, or traverse the provisional rejection with substantive arguments why the claims are patentably distinct, specifically addressing why the '801 application (with curcumin) does not render the instant claims obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights