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 .
DETAILED ACTION
Action Is Final, Necessitated by Amendment
Applicants' response to the Non-Final Office Action mailed 13 January 2025, has been entered and the Remarks therein, filed 09 June 2025, are fully considered here.
This action is a Final Office Action, based on new grounds under 35 U.S.C. §112(b), and 35 U.S.C. §103 over Kim et al. in view of Gibbons et al., necessitated by Applicants’ amendment received 09 June 2025, specifically, amended claims 11 and 16. See MPEP 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Status of Claims
Claims 1-20 are pending.
Claims 1-10 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group I. Election is being considered as an election without traverse with regard to the reply filed on 15 October 2024 to the Restriction/Election Office Action mailed 07 October 2024.
Claims 11-20 are rejected.
Claim 11 is objected to.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. This application repeats a substantial portion of prior Application No. 17/093,557, filed 11/09/2020, adds and claims additional disclosure not presented in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, the application constitutes a continuation-in-part of the prior application. The parent application claims benefit of 63/052,745, filed 07/16/2020, claims benefit of 63/039,694, 06/16/2020, claims benefit of 63/036,274, 06/08/2020, claims benefit of 63/035,797, 06/07/2020, claims benefit of 62/932,684, 11/08/2019, and claims benefit of 63/145,738, filed 02/04/2021.
Applicant has claimed the benefit of the filing date of the prior application, and designates the instant application as a "CIP" of 17/093,557.
Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
It is noted that the instantly-claimed subject matter (i.e., a method of preventing, treating or providing a prophylactic against Acute Hepatopancreatic Necrosis Syndrome (AHPND)/Early Mortality Syndrome (EMS) caused by Vibrio species in shellfish) was first described in provisional application 63/145,738.
Therefore, claims 11-20 have the effective filing date of 04 February 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09 June 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Drawings
The objection to the drawings received 04 February 2022, cited in the Non-Final Office Action mailed 13 January 2025, is withdrawn in view of Applicants' amendment received 09 June 2025.
Replacement drawings were received on 09 June 2025. These drawings are accepted.
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), MPEP 608.01(o), MPEP 608.01(l) and MPEP 2173.03. See also MPEP 2163.06 (III). Correction of the following is required:
Sequence Compliance
(2) Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Appropriate correction is required.
It is noted that Applicant supplied an 'incorporation by reference' paragraph; however, the submission is defective for the following reasons:
1) The paragraph is not added to the specification at the preferred location in the specification. The paragraph should be added either before or after the "Cross Reference to Related Applications" paragraph and be entitled "Reference to an Electronic Sequence Listing".
Applicant added the paragraph at the end of the body of the specification and designated the paragraph with continued numbering "[00262]".
2) Although Applicant submitted two 'substitute' specifications on 09 June 2025, each is not labeled as "clean" or "marked-up".
3) The paragraph does not include a "no new matter" statement (although Applicant contends that it does). Applicant filed an amended sequence listing on 09 June 2025, which would require a 'no new matter' clarification.
It is also noted that Applicant's substitute specification (filed as what appears to be the 'clean' copy) contains a term with amendment markings. The misspelled word 'salinity', on pg. 56 in continued Table 8, contains letters which are visibly crossed out.
Claim Objections
The objections to Claims 11, 16 and 18, in the Non-Final Office Action mailed 13 January 2025, are withdrawn in view of Applicants' amendment received 09 June 2025, in which the cited claims were amended.
Claim 11 is objected to because of the following informalities:
Claim 11 recites: "...containing fermented soy, an ash content of up to about 4%, and Aureobasidium pullulans (A. pullulans) biomass...", which should read: "...containing fermented soy, an ash content of up to about 4%, and an Aureobasidium pullulans (A. pullulans) biomass..."
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
35 U.S.C. § 112(b)
The rejection of Claims 11-20 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 pre-AIA the applicant regards as the invention, in the Non-Final Office Action mailed 13 January 2025, is withdrawn in view of Applicants’ amendment received 09 June 2025, in which the cited claims were amended.
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.
Claim 16 is 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 pre-AIA the applicant regards as the invention.
[This rejection cited in view of Applicant's amendment.]
Claim 16 is indefinite, because it recites insufficient, improper or unclear antecedent basis for the limitations in the claim(s).
Claim 16 recites: "The method of claim 11,..., wherein the HQPC comprises a low-pullulan yielding A. pullulans and..."
Claim 11 recites: "...comprising a High Quality Protein Concentrate (HQPC) containing..., and Aureobasidium pullulans (A. pullulans) biomass..."
However, it is not clear if the low-pullulan yielding A. pullulans microbe is the same microbe as the A. pullulans which is contained within the biomass described in claim 11. That is, it is not clear if the HQPC comprises two different strains of A. pullulans.
For the purpose of proper antecedent basis, claim 16 could read: "The method of claim 11,..., wherein the HQPC comprises the A. pullulans biomass as a low-pullulan yielding A. pullulans and..."
Other language will be considered.
Claim Interpretations
(1) Claim 11 recites an intended use in its preamble language.
Claim 11 recites: “A method of preventing, treating or providing a prophylactic against Acute Hepatopancreatic Necrosis Disease (AHPND)/Early Mortality Syndrome (EMS)… in shrimp comprising…”
The phrase as an intended use merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations. Also, the intended use terminology does not limit the structure or method steps of the claimed invention. Therefore, the phrase as an intended use does not limit the scope of the claimed subject matter. (See MPEP 2111.02 (I)(II).) That is, the intended use recited in the preamble does not result in a structural or manipulative difference between the claimed invention and the prior art. Deletion of the preamble phrase does not affect the structure or steps of the claimed invention (MPEP 2111.02 (II)).
On the other hand, the limitation(s) cited in the preamble language may be addressed at the discretion of the Examiner.
(2) Claim 11 recites inherent claim language.
Claim 11 recites: “A method of preventing, treating or providing a prophylactic against Acute Hepatopancreatic Necrosis Disease (AHPND)/Early Mortality Syndrome (EMS) caused by Vibrio species in shrimp…”
Li et al. ((2017) Appl. Env. Microbiol. 83(13): 1-17 (cited in previously and on the record)) teaches that acute hepatopancreatic necrosis disease (AHPND) is a newly emerging shrimp disease that has severely damaged the global shrimp industry. AHPND is caused by toxic strains of Vibrio parahaemolyticus that have acquired a “selfish plasmid” encoding the deadly binary toxins PirAvp/PirBvp (pg. 1, Abstract). The conjugative transfer and mobilization genes carried on this toxic plasmid could facilitate its spread to V. parahaemolyticus strains all over world and to other Vibrio species (pg. 12, lines 3-5).
That is, AHPND and EMS appear to only be caused by a strain of Vibrio bacterium.
Therefore, for the purpose of examination, prior art which shows that feeding shellfish or shrimp larvae a feed composition comprising a High Quality Protein Concentrate results in a reduction or elimination of Vibrio sp bacteria, will also be considered to prevent or treat AHPND and/or EMS. Alternatively, prior art which shows that feeding shellfish or shrimp larvae a feed composition comprising a High Quality Protein Concentrate results in the prevention or treatment of AHPND/EMS will also be considered to reduce or eliminate Vibrio sp bacteria.
In addition, Li et al. teaches that acute hepatopancreatic necrosis disease (AHPND) was previously named early mortality syndrome (EMS) (pg. 2, para. 1).
In addition, the instant specification recites: “As used herein, ‘AP4 toxin’ refers to the PirvpA gene product…” (originally-filed specification, pg. 13, para. [0083]). Therefore, prior art that shows shellfish infected with AHPND will be considered to harbor a Vibrio sp containing PirAvp/AP4 toxin (e.g., Kim et al. cited below).
(3) Claim 11 recites the term “High Quality Protein Concentrate (HQPC)”.
The specification recites: “…, ‘HQPC’ means high quality protein concentrate from one or more fermented plant-based materials. Such HQPC may be used as a feed, feedstock, alone or in combination with other feed or feedstock constituents, a pro-biotic, or a constituent thereof,…” (originally-filed specification, pg. 14, para. [0093]).
That is, the specification describes the source of the high quality protein concentrate (i.e., fermented plant-based materials), but not the contents or ingredients of said HQPC.
Therefore, for the purpose of examination, prior art which shows a feed composition comprising protein derived from (a) fermented plant-based material(s) or which contains (a) fermented plant-based material(s) which comprise(s) protein, will be considered to be applicable prior art; i.e., will be considered to be a High Quality Protein Concentrate. In addition, a feed composition comprising a plant-based material and a microorganism that can feed or ferment said plant-based material will be considered to be a High Quality Protein Concentrate.
(4) Claim 12 recites the relative terms “high” and “hyper-intensive”.
The specification recites: “As used herein, ‘high stocking density’ for shrimp means 100 to 500 individuals/m2 in a pond or aquaculture tank. As used herein, ‘hyper-intensive stocking density’ for shrimp means greater than 500 individuals/m2 in a pond or aquaculture tank” (spec., pg. 10, para. [0067]-[0068]).
(5) Claim 16 recites the relative term “about”.
The specification recites: “As used herein, ‘about’, ‘approximately’, ‘substantially’ and ‘significantly’ will be understood by a person of ordinary skill in the art…’about’ and ‘approximately’ will mean plus or minus <10% of the particular term and ‘substantially’ and ‘significantly’ will mean plus or minus > 10% of the particular term (spec., pg. 7, para. [0054] thru pg. 8, cont. para. [0054]).
(6) Claim 16 recites the abbreviation “(dmb)”.
The specification recites: “…, the protein content of the HQPC may be about 60% to about 65%,…, about 70% to about 75% or greater (dry matter basis (dmb)) (spec., pg. 14, para. [0093]).
(7) Claim 16 recites the relative term “low”, as in “low-pullulan yielding A. pullulans”.
The specification recites: “…, for example, low pullulan yield is considered less than about 3.0 g/L when grown in yeast extract (YE) containing media,…” (spec., pg. 18, para. [00109]).
(8) Claim 20 recites the abbreviation “NIR”.
The specification recites: “As used herein, ‘NIR (near-infrared spectroscopy)’ is a non-invasive detection method for determining protein content (spec., pg. 13, para. [0085]).
Claim Rejections - 35 U.S.C. § 102
The rejection of Claims 11, 13, 14 and 17-19 under 35 U.S.C. §102(a)(1)/(a)(2) as being anticipated by Kim et al., in the Non-Final Office Action mailed 13 January 2025, is withdrawn in view of Applicants' amendment received 09 June 2025, in which claim 11 was amended.
Claim Rejections - 35 U.S.C. § 103
The rejection of Claims 11-14 and 16-19 under 35 U.S.C. §103 as being unpatentable over Kim et al. in view of Gibbons et al., in the Non-Final Office Action mailed 13 January 2025, is withdrawn in view of Applicants' amendment received 09 June 2025.
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 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 of this title, 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 11-14 and 16-19 are rejected under 35 U.S.C. §103 as being unpatentable over Kim et al. (U.S. Patent Application Publication No. 2020/0315211 A1; PCT filed: Dec. 28, 2018) in view of Gibbons et al. (U.S. Patent Application Publication No. 2013/0142905 A1).
[All references cited in the Non-Final Office Action mailed 13 January 2025.]
[This rejection cited in view of Applicant's amendment.]
Kim et al. addresses some of the limitations of claim 11.
Regarding claim 11, pertaining to a method of preventing, treating or providing a prophylactic against Acute Hepatopancreatic Necrosis Disease (AHPND)/Early Mortality Syndrome (EMS) caused by Vibrio species in shrimp,
Kim et al. shows a feed composition for preventing or treating acute hepatopancreatic necrosis disease (AHPND) or white spot syndrome (WSS), comprising a Bacillus subtilis strain, a culture medium thereof, a concentrate thereof, or a dry matter thereof as an active ingredient (pg. 1, para. [0001]). Early mortality syndrome (EMS), acute hepatopancreatic necrosis disease (AHPND), and acute hepatopancreatic necrosis syndrome (AHPNS) are rapidly growing diseases in shrimp farming, and Vibrio parahaemolyticus is an etiologic agent of these diseases (pg. 1, para. [0002]).
Further regarding claim 11, a feed composition comprising a High Quality Protein Concentrate (HQPC); wherein said HQPC is obtained in the absence of alcohol washing and/or alcohol precipitation,
[See Claim Interpretations section- (3) above.]
Kim et al. shows feed compositions (Example 1 and Example 2) comprising, minimally, wheat flour and Bacillus species (pg. 5, para. [0067], Table 2 [i.e., fermented plant-based protein]). The crude protein content of these compositions was 47.4% and 47.4% (% dry matter), respectively (pg. 5, para. [0067], cont. Table 2). The feed compositions of Examples 1 and 2 were dried at 25°C for about 24 hours using a dryer and stored at -20°C (pg. 5, para. [0067] [i.e., HQPC is obtained in the absence of alcohol washing and/or precipitation]).
Further regarding claim 11, pertaining to feeding shrimp larvae the feed composition within 20-30 days after stocking an aquaculture pond and/or aquaculture tank,
Kim et al. shows that the test of Vibrio parahaemolyticus attack on shrimps was carried out once. In the case of the Vibrio strain, AHPND (EMS)-induced strains isolated from Vietnam were used for the test. The attack test was carried out as follows: The feed compositions of the Examples were fed to shrimps for 4 weeks and then the shrimps with the same weight were distributed into 4 replicates with 96 shrimps per group (pg. 6, para. [0078]).
Kim et al. does not show a(n) HQPC comprising: 1) fermented soy [Claim 11]; 2) an ash content of up to about 4% [Claim 11]; and 3) an Aureobasidium pullulans (A. pullulans) biomass [Claim 11].
Gibbons et al. addresses some of the limitations of claim 11.
Gibbons et al. shows an organic, microbially-based system to convert plant material into a highly digestible, concentrated protein source (pg. 1, para. [0010]). The described invention is directed to a microbial-based process for High-Quality Protein Concentrate (Title [nexus to Kim et al.- a composition comprising a high quality protein concentrate (HQPC)]). The concentrated protein source is suitable for use as a feed for animals used for human consumption (pg. 1, para. [0010]). The term 'animal' includes, minimally, crustaceans such as lobster and shrimp (pg. 3, para. [0037] [nexus to Kim et al.- HQPC as a feed for shrimp]).
Regarding claim 11, pertaining to the HQPC contains fermented soy,
Gibbons et al. shows that the non-animal based protein concentrate is isolated from cereal grain and oilseed plant material, including, minimally, soybeans (pg. 1, para. [0012]). The described invention relates to incubation processes, including microbial-based aerobic fermentation processes to produce high quality protein concentrates (HQPCs) (pg. 1, para. [0004]). The term 'incubation process' may include fermentation (pg. 3, para. [0040]). In certain embodiments, performance of the HQPC, such as high-quality soy protein concentrate (HQSPC) or high-quality DDGS (HP-DDGS), may be measured (pg. 6, para. [0067]).
Further regarding claim 11, pertaining to the HQPC contains a percent ash content,
Gibbons et al. shows that the ash content of two (2) HQSPC formulations was 8.82g and 5.21g per 100g dry matter basis (pg. 13, para. [0129], Table 2 [i.e., 8.82% and 5.21%]).
Further regarding claim 11, pertaining to the HQPC contains an Aureobasidium pullulans biomass,
Gibbons et al. shows that the microbial organisms that may be used in the described process includes, minimally, Aureobasidium pullulans (pg. 4, para. [0056]). The microorganisms may be present in an incubation system, the incubation broth and/or incubation biomass (pg. 9, para. [0089]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of preventing or treating Acute Hepatopancreatic Necrosis Disease (AHPND)/Early Mortality Syndrome (EMS) caused by Vibrio species in shrimp comprising feeding shrimp larvae a feed composition comprising High Quality Protein Concentrate (HQPC), as shown by Kim et al., by including fermented soy in the HQPC, as shown by Gibbons et al., with a reasonable expectation of success, because Gibbons et al. shows a plant-based HQPC which can be fed to shrimp, which is the HQPC shown by Kim et al. (MPEP 2143 (I)(G)).
It would have been further obvious to have produced a(n) HQPC containing an ash content of up to about 4% [Claim 11], with a reasonable expectation of success, because Gibbons et al. shows HQSPC compositions which include 8.82% and 5.21% ash. In addition, Kim et al. also shows HQPC compositions which include 6.01%, 6.18%, 6.12% and 6.10% crude ash (pg. 5, para. [0067]; and Table 2 cont.). Therefore, it would have been obvious to one of ordinary skill in the art of producing a(n) HQPC feed to have used routine optimization to have developed a(n) HQPC with a desired ash content, such as up to about 4%, barring a showing of criticality for the specific limitation (MPEP 2144.05 (II) and MPEP 2144 (III)).
It would have been further obvious to have produced a(n) HQPC containing an Aureobasidium pullulans biomass [Claim 11], as shown by Gibbons et al., with a reasonable expectation of success, because Gibbons et al. shows a plant-based, microbe-containing HQPC which can be fed to shrimp, which is the HQPC shown by Kim et al. (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made those modifications, because Gibbons et al. shows that treated soy products have higher protein digestibility (pg. 4, para. [0047]).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Kim et al. further addresses the limitations of claims 13, 14, 17, 18 and 19.
Regarding claims 13 and 14, and
regarding claim 17, pertaining to V. parahaemolyticus,
[See Claim Interpretations section- (2) above.]
Kim et al. shows that at each time-point of the initiation (before infection), intermediate time (infection), and completion of the attack test of Vibrio parahaemolyticus against shrimp, two shrimp per group were randomly selected and their hepatopancreases were extracted. Part of the extracted hepatopancreas was stored in ethyl alcohol for quantitative real-time PCR (qPCR) analysis (pg. 6, para. [0081]). qPCR analysis was performed with regard to the amount of AHPND toxin present in the sampled hepatopancreas (pg. 7, cont. para. [0083]).
Regarding claim 18, pertaining to whiteleg shrimp,
Kim et al. shows that in the cited experiments whiteleg shrimp were used (e.g., pg. 5, para. [0069]; pg. 7, para. [0092]; pg. 10, para. [0129]; and pg. 10, para. [0139]).
Regarding claim 19, in the case of the white spot syndrome virus (WSSV), viruses isolated from whiteleg shrimps (Litopenaeus vannamei) infected with WSSV were obtained from domestic farms and used for the test (pg. 11, para. [0142] [i.e., Litopenaeus vannamei is the genus/species name for whiteleg shrimp]).
Gibbons et al. further addresses some of the limitations of claims 12 and 16.
Regarding claim 12, pertaining to the HQPC content of the feed composition,
Gibbons et al. shows formulations in which the high quality soy protein concentrate (HQSPC) is 45% (based on grams of dry weight) of the formulations (pg. 14, para. [0138], Table 3). Other diet formulations contain 35% HQSPC (pg. 17, para. [0159], Table 7). The 35% inclusion level was used to exceed the 30% inclusion recommended for other soy protein concentrates (SPC) (pg. 17, para. [0160]).
Therefore, barring a showing of criticality for the specific limitation, one of ordinary skill in the art of feed production would have used routine optimization to have determined the optimal amount of HQPC/protein content in a feed composition, such as between 1% and 10% [Claim 12], depending on, for example, the type of animal receiving said feed composition and whether the feed composition is the only feed or a supplementary feed in the animal’s diet (MPEP 2144 (I) and (III)).
Further regarding claim 12, it would have been obvious to have fed the feed composition to shellfish at high stocking density or at hyper-intensive stocking density [Claim 12], with a reasonable expectation of success, because Kim et al. shows an experiment in which 96 shrimps per group were tested for their resistance to a V. parahaemolyticus attack (pg. 6, para. [0074]) (see Claim Interpretations section– (4) above) (MPEP 2143 (I)(G)).
Therefore, barring a showing of criticality for the limitation, it would have been obvious (and one of ordinary skill in the art would have been motivated) to have fed the feed composition to shellfish at a high stocking density in order to try to prevent from or to treat as many shellfish as possible for AHPND/EMS, in view of the “treatment regimen” being merely feeding said shellfish the feed composition.
Regarding claim 16, pertaining to the feed comprises distiller's dried grains with solubles,
Gibbons et al. shows that in some embodiments, the plant material of the non-animal based protein concentrate is from distiller’s dried grains with solubles (DDGS) (pg. 1, para. [0015]; and pg. 4, para. [0051]).
Further regarding claim 16, pertaining to the HQPC comprises fermented plant product containing low-pullulan yielding A. pullulans,
Gibbons et al. shows that, in one aspect, the composition containing a non-animal based protein concentrate contains Aureobasidium pullulans (pg. 1, para. [0011]). From the HQSPC yields and protein levels, the following were noted: 1) an incubation pH of 3-3.5 and temperature of 30-32°C., along with high aeration maximized growth of A. pullulans and minimized pullulan production (pg. 12, para. [0113]).
Further regarding claim 16, pertaining to the protein content (dmb) of the HQPC is from at least about 65% to about 75%,
Gibbons et al. shows that the protein content of two (2) HQSPC formulations was 61.61g and 56.86g per 100g dry matter basis (pg. 13, para. [0129], Table 2). The protein content of the composition is in the range of from about 56% to about 90% on a dry matter basis (pg. 1, para. [0013]).
Further regarding claim 16, pertaining to a potassium or magnesium content of less than about 0.1 ppm [= 0.00001%],
Both Kim et al. and Gibbons et al. are silent on whether or not potassium or magnesium is detectable in the described HQPC, let alone at 0.1ppm or 0.00001%. In addition, complex spectroscopy instrumentation (e.g., atomic absorption spectroscopy) is required to detect magnesium or potassium down to the negligible level of 0.1ppm. (Applicant has not shown that this measurement has been made by way of verifying the level of magnesium or potassium in the HQPC.)
Therefore, barring a showing of criticality for the specific limitation, it would have been obvious to have not measured the levels of potassium or magnesium in the HQPC, as shown by Kim et al. and Gibbons et al., and understood that the HQPC would have barely detectable levels of magnesium or potassium, in view of the silence of Kim et al. and Gibbons et al.
Claim 15 is rejected under 35 U.S.C. §103 as being unpatentable over Kim et al. in view of Gibbons et al., as applied to claims 11-14 and 16-19 above, and further in view of Dangtip et al. ((2015) Aquacul. Rep. 2: 158-162).
[Dangtip et al. cited in the Non-Final Office Action mailed 13 January 2025.]
Kim et al. in view of Gibbons et al., as applied to claims 11-14 and 16-19 above, do not show: 1) the primers for PCR comprise sequences as set forth in SEQ ID NO: 23 and SEQ ID NO: 24 [Claim 15].
Dangtip et al. addresses the limitations of claim 15.
Dangtip et al. teaches that the mechanism of virulence of Vibrio parahaemolyticus that causes acute hepatopancreatic necrosis disease (VPAHPND) is mediated by a binary Pir-like toxin pair ToxA and ToxB (pg. 158, Abstract [nexus to Kim et al.- a toxin produced by Vibrio causes AHPND]). Described is an AP4 (abbreviation of AHPND detection version 4) method for targeting the tandem genes ToxA and ToxB in a two-tube nested PCR method (pg. 158, Abstract [nexus to Kim et al.- PCR method for detecting Vibrio toxin] [see instant claim 14- AP4 toxin]).
Regarding claim 15, Dangtip et al. shows that details of the primers and PCR conditions are given in Tables 1–3 (pg. 159, column 2, para. 2.1). Table 1 shows the primers for the AP4 method, which include AP4-R1 and AP4-F2 (pg. 160, Table 1).
Comparison of the AP4-R1 and AP4-F2 primers to instantly-claimed SEQ ID NO.: 23 and SEQ ID NO.: 24 demonstrate that AP4-R1 is the same nucleotide sequence as SEQ ID NO.: 23, and AP4-F2 is the same nucleotide sequence as SEQ ID NO.: 24.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of preventing or treating AHPND/EMS caused by Vibrio species in shellfish comprising feeding shellfish larvae a feed composition comprising High Quality Protein Concentrate (HQPC), as shown by Kim et al. in view of Gibbons et al., as applied to claims 11-14 and 16-19 above, by adding a method step comprising evaluating the shellfish for the presence of Vibrio species via PCR detection of AP4/AHPND toxin, as shown by Kim et al., and by using the specific PCR primers represented by SEQ ID NOs.: 23 and 24 [Claim 15], as shown by Dangtip et al., with a reasonable expectation of success, because Dangtip et al. shows a PCR method for detecting AP4 toxin (i.e., ToxA and ToxB), which is the method for detecting AHPND toxin in shrimp infected with V. parahaemolyticus, as shown by Kim et al. (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because one of ordinary skill in the art of determining the presence of Vibrio sp in shellfish would prefer to use primers that detect the presence of not only ToxA, but ToxB as well, in order to increase the accuracy and predictive value of determining whether or not said shellfish are infected with a Vibrio sp. Dangtip et al. shows that testing of the method revealed that it gave 100% positive and negative predictive values for VPAHPND using a panel of 104 bacterial isolates including 51 VPAHPND isolates and 53 non-AHPND isolates, the latter including 34 isolates of V. parahaemolyticus and 19 isolates of other bacteria found in shrimp ponds, including other Vibrio species (pg. 158, Abstract). ToxA and ToxB are present only in a protein sub-fraction of cell-free culture broth from isolates of V. parahaemolyticus that cause AHPND (VPAHPND), but not from similar sub-fractions of protein from broth of non-AHPND V. parahaemolyticus cultures or of other bacteria that do not cause AHPND (pg. 158, column 2, last two lines thru pg. 159, lines 1-4).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim 20 is rejected under 35 U.S.C. §103 as being unpatentable over Kim et al. in view of Gibbons et al., as applied to claims 11-14 and 16-19 above, and further in view of Fan et al. ((2016) PLoS ONE 11(9): 1-12).
[Fan et al. cited in the Non-Final Office Action mailed 13 January 2025.]
Kim et al. in view of Gibbons et al., as applied to claims 11-14 and 16-19 above, do not show: 1) said HQPC exhibits a shift downward in a raw NIR spectra between 4664cm-1 and 4836cm-1 relative to the feed stock from which it is produced [Claim 20].
Fan et al. addresses some of the limitations of claim 20.
Fan et al. shows that near-infrared spectroscopy was combined with chemometrics to construct a hybrid model for the non-invasive detection of protein content in different types of plant feed materials. 829 samples of plant feed materials, which included corn distillers’ dried grains with solubles (DDGS), corn germ meal, corn gluten meal, distillers’ dried grains (DDG) and rapeseed meal, were collected from markets in China (pg. 1, Abstract [nexus to Gibbons et al.- a high quality protein concentrate made from and/or including DDGS]). Due to the shortage of protein-based feed materials, plant feed materials are popularly used in China. The protein content in feed materials is essential for livestock diet formulation and is a major determinant of the feed price. Near-infrared reflectance (NIR) spectroscopy is a rapid, non-invasive, reliable and environmentally friendly detection technology and has been successfully used to determine the protein content in many feed materials (pg. 2, para. 1).
Regarding claim 20, Fan et al. teaches that wavenumbers around 4500 cm-1, 4664 cm-1 and 4836 cm-1 were found to be the key wavenumbers in modeling protein content in these plant feed materials (pg. 1, Abstract).
Fan et al. further teaches that the wavenumbers are closely related to the chemical structure of proteins; specifically, 4500 cm-1 and 4660 cm-1 are associated with the combination of the N-H, C-N and C = O vibrations of the amide group; 4836 cm-1 is associated with the N-H vibration of proteins; 5684 cm-1 and 5724 cm-1 are associated with the C-H vibration of lipids, respectively, and 6728 cm-1 is associated with the N-H vibration of aromatic amines. However, different plant feed materials had distinctive VIP (variable importance in the projection) scores peaks, even for materials with the same origin (pg. 6, lines 2-6 thru para. 1). Results indicate that corn DDGS and corn gluten meal significantly differ in protein content, more specifically, in the aliphatic and aromatic amino acid contents. The results imply that distinctive VIP score peaks of different plant feed materials can be used to express their chemical composition characteristics (pg. 6, last two lines to pg. 8, lines 1-8).
That is, Fan et al. teaches that the NIR wavenumbers indicate the amino acid content of the protein in the type of sample being analyzed.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of preventing or treating AHPND/EMS caused by Vibrio species in shellfish comprising feeding shellfish larvae a feed composition comprising High Quality Protein Concentrate (HQPC), as shown by Kim et al. in view of Gibbons et al., as applied to claims 11-14 and 16-19 above, by determining a downward shift in raw NIR spectra of between 4664cm-1 and 4836cm-1 of the HQPC relative to the feed stock from which it is produced [Claim 20], with a reasonable expectation of success.
Fan et al. shows that NIR spectra of 4664cm-1 and 4836cm-1 are predictive of the presence of protein in plant feed materials, specifically, specific types of plant feed material, as well as specific amino acid content of the protein. Therefore, it would have been obvious (and one of ordinary skill in the art would have been motivated) to have analyzed the HQPC to determine that its protein content is at an optimal amount and amino acid composition via the NIR analysis, shown by Fan et al. (MPEP 2143 (I)(G)), for its intended use.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 17/093,557.
The claimed subject matter of instant Application No. 17/665,113 is:
Claim 11. A method of preventing, treating or providing a prophylactic against Acute Hepatopancreatic Necrosis Disease (AHPND)/Early Mortality Syndrome (EMS) caused by Vibrio species in shrimp. The method comprises feeding shrimp larvae a feed composition comprising High Quality Protein Concentrate (HQPC). The HQPC contains: 1) fermented soy; 2) an ash content of up to about 4%; and 3) an Aureobasidium pullulans biomass. The HQPC is obtained in the absence of alcohol washing and/or alcohol precipitation. The shrimp larvae should be fed the composition within 20-30 days after stocking an aquaculture pond and/or aquaculture tank.
The claimed subject matter of copending Application No. 17/093,557 is:
Claim 1. A composition comprising a non-animal based protein concentrate. The non-animal based protein concentrate contains a fermented plant product and contains a microbe.
The non-animal based protein concentrate contains at least between 65% to about 75% protein content (dry matter basis), and
an ash content of less than 2.5% or not greater than about 4% (dry matter basis).
The concentrate is obtained in the absence of alcohol washing and/or alcohol precipitation.
Claim 2. The microbe is Aureobasidium pullulans, and produces less than about 3.0g/L pullulan when grown in a medium comprising between 0.35 and 0.5g/L yeast extract.
Claim 3. The non-animal based protein concentrate is derived from plant material from the group consisting of soybeans, sorghum, peanuts, pulses, rapeseeds, oats, barley, rye, lupins, fava beans, canola, peas, sesame seeds, cottonseeds, palm kernels, barley, grape seeds, olives, safflowers, sunflowers, copra, com, coconuts, linseed, hazelnuts, wheat, rice, potatoes, cassavas, legumes, camelina seeds, mustard seeds, germ meal, com gluten meal, distillery/brewery by-products, and combinations thereof.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the composition comprising a non-animal based protein concentrate, described in copending Application No. 17/093,557 anticipates both the feed composition comprising a high quality protein concentrate and the method of its use, described in instant Application No. 17/663,113 in view of the following definitions or descriptions of some of the terms cited in the applications.
For example, the instant specification describes the high quality protein concentrate (HQPC) as a high quality protein concentrate from one or more fermented plant-based materials (originally-filed specification, pg. 14, para. [0093]).
The instant specification describes a low-pullulan yielding A. pullulans as producing a pullulan yield that is less than about 3.0 g/L when grown in yeast extract (YE) containing media, where YE (as nitrogen source) is present between 0.35 and 0.5 g/L (spec., pg. 18, para. [00109]).
This is a provisional nonstatutory double patenting rejection because the patentably distinct claims have not been patented.
Response to Arguments
Applicant’s arguments, pp. 10-13, filed 09 June 2025, with respect to the prior art references cited in the 35 U.S.C. §103 rejection(s), have been fully considered but they are either not persuasive or are moot because the arguments do not apply to the references as they are applied in the context of the current rejection, or as new grounds necessitated by Applicant’s amendment, in which claims 11 and 16 were amended.
1. Applicant remarks (pg. 10, para. 6) that the protein concentrate as recited would not result from the processes as taught or suggested by Kim et al. alone or in combination with Gibbons et al., this is because the contents of a protein concentrate obtained by alcohol washing/precipitation would not contain the same alcohol soluble components as a protein concentrate obtained in the absence of alcohol washing/precipitation. Thus, a method containing the protein concentrate element as claimed would not be obvious in view of the cited references.
However, in response to Applicant, Kim et al. does not show using alcohol washing and/or alcohol precipitation in the HQPC production process. Kim et al. only uses the term 'ethyl alcohol' within the context of preserving the hepatopancreases extracted from shrimp (in order to conduct histopathological analyses) (Kim et al., pg. 6, para. [0081]). Gibbons et al. teaches that alcohol precipitation and centrifugation is an optional process (pg. 5, para. [0060]).
2. Applicant remarks (pg. 10, para. 7 thru pg. 11, para. 1) that to reiterate, Applicant submits the composition of an alcohol washed/precipitated plant-based protein product would not be the same as that of a plant-based protein product obtained in the absence of alcohol washing/precipitation. Not only does Gibbons et al. not teach the ash content of the protein products disclosed in the instant claims, but in addition, Gibbons et al. teach that alcohol precipitation can result in a protein product that has an ash content which is higher than what is typical for the feedstock from which it is derived. Even if the processes taught or suggested by Gibbons et al. could achieve the ash content as claimed, the resulting product would not be the same as the claimed product because alcohol soluble components, and thus, alcohol soluble component contents, would be fewer and concentrations lower compared to the recited concentrate. And that fact is not cured by Kim et al.
However, in response to Applicant, as noted above, Gibbons et al. teaches an alcohol extraction process, not an alcohol washing or precipitation step (pg. 13, cont. para. [0128]). In any case, Gibbons et al. teaches that alcohol precipitation is optional. In addition, Applicant does not indicate where in the document Gibbons et al. teaches that alcohol precipitation can result in a higher ash content than what is "typical" for the feedstock from which it is derived. Therefore, this comment appears to be opinion evidence, not supported by factual information. On the other hand, in the event that this information is true (i.e., that alcohol precipitation can result in a higher ash content than what is "typical" for the feedstock from which it is derived), then the source of the information would provide motivation for not incorporating alcohol washing and/or precipitation into the method.
3. Applicant remarks (pg. 12 thru pg. 13), with regard to the 103 rejections of dependent claims 15 and 20, that the deficiencies of Kim et al. and Gibbons et al. are not cured by Dangtip et al. or Fan et al.
However, in response to Applicant, the secondary references of Dangtip et al. and Fan et al. address dependent claim limitations which are unrelated to Applicant's statement about the result of obtaining a protein concentrate via alcohol washing/precipitation, which is addressed by Kim et al. and Gibbons et al. above.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON M PAPCIAK whose telephone number is (571)272-6235. The examiner can normally be reached M-F 8:30am-5:00pm.
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