DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1-6 are pending and under consideration in this action.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities: it is noted that the claims list steps as “a. … b. … c. … d. ….” As per MPEP 608.01(m), “[e]ach claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.” Thus, is it suggested the listing elements be amended as, for example “(a) … (b) … (c) … (d)…” or the like. Appropriate correction is required.
Claims 1 and 4 are objected to because of the following informalities: “~” in step (c) should be a dash.
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 1-6 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.
With regards to Claim 1, because of the inconsistent use of “KHP solution” and “solution” throughout the body of the claim, and without recitation of what the solution/mixture is called after a particular step is done, it is unclear what the actual composition is that is ultimately applied in step (d). Furthermore, because of the inconsistent usage of the term “KHP solution” and “solution”, it is unclear if each have antecedent basis, and/or if the terms are referring to the same thing.
Step (a) recites “preparing the KHP solution by mixing 66 kg of feathers … and 44 kg of water in a sealed container.” Step (b) recites hydrolyzing the mixture (referring to the mixture of feathers and water in step (a)), but as currently written, it is unclear if the product resulting from the hydrolyzing step (b) is also the “KHP solution” or something else.
Step (c) recites “using a mass spectrometer to confirm the combination of peptides in the solution”, but as currently written, it is unclear if “the solution” is referring to “the KHP solution” recited in step (a) or the hydrolyzed solution in step (b).
Step (d) recites “applying the KHP solution”, but as currently written, it is unclear if it is referring to “the KHP solution” of step (a) or the hydrolyzed solution of step (b).
For improved clarity, Examiner suggests, for example, amending steps (a) and (b) to recite: “(a) Preparing a mixture by mixing 66 kg of feathers … and 44 kg of water…; (b) hydrolyzing the mixture … for a duration of 40 minutes to form the KHP solution ….” (or the like).
Further, for improved clarity, Examiner suggests, for example, amending step (c) to recite: “(c) using a mass spectrometer to confirm the combination of peptides in the KHP solution ….” (or the like).
As Claim 4 recites similar language to claim 1, claim 4 is indefinite for the same reasons discussed above for claim 1.
Further regarding Claims 1 and 4, the claims recite “preparing the KHP solution by mixing … feathers … and water ….” Although Applicant can be their own lexicographer, the specification does not appear to have a special definition for “solution”, and the definition of solution as known by one of ordinary skill in the art is “a homogenous mixture of two or more substances”. In the claimed step (a), the mixture would result in a suspension/dispersion, not a solution (i.e., a homogenous mixture), of feathers in water. Therefore, it is unclear how one could obtain a solution by mixing feathers and water (e.g., are additional components required to be included or additional steps required to form a homogenous mixture?). Claims 2, 3, 5, and 6 also recite “the solution”. Thus, the metes and bounds of the claims cannot be determined.
Further regarding Claims 1 and 4, the claims are indefinite as they recite “…contain at least 253 peptides as listed in the specification…” in step (c). As per MPEP 2173.05(s), “Where possible, claims are to be complete in themselves.” Incorporation by reference to a specific table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is by a necessity doctrine, not for applicant’s convenience.” In the present case, the peptides may be recited in the claims directly as, for example, “amino acid sequences of SEQ ID Nos.: 1-253”. Furthermore, the limitation is indefinite because the list of peptides incorporated by the specification appears to only include 253 peptides. However, the phrase “at least” means additional peptides may be included. It is unclear if the limitation is intended to mean (i) that the solution contains at least 253 peptides, and if there more than 253 peptides that 253 of the peptides included must be those of SEQ ID Nos. 1-253; (ii) the solution contains at least 253 peptides and must contain at least one of those listed in SEQ ID Nos. 1-253; or (iii) the peptides in the solution are only limited to those explicitly recited in the specification (in which case it is unclear where else in the specification beyond the 253 peptides explicitly listed are).
Further regarding Claims 1 and 4, “their molecular masses are between 500 and 4,000 Daltons” in step (c) is indefinite because it is unclear if the limitation is referring to the mass of each individual peptide or the mass of the combination of all “at least 253” peptides.
Further regarding Claims 1 and 4, “the concentration is in the range of 2.0 x 105 ~ 4.5 x 105” in step (c) is indefinite because it is unclear if the limitation is referring to the concentration of each individual peptide or the concentration of the combination of all “at least 253” peptides.
Further regarding Claims 1 and 4, the claims recite the limitation “the lettuce plants” in the first line of step (d). There is insufficient antecedent basis for this limitation because the only previous mention is directed to “lettuce leaves” in the preamble of the claim, which does not necessarily indicate it is directed to the entire lettuce plant(s) (e.g., it may be to individual, already harvested lettuce leaves). Furthermore, the limitation “the soil” in the first line of step (d) lacks antecedent basis as there is no previous mention of “soil containing lettuce plants”.
Claims 2, 3, 5, and 6 are subsequently rejected as they ultimately incorporate the limitations of either claims 1 or 4 as discussed above and do not remedy the issues discussed above.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following Copending Applications in view of Wei et al. (Wei) (US 2016/0095314 A1; published Apr. 7, 2016):
Claims
Copending Application No.
Crop
1-8
18/527,787
1-8
18/534,628
grape
1-8
18/537,395
cotton
1-12
18/389,780
grape
1-6
18/533,181
tea plant
9-16
18/536,211
wheat
1-5
18/403,246
cucumber
1-4
18/412,611
corn
1-3
18/418,259
corn
1-4
18/412,615
wheat
1-4
18/408,257
wheat
1-6
18/645,293
lettuce
1-3
18/642,007
corn
1-6
18/643,738
wheat
1-7
18/643,756
corn
1-8
18/658,834
soybean
1-6
18/658,824
corn
1-4
18/671,837
wheat
1-10
18/748,493
corn
1-10
18/758,140
tea plant
1-4
18/902,317
farming plants
1-9
18/898,195
rice
1-3
18/409,790
cotton
1-4
18/409,792
cotton
1-8
18/428,193
tomato
1-5
18/531,687
coffee
1-9
18/639,751
soybean
1-3
18/639,950
soybean
1-4
18/642,445
asparagus
1-8
18/642,487
cotton
1-3
18/645,354
soybean
1-8
18/656,153
tomato
1-6
18/671,848
soybean
1-8
18/758,198
cotton
1-6
18/774,885
melon
1-6
18/778,049
cabbage
1-6
18/668,598
cotton
Although the claims at issue are not identical, they are not patentably distinct from each other because all cited claim sets are drawn to the same method of treating a plant species (“crop” column of above table) comprising preparing a KHP solution by mixing a keratin product (e.g., feathers) with overlapping water content and overlapping and/or similar amount of water in a sealed container, hydrolyzing said mixture in the sealed container under overlapping and/or similar temperature and pressure conditions, confirming the solution has the 253 peptides (SEQ ID Nos.: 1-253) with the same and/or overlapping molecular masses and concentration via mass spectrometer analysis, and applying said KHP solution, which has been diluted with water (in overlapping and/or similar ratio ranges) to the plant species via leaf spray or soil infusion at various times of plant development. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
The primary difference is that the copending applications recite different crop plant species (see species in “crop” column of above table) that is treated by the same method steps with the same composition. Wei is relied upon for this disclosure. The teachings of Wei are set forth herein below.
Wei teaches that peptide compositions are known to treat plants or plant seeds for example, when it is known that harvested cuttings or fruit or vegetables are intended to be shipped great distances or stored for long periods of time post-harvest. Peptide compositions are known to modulate plant biochemical signaling, impart disease resistance to plants, enhance plant growth, impart tolerance to biotic and abiotic stresses, impart post-harvest disease resistance to fruit or vegetable, and enhance the longevity of fruit or vegetable ripeness (abstract; para.0498, 0500). Among the plants suitable for treatment include, for example, asparagus, cabbage, grapes, coffee, corn, cotton, cucumber, lettuce, melon, rice, soybean, tea, tomato, watermelon, and wheat (par.0501).
Such teachings provide support in the prior art that a peptide composition can provide enhanced plant yield and other aforementioned benefits to a large variety of plants, including lettuce and the copending crop species. Therefore, it would have been prima facie obvious before the effective filing date of the instant invention to use the method of the copending claims and choose application to lettuce from the limited number of plants disclosed by Wei as a design choice, with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so as Wei specifically indicated that peptide compositions are effecting at enhancing plant yield and providing other benefits to a vast array of plants, including lettuce. By doing such, one of ordinary skill in the art would have chosen from a finite number of predictable solutions and would have used the identified lettuce as suitable to be used in the copending claimed method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that a Notice of Allowance has been issued for Copending Application No. 18/668,598.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,527,269 B2 (USPN 269) in view of Wei et al. (Wei) (US 2016/0095314 A1; published Apr. 7, 2016).
Although the claims at issue are not identical, they are not patentably distinct from each other because all cited claim sets are drawn to the same method of treating a plant species (soybean in the case of USPN 269; lettuce in the instant claims) comprising preparing a KHP solution by mixing a keratin product (e.g., feathers) with overlapping water content and overlapping and/or similar amount of water in a sealed container, hydrolyzing said mixture in the sealed container under overlapping and/or similar temperature and pressure conditions, confirming the solution has the 253 peptides (SEQ ID Nos.: 1-253) with the same and/or overlapping molecular masses and concentration via mass spectrometer analysis, and applying said KHP solution, which has been diluted with water (in overlapping and/or similar ratio ranges) to the plant species via leaf spray or soil infusion at various times of plant development. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
The primary difference is that the copending applications recite different crop plant species that is treated by the same method steps with the same composition. Wei is relied upon for this disclosure. The teachings of Wei are set forth above and incorporated herein.
Such teachings of Wei provide support in the prior art that a peptide composition can provide enhanced plant yield and other aforementioned benefits to a large variety of plants, including lettuce and the copending crop species. Therefore, it would have been prima facie obvious before the effective filing date of the instant invention to use the method of the copending claims and choose application to lettuce from the limited number of plants disclosed by Wei as a design choice, with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so as Wei specifically indicated that peptide compositions are effecting at enhancing plant yield and providing other benefits to a vast array of plants, including lettuce. By doing such, one of ordinary skill in the art would have chosen from a finite number of predictable solutions and would have used the identified lettuce as suitable to be used in the copending claimed method.
Relevant Prior Art Teachings
The following prior art references are briefly discussed to show the state of the art.
Bhari et al. (Current Microbiology; published 2021) discloses that chicken feathers have 92% keratin that can be a good source of peptides, amino acids, and minerals. The formulation of hydrolysate from chicken feathers can be used as bioactive peptides, protein supplement, livestock feed, biofertilizer, etc. The plant growth promoting activities of hydrolysate potentiates its possible use in organic farming, and improves soil ecosystem and microbiota (abstract). Keratinous waste, e.g., feathers, are known to be treated via hydro-thermal methods (high pressure and temperature), chemical methods (acid, alkali or solvents), and biological methods (keratinolytic microbes) (Fig. 2).
Cheng et al. (Bioresources Technology; published 2008) discloses that hydrolysis of biomass waste (e.g., feathers) to produce amino acids was studied in sub-critical water, with reaction temperatures from 180 to 320 oC and reaction pressures from 3 to 30 MPa (about 30.6 to 305.9 kg/cm2). The results showed that the controlling of reaction atmosphere, pressure, temperature, and time of hydrolysis is very important to obtain high yield of amino acid; most of amino acids reached maximum yield at reaction temperature range of 200-290 oC and reaction time range of 5-20 min. There are obvious changes of amino acids yield at reaction temperatures of 6-16 MPa and reaction temperature around 260 oC (abstract).
Nurdiawati et al. (Applied Soil Ecology; published 2019) discloses that utilization and management of biomass residues are important global issues to ensure sustainability in agricultural production. Among biomass residues, a feather is one of the excellent raw materials for fertilizer because it has high nitrogen content. Through hydrolysis, liquid feather hydrolysates could be obtained that are potentially desirable for use in agriculture practices. In the study, Nurdiawati discloses four liquid feather hydrolysates produced by hydrothermal treatment under various temperatures and one commercial liquid fertilizer were added to two adjacent soils and evaluated for nitrogen mineralization behavior in a 30-day incubation study (abstract).
Nurdiawati discloses that feathers are proteinaceous wastes, and when subjected to hydrothermal treatment, the hydrolysis reaction forms corresponding amino acids and peptides that are highly soluble in water. The produce amino acids, nitrogen compounds, and short-chain peptides can be the primary source of nitrogen in plant fertilization. A previous study showed that processing feathers at hydrothermal treatment temperature of 180 oC with a reaction time of 30 minutes and a feather-to-water ratio of 1:5 can produce a liquid product containing around 3% nitrogen and consideration quantities of amino acids and peptides. This study indicated the potential use of feather hydrolysate as liquid organic fertilizer (p.98, Introduction, para.1-3).
Nurdiawati discloses a hydrothermal treatment (HTT) method for producing feather hydrolysate from chicken feathers. The HTT was performed in a 500 mL-batch type autoclave reactor. The prepared feather, distilled water (1:5 feather-to-water ratio), and 0.1g lime/g feather was supplied to the reactor. The reactor was then heated at an average heating rate of 7.2 oC/min and kept at the target temperature for a reaction time of 30 min. Final temperatures of 140, 150, 180, and 200 oC were used to evaluate the effect of this variable on the mineralization behavior of the liquid product (p.99, col.1, 2.1. Chicken feather hydrolysate production).
Nurdiawati discloses that their results indicate that N mineralization was significantly affected by soil type, fertilizer treatments, sampling time, and interaction among parameters. At a higher temperature treatment, samples contained simpler or shorter chain N compounds that would decompose more easily and more rapidly during mineralization. However, products obtained at a high HTT temperature (200 oC) can contain toxic compound which inhibit mineralization process reducing N availability of the hydrolysate (p.103, 4. Conclusions).
Conclusion
Claims 1-6 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MONICA A SHIN/Primary Examiner, Art Unit 1616
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