DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after January 11, 2024, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 01/11/2024 in the matter of Application N° 18/409,792. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-4 represent all claims currently under consideration.
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 3 and 4 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.
Claims 3 and 4 are unclear in reciting “ratio of 1:50-1000” and 1:100-500 in claims 3 and 4. It is unclear if this ratio range is 1:50 to 1000:1 or 1:100 to 500:1. Since each interpretation has a different scope, the metes and bounds of the claims cannot be determined and the claims are indefinite.
Claim Rejections - 35 USC § 103
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Juarez Molina et al. (WO2023/001946) in view of Wei et al. (WO2016/054310).
Regarding claim 1, Juarez Molina et al. teach a process for converting a keratin-containing material into a keratin- containing material into a keratin hydrolysate comprising peptides and/or amino acids. Juarez Molina et al. teach that the resulting peptides have a molecular weight between about 150 and 10,000 Daltons (See p. 3, lines 29-31), which encompasses the instantly claimed molecular weight range of 500 to 4,000 Daltons.
Juarez Molina et al. further teach the use of a steam explosion process wherein biomass is treated with hot steam at a temperature ranging from about 110°C to 160°C under a pressure ranging from about 1 to 5 bar, thereby resulting in rupture of the keratin fibrous structure (See p. 6, lines 22-27). Thus, Juarez Molina et al. teach subjecting keratin-containing material to elevated temperature and pressure to facilitate disruption and subsequent hydrolysis of the keratin material. With regard to the dilution limitations of instant claim 1, Juarez Molina et al. teach that the keratin-containing material is diluted is diluted in water in a proportion of about 15-40% w/v prior to the steam explosion process. As indicated in the rejection under 35 U.S.C. 112(b), the instantly recited ratio may be interpreted as encompassing ratio ranging from 1:50 to 1000:1 or 1:100 to 1:500, depending upon the construction of the recited limitation.
Juarez Molina et al. do not expressly exemplify an embodiment in which feathers are used as the starting keratin-containing material, as required by instant claim 1. Rather, Juarez Molina et al. exemplify the use of pig hair as the keratin- containing starting material in Example 1.
Nevertheless, Juarez Molina et al. generally teach that keratin is a major structural component of animal-derived materials, including feathers, and specifically recognize that bird feathers have a high keratin content (See page 1, lines 9-21). Therefore, Juarez Molina et al. expressly identify feathers as a known keratin containing starting material suitable for the disclosed keratin-conversion process.
Although the working examples employ pig hair, the disclosure of Juarez Molina et al. would have suggested to one of ordinary skill in the art, prior to the instant effective filing date that feathers constitute an alternative keratin-containing starting material for producing the disclosed keratin hydrolysate. Substitution of feathers for pig hair would have involved the use of a known keratin-rich starting material for the same disclosed purpose of producing keratin-derived peptides and/or amino acids, with a reasonable expectation of successfully obtaining a keratin hydrolysate.
Although Juarez Molina et al. teach that the liquid mixture comprising peptides may be applied, in its different variants, to any type of plant, and further teach that the composition may be used to improve and/or stimulate germination, rooting, growth, flowering, curdling, and maturation of plants and fruits, Juarez Molina et al. do not specifically teach wherein the plant being treated is cotton.
However, this deficiency is cured by Wei et al.
Wei et al. are directed to hypersensitive response eliciting peptides exhibiting improved solubility, stability, resistance to chemical degradation, or a combination thereof. Wei et al. teach treating plants or plant seeds with peptide compositions and disclose that such treatment may be useful, for example, when harvested cuttings, fruits or vegetables, are intended to be shipped over great distances or stored for extended periods after harvest. Wei et al. further identifies exemplary plants that may be treated, including, without limitation, alfalfa, beans, bananas, begonia, castor oil plant, cotton, and zinnia, among others (See paragraph 0206).
Thus, Wei et al. provide evidence in the prior art that a peptide-containing composition may be applied to cotton, thereby supporting the use of a peptide composition for enhancing or otherwise beneficially affecting the growth and/or yield of cotton plants.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time of the invention to apply the peptide-containing liquid mixture of Juarez Molina et al. to cotton plants, as taught by Wei et al., because Juarez Molina et al. expressly teach that their peptide-containing liquid mixture is suitable for application to any type of plant to improve and/or stimulate plant development, while Wei et al. specifically identify cotton among the plants suitable for treatment with a peptide composition. one of ordinary skill in the art would therefore have had a reasonable expectation that the peptide containing composition of Juarez Molina et al. could similarly be applied to cotton to obtain the disclosed plant-growth promoting benefits.
Juarez Molina et al. further teach that the liquid mixture comprising peptides may be applied to any type of plant, at any stage of plant development, and on any soil or form of cultivation, including by foliar application (leaf spray) and irrigation (soil infusion) (See page 3, lines 6-16).
Regarding claim 2, Juarez Molina et al. teach that the keratin-derived peptide/amino-acid composition may be applied to plants by different agricultural application methods, including foliar application (See page 3, lines 6-16).
Wei et al. more specifically teaches dissolving peptides in water and applying the resulting aqueous peptide composition to growing plants by foliar spraying. Wei et al. describe spraying the plants until the peptide-containing liquid is present on the leaves and subsequently evaluating plant growth (See paragraph 0250).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to apply the keratin hydrolysate of Juarez Molina et al. by spraying the composition onto plants during an early stage of growth, as taught by Wei et al., because foliar spraying was a known method for delivering growth-promoting peptide compositions directly to growing plants with a reasonable expectation of obtaining the plant-growth-promoting effects taught by both references.
Regarding claim 3, Juarez Molina et al. teach that the keratin -containing material is diluted with water prior to processing and specifically disclose dilution of the keratin-containing material in water in a proportion of about 15-40% w/v prior to steam explosion. Juarez Molina et al. further teach that the resulting liquid mixture comprising peptides may be applied to plants by different methods, including foliar application (leaf spray) and irrigation (soil infusion).
Although Juarez Molina et al. do not expressly disclose the particular dilution ratio recited in instant claim 3, Juarez Molina et al. establish that the amount of water relative to the keratin containing material and resulting peptide containing composition is a formulation parameter that may be varied depending upon the intended preparation and application.
Wei et al. further teaches aqueous peptide compositions for treatment of plants and plant seeds, thereby providing additional evidence that peptide-containing plant-treatment compositions were conventionally formulated in water at concentrations appropriate for their intended agricultural application.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to adjust the amount of water used with the peptide-containing composition of Juarez Molina et al. to provide a suitable dilution for foliar or soil application. The particular dilution would have been arrived at through routine optimization of the amount of water necessary to provide an effective and practically applicable peptide-containing plant treatment composition.
Moreover, as set forth in the rejection under 35 U.S.C. 112 (b), the presently recited ratio is subject to the interpretation previously stated in the office action. Under that interpretation, the teachings of Juarez Molina et al. regarding dilution of the keratin-containing material with water are pertinent to the claimed limitation.
Regarding claim 4, Juarez Molina et al. teach, as discussed above, dilution of keratin containing material with water and subsequent use of the resulting peptide-containing liquid mixture for agricultural treatment, including by foliar spraying and soil irrigation. Wei et al. further establishes that aqueous peptide compositions may be administered to plants for beneficial plant treatment.
Although Juarez Molina et al. and Wei et al. do not expressly disclose the particular narrower dilution ratio recited in instant claim 4, selection of an appropriate dilution for application of the peptide-containing composition would have been within the level of ordinary skill in the art.
It would have been obvious to one of ordinary skill in the art to optimize the amount of water relative to the peptide-containing composition to obtain a concentration suitable for application to the plant while retaining the desired plant-treatment effect. The claimed dilution represents selection of a suitable concentration from a parameter that the prior art teaches maybe varied according to the intended agricultural application, and no criticality or unexpected result attributable to the particular claimed dilution has been established.
Finding of Prima Facie Obviousness Rational and Motivation (MPEP 2142-2143)
Based on the teachings of Juarez Molina et al., it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the exemplified process of Juarez Molina et al. by utilizing feathers instead of pig hair as the keratin containing starting material for producing keratin hydrolyzed peptides. Such a modification would have involved the substitution of one known keratin-containing material for another to obtain the predictable result of producing a composition comprising keratin hydrolyzed peptides. One of ordinary skill in the art would have been motivated to make this substitution because Juarez Molina et al. expressly recognize that bird feathers have a high keratin content, thereby identifying feathers as a suitable source of keratin for the disclosed process.
Furthermore, in view of the teachings of Wei et al., it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to apply the peptide containing composition produced according to Juarez Molina et al. to cotton plants. Wei et al. teach the application of peptide compositions to a variety of plants and specifically identify cotton among the plants suitable for such treatment. Accordingly, one of ordinary skill in the art would have had reason to select cotton from the finite number of identified plant species for treatment with the peptide-containing composition of Juarez Molina et al., with a reasonable expectation of obtaining the known beneficial plant-treatment effects. Such a selection would have amounted to choosing from a finite number of identified and predictable alternative suitable for the intended purpose.
With respect to the timing of the soil-infusion or foliar-spray application, the Examiner directs attention to MPEP 2144.05 (I), which provides that where the claimed range overlaps or lies within a range disclosed by the prior art, a prima facie case of obviousness may be established. The Examiner further directs attention to MPEP 2144.05 (III), which addresses differences between the claimed invention and the prior art involving ranges or other variables. As explained in In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990), where the difference between the prior art and the claimed invention concerns a range of variable, evidence that the claimed range is critical, such as evidence demonstrating unexpected results relative to the prior-art range, may be necessary to overcome the prima facie of obviousness. In the present case, Applicant has not provided persuasive evidence establishing that the specifically claimed timing of the soil-infusion or foliar-spray application is critical or produces unexpected results relative to the broader application teachings of the prior art.
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 AlA. 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 |.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 3, and 4 of US Patent Application No. 18/902,317 (plants).
claims 1-3 of US Patent Application No.18/827,519 (cabbage).
Claims 1 and 3 of US Patent Application No.18/642,445 (asparagus).
Claims 1 3 and 4 of US Patent Application No.18/902,317 (plants).
Claim 4 of US Patent Application No.18/898,195 (rice).
Claims 1, 2, and 3 of US Patent Application No.18/827,519 (cabbage).
Claims 1-3 of US Patent Application No.18/778,049 (cabbage).
Claim 1 of US Patent Application No.18/758,198 (cotton).
Claims 1 3, 4, and 6 of US Patent Application No.18/774,885 (melon).
Claims 1, 3 5, 6, 8, and 10 of US Patent Application No.18/758,140 (tea leaves).
Claims 9-16 of US Patent Application No.18/536,211 (wheat).
Claims 4-5, and 7-9 of US Patent Application No.18/639,751 (soybean).
Claims 1- 3 of US Patent Application No.18/639,950 (soybean).
Claims 1, 2, and 4 of US Patent Application No.18/408,245 (soybean).
Claims 2, and 3 of US Patent Application No.18/409,790 (cotton).
Claims 1-5, and 7 of US Patent Application No.18/537,395 (cotton).
Claims 1-3 of US Patent Application No.18/639,950 (soybean).
Claims 1, 3, and 4 of US Patent Application No.18/642,445 (asparagus).
Claims 1, 2, 4, 5-6 and 8 of US Patent Application No.18/658,834 (lettuce).
Claims 1-6 of US Patent Application No.18/668,598 (cotton).
Claims 1-6 of US Patent Application No.18/671,848 (soybeans).
Although the conflicting claims at issue are not identical, they are not patentably distinct from each other. The respective claim sets are directed to substantially the same method of preparing and applying a keratin hydrolysis peptide (KHP) solution, with the principal distinction being the particular plant species to which the KHP solution is applied.
Most specifically, the conflicting claims recite preparing a KHP solution by combining a keratin containing starting material, such as feathers, having the same or overlapping water content with the same or overlapping amount of water in a sealed container; hydrolyzing the resulting mixture under the same, overlapping, or substantially similar temperature and pressure conditions; confirming by mass spectrometric analysis that the resulting solution contains the same 253 peptides (SEQ ID Nos: 1-253) having the same or overlapping molecular-mass and concentration ranges. diluting the resulting KHP solution with water within the same or overlapping volume-ratio ranges, including 1:50-1000 and/or 1:100-500; and applying the diluted KHP solution to a plant by substantially the same modes of administration, including foliar/leaf spraying or soil infusion, during selected stages of plant development.
Thus, the substantive difference among the conflicting claims resides primarily in the identity of the plant being treated, for example, cotton, wheat, cabbage, asparagus, lettuce, soybean, tea, or melon, rather than in the KHP composition, its method of preparation, its peptide characteristics, or the manner in which the KHP composition is administered to the plant.
The Examiner further notes that the prior art provides evidence that selection of a particular plant species from among these plant species would have been predictable rather than inventive. Specifically, Wei et al. teach that peptide compositions may be used to treat plants or plant seeds and expressly identify a broad but finite group of suitable plants, including, inter alia, alfalfa, apple, apricot, asparagus, cabbage, lettuce, cotton, melon rice, tea, wheat, and tomato (See Wei et al. paragraph 0206). Thus, Wei et al. provide evidence that peptide-based plant treatment was known to be applicable to numerous different plant species and, importantly, expressly identify the plant species recited by the conflicting claim as suitable subjects for peptide treatment.
Accordingly, one of ordinary skill in the art, presented with the KHP preparation and plant treatment method recited in one of the conflicting claim sets, would have found it obvious to employ that same method for cotton rather than another expressly identified plant species, such as wheat, cabbage, asparagus, lettuce, soybean, tea, or melon. The substitution of one expressly identified and suitable plant species for another would not require a change in the underlying KHP preparation, peptide composition, or general method of treatment. Rather, it would constitute selection of a particular plant from a finite group of known plant species recognized in the art as suitable for peptide treatment, with a reasonable expectation that the peptide treatment would provide its known beneficial effect when applied to the selected plant.
Therefore, merely limiting one claim set to promoting the development and growth of cotton seedlings, while the conflicting claims recite substantially the same KHP composition and treatment methodology for other expressly identified plant species, does not render the presently claimed method patentably distinct. The record does not establish that application of the KHP treatment to cotton involves a different mechanism, requires materially different processing or application conditions, or produces an unexpected result sufficient to distinguish the cotton method from the corresponding KHP treatment methods directed to the other plant species.
With respect to any differences in the numerical processing, dilution, or application parameters among the conflicting claims, the Examiner directs attention to MPEP 2144.05(I), which explains that a prima facie case of obviousness may exist where claimed ranges overlap or lie within ranges disclosed by the prior art, and may also exist where the respective ranges do not overlap but are sufficiently close such that one of ordinary skill in the art would have expected them to provide the same properties or results. Accordingly, overlapping or closely related processing and application ranges do not, without evidence or criticality or unexpected results, establish patentable distinctness between the conflicting claims.
For at least these reasons, the presently claimed method of treating cotton seedlings with the KHP solution is not patentably distinct from the conflicting claims directed to treatment of the other identified plant species using substantially the same KHP composition, preparation process, dilution, and application methodology.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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