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
1. Claims 1-20 are under consideration.
Information Disclosure Statement
2. It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s duty to disclose all information known to be material to patentability.
Drawings
3. The drawings are objected to because: Figures 6, 8, 10 recite colors.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
4. The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 28. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
5. Applicant is advised that should claims 1, 6, 7, 8, 11, 12, 13 be found allowable, claims 14-20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
6. Claim 9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claim 9 as submitted 3/6/2024.
The term “safe” in claim 9 is a relative term which renders the claim indefinite. The term “safe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 1, 6-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the instantly claimed methods with respect to ASFV megavirus and ASFV surrogate virus Emiliania huxleyi virus, does not reasonably provide enablement for the instantly claimed method with respect to any megavirus and any surrogate virus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
See claims 1, 6-20 as submitted 3/6/2024.
In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantityof experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6)the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) thebreadth of the claims. Id. While it is not essential that every factor be examined in detail, thosefactors deemed most relevant should be considered. In the present case, the factors deemedrelevant are those of: the breadth of the claims; the (un)predictability of the art; the amount of direction and the working examples provided, and the quantity of experimentation necessary.
Breadth of the claims: Claims 1, 14 recite a method for monitoring the viability of a megavirus in an animal feed or an animal feed ingredient, the method comprising: inoculating the animal feed or animal feed ingredient with a surrogate virus as a proxy for the megavirus;
subjecting the animal feed or animal feed ingredient to a treatment that inactivates the megavirus and the surrogate virus; subjecting the animal feed or animal feed ingredient to storage or transportation conditions for at least 14 days; and determining the viability of the surrogate virus in the animal feed or animal feed ingredient, thereby monitoring the viability of the megavirus in the animal feed or animal feed ingredient. Said methods recite megavirus and surrogate virus as a proxy for the megavirus. Such recitations read on any megavirus and any surrogate virus as a proxy for the megavirus.
State of the art: The art teaches that as in July 2020, “there are no appropriate surrogate viruses for ASFV. Thus, the effects of mitigants on other viruses or bacteria cannot be extended or translated to ASFV without direct evidence of the mitigant on the virus itself” [0003](See Niederwerder et al. (US20200221730)(See PTO-892: Notice of References Cited). Further, species of Megavirus such as Megavirus chilensis have large genomes (1259197 bp), which encodes 1,120 putative proteins, of which 258 (23%) have no mimivirus orthologs (abstract; Arslan et al. “Distant Mimivirus relative with a larger genome highlights the fundamental features of Megaviridae,” PNAS, Vol. 108, No. 42: 17584-17491 (2011))(See PTO-892: Notice of References Cited). Schroeder et al. cited below teaches Emiliania huxleyi virus as a surrogate virus for ASFV. Thus the art teaches or suggests uncertainty and great variation with respect to species of Megavirus as well as limited results for surrogate viruses for megavirus.
The amount of direction and the working examples provided: The present specification merely discloses E. huxleyi (EhV-86; Examples 1, 2) as a surrogate virus for AFSV.
In view of the breadth of the claims, the limited knowledge in the art, and the limited teachings in the specification, the skilled artisan would be required to conduct undue amount of experimentation in order to use any surrogate virus for any megavirus as to the instantly claimed methods.
As discussed above undue experimentation would be required to practice the claimedinvention commensurate with the scope of the claims. Reasonable correlation must exist betweenthe scope of the claims and scope of enablement set forth. In view of the quantity ofexperimentation necessary, the limited working examples, the unpredictability of the art, the lackof sufficient guidance in specification, and the breadth of the claims, it would take undue trialsand errors to practice the claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
8. Claims 1-11, 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
See claims 1-11, 14-18 as submitted 10/11/2022.
The instant claims are drawn to a method for monitoring the viability of a megavirus in an animal feed or an animal feed ingredient, the method comprising: inoculating the animal feed or animal feed ingredient with a surrogate virus as a proxy for the megavirus; subjecting the animal feed or animal feed ingredient to a treatment that inactivates the megavirus and the surrogate virus; subjecting the animal feed or animal feed ingredient to storage or transportation
conditions for at least 14 days; and determining the viability of the surrogate virus in the animal feed or animal feed ingredient, thereby monitoring the viability of the megavirus in the animal feed or animal feed ingredient, which is a statutory category of invention (Step 1: YES).
The instant claims are directed to determining the viability of the surrogate virus in the animal feed or animal feed ingredient (as recited in claims 1, 14); determining that the animal feed or animal feed ingredient with no detectable viable surrogate virus is safe for livestock (as recited in claim 9); identifying a treatment that results in no detectable viable surrogate virus as effective to permanently inactivate the megavirus (as recited in claim 10); wherein determining the viability of the surrogate virus comprises performing viability PCR or viability qPCR and interpreting the results (as recited in claims 11, 18); further comprising determining the viability of a virus unrelated to either the surrogate virus or the megavirus (as recited in claims 12, 19); As such, the instant claims recite judicial exceptions (JE) in the form of mental processes (determining, identifying, interpreting) or an abstract idea (Step 2A, Prong One: YES).
The crux of the claimed method is the determining the viability of the surrogate virus in the animal feed or animal feed ingredient. The claims do not recite e.g., any particular treatment or prophylaxis; rather the instant claims merely recite insignificant extra-solution activities. As such, the instant claims do not recite additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO).
Further, the claims do not recite additional elements that amount to significantly more than the judicial exception. As to claims 2-11, 15-18 it was well-understood, routine, and conventional (WURC) at the time of filing to use E. huxleyi as ASFV surrogate virus in a monitoring method as indicated below by the teachings of Schroeder et al. As such, beyond the JE, the instant claims only recite WURC data-gathering steps. These WURC data-gathering steps constitute insignificant extra-solution activities, which does not reasonably provide an inventive concept. As such, the instant claims do not recite significantly more than the JE (Step 2B: NO).
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C § 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
9. Claims 1-11, 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al. (WO2020263788)(See PTO-892: Notice of References Cited).
See claims 1-11, 14-18 as submitted 3/6/2024.
Schroeder et al. teaches: a method for monitoring the presence or absence of a megavirus in animal feed, an animal feed ingredient, or an animal product using a surrogate virus assay. The surrogate virus assay generally includes, inoculating the animal feed, animal feed ingredient, or animal product with a surrogate virus as a proxy for the megavirus, subjecting the animal feed, animal feed ingredient, or animal product to a treatment that inactivates the megavirus and the surrogate virus, waiting a predetermined period of time, and determining the presence or absence of the surrogate virus in the animal feed, animal feed ingredient, or animal product, thereby monitoring the presence or absence of the megavirus in the animal feed, animal feed ingredient, or animal product (abstract)(as recited in claim 1). Schroeder et al. teaches that the predetermined period of time includes storage of the animal feed or animal feed ingredient prior to use (as recited in claim 1)(p. 1). Schroeder et al. also teaches: determining effectiveness of treatment to inactivate megavirus under predetermined conditions (p 3); as well as a surveillance tool for the effective monitoring of megaviruses in complete feed after, for example, transport and/or storage (p. 3). Further, Schroeder et al. teaches that treatments that damage physiology of the virion and/or genome of the virus can render the virus permanently disabled; such treatments can be analyzed to determine their efficacy.
In view of such teachings or suggestions of Schroeder et al., it would be obvious to one of ordinary skill in the art to determine viability of the surrogate virus (as recited in claims 1, 14), as effectiveness of inactivating treatments and surveillance are used for effective monitoring of megavirus in feed.
Schroeder et al. also teaches: ASFV surrogate virus (p. 1)(as recited in claim 2); Coccolithovirus (p. 1)(as recited in claim 3); E. huxleyi virus (p. 1)(as recited in claim 4); treatment that inactivates ASFV and the ASFV surrogate virus includes exposure to a temperature of at least 65°C for at least one minute, exposure to a temperature of at least 85°C for at least one second, exposure to citric acid, or exposure to increased salinity (p. 1)(as recited in claim 5); assay may be performed after storage and/or transport to ensure that the feed being received is safe for livestock consumption (p. 7)(as recited in claim 9); identifying treatments that damage the physiology and/or genome of the virus, thereby rendering the virus permanently inactivated (p. 7)(as recited in claim 10); using PCR (p. 7)(as recited in claims 11, 18).
As to claims 1, 6, 7, 8, 15-17, absent a showing of unexpected results, such parameter recitations as to time and temperature are considered to be those determined by routine optimization to one of ordinary skill in the art in view of the teachings or suggestions of Schroeder et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
In view of the foregoing, the claimed limitations are found in one reference and are taught to be variations to a ‘base’ method they exemplify. As such, the claimed methods are within the scope of Schroeder et al., and thus Schroeder et al. renders the instantly claimed methods prima facie obvious. The rationale to support this conclusion of obviousness is that Schroeder et al. provides a teaching, suggestion, and motivation to arrive at the instant claims. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art 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.
10. Claims 1-9, 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-11, 13, 14 of U.S. Patent No. 12486326.
See claims 1-9, 14-17 as submitted 3/6/2024,
Claims 1-4, 6-11, 13, 14 of U.S. Patent No. 12486326 recite a method for monitoring the presence or absence of African swine fever virus (ASFV) in animal feed or an animal feed ingredient, the method comprising: inoculating the animal feed or animal feed ingredient with an ASFV surrogate virus, Emiliania huxleyi virus (EhV), as a proxy for the ASFV; subjecting the animal feed or animal feed ingredient to a treatment that inactivates the ASFV and the EhV; waiting a predetermined period of time; and determining the presence or absence of the EhV in the animal feed or animal feed ingredient, thereby monitoring the presence or absence of the ASFV in the animal feed or animal feed ingredient.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1-9, 14-17 and claims 1-4, 6-11, 13, 14 of U.S. Patent No. 12486326 recite a method for monitoring the viability of a megavirus in an animal feed or an
animal feed ingredient, the method comprising: inoculating the animal feed or animal feed ingredient with a surrogate virus as a proxy for the megavirus; subjecting the animal feed or animal feed ingredient to a treatment that inactivates the megavirus and the surrogate virus;
subjecting the animal feed or animal feed ingredient to storage or transportation conditions for at least 14 days; and determining the viability of the surrogate virus in the animal feed or animal feed ingredient, thereby monitoring the viability of the megavirus in the animal feed or animal feed ingredient. In view of such teachings of claims 1-4, 6-11, 13, 14 of U.S. Patent No. 12486326, it would be obvious to one of ordinary skill in the art to determine viability of the surrogate virus (as recited in claims 1, 14), as claims 1-4, 6-11, 13, 14 of U.S. Patent No. 12486326 recite determining safety of livestock (claims 4, 11), effectiveness of treatment (claims 5, 12).
Further, as to claims 1, 6, 7, 8, 15-17, absent a showing of unexpected results, such parameter recitations as to time and temperature are considered to be those determined by routine optimization to one of ordinary skill in the art in view of the teachings of claims 1-4, 6-11, 13, 14 of U.S. Patent No. 12486326 (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Conclusion
11. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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