DETAILED ACTION
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 .
All objections and rejections not reiterated herein below are withdrawn in view of amendments and cancellation to the claims and/or Applicant’s arguments.
Status of the Claims
Claim 4 has been canceled. Claims 1-3, 4-14 are pending. Claims 14-15 and 23-24 have been withdrawn. Claims 1-3, 5-13 and 16-22 are examined herein.
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.
Claim 3 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 for reasons of record which are reiterated herein below.
The term “elevated amount” in claim 3 is a relative term which renders the claim indefinite. The term “elevated amount” 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 specification discloses that "depending upon cell type, context, and/or stress type, severity, and duration, GRP75 has been shown to function as a guardian, a killer, or as a housekeeper within cells" (para. [0049]), but does not give an indication of what “normal” amounts of expression of GRP75 are in any type of cell or condition, and the claims do not reference what cell, tissue, or sample type is being evaluated so there is no way to measure if the GRP75 expression is considered elevated compared to normal conditions. For instance, if GRP75 can be a housekeeper, then it would be expressed under most conditions, not just in the case of environmental stress. Without knowing what a normal amount of expression is, there is no way to determine if the levels are elevated or considered within a normal range. The western blots shown in FIGs. 3A and 3C show detectable levels of GRP75 expression in thermoneutral conditions, so without a baseline level of expression to compare to, it would not be possible to determine if the expression is elevated.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 10-11 and 13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Southern, US Patent No. 8,518,649 B2.
Southern teaches a method of measuring levels of biomarkers related to stress in order to detect and monitor different types of stress (environmental, physical, chemical, etc.) (col. 1, lines 18-22 and col. 2, lines 44-47) in a multitude of organisms (col. 3, lines 55-58), including avian species (col. 5, lines 2-10).
Regarding claim 1, Southern teaches a non-invasive method (col. 20, lines 65-67) of detecting heat stress (col. 13, lines 30-35) in an avian species (col. 13, lines 36-39), said method comprising the steps of: (a) obtaining a sample from said avian species (col. 17, lines 36-39); and (b) detecting the expression of GRP75 (col. 3, lines 18-23) in said sample with an anti-GRP75 antibody and detecting binding between GRP75 and the antibody (col. 14, lines 42-45).
Regarding claim 2, Southern teaches the method of claim 1, further comprising the step of assaying said sample for expression level of a heat stress-related marker (col. 13, lines 30-35), said marker being a protein (col. 15, lines 12-17) encoded by the gene of GRP75 or fragments of GRP75 which are immunoreactive with an antibody that binds GRP75 (col. 14, lines 42-45).
Regarding claim 3, Southern teaches the method of claim 1 further comprising the step of determining the amount of GRP75 in the sample (col. 15, lines 19-25), wherein an elevated amount of GRP75 indicates the presence of stress (col. 11, lines 63-67), including heat stress (col. 13, lines 30-35) in the avian species (col. 17, lines 38-39).
Regarding claims 10-11, Southern teaches the method of claim 1 wherein said avian species is a chicken, which is a species of poultry (col. 17, lines 43-46).
Regarding claim 13, Southern teaches the method of claim 1 wherein said sample is non-invasively obtained without biopsy or euthanasia (col. 20, line 65- col. 21, line 1).
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 5-9 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Southern as applied to claims 1-3 and 10-11 and 13 above, and further in view of Nawab et al., "Heat stress in poultry production: Mitigation strategies to overcome the future challenges facing the global poultry industry." Journal of thermal biology 78 (2018): 131-139.
Regarding claim 4, Southern teaches the method of claim 1, and that the biomarker measurement can be used for the implementation of therapeutic intervention (col. 14, lines 36-40) and personalized assessment of animal management procedures, including habitat change and handling procedures (col. 21, lines 15-22), but does not explicitly state the administration of a heat stress-specific mitigation treatment.
Nawab teaches the mechanism of heat stress in poultry birds and some markers that may be used to measure heat stress (page 132, section 3), as well as the administration of a heat stress mitigation treatment to an avian species including environmental modification (page 135, last paragraph) and nutritional modification (page 136, col. 1, last paragraph).
It would have been prima facie obvious for one of ordinary skill in the art at the time of filing to implement the heat stress mitigation treatment taught by Nawab as the therapeutic intervention in response to elevated GRP75 levels as taught by Southern because although Southern did not specifically teach the method and specifics of intervention, the techniques and procedures described by Nawab to treat heat stress in poultry species were known to be successful therapeutic interventions to mitigate heat stress in chickens. One would be motivated to implement the heat stress mitigation strategies taught by Nawab with the identification of heat stress taught by Southern because heat stress in commercial poultry “results in annual economic losses of $128 to $165 million in the poultry industry alone” (Nawab, page 131, col.2, para. 2) and thus various effective mitigation strategies “reduce consequential production loss” (Nawab, page 132, first paragraph). One would have a reasonable expectation of success because the observation that GRP75 levels are elevated during heat stress in poultry is an inherent feature of heat stress, so regardless of the GRP75 level, the heat stress mitigation treatment would predictably have the same level of success even if the expression levels were not measured at all.
Regarding claims 5-7, Southern and Nawab teach the method of claim 4. Nawab specifically teaches heat stress mitigation treatment comprises managerial treatment such as house design and location (page 136, col. 1, para. 1) and ventilation (page 136, col. 1, para. 2), as well as nutritional treatment such as restricting feed, addition of fat in diets, and supplementing vitamins, minerals, and electrolytes (page 136, col. 1, last paragraph). It would have been prima facie obvious for one of ordinary skill in the art at the time of filing to implement the heat stress mitigation treatment taught by Nawab as the therapeutic intervention in response to elevated GRP75 levels as taught by Southern because although Southern did not specifically teach the method and specifics of intervention, the techniques and procedures described by Nawab to treat heat stress in poultry species were known to be successful therapeutic interventions to mitigate heat stress in chickens. One would be motivated to implement the heat stress mitigation strategies taught by Nawab with the identification of heat stress taught by Southern because heat stress in commercial poultry “results in annual economic losses of $128 to $165 million in the poultry industry alone” (Nawab, page 131, col.2, para. 2) and thus various effective mitigation strategies “reduce consequential production loss” (Nawab, page 132, first paragraph). One would have a reasonable expectation of success because the observation that GRP75 levels are elevated during heat stress in poultry is an inherent feature of heat stress, so regardless of the GRP75 level, the heat stress mitigation treatment would predictably have the same level of success even if the expression levels were not measured at all.
Regarding claims 8 and 9, Southern and Nawab teach the method of claim 4, and Southern further teaches monitoring the heat stress response during treatment (col. 21, lines 15-22) , including measuring changes in stress levels (col. 13, lines 14-21) and levels over a time-course (col. 15, lines 33-35).
Regarding claim 16, Southern and Nawab teach a method of detecting and treating heat stress in a poultry species as described above, said method comprising the steps of: (a) non-invasively obtaining a sample (Southern col. 20, line 65- col. 21, line 1) from a poultry species (Southern col. 17, lines 43-46); (b) assaying said sample for the expression level of a heat stress-related marker (Southern col. 13, lines 30-35), said marker being a protein encoded by the gene of GRP75 (Southern col. 3, lines 18-23) which are immunoreactive to an antibody that binds GRP75 (Southern col. 14, lines 42-45), wherein expression of GRP75 is indicative of stress (Southern col. 11, lines 63-67), including heat stress (Southern col. 13, lines 30-35) in the poultry species (Southern col. 17, lines 42-46).; and (c) administering a heat stress mitigation treatment to said poultry species (Nawab page 135, col. 2, last paragraph).
Regarding claims 17-19, Southern and Nawab teach the method of claim 16, wherein heat stress mitigation treatment comprises managerial treatment such as house design and location (Nawab page 136, col. 1, para. 1) and ventilation (Nawab page 136, col. 1, para. 2), as well as nutritional treatment such as restricting feed, addition of fat in diets, and supplementing vitamins, minerals, and electrolytes (Nawab page 136, col. 1, last paragraph).
It would have been prima facie obvious for one of ordinary skill in the art at the time of filing to implement the heat stress mitigation treatment taught by Nawab as the therapeutic intervention in response to elevated GRP75 levels as taught by Southern because although Southern did not specifically teach the method and specifics of intervention, the techniques and procedures described by Nawab to treat heat stress in poultry species were known to be successful therapeutic interventions to mitigate heat stress in chickens. One would be motivated to implement the heat stress mitigation strategies taught by Nawab with the identification of heat stress taught by Southern because heat stress in commercial poultry “results in annual economic losses of $128 to $165 million in the poultry industry alone” (Nawab, page 131, col.2, para. 2) and thus various effective mitigation strategies “reduce consequential production loss” (Nawab, page 132, first paragraph). One would have a reasonable expectation of success because the observation that GRP75 levels are elevated during heat stress in poultry is an inherent feature of heat stress, so regardless of the GRP75 level, the heat stress mitigation treatment would predictably have the same level of success even if the expression levels were not measured at all.
Regarding claims 20 and 21, Southern and Nawab teach the method of claim 16, and Southern further teaches monitoring the heat stress response during treatment (col. 21, lines 15-22) , including measuring changes in stress levels (col. 13, lines 14-21) and levels over a time-course (col. 15, lines 33-35).
Regarding claim 22, Southern and Nawab teach the method of claim 16, and both Southern and Nawab teach that the poultry species is a chicken (Southern col. 17, lines 43-46; Nawab page 135, col.1, para. 2).
Response to Arguments
Applicant's arguments filed 7/8/2025 have been fully considered but they are not persuasive.
Applicant argue claim 3 is not indefinite because figures 3B and 3D shows the protein levels of GRP75 in heat-stressed birds is significantly higher than GRP75 in thermoneutral birds.
This argument is not persuasive. The term “elevate” is a relative term and while the drawings shows higher levels of GRP75 in heat-stressed birds, it does not provide adequate guidance for one to determine how “elevate” the level of GRP75 has to be before one can diagnose the birds as “heat-stressed”. While Figures 3B and D shows 1.4 fold and 1.8 fold higher GRP75 in heat stressed birds, these levels are not reflected in the claims. As written, claim 3 recites “wherein an elevated amount of GRP75 indicates the present of heat stress in the avian species”, this could mean any elevated levels which is clearly not supported by the specification. While the claims are interpreted in light of the specification, limitations in the specification are not read into the claims. See MPEP 2111.
Applicant argues Southern fails to disclose the detection of GRP75 specifically in an avian sample. While Southern describes a panel and SR biomarkers for profiling stress responses in multiple species at once, Southern does not specifically teach antibodies for GERP75 to avian samples. The antibodies used by Southern to detect GRP75 are obtained from marsupial host tissue and do not cross react with avian GRP75, thus Applicant alleges that Southern does not teach detection of GRP75 from avian species using the antibody. Applicant also argues that Southern does not teach identifying cell death via the GRP75 biomarker and that the samples tested by South lack avian specific features.
These arguments have been fully considered but are not persuasive. While Southern does not disclosed a reduction to practice example of a specific embodiment where GRP75 in avian species are detected using an antibody, Southern does clearly teach GRP75 is related to stress including environmental, physical, etc in avian species. Southern further teaches biomarkers detection using an antibody specific for the biomarkers selected. Therefore, Southern constructively reduce to a practice an invention where GRP75 in non-invasive avian samples is detected using binding molecules such as antibody.
The argument that Southern does not teach identifying cell death via the GRP75 biomaker is not persuasive because this is not a claimed limitation.
For these reasons, the claims are rejected as detailed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/BAO-THUY L NGUYEN/ Supervisory Patent Examiner, Art Unit 1677 August 27, 2025