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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-3, 5-6, 8, 10, and 14-15, and the required species in the replies filed on 7/6/2026 and 8/4/2026 is acknowledged. The traversal is on the ground(s) that the pending claims are directed to different statutory categories of the same inventive concept, rather than to separate inventions, the present claims are precisely the type of claims contemplated by 37 CFR 1.475(b)(4), linked by the same corresponding technical feature and define a single general inventive concept within the meaning of 37 CFR 1.475 and PCT Rules 13.1 and 13.2. Applicant further argues that the question presented by the present Restriction Requirement is not whether the shared technical features are ultimately determined to be patentable over the cited references, but whether the pending claims are directed to a single general inventive concept, and whether those common technical features are ultimately found to be novel and non-obvious is an issue properly resolved during substantive examination on the merits. This is not found persuasive because: Applicant is applying an incorrect legal standard in p. 3 of its 7/6/2026 remarks, where they state whether the common technical features are ultimately found to be novel and non-obvious is an issue properly resolved during substantive examination on the merits, because the examiner broke unity of invention a posteriori. The examiner agrees that the inventive groups are connected by a common technical feature, but as indicated by the restriction requirement, it is not a special technical feature. The examiner also agrees that the groups involve different statutory classes.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-18, 20-23, 25, and 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/6/2026.
Interview Summary
The examiner called Applicant’s representative Avi Jencmen on 8/3/2026 to discuss the election of species requirement made in the Restriction Requirement filed 6/17/2026, and to request an election for each of the required Groups.
In response, Applicant’s representatives elected the following species for examination:
Sequencing target: HVT viral sequence
Organ/tissue: Spleen
Vaccine: Turkey Herpesvirus (HVT)-based vaccine
Animal: Chicken
Claims 1-3, 5-6, 8, 10, and 14-15 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 1/18/2024, 6/11/2025, 11/12/2025, and 11/17/2025 are in compliance with 37 CFR 1.97. Accordingly, the references listed in the IDSs are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: recites “associated with the effect of the herpesvirus-based vaccine in a plurality of animal populations” on lines 11-12. The claim should instead recite “associated with the effect of the herpesvirus-based vaccine in a plurality of animal populations in the same species”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: claim 2 recites "said herpesvirus-based vaccine involves the use of a turkey Herpesvirus (HVT)" on lines 1-2, but should instead recite "said herpesvirus-based vaccine comprises a turkey Herpesvirus (HVT)”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: claim 14 recites “at specific age range” on line 2, but should instead recite “within a specific age range”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: claim 15 recites “said specific age range is between day 21 and day 25” on lines 1-2, but should instead recite “wherein said specific age range is day 21 to day 25”. Appropriate correction is required.
Drawings
The drawings are objected to because Figure 6B (“402” and “404”) and Figure 7A-C (“506” and “508”) are not described in the specification. A separate problem is that Figure 5 and Figure 8 do not have y-axis labels. 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.
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 1-3, 5-6, 8, 10, and 14-15 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.
Claim 1 recites “monitoring the effect of a herpesvirus-based vaccine in an animal population” in lines 1-2, but the claim allows for vaccinating at least one and obtaining tissue samples from “one or more respective animals of said animal population” (lines 3-5). Accordingly, the method is meant to monitor the effect on a population, but if it is only monitored in one animal, which is not a population, it is not clear how that could monitor the effect in a population. Claims 2-3, 5-6, 8, 10, and 14-15 depend on claim 1 but do not remedy this deficiency, and are thus also indefinite and rejected herein.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-6, 8, 10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Prandini, et al. (Avian Pathol. 2016;45(1):114-25, on IDS), Winegar, et al. (Hum. Gene Ther. 7:2185-2194, 1996), De Wit, et al. (Avian Pathology April 2010 39(2), 123-131), Bratton, et al. (US Patent No. 10,984,076 B1, issued 4/20/2021), Compton, et al. (US Patent No. 6,500,633 B1, issued 12/31/2002), Basta, et al. (Am J Epidemiol. 2008 Dec 15;168(12):1343-52. doi: 10.1093/aje/kwn259. Epub 2008 Oct 29. PMID: 18974084), and Sonis, et al. (Mucositis Study Group. Cancer. 1999 May 15;85(10):2103-13. PMID: 10326686).
The claimed invention encompasses a method for monitoring the effect of a herpesvirus-based vaccine in an animal population comprising: vaccinating at least one of the animals in the animal population with said vaccine; obtaining one or more tissue samples of one or more respective animals of said animal population; sequencing each of said tissue samples to assess the presence and quantity of said vaccine in the one or more tissue samples; calculating a score associated with said animal population based on said presence and quantity; comparing said score to a benchmark determined from a dataset containing data associated with the effect of the herpesvirus-based vaccine in a plurality of animal populations; and, executing an action in response to said comparison to said benchmark (claim 1).
The Prior Art
Prandini teaches vaccination of layer pullets with two IBD live vaccines or a herpesvirus of turkey vector vaccine expressing viral protein 2 of IBDV (vHVT-IBD; Abstract). vHVT-IBD expresses the IBDV VP2 gene inserted into an inter-genic locus of the HVT genome (p. 115, col. 1). The vaccinated birds were challenged with vvIBDV (very virulent IBDV) strain by eye-drop, sacrificed 7 days later and pathological and histopathological analysis of lesions in the bursa of Fabricus assessed, as well as RT-PCR performed to detect IBDV in bursa tissue (p. 117). Sequencing of the bursa samples indicated that the dominating IBD virus in the bursa of Fabricius of IBD live-vaccinated birds was the vaccine strain, although vvIBDV was also detected (p. 120). Prandini further discloses that three out of three, six out of 10, and seven out of 10 birds of the challenged groups of the non-vaccinated SPF birds, hVT+IBD- and IBD live-vaccinated chickens were positive for IBDV by RT-PCR, and that three of the challenged vHVT+IBD-vaccinated birds showed no bursa lesions but were positive for IBDV challenge virus by RT-PCR (p. 119, col. 2).
Additionally, three of 10 IBD live vaccine-inoculated birds, which showed lesion scores of 2-4, were negative by RT-PCR for IBDV (p. 120, col. 1). Further, Prandini discloses analysis and comparison of group responses within experiments by Student's t-test, ANOVA, and Kruska-Wallis pair-wise comparison tests, and differences in the number of birds and groups of birds developing histological lesions were determined by the chi-square test (p. 117, col. 2, para. 2). Prandini also teaches that the data of its study can be used to optimize IBD vaccination for layer pullets in the field (p. 123, col. 2, para. 3).
Prandini also discloses measuring anti IBDV antibody levels in layer pullets after vaccination with different IBD vaccines, including vHVT-IBD, wherein pullets were vaccinated with vHVT-IBD at one day post-hatch and then anti-IBDV antibody levels monitored in sera at 14, 21, 28, 35, and 42 days of age (Fig. 2; p. 116, col. 1, para. 3).
However, Prandini does not disclose calculating a score associated with said animal population based on said presence and quantity and executing an action in response to a comparison to a benchmark.
Winegar discloses that the use of nucleic acid-based therapeutics has created a need for methods of determining tissue distribution and levels, and that when identifying the distribution of a nucleic acid therapeutic, determining that its specific sequence is present is desirable (Abstract; p. 2185, col. 2, para. 2). Winegar further discloses qPCR and in situ hybridization techniques to study the pharmacokinetics and distribution of a potential anti-HIV plasmid vaccine in rabbits (Abstract). Winegar also teaches that pharmacokinetics studies require the calculation of the amount of drug in various tissues of treated animals (p. 2192, col. 2, para. 2).
Accordingly, it would have been obvious to one of ordinary skill in the art to adapt Prandini's method to incorporate use of qPCR and in situ hybridization techniques to study the pharmacokinetics and distribution of Prandini's vaccines.
De Wit discloses that factors including flock size, type of chicken, housing, age, application route, vaccine, dose, water quantity and temperature, ventilation, and light management are associated with Infectious bronchitis virus efficacy (IgM levels; Abstract). De Wit further teaches that the average efficacy of IBV vaccination in the field can be improved by considering these factors in the field (Abstract; p. 130, col. 2, para. 2). De Wit also teaches that a possible cause of the insufficient protection induced by vaccination is an inadequate application of the vaccine (Abstract). Additionally, De Wit discloses a method for generating a protection score for a group of birds determined by: Protection score = [(total of the individual scores)/(number of individuals x20)] x 100%, where each individual score is between 0 and 20, based on five tracheal rings per bird, and each ring’s score determined to be between 0 and 4 (p. 124, bridging para.), this method, also called a cioliostasis test, relied on measuring and scoring the beating of the cilia for each tracheal ring (0% beating of cilia, total lack of protection), (1 (>0 to 25% beating), 2(>25 to 50% beating), 3 (>50 to 75% beating), or 4 (>75 to 100% beating), where one bird could score between 0 and 20 (five rings from each trachea; maximum score 4 per ring), and an individual chick was recorded as protected against challenge if the cioliostasis score was 10 or more (p. 124, cols. 1-2, bridging para.).
Bratton teaches an immunization web portal to identify whether a patient is eligible to receive vaccines for a specified vaccine-preventable disease (Abstract). Bratton further teaches that a vaccine may be assigned a first score corresponding to the efficacy of the vaccine, a second score corresponding to the amount and/or severity of the side effects associated with the vaccine, and a third score corresponding to the cost of the vaccine (Column 16, para. 3). The scores may then be combined and/or aggregated in any suitable manner to generate an overall score for each vaccine, and the vaccines may be ranked based on their corresponding overall scores (Column 16, para. 3). Bratton also teaches determining, by one or more processors, whether a patient is high risk for a specified disease, and causing indications of the plurality of vaccines to be displayed in a ranked order on a user interface for administering one of the plurality of vaccines to the patient, causing a vaccination standing order to be pre-populated for the patient, and vaccinating the patient with the selected vaccine (Bratton, claim 1).
Compton explicitly states that one of ordinary skill in the art would know to first establish a positive indicator threshold level for a particular sample technique such as serum by comparing samples from normal patients with those having particular cancers (Column 6, Paragraph, second). By making such a comparison, one may establish the proper indicative threshold to diagnose a patient as having a cancer (Column 6, Paragraph, second). Thus, the recited threshold values of the claim would be arrived at by routine experimentation by one of ordinary skill in this art. Also, they are clearly results effective variables. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
One of ordinary skill in the art would have been motivated to monitor the presence of a herpesvirus-based vaccine in tissues by sequencing, determining whether the tissues contain the vaccine (e.g., calculating a score associated with said animal population), comparing the score to a benchmark determined from a dataset (whether the tissue sequencing is positive for the vaccine), and executing an action in response. Bratton teaches that a vaccine may be assigned a first score corresponding to the efficacy of the vaccine, a second score corresponding to the amount and/or severity of the side effects associated with the vaccine, and a third score corresponding to the cost of the vaccine. It would have been obvious that efficiency of vaccination could include a first score associated with quantity of vaccine and be multiplied or divided by a score for negative side effects, for example. A person of ordinary skill in the art can make this score for pullet groups that have good disease prevention results and make that a standard or part of a standard range. So, in each new pullet population one would want to get in that score range after vaccination to be confident your pullets are protected. Based on Bratton, it would be obvious to one of ordinary skill in the art that if the score is below the threshold for "sufficiently protected from virus" then one would execute an action to revaccinate the subjects with the same or a different vaccine. Compton makes clear that it is obvious to establish thresholds for positive and negative diagnoses.
Regarding claim 2, which requires said herpesvirus-based vaccine involves the use of a turkey Herpesvirus (HVT), also would have been obvious to a person having ordinary skill in the art, because Prandini discloses HVT vaccine vectors.
Regarding claim 3, which requires said animal population to be a flock of poultry, that would have been obvious to one of ordinary skill in the art, because Prandini discloses vaccination of poultry flocks, and with HVT vectors specifically.
Regarding claim 5, which requires following the sequencing step, each of said tissue samples receives an individual score associated with the presence and quantity of said herpesvirus-based vaccine within the respective tissue sample, De Wit discloses scoring tissues to reflect vaccine protection, and it would have been obvious to do a similar scoring based on the presence and quantity of a herpesvirus-based vaccine within the tissue sample, which would enable a person of ordinary skill in the art to assess the amount of vaccine in various tissues, which is important, as Winegar teaches that pharmacokinetics studies require the calculation of the amount of drug in various tissues of treated animals. It would have been obvious to score each sample individually, as a facile way to aggregate scores in the obvious method. For example, De Wit teaches that generating a protection score for a vaccine in a group of birds determined by: Protection score = [(total of the individual scores)/(number of individuals x20)] x 100%, and thus individual scores are necessary to generate a protection score for a vaccine in a group of birds.
Regarding claim 8, which requires said action involves sending a notification to an end user, indicating that said score is below said threshold, and claim 10, wherein said action further involves providing the end user with at least one potential action aimed to improve said score, that would have been obvious to one of ordinary skill in the art because Bratton teaches causing indications of the plurality of vaccines to be displayed in a ranked order on a user interface for administering one of the plurality of vaccines to the patient, causing a vaccination standing order to be pre-populated for the patient, and vaccinating the patient with the selected vaccine. Bratton’s process includes causing indications of the plurality of vaccines to be displayed in a ranked order on a user interface for administering one of the plurality of vaccines to the patient, causing a vaccination standing order to be pre-populated for the patient, and vaccinating the patient with the selected vaccine , which the examiner is interpreting to involve sending a notification to an end user, indicating that said score is below said threshold, and further involves providing the end user with at least one potential action aimed to improve said score, as required by claim 8.
Regarding claim 14, which requires the one or more tissue samples are obtained from said one or more respective animals at a specific age range, that would be obvious because Prandini teaches tissue harvest and analysis at particular timepoints of age after vaccination. One of ordinary skill in the art would have been motivated to ensure vaccine efficacy.
Regarding claim 15, which requires the specific age range is between day 21 and day 25, that too would be obvious, because Prandini teaches tissue harvest and analysis at 21 and 28 days of age, following vaccination. Further, it would have been obvious to one of ordinary skill in the art to find and use the optimal timepoint for their individual system through routine optimization. A person having ordinary skill in the art would have an interest in determining the optimal time after vaccination, and of age, for when their assay for monitoring the presence and quantity of the vaccine is present in the tissues, and would have a reasonable expectation of success because Prandini discloses tissue harvest and analysis at 21 and 28 days of age. See MPEP §2144.05.
There would have been a reasonable expectation of success because Prandini discloses herpesvirus of turkey vaccines, De Wit discloses that many factors are associated with vaccine efficacy in birds, and such factors should be taken to into account if vaccine efficacy is low. Winegar discloses that qPCR and in situ hybridization techniques are useful for determining whether a vaccine is present in particular tissues. Therefore, claims 1-3, 5, 8, 10, 14 and 15 were prima facie obvious before the priority date of the instant invention.
However, Prandini, Winegar, Bratton, and Compton do not disclose wherein said score associated with said animal population is a weighted arithmetic mean of the individual scores associated with said tissue samples.
Basta teaches estimates of 4 measures of vaccine efficacy for live, attenuated, and inactivated influenza vaccine based on secondary analysis of 5 experimental influenza challenge studies in seronegative adults and community-based vaccine trials (Abstract). Basta further discloses point estimates and weighted mean efficacies derived from previous studies for the absolute efficacy of influenza vaccines (p. 1345, col. 1, paras. 3-4; Fig. 1; Table 2). Basta teaches that in the absence of reliable estimates from vaccine trials, vaccine efficacy values could be used as rough guides in planning potential vaccination strategies for seasonal influenza and pandemic influenza, using mathematical models (p. 1350, col. 1, para. 3; Table 3).
Sonis teaches that with the availability of cytokine therapy to reduce the duration and severity of hematologic toxicities associated with cancer chemotherapy, the importance of oral mucositis as a significant side effect has increased dramatically (p. 2104, col. 1, para. 1). Sonis further discloses an objective, simple, and reproducible assessment tool to evaluate mucositis with specific application to multicenter clinical trials, developed a scale that measured objective and subjective indicators of mucositis (p. 2103, Methods). The weighted mean mucositis score was equal to 2.5[∑uu/3nu) + (∑ei/2ne)], where nu and ne were the number of locations of nonmissing measurements of ulceration (pp. 2107-08, bridging para.). This score, which ranged from 0–5, reweighed the previous score to equalize the influence of ulceration and erythema (p. 2108, col. 1). Sonis also teaches that each form of mucositis score evaluated (mean, weighted mean, worst site, and extent of mucositis) showed highly statistically significant associations (P , 0.001) with pain, swallowing, and NCI score in chemotherapy patients (p. 2112, col. 1, para. 4), and that the mean and weighted mean had similar properties, where the mean, which is simpler to interpret, measured the average level of mucositis, and the maximum mucositis score was less reproducible than the others (p. 2112, col. 2, para. 3).
It would have been obvious to one of ordinary skill in the art to modify the obvious method of Prandini, Winegar, Bratton, and Compton such that the score associated with the animal population is a weighted arithmetic mean of the individual scores associated with said tissue samples. Sonis teaches that weighted means can be utilized to evaluate scores and equalize other relevant factors to disease, such as ulceration and erythema in the case of mucositis. In the obvious method, a weighted mean would allow a person having ordinary skill in the art to incorporate other relevant factors, such as anti IBDV antibody levels in layer pullets after vaccination measured in Prandini, to assess vaccine efficacy. One of ordinary skill in the art would have been motivated to estimate vaccine efficacy. There would be a reasonable expectation of success because Basta teaches using weighted efficacies for the absolute efficacy of virus vaccines. Therefore, claims 1-3, 5, 6, 8, 10, 14 and 15 were prima facie obvious before the priority date of the instant invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is 571-272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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