DETAILED ACTION
Applicant’s response, filed Nov 18 2025, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
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 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.
Claim Status
Claims 1-3, 5 and 9-22 are pending.
Claims 3, 5, 9-13, 19-20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, as set forth in the Non-Final Office Action dated 30 Dec 2020.
Claims 4, 6-8, and 23 are canceled.
Claims 1-2, 14-18, and 21 are examined herein.
Claims 1-3, 5 and 9-22 are rejected.
Examination Note: Applicant submitted amended claims on Nov 5 2025 and supplemental amendments to the claims on Nov 18 2025. Those supplemental amendments submitted Nov 18 are not proper amendments because they do not include the marked up version of the amendments included in the Nov 5 2025 claims, which have not yet been examined. Although technically not proper, the only amendments included in the Nov 5 2025 are to the first limitation of claim 1, and the claims will be examined herein.
Priority
The effective filing date of claims 1-2, 14-18, and 21 is 1 Sep 2020.
Information Disclosure Statement
The information disclosure statement (IDS) filed on Nov 19 2025 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS document is included with this Office Action.
Claim Objections
The outstanding objections to the claims are withdrawn in view of the amendments submitted herein.
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.
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.
A. Claims 1-2, 14-15, 17-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Roys (US 2015/0069118 A1; previously cited), as evidenced by Robyn (“Understanding Hunting Seasons and Tags” Modern Hunters, 29 November 2014, pgs. 1-16, modern-hunters.com/hunting-seasons-and-tags/; previously cited), in view of Shirley et al. (US 2006/0014298 A1; previously cited), Moore et al. (J. Forensic Sci. Nov 2016, vol. 64, no. 6, pgs. 1603-1621; previously cited), and Jobin et al. (Forensic Science International: Genetics 2008, vol. 2, pgs. 190-197; previously cited). The instant rejection is maintained from the previous Office Action and any newly recited portions are necessitated by claim amendment.
With respect to claims 1 and 17, Roys discloses a method and an apparatus for reporting dead wildlife, including animals killed by hunters, in accidents, or dying from natural causes (abstract; para. [0033]). Roys discloses that the system includes a tag encoded with a unique identifier for the tag and a second unique ID of a person to whom the tag is issued and that these tags are required to be attached to the harvested animal at the time of the kill (paras. [0034]; [0042]). Either the unique identifier for the tag or the second unique ID are considered to read on a hunting tag identifier that corresponds to a key in a database. Roys discloses that both unique identifies are uploaded to a database and linked (para. [0034]).While Roys does not specifically teach issuing “a hunting tag to a hunter of a multiplicity of hunters for a region”, this is a term known in the art with a specific definition, as evidenced by Robyn. Robyn discloses that a tag is an additional permit that is added on top of a basic hunting license that allows the hunter to pursue certain animals and that one tag equals the right to harvest one animal of a particular type (pg. 4, last para. to pg. 5, first para.), where tags are limited in number but are still bought in the thousands each year by thousands of people (pg. 5, second para.) and can regulated the category and sex of the animal being hunted (pg. 7, second para.). Therefore, each tag in the system of Roys corresponds to a permit for one particular type of animal and the ID of a person corresponds to a hunting license (i.e. the hunting tag in the claims under the broadest reasonable interpretation of this term) where a multiplicity of people may purchase thousands of tags per region each year. As such, if an individual is issued multiple tags, then the ID of each tag is also associated with the license of the individual in the database. Because Roys teaches that the tag is attached to the harvested animal at the time of the kill (abstract; paras. [0034]; [0042]), the tag is considered to also constitute the harvest report of the instant claims. Roys discloses that the harvested wildlife is documented by reading the barcode on the tag of the animal and entering information about the sex, estimated age, a photograph and GPS location of the animal harvest, and uploading this information to the database and that the uploading information is a combination of information read from the tag and information determined independently from the tag (paras. [0043], [0048] and [0052]). Roys then discloses that the uploaded information is matched with the information uploaded when the tag was issued using the unique identifier associated with the tag (para. [0048] and [0052]). Roys also discloses that the system can include handheld scanners for law enforcement officials to verify that the kill has been reported properly and that the database can be queried to confirm the legality of the kill (i.e., compare the authorized kills allowed by the hunting tag… to the profile of the animal of the harvest report) (paras. [0034] and [0045]). Roys et al. also require that certain kinds of animals have to be presented to a game department official for inspection and tagging with a certain time period and the pelt and skull must be unfrozen (para. [0011]).
Roys et al. is silent to a sample collection area configured to receive a sample of the animal and protect the sample until it is analyzed, receiving a harvest sample analysis report comprising a profile of the animal based on analysis of the sample of the animal in the sample collection area of the harvest report in claim 1; performing a DNA analysis that at least amplifies chromosomes or DNA of the sample of the animal that is collected from the sample collection area of the harvest report wherein the DNA analysis provides a category of said animal indicated by the chromosomes or said DNA in the sample of the animal, a sex of said animal indicated by the chromosomes or said DNA, or blood markers, or genetic markers in the sample of the animal, wherein one or both of the category of the authorized animals and the category of the animal indicated by the DNA in the sample of the animal comprise one or more of a species, a subspecies, a population, a subpopulation, a genus, a family, a breed; in claim 1; wherein the sample of the animal comprises a blood sample in claim 2; the harvest report further comprises a seal configured to cover the sample collection area in claim 14; wherein the seal is transparent in claim 15; an inspection kit comprising an inspection sample collection are configured to receive an inspection sample of a carcass and protect the inspection sample until it is analyzed, receiving an inspection sample analysis report comprising a profile of the carcass based on the analysis of the inspection sample of the carcass in the inspection sample collection area of the inspection kit and comparing the profile of the animal to the profile of the carcass to determine whether the carcass is part of the animal killed by the hunter in claim 17; wherein the profile of the animal comprises a DNA fingerprint of the sample of the animal; the profile of the carcass comprises a DNA fingerprint of the sample of the carcass; and comparing the profile of the animal to the profile of the carcass comprises determining whether the DNA fingerprint of the sample of the animal matches the DNA fingerprint of the sample of the carcass in claim 18; and wherein the sample of the carcass is blood in claim 21. However, these limitations were known in the art at the time of the effective filing date of the invention, as taught by Shirley et al., Moore et al. and Jobin et al.
Regarding claims 1 and 17, Shirley et al. discloses a method and kitset for rapid collecting and storing of a plurality of biological samples for later identification of sources of the samples that can be useful in tracing of meat specimens back to the carcasses from which they originated (abstract). Shirley et al. discloses that the invention includes a sampling strip that has one face with an absorbent are impregnated with a DNA stabilizing composition and an adhesive area, and the other face covers and protects the sampling area (i.e., a sample collection area) (paras. [0015]; Figs. 1-6). Shirley et al. further discloses that each substrate and/or sampling strip is marked with indicia, such as a bar code, to identify the source of the biological sample collected on the sampling strip (paras. [0017] and [0055]). Shirley et al. also discloses that a unique code could be printed on the sampling strip at the time of manufacture (para. [0056]). Shirley et al. also discloses that the biological sample is taken from an animal carcass (para. [0021]). Shirley et al. discloses that the purpose of storing the DNA samples with records of the sources and performing genetic analysis at a laboratory for analysis (i.e., DNA analysis) is to allow tracing of meat cuts from animal carcasses by doing a comparative DNA analysis and provide positive identification of one or more animals (paras. [0058], [0078], and [0082]). As Shirley et al. discloses performing genetic analysis on the DNA from the samples after washing with purification reagent and performing polymerase chain reaction (paras. [0058] and [0084-0086]), it is considered that Shirley et al. fairly teaches isolating or extracting the DNA from the sample and amplifying the DNA as instantly claimed. Shirley et al. also discloses that samples of meat for which a trace is requested can be taken on FTA paper, mailed to a laboratory for analysis and identified by a barcode or unique identifier (para. [0082]). Shirley et al. also discloses that the unique identifiers or barcodes from the trace sample and the carcass ticket were both entered into a spreadsheet or database and stored for later use in relating the DNA profile to the carcass information (para. [0083]). Shirley et al. then discloses that samples from both the carcass ticket and the trace sample were sequenced to determine a single matching carcass ticket matched a meat sample (paras. [0082]-[0088]). Shirley et al. also discloses that the method can be used for DNA sequencing to identify an animal, parentage testing, and species or strain identification (para. [0092]). Shirley et al. further discloses that a single matching carcass ticket sample is identified for each meat sample (para. [0087]).
Concerning claims 1 and 17, Moore et al. discloses that wildlife forensics is used to determine taxonomic identity, geographic source, sex or familial relationships among a group of samples (abstract; Table 1), especially for wildlife samples that have already been processed (pg. 1603, col. 2, para. 2). Moore et al. also discloses that specific laws control what animals are legal to kill based on time of year, geographic area, proper licensing, species or sex (pg. 1604, col. 2, para. 3 to pg. 1605, col. 1, para. 1). Moore et al. further discloses that the such analyses include receiving sample for identification, amplifying and sequencing the sample to determine the species, geographic region, sex, familial relationships or even confirm individual identity (pg. 1608, col. 1, para. 1 to pg. 1611, col. 2, para. 1; Fig. 2). Moore et al. further discloses an example in which the laboratory received two items from kill sites in two separate areas and a tissue sample from a mule deer and through the analysis of these samples was able to confirm species and individually match each of the samples to confirm that the deer in question had in fact been illegally hunted in a manner that did not conform with the hunter’s permit (pg. 1612, col. 2, para. 4 to pg. 1613, col. 2, para. 2).
As to the limitations of claim 1 directed to the profile of the animal generated via a DNA analysis and claims 17-18 directed to the DNA fingerprints, Moore et al. discloses that the analysis of the samples includes determining the DNA profile (i.e., fingerprint) of the particular sample and then utilizing information including the species and sex of the animals to determine the legality of the kill (pg. 1604, col. 2, para. 3 to pg. 1605, col. 1, para. 1; pg. 1612, col. 2, para. 3 to pg. 1613, col. 2, para. 4).
Pertaining to claims 2 and 21, Shirley et al. discloses that the biological sample stored on the sampling strip is blood (paras. [0019]-[0020] and [0080]).
With respect to claims 14-15, Shirley et al. discloses that the sampling strip includes a backing sheet, one side of which covers and protects the sampling area by forming a seal with adhesive, and the backing sheet is a clear polystyrene film (paras. [0029]-[0030] and [0060]-[0062]; Fig. 3).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Jobin et al. discloses that the number of illegally taken deer is estimated to be between 9 and 61% of the legal harvest and that forensic DNA testing has been developed to help protect deer populations (pg. 190, col. 1, para. 1 to col. 2, para. 2). Moore et al. discloses a review of wildlife forensics systems that are utilized to determine if illegal killing has occurred (see above). Roys discloses a system for more reliable and simplified method of accounting for animal harvesting that can further be used by law enforcement to confirm the legality of the kill (para. [0034]). Therefore, one of ordinary skill in the art would have been motivated to add the forensic analysis methods to confirm species and/or sex of hunted animals as taught by Moore et al. as part of the animal harvesting system taught by Roys in order to reduce the large number of illegally hunted animals as taught by Jobin et al. Furthermore, one of ordinary skill in the art would predict that the methods of Moore et al. could be readily added to the system of Roys with a reasonable expectation of success as the methods of Moore would provide further information, in addition to the images taught by Roys, for verifying the legality of a harvested animal by law enforcement that is taught by Roys.
Additionally, Shirley et al. reports a kitset that allows for rapid collection and storage of DNA samples of animal carcasses that are particularly useful for tracing meat specimens back to the carcasses where they originated (abstract). Shirley et al. further discloses that quick and accurate sample taking is required in non-laboratory conditions and can be used in any situation requiring rapid sampling of animal tissue when clear identification of the sample is paramount (paras. [0011] and [0094]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to utilize the kitset and tracing method taught by Shirley et al. as the sample collection method in the combination of Moore et al., Jobin et al. and Roys to enable a rapid and accurate sample collection by the hunters. Although Roys teaches providing information about the kill using an electronic device to generate a report which is linked to their hunting tag, it would have been obvious to include that same information on the tag itself, as taught by Shirley. Furthermore, one of ordinary skill in the art would predict that the kitset and method taught by Shirley et al. et al. could be readily added to the system of Roys, Jobin et al. and Moore et al. with a reasonable expectation of success because Moore et al. discloses utilizing obtained biological samples and Shirley et al. discloses that the kitset and method can be used for animal identification and validation. The invention is therefore prima facie obvious.
B. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Roys (US 2015/0069118 A1; previously cited), as evidenced by Robyn (“Understanding Hunting Seasons and Tags” Modern Hunters, 29 November 2014, pgs. 1-16, modern-hunters.com/hunting-seasons-and-tags/; previously cited), in view of Shirley et al. (US 2006/0014298 A1; previously cited), Moore et al. (J. Forensic Sci. Nov 2016, vol. 64, no. 6, pgs. 1603-1621; previously cited) and Jobin et al. (Forensic Science International: Genetics 2008, vol. 2, pgs. 190-197; previously cited) as applied to claims 1 and 14 above, and further in view of GE Healthcare Life Sciences (“Your forensic samples, our experience” 2011, pgs. 1-28; previously cited). The instant rejection is maintained from the previous Office Action and any newly recited portions are necessitated by claim amendment.
The limitations of claims 1 and 14 have been taught by Roys, Robyn, Shirley et al., Moore et al. and Jobin et al. as set forth in the above rejection.
Regarding claim 16, Shirley et al. discloses that the absorbent pad can be FTA paper sold by Whatman PLC (paras. [0063]-[0064]).
Roys, Robyn, Shirley et al., Moore et al. and Jobin et al. are silent to wherein the seal comprises a tamper-evident seal with a tamper indicator that indicates that the seal has been opened or resealed after it had been sealed in claim 16. However, these limitations were known in the art at the time of the effective filing date of the invention, as taught by GE Healthcare Life Sciences.
With respect to claim 16, GE Healthcare Life Sciences discloses a brochure for Whatman FTA technologies, including databasing paper. GE Healthcare Life Sciences also discloses that the FTA cards also come in kits for field-based sample collection that include data collection forms, barcodes to help ensure chain of custody, a multi-barrier pouch and shipping envelope (pgs. 6 and 17). GE Healthcare Life Sciences further discloses that the multi-barrier pouch included with the kit includes a tamper-evident seal and desiccant packs that help protect the samples during transport and storage (pg. 24) which maintain sample security (pg. 25). While GE Healthcare Life Sciences does not specifically disclose if the multi-barrier pouch is transparent or not, merely changing the color of the pouch from opaque to transparent amounts to an aesthetic design change that has no mechanical function and cannot be relied upon to patentably distinguish the claimed invention from the prior art. Therefore, a transparent seal does not patentably distinguish over the multi-barrier pouch seal taught by GE Healthcare Life Sciences.
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. GE Healthcare Life Sciences discloses commercially available kits including FTA databasing paper that include elements to further protect the sample and assist with tracking chain of custody. Therefore, one of ordinary skill in the art would have been motivated to utilize the kits taught by GE Healthcare Life Sciences in system of Roys, Shirley et al. and Moore et al. to improve tracking chain of custody of the biological samples and further protect the sample. Furthermore, one of ordinary skill in the art would predict that the kit of GE Healthcare Life Sciences could be readily added to the system of Roys, Shirley et al. and Moore et al. with a reasonable expectation of success as the system of Roys, Shirley et al. and Moore et al. already utilized FTA paper. The invention is therefore prima facie obvious.
Response to Applicant Arguments
At p. 9-16, Applicant submits that the previous Office Action did not address Applicant’s remarks regarding combining Roys with the cited references would change the principle of operation, resulting in a drastic change of the principle of operation, which is not allowed as per MPEP 2143.01(VI). Applicant submits that the previous Office Action focused on the intended use of the invention or Roys as verifying the legality of a kill or assessing a hunter’s kill for compliance, while Applicant asserts that the principle of operation of Roys requires the use of a smart phone, a picture of the animal, a GPS location, and software that transmits that information to a database accessible through a computer network with the intended purpose.
It is respectfully submitted that this is not persuasive. It is maintained, as stated in the previous Office Action, that one of ordinary skill in the art would recognize that a kill could be verified in a number of ways, including through DNA analysis, and would then recognize that a carcass sample cannot be electronically uploaded for automatic analysis as taught by Roys, and as such is not considered to change the principle of operation of Roys. Such a realization would lead one of ordinary skill in the art to look for other teachings by analogous art for systems/methods to perform such sample collection and DNA analysis, which Shirley reasonably teaches. Additionally, separately from the combination of Roys and Shirley, Moore actually teaches using DNA analysis to verify a kill or catch an illegal kill, providing the suggestion to one of ordinary skill in the art that DNA could be used in such a way, with Jobin providing the motivation of reducing the large number of illegally hunted animals. While substituting the type of data being analyzed to verify a hunter’s kill from an electronic image to a carcass sample would preclude an automatic process as argued by Applicant, one of ordinary skill in the art would understand how to use the system and method taught by Shirley to ultimately send the sample for DNA analysis and obtain a profile that could be used to compare the animal to an authorized kill list, which is ultimately the intended purpose of Roys. Additionally, one of ordinary skill in the art would recognize that the kill could be verified both by the image analysis method taught by Roys and by DNA analysis, as taught by Shirely in view of Moore. Therefore, the combined invention would have a reasonable expectation of success. Applicant is directed to MPEP 2143 generally, which discloses the various permissible rationales for a conclusion of obviousness, including at least combining prior art elements and simple substitution which are both applicable to the instant claims. Applicant is further reminded that obviousness “can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so” (MPEP 2143.01), as has been explained in the above rejection, and that motivation need not be found in the primary reference, but may be found explicitly or implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill." Zup v. Nash Mfg., 896 F.3d 1365, 1371, 127 USPQ2d 1423, 1427 (Fed. Cir. 2018) (quoting Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 [107 USPQ2d 1706] (Fed. Cir. 2013) (citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328 [92 USPQ2d 1849] (Fed. Cir. 2009) (quoting KSR, 550 U.S. at 418-21)).
Regarding MPEP 2143.01(VI), the example provided by the MPEP notes that the substitution of one oil seal which required rigidity for another oil seal which required resiliency “would require a substantial reconstruction and redesign of the elements shown in [the primary reference] as well as a change in the basic principle under which the [primary reference] construction was designed to operate”. It is respectfully submitted that this example and rationale does not apply to the instant claims because each of the features that would need to be modified in Roys to arrive at the instant invention are taught by the secondary references. It is maintained that one of ordinary skill in the art would understand that those features taught by the secondary references are alternatives to those features taught in Roys. Ultimately, Roys requires information about a kill to be transmitted to a database, which still occurs during the method of Roys in view of Shirley, Moore, and Jobin. The idea of gathering and transmitting information to verify a kill in a database is not novel, as taught by Roys, and neither is the use of a sampling strip to collect and store DNA, as taught by Shirley, or using DNA from a killed animal to verify its identity, as taught by Moore and Jobin. The combination of the system of Roys for formalized information collection and analysis to verify a kill with the idea of Moore and Jobin for using DNA to verify such a kill using the kitset by Shirley to collect the DNA therefore teaches the instant claims. Such a combination does not change the principle of operation of Roys because the combination of the references represents a simple substitution of one known element for another to obtain a predictable result (see MPEP 2143(I)(B)). Following the analysis, (1) Roys contains a method which differs from the claimed method by the substitution of the collection and analysis of DNA from the killed animal; (2), such substituted components are known in the art by Shirley, Moore, and Jobin; (3) it is considered that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable, i.e., that one could have verified the kill made to be one allowed by the hunter using the method of Roys in view of Shirley, Moore, and Jobin; and (4) motivations for combining each of Shirley, Moore, and Jobin to the method of Roys are provided in the above rejections.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANNA NICOLE SCHULTZHAUS whose telephone number is (571)272-0812. The examiner can normally be reached on Monday - Friday 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached on (571)272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.N.S./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685