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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 26 May 2026 has been entered.
Claims 1-14 remain pending in the application.
Claims 8, 9, 12, and 14 are amended.
Claims 1-7 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 8-14 are under consideration.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Greece on 12/06/2022. It is noted, however, that applicant has not filed a certified copy of the GREECE 20220101009 application as required by 37 CFR 1.55.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 23 Jan 2026 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 103
The rejections under 35 U.S.C. 103 are withdrawn in light of applicant’s amendment of the claims, in favor of the new grounds of rejection set forth below.
New Grounds of Rejections
Claim Rejections - 35 USC § 112
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.
Claims 8-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendment filed 26 May 2026 has introduced new matter into the claims. Amended claim 8 recites a “color band sequence.” The response filed 26 May 2026 indicates that support for amended claim 8 can be found on in paragraphs 0011, 0012, 0019, 0020, and 0025 of the specification. This has been fully considered but is not found persuasive. The originally filed disclosure indicates “colors” and “color combinations’ but does not provide support for a “color band sequence” which is more specific than just “color.” Instant claim 8 now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly amended claim 8, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 8 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 12-14 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 8 recites the limitation of “the capsule.” There is insufficient antecedent basis for this limitation in the claims. Base claim 8 recites “each capsule” and “a plurality of capsules”, which encompasses multiple capsules, and it is unclear whether “the capsule” includes just one or more than one capsule. Claims 12-14 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 8.
Claim 12 recites “the particular animal” but this limitation lacks sufficient antecedent basis. Claim 8 refers to both a diseased animal and a group of animals and it is unclear whether “the particular animal” refers to the diseased animal or group of animals.
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive. Applicant argues that the amendments overcome the 112(b) rejections but the examiner maintains that the claims are indefinite for the reasons given above. Regarding the use of “the capsule” in claim 8, the examiner notes that the phrase “for each capsule of the plurality of capsules” has been added to the claim, but the use of “the capsule” following this at the various points in the claim remains unclear as to whether a single capsule or multiple capsules or all of the capsules are in view.
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.
Claims 8-10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. (Contemporary Topics by the American Association for Laboratory Animal Science, Vol 41, No 2, Mar 2002) in view of Chandler et al. (Journal of Veterinary Internal Medicine, Vol 11, No 6 (November-December), 1997: pp 361-364), Porter (Coating of tablets and multiparticulates, Clinical Gate, 15 Jun 2021), and Janzon et al. (GB 2563208, published 12 Dec 2018, listed in IDS filed 01 Dec 2023).
Griffin teaches the use of fecal markers to facilitate sample collection in group housed cats (title). Griffin teaches that some studies require the collection of fecal samples but depending on the number of cats, individual sampling can be laborious and time consuming (page 51 left column). Griffin teaches that marking the stool of individual cats facilitates noninvasive sample collection in group-housed cats and eliminates the need for individual housing (page 51 left column). Griffin teaches marking the feces by adding food coloring to the cat food which imparts a distinct color to each cat’s feces and allows for identification (abstract). Griffin notes that products other than food coloring have been used for identification, including plastic beads (page 51 left column last sentence – right column).
Griffin does not teach that fecal marker beads are enclosed in a capsule with a film and with alphanumeric indications engraved thereon. These deficiencies are made up for in the teachings of Chandler, Porter, and Janzen.
Chandler teaches radiopaque markers for evaluating gastric emptying and small intestinal transit time in cats (title). Chandler teaches providing cats with two sizes of nondigestible radiopaque markers (page 361 left column) which were thirty small and 9 large barium impregnated polyethylene spheres (page 362 left column). Cats that were fed had the spheres mixed in with their food but cats that were unfed as part of the study were administered the spheres in a gelatin capsule by mouth (page 362 left column).
Porter teaches that coatings are applied to various oral dosage forms such as capsules (Introduction). Porter teaches that film coatings are contemporary and commonplace for products such as capsules and that all newly launched coated products are film coated (page 2 Film coating). Porter teaches that coatings provide various benefits such as masking the taste of unpleasant drug substances, improving ease of swallowing large dosage forms and providing a means of improving product appearance and aiding in brand identification (page 1 Reasons for coating).
Janzon teaches a means for marking animals that allows the identification of the origin of animals where the marking comprises a plurality of marker particles where the particles comprise indicia comprising identification means such as alphanumeric indicia (abstract, page 1). Janzon teaches the alphanumeric codes can be etched (page 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed film coated capsules and comprising a plurality of beads for oral delivery to an animal such as a cat and where each of the capsules and beads have a distinguishing feature such as etched alphanumeric indicia that allow for differentiation between the capsules/beads and correlation to the animal that received the capsule. The process of using fecal markers such as plastic beads and coloring fecal matter to distinguish the fecal samples of cats is known from Griffin. It is additionally known from Chandler that a plurality of spheres may be administered to a cat through the use of a capsule containing the spheres. Thus, it would have been obvious to have capsules comprising beads to administer to a group of cats and for identifying what fecal matter belongs to the cat based on the presence of the particular beads present in the fecal matter. One would have a reasonable expectation of success in administering the beads orally via a capsule as capsules are known to be suitable vessels for delivery of spheres to cats where the spheres are nondigestible and pass through cat. Additionally, capsules allow for the option of administering the beads to the cat even if the cat may be under a strict diet with limited food, as taught by Chandler. Thus, incorporating the fecal marker beads into a capsule is merely an alternative means of delivering beads to cats instead of incorporating into food. Each capsule with beads would be distinguishable from other capsules/beads, for example by etched alphanumeric indicia, so that the fecal matter could be accurately associated with the correct cat. It is further known form Porter that film coatings are commonly applied and provide benefits such as improving ease of swallowing. Thus, it would have been obvious to coat the capsules in a film as this is a common practice for capsule formation that provides benefits such as improved swallowing. It is further known from Janzon that alphanumeric markings may be applied as part of a system of identifying markers with a particular animal. Thus, one of ordinary skill would understand alphanumeric markings as an alternative means of associating the capsules and beads to the appropriate animal and would offer a more definite means of identifying the fecal marker in the sample with the animal than other means such as color identifiers. As noted above, Janzon teaches marking with etching and thus renders obvious a surface with identifiers that are formed as grooves in the capsule, thereby rendering obvious forming by an engraving process.
Regarding the limitation of claim 8 that the product is “for identifying a diseased animal,” the examiner notes that the intended use of a product claim carries no patentable weight. See MPEP 2111.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive. Applicant states that Griffin, Chandler, and Porter do not teach alphanumeric identifiers for the capsules and beads. The examiner is not persuaded by this argument as the deficiency is made up for in the teachings of Janzen. Marking a plurality of particles with alphanumeric indicia for identifying animals is known from Janzen and it would be obvious to use such a system with the fecal capsules for identifying particular animals in a group as is obvious from Griffin, Chandler and Porter as this is an alternative means of identification for animals.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. (Contemporary Topics by the American Association for Laboratory Animal Science, Vol 41, No 2, Mar 2002) in view of Chandler et al. (Journal of Veterinary Internal Medicine, Vol 11, No 6 (November-December), 1997: pp 361-364), Porter (Coating of tablets and multiparticulates, Clinical Gate, 15 Jun 2021), and Janzon et al. (GB 2563208, published 12 Dec 2018, listed in IDS filed 01 Dec 2023) as applied to claims 8-10, 12, and 14 above, and further in view of Higuchi et al. (US 4,406,896, published 27 Sep 1983).
The teachings of Griffin, Chandler, Porter and Janzen are described supra.
Griffin, Chandler, Porter and Janzen do not teach the form of a suppository. This deficiency is made up for in the teachings of Higuchi.
Higuchi teaches adjuvants for rectal delivery of drug substances to warm blooded animals (title, col 1 lines 14-15). Higuchi specifically teaches the delivery form as a suppository (col 1 lines 20-25). Higuchi teaches the suppositories as soft elastic gelatin capsules (col 2 lines 37-44) and teaches that suppositories offer advantages over oral administration such as avoiding the acidic, enzymatic content of the stomach and digestive attacks and microbial degradation in the gut (col 1 lines 45-54).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the capsules comprising fecal markers as suppositories. Suppositories are a form of administration to warm blooded animals for capsules that is an alternative to oral delivery and offers benefits such as avoiding the harsh conditions of the stomach and gut. Thus, the use of the capsule containing fecal marker beads as a suppository merely represents an alternative method for administering capsules and their contents and thus is simply the use of known prior art elements for their known function.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. (Contemporary Topics by the American Association for Laboratory Animal Science, Vol 41, No 2, Mar 2002) in view of Chandler et al. (Journal of Veterinary Internal Medicine, Vol 11, No 6 (November-December), 1997: pp 361-364), Porter (Coating of tablets and multiparticulates, Clinical Gate, 15 Jun 2021), and Janzon et al. (GB 2563208, published 12 Dec 2018, listed in IDS filed 01 Dec 2023) as applied to claims 8-10, 12 and 14 above, and further in view of Ju et al. (Green Chem., 23, published 21 Jul 2021).
The teachings of Griffin, Chandler, Porter, and Janzen are described supra.
Griffin, Chandler, Porter, and Janzen do not teach the beads as a biodegradable material. This deficiency is made up for in the teachings of Ju.
Ju teaches that due to the small size of microplastics that there is no systemic method to retrieve all types of microplastics released into nature and that microplastics carry organic pollutants and are ingested by marine animals and have been found in drinking water, coastal areas, and rivers (page 6953 left column). Ju teaches that microplastics have negative effect on the human body such as cellular damage and inflammatory and immune reactions and that microplastic pollution is irreversible because plastics are generally non-degradable and there are no practical means of collecting scattered microplastics in the ocean (page 6953 Introduction). Ju teaches that plastic microbeads are banned in rinse-off cosmetics but that there are known biodegradable alternatives to microplastics (page 6953 right column).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have substituted the plastic beads as fecal markers with biodegradable beads. Microplastics are known to be associated with a variety of negative environmental and human health issues and there is not a practical means of removing the microplastics once exposed to the environment, as taught by Ju. It is further known that the alternative to using microplastic beads is to use biodegradable options, as taught by Ju. Thus, there is a known problem associated with using microplastics and it would have been desirable to one of ordinary skill to use an alternative biodegradable bead to avoid the environmental and health related problems associated with microplastics.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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