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 elects Group III (claims 11-13, 15-17 and 19) with traverse.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The election is made FINAL.
Summary
Receipt of Applicant’s Election, Remarks and Amendments filed on 12/01/2025 is acknowledged. Claims 1-13, 15-17 and 19 are pending.
Claims 14 and 18 have been have been cancelled.
Claims 11-13, 15-17 have been amended.
Claims 11-13, 15-17 and 19 are pending and under examination in this application.
Priority
The current application filed on 10/24/2022 is a 371 of PCT/IB2021/053803 filed 05/05/2021, which in turn claims priority to patent application IT102020000009922 filed on 05/05/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/06/2025, 08/12/2024 and 10/24/2022 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
Claim Objections
Claims 1-10 and 17 are objected to because of the following informalities: claims 1-10 displays status identifiers “original and previously presented” and should be corrected to reflect proper status to say “withdrawn”.
Claim 17 is missing “of” after the word consisting.
Appropriate correction for the above objection is required.
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.
Claim 11-13, 15-17 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of an inflammatory and/or functional bowel disease or of a related symptom, does not reasonably provide enablement for preventive and/or curative treatment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In making a determination that a disclosure does not satisfy the enablement requirement, the factors that may be considered include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. The claims are drawn to a method for preventive and/or curative treatment of, an inflammatory and/or functional bowel disease (IBD) or of a related symptom… in subject selected from a human being, a monogastric animal for example pigs.
Breadth of the claims. The breadth of the claimed invention is exceedingly large and fails to receive adequate support in the specification. Claims 11 and 13 encompass preventive and/or curative treatment of an inflammatory and/or functional bowel disease or of a related symptom by modulating receptors and/or enzymes of the endocannabinoid system, chronic IBD, IBS, diarrhoeic IBS, and diarrhoea or of a related symptom in humans.
State of the prior art and Unpredictability. The state of the art is limited to the treatment or alleviation of symptoms in animals (pigs). No prior art teachings show the preventive and/or curative treatment of, an inflammatory and/or functional bowel disease (IBD) in humans. Prior art reference Evaluation of lipid matrix microencapsulation for intestinal delivery of thymol in weaned pigs (hereinafter the reference is referred as Choi) in view of Phytogenic Compounds as Alternatives to In-Feed Antibiotics: Potentials and Challenges in Application (hereinafter the reference is referred as Yang) teaches thymol in lipid matrix directed to bowel related symptoms for use in pigs and other animals. Therefore, the claimed method of for preventive and/or curative treatment of an inflammatory and/or functional bowel disease or of related symptom in human is highly unpredictable.
Guidance in the specification and working examples. The guidance in the specification is not commensurate in scope with the claimed invention. The description is limited to response against inflammatory or functional diseases or symptoms of the intestinal tract in monogastric animal in the weaning phase for example of birds, chickens, fish and said monogastric mammals, adult or in the weaning phase selected from: dogs, cats, monkeys, pigs, equines, such as horses and donkeys, rabbits before weaning, rodents, such as hamsters, cavies, mice, gerbils, chinchillas, degus, squirrels, guinea pigs and rats; weasels, ferrets and ermines (specification, page 4 lines 26-34), and poultry species (specification, page 5, lines 1-5) and further exemplified on (page 2 lines 8-13). The specification fails to provide guidance pertaining to preventive and/or curative treatment of an inflammatory and/or functional bowel disease or of related symptom in humans.
Amount of experimentation necessary. The aforementioned details establish that one skilled in the art would not be able to make or use the full scope of claimed invention with a reasonable expectation of success and without undue experimentation.
Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of the claimed invention. Thus, the claims are not fully enabled by the disclosure.
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.
Claims 11, 12, 15 and 19 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.
Regarding claims 11, 12, and 19, the phrase "such as", “like in” and “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, the presence of “comprising”, “comprises” and “consisting” in claims 11, 15, and 17 renders the claims indefinite because it makes it impossible to determine the scope of the claim.
Regarding claim 15, the set of parentheses around the words “botanicals” and “anthocyanin” renders the claim indefinite because it is unclear whether the limitations inside the set of parentheses are part of the claimed invention, and anthocyanin is repeated twice, so unclear if there are differences of plural vs. singular terms of the word.
Appropriate correction for the above rejections and all claims affected is required.
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 11-13, 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Evaluation of lipid matrix microencapsulation for intestinal delivery of thymol in weaned pigs (hereinafter the reference is referred as Choi) in view of Phytogenic Compounds as Alternatives to In-Feed Antibiotics: Potentials and Challenges in Application (hereinafter the reference is referred as Yang).
Choi teaches the stability of thymol microencapsulated in combination with organic acids in commercially available lipid matrix microparticles during feed pelleting process and storage (abstract).
Regarding claim 11, Choi teaches a method of administering a composition comprising thymol, pigs and hydrogenated vegetable oil (hydrogenated fatty acid) and ingredients embedded (micro-encapsulated) withing the lipid matrix (page 2, right column, ¶ materials), and the stability of thymol in the lipid matrix microparticles was determined during the pelleting process comprising the lipid matrix microparticles were premixed with corn (page 2, right column, last ¶), corn oil, soybean oil (Table 1), and the experimental and animal care protocol in pigs (page 3, right column, last ¶).
Regarding claims 12 and 13, Choi teaches weaning phase of piglets have frequently have diarrheic symptoms and other intestinal disturbances, which can result in decreased growth performance and mortality (page 1, ¶ introduction) and weaning pigs (page 2, right column, last ¶).
Regarding claim 15, Choi teaches thymol, cinnamaldehyde (page 2, left column, ¶ 2 & right column, ¶ mater materials), carvacrol (page 9, left column, ¶ 2).
Regarding claim 17, Choi teaches organic acids (OA) will maintain their stability during the pelleting process and storage and EO may be slowly released in the pigs’ gut, and research were performed to evaluate the stability of thymol in the lipid matrix microparticles during feed pelleting and feed storage and to determine the intestinal release of thymol using in vitro and in vivo approaches (page 2, right column, ¶ 1). Therefore, it would have been obvious to a person having ordinary skill in the art to select an organic acid through routine experimentation that would encompass an organic acid to from the group consisting of octanoic acid, heptanoic acid, dodecanoic acid and mixture thereof.
Regarding claim 19, Choi teaches feed and feed additive, comprising lipid matrix microparticles able to maintain process and storage and allow a slow and progressive intestinal release of thymol in weaned pigs (page 1, right column, last ¶).
Choi fails to specifically teach anthocyanins.
Yang teaches application of phytogenic products as feed additives for food-producing animals, and numerous studies have demonstrated that phytogenic compounds have a variety of functions, including antimicrobial/antiviral, antioxidative and anti-inflammation effects and improvement in the palatability of feed and gut development/health, and the lipophilic nature of photogenic compounds also presents a challenge in effective delivery to the animal gut and this can partially be resolved by microencapsulation and combination with other compounds (synergistic effect). Interestingly, the effects of photogenic compounds on anti-inflammation, gut chemosensing and possible disruption of bacterial quorum sensing could explain a certain number of studies with different animal species for the better production performance of animals that have received phytogenic feed additives. It is obvious that phytogenic compounds have good potential as an alternative to antibiotics in feed for food animal production and the combination of different phytogenic compounds appears to be an approach to improve the efficacy and safety of phytogenic compounds in the application (abstract).
Regarding claim 16, Yang teaches phytogenic compounds have the potential to increase feed intake by improving the palatability of diet resulting from the enhanced flavor and odor, especially with the use of Eos (page 140, last ¶), and the phytogenic compounds are carvacrol or thymol (page 141, 1st ¶). Moreover, Yang discloses
phytogenic compounds have been shown to manipulate the Nrf2 and NF-κB transcription factors to provide oxidative stress defense and suppress inflammation both in vitro and a number of studies have demonstrated that phytochemicals including cinnamaldeyde, and anthocyanins from purple sweet potato increased the expression or translocation of Nrf2 and reduced or inhibited the activation of NF-κB, suggesting that phytogenic compounds which modify the Nrf2 and NF-κB pathways can protect against oxidative stress and reduce inflammation, and eventually lead to the improvement of animal health and growth performance, and Yang further discloses three phytochemicals (carvacrol, cinnamaldehyde, and capsicum) at low doses presented immune-enhancing properties that could protect broiler chickens against live coccidiosis challenge infection and a more recent study indicated that inclusion of alkaloid sanguinarine in weaner feed has beneficial effects on their growth performance and stimulates anti-inflammatory activity. Therefore, in view of these facts, it is clear that phytochemicals can modulate animal immune response through different pathways to enhance animal health (page 142 last ¶ to 143 1st ¶). Therefore, the limitation of anthocyanins is explicitly taught.
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 make/use a composition comprising thymol, hydrogenated fatty acid or plant origin in a lipid matrix that allows a gastroprotection and/or controlled release properties in the bowel of weaned pigs as taught by Choi and further improve the composition by incorporating anthocyanins for increased feed efficiency and the beneficial effects on their growth performance and stimulates anti-inflammatory activity, and enhance the immune response through different pathways to improve animal health as taught by Yang. One of ordinary skill in the art would have been motivated to do this because all the references are drawn to methods for improving feed or additive feed in weaned pigs and/or monogastric animal in a preventive and/or curative treatment of an inflammatory and/or functional bowel disease or of a related symptom. One of ordinary skill in the art would have found it obvious to apply the different methods of administering a composition to improve inflammatory and/or functional bowel disease or of a related symptom and use as taught by Choi in view of Yang.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
It is obvious to combine prior art elements according to the known methods to yield predictable results. Please see MPEP 2141 (III)(A)-(G).
Conclusion
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615