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 .
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.
This office action is a response to applicant’s communication submitted June 6, 2023, wherein claims 1, 3-4, 7-9, 12-14, and 16-18 were preliminarily amended, and claims 6 and 10-11 were canceled.
Claims 1-5, 7-9, and 12-19 are pending in this application.
Priority
This application claims priority under 35 U.S.C. § 371 to International Application No. PCT/JP2021/044875, filed December 7, 2021, and claims priority therethrough under 35 U.S.C. § 119 to Japanese Patent Application No. 2021-089998, filed May 28, 2021, and Japanese Patent Application No. 2020-202884, filed December 7, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been received. The Examiner notes that no English language translation was provided.
Claim Interpretation
With respect to instant claim 1, which is directed to a pharmaceutical composition and recites the phrase “A prebiotic composition for a butyrate-producing bacterium”. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “for a butyrate-producing bacterium”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02 (II)).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 59, second to last para. on the page (labelled para. 0085)). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112 (a)
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.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The specification, while being enabling for treating or reducing recurrence of diarrhea or inflammatory bowel disease does not reasonably provide enablement for prevention of the same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most clear connected, to make and use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)).
These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4)
relative skill in the art; (5) amount of direction provided by the inventor; (6) the level of
predictability in the art; (7) the existence of working examples; and (8) quantity of
experimentation needed to make or use the invention based on the content of the disclosure. All
of the factors have been considered with regard to the claim, with the most relevant factors
discussed below:
(1& 2) The breadth of the claims and nature of the invention: The claims are drawn to compositions for promoting the growth of butyrate-producing bacteria, methods of administering said composition to an animal, and methods of producing said composition.
(3) The state of the prior art: While there are publications that describe butyrate (i.e. butyric acid), may be beneficial in the treatment of symptoms of diarrhea or inflammatory bowel disease there is no evidence in the prior art that the claimed composition would prevent them from occurring as claimed. For example, Recharla (Nutrients, 2023, cited on PTO-892) discloses butyrate is a potential add-on therapy to reduce inflammation and maintain inflammatory bowel disease remission (abstract). Krokowicz (Travel Medicine and Infectious Disease, 2014, cited on PTO-892) discloses sodium butyrate may decrease the occurrence of travelers diarrhea (abstract). Scarpellini (Digestive and Liver Disease Supplements 1, 2007, cited on PTO-892) discloses butyric acid may regulate status and improve symptoms in patients with diarrhea predominant irritable bowel syndrome (abstract). Thus, in short, the art recognizes butyric acid has therapeutic potential in treating or ameliorating symptoms of diarrhea or inflammatory bowel disease, but the art does not recognize such compositions are capable of preventing the condition from occurring in the first place.
(4) The level of skill in the art: The level of skill in the art would be high, mostly likely at
the Ph.D. /MD level.
(5 & 7) The amount of direction provided by the inventor and the existence of working
examples: Applicant has not provided examples that demonstrate that the composition claimed
is effective at preventing diarrhea or inflammatory bowel diseases. The instant specification has demonstrated methods of producing an oligosaccharide composition (pgs. 46-47, sample preparation, pg. 52, sample preparation) and oligosaccharides are capable of promoting growth in Faecalibacterium prausnitzii (pgs. 59-60, bridging para.).
(6) The level of predictability in the art: The prior art does not teach a method of preventing diarrhea or inflammatory bowel disease by administering a composition comprising butyric acid or by promoting growth of butyrate producing bacterium. Although some methods may treat symptoms or reduce frequency, there is nothing in the prior art that indicates that prevention of diarrhea or inflammatory bowel disease is possible.
(8) The quantity of experimentation necessary: Neither the instant specification nor the state of the art have demonstrated how compositions, such as the compositions claimed, can prevent diarrhea or inflammatory bowel disease. An undetermined number of experimental factors utilizing a compound and its method for preventing would have to be resolved by the practitioner and/or the patient for the following reasons: the factors are not sufficiently discussed in the specification to provide guidance to utilize the invention as claimed.
Therefore, other than proposing an initial hypothesis, the entire burden of research
involved in utilizing the compositions claimed to prevent diarrhea or inflammatory bowel disease as claimed would fall on the shoulders of the skilled artisan attempting to practice the claimed invention, presenting an undue burden of unpredictable experimentation.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a
reward for search, but compensation for its successful conclusion.” And “patent protection is
granted in return for an enabling disclosure of an invention, not for vague intimations of general
ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the state of the art and the lack of guidance or working examples, Applicant fails to provide information sufficient to practice the claimed invention without undue experimentation.
Claim Rejections - 35 USC § 112 (b)
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 8-9, and 14-19 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 8-9: Claim 8 recites, “The composition according to claim 1 which is a food or a drink.”. Claim 9 recites, “The composition according to claim 1 which is a pharmaceutical product.” The phrases “is a food”, “a drink” and “a pharmaceutical product” render the claims indefinite because it is unclear which change to the composition is required for the composition to be considered a food, drink or pharmaceutical product. For example, if the composition is fed to a mouse, would this be considered a food or a pharmaceutical product, or both? If the composition formulated in a liquid composition with supplements, couldn’t this also be considered food? In short a person of ordinary skill in the art would be unable to differentiate between a food, drink, and pharmaceutical product, thereby rendering claims 8-9 indefinite.
Regarding claims 14-19: Claims 14 and 16 recite inter alia the phrases “allowing the alginate lyase to act” and “formulating the resulting degradation product”. The phrase “allowing the alginate lyase to act” renders the claims indefinite because it is unclear what constitutes “allowing”. It is unclear whether “allowing” constitutes an active step, or is merely a placeholder for time. The phrase “formulating” renders the claims indefinite, because it is unclear what constitutes, if any, a formulating step. It is unclear whether merely obtaining the degradation product constitutes a formulation step, or whether an active step is required. Thus, claims 14 and 16 are rendered indefinite. Claims 15-19 which depend from claim 14 are similarly rejected.
Regarding claim 15: Claim 15 recites inter alia, “wherein the alginate lyase is an endo-type alginate lyase and/or an exo-type lyase.”. The phrase “is an” in combination with “and/or” renders the claim indefinite because it is unclear whether the claim is including a lyase which is both an endo- and exo-type lyase or is limiting to include a combination of lyases (i.e. both an endo- and exo-type lyase). Thus, claim 15 is rendered indefinite.
Regarding claim 17: Claim 17 recites, “The method according to claim 14 which further includes a step of collecting an oligosaccharide having a polymerization degree of 2 to 3 and/or salt thereof.”. Claim 14 recites a method for producing a prebiotic composition, wherein the second step (ii)) recites formulating the resulting degradation product as a prebiotic composition. As written, it is unclear where the step of collecting is to be added, (between steps i) and ii), or after ii)). Thus, claim 17 is rendered indefinite.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5, 7, 15 and 18-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 4-5, and 7: Claim 4, which depends from claim 1, and recites, “wherein the butyrate-producing bacterium is a bacterium of Faecalibacterium.”. Claim 5 which depends from claim 4 recites, “wherein the bacterium of Faecalibacterium is Faecalibacterium prausnitzii.”. Claim 7, which depends from claim 1, and recites inter alia “is effective for intestinal regulation….”. However, these claims are ultimately dependent on claim 1 which is drawn to a composition. Claims 4, 5, and 7, merely recite intended use limitations which do not limit the compositional makeup of claim 1. Thus, the claims fail to further limit the claim.
Regarding claim 15: Claim 15, which depends from claim 14, recites inter alia, “wherein the alginate lyase is an endo-type alginate lyase and/or an exo-type alginate lyase. However, these are the only possible types of alginate lyases which is already encompassed by the phrase “alginate lyase” recited in claim 14. Thus, the recitation of each individual species of the recited genus fails to further limit the claim.
Regarding claims 18-19: Claim 18, which depends from claim 14, and recites, “wherein the butyrate-producing bacterium is a bacterium of Faecalibacterium.”. Claim 19 which depends from claim 18 recites, “wherein the bacterium of Faecalibacterium is Faecalibacterium prausnitzii.” However, these claims are ultimately dependent on claim 14 which is drawn to a method of making a composition. Claims 18-19 merely recite intended use limitations which do not limit the method of claim 14. Thus, the claims fail to further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-9, and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (Mar. Drugs, 2019, cited on PTO-892) as evidenced by Wang (Mar. Drugs, 2019, cited on PTO-892) and Miquel (Gut Microbes, 2014, cited on PTO-892).
Regarding claims 1-2, 4-5, 8-9, 12-14, 16, and 18-19: Li teaches the preparation of a composition comprising unsaturated mannuronate oligosaccharides (UAOS) and unsaturated guluronate oligosaccharides (UGOS) from reacting the enzyme alginate lyase Aly08 with Polyguluronate block (Poly G) and polymannuronate (Poly M) (DP = 20–24) prepared from sodium alginate (i.e. allowing an alginate lyase to act on a hydrolysate of sodium alginate, pg. 3, para. 2). Li teaches the administration of the UAOS to mice via feeding (i.e. formulated as food) exhibited anti-obesity effects (i.e. a pharmaceutical product, abstract). Li teaches the structures of the enzymatic unsaturated alginate oligosaccharides (UAOs) are as follows:
PNG
media_image1.png
161
160
media_image1.png
Greyscale
with an unsaturated double bond between C4 and C5 (pg. 5, para. 1, figure 1A, i.e. instant claim 2). According to the instant specification a double bond at position 4 and 5 of the mannuronic or guluronic acid residues are at the non-reducing end (pg. 17, para. 0025).
Although Li does not explicitly disclose that the composition promotes the growth of bacteria, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112). Miquel discloses that Faecalibacterium prausnitzii is a major commensal bacterium that is widely distributed in the GIT of mammals, including mice (abstract, pg. 147, col. 2, last para.). Wherein mice possess Faecalibacterium prausnitzii as commensal bacterium as disclosed by Miquel, upon administration of the composition Li, the resulting promotion in growth necessarily occurs as a result of practicing the method, absent evidence to the contrary.
Regarding claims 3 and 17: Li teaches the main ingredients of the UAOS were disaccharides and trisaccharides (i.e. degree of polymerization of 2-3, pg. 5, last para.). Li teaches the UMOS and UGOS were separated (i.e. collected, pg. 5, para. 1).
Regarding claim 7: Li teaches the double bonds on the non-reducing ends give them greater anti-oxidant activity, and decreased antioxidant activity leads to oxidative stress through reactive oxygen species induced by obesity (pg. 2, para. 2). Li teaches that the composition exhibited anti-obesity effects, including the reduction of ROS formation (pg. 2, para. 3). Thus the composition of Li is effective at reducing oxidative stress as recited by claim 7.
Regarding claim 15: According to Wang, Aly08 degrades (hydrolytically) alginates into disaccharides and trisaccharides in an endo-manner (i.e. endo-lyase, abstract, pg. 7, paras. 1-2).
Conclusion
No claims are allowed in this action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yu (US 2010/0256090, cited on PTO-892) teaches alginic acids with low molecular weight comprising guluronic acid and mannuronic acid for treatment of hyperglycemia (abstract)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693