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 .
The preliminary amendment filed 9-20-2024 has been entered.
Status of Claims
Claims 1-19 are pending. Claims 20-57 have been canceled.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
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 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(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.
Claims 1-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of bacterial strain ART24. Because it is not clear that cell lines possessing the properties of ART24 are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of ART24, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the strain ART24 in the claims is required. Without a publicly available deposit of the above strain, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the strain is an unpredictable event.
Applicant's referral to the deposit of the strain at paragraph [0071] on page 13 of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the hybridoma cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed. Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Additionally, with respect to the claimed “prevention” of ulcerative colitis (e.g. proctitis, proctosigmoiditis, pancolitis), the art teaches that ulcerative colitis is an inflammatory bowel disease of unknown etiology limited to the large intestine. The specification acknowledges that the exact cause of ulcerative colitis is unknown (see page 18, line 1). A number of murine models exist to provide for understanding of the disease pathogenesis of ulcerative colitis (see Flynn et al Arch Pharm Res 26(6):433-440, 2003; see abstract and page 433, Figure 1), but do not provide for the naturally occurring disease trigger. The specification defines prevention at page 16, paragraph [0083]. Unlike the rodent models of ulcerative colitis of the art, the disease trigger(s) or etiology in humans is unknown so when and to whom to administer the ART24 to remains unknown. The specification does not teach how to identify or predict those individuals in a population who would benefit from “prevention” by means of administration of ART24 as claimed. Applicant has not demonstrated prevention in humans and the examples are merely prophetic and can only provide treatment to those who have been diagnosed and those displaying one or more symptoms and/or pathologies of ulcerative colitis (see page 38, paragraph [0134]). There is no process to describe those individuals who will get ulcerative colitis to even begin to study potential prevention/prophylaxis in humans. Given that the specification does not provide evidence of prevention of ulcerative colitis in humans, it is not enabled for such and would require undue experimentation to determine the etiology of human ulcerative colitis in order to then determine to whom and when to administer the ART24 strain.
Claims 1-19 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 1 and every claim dependent thereon (2-19), the claims recite strain ART24 (NCIMB Accession No. 43088) and it is unclear if the strain is limited to the specific strain recited in the parenthesis. It is suggested that Applicant amend the claims to recite “…strain ART24 deposited as NCIMB Accession No. 43088.” to resolve this issue.
As to claims 18 and 19, it is unclear how the treatment comprises weight loss/improvement in disease activity index or reduce colonic inflammatory markers. How are these administered or provided as part of the treatment? Clarification is requested.
Claims 18 and 19 are rejected under 35 U.S.C. 112(d), 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. The specific language of the claims does not properly further limit the treatment provided by providing an additional ingredient, specific amount or route of administration. 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 § 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 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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-9, 13-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yum et al (US 2020/0316177; 10-8-2020 with priority to at least December 26, 2018) in view of Fiorucci (WO 2020/229924, published 11-19-2020 with priority to at least April 29, 2020) and Murphy et al (WO 2019/236806, published 12-12-2019 with priority to at least 6-6-2019).
Yum et al teach Bacillus amyloliquefaciens, spores and superoxide dismutase (SOD) derived therefrom for the prevention and treatment of inflammatory bowel disease and ulcerative colitis, in particular (see paragraphs [0031-0032]). Yum et al teach that ulcerative colitis symptoms include cramping, lower abdominal pain, rectal bleeding and frequent, loose discharges consisting mainly of blood, pus and mucus with scanty fecal particles (see paragraph [0032]). Yum et al teach that the vegetative cells, spores and SOD derived therefrom can be administered in various forms (paragraphs [0038-0043]; [0051-0065]) including dietary supplements, edible products (i.e. functional foods with excipients, binders etc, freeze-dried with coatings provided in capsules). Yum et al teach the effectiveness of administration using a murine mode of acute ulcerative colitis. Yum et al teach the effective treatment and reduction of inflammation and pro-inflammatory cytokines in a murine model of ulcerative colitis in humans. Yum et al differ by not teaching strain ART24 in the treatment. The specification teaches that strain ART24 belongs to the operational group of Bacillus amyloliquefaciens bacteria (see paragraph [0002]).
Fiorucci teaches that use of Bacillus amyloliquefaciens alone or in combination with other probiotics for the treatment and/or prevention of inflammatory bowel diseases such as ulcerative colitis, indeterminate colitis and microscopic colitis (see abstract). Fiorucci teach that the addition of Bacillus amyloliquefaciens made the composition active in prevention the reduction of body weight loss as well as inducing an improvement in inflammation measured as CDAI (see page 16, second paragraph).
Murphy et al teach Bacillus amyloliquefaciens strain ART24 (paragraph [0007]). Murphy et al teach ART24 for use as a probiotic in vegetative, spore in multiple different function forms (see paragraph [0008]). The pharmaceutical compositions can comprise a carrier where the carrier comprises polysaccharides) Murphy et al teach that composition formulated for enteric administration, oral , sublingual, for rectal delivery or use as a probiotic (see paragraph [0011]). The bacterial strain my be lyophilized or in the form of a spore (see paragraph [0013]). Murphy et al teach that compositions may be formulated for adding to fud or used directly as a food supplement and may include other probiotic agents to nutrients for promoting spore germination and/or bacterial growth. Additional components can be used and formulated as a solid food, packaged food, wafer, tablets, troches, capsules or the like (see paragraph [0107-0110]). Murphy et al teach the dosages may be varied based upon severity or route (see paragraph [0115]). Murphy et alt teach that the strains Bacillus amyloliquefaciens strain ART24 may be combined with one or more additional therapies. The multiple therapeutics may be administered in any order or even simultaneously, in multiple doses, separate doses or both at multiple doses (see paragraphs [0116-0119]).
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to substitute the Bacillus amyloliquefaciens strain ART24 of Murphy et al for the Bacillus amyloliquefaciens strain in the methods and formulations of Yum et al for the treatment and/or prevention of ulcerative colitis as the substitution of one strain for another as functional equivalent is prima facie obvious. It further would have been prima facie obvious to the skilled artisan to treat human patients as the murine models are used as a model of human ulcerative colitis. One would have had a reasonable expectation of success given that both Yum et al and Fiorucci teach that strains of Bacillus amyloliquefaciens provide for treatment and amelioration of symptoms in ulcerative colitis animal models. It would have been prima facie to treat all the different categories of ulcerative colitis as the treatment modalities are the same or similar in the art.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yum et al (US 2020/0316177; 10-8-2020 with priority to at least December 26, 2018),Fiorucci (WO 2020/229924, published 11-19-2020 with priority to at least April 29, 2020) and Murphy et al (WO 2019/236806, published 12-12-2019 with priority to at least 6-6-2019) as applied to claims 1-9, 13-15 and 17-20 above and further in view of Farquhar et al (WO 2021/116983, published June 17, 2021 with priority to 12-11-2019).
The combination of Yum et al (US 2020/0316177; 10-8-2020 with priority to at least December 26, 2018),Fiorucci (WO 2020/229924, published 11-19-2020 with priority to at least April 29, 2020) and Murphy et al (WO 2019/236806, published 12-12-2019 with priority to at least 6-6-2019) is set forth supra. The combination differs by not teaches the edible product comprises a fermented food as set forth in the claims.
Farquhar et al teach that the Bacillus amyloliquefaciens strains including ART24 may be provided in an edible product comprising fermented food products such as soybean or soybean past and include Cheonggukjang, Douchi, Hawaijar, Bekang, Peruyaan, Tungrymbai,Eoyukjang, Kinema, Aakhone, Miso, Natto, or Thua-nao (see claims 6-13 at pages 36-37).
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to provide Bacillus amyloliquefaciens strain ART24 in an edible product comprising fermented food products such as soybean or soybean past and include Cheonggukjang, Douchi, Hawaijar, Bekang, Peruyaan, Tungrymbai,Eoyukjang, Kinema, Aakhone, Miso, Natto, or Thua-nao according to Farquhar et al because Yum et al teach that the Bacillus amyloliquefaciens can be provided in edible products for the treatment/prevention of ulcerative colitis.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yum et al (US 2020/0316177; 10-8-2020 with priority to at least December 26, 2018), Fiorucci (WO 2020/229924, published 11-19-2020 with priority to at least April 29, 2020) and Murphy et al (WO 2019/236806, published 12-12-2019 with priority to at least 6-6-2019) as applied to claims 1-9, 13-15 and 17-20 above and further in view of Monteleone et al (Expert Opin. Investig. Drugs, 22(9):1123-1132, 2013).
The combination of Yum et al (US 2020/0316177; 10-8-2020 with priority to at least December 26, 2018),Fiorucci (WO 2020/229924, published 11-19-2020 with priority to at least April 29, 2020) and Murphy et al (WO 2019/236806, published 12-12-2019 with priority to at least 6-6-2019) is set forth supra. The combination differs by not teaching the administration of one or more of the additional agents as set forth in claim 16.
Monteleone et al teach that the standard treatment medication for ulcerative colitis is mesalamine (aminosalicate family), steroids (an immunomodulator) and thiopurines (see abstract). Monteleone et al teach that novel TNF-alpha blockers have demonstrated therapeutic effectiveness in steroid-refractory and/or steroid dependent ulcerative colitis (see page 1124, column 1). Monteleone et al teach other cytokine targeted-drugs for the treatment of ulcerative colitis, either licensed or under development (see Table 1, page 1125).
It would have been prima facie obvious at the time of filing to add one or more of the treatment medications as taught by Monteleone et al for ulcerative colitis to the method as combined supra because Murphy et al teach that Bacillus amyloliquefaciens strains ART24 can be combined with other medications for the treatment of disease. The idea of combining the treatments flows from their being individually taught for the treatment of inflammation in the colon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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