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 Restriction Requirement dated 6/25/25 is VACATED in favor of this Office Action
1. Formal Matters
Claims 1, 2, 4-8 and 10-22 are pending and are the subject of this Office Action.
2. Specification
A. If applicable, the first line of the specification should be updated to reflect the status (e.g. “now U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be found, any U.S. or Foreign Applications cited in the specification which have since issued should be updated with the corresponding Patent No.
B. Though none could be found, any listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
C. Though no issues could be found, Applicant is advised that embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. The attempt to incorporate subject matter into the patent application by reference to a hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01(p), paragraph I regarding incorporation by reference. It is noted that the recitation of “www.” alone, as opposed to “http://www.”, is also active and should not be used.
D. Though no issues could be found, trade names or marks used in commerce should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
E. Though no issues could be found, according to 37 CFR 1.821(d) (MPEP § 2422), where the description or claims of a patent application discuss a sequence listing that is set forth in the "Sequence Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
F. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Objections
Claims 1, 13-18 and 20 are objected to since “cell free” should be hyphenated.
4. Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
A. Claims 1, 2, 4-7, 11 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SOFAR SPA (WO 2015/162570 – cited on the IDS dated 4/5/23).
SOFAR teaches treatment of IBD, including CD and UC (page 3, lines 9-10) by administration of L. casei DG (page 3, especially the paragraph starting with “Preferably”. L. casei DG is also known as instantly claimed L. paracasei (see U.S. National Library of Medicine – cited as reference 14 on the IDS dated 4/5/23. This reference is not being used as part of the rejection, rather only to show an alternate name). SOFAR also teaches that Lactobacillus may be administered in combination with compounds including 5-ASA, cyclosporine (also known as cyclosporin A) and anti-TNFa agents (page 6, lines 4-7). Regarding claim 19, it would have been obvious to have used one of the two available possibilities (i.e. administered either together or separately).
Regardless, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955). Furthermore, "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and, therefore, obvious) and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (“it is not inventive to discover the optimum or workable ranges by routine experimentation.”). Regarding claim 20, case law has established that a compound and all of its properties are inseparable, as are its processes and yields (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
B. Claims 1, 2, 4, 11 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tursi et al. (cited on the IDS dated 4/5/23).
Tursi teaches treatment of UC (Title, Abstract) by administration of L. paracasei (page 2220, line 4). This treatment is performed along with 5-ASA and/or an immunosuppressant (page 2220, lines 1-2 and under “Concomitant treatments”). See also In re Aller and In re Papesch.
C. Claims 1, 2, 4, 11 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’Inca et al. (cited on the IDS dated 4/5/23).
D’Inca teaches the administration of oral 5-ASA in combination with orally or rectally administered L. casei DG (L. paracasei) to UC patients (Abstract; “Study Design” on page 1179). Cytokines, including TNF-a, was reduced (page 1181, right column, second full paragraph). See also In re Aller and In re Papesch.
D. Claims 1, 2, 4, 11 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Federico et al. (cited on the IDS dated 4/5/23).
Federico teaches the administration L. paracasei to UC patients currently taking mesalamine (page 286 under “Materials and Methods”), with decreases in various pro-inflammatory cytokines, including IL6 See also In re Aller and In re Papesch.
5. 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.
A. Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over either (1) SOFAR SPA, (2) Tursi et al., (3) D’Inca or (4) Federico et al., each in view of Applicant’s specification.
The teachings of each of the four primary references are seen above under 35 USC 102. None of the references teach tofacitinib. However, paragraph [0004] does teach that its use was well-known at the time of the instant invention.
B. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over either (1) SOFAR SPA, (2) Tursi et al., (3) D’Inca or (4) Federico et al., each in view of Applicant’s specification.
The teachings of each of the four primary references are seen above under 35 USC 102. None of the five references teach adalimumab. However, paragraph [0004] does teach that its use was well-known at the time of the instant invention.
C. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over either (1) SOFAR SPA, (2) Tursi et al., (3) D’Inca or (4) Federico et al., each in view of Servatus LTD (WO 2018/187838 – cited on the IDS dated 4/5/23).
The teachings of each of the four primary references are seen above under 35 USC 102. None teach the claimed Lactobacillus combination. However, Servatus does teach treatment of DSS-induced UC by administering the claimed combination (paragraphs [00012], [00013], [00014], [00024], Example 3), but it is disclosed that a particular embodiment can also be CD (paragraph [0008]).
D. Claims 13 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over SOFAR SPA in view of Servatus LTD (WO 2018/187838 – cited on the IDS dated 4/5/23)
The teachings of SOFAR are seen above under 35 USC 102. SOFAR does not teach the claimed Lactobacillus combination. However, Servatus does (see paragraph C in the above rejection under 35 USC 103.
E. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over either (1) SOFAR SPA, (2) Tursi et al., (3) D’Inca or (4) Federico et al., each in view of Servatus LTD (WO 2018/187838 – cited on the IDS dated 4/5/23) and further in view of Applicant’s specification
The teachings of each of the four primary references are seen above under 35 USC 102, and Servatus is seen in paragraph C in the above rejection under 35 USC 102. None teach adalimumab. However, paragraph [0004] does teach that its use was well-known at the time of the instant invention.
F. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over either (1) SOFAR SPA, (2) Tursi et al., (3) D’Inca or (4) Federico et al., each in view of Servatus LTD (WO 2018/187838 – cited on the IDS dated 4/5/23) and further in view of Applicant’s specification.
The teachings of each of the four primary references are seen above under 35 USC 102, and Servatus is seen in paragraph C in the above rejection under 35 USC 102. None teach tofacitinib. However, paragraph [0004] does teach that its use was well-known at the time of the instant invention.
G. Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over either (1) SOFAR SPA, (2) Tursi et al., (3) D’Inca or (4) Federico et al., each in view of Servatus LTD (WO 2018/187838 – cited on the IDS dated 4/5/23).
The teachings of each of the four primary references are seen above under 35 USC 102, and Servatus is seen in paragraph C in the above rejection under 35 USC 102.
6. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647