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 .
Response to Arguments
In the Applicant’s Response, dated 12/1/2025, the Applicant provides arguments to the 35 USC 103 rejections. Based upon the claim language, the arguments, and the prior art used by the previous examiner, the previously used Borody (PGPub 2013/0195804 [Borody 1]) and Borody (WO 2014/078911 [Borody 2]) continue to apply. However, based upon a reanalysis of the previous examiner’s rejections, and the Applicant’s response to these rejections, an additional reference will be used to bolster the previously used prior art.
Generally speaking, the Applicant’s arguments revolve around the fact that the cited prior art provides for all of the claimed ingredients, but does not necessarily provide for all of the ingredients provided in the same composition; the Applicant points to the fact that the prior art provides these compounds in alternative embodiments. The newly entered art will be used to provide rationale for expectations of predictability, and as such, will account for the arguments provided by the Applicant. See MPEP 2143(I)(A) and (D). Since the claims are being reassessed with additional art, and being examined by a different examiner, these rejections will be considered new. As such, this action is non-final.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21, 24-27, 33, 34, 37-43, 46, and 49-55 are rejected under 35 U.S.C. 103 as being unpatentable over Borody (PGPub 2013/0195804 [Borody 1]) and Borody (WO 2014/078911 [Borody 2]) and evidenced by Mehmood, et al (Open Science Journal of Pharmacy and Pharmacology, 3, 19-27, 2015) and Taravati, et al (World Applied Sciences Journal 2, 353-363, 2007). Borody 1 teaches methods of microbiota restoration by providing a treated fecal microbiota composition. See paragraph [0001]. Borody indicates that it can be administered by the oral route and can be provided as a lyophilize composition. See paragraph [0042] [0136]. Borody 1 indicates that the composition can include compounds that help reduce the destruction of living bacteria, which can be polyethylene glycol, and sugars that include the monosaccharide components of sucrose. See paragraph [0157]. Borody 1 indicates that trehalose can be used as a cryoprotectant. See paragraph [0167]. Borody 1 indicates that glycerol is added as a stabilizing agent and to help reduce the formation of ice crystals in the lyophlizatsion process/ See paragraph [0147] [0156]. Although Borody teaches glucose and fructose (to aid in bacteria survival), the monosaccharide components of the disaccharide sucrose, Borody 1 is silent towards sucrose. Since each of the 3 named ingredients of Borody 1 are all used for different purposes, there is nothing in Borody 1 to suggest that these should be used separately. Furthermore, the ordinary artisan possesses ample knowledge of fecal processing and lyophilization, and as such, would find the inclusion of known compounds already used in lyophilization and cryopreservation as being obvious, since the ordinary artisan is fully aware of their uses and functions. See MPEP 2141.03
Borody 2 provides for a method that overlaps with Borody 1, wherein methods of providing fecal microbiota are taught. See page 1, lines 5-23. Borody 2 provides the composition by oral route. See page 17, line 16. Borody 2 indicates that the composition can be provided in a lyophilized form. See page 9, line 27. Borody 2 indicates that various sugars, including sucrose and trehalose can be used; Borody 2 also indicates that both polyethylene glycol and glycerol can be added to the composition. See page 21, lines 1-3. Borody 2 notes that polyethylene glycol can be used for delayed or gradual enteric release. See page 27, line 19. Borody 2 states that glycerol is used to stabilize the composition. See page 32, line 30. Borody 2 does not state the purpose for including trehalose or sucrose, but generally suggests that these can be used as lyoprotectants and food for the microbiota. See page 7, line 3; page 20, lines 28-32 (continuing to page 21, lines 1 and 2; page 23, line 14. As such, even though Borody 2 is broadly describing the inclusion of these sugars, and is not explicitly teaching the inclusion of sucrose with the other claimed compounds, the uses of these compounds are well-described, known and predictable.
To elaborate on the predictability of these compounds, both Mehmood and Taravati teach these compounds as well-known, and widely-used, excipients that possesses highly predictable outcomes when included in a composition.
Mehmood provides a review that discusses common excipients for lyophilized pharmaceutical compositions. See page 19, “Abstract” section. Mehmood notes all of the claimed excipients and describes their well-known and highly-predictable uses in lyophilization methods. See page 20 and 21. Mehmood also presents a table of well-known drugs, and the various combinations of excipients used, in order to elicit certain properties. See Table 3. Based upon this, there is no reason to expect that the ordinary artisan would find the inclusion of multiple well-known excipients to by non-obvious. Furthermore, since all of the claimed excipients have well-known and highly predictable physical properties, especially when used in lyophilization methods, the claimed combination would have been obvious to the ordinary artisan.
Taravati, similarly, provides a review paper discussing how various well-known and widely-used excipients affect the stability of a protein. See page 353, “Abstract” section. Specifically, Taravati notes that sucrose, trehalose and glycerol are all known to aid in stabilizing proteins. See page 353, right column, last paragraph. As such, Taravati provides even more evidence that the claimed excipients provide for highly predictable behaviors.
Since it has been shown that all of the claimed compounds can be used in a method of providing fecal microbiota to a subject, using a lyophilized product, either individually, and all of their respective behaviors are well-known to the ordinary artisan, their inclusion in a larger composition would be both predictable and obvious. It would be obvious because each compound has overlapping, yet different, functions, wherein their specific inclusion to a composition would yield predictable results.
If the Applicant believes that the claimed composition yields result that would not be predicted by the prior art, the Applicant should present this evidence; however, barring evidence of unexpected properties, the claimed method should be predictable. This predictability must be underscored by the fact that “excipient” is generally defined as an inert additive.
With respect to claims 21, 25-27, 33, and 34 the cited prior art teaches the claimed method. Providing the composition by the oral route suggests the use of a capsule.
With respect to claims 24, 30, 37 and 40, Borody teaches polyethylene glycol. Although no specific form is described, the properties of the claimed form would be well-known and predictable to the ordinary artisan. There is no evidence to suggest that the claimed form provides for any unexpected benefits.
With respect to claims 43, 46 and 49, Borody 2 suggests including mineral salts. See page 7, line 3. Since NaCl is a common salt that is essential for life, it would be obvious to include.
With respect to claims 50-55, based upon Mehmood, the glass transition temperature of the claimed excipients is known. See Table 1. Since all of these compounds are well-known, with highly predictable (and well-documented) physical properties, their glass transition temperature would be obvious. Furthermore, the ordinary artisan, who possesses ample knowledge in pharmaceutical formulations, would find particular temperature more suitable for the method of Borody than others. It is highly probable that the composition of Borody provides for a glass transition temperature with an overlapping range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651