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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 03/17/2026 are acknowledged and have been fully considered. Claims 1-7, 18, and 20-34 are now pending. Claims 8-17 and 19 are canceled; claims 18 and 33-34 are amended; claims 1-7, and 22-30 are withdrawn.
Claims 18, 20-21, and 31-34 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 18, 20-21, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018106844 A1 (Cutcliffe, 2018).
In regards to claims 18, 20, and 33-34, Cutcliffe teaches a composition comprising a microbe such as Methanobrevibacter smithii (see paragraph 013-014) that are dead (see paragraph 0239). It is also taught that the composition comprises whole bacteria (i.e. with all of its parts). The composition is taught to be in the form of a tablet or medical food (see paragraphs 017, 58-60, 90). As the teachings of Cutcliffe would yield an identical composition as instantly claimed, the properties, such as the MAMP signal potential, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Further, it is taught that the microbe is used in an amount of at least 1.0x108 cells/g (see paragraph 07). It is also taught that the microbe is used in an amount of about 8.2 x 109 cells/g (see paragraph 0175). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 21, it is taught that composition comprises a carrier, such as soybean oil (see paragraph 0265).
In regards to claims 31-32, the composition is taught to comprise a prebiotic, which is taught to be fiber (see paragraphs 066 and paragraph 015; claim 32).
Cutcliffe does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Cutcliffe with a reasonable expectation of success to obtain the compositions of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
First, the declaration of Dr. Sutherland is appreciated. However unfortunately it is not enough to overcome the rejections of record.
In the declaration and remarks, applicant argues that Cutcliffe requires active or viable cells, it is pointed out that Cutcliffe teaches that the microbes used in the composition are dead (see paragraph 0239). While there are other embodiments using live or active cells, it is taught that the composition is made with dead cells as well. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). Applicant further quotes paragraph 0239 to show that the composition includes a dead microbial strain and states that this means that the composition “further include dead microbes.” However the full context of the paragraph (shown below) clearly shows that the teaching equates viable, dormant, inactivated, or dead microbes. They are all given in the same statement as part of the composition.
“A composition can include microbes that are, for example, whole microbes (e.g., whole bacteria). The composition can include, for example, viable (e.g., live), dormant, inactivated, or dead microbes (e.g., bacteria). In some embodiments, the composition can include a live microbial strain. In some embodiments, the composition can include a dead microbial strain. In some embodiments, the composition can include a live and a dead microbial strain. The microbial strain can be, for example, any microbial strain disclosed herein.” (Cutcliffe, paragraph 0239)
Applicant also argues that the amount of cells taught is not of dead cells, but rather of active cells. While it is true that there are no embodiments using dead cells, as the dead and active cells are taught as equivalents as mentioned above, it would be within the purview of one with ordinary skill in the art to use the same amount of cells for the composition, whether dead, inactivated, or active.
In the declaration and remarks, it is argued that the structural and functional features of M. smithii and Archaeabacteria are different than those listed in Cutcliffe, however it is pointed out that the prior art teaches M. smithii as a bacteria that is able to be used in the composition. As such, while it is appreciated that there is a difference between the types of bacteria, it is still taught in the art as a viable option. It is also argued that Cutcliffe doesn’t teach the MAMPs signal potential in the inactivated or killed cells, however one with ordinary skill in the art would expect the same properties for the composition as instantly claimed using the teachings of Cutcliffe. Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
In the declaration and remarks, it is argued that the method of making the composition is different and would not yield the same composition as the instant claims, however the claims are not drawn to a method of making, rather a composition. Even if the method was part of the claims, it would be considered a product-by-process limitation. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. The declaration goes into detail about the difference in method and how the lyophilization of Cutcliffe would not work with the instant invention, which is appreciated however those steps and limitations are not part of the claims as written currently and as such cannot be used to achieve patentability.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Isis A Ghali/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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