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 10/17/2025 are acknowledged and have been fully considered. Claims 1, 4, 7, 9-10, 16-17, 19, 22, 32, 64, 98, 132, 136, and 173-174 are now pending. It is noted that in the response to election of 10/06/2023, the first microbiome regulator was elected to be glucose and the second microbiome regulator was elected to be cysteine. With the amendments of 10/17/2025, there are now more microbiome regulators in the claim, which do not read on the elected species. However, seeing that the additional microbiome regulators are similar, the species election is withdrawn in regards to leucine and xylose (i.e., claims 1 and 173-174). In regards to claim 32, the microbiome regulator has been limited to a different category of compound (i.e., micronutrient or polyphenol; micronutrients are taught to be a vitamin, an element, or a mineral (see specification as filed, page 8, 3rd full paragraph)), which would lead to an undue burden of search and examination as discussed in the restriction requirement of 09/07/2023. Further, since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits (i.e., claim 32 will be withdrawn due to the amendment).
Claims 2-3, 5-6, 8, 11-15, 18, 20-21, 23-31, 33-63, 65-97, 99-131, 133-135, and 137-172 are canceled; claims 1 and 32 are amended; claims 22, 32, 64, 98, 132, and 136 are withdrawn.
Claims 1, 4, 7, 9-10, 16-17, 19, and 173-174 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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 1, 4, 7, 9-10, 17, 19, and 173 are rejected under 35 U.S.C. 103 as being unpatentable over PGPUB 20170216328 A1 (Ritter, 2015) with priority to US provisional 61975531 (2014); the published application is used for the citations in the rejection below.
In regards to claims 1, 19, and 173, Ritter teaches a composition comprising a galacto-oligosaccharide (GOS) wherein the GOS is galactose and glucose molecules (see Ritter, paragraph 0091). It is taught that the GOS comprises from 1-100 % by weight of the composition (see Ritter, paragraph 0116). Further, it is taught that the composition comprises about 38% of a monosaccharide and 10% of lactose (see Ritter, paragraph 0098). Lactose is taught as an equivalent of glucose as a digestible saccharide (see Ritter, paragraph 0110). It would be within the purview for one with ordinary skill in the art to envisage a composition comprising 38% of a monosaccharide, such as glucose, and substituting the 10% lactose with 10% of glucose, for a total of 48% of glucose. It is also taught that the composition comprises leucine as an additive (see Ritter, paragraph 0287). While the amount of leucine is not taught in the art, it is mentioned that the amount of the additives in the composition can be properly selected based on their relation to other components and properties of the preparation, production method, etc. (see Ritter, paragraph 0287). As the relation to other components and properties of the preparation, production method, etc. of the leucine are variables that can be modified, among others, by adjusting the amount of leucine, the relation to other components and properties of the preparation, production method, etc. of the leucine changing as the amount of leucine is changed, the amount of leucine would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed amount of leucine cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, amount of leucine in Ritter to obtain the desired balance between the relation to other components and properties of the preparation, production method, etc. of leucine as taught by Ritter (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here 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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). As such, the total of glucose, which can be up to 48% as discussed above and the variable amount of leucine gives one with ordinary skill in the art reasonable motivation to have the composition comprise more than 50% of the composition by weight to be a combination of glucose and leucine.
Further in regards to claims 1 and 17, specifically to the limitation of “wherein the dosage form targets the release of the composition substantially in the small intestine or large intestine”, the composition is taught as a prebiotic composition (see Ritter, paragraphs 0072-0075). Prebiotics are non-digestible by the digestive tract, until the small intestine and colon, where bacteria are able to digest the prebiotic into simple sugars that the bacteria can use (see Ritter, paragraph 0076). It is also taught that the composition is in the form to allow for the release of the drug in the intestines (see Ritter, paragraph 0232).
In regards to claim 4, the composition is taught to be in the form of a suspension, solution, syrup, an emulsion, or elixir (see Ritter, paragraph 0226).
In regards to claims 9-10, the composition is taught to be in the form of a tablet or capsule with an enteric coating (see Ritter, paragraph 0232).
Ritter 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 Ritter with a reasonable expectation of success to obtain the dosage form 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 dosage form of the instant claims with predictable results.
Claims 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over PGPUB 20170216328 A1 (Ritter, 2015) with priority to US provisional 61975531 (2014) (the published application is used for the citations in the rejection below) as detailed above for claims 1, 4, 7, 9-10, 17, 19, and 173 in view of Zhu (2011).
The teachings of Ritter have been described supra. Further, Ritter teaches that the enteric coating is Eudragit® to allow for the prebiotic composition to not dissolve in the stomach, rather travel to the small intestine where it dissolves (see Ritter, paragraph 0228).
Ritter is silent on the composition being targeted to a portion of the small intestine, chosen from the duodenum, jejunum, or ileum.
Zhu teaches a method of drug delivery directly to the small intestine, specifically the duodenum (see Zhu, abstract; figure 1) using Eudragit® coatings, specifically Eudragit S100 as an enteric coating (see Zhu, page 114, column 1, paragraph 2).
In regards to claim 17, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Ritter and Zhu as both compositions are drawn to drug compositions being delivered to the intestines. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, Ritter also teaches that the composition is delivered to the small intestine where it is dissolved (see Ritter, paragraph 0228) and the method of Zhu allows for successful drug delivery in part of the small intestine (see Zhu, page 118, 4. Conclusion). One with ordinary skill in the art would be motivated to combine the prebiotic composition of Ritter and Zhu according to the known method of delivering drugs to the duodenum (see Zhu, materials and methods) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 1 and 174 are rejected under 35 U.S.C. 103 as being unpatentable over PGPUB 20170216328 A1 (Ritter, 2015) with priority to US provisional 61975531 (2014) (the published application is used for the citations in the rejection below) as detailed above for claims 1, 4, 7, 9-10, 17, 19, and 173 in view of USPGPUB 20070116832 A1 (Prakash, 2007).
The teachings of Ritter have been described supra. Further, Ritter teaches the composition comprises xylose (see Ritter, paragraph 0287).
Ritter is silent on the composition comprising cysteine.
Prakash teaches an oral composition (see Prakash, paragraph 0866) comprising additives such as glucose, xylose, cysteine, and leucine (see Prakash, paragraphs 0814 and 0816).
In regards to claims 1 and 174, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Ritter and Prakash as both references are drawn towards orally ingestible compositions comprising similar compounds. Further, Prakash teaches that glucose and xylose are equivalents and leucine and cysteine are equivalents (see Prakash, paragraphs 0814 and 0816). It would be obvious to one with ordinary skill in the art to simply substitute known elements, such as the glucose and leucine in Ritter, with others known in the art, such as the xylose and cysteine of Prakash, to obtain predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to simply substitute one known element for another to obtain predictable results.
Response to Arguments
Applicant’s arguments of 10/17/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that the art does not teach the combination of xylose and cysteine, it is noted that the rejection has been modified as necessitated by amendment to be over Ritter in view of Prakash, the teachings of which have been described above. Applicant further argues that the art fails to teach any sort of synergy or synergistic effect of the combination of the glucose/leucine or xylose/cysteine combination, however it is noted that there is no requirement of synergy or a synergistic effect in the claims, only that the compounds are present in the amounts taught in the claim. These limitations are met by the prior art as discussed in the rejections and as such are rendered obvious.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the teachings of Ritter do 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 Ritter with a reasonable expectation of success to obtain the dosage form 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 dosage form of the instant claims with predictable results.
Further, it is noted that the teachings of Ritter teach a composition that comprises 48% of glucose and a variable amount of leucine as discussed in the rejection above. While the combination of these compounds is not directly taught, it is within the purview of one with ordinary skill in the art to take the teachings of Ritter and rearrange them to achieve the instant composition.
In regards to the unexpected results, applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, the data of Table 8 (example 3 in the instant specification as filed) is drawn towards using fructose, glucose, and xylose with cysteine only. The claims are broader (i.e., glucose with leucine and xylose with cysteine) and as such are not commensurate in scope with the data presented for establishing unexpected results. Further, the amount of microbiome regulators for the examples using cysteine are all within the range of the instant claim. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
In regards to the applicant’s argument of claim 32, it is noted that claim 32 has been withdrawn as discussed above.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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, Bethany Barham can be reached at 571-272-6175. 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.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
Prosecution Insights