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 .
Election/Restrictions
Applicant’s election of the invention of Group I, claims 1-12, and the species of Panax ginseng, Wolfiporia cocos, nattokinase, and the combination of guar gum, alginic acid, laminarin, Pericarpium citri reticulatae, glucomannan, and Psyllium seed husk in the reply filed on 12/23/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
The amendment of 07/09/2025 has been entered. Claims 1, 4, 7, and 9-25 are pending in this US patent application. Claims 13-25 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2024.
Claims 1, 4, 7 and 9-12 are currently under examination and were examined on their merits.
Withdrawn Rejections
All rejections of claims 2-3 and 8 set forth in the previous Office action are withdrawn in light of the amendment of 07/09/2025, which canceled these claims.
The rejections of the claims under 35 U.S.C. 112(b) for indefinite language as set forth in the previous Office action are withdrawn in light of the amendment of 07/09/2025, which removed the indefinite language from the claims.
The rejection of claims 1-3 and 7 under 35 U.S.C. 103 as being unpatentable over Wang as set forth in the previous Office action is withdrawn in light of the amendment of 07/09/2025, which brought the limitations of previous claim 8 into claim 1.
Claim Interpretation
Claim 9 has been amended in the amendment of 07/09/2025 to recite that the daily dose “consists of” certain ingredients. However, the claim has been interpreted by the Examiner to depend from claim 1 (see below under Claim Rejections – 35 USC 112), which recites a composition “comprising” certain ingredients. As such, the composition of claim 9 may contain other ingredients besides those recited in the table that constitute the “daily dose” because the overall composition is recited using open-ended “comprising” language.
Claim Rejections - 35 USC § 112
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 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 are newly rejected as necessitated by amendment under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9-10 depend from claim 8. However, in the amendment of 07/09/2025, claim 8 was canceled. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 9-10, rendering them indefinite. Therefore, claims 9-10 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claims 9-10 to depend from claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 7 and 9-12 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) not be directed to a judicial exception or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Directed to a judicial exception’ analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
Claims 1, 4, 7, and 9-12 recite compositions that only contain naturally-occurring ingredients. Some of the claims provide amounts/concentrations of ingredients. None of the claims recite a composition for which a marked difference in structure or function has been established for the entirety of the claimed scope. As such, claims 1, 4, 7, and 9-12 recite judicial exceptions.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 4, 7, and 9-12 do not recite additional elements that integrate the judicial exception into a practical application because the claims do not recite any elements other than the judicial exceptions.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any elements other than the judicial exceptions.
Therefore, claims 1, 4, 7, and 9-12 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
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.
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.
Claims 1, 4, 7, and 9-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Chinese patent application CN 108077912 filed by Wang et al., published 05/29/2018, in view of Japanese patent application JP 2009215276 filed by Izumi et al., published 09/24/2009.
Please note: the page and paragraph numbers for the Wang and Izumi references correspond to the translated copies of the document attached to the Office action mailed 04/09/2025.
Wang teaches foods for special medical purposes (see entire document, including page 1, paragraph 1). In a particular embodiment, the food contains ginseng, Poria cocos, natto extract, and dietary fiber (pages 10-11, under “2. A full-nutrition special medical use formula food preparation method”; cf. claims 1 and 9; the Examiner notes that Poria cocos is a synonym for Wolfiporia cocos and that dietary fiber is a substrate for intestinal bacteria). The natto extract may be nattokinase (page 4, paragraph 3; cf. claims 1 and 9). The medical food can be used for enteral nutrition tube feeding (page 2, paragraph 2; cf. claim 7; the Examiner notes that a composition used for tube feeding must be a liquid and, thus, intrinsically contains water; because Siraitia grosvenorii, almond, and perilla seed all necessarily contain water and the claims do not further limit what the “extracts” of these organisms are, water can be considered an extract of Siraitia grosvenorii, an extract of almond, and/or an extract of perilla seed as recited in claims 7, 10, and 12). In addition, Wang teaches that the composition can be used for patients with gastrointestinal dysfunction (page 2, paragraph 2).
However, Wang does not expressly teach that the natto extract in the composition is nattokinase or that the dietary fiber is provided by the combination of ingredients required by claims 1, 4, and 9-12.
Izumi teaches that a dietary fiber component in an oral composition can contain alginic acid, glucomannan, psyllium, laminarin, and guar gum (see entire document, including page 4, paragraph 10; cf. claims 1, 4, and 9-12). The composition can also include chimpi as an antidiarrheal medication (page 3, paragraph 1; cf. claims 1, 4, and 9-12; the Examiner notes that “chimpi” is a synonym for Pericarpium citri reticulatae as instantly recited).
While Wang does not expressly teach that the natto extract in the composition is nattokinase, it would have been obvious to one of ordinary skill in the art to do so because Wang teaches that nattokinase is a useful natto extract for foods of their invention. While Wang does not expressly teach mixing the powdered medical food with water, it would have been obvious to one of ordinary skill in the art to do so because doing so would allow the food to be administered through a feeding tube, which is taught by Wang as one of the uses for the food powder. One of ordinary skill in the art would have a reasonable expectation that using nattokinase as the natto extract in the food powder of Wang and mixing the powder with water would successfully result in the production of a composition that can be administered through a feeding tube to provide nutrition to a patient.
While Wang does not teach that the dietary fiber in the medical food composition for patients with gastrointestinal dysfunction includes alginic acid, glucomannan, psyllium, laminarin, and guar gum, it would have been obvious to one of ordinary skill in the art to do so because Izumi teaches that these ingredients can be used in combination as a dietary fiber component in oral nutritional compositions. While Wang does not teach that the medical food composition for patients with gastrointestinal dysfunction contains chimpi, it would have been obvious to one of ordinary skill in the art to include chimpi in the composition of Wang because Izumi teaches that it has an antidiarrheal effect. One of ordinary skill in the art would have a reasonable expectation that including the chimpi and dietary fiber ingredients of Izumi in the composition of Wang would successfully result in the production of a composition that provides nutrition for patients with gastrointestinal dysfunction.
Wang and Izumi do not teach the specific amounts of the ingredients recited in instant claims 1 and 9-12. However, the recited amounts would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of all of the ingredients in the medical food composition because the concentrations of nutritional and medicinal ingredients administered to patients are art-recognized, result-effective variable known to affect the ability of the compositions to treat the symptoms of the patients, which would have been optimized in the pharmaceutical art to provide the desired treatment to the patient.
Therefore, claims 1, 4, 7, and 9-12 are rendered obvious by Wang in view of Izumi and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 101. Applicant states that the embodiments currently claimed are not drawn to naturally-occurring ingredients because the claimed combination of extracts, purified, and isolated ingredients significantly improves personalized gut microbiota diversity, metabolic function, bidirectional normalization of bowel movements, and serum creatinine values, as shown in the instant specification. Applicant states that the results shown correspond to Example 10 of the USPTO July 2015 Update on Subject Matter Eligibility because the nature-based components of the instantly recited composition are changed by their combination (remarks, pages 7-9). These arguments have been fully considered but have not been found persuasive.
The Examiner notes that the results shown in the instant specification are relevant to a highly specific composition that consists of (i.e., closed language) highly specific extracts obtained in particular ways and containing particular ingredients. However, the instant claims recite compositions comprising (i.e., open language) ingredients like “Panax ginseng extract,” a phrase that is sufficiently broad to read on any compound that could possibly be extracted from the organism Panax ginseng, including water. As such, the results shown in Applicant’s specification are not commensurate in scope with the instant claims and, thus, cannot be seen to provide evidence of the presence of a change in combination of any nature-based components that fall within the broad scope of the instant claims. The Examiner reminds Applicant that a claim must represent patent-eligible subject matter for the entire breadth of the claim in order to avoid rejection under 35 U.S.C. 101.
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Wang in view of Izumi. Applicant states that Wang and Izumi do not teach the use of the combination to achieve functional recovery of intestinal flora, a combination of ingredients guided by traditional Chinese medicine theory, a combination logic for the dietary fibers in Izumi, the goal of regulating the balance of microecology and achieving systemic physiological harmony, or bidirectional regulation of multiple indicators (remarks, pages 10-12). These arguments have been fully considered but have not been found persuasive.
The Examiner notes that the instant claims are drawn to a composition, not to a method of treating a specific patient population. The prior art must simply show the combination of claimed ingredients to render the claimed composition obvious, not any particular effect of the composition. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are 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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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, Sharmila Landau, can be reached at (571)272-0614. 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.
/Erin M. Bowers/Primary Examiner, Art Unit 1653 10/27/2025