Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This Office Action is in response to the papers filed on 22 May 2026.
APPLICANT’S ELECTION
Applicants’ election without traverse of Group I (Claims 64-74; drawn to a method for promoting development of beneficial gut flora) in the reply filed on 22 May 2026 is acknowledged. Claim 75-82 have been cancelled by the Applicant.
CLAIMS UNDER EXAMINATION
Claims 64-74 are pending and have been examined on their merits.
PRIORITY
Provisional Application 61/193546, filed on 02 December 2008, is acknowledged. It does not provide support for the limitations recited in claims 65-66.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 65-66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The current application comprises administering a concentrated human milk permeate comprising a plurality of human milk oligosaccharides. Claim 65 recites the plurality comprises at least 10 human milk oligosaccharides. Claim 65 recites the plurality comprises at least 25 human milk oligosaccharides. The claims recite open ended ranges encompassing an unlimited number of known, and unknown, oligosaccharides. Figures 4-6 of the instant specification disclose graphs with round dots representing human milk oligosaccharides (see page 5, description of drawings). Figure 4 discloses 15 dots. Figure 5 discloses 18 dots. Figure 6 discloses 21 dots. The specification does not provide support for the entire range of oligosaccharides encompassed by claims 65-66).
A consideration of the four corners of the specification does not reflect that applicants have actually invented the claimed invention, since the specification does not permit the skilled artisan to visualize or recognize all of the members of the genus being utilized in the claimed method.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 64-71 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ur-Rehman et al. (Dairy Compositions And Method of Making. US 2007/0166447, 19 July 2007).
Uh-Rehman et al. teach a method of separating components from milk. In addition to other types of mammalian milk, the art teaches the source of the milk used in the disclosed method may be human milk ([0018]). As evidenced by the instant specification, human milk permeate inherently contains oligosaccharides (see page 6, first paragraph). Therefore the human milk taught by the prior art would inherently contain oligosaccharides.
As evidenced by the specification, “permeate” is a portion of milk that has been process by filtration, e.g. ultrafiltration, of human milk, e.g. skim milk (page 6, last paragraph).
Figure 2 Uh-Rehman discloses whole milk is separated to produce skim milk and cream. Skim milk undergoes ultrafiltration (UF unit) to produce an ultrafiltration permeate (UF permeate). Therefore it reads on the permeate as defined by the specification.
Uh-Rehman teaches the ultrafiltered permeate enters a nanofiltration unit (NF unit) to produce a nanofiltered permeate (NF permeate). Subsequently, the NF permeate enters a reverse osmosis unit (RO unit) to produce an RO permeate. The Instant Specification identifies reverse osmosis as a method of concentration (page 3, lines 4-6). Because the art teaches reverse osmosis of the permeate, the permeate taught by Uh-Rehman is concentrated. Because the art teaches the steps disclosed in the specification to produce a concentrated permeate, it would be expected to produce a concentrated permeate containing oligosaccharides.
Uh-Rehman teaches embodiments of the invention provide compositions prepared from RO permeate ([0029]).
The art teaches the compositions of the present invention can be formulated into a drink/ beverage ([0041]) or a frozen dessert or ice cream ([0042]). Therefore the compositions disclosed by the art are formulated for administration.
Ur-Rehman teaches it is desirable to exploit the nutritional advantages present in milk by separating milk into its individual components and to produce compositions suitable for consumption by using these individual components in food products. In addition, there is a need in the dairy industry to design dairy compositions that can meet the nutritional requirements of individual groups of the human population such as athletes, lactating women, elderly persons, children, lactose-intolerant populations and diabetics ([0007]). Therefore the art suggests administration of the disclosed nutritional composition to an adult.
Claim 64 recites administration to a subject in need of establishing or maintaining beneficial gut flora. Any mammal with a gut is interpreted to be in need of said benefits.
The art does not provide sufficient specificity to anticipate claim 64.
It would have been obvious to try using human milk to prepare a concentrated permeate comprising human oligosaccharides. KSR Rationale E indicates “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and commonsense” (MPEP 2143 “Rationale E. Obvious to Try” section). In the instant case, the art teaches human milk can be used. One would use human milk to source human oligosaccharides. Uh-Rehman teaches a composition which meets the needs of humans. The skilled artisan would use a composition comprising human oligosaccharides when administering to a human. One would have had a reasonable expectation of success since the art teaches human milk can be used.
It would be obvious to administer a concentrated human milk permeate to an adult. One would have been motivated to do so to meet the nutritional requirements of a subject. One would have had a reasonable expectation of success since Ur-Rehman teaches RO permeate can successfully be used in nutritional compositions for consumption. Because the claimed method step is rendered obvious by the prior art, administration would be expected to promote beneficial gut flora. Therefore claim 64 is rendered obvious as claimed.
Uh-Rehman teaches human milk. The art teaches the steps disclosed in the specification to produce a concentrated permeate. Because the art teaches these steps, it would be expected to produce a concentrated permeate with the claimed number of oligosaccharides. See MPEP 2113 II. Therefore claims 65-66 are included in this rejection.
The compositions can be formulated into a yogurt ([0046]). The art teaches yogurt can be produced by culturing the composition with a bacterial culture such as Lactobacillus bulgaricus ([0046]). Lactobacillus reads on an additional composition and a probiotic. Therefore claims 67-70 are rendered obvious.
The art teaches formulation food product that are eaten (ice cream). Thus reads on oral administration. Therefore claim 71 is rejected.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 72 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Uh-Rehman et al. and further in view of Cicon et al (Tube feedings in elderly patients. Indications, benefits, and complications. Arch Intern Med. 1988 Feb;148(2):429-33).
Claim 64 is rejected as set forth above.
As recited above, Ur-Rehman suggests the disclosed composition can be used to meet the nutritional requirements of a human. Oral administration is rendered obvious on the grounds set forth above.
The prior art does not teach oral administration via feeding tube.
Cicon teaches difficulty in maintaining adequate nutritional orally in elderly populations is not uncommon. Tube feeding is advocated in these patients. See page 429, right column, first paragraph. Cicon teaches tube feeding is regarded as a safe method of alimentation for selected patients (page 429, left column, first paragraph).
It would have been obvious to combine the teachings of the prior art by administering the nutritional composition taught by Uh-Rehman using a feeding tube. Uh-Rehman teaches a nutritional compositions and suggests its use to meet the needs of an elderly population. Cicon teaches tube feeding the elderly. One would have been motivated to do so when administering to a patient who has difficulty in maintaining adequate nutritional orally, as taught by Cicon. One would have expected similar results since both references are directed to providing nutrition for elderly humans. One would have had a reasonable expectation of success since Cicon teaches it is a safe method of administration. Therefore claim 72 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 73 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Uh-Rehman et al. as applied to claim 64 above, and further in view of Harn et al. (Immunomodulatory Methods Using Oligosaccharides. US2006/0040893).
Claim 64 is rejected as recited above.
The teachings of Uh-Rehman as set forth above are reiterated. The art teaches the disclosed composition provides nutrition, and suggests administration to an adult. The art is silent regarding a subject with inflammatory bowel disease.
Harn teaches a method for modulating immune responses using oligosaccharides, including Lewis oligosaccharides (see Title, Abstract). The art teaches administration to a human subject ([0062]). The art teaches administration of said compounds to inhibit colitis/inflammatory bowel disease ([0084]).
It is noted Harn teaches the largest biological source for Lewis antigen containing oligosaccharides is human breast milk ([0084]).
It would have been obvious to combine the teachings of the prior art by using a composition comprising human milk oligosaccharides to treat a patient with colitis/inflammatory bowel disease. One would have been motivated to do so since Harn teaches composition containing oligosaccharides inherent to human milk can be used to treat said disorder. One would have had a reasonable expectation of success since Harn teaches oligosaccharides found in human milk successfully treat colitis/inflammatory bowel disease. One would have expected similar results since both Ur-Rehman and Harn are directed to nutritional compositions containing oligosaccharides found in milk that can be administered to humans. Therefore claim 73 is rendered obvious.
Harn teaches Crohn’s disease, ulcerative colitis ([0082]). Therefore claim 74 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
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