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 .
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 1-19 are rejected 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.
The phrase “oxidation sensitive edible oil” in Claim 1, line 3 is vague and indefinite as it is unclear whether the oil just refers to ARA and DHA or does it include all fatty acid chains with at least one double bond like oleic acid, C18:1. All double bonds in a chain are subject to reaction and thus oxidation.
The phrase “human milk oligosaccharide (HMO)” in Claim 1, line 5 is vague and indefinite as it is unclear whether Applicant intended to state “at least one or more human milk oligosaccharide (HMO)” as this is what some dependent claims, like claim 7, refer to.
Claims 2-9 and 16-19 recite the limitation "[p]owder composition" in line 1 of each claim. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "[T]he powder composition".
The phrase “polyunsaturated fatty acids” in claim 2, line 2 is vague and indefinite as it is unclear whether Applicant means “acids” as literally stated or does Applicant mean “esterified polyunsaturated fatty acid chains” in the form of triglycerides as is the form of most oils. An oil including “polyunsaturated fatty acids” is not very common. A triglyceride is not an acid but rather an ester.
Claim 3 recite the limitation "the emulsifier" in line 2 of each claim. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "the at least one emulsifier".
Claim 3 recite the limitation "a protein" in line 2 of each claim. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "the protein".
Claim 4 recite the limitation "galacto-oligosaccharide (GOS)" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "of the galacto-oligosaccharide (GOS)".
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “0-60 wt%”, and the claim also recites “0-40 wt%” and “0-30 wt%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “10-65 wt%”, and the claim also recites “20-60 wt%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 7 recite the limitation “one or more human milk oligosaccharides (HMOs)” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “one or more of the human milk oligosaccharide (HMO)”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “10-65 wt%”, and the claim also recites “20-60 wt%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 recite the limitation “one or more human milk oligosaccharides (HMOs)” in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “one or more of the human milk oligosaccharide (HMO)”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), 3′-sialyllactose (3′-SL), 6′-sialyllactose (6′-SL), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof, more preferably selected from 2′-fucosyllactose (2′-FL) or combination of 2′-FL and one or more additional HMOs, most preferably being 2′-FL” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 recite the limitation “one or more additional HMOs” in line 7. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “one or more of the HMO”.
Claim 10 recite the limitation "a powder composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "the powder composition".
Claim 10 recite the limitation "said emulsifier" in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "said at least one emulsifier".
Claim 10 recite the limitation "said carbohydrate source" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider earlier stating "carbohydrate source".
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “0.01-10 wt%”, and the claim also recites “0.01-5 wt%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The phrase “long-chain polyunsaturated fatty acid” in claim 15, line 2 is vague and indefinite as it is unclear whether Applicant means “acids” as literally stated or does Applicant mean “esterified polyunsaturated fatty acid chains” in the form of triglycerides as is the form of most oils. An oil including “polyunsaturated fatty acids” is not very common. A triglyceride is not an acid but rather an ester.
Clarification and/or correction required.
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.
Claim(s) 1-6, 10-12 and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garssen et al. (US 2008/0171720).
Regarding claims 1-6, 10-12 and 14-19, Garssen (‘720) teaches a powder composition in the form of supplements, snacks, nutritional bars, a process of preparing the powder composition and a product comprising, based on the total weight of the powder: 10-80 wt % of an oxidation sensitive edible oil, including plyunsaturated fatty acids including DHA (See paras. 89-101, 110-115, claims 23, 25, 28 where the lipid/oil can be 5-50% or 15-50% oil, including DHA PUFA oil.), 5-30 wt % of at least one emulsifier selected from protein and starch (See paras. 89-101, 110-115, claims 23 where the protein can be 10-60% or 35-60%.), galacto-oligosaccharide (GOS) (See paras. 45, 59-64 and claim 23.), however, fails to expressly disclose the claimed amounts of galacto-oligosaccharide (GOS) and/or human milk oligosaccharide (HMO), amount of powder in a food product and nature of the ingredients.
It is noted that Applicant does not set forth any non-obvious unexpected results for providing one amount of GOS, powder and nature of ingredients. The claimed amount of GOS is very broad and includes virtually every conceivable amount.
Garssen (‘720) teaches providing its composition including 15-85% carbohydrates, including 15-50% carbohydrates and oligosaccharide, which include galacto-oligosaccharide (GOS) for HIV patients with nutritionally related symptoms wherein in the amount being therapeutically effective and being effective for a healthy gut flora wherein the neutral and acid oligosaccharides, including GOS can be 19-90% (See Abs., paras. 44, 45.).
It would have been foreseeable and obvious prior to the earliest effective filing date for a person having ordinary skill in the art to select an amount of GOS and the other claimed amounts of the other ingredients for the powder in the food, including an amount within the very broad claimed range, that is therapeutically effective and being effective for a healthy gut flora. The selection of amount would have been within the skill set of a person having ordinary skill in the art.
Regarding the nature of the ingredients, it would have been foreseeable and obvious prior to the earliest effective filing date that the nature of Garssen’s (‘720) ingredients would be the same as claimed as the sources and end uses are substantially the same.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T O'HERN whose telephone number is (571)272-6385. The examiner can normally be reached M-Th 5:00 am - 3:30 pm.
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, Emily Le can be reached at 571-272-0903. 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.
/BRENT T O'HERN/ Primary Examiner, Art Unit 1793 January 22, 2026