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 .
Status of the Claims
Claims 12-22 are pending.
Applicant’s arguments filed on 04/17/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.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. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicant’s amendments filed on 04/17/2026, have each been entered into the record. Applicant has amended claims 12-22. Claims 12-22 are subject of the Office action below.
Withdrawn Rejections
The rejection of claims 12-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is overcome by the Applicant’s amendments and is hereby withdrawn. For example, Applicant amended claim 12, so that claim 12 no longer recite “preferably maltodextrin”.
Maintained Rejections
Claim Rejections - 35 USC § 103-Maintained
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.
The rejection of claims 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bulbarello of record (WO2019206983A1) in view of MacDonald of record (U.S. Pub. No. 20080311265), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
By way of a background, Applicants’ invention is directed to a powderous composition comprising at least one polyunsaturated fatty acid (PUFA), at least one D-glycose oligomer, at least one modified polysaccharide and at least one dietary fiber (see page 1 of the specification). Applicants have surprisingly and unexpectedly discovered that the at least one dietary fiber such as inulin, was found to improve composition flowability (see page 1 of the specification).
Independent claim 12 is directed to a powderous composition comprising:
i) 10-70 wt%, based on the total weight of the powderous composition, of at least one polyunsaturated fatty;
ii) 5-3 wt%, based on the total weight of the powderous composition, of at least one D-glucose oligomer (GO1) having a DE of < 18;
iii) 5-3 wt%, based on the total weight of the powderous composition, of at least one D-glucose oligomer (G02) having a DE of > 18;
iv) 5-70 wt%, based on the total weight of the powderous composition, of at least one modified polysaccharide; and
v) 1-10 wt%, based on the total weight of the powderous composition, of at least one water-soluble dietary fiber.
Similar to claim 12, Bulbarello (see reference claim 1), teaches:
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Bulbarello differs from the claimed invention only insofar as Bulbarello is not explicit in teaching at least one water-soluble dietary fiber in the composition. However, the claimed invention would have been obvious over Bulbarello, because at the time of the instant invention, it was known in the art that a water-soluble fiber can improve flowability and cold-water solubility of powdered compositions.
For example, MacDonald (see abstract and ¶s 0005-0006), teaches a powdered beverage composition where it was known to include a water-soluble fiber to improve the flowability and cold-water solubility of the powdered compositions. Similar to the Applicants’ invention (see discussions above), MacDonald teaches water-soluble fiber including but not limited to inulin (see ¶ 0015). In embodiments, the soluble fiber is use in an amount of about 2 to about 10 grams (see ¶s 0005, 0012) and also teaches fiber in amount of 11 wt%, calculated from the weight in grams of each component in (see ¶ 00012 of MacDonald).
The claimed wt% range of components i) – iv) recited in claim 12, overlaps or lies within the range disclosed by Bulbarello (see discussions above). The claimed 1-10 wt% of at least one water soluble dietary fiber recited in claim 12, is merely close to the 11 wt% disclose by McDonald (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05). As recognized by MPEP § 2144.05.
In the instant case, because the claimed range of at least one PUFA, overlaps or lies inside ranges and/or are merely close to ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed ranges recited in claim 12.
Accordingly, since Bulbarello discloses powdered formulations where good flowability is desired (see page 1), it would have been obvious to a person skilled in the art to include a water-soluble fiber known to improve the flowability and water solubility of powdered compositions (e.g., inulin taught by MacDonald) in the powdered composition of Bulbarello. One skilled in the art would have had a reasonable expectation that the addition of a water-soluble fiber (e.g., inulin) to the composition of Bulbarello, would improve the flowability and water solubility of powdered composition.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Regarding claims 12 and 20, each of the claimed amount of dietary fiber, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. For example, MacDonald discloses that the fiber is use in an amount of about 2 to about 10 grams and also teaches fiber in amount of 11 wt%, calculated from the weight in grams of each component in ¶ 00012 (see discussions above). The term “about 2 grams”, implies an amount below 2 grams (e.g., 1.5 grams), which would result in lower than 11 wt%.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed ranges recited in claim 12 and 20.
Regarding claim 13, Bulbarello teaches, wherein the at least one polyunsaturated fatty acid is chosen from the group consisting of eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid, linoleic acid, a-linolenic acid, dihomo-y-linolenic acid, y-linolenic acid and ethylester thereof (see reference claim 2).
Regarding claim 14, Bulbarello teaches, wherein the powderous formulation comprises 1-60 wt-% of the at least one polyunsaturated fatty acid (see, e.g., page 2, lines 21-23).
Regarding claim 15, Bulbarello teaches, wherein (GO1) has a DE of less than 15 (see reference claim 4).
Regarding claim 16, Bulbarello teaches, wherein (GO2) has a DE of more than 20 (see reference claim 6).
Regarding claim 17, the claimed ratio of 1:1 for GO1:GO2, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. For example, Bulbarello teaches 5-30 wt% GO1 and 5-30 wt% GO2 in the composition (see discussions above).
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Regarding claim 18, Bulbarello teaches, wherein the modified polysaccharide is modified starch (see reference claim 8).
Regarding claim 19, Bulbarello teaches, wherein the modified polysaccharide is starch sodium octenyl succinate (see page 5, line 14).
Regarding claim 21, MacDonald teaches inulin (see discussions above).
Regarding claim 22, Bulbarello teaches wherein, a food, feed and personal care formulations comprising at least one powderous composition is also claimed (see abstract).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Response to Applicants’ Arguments/Remarks
Applicant raised several arguments (see pages 4-6 of Remarks) alleging that the rejection is improper on the grounds that:
1) the claimed invention is non-obvious over the cited references because claim 12 has been amended to recite in part: i) 10-70 wt% of at least one poly unsaturated fatty acid (PUFA); and ii) 1-10 wt% of at least one water soluble dietary fiber (see pages 4-5 of Remarks).
Response:
The claimed wt% ranges recited in claim 12, overlaps or lies inside ranges and/or are merely close to ranges disclosed by the prior art (see discussions above), therefore, a prima facie case of obviousness exists.
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed ranges recited in claim 12.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
2) the lowest permissible wt% of McDonald is 11.3 wt% based on Table presented at ¶ 0012 (see pages 5-6 of Remarks).
Response:
MacDonald discloses that the fiber is use in an amount of about 2 to about 10 grams and also teaches fiber in amount of 11 wt%, calculated from the weight in grams of each component in ¶ 00012 (see discussions above). The term “about 2 grams”, encompasses an amount below 2 grams (e.g., 1.5 grams), which would result in lower than 11 wt%.
It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed ranges recited in claim 12 and 20.
Non-Statutory Obviousness-Type Double Patenting-Maintained
The rejection of claims 12-22 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/262,078 in view of: 1) Bulbarello of record (WO2019206983A1); and 2) MacDonald of record (U.S. Pub. No. 20080311265), is maintained for the reasons of record set forth in the previous Office action.
The rejection of claims 12-22 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/262,088 in view of: 1) Bulbarello (WO2019206983A1); and 2) MacDonald (U.S. Pub. No. 20080311265), is maintained for the reasons of record set forth in the previous Office action.
Response to the Applicant’s Arguments
Applicant’s response (see pages 4-6 of Remarks filed on 04/17/2026), did not address the specific grounds of rejection as discussed in the previous Office action setting.
For the reasons above and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
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 extension fee 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 date of this final action.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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