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 .
Priority
This application filed on 07/14/2023, is a 371 of PCT/EP2022/053000, filed on 02/08/2022, which claims priority to EPO No. 21156262.4, filed on 02/10/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/14/2023, was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Status of the claims
Claims 12-22 are pending.
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 12-22 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. Claims 13-22 depend from claim 12, and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
The recitation of a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) in claim 1, is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 12 recites the phrase “preferably maltodextrin”, when referring to D-glycose oligomer, which is the narrower statement of the range/limitation. Appropriate correction is required.
Regarding claim 12, the phrase “preferably” also renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. As explained in MPEP 2173.05(d), statements of examples or preferences belong in the specification, not the claims. In the claims such expressions can lead to confusion as to the intended scope of the claim. Appropriate correction is required.
Regarding claims 12, 14-17, each of the phrase “and/or derivative thereof”, and “preferably a maltodextrin”, that is enclosed in parenthesis when referring to, for example, polyunsaturated fatty acid, renders the claims indefinite because it is unclear whether the subject matter within parentheses is: i) part of the claim; or ii) optional. Please see MPEP § 2173.05(d). Appropriate correction is required.
Each of claims 13-21, recites the limitation “Powderous composition according to claim 12”, in line 1. There is insufficient antecedent basis for this limitation in the claims because the preamble of claim 12 from which claims 13-21 depend, recites “A powderous composition”. The Examiner recommends amending the claims to recite the limitation “The powderous composition according to claim 12”. Appropriate correction is required.
Claim 15 is rendered indefinite for reciting the limitation “(GO1) or a mixture of (GO1)s” because the abbreviated (GO1) limitation recited in claim 12, is already inclusive of “mixtures” (i.e., at least one …). Therefore, the recitation of “(GO1)s”, is not only seemingly redundant, but also indefinite since it is not clear to a person skilled in the art as to what else is meant to be included in the limitation “(GO1)s”.
Claim 16 is rendered indefinite for reciting the limitation “(G21) or a mixture of (GO2)s” because the abbreviated (GO2) limitation recited in claim 12, is already inclusive of “mixtures” (i.e., at least one …). Therefore, the recitation of “(GO2)s”, is not only seemingly redundant, but also indefinite since it is not clear to a person skilled in the art as to what else is meant to be included in the limitation “(GO2)s”.
Claim 17 recites the limitation “are used in a 1:1 mixture”, in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 17 lacks antecedent basis because claim 12 from which claim 17 depends, fails to recite the limitation of “a mixture”. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected.
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 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bulbarello et al (hereinafter “Bulbarello”, WO2019206983A1, published 10/31/2019) in view of MacDonald et al (hereinafter “MacDonald”, U.S. Pub. No. 20080311265, published 12/18/2008).
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 recites:
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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 ¶ 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 2-10 grams (see ¶s 0005, 0012).
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 2-10 grams (see discussions above) and also teaches fiber in amount of 11 wt%, calculated from the weight in grams of each component in (see ¶ 00012 of MacDonald). 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 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 0.1 - 70 wt-% of the at least one polyunsaturated fatty acid (see reference claim 3).
Regarding claim 15, Bulbarello teaches, wherein (GO1) or mixture of (GO1)s has a DE of less than 15 (see reference claim 4).
Regarding claim 16, Bulbarello teaches, wherein (GO2) or mixture of (GO2)s 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.
Non-Statutory Obviousness-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. patent application No. 18/262,078 (‘078 application), in view of: 1) Bulbarello (WO2019206983A1); and 2) MacDonald (U.S. Pub. No. 20080311265).
The corresponding teachings of Bulbarello and MacDonald, are discussed above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and ‘078 application claims are similarly drawn to a powderous composition. For example, the claims of the instant application are drawn to a powderous composition comprising:
i) up to 70 wt% of at least one PUFA;
ii) 5-30 wt% of at least one D-glycose having a DE of <18;
iii) 5-30 wt% of at least one D-glycose having a DE of >18;
iv) 5-70 wt% of at least one modified polysaccharide; and
v) at least 1 wt% of at least one water-soluble dietary fiber,
whereas, the claims of the ‘078 application are drawn to a powderous composition comprising:
i) up to 70 wt% of at least one fat-soluble vitamin;
ii) 5-30 wt% of at least one D-glycose having a DE of <18;
iii) 5-30 wt% of at least one D-glycose having a DE of >18;
iv) 5-70 wt% of at least one modified polysaccharide; and
v) at least 1 wt% of at least one water-soluble dietary fiber.
Although the ‘078 application is not explicit in claiming up to 70 wt% of at least one PUFA, the selection of a powderous composition comprising up to 70 wt% of at least one PUFA from the ‘078 application embodiment, would have been obvious in view of Bulbarello and MacDonald.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. patent application No. 18/262,088 (‘088 application), in view of: 1) Bulbarello (WO2019206983A1); and 2) MacDonald (U.S. Pub. No. 20080311265).
The corresponding teachings of Bulbarello and MacDonald, are discussed above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and ‘088 application claims are similarly drawn to a powderous composition. For example, the claims of the instant application are drawn to a powderous composition comprising:
i) up to 70 wt% of at least one PUFA;
ii) 5-30 wt% of at least one D-glycose having a DE of <18;
iii) 5-30 wt% of at least one D-glycose having a DE of >18;
iv) 5-70 wt% of at least one modified polysaccharide; and
v) at least 1 wt% of at least one water-soluble dietary fiber,
whereas, the claims of the ‘088 application are drawn to a powderous composition comprising:
i) up to 70 wt% of at least one carotenoid;
ii) 5-30 wt% of at least one D-glycose having a DE of <18;
iii) 5-30 wt% of at least one D-glycose having a DE of >18;
iv) 5-70 wt% of at least one modified polysaccharide; and
v) at least 1 wt% of at least one water-soluble dietary fiber.
Although the ‘088 application is not explicit in claiming up to 70 wt% of at least one PUFA, the selection of a powderous composition comprising up to 70 wt% of at least one PUFA from the ‘088 application embodiment, would have been obvious in view of Bulbarello and MacDonald.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
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