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 1-19 are pending.
Applicants’ arguments filed on 08/26/2026, 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 Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.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.
Applicants’ amendments filed on 08/26/2026, have been fully considered. Applicants have amended claims 1, 3 and 12. Applicants have newly added claims 15-19. Claims 2 and 10-11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected species. Claim 13-14 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention. Therefore, claims 1, 3-9, 12 and 15-19 are subject of the Office action below.
Withdrawn Rejections:
The rejection of claims 1, 3-9 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Moran of record (Int. J. Obesity, 2013), is overcome by the Applicants’ amendments and is hereby withdrawn. For example, claim 1 has been amended to introduce the limitation “wherein the mother has metabolic syndrome, and the composition does not contain docosahexaenoic acid (DHA)”.
The rejection of claims 1, 3-7, 9 and 12 under 35 U.S.C. 103 as being unpatentable over Haschke of record (U.S. Pub. No. 20090142314), in view of: 1) Haschke2010 of record (U.S. Pub. No. 20100092610); and 2) Boderke of record (U.S. Pub. No. 20050143347), is overcome by the Applicants’ amendments and is hereby withdrawn. For example, claim 1 has been amended to introduce the limitation “wherein the mother has metabolic syndrome, and the composition does not contain docosahexaenoic acid (DHA)”.
Response to the Applicant’s Arguments/Declarations
Applicants’ arguments filed on 08/26/2026 (see pages 5-11 of Remarks), have been fully considered, but they are rendered moot in view of the Applicants’ amendments. For example, Applicants’ amendment of claim 1 to introduce the limitation “wherein the mother has metabolic syndrome, and the composition does not contain docosahexaenoic acid (DHA)”, necessitates new grounds of rejection set forth below in the instant rejection.
Claim Rejections - 35 USC § 112
New Grounds of Rejection, Necessitated by Applicants’ Amendments
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 16-19 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. Claims 17-19 depend from claim 16 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.
Claim 16 recites the limitation of “wherein the composition is administered in an amount such that 0.14-14 mg Vitamin B2 is delivered to the mother per day” (emphasis added), however, a person of the ordinary skill in the art cannot reasonably determine the meets and bounds of the recited limitation in the claims. This is because the recited “an amount such that 0.14-14 mg Vitamin B2 is delivered to the mother per day”, is not defined by the claims and the specification does not provide a standard for ascertaining the requisite degree. The specification (see, e.g., page 7, lines 20-22), states that vitamin B2 can be administered in an amount ranging from 0.14-14mg/day. It is unclear from the claims or the specification as to, for example, what administered amount(s) of vitamin B2:
a) would deliver 0.14-14mg/day vitamin B2 to the mother;
b) would not deliver 0.14-14mg/day vitamin B2 to the mother.
Thus, a person of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
For the purpose of examination, an administration of 0.14-14mg/day vitamin B2 to a patient population of claim 1, is included in the interpretation of “wherein the composition is administered in an amount such that 0.14-14 mg Vitamin B2 is delivered to the mother per day”.
It is recommended that Applicants amend the claims to recite specific amount(s) of vitamin B2 that would deliver 0.14-14mg/day vitamin B2 to the mother, in order to overcome the rejections. Appropriate correction is required.
Similar to claim 16, claim 19 recites “wherein the composition is administered in an amount such that 1.5-2 mg vitamin B2 is delivered to the mother per day”, and is similarly rejected as in claim 16 above. Appropriate correction is required.
Each of claims 17-18 recites “an effective amount” for the prevention of overweight, obesity and/or excessive fat accumulation in the offspring at an age of at least: i) 4 years old (claim 17) and ii) 6 years old (claim 18). However, a person skilled in the art cannot reasonably determine the meets and bounds of the recited limitation in claims 17-18. This is because, the recited “an effective amount” is a relative term in that the recited “an effective amount” is not defined by the claim or the specification to any specific dosage or dosage range, for the recited active ingredient. The specification does not provide a standard for ascertaining the requisite degree. For example, it is unclear from claim 17 or the specification as to:
a) what amount of amount of vitamin B2 would be considered as “an effective amount” for preventing overweight;
b) what amount of amount of vitamin B2 would be considered as “an effective amount” for preventing obesity; and
c) what amount of amount of vitamin B2 would be considered as “an effective amount” for preventing excessive fat accumulation.
Thus, a person skilled in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
The phrase “an effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. Please see MPEP § 2173.059c)(III).
In the instant case, the more than one effect that can implied from the specification are: i) preventing overweight; ii) preventing obesity and iii) preventing excessive fat accumulation. The specification does not appear to provide guidelines that are elaborate enough for determining “an effective amount”, for vitamin B2 recited in claims 17-18, which would: i) prevent overweight; ii) prevent obesity and iii) prevent excessive fat accumulation. The artisan of the ordinary skill cannot tell from the specification, what is “an effective amount” for the vitamin B2 of claims 17-18, from what is not “an effective amount” for the vitamin B2 of claims 17-18.
Accordingly, without guidelines that are elaborate enough for determining “an effective amount” in the specification, the skilled artisan cannot reasonably determine from the specification, what amount constitutes “an effective amount” from an amount that does not constitutes “an effective amount”. Therefore, for the purpose of examination, an amount of vitamin B2 that is employed in order to elicit the desired biological outcome, is included in the interpretation of “an effective amount”. Appropriate correction is required.
A patent must be precise enough to afford clear notice of what is claimed, thereby "'appris[ing] the public of what is still open to them.'" Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (quoting McClain v. Ortmayer, 141 U.S. 419, 424 (1891)). Otherwise there would be "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims." United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942). A claim fails to satisfy this statutory requirement and is thus invalid for indefiniteness if its language, when read in light of the specification and the prosecution history, "fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014).
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 § 102
New Grounds of Rejection, Necessitated by Applicants’ Amendments
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-9, 12 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noakes et al (hereinafter, “Noakes”, J. Nutrition, 2004, 134, 1894-1899).
Independent claim 1 is drawn to a method for preventing overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in offspring of a mother who has metabolic syndrome, with a DHA free composition comprising vitamin B2 (riboflavin). The composition is administered to the mother before pregnancy, during pregnancy, and/or during lactation.
Regarding claim 1, Noakes discloses administering a composition comprising riboflavin at 1.71 mg/d to overweight/obese adults (of age between 20 and 65 years), with features of metabolic syndrome, in order to treat overweight/obesity in the adults. The composition of Noakes does not contain DHA. Noakes discloses, wherein the subjects, if females, were not pregnant or breast feeding. Please see abstract, pages 1895-1897, under the title “METHODS” and Table 3. An overweight/obese female subject of age between 20 and 65 years, who is not pregnant or breast feeding and who has features of metabolic syndrome, reads on the “a mother before pregnancy, wherein the mother has metabolic syndrome” of instant claim 1.
Instant claim 1 requires that the active step of administering a DHA free composition comprising vitamin B2 (riboflavin) to a mother (who has metabolic syndrome) before pregnancy, during pregnancy, and/or during lactation, would prevent overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in offspring of the mother. Noakes discloses administering a DHA free composition comprising vitamin B2 (riboflavin) to a mother who has metabolic syndrome (see discussions above). Therefore, the method of Noakes must necessarily results in the prevention of overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in the offspring of the mother, because the prevention of overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in offspring of the mother, is a natural process that flows from the mother and the administered DHA free composition comprising vitamin B2 (riboflavin).
Therefore, claim 1 is necessarily anticipated by Noakes.
Regarding claims 3-4, 8 and 15, Noakes discloses dietary micronutrients (a nutritional supplement), cereal, vegetables and milk (see Table 1 and Table 3).
Regarding claims 5 and 16-19, Noakes teaches 1.71 mg/day vitamin B2 (see discussions and rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, above). The 1.71 mg/day vitamin B2 disclosed by Noakes, is within the 0.14-14 mg/day vitamin B2 and 1.5-2 mg/day vitamin B2 recited in claims 5, 16 and 19. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Regarding claim 6, Noakes discloses daily administration initially for 3 months (stage 1), followed by extension for a further 3 months (stage 2). Please see pages 1895-1896, under the title “METHODS”
Regarding claim 7, Noakes discloses daily administration (see pages 1895-1896, under the title “METHODS”).
Regarding claims 9, the recitation of the intended outcome of a method of claim 1 resulting in preventing overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in the offspring later in life, is not given any patentable weight because the recited clause is simply expressing the intended result of a process positively recited (see Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Please see claim interpretation in the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, discussed above.
Since Noakes discloses a method of claim 1(see discussions above), the method of Noakes must necessarily produce the same outcome recited in claim 9. This is because the recited outcome is a natural process that flows from the mother and the administered DHA free composition comprising vitamin B2 (riboflavin). Therefore, claim 9 is anticipated by Noakes.
Regarding claim 12, Noakes teaches obese and overweight mother (see discussions above).
Claim Rejections - 35 USC § 103
New Grounds of Rejection, Necessitated by Applicants’ Amendments
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 1, 3-9, 12 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Salminen et al (hereinafter “Salminen”, EP2011506A1, published 07/01/2009) in view of Catalano et al (hereinafter “Catalano”, Obstetrics & Gynecology, 2007, 109(2), 419-433).
Independent claim 1 is drawn to a method for preventing overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in offspring of a mother who has metabolic syndrome, with a DHA free composition comprising vitamin B2 (riboflavin). The composition is administered to the mother before pregnancy, during pregnancy, and/or during lactation.
Similar to the claimed invention, Salminen teaches a method reducing the risk of metabolic syndrome (¶s 0009, 0012, 0015, 0071), comprising administering to pregnant women, a composition comprising 1.3 mg vitamin B2, probiotic bacteria, vitamin D, vitamin B6, vitamin B12, and zinc. Please see ¶s 0046-0065, Tables 1-2 and reference claims 1-12. Vitamin B2 can be from 0.5-2 mg/day (see ¶ 0030). Metabolic syndrome may be defined as a combination of obesity, high waist circumference, altered glucose metabolism and insulin resistance and abnormal blood lipid levels and often precedes the development of cardiovascular disease (see ¶ 0015). Treatment was found to result in reduction in the infants’ weight and mothers’ body mass indices (BMI), compared to the control group (see Table 1). The composition of Salminen does not contain DHA (see ¶ 0046).
Salminen differs from the claimed invention only insofar as Salminen is not explicit in disclosing a mother having metabolic syndrome.
However, the claimed invention would have been obvious over Salminen, because at the time the instant invention was filed, offspring of mothers having metabolic syndrome are known to be at risk of associated metabolic disorders. For example, Catalano discloses that offspring of obese mothers has increased risk of metabolic syndrome (obesity, hypertension, insulin resistance and dyslipidemia). Please see abstract, pages 429-430 and Table 3.
At the time the instant invention was filed, one skilled in the art would have envisaged a method for preventing overweight, obesity, excessive fat accumulation and/or associated metabolic disorders in offspring of a mother who has metabolic syndrome, with a DHA free composition comprising vitamin B2, in the disclosures of Salminen and Catalano.
A person of the ordinary skill in the art would have had a reasonable expectation that the administration of a modified composition of Salminen comprising 0.5-2 mg/day of vitamin B2 to a mother having metabolic syndrome, would reduce the risk of developing metabolic syndrome (obesity, hypertension, insulin resistance and dyslipidemia), in the offspring.
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).
Therefore, claim 1 is obvious over Salminen and Catalano.
Regarding claims 3-4, 8 and 15, Salminen discloses dietary food, meat, milk, vegetables (see abstract, ¶s 0001, 0027, 0029, 0032 and Table 1).
Regarding claims 6-7, each of the claimed vitamin B2 dosing schedule of at least: i) 4 consecutive weeks (claim 6); and ii) once daily (claim 7), is a result-effective variable that would have been routinely determined and optimized in the pharmaceutical art.
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.”
Factors that would have been taken into consideration when determining the optimum riboflavin dosing schedule, would have included, but not have been limited to, the age, weight, medical condition of the mother and severity of the metabolic syndrome. Thus, the specific riboflavin dosing schedule that would have actually been determined would have been expected to vary widely and, in the absence of evidence to the contrary, would not have been inconsistent with that which is presently claimed.
It is noted that no criticality (emphasis added), has been demonstrated in the specification with regard to the vitamin B2 dosing schedule of at least: i) 4 consecutive weeks (claim 6); and ii) once daily (claim 7).
Regarding claim 9, the recitation outcomes of a method of claim 1 resulting in preventing overweight, obesity, excessive fat accumulation and/or associated metabolic disorder in the offspring later in life, is not given any patentable weight because each of the recited outcome is simply expressing the intended result of a process positively recited. Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). Since Salminen and Catalano combined to teach a method of claim 1 (see discussions above), the method of Salminen and Catalano, must necessarily produce the same outcomes of recited in claim 9. This is because the recited outcomes in claim 9 is a natural process that flows from, for a patient population of instant claim 1 and the DHA free vitamin B2 composition administered.
Therefore, claim 9 is obvious over Salminen and Catalano.
Regarding claim 12, Catalano discloses obese women (see abstract).
Regarding claims 5 and 16-19, Salminen discloses 0.5-2 mg/day vitamin B2 (see discussions and rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, above), which lies within the claimed 0.14-14 mg/day vitamin B2 and/or overlaps with the claimed 1.5-2 mg/day vitamin B2 recited in claims 5, 16 and 19.
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).
In the instant case, because the claimed range of 0.14-14 mg/day vitamin B2 and 1.5-2 mg/day vitamin B2 overlaps or lies inside ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
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 administration of the claimed range of 0.14-14 mg/day vitamin B2 and 1.5-2 mg/day vitamin B2.
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 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. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusion
No claim is allowable.
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.
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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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