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 1-14 are pending.
Election of Invention
Applicants’ election with traverse (see page 2 of reply filed on 5/06/2026), of the invention of Group I (claims 1-12), is acknowledged and entered.
The traversal is on the grounds that independent claim 1 requires administering vitamin B2, whereas, independent claim 3 is drawn to a maternal food composition (see page 2 of Remarks).
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because at stated in the previous Office action, the groups of inventions I-II listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special tech-nical features for the following reasons: The special technical feature shared between the inventions of Groups I-II is a composition comprising vitamin B2.
However, Lim et al (Clinical Nutrition Research, 2013, 2, 81-90), discloses a composition comprising vitamin B2 (see Table 3). Therefore, lack of unity of invention exits between the inventions of groups I-II.
The Restriction Requirement is still deemed proper and is therefore, made FINAL.
Applicants’ election of following species (see page 2 of reply filed on 5/06/2026), is acknowledged and entered:
a) a method for preventing excessive fat accumulation, as the elected species of a method;
b) maternal food composition, as the elected form of vitamin B2.
Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of invention has been treated as an election of invention without traverse (MPEP § 818.01(a)).
Claims 2 and 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected species. Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention. Therefore, claims 1, 3-9 and 12 are subject of the Office action below.
Priority
This application filed on 12/26/2023, is a DIV of U.S. Application No. 15/127,848, filed on 09/21/2016 (ABN), which is a 371 of PCT/EP15/55732, filed on 03/18/2015, which claims benefit of EPO Application No. 14161190.5, filed on 03/21/2014. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moran et al (hereinafter, “Moran”, Int. J. Obesity, 2013, 37, 704-711).
By way of a background, Applicants’ invention is drawn to a method for preventing for example, excessive fat accumulation in an offspring of a woman, comprising administering vitamin B2 to the woman before pregnancy, during pregnancy and/or during lactation (see page 3 of the specification). The specification provides support in the form of a measured correlation between offspring fat deposition and maternal vitamin B2 levels (see pages 11-14 and Figure 1).
Under the broadest reasonable interpretation (BRI), consistent with the specification, independent claim 1 is being interpreted as a method for preventing overweight, obesity, excessive fat accumulation and/or an associated metabolic disorder in an offspring, comprising administering vitamin B2 to a mother before pregnancy, during pregnancy and/or during lactation.
Similar to the Applicants’ invention (see discussions above), Moran teaches administering micronutrient composition comprising vitamin B2 to women during pregnancy and post part-partum (see Tables 3 and 4, abstract and page 705-707).
Regarding claim 1, the method steps require that administering vitamin B2 to a mother before pregnancy, during pregnancy and/or during lactation, would result in the prevention of overweight, obesity, excessive fat accumulation and/or an associated metabolic disorder in an offspring of the mother. Moran teaches administering micronutrient composition comprising vitamin B2 to women during pregnancy and post part-partum (see discussions above). Therefore, the method of Moran must necessarily result in the prevention of overweight, obesity, excessive fat accumulation and/or an associated metabolic disorder in an offspring of the mother. The execution of the same method step must necessarily produce the same result, because the prevention of, for example, excessive fat accumulation in the offspring of a mother, is a natural process that flows from the mother and the B2 administered to the mother.
Therefore, claim 1 is anticipated Moran.
Regarding claims 3-4, Moran discloses, for example, milk (a drink) and whole grains (a cereal based product). Please see Table 2.
Regarding claim 5, Moran discloses vitamin B2 in an amount of 1.4 mg/day (see Table 4), which is within the claimed range of “0.14-14 mg/day”, recited in claim 5.
A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Regarding claim 6, Moran discloses up to 28 weeks gestation through 4 months post-partum (see Table 3).
Regarding claim 7, Moran discloses daily nutrient intake (see page 705, under the title “Food frequency questionnaire”).
Regarding claim 8, Moran discloses eggs (see page 705, under the title “Healthy eating index”).
Regarding claim 9, Moran teaches a method of claim 1 (see discussions above). Therefore, the method of Moran must necessarily result in the same outcome recited in claim 9. This is because the outcome recited in claim 9, is a natural process that flows from the mother and the B2 administered.
Regarding claim 12, Moran teaches overweight and obese women (see abstract).
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 1, 3-7, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Haschke et al (hereinafter “Haschke”, U.S. Pub. No. 20090142314, published 06/04/2009), in view of: 1) Haschke et al (hereinafter, “Haschke2010”, U.S. Pub. No. 20100092610, published 04/15/2010); and 2) Boderke et al (hereinafter “Boderke”, U.S. Pub. No. 20050143347, published 06/30/2005).
By way of a background, Applicants’ invention is drawn to a method for preventing for example, excessive fat accumulation in an offspring of a woman, comprising administering vitamin B2 to the woman before pregnancy, during pregnancy and/or during lactation (see page 3 of the specification). The specification provides support in the form of a measured correlation between offspring fat deposition and maternal vitamin B2 levels (see pages 11-14 and Figure 1).
Under the broadest reasonable interpretation (BRI), consistent with the specification, independent claim 1 is being interpreted as a method for preventing overweight, obesity, excessive fat accumulation and/or an associated metabolic disorder in an offspring, comprising administering vitamin B2 to a mother before pregnancy, during pregnancy and/or during lactation.
Similar to the Applicants’ invention (see discussions above), Haschke discloses a nutritional supplement composition comprising vitamin B2 (see ¶s 0024, 0028 and 0041, Example 1). Haschke discloses, wherein the composition can be administered to pregnant women in order to reduce the risk of developing overweight or obesity of the baby in later life such as in infancy and/or early childhood (see title of the invention, abstract and ¶s 0001, 0010-0014, 0017 and reference claims 1-25). Haschke discloses that the prevalence of obesity in adults, adolescents and children has increased rapidly (see ¶ 0005). The prevalence of obesity in adults necessarily include a mother (an adult) having obesity.
Haschke discloses, wherein reduction in fat accumulation has been suggested as one of the underlying mechanism actions in the therapy of overweight or obesity (see ¶ 0006). Haschke discloses the effects of administering the nutritional supplement composition to pregnant women and the evolution of weight and body mass of their children (see ¶s 0042-0047). Haschke discloses that the administration of the supplement composition is continued after delivery, wherein the supplement composition is administered to the infant via the breast-feeding mother or may be administered directly to the infant (¶ 0015).
Although Haschke discloses: i) prevalence of obesity in adults, adolescents and children; and ii) a composition comprising vitamin B2 that can be administered to pregnant women in order to reduce the risk of developing overweight or obesity of the baby in later life, Haschke differs from the invention of instant claim 1 only insofar as Haschke does not explicitly disclose:
i) wherein the adult is, for example, an obese or overweight mother; and
ii) the utility of vitamin B2 in the prevention of fat accumulation.
However, the prevalence of obesity in adults necessarily include a mother (an adult) having obesity. For example, Haschke2010 discloses infant at risk of developing obesity later in life as meaning an infant born to an obese mother (see ¶s 0011 and 0015). Similar to Haschke, Haschke2010 discloses that the prevalence of obesity and overweight in adults, children and adolescents has increased rapidly over the past 30 years in the United States and globally (see ¶ 0003). Haschke2010 also discloses a nutritional composition comprising vitamin B2 that finds utility in the prevention of obesity (see abstract, ¶s 0001, 0026, 0029, 0031 and 0034).
Furthermore, the addition of vitamin B2 to a nutritional supplement composition in order to prevent, for example, fat accumulation, overweight or obesity, would have been a matter well within the skill of the artisan at the time of the filing and would not have been outside the realm of the knowledge generally available to the skilled artisan.
This is because the utility of vitamin B2 in prevention of, for example, fat accumulation, overweight or obesity, was well known in the art at the time of the filing. For example, Boderke discloses the utility of riboflavin in the degradation of fat, thus preventing fat accumulation (see title of the invention, abstract, ¶s 0002, 0033-0034 and 0044). Boderke discloses that riboflavin is also referred to as vitamin B2 and further discloses that riboflavin acts in humans in the form of its active coenzymes (see ¶ 0040). Similar to Haschke, Boderke discloses obesity and diabetes among diseases associated with fat accumulation. Boderke discloses, wherein administration of the inventive composition to a female patient result in the decrease in fat accumulation (see ¶0079).
Therefore, a person skilled in the art would have found it obvious to administer a nutritional supplement composition comprising vitamin B2 (riboflavin) to, for example, an obese mother before pregnancy, during pregnancy and/or during lactation with a reasonable expectation of degrading fat, thus preventing, for example, fat accumulation in an offspring of the mother. 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).
The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflexlnc., 550 U.S. 398,416 (2007). "If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability." Id. at 417. As noted by the Supreme Court in KSR, "[a] person of ordinary skill is also a person of ordinary creativity, not an automaton." Id. at 421.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “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 that product [was] not of innovation but of ordinary skill and common sense.
Regarding claims 3 and 4, each of Haschke and Haschke2010discloses nutritional supplement (see discussions above).
Regarding claims 5 and 7, Haschke discloses 0.50 to 2 mg vitamin B2 per daily dose (see ¶s 0028 and 0049), and Haschke2010 discloses vitamin B2 at 0.15 mg/100 kcal (see ¶ 0034), each of which is within the claimed range of “0.14-14 mg/day”, recited in claim 5.
A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Regarding claim 6, Haschke discloses treating women in the 20th to 22nd of pregnancy willing to breastfeed for at least 3 months and compliance checked every six weeks (see ¶s 0043, 0049 and 0050).
Regarding claim 9, Haschke discloses the composition can be administered to pregnant women in order to reduce the risk of developing overweight or obesity of the baby in later life such as in infancy and/or early childhood (see discussions above).
Regarding claim 12, the cited references combine to disclose obese mother (see discussions above).
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.
Claims 1, 3-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Haschke (U.S. Pub. No. 20090142314), in view of: 1) Haschke2010 (U.S. Pub. No. 20100092610); and 2) Boderke (U.S. Pub. No. 20050143347), as applied to claims 1, 3-7, 9 and 12 above, and further in view of Layman et al (hereinafter “Layman”, Nutrition Today, 2009, 44(1) 43-48, Abstract).
The limitations of claims 1, 3-7, 9, 11 and 14, as well as the corresponding teachings of Haschke, Haschke2010 and Boderke are discussed above, and are hereby incorporated into the instant rejection.
The invention of 8 is similar to claim 1, however, claim 8 differs slightly from claim 1 in that claim 8 requires, wherein the source of vitamin B2 is a natural source such as eggs.
Regarding claim 8, although Haschke, Haschke2010 and Boderke do not combine disclose, for example, egg as a natural source of vitamin B2, egg is a well know source of vitamin B2. For example, Layman, discloses egg as a source of riboflavin (see abstract).
Therefore, one skilled in the art in the would have found it obvious to administer a nutritional supplement composition comprising vitamin B2 (e.g., vitamin B2 from an egg) to, for example, an obese mother before pregnancy, during pregnancy and/or during lactation with a reasonable expectation of degrading fat, thus preventing, for example, fat accumulation in an offspring of the mother. 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).
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.
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.
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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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