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 .
Claims 1-4 are pending.
Claims 1 and 3-4 stand withdrawn.
Claim 2 is examined on the merits.
Withdrawn Rejections
The previous rejection made under 35 U.S.C. 112(b) is withdrawn in light of the amendment.
The previous rejection made under 35 U.S.C 103 has been withdrawn upon further consideration and in light of Applicant’s arguments, which are found persuasive. Reising et al. does not teach the method instantly claimed.
Claim Objections
Claim 2 is objected to because of the following informalities: the word “of” should be entered following “mitigation” in line 1. Appropriate correction is required.
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.
Claim 2 is 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.
Claim 2 is drawn to a “method of mitigation chronic malnutrition in an infant, the method comprising the administration to said infant transitional breast milk, early mature breast milk, and fully mature breast milk produced by a lactating mother consuming a composition comprising”…. “wherein the mother starts consuming the composition within the last 6 weeks of pregnancy and continues for at least 6 months after giving birth to the infant”.
It is not clear as drafted if the infant recited in the instant claims, to which breast milk from a lactating mother consuming the product of the instant claims is administered, must already be chronically malnourished prior to administration of their own mother’s breast milk. The use of the phrase “the mother starts consuming the composition within the last 6 weeks of pregnancy and continues for at least 6 months after giving birth to the infant” implies that “the infant” receiving the breast milk is a child born from the mother consuming the product recited in the claims. The instant claim requires that the mother consume the product within the last 6 weeks prior to giving birth. The claims also require that the mother produces a volume of breast milk from 500 ml to 1000 ml per day. If the mother is producing this amount of breast milk each day (which would not occur if the mother were not continuously nursing following birth), it is unclear how the infant born from that mother and nursing from that mother, would have chronic malnutrition. Therefore, it is unclear if the term “mitigation” is being used in a manner different from its plan meaning (reduce the severity) and if the claim intends to capture reducing the likelihood of chronic malnutrition from occurring. This appears to be the only logical interpretation of the claim, since a mother with an already chronically malnourished baby cannot go back in time and consume the claimed product at some point within the last 6 weeks of their pregnancy to mitigate the chronic malnutrition. Further, according the instant specification, the consumption of this product would result in an increase in the production of all 3 types of breast milk (see e.g. [0028]-[0030]).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,547,135 in view of Lynch et al. (US 8,945,642) and Nisar et al. (2016).
Claims 1-3 of US 11,547,135 are drawn to a method of mitigation of chronic malnutrition in an infant comprising the infant breastfeeding from a lactating mother ingesting a nutraceutical comprising a hydrophilic soluble fraction/lipophilic soluble fiber fraction blend, wherein the hydrophilic soluble fraction/lipophilic fiber fraction blend ratio is from 1.2 to 1.4. Therefore, the claims of ‘135 teach administration to an infant breast milk produced by a mother consuming a product with the same hydrophilic soluble fraction/lipophilic soluble fiber fraction blend as recited in the instant claims. The fiber fraction blend of the claims of ‘135 contains a ratio of hydrophilic fraction to the lipophilic fraction within the ratios instantly claimed. The claims of ‘135 also disclose feeding an infant breast milk produced by a lactating mother that is consuming a nutraceutical that contains a hydrophilic soluble fraction/lipophilic fiber fraction blend in the ratio instantly claimed wherein the mother is ingesting 35-45 grams per day of the nutraceutical, which is squarely within the range of composition consumed by the lactating mother of the instant claims.
The claims of ‘135 do not explicitly teach that the fiber fraction blend is derived form enzymatically hydrolyzed rice bran or that the mother begins consuming the blend within the last 6 weeks of pregnancy and continues through at least 6 moths after giving birth to the infant.
Lynch et al. teaches a nutritionally enhanced derivative from stabilized rice bran prepared by enzyme treatment and extraction of rice bran (see e.g. abstract). Lynch teaches a method of making a rice bran isolate with a hydrophilic soluble fraction and lipophilic fraction as claimed since the product taught by Lynch contains soluble dextrin, protein and fat components (see e.g. claims 1 and 4).
Nisar et al. teaches that an analysis of factors contributing to malnutrition in children under 5 months of age revealed that children that were breastfed were less likely to have severe malnutrition (see e.g. Discussion, p 9, first para). Nisar et al. further teaches that breastfeeding is a cost-effective mechanism to reduce malnutrition in developing countries and that exclusive breastfeeding for the first 6 months of life is the single most important factor in decreasing infant morbidity and mortality (see e.g. page 10).
It would have been obvious to one of ordinary skill in the art, based on the claims of ‘135 in combination with Lynch et al. and Nisar et al. to administer breast milk from a lactating mother consuming an enzymatically hydrolyzed rice bran extract with the instantly claimed blend of hydrophilic and lipophilic fractions in order to reduce the likelihood of or treat chronic malnutrition in an infant. The claims of ‘135 disclose mitigating malnutrition by feeding an infant breast milk produced by a lactating mother that is consuming a nutraceutical that contains a hydrophilic soluble fraction/lipophilic fiber fraction blend in the ratio instantly claimed wherein the mother is ingesting 35-45 grams per day of the nutraceutical (which is squarely within the range instantly claimed). The claims of ‘135 do not explicitly state that the hydrophilic soluble fraction/lipophilic fiber fraction blend is from an enzymatically hydrolyzed rice bran extract, however, the blend recited in ‘135 and instantly claimed can be made that way, as shown by Lynch et al. It should be noted that the term “extract” recited in the instant claims is broad and reads on the hydrophilic soluble fraction/lipophilic fiber fraction blend of ‘135 since those components can be extracted from rice bran (and therefore are extracts themselves). Further, it would have been obvious to one of ordinary skill in the art use an enzymatically hydrolyzed rice bran extract in order to prepare a nutraceutical with the blend recited in the claims of ‘135 since Lynch et al. teaches that these components are prepared from rice bran for use in nutraceutical.
One of ordinary skill in the art would have understood that that mother should consume the product when lactation is starting, which includes the last 6 weeks of pregnancy, and continue consuming the product during lactation and throughout the time the mother is breastfeeding the infant, which would be for at least the first 6 months of life. Based on the teaching of Nisar et al. one would have understood that breastfeeding should be started on the first day of birth (with lactation starting before that) and continue through at least 6 months of age for an infant in order to reduce the incidence of malnutrition. The type of milk recited in the instant claims (transitional, early mature and fully mature) would necessarily be produced by a lactating mother, including one consuming the composition of ‘135 and instantly claimed. Further, the volume of breast milk, including the types recited in the claims, would necessarily be produced when consuming the claimed composition. It should also be noted that the instant claims do not require a particular amount of breast milk is administered and do not require a step of administering the composition to a mother, only that milk from a lactating mother consuming the composition for a certain period of time is fed to an infant.
Therefore, the instant claims are obvious of ‘135 in view of Lynch et al. and Nisar et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Melenie Gordon whose telephone number is (571)272-8037. The examiner can normally be reached M-F 9-5.
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/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657