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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4, 7, 10, 17, 19, 22-23, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chang US 2014/0234488 in view of Allio et al. US 2016/0256383 and Madhavamenon et al. US 2015/0352173.
Regarding Claim 1, Chang discloses a beverage composition comprising an herbal blend (‘488, Paragraphs [0027]-[0028]) of fennel, anise, coriander, lemon grass, lemon verbena (‘488, Paragraph [0051]), marshmallow root, and blessed thistle and a sweetener (‘488, Paragraph [0057]).
Chang discloses the beverage composition comprising marshmallow (‘488, Paragraph [0048]). However, Chang is silent regarding the beverage comprising marshmallow root.
Allio et al. discloses a beverage (‘383, Paragraph [0047]) comprising dried milk solids (‘383, Paragraph [0059]) and an herbal active ingredient comprising marshmallow root (‘383, Paragraph [0062]).
Both Chang and Allio et al. are directed towards the same field of endeavor of beverage compositions comprising herbal ingredients and a marshmallow derived ingredient. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beverage composition of Chang and incorporate marshmallow root as taught by Allio et al. since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Allio et al. teaches that there was known utility in the beverage art to incorporate marshmallow root in an herbal based beverage.
Further regarding Claim 1, Chang modified with Allio et al. is silent regarding the beverage composition being a ready to drink beverage composition.
Madhavamenon et al. discloses a beverage composition comprising an herbal blend wherein the beverage composition is in a ready to use form (‘173, Paragraph [0001]).
Both modified Chang and Madhavamenon et al. are directed towards the same field of endeavor of beverage compositions comprising an herbal blend. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beverage composition of modified Chang to be in a ready to drink beverage composition form as taught by Madhavamenon et al. based upon the particular form the use wishes to package the beverage composition.
Regarding Claims 4, 7, and 10, Chang discloses the herbal blend comprising fenugreek and spearmint (‘488, Paragraph [0051]).
Regarding Claim 17, Chang discloses the sweetener being honey or sugar (‘488, Paragraph [0043]).
Regarding Claims 19 and 22, Chang discloses the beverage comprising lemon juice (‘488, Paragraphs [0049] and [0055]).
Regarding Claim 23, Chang discloses a spice blend comprising cinnamon, ginger, nutmeg, and cloves (‘488, Paragraph [0051]).
Regarding Claim 25, Chang discloses the beverage being milk (‘488, Paragraph [0015]).
Regarding Claim 27, Chang discloses the beverage consumption being prepared using a hot or cold brew production process (‘488, Paragraphs [0015] and [0026]).
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Chang US 2014/0234488 in view of Allio et al. US 2016/0256383 and Madhavamenon et al. US 2015/0352173 as applied to claim 1 or claim 4 above in further view of Budzynska et al. “Complementary, Holistic, and Integrative Medicine: Advice for Clinicians on Herbs and Breastfeeding” (published August 2013) (herein referred to as “Budzynska et al.”), Andrews et al. US 2016/0038553, Ozalkaya et al. “Effect of a Galactagogue Herbal Tea on Breast Milk Production and Prolactin Secretion by Mothers of Preterm Babies” (published January 2018), and Pregnant Mama Baby Life “Mothers Milk Tea Review” (published July 5, 2018) (cited on Information Disclosure Statement filed March 16, 2023).
Regarding Claims 2 and 5, Chang modified with Allio et al. and Madhavamenon et al. is silent regarding the herbal blend comprising about 39-41 wr% fennel seed, about 31-33 wt% anise seed, about 11-13 wf% coriander seed, about 2-4 wt% blessed thistle leaves, about 3-5 wt% marshmallow root, about 2-4 wt% lemongrass leaves, and about 2-4 wt% lemon verbena leaves, or about 34-36 wt% fennel seed, about 27-29 wt% anise seed, about 9-11 wt% coriander seed, about 2-4 wt% blessed thistle leaves, about 10-12 wt% fenugreek seed, about 3-5 wt% marshmallow root, about 2-4 wt% lemongrass leaves, and about 1-3 wt% lemon verbena leaves.
Budzynska et al. discloses herbal remedies for breastfeeding and postpartum support have been used to increase milk supply, relief of engorgement, treatment of mastitis, or other therapeutic indications unrelated to lactation and plants contain numerous physiologically active constituents in relatively small amounts (Page 343) wherein galactagogues are herbs or medications that increase breast milk production which galactagogues include common culinary herbs such as fennel seed, anise seed, fenugreek seed, marshmallow root, and blessed thistle herb (Table 1, Page 344). Andrews et al. discloses a nutritional supplement for breastfeeding females to enhance breast milk supply and/or lactation wherein the nutritional supplement comprises an effective amount of an herbal galactagogue and a postnatal vitamin comprising coriander (‘553, Paragraph [0024]). Ozalkaya et al. discloses a mixture of herbal tea on daily milk production wherein the herbal tea comprises anise, fennel, and lemon grass and increases the daily milk production of the mother (Page 40). Pregnant Mama Baby Life discloses an herbal tea that encourages a mothers body to produce more milk for her baby wherein a lactation tea helps increase your milk supply (Page 1) wherein the herbal tea that helps promote healthy lactation comprises fennel fruit, anise fruit, coriander fruit, fenugreek seed, thistle, spearmint, lemongrass, lemon verbena, and marshmallow root (Page 2).
Modified Chang, Budzynska et al., Andrews et al., Ozalkaya et al., and Pregnant Mama Baby Life are all directed towards the same field of endeavor of beverage compositions comprising an herbal blend for breastfeeding to increase milk supply. Although Budzynska et al., Andrews et al., Ozalkaya et al., and Pregnant Mama Baby Life does not explicitly disclose the claimed concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves, differences in concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation in view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Budzynska et al., Andrews et al., Ozalkaya et al., and Pregnant Mama Baby Life all teach beverage compositions comprising herbal blends comprising the claimed ingredients for breastfeeding. It would have been obvious to one of ordinary skill in the art at the time of the invention to adjust the amounts of each of the claimed ingredients to fall within the claimed concentrations of each ingredient based upon the desired flavor profile of the beverage composition.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chang US 2014/0234488 in view of Allio et al. US 2016/0256383 and Madhavamenon et al. US 2015/0352173 as applied to claim 7 or claim 10 above in further view of Budzynska et al. “Complementary, Holistic, and Integrative Medicine: Advice for Clinicians on Herbs and Breastfeeding” (published August 2013) (herein referred to as “Budzynska et al.”), Andrews et al. US 2016/0038553, Ozalkaya et al. “Effect of a Galactagogue Herbal Tea on Breast Milk Production and Prolactin Secretion by Mothers of Preterm Babies” (published January 2018), Sievert US 2006/0099321, and Pregnant Mama Baby Life “Mothers Milk Tea Review” (published July 5, 2018) (cited on Information Disclosure Statement filed March 16, 2023).
Regarding Claims 8 and 11, Chang modified with Allio et al. and Madhavamenon et al. is silent regarding the herbal blend comprising about 37-39 wt% fennel seed, about 30-32 wt% anise seed, about 10-12 wt% coriander seed, about 2-4 wt% blessed thistle leaves, about 3-5 wt% marshmallow root, about 2-4 wt% lemongrass leaves, about 2-4 wt% lemon verbena leaves, and about 2-4 wt% spearmint leaves, or about 33-35 wt% fennel seed, about 26-28 wt% anise seed, about 9-11 wt% coriander seed, about 1-3 wt% blessed thistle leaves, about 10-12 wt% fenugreek seed, about 3-5 wt% marshmallow root, about 2-4 wt% lemongrass leaves, about 1-3 wt% lemon verbena leaves, and about 2-4 wt% spearmint leaves.
Budzynska et al. discloses herbal remedies for breastfeeding and postpartum support have been used to increase milk supply, relief of engorgement, treatment of mastitis, or other therapeutic indications unrelated to lactation and plants contain numerous physiologically active constituents in relatively small amounts (Page 343) wherein galactagogues are herbs or medications that increase breast milk production which galactagogues include common culinary herbs such as fennel seed, anise seed, fenugreek seed, marshmallow root, and blessed thistle herb (Table 1, Page 344). Andrews et al. discloses a nutritional supplement for breastfeeding females to enhance breast milk supply and/or lactation wherein the nutritional supplement comprises an effective amount of an herbal galactagogue and a postnatal vitamin comprising coriander (‘553, Paragraph [0024]). Ozalkaya et al. discloses a mixture of herbal tea on daily milk production wherein the herbal tea comprises anise, fennel, and lemon grass and increases the daily milk production of the mother (Page 40). Sievert discloses a food product comprising DHA (decosahexanoic acid) without fish off tastes and odors (‘321, Paragraph [0001]) wherein DHA is a long chain omega 3 polyunsaturated fatty acid that is important throughout pregnancy and lactation for the health of both the mother and the fetus/infant (‘321, Paragraph [0002]) wherein DHA is well known to have a strong odor and off taste of fish oil that can be masked by adding a sensory masking agent of spearmint (‘321, Paragraph [0014]). Pregnant Mama Baby Life discloses an herbal tea that encourages a mothers body to produce more milk for her baby wherein a lactation tea helps increase your milk supply (Page 1) wherein the herbal tea that helps promote healthy lactation comprises fennel fruit, anise fruit, coriander fruit, fenugreek seed, thistle, spearmint, lemongrass, lemon verbena, and marshmallow root (Page 2).
Modified Chang, Budzynska et al., Andrews et al., Ozalkaya et al., Sievert, and Pregnant Mama Baby Life are all directed towards the same field of endeavor of beverage compositions comprising an herbal blend for breastfeeding to increase milk supply. Although Budzynska et al., Andrews et al., Ozalkaya et al., and Pregnant Mama Baby Life does not explicitly disclose the claimed concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves, differences in concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of fennel seed, anise seed, coriander seed, blessed thistle leaves, marshmallow root, lemongrass leaves, and lemon verbena leaves is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation in view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Budzynska et al., Andrews et al., Ozalkaya et al., and Pregnant Mama Baby Life all teach beverage compositions comprising herbal blends comprising the claimed ingredients for breastfeeding. It would have been obvious to one of ordinary skill in the art at the time of the invention to adjust the amounts of each of the claimed ingredients to fall within the claimed concentrations of each ingredient based upon the desired flavor profile of the beverage composition. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of spearmint used in the beverage of modified Chang to fall within the claimed concentration of spearmint based upon the desired taste masking of the odor and off taste of fish oil as taught by Sievert (‘321, Paragraph [0014]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chang US 2014/0234488 in view of Allio et al. US 2016/0256383 and Madhavamenon et al. US 2015/0352173 as applied to claim 1 above in further view of The Second 9 Months “Fenugreek May be Hazardous to your Health” (<https://www.second9months.com/fenugreek-may-be-hazardous-to-your-health/>) (published May 15, 2012).
Regarding Claim 13, Chang modified with Allio et al. and Madhavamenon et al. is silent regarding the herbal blend not comprising fenugreek and/or spearmint.
The Second 9 Months discloses fenugreek is a type of herbal galactagogue used by breastfeeding moms that helps increase milk supply but also has uncomfortable side effects such as loose stools and digestive issues and may worsen asthma (Page 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beverage composition of modified Chang to explicitly omit the presence of fenugreek in order to eliminate the side effects associated with fenugreek such as loose stools and digestive issues and worsening asthma effects as taught by The Second 9 Months.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Chang US 2014/0234488 in view of Allio et al. US 2016/0256383 and Madhavamenon et al. US 2015/0352173 as applied to claim 1 above in further view of Andrews et al. US 2016/0038553.
Regarding Claim 28, Chang discloses the beverage composition comprising fenugreek (‘488, Paragraph [0051]). However, Chang modified with Allio et al. and Madhavamenon et al. is silent regarding consumption of the beverage composition by a nursing mother resulting in increased lactation.
Andrews et al. discloses a beverage composition (breast milk) (‘553, Paragraph [0005]) comprising an herbal blend containing fenugreek (‘553, Paragraph [0008]) wherein the beverage contains essential nutrients (‘553, Paragraph [0006]) effective for improving lactation and/or breast milk production in a breastfeeding female (‘553, Paragraph [0026]).
Both modified Chang and Andrews et al. are directed towards the same field of endeavor of beverage compositions comprising an herbal blend containing fenugreek. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beverage composition of modified Chang to result in increased lactation by a nursing mother as taught by Andrews et al. based upon the desired population desired to administer the beverage composition to. Andrews et al. establishes that women have higher nutrition requirements while nursing due to the nutritional demands of producing breast milk (‘553, Paragraph [0004]).
Response to Arguments
Examiner notes that the previous indefiniteness rejections under 35 USC 112(b) have been withdrawn in view of the amendments.
Applicant's arguments filed October 27, 2025 with respect to the obviousness rejections under 35 USC 103(a) have been fully considered but they are not persuasive.
Applicant argues on Page 6 of the Remarks that Paragraph [0051] of Chang teaches a beverage comprising an herb flavor that can be selected from a laundry list of ingredients. Applicant contends that Chang fails to disclose a combination of ingredients and that the list of ingredients recited by Chang is listed in the alternative and does not teach or suggest that one or more ingredients may be combined in a ready to drink beverage and that Chang fails to disclose an herbal blend of fennel, anise, coriander, lemon grass, lemon verbena, marshmallow root, and blessed thistle.
Examiner argues Chang discloses the beverage including at least one flavoring ingredient, at least one nutritional ingredient, at least one health ingredient, and at least one other ingredient (‘488, Paragraph [0011]) wherein the at least one flavoring ingredient is selected from natural flavor, artificial flavor, fruit flavor, plant flavor, herb flavor, nut flavor, vegetable flavor, meat flavor, and other flavor (‘488, Paragraph [0047]). The beverage composition comprises an herbal blend (‘488, Paragraphs [0027]-[0028]) of fennel, anise, coriander, lemon grass, lemon verbena (‘488, Paragraph [0051]), marshmallow, blessed thistle (‘488, Paragraph [0051]) and a sweetener (‘488, Paragraph [0057]). The disclosure of Chang that the beverage includes at least one flavoring ingredient (‘488, Paragraph [0011]) which flavoring ingredient includes all of the claimed ingredients of the herbal blend with the exception of the marshmallow root, which is taught by Allio et al., indicates that one or more flavoring ingredients may be combined in a beverage by virtue of the phrase “at least one flavoring ingredient and at least one nutritional ingredient (‘488, Paragraph [0011]). Madhavamenon et al. is being relied upon to teach an herbal blend being used in a beverage composition having a ready to use form (‘173, Paragraph [0001]). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, this argument is not found persuasive.
Applicant argues on Pages 6-7 of the Remarks that Allio discloses compositions for relief of a cough, cold, sore throat, or allergy and the use of a botanical ingredient taken from products which treat or ameliorate a cough, cold, sore throat, or allergy or a disease state as disclosed in Paragraphs [0031] and [0062]). Applicant contends that Allio fails to disclose the specific combination of herbs as recited and fails to provide any suggestion to select the specific combination of herbs for inclusion in a ready to drink beverage.
Examiner argues the primary reference Chang already teaches all of the claimed herbal ingredients with the exception of marshmallow root. The secondary reference of Allio is being relied upon to teach a beverage composition (‘383, Paragraph [0064]) comprising an herbal active ingredient (‘383, Paragraph [0068]) of marshmallow root (‘383, Paragraph [0062]). Madhavamenon et al. is being relied upon to teach an herbal blend being used in a beverage composition having a ready to use form (‘173, Paragraph [0001]). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, this argument is not found persuasive.
Examiner notes that applicant’s comments on Pages 7-9 of the Remarks with respect to the elected dependent claims does not specifically and distinctly point out the supposed errors of the Office Action.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICSON M LACHICA whose telephone number is (571)270-0278. The examiner can normally be reached M-F, 8:30am-5pm, EST.
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/ERICSON M LACHICA/Examiner, Art Unit 1792