DETAILED ACTION
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 Application
Receipt of the Response and Amendment after Non-Final Office Action filed 04/13/2026 is acknowledged.
Applicant has overcome the following rejections by cancellation of the claims: (1) the 35 U.S.C. §103 rejection of claim 15/14 over Van, Cleverly, and Barnvos has been withdrawn; (2) the U.S.C. §103 rejection of claims 16 and 17 (in view of claim 15/14) over Van, Cleverly, Barnvos, Kovaleski, and Newton has been withdrawn; and (3) the U.S.C. §103 rejection of claim 22 (in view of claim 15/14) over Van, Cleverly, Barnvos, and Kovaleski has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-13, 15-17, 22-26
Withdrawn claims: 1-13
Previously cancelled claims: 21
Newly cancelled claims: 14, 18-20
Amended claims: 15
New claims: 23-26
Claims currently under consideration: 15-17, 22-26
Currently rejected claims: 15-17, 22-26
Allowed claims: None
Claim Objections
Claim 15 is objected to because of the following minor informalities:
“any one of Claim 1 to Claim 14” should be read as “any one of Claim 1 to Claim 13”.
“has at least one characteristics selected from the group” should be read as “has at least characteristic selected from the group”
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.
Claims 15-17 and 22-26 are rejected under 35 U.S.C. 112(b) 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 15 recites that the edible chew has at least one of the characteristics selected from the group consisting of options (I)-(IV), wherein option (I) recites a texture adapted from at least one effect of (i) not adhering to the gums of the human child or (ii) dissolving in the mouth of the child without breaking to pieces. However, claim 1, which is incorporated into claim 15, recites that the edible chew has a texture adapted for at least one effect selected from the group consisting of (i) massaging the gums of the child, (ii) alleviating teething pain, (iii) not adhering to the gums, (iv) dissolving in the mouth without breaking to pieces, and (v) helping practice chewing. Since claims 1 and 15 each recite their own list of characteristics wherein some characteristics from each list are shared between them, it is unclear as to what characteristics are actually required (e.g., does an edible chew having the diameter, length, and weight recited in option (II) of claim 15, but does not accomplish one of (i)-(v) recited in claim 1 meet the requirements of claim 15?). Therefore, the claim is indefinite.
For the purpose of this examination, claim 15 will be interpreted as meaning that edible chew is required to have at least one of the characteristics of claim 15, but is not required to have the characteristics of claim 1.
Claims 16-17 and 22-26 are rejected by reason of dependency from claim 15.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15/1-15/8, 15/10-15/11, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over van Lengerich (US 6,723,358 B1), hereinafter referred to as “Van”, in view of Cleverly (US 2015/0190417; previously cited).
Regarding claim 15/1, Van teaches a method of delivering an active ingredient (corresponding to a biologically active component, pharmaceutical component, nutraceutical component, and/or microorganism) to a human child, wherein the human child is an infant or a toddler (abstract; column 18, lines 21-32) as recited in present claim 15/1. Van teaches that the method comprises administering an edible chew (corresponding to an edible matrix composition that has a chewable texture) to the human child, wherein the edible chew may have a moisture content of less than about 30 wt.% (abstract; column 16, line 64-column 17, line 10). This disclosed moisture content range encompasses the claimed moisture content range recited in present claim 15. Van teaches that the teaches that the edible chew comprises a cereal flour matrix (corresponding to a free-flowing mixture containing flour from grain sources) and a plasticizer (column 3, lines 23-27). Van teaches that the cereal flour matrix may comprise about 45 wt.% to about 75 wt.% flour (column 4, lines 22-26); and that the edible chew may comprise from about 60 wt.% to about 95 wt.% of the cereal flour matrix (column 5, lines 17-23), thereby providing amounts of cereal flour matrix in the edible chew that overlap the claimed concentration recited in present claim 15/1.
Wherein Van discloses amounts which encompass or overlap the claimed ranges, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Van teaches that the cereal flour matrix has a degree of starch gelatinization of less than about 50% (column 5, lines 10-13). Wherein the degree of starch gelatinization is greater than 0%, the cereal flour matrix qualifies as a pre-gelatinized flour matrix as recited in present claim 15/1. Van also teaches that the edible chew does not have substantial development of an expanded structure after extrusion or cooking (column 16, lines 24-25). Since the phrase “substantial development” means that the cereal flour matrix may undergo even the smallest amount of expansion, wherein the edible chew undergoes any amount of expansion, the cereal flour matrix qualifies as being an expanded cereal flour matrix as recited in present claim 15/1. Since Van discloses that the product is an edible chew for oral consumption (column 18, lines 21-32), Van at least suggests that the edible chew has a texture adapted for helping the human child practice chewing as present claimed since “edible chew” implies that the act of chewing is involved in the oral consumption of the edible chew.
Van teaches that the penetration of water into the matrix of the edible chew may be prevented or delayed by the inclusion of vegetable oil, hydrophobic ingredients, and proteins (column 7, lines 11-13; column 8, lines 8-13, 33-36). Van does not disclose that the edible chew is sized for a human child to hold and to place in their mouth; that the edible chew takes more than five minutes to dissolve; or that the edible chew has an outer diameter as recited in (II) of present claim 15/1.
However, Cleverly teaches a method of delivering an active ingredient [0547], [0550] to a human [0548], the method comprising administering an edible chew (corresponding to chewable formulation) to the human [0548], [0550]. Cleverly teaches that the edible chew comprises a cereal flour matrix (corresponding to oat flour, pea flour, pearled barley flour, rice flour, wheat flour, rye grain flour, and cereal flour) [0453]-[0454] and a plasticizer [0062], [0067]; and that the edible chew takes an average of more than 30 minutes to dissolve (corresponding to an average of 56.6 wt.% of the active ingredient in the chew being released in thirty minutes) (page 22, Table 5). Therefore, the dissolution time of the edible chew falls within the time range recited in present claim 15/1. Since Cleverly teaches that the chew has an outer diameter of 15 mm [0632], which falls within the size range required in present claim 15/4 and (II) of present claim 15/1, Cleverly teaches that the chew is sized for a human child to hold the chew and place the chew in their mouth. Cleverly does not disclose that the chew also has a length and weight which falls within the ranges recited in (II) of present claim 15/1. However, changes in size/proportion is obvious, especially wherein infants are known to be able to hold and chew on items of various shape and size (e.g., blanket, corn cob). MPEP §2144.04.IV.A.
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the edible chew in the method of Van to be sized for a human child to hold and place in their mouth as taught by Cleverly. Since Van discloses that its edible chew is for infants and toddlers (column 18, lines 21-32), but does not disclose a size of a chew that is suitable for infants and toddlers, a skilled practitioner would have been motivated to consult an additional reference such as Cleverly in order to determine a suitable size for the edible chew, thereby rendering the limitation that the edible chew is sized for a human child to hold and to place in their mouth obvious. Furthermore, changes in size/proportion is obvious, thereby rendering (II) of present claim 15/1 obvious.
In reference to the edible chew taking more than five minutes to dissolve, as the dissolution time is a variable that can be modified, among others, by adjusting the content of vegetable oil, hydrophobic ingredients, and proteins (column 7, lines 11-13; column 8, lines 8-13, 33-36), the dissolution time would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed dissolution time cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the dissolution time in the edible chew of Van to obtain the desired release rate of the active ingredient by using the more than 30 minute dissolution time disclosed by Cleverly as a guide (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here 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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 15/2, Van teaches the invention as described above in claim 15/1, including the edible chew contains at least one flavor selected from the group consisting of a cereal (corresponding to grain sources), a fruit (corresponding to fruit juice), a vegetable (corresponding to potatoes or other roots), and a spice (corresponding to salt) (column 2, lines 47-53; column 3, lines 42-46; column 4, lines 29-40).
Regarding claim 15/3, modified Van teaches the invention as described above in claim 15/1, including the edible chew has a water activity of less than 0.6 (Cleverly [0061]), which falls within the claimed range.
Regarding claim 15/4, modified Van teaches the invention as described above in claim 15/1, including the edible chew has an outer diameter of 15 mm (Cleverly [0632]) which falls within the size range.
Regarding claims 15/5-15/6, Van teaches the invention as described above in claim 15/1, including the edible chew comprises at least one active ingredient selected from the group consisting of a vitamin, a mineral, a prebiotic, a probiotic, a nutraceutical, a pharmaceutical compound, a protein (corresponding to enzymes), an amino acid, a sugar alcohol other than glycol (corresponding to sorbitol), and mixtures thereof (column 5, lines 37-44; column 9, lines 1-24).
Regarding claim 15/7, Van teaches the invention as disclosed above in claim 15/1, but does not disclose that the edible chew is formulated to be at ambient temperature. However, the claim does not actually require the edible chew to be at ambient temperature and the edible chew of the prior art containing an expanded pre-gelatinized cereal flour matrix and a plasticizer (column 3, lines 23-27) does not have any ingredients that would prevent it from being at ambient temperature.
Regarding claim 15/8, Van teaches the invention as disclosed above in claim 15/1, but does not disclose that the edible chew is formulated to be chilled or frozen. However, the claim does not actually require the edible chew to be chilled or frozen and the edible chew of the prior art containing an expanded pre-gelatinized cereal flour matrix and a plasticizer (column 3, lines 23-27) does not have any ingredients that would prevent it from being chilled or frozen.
Regarding claim 15/10, Van teaches the invention as disclosed above in claim 15/1, including the edible chew is gluten-free (corresponding to formulations made without wheat) and nut-free (corresponding to formulations made with grain and a plasticizer) (column 3, lines 23-27, 42-46).
Regarding claim 15/11, Van teaches the invention as disclosed above in claim 15/1, including that the cereal flour matrix may comprise about 45 wt.% to about 75 wt.% flour (column 4, lines 22-26); and that the edible chew may comprise from about 60 wt.% to about 95 wt.% of the cereal flour matrix (column 5, lines 17-23) Since any food ingredient has the potential to be an allergen to a human and there is no definitive amount of allergen that has been determined to be effective for early tolerance introduction, the amount of cereal flour taught by Van falls within the claimed range.
Regarding claim 23, modified Van teaches the invention as disclosed above in claims 15/1-15/8 and 15/10-15/11, including that the chew has an outer diameter of 15 mm (Cleverly [0632]), which falls within the size range required in present claim 23. Cleverly does not disclose that the chew also has a length and weight which falls within the ranges recited in present claim 23. However, changes in size/proportion is obvious, especially wherein infants are known to be able to hold and chew on items of various shape and size (e.g., blanket, corn cob). MPEP §2144.04.IV.A.
Regarding claim 25, Van teaches the invention as disclosed above in claims 15/1-15/8 and 15/10-15/11, including the edible chew may comprise a plasticizer in the form of a fruit juice (column 5, lines 42-45; column 6, lines 37-42); and that the edible chew may comprise a concentrated fruit juice (column 8, lines 39-46). As such, it would have been obvious for a skilled practitioner to have used fruit juice concentrate as the plasticizer since Van merely requires the plasticizer to be any edible liquid which enables the formation of a substantially homogenous dough (column 5, lines 38-41). Since Cleverly discloses that the chew may have an apple flavor [0390], it would have been obvious for the skilled practitioner to have used apple juice concentrate, thereby rendering present claim 25 obvious.
Claims 15/9, 15/12-15/13, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) as applied to claim 15/1 above, and further in view of Mahe (US 2016/0143320; previously cited).
Regarding claim 15/9, modified Van teaches the invention as disclosed above in claim 15/1, including the edible chew may comprise a coloring agent (Cleverly [0144]). However, the combination of Van and Cleverly does not disclose that the edible chew has a bright color and/or a plurality of colors.
However, Mahe teaches an edible chew formulated for oral consumption [0002], [0056] comprising an expanded pre-gelatinized cereal flour matrix [0007] and a plasticizer (corresponding to component capable of forming hydrogen bonds in pre-gelatinized cereal flour [0065]), wherein the edible chew takes at least one minute of chewing before the product can be ingested [0056]. Mahe teaches that the edible chew has a bright color (corresponding to the edible chew containing blue no. 1, blue no. 2, green no. 3, red no. 3, red no. 40, yellow no. 5, yellow no. 6, annatto, chlorophyllin, cochineal, betanin, turmeric, saffron, and paprika as a colorant) [0063].
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the edible chew of modified Van to have a bright color as taught by Mahe. Since modified Van discloses that the edible chew may comprise a coloring agent (Cleverly [0144]), but does not specify a coloring agent, a skilled practitioner would have been motivated to consult an additional reference such as Mahe in order to determine a suitable coloring agent for an edible chew, thereby rendering the claim obvious.
Regarding claims 15/12 and 15/13, Van teaches the invention as disclosed above in claim 15/1, including the edible chew may be shaped into discrete shapes (column 15, lines 8-11). The combination of Van and Cleverly does not disclose that the edible chew has a hollow center or that the chew comprises at least one filling within the hollow center as recited by present claims 15/12 and 15/13.
However, Mahe teaches an edible chew formulated for oral consumption [0002], [0056] comprising an expanded pre-gelatinized cereal flour matrix [0007] and a plasticizer (corresponding to component capable of forming hydrogen bonds in pre-gelatinized cereal flour [0065]), wherein the edible chew takes at least one minute of chewing before the product can be ingested [0056]. Mahe teaches that the edible chew has a hollow center (Fig. 7A). Since the mere presence of a hollow cavity in the center of the edible chew reduces a risk of choking on the edible chew as determined by the disclosure in [0013] of the present specification, the hollow center disclosed by Mahe reduces a risk of choking on the edible chew during oral consumption as presently claimed. Mahe also teaches that the edible chew comprising at least one filling within a hollow center [0079] as presently claimed
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the edible chew of modified Van to have a hollow center or to have at least one filling in a hollow center as taught by Mahe. Since Van discloses that the edible chew may be shaped into discrete shapes (column 15, lines 8-11), but does not specify a formed shape, a skilled practitioner would have been motivated to consult an additional reference such as Mahe in order to determine a suitable formed shape for an edible chew, thereby rendering the claims obvious.
Regarding claim 23, modified Van teaches the invention as disclosed above in claims 15/9 and 15/12-15/13, including that the chew has an outer diameter of 15 mm (Cleverly [0632]), which falls within the size range required in present claim 23. Cleverly does not disclose that the chew also has a length and weight which falls within the ranges recited in present claim 23. However, changes in size/proportion is obvious, especially wherein infants are known to be able to hold and chew on items of various shape and size (e.g., blanket, corn cob). MPEP §2144.04.IV.A.
Regarding claim 25, Van teaches the invention as disclosed above in claims 15/9 and 15/12-15/13, including the edible chew may comprise a plasticizer in the form of a fruit juice (column 5, lines 42-45; column 6, lines 37-42); and that the edible chew may comprise a concentrated fruit juice (column 8, lines 39-46). As such, it would have been obvious for a skilled practitioner to have used fruit juice concentrate as the plasticizer since Van merely requires the plasticizer to be any edible liquid which enables the formation of a substantially homogenous dough (column 5, lines 38-41). Since Cleverly discloses that the chew may have an apple flavor [0390], it would have been obvious for the skilled practitioner to have used apple juice concentrate, thereby rendering present claim 25 obvious.
Claims 16-17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) as applied to claims 15/1-15/8 and 15/10-15/11 above, and further in view of Kovaleski (US 10,212,919; previously cited) and Newton (Newton, A., “The 5 Best Natural Teething Remedies”, 2015, Healthline, https://www.healthline.com/health/parenting/natural-teething-remedies; previously cited).
Regarding claims 16, 17, and 26, Van teaches the invention as described above in claims 15/1-15/8 and 15/10-15/11, including that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32). The combination of prior art does not disclose that the edible chew is administered to the infant or toddler while having a temperature at or less than ambient temperature or that the edible chew is administered while frozen as recited in present claims 16 and 17. The combination of prior art also does not teach that the edible chew has a texture adapted for at least one of effects (i) or (ii) as recited in present claim 26.
However, Kovaleski discloses that chew products for animals, infants, and babies are known in the art (column 1, lines 22-25) for the purpose of relieving teething pain (column 1, lines 36-41).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of modified Van to include administering the edible chew to an infant or toddler to provide teething support to the infant or toddler who is teething as taught by Kovaleski. Since Van discloses that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32) and since it is known in the art that chew products relieve teething pain (Kovaleski, column 1, lines 36-41), the method of modified Van also renders the claimed purpose of providing teething support to a human child who is teething as recited in present claim 15 obvious.
The combination of Van, Cleverly, and Kovaleski does not disclose that the edible chew is administered to the infant or toddler while having a temperature at or less than ambient temperature or that the edible chew is administered while frozen as recited in present claims 16 and 17. The combination of prior art also does not teach that the edible chew has a texture adapted for at least one of effects (i) or (ii) as recited in present claim 26.
However, Newton teaches that cold is a very popular remedy for teething pain. Newton discloses freezing items such as a chew (corresponding to teether) for the infant or baby (page 2, paragraphs 1 and 3). Newton also discloses a caution against providing teething materials which might become a choking hazard to the teething infant, including beaded necklaces that fall apart (page 3, paragraph 2).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of modified Van to include freezing the chew as taught by Newton. Since modified Van discloses that the chew is for infants, babies, and toddlers (Kovaleski, column 1, lines 22-25; column 8, lines 4-7) who have teething pain (Kovaleski, column 1, lines 38-40) and using cold to relieve teething pain is known in the art (Newtons, page 2, paragraph 1), a skilled practitioner would readily recognize that freezing the edible chew of modified Van and administering the frozen edible chew would help to further relieve teething pain. Therefore, the claimed administration of the chew while having a temperature less than ambient temperature and the claimed administration of the chew while frozen as recited in present claims 16 and 17 are rendered obvious.
Furthermore, since Cleverly discloses that the edible chew dissolves (page 22, Table 5) and since Newton discloses a caution against providing teething materials which might become a choking hazard to the teething infant, including beaded necklaces that fall apart (page 3, paragraph 2), it would have been obvious for the edible chew of the cited prior art to dissolve in the mouth of the child without breaking into pieces so as to prevent choking. Therefore, effect (ii) of claim 26 is rendered obvious.
Claims 16-17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) and Mahe (US 2016/0143320; previously cited) as applied to claims 15/9 and 15/12-15/13 above, and further in view of Kovaleski (US 10,212,919; previously cited) and Newton (Newton, A., “The 5 Best Natural Teething Remedies”, 2015, Healthline, https://www.healthline.com/health/parenting/natural-teething-remedies; previously cited).
Regarding claims 16, 17, and 26, Van teaches the invention as described above in claims 15/9 and 15/12-15/13, including that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32). The combination of prior art does not disclose that the edible chew is administered to the infant or toddler while having a temperature at or less than ambient temperature or that the edible chew is administered while frozen as recited in present claims 16 and 17. The combination of prior art also does not teach that the edible chew has a texture adapted for at least one of effects (i) or (ii) as recited in present claim 26.
However, Kovaleski discloses that chew products for animals, infants, and babies are known in the art (column 1, lines 22-25) for the purpose of relieving teething pain (column 1, lines 36-41).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of modified Van to include administering the edible chew to an infant or toddler to provide teething support to the infant or toddler who is teething as taught by Kovaleski. Since Van discloses that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32) and since it is known in the art that chew products relieve teething pain (Kovaleski, column 1, lines 36-41), the method of modified Van also renders the claimed purpose of providing teething support to a human child who is teething as recited in present claim 15 obvious.
The combination of Van, Cleverly, and Kovaleski does not disclose that the edible chew is administered to the infant or toddler while having a temperature at or less than ambient temperature or that the edible chew is administered while frozen as recited in present claims 16 and 17. The combination of prior art also does not teach that the edible chew has a texture adapted for at least one of effects (i) or (ii) as recited in present claim 26.
However, Newton teaches that cold is a very popular remedy for teething pain. Newton discloses freezing items such as a chew (corresponding to teether) for the infant or baby (page 2, paragraphs 1 and 3). Newton also discloses a caution against providing teething materials which might become a choking hazard to the teething infant, including beaded necklaces that fall apart (page 3, paragraph 2).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of modified Van to include freezing the chew as taught by Newton. Since modified Van discloses that the chew is for infants, babies, and toddlers (Kovaleski, column 1, lines 22-25; column 8, lines 4-7) who have teething pain (Kovaleski, column 1, lines 38-40) and using cold to relieve teething pain is known in the art (Newtons, page 2, paragraph 1), a skilled practitioner would readily recognize that freezing the edible chew of modified Van and administering the frozen edible chew would help to further relieve teething pain. Therefore, the claimed administration of the chew while having a temperature less than ambient temperature and the claimed administration of the chew while frozen as recited in present claims 16 and 17 are rendered obvious.
Furthermore, since Cleverly discloses that the edible chew dissolves (page 22, Table 5) and since Newton discloses a caution against providing teething materials which might become a choking hazard to the teething infant, including beaded necklaces that fall apart (page 3, paragraph 2), it would have been obvious for the edible chew of the cited prior art to dissolve in the mouth of the child without breaking into pieces so as to prevent choking. Therefore, effect (ii) of claim 26 is rendered obvious.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) as applied to claims 15/1-15/8 and 15/10-15/11 above, and further in view of Kovaleski (US 10,212,919; previously cited).
Regarding claim 22, modified Van teaches the invention as described above in claims 15/1-15/8 and 15/10-15/11, including that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32). The combination of prior art does not disclose that the edible chew is administered to the infant or toddler who has teething pain.
However, Kovaleski discloses that chew products for animals, infants, and babies are known in the art (column 1, lines 22-25) for the purpose of relieving teething pain (column 1, lines 36-41).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of modified Van to include administering the edible chew to an infant or toddler to provide teething support to the infant or toddler who has teething pain as taught by Kovaleski. Since Van discloses that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32) and since it is known in the art that chew products relieve teething pain (Kovaleski, column 1, lines 36-41), the method of modified Van also renders the claimed purpose of providing teething support to a human child who has teething pain obvious.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) and Mahe (US 2016/0143320; previously cited) as applied to claims 15/9 and 15/12-15/13 above, and further in view of Kovaleski (US 10,212,919; previously cited).
Regarding claim 22, modified Van teaches the invention as described above in claims 15/9 and 15/12-15/13, including that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32). The combination of prior art does not disclose that the edible chew is administered to the infant or toddler who has teething pain.
However, Kovaleski discloses that chew products for animals, infants, and babies are known in the art (column 1, lines 22-25) for the purpose of relieving teething pain (column 1, lines 36-41).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of modified Van to include administering the edible chew to an infant or toddler to provide teething support to the infant or toddler who has teething pain as taught by Kovaleski. Since Van discloses that the edible chew may be for infants and toddlers (abstract; column 18, lines 21-32) and since it is known in the art that chew products relieve teething pain (Kovaleski, column 1, lines 36-41), the method of modified Van also renders the claimed purpose of providing teething support to a human child who has teething pain obvious.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) as applied to claims 15/1-15/8 and 15/10-15/11 above, as evidenced by Hendel (Hendel, R.S.B., “What is Vegetable Oil?”, 2023, OK, https://www.ok.org/consumers/a-closer-look-ingredients/what-is-vegetable-oil/).
Regarding claim 24, Van teaches the invention as described above in claims 15/1-15/8 and 15/10-15/11, including the edible chew may further comprise vegetable oil to aid in forming a smooth continuous dough during mixing (column 8, lines 47-52). Vegetable oil is a generic name for an oil that comprises oil from various fruits, seeds, grains, and nuts, including sunflower oil as evidenced by Hendel (page 1, paragraph – page 2, 1st paragraph). Therefore, it would have been obvious for the vegetable oil of Van to have contained sunflower oil so that the edible chew would further comprise sunflower oil, thereby rendering present claim 24 obvious.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Van (US 6,723,358 B1) in view of Cleverly (US 2015/0190417; previously cited) and Mahe (US 2016/0143320; previously cited) as applied to claims 15/9 and 15/12-15/13 above, as evidenced by Hendel (Hendel, R.S.B., “What is Vegetable Oil?”, 2023, OK, https://www.ok.org/consumers/a-closer-look-ingredients/what-is-vegetable-oil/).
Regarding claim 24, Van teaches the invention as described above in claims 15/9 and 15/12-15/13, including the edible chew may further comprise vegetable oil to aid in forming a smooth continuous dough during mixing (column 8, lines 47-52). Vegetable oil is a generic name for an oil that comprises oil from various fruits, seeds, grains, and nuts, including sunflower oil as evidenced by Hendel (page 1, paragraph – page 2, 1st paragraph). Therefore, it would have been obvious for the vegetable oil of Van to have contained sunflower oil so that the edible chew would further comprise sunflower oil, thereby rendering present claim 24 obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 15/1-15/8 and 15/10-15/11 over Van and Cleverly; claims 15/9 and 15/12-15/13 over Van, Cleverly, and Mahe; claim 15/14 over Van, Cleverly, and Barnvos; claims 16 and 17 (in view of claims 15/1-15/8 and 15/10-15/11) over Van, Cleverly, Kovaleski, and Newton; claims 16 and 17 (in view of claims 15/9 and 15/12-15/13) over Van, Cleverly, Mahe, Kovaleski, and Newton; claims 16 and 17 (in view of claim 15/14) over Van, Cleverly, Barnvos, Kovaleski, and Newton; claim 22 (in view of claims 15/1-15/8 and 15/10-15/11) over Van, Cleverly, and Kovaleski; claim 22 (in view of claims 15/9 and 15/12-15/13) over Van, Cleverly, Mahe, and Kovaleski; claims 16 and 17 (in view of claim 15/14) over Van, Cleverly, Barnvos, and Kovaleski: Applicant amendments and arguments have been fully considered and are considered unpersuasive.
Applicant canceled claim 14, thereby mooting its rejections. Applicant amended claim 15 to recite that the edible chew had at least one of the characteristics selected from the group consisting of (I)-(IV). Applicant argued that none of the cited prior art references disclose that the edible chew has at least one of characteristics (I)-(IV) (Applicant’s Remarks, page 6, 6th paragraph – page 9, 3rd paragraph).
However, as described above in the rejection of amended claim 15/1, Cleverly teaches that the chew has an outer diameter of 15 mm [0632], which falls within the size range required in characteristic (II) of present claim 15/1. Cleverly does not disclose that the chew also has a length and a weight which fall within the ranges recited in (II) of present claim 15/1. However, changes in size/proportion is obvious, especially wherein infants are known to be able to hold and chew on items of various shape, size, and weight (e.g., blanket, corn cob). MPEP §2144.04.IV.A.
Applicant added new claims 23-26 which each recite one of the characteristics (I)-(IV). Applicant argued that the cited prior art does not disclose these features (Applicant’s Remarks, page 9, 5th paragraph).
However, new claims 23-26 stand rejected as written in the prior art rejections above.
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of the claims stand as written herein. The rejection of claim 15/14 and rejections dependent therefrom are moot due to the cancellation of claim 14.
Conclusion
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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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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