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 .
DETAILED ACTION
Response to Amendment
As a result of the amendments to the claim, the 112(b) rejection over Claim 5 with respect to the trademark/tradename MonoSol has been withdrawn. However, the rejection over Claim 5 with respect to the term “makiid” does not appear to addressed and therefore is maintained.
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.
Claims 5 and 11-16, 22-26 and 28 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.
Regarding Claim 5, the term “makiid” renders the claim indefinite because it is not clear what a “makiid” is, and the specification do not define the term.
Regarding Claim 11, the claim recites that both the first and the second compartment conforms to the first pharmaceutical solid which renders the claim indefinite because there is no recitation that the first pharmaceutical solid is disposed in the second pharmaceutical compartment. It appears applicant may have intended to recite the second compartment conforming to the second pharmaceutical solid, which will be construed accordingly for purpose of applying prior art.
Claims 12-16, 22-26 and 28 are rejected based on its dependency on a rejected claim.
Regarding Claim 26, the term “a different number of first compartments” renders the claim indefinite because “first compartment” appears to refer to a single compartment hence the term “first”. Therefore, it is not clear how a carrier can have multiple “first compartments”.
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.
Claim(s) 1-5, 11-13, 15-16, 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ronnback et al. (WO 2020/074734 A1- see machine translations) in view of Souter et al. (US 10,907,117).
Regarding Claim 1, Ronnback discloses an edible pharmaceutical receptacle (edible substrate portion 12, see abstract) comprising:
a plurality of pharmaceuticals including solids (solid formulation, 10, 40, 60, see abstract) of a first pharmaceutical (first composition 14, Pg. 7, first paragraph of the translations) and second pharmaceutical (second composition 16, Pg. 7, sixth paragraph of the translations), the second pharmaceutical being different than the first pharmaceutical;
an edible pharmaceutical card including a base (substrate 12, page 6 third paragraph) and a cover (packaging material 162, page 12, last paragraph) forming a plurality of edible dosing sections joined together (Fig. 1), the plurality of edible dosing sections including a first edible dosing section (Zone 46, Fig. 1) directly joined to a second edible dosing section (Zone 48, Fig. 1), the first and second edible dosing sections arranged to be manually broken apart to separate the first and second edible dosing sections from one another (allowing later to easily separate such a portion, page 4, last paragraph), the first edible dosing section containing the first pharmaceutical of the plurality of pharmaceuticals and the second edible dosing section containing the second pharmaceutical of the plurality of pharmaceuticals (Pg. 6, last paragraph to Pg. 7, fifth paragraph).
Ronnback is silent to wherein the base being formed with a first recess in at least one of the plurality of dosing sections and a second recess in at least one of the plurality of dosing sections, the first recess receives the solid of the first pharmaceutical, the second recess receives the solid of the second pharmaceutical, and the cover being formed over the base and the solids in the first recess and the second recess to secure the solids in the respective first recess and second recess. However, the difference is merely a difference in shape in that the first and second pharmaceuticals are comprised within the recesses; however, the particular configuration does not appear to be significant over the prior art as Ronnback is also directed to an edible pharmaceutical receptacle comprising separate dosing sections of first and second pharmaceuticals and that the configuration of the shape do not provide any unexpected results.
In any case, Souter is relied on to teach an edible receptacle comprising a base and a cover (see Fig. 2) comprising food material (food and nutritive composition, col. 14, lines 38-40) within a recess (Fig. 2). It is also noted that Souter is directed to multiple compartments to house multiple ingredients (see Fig. 3). Therefore, since Souter is also directed to an edible receptacle comprising food material, it would have been obvious to one of ordinary skill in the art comprise the pharmaceuticals within recesses based on design choices.
Regarding Claim 2, Ronnback further teaches wherein the first edible dosing section defines a first dosing compartment, the first pharmaceutical disposed in the first dosing compartment, and wherein the second edible dosing section defines a second dosing compartment, the second pharmaceutical disposed in the second dosing compartment (See 14 and 16 of Fig. 1 and Pg. 6, last paragraph to Pg. 7, fifth paragraph).
Regarding Claim 3, Ronnback further teaches wherein the first pharmaceutical is embedded in the first edible dosing section, and wherein the second pharmaceutical is embedded in the section edible dosing section (See 14 and 16 of Fig. 1 and Pg. 6, last paragraph to Pg. 7, fifth paragraph).
Regarding Claim 4, Ronnback further teaches wherein the edible pharmaceutical card is constructed of one or more edible materials (The substrate 12 is an edible substrate, Pg. 6, third paragraph).
Regarding Claim 5, Ronnback further teaches wherein the edible pharmaceutical card comprises gelatin (Pg. 6, fourth paragraph).
Regarding Claim 11, Ronnback discloses an edible pharmaceutical receptacle (see abstract) comprising:
a plurality of pharmaceuticals including a first pharmaceutical and second pharmaceutical solid (composition 14 and 16);
an edible pharmaceutical carrier (substrate 12), the edible pharmaceutical carrier including a base (substrate 12, page 6 third paragraph) and a cover (packaging material 162, page 12, last paragraph) forming an enclosed first compartment (zone 46, Fig. 1), an enclosed second compartment (zone 48, Fig. 1), and a partition separating the first and second compartments (space 30, Fig. 1), the first pharmaceutical disposed in the first compartment and the second pharmaceutical disposed in the second compartment (See 14 and 16 of Fig. 1 and Pg. 6, last paragraph to Pg. 7, fifth paragraph), the first compartment conforming to the pharmaceutical solid, the second compartment conforming to the second pharmaceutical solid. That is, since Ronnback discloses a substrate applied with pharmaceutical solids, it is construed that the compartment is “conformed” to the pharmaceutical solids. Note that the claim is directed to a product claim and cannot be limited by process steps such as a step of “conforming”.
While Ronnback is also directed to an edible pharmaceutical product, he does not specifically recite wherein the edible pharmaceutical carrier has a bite-sized size and shape such that the edible pharmaceutical carrier can be eaten by a patient in one mouthful. However, since the edible pharmaceutical product of Ronnback is custom made by adapting the dosage to each patient (page 14, 8th paragraph), the particular size of the edible pharmaceutical receptacle would have been obvious to one of ordinary skill in the art based on the desired dosage. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In this case, since Ronnback is also directed to a method of delivery a plurality of pharmaceutical compositions using an edible pharmaceutical carrier, the recited size is not patentably distinct from the prior art and would have been an obvious matter of design choice.
Regarding Claim 12, Ronnback further teaches wherein the first and second compartments are arranged side-by-side (see 46 and 48 of Fig. 1).
Regarding Claim 13, Ronnback further teaches wherein the first and second compartment are arranged on top of one another (see 66 and 68 of Fig. 1).
Regarding Claim 15, Ronnback further teaches wherein the edible pharmaceutical carrier is constructed of one or more edible materials (The substrate 12 is an edible substrate, Pg. 6, third paragraph).
Regarding Claim 16, Ronnback further teaches wherein the edible pharmaceutical carrier comprises gelatin (Pg. 6, fourth paragraph).
Regarding Claim 22, Ronnback further teaches wherein the first compartment holds a different dose of pharmaceutical than the second compartment and differ in size (page 14, sixth paragraph and Fig. 1).
Regarding Claims 23 and 24, Ronnback does not specifically recite wherein the cover includes indicia for when the different doses are to be taken; however, providing indicia would have been an obvious matter of design for the purpose of providing instruction to the consumer. Providing an indicia is not seen to provide unexpected results since one would reasonably expect instructions included with their pharmaceutical products. In any case, Souter further teaches a film comprising a printed area where colors are additively printed in the cover (Col. 9, lines 28-64). Therefore, it would have been obvious to one of ordinary skill in the art to provide a printed area on the cover to produce an indicia for commercial purposes.
Regarding Claim 25, Ronnback further teaches wherein the partition seals the first pharmaceutical solid from the second pharmaceutical solid (form a closed compartment around each solid formulations, page 13, third paragraph).
Regarding Claim 26, Ronnback further teaches a plurality of pharmaceutical carriers with at least one pharmaceutical carrier containing a different dose than another pharmaceutical carrier and having a different number of first compartments than the another pharmaceutical carrier (see first, second, and third embodiment of Fig. 1).
Regarding Claim 27, Ronnback further teaches wherein the cover is additively formed (3D printing, page 8, fourth paragraph) onto the base and over the solids in the first recess and the second recess (form a closed compartment around each solid formulations, page 13, third paragraph).
Regarding Claim 28, Ronnback further teaches wherein the base is additively formed (3D printing, page 8, fourth paragraph).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 11, further in view of Waroengvitamin (VICKS DayQuil/NyQuil Severe Cold & Flu Relief (72 LiquiCaps), Facebook.com).
Regarding Claim 14, the combination is silent to wherein the first pharmaceutical solid and the second pharmaceutical solid are each in a powder form in a gelcap with the first recess conforming to the gelcap of the first pharmaceutical solid and the second recess conforming to the gelcap of the second pharmaceutical solid. Waroengvitamin is relied on to teach conventional blister packs comprising a base and a cover, where gel capsules are comprised within the recesses of the base to store pharmaceutical solids. This is a well known method of packaging medicines in predetermined portion. Note that Waroengvitamin discloses a pharmaceutical carrier that contains first and second pharmaceutical solid. Therefore, since both Ronnback and Waroengvitamin are directed to receptacles for holding pharmaceutical solids in a portions that are separable and contains more than one type of pharmaceutical, it would have been obvious to one of ordinary skill in the art to provide gel capsule in the packaging of Ronnback as a substitution of equivalents known for the same purpose (i.e. deliver pharmaceuticals). See MPEP 2144.06.
Response to Arguments
Applicant’s arguments in the response filed 2 January 2026 has been considered, but is rendered moot in view of the new grounds of rejections necessitated by amendment.
That is, all arguments directed to the rejections under 35 U.S.C. 102(a)(1) are moot due to withdrawal of the rejections.
In response to Applicant’s argument that Ronnback teaches away from the presently claimed invention as it is directed to spraying liquids on a substrate (page 7 of the remarks), the argument is not persuasive because the final product of Ronnback still present a solid form of pharmaceutical because the spray liquid undergoes drying (see page 10, third paragraph). Furthermore, the claims are directed to a product claim and therefore does not exclude spraying the liquid pharmaceutical so long as the final product is a solid pharmaceutical product as required by the claim.
In response to Applicant’s argument regarding Office Notice taken by the Office Action, the Examiner did not make a rejection based on Official notice. Rather, the obviousness as a matter of desired dosage is suggested by Ronnback’s teaching of “custom-made medicine” and “adapting the dosage to each patient” (page 14, eight paragraph). This suggestion would necessarily include increasing or decreasing the dosage, and thus affect the size of the pharmaceutical product. Applicant also argues that Ronnback teaches away from the claimed limitation due providing three similar sized pharmaceutical cards in Fig. 1. However, there are no evidence in the reference to suggest that this is a limiting factor of the invention taught by Ronnback. Again it is reiterated that in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. For these reason, the rejection is maintained.
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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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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