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
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-5 and 11-16 in the reply filed on 18 July 2025 is acknowledged. Claims 6-10, and 17-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 5 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.
Also, Claim 5 contains the trademark/trade name MonoSol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an edible film and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ronnback et al. (WO 2020/074734 A1- see machine translations).
Regarding Claim 1, Ronnback discloses an edible pharmaceutical receptacle (edible substrate portion 12, see abstract) comprising:
a plurality of pharmaceuticals including 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 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).
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).
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) 11-13, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ronnback et al. (WO 2020/074734 A1- see machine translations).
Regarding Claim 11, Ronnback discloses an edible pharmaceutical receptacle (see abstract) comprising:
a plurality of pharmaceuticals including a first pharmaceutical and second pharmaceutical (composition 14 and 16);
an edible pharmaceutical carrier (substrate 12), the edible pharmaceutical carrier including 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).
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 card comprises gelatin (Pg. 6, fourth paragraph).
Claim(s) 14 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 Durschlag et al. (WO 2006/119286 A1).
Regarding Claim 14, Ronnback is silent to wherein the first pharmaceutical and the second pharmaceutical are each in a powder form. Durschlag is relied on to teach an edible film containing comprising a pharmaceutical composition that rapidly dissolves in an oral cavity (see abstract) wherein the film is coated with a powder matrix comprising the pharmaceutical composition (see abstract) which allows inclusion of a variety of different auxiliary compositions (paragraph 41). Since both Ronnback and Durschlag are directed to spraying a pharmaceutical composition on to an edible film substrate, it would have been obvious to one of ordinary skill in the art to use a powder matrix for the purpose of adding additional auxiliary compositions along with the pharmaceutical composition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANH H NGUYEN whose telephone number is (571)270-0346. The examiner can normally be reached 10am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.H.N/Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
Prosecution Insights